UNEP

ROMANIA
Ministry of Environment and Water Management

NATIONAL BIOSAFETY FRAMEWORK

FOR ROMANIA

BUCHAREST, January 2006

UNEP
ROMANIA
Ministry of Environment and Water Management

BUCHAREST, January 2006

This publication is addressing to authorities, non-governmental organizations and civil society
from Romania and it was elaborated within the UNEP/GEF Project “Development of the National
Biosafety Framework for Romania” GF/2716-02-4596 running within the Ministry of Environment
and Water Management, the Nature Conservation, Biodiversity and Biosafety Directorate

Editors and Authors

Maria-Mihaela Antofie, UNEP/GEF National Project Coordinator

Institute of Biology of Romanian Academy, 296 Splaiul Independentei St., 060031, District 6,
Bucharest, Romania

Adriana Baz, Director

Ministry of Environment and Water Management, the Nature Conservation, Biodiversity and
Biosafety Directorate
12 Libertăţii Bd., 040129, District 5, Bucharest, Romania

Reviewed by

Liina Eek, UNEP/GEF Biosafety Unit, International Environment House, Geneva, Switzerland
Michael Eckerstorfer, Environment Agency Ltd., Vienna, Austria
Helmut Gaugitsch, Environment Agency Ltd., Vienna, Austria
Andreas Heissenberger, Environment Agency Ltd., Vienna, Austria
Piet van der Meer Horizons Sprl, Belgium

Copyright
Ministry of Environment and Water Management, Institute of Biology of Romanian Academy,
UNEP/GEF

ISBN 973-87565-2-9

Photos
MEWM archive

Publishing House:
SC Eurografix SRL

Exemplars
100

Available to the address

Ministry of Environment and Water Management, the Nature Conservation, Biodiversity and
Biosafety Directorate, 12 Bd. Libertăţii, 040129, District 5, Bucharest, Romania
Institute of Biology of Romanian Academy, 296 Splaiul Independentei St., 060031, District 6,
Bucharest, Romania
Web page: www.biosafety.ro

BUCHAREST, January 2006

 Forward

Genetically modified organisms, which are created and experimented by using

modern biotechnology techniques, is a subject of great actuality at international
level. Using the instruments offered by the modern biotechnology may
constitute one of the main factors required for the socio- economic system
development, especially for developing countries, under condition of strictly
applying the precautionary principle and taking into account the possible
adverse effects on biological diversity and on human health.

As a country which ratified the Cartagena Protocol on Biosafety to the Convention on Biological Diversity,
Romania beneficed of technical and financial assistance offered by international organizations such as
United Nations Environment Programme and Global Environment Facility by joining the Project
“Development of the National Biosafety framework for Romania”. The main objectives of this project, ruled
under the aegis of the Ministry of Environment and Water Management, are the evaluation and development
of the National Biosafety Framework, respectively Romanian capacity building in implementing Cartagena
Protocol. During the Project development, Romania beneficed of the scientific and technical assistance of
some famous experts in the field from EU Member States such as: Austria, Belgium and Netherlands.
Regarding the Project results we can enumerate: regulatory framework evaluation regarding biosafety
according to Cartagena Protocol and EU regulations, authorization procedure management evaluation,
modern biotechnology research capacity evaluation as well as the evaluation of the level of education,
information and awareness for public participation in decision making process.

Also, it should be mentioned the sub-regional collaboration activity and Romania preparation to access the
international biosafety information system. Biosafety is a major goal of national interest as well as global
interest and it will be not possible without the Biosafety Clearing-House mechanism established by the
Cartagena Protocol.

We express our hope that the information of this publication will contribute for the further development of the
regulatory system as well as for the development at national level of Biosafety Policies and Strategies
according to EU accession demands.

We are expressing our gratitude to United Nations Environment Programme- the Biosafety Unit from
Geneva, to Global Environment Facility as well as to all National Coordinating Committee members and all
collaborators from our country or from abroad.

Sulfina BARBU

Ministry of Environment and Water Management

“Biosafety is one of the issues addressed by the Convention. This
concept refers to the need to protect human health and the
environment from the possible adverse effects of the products of
modern biotechnology. At the same time, modern biotechnology is
recognized as having a great potential for the promotion of human
well-being, particularly in meeting critical needs for food,
agriculture and health care. The Convention clearly recognizes these
twin aspects of modern biotechnology. On the one hand, it provides
for the access to and transfer of technologies, including
biotechnologies, that are relevant to the conservation and sustainable
use of biological diversity and on the other hand seek to ensure the
development of appropriate procedures to enhance the safety of
biotechnology in the context of the Convention's overall goal of
reducing all potential threats to biological diversity, taking also into
account the risks to human health”

Cartagena Protocol on Biosafety, Introduction

Content

Introduction
Romanian UNEP/GEF project

Chapter I
Romanian biosafety policy

Chapter II
Romanian biosafety regulatory system

Chapter III
System for handling notifications and requests
for permits or product authorizations

Chapter IV
Monitoring

Chapter V
Labelling and traceability

Chapter VI
Enforcement

Chapter VII
Mechanisms to promote and
facilitate public awareness,
education and participation

Chapter VIII
Romanian modern biotechnology
development strategy

Annex I .......................................99
Annex II ...................................101
Annex III .................................101
Annex IV .................................117
Annex V ...................................121
Annex VI .................................123

7 15 27 41 47 53 69 85
 Introduction

ROMANIAN UNEP/GEF PROJECT

Romania, through the Ministry of Environment and Water

Management, joined the UNEP/GEF project “Development of the
National Biosafety Frameworks” by signing the subproject
“Development of the National Biosafety Framework for Romania”
GF/2716-02-4596. 1 April 2004 was the starting date for the Project
and the National Executing Agency (NEA), represented by the
Ministry of Environment and Water Management, the Nature
Conservation, Biodiversity and Biosafety Directorate, established
the National Coordinating Committee composed of stakeholders
such as: government authorities with mandates relevant to the
Cartagena Protocol on Biosafety, research institutions,
representatives from the public and private sectors (Annex 4).

As a Party to the Convention on Biological Diversity (CBD),

Romania signed the Cartagena Protocol on Biosafety, on 11
October, 2000. It also ratified the Protocol by the Law 59/2003 from
30 June 2003 which entered into force on 28 September 2003.

The project was carried out according to administrative and

financial procedures of the United Nations Development
Programme for Romania. The administrative and technical
support of UNEP was ensured through the constant collaboration
with Liina Eek PhD, Assistant Regional Coordinator for Central
and Eastern Europe (CEE), UNEP/GEF Biosafety Unit,
International Environment House, Geneva, Switzerland.

Generally, the project followed the proposed quarterly work plan.

The greatest attention was focused on inventories, survey actions,

1

and on evaluating the regulatory system taking also into account the modern
biotechnology research capacity. Biosafety stakeholders participated in a broad
spectrum because of the open attitude and transparency of the project team (Annex
2).
This report is structured in eight chapters as follows:
[1] Romanian Biosafety Policy This chapter describes the Romanian political
orientation on the biosafety domain and reveals specific aspects belonging to the
present Government for the period 2005-2008. It is important to underline that in the
chapter 18 entitled “Environment Policy” belonging to the “Governmental
Programme 2005-2008” relevant issues regarding the development of the national
biosafety framework are presented.
[2] Romanian Biosafety Regulatory System This chapter includes a listing of all
regulatory legislation related to biosafety focusing on genetically modified
organisms (GMOs). Interfacing regulatory acts are also described as well as the main
international environmental conventions and agreements to which Romanian is a
signatory Party (Annex 3). Moreover, since 1995 Romania is a Party to the World
Trade Organization (WTO) and signed the Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPs), Agreement on the Application of Sanitary and
Phyto-sanitary Measures (SPS), and Agreement on Technical Barriers to Trade (TBT)
under the WTO. Legislative acts regarding the transposing of European Union (EU)
regulation are also underlined as Romania is preparing for EU accession in January
2007.
[3] System for handling notifications or requests for authorizations This chapter
describes all appropriate procedures required for permits, authorization and
approval issuing.
[4] Monitoring This chapter describes the importance of monitoring activity within
the biosafety system
[5] Labelling and traceability This chapter describes the current situation in
Romania for these activities and also includes future recommendations.
[6] Enforcement The most important activity of the national biosafety framework is
described in this chapter and reveals how the regulation system is enforced in
Romania now.
[7] Mechanisms for promoting and facilitating public awareness, education and
participation in decision making process This chapter describes procedures,
methods, tools and instruments as well as relevant developmental goals.
2 3
ROMANIAN UNEP/GEF PROJECT
[8] Approaches on the Development of the Romanian Modern Biotechnology
Strategy This chapter describes proposals for the future development.
We address our thanks to the Ministry of Environment and Water Management
which ensured the constant positive support and expertise during project activities.
National Coordinating Committee (NCC) members have actively participated
during all project actions, establishing an exceptional collaboration with the project
(Annex 4). Special thanks are addressed to all NCC members, which by their
expertise ensured a constant and appropriate framework required for project
activities development and also for project results.
We are expressing our thanks to all contributors in the development of the
UNEP/GEF project activities (Annex 2 and 4). Getting together all stakeholders was
the most important achievement of drafting the Romanian National Biosafety
Framework. Thus, there were got together for the first time in biosafety domain:
authorities, research area, industry, non governmental organizations, and mass
media as well as Romanian and Foreign experts: we thank you all.
Maria-Mihaela Antofie
National Project Coordinator
UNEP/GEF
Adriana Baz
Director
Nature Conservation, Biodiversity and Biosafety Directorate
Ministry of Environment and Water Management
Cartagena Protocol on
Biosafety to the Convention
on the Biological Diversity
is the main international
instrument protecting
biodiversity in a
transborder context against
the potential negative
effects that can arise from
not properly applying
modern biotechnology
 CHAPTER 1

ROMANIAN BIOSAFETY POLICY

Romania was one of the first countries in Eastern Europe that

put in place its national biosafety framework. In this context, at
the end of the year 1999, the Government Ordinance 49/2000
(GO) on the obtaining, testing, use and commercialization of
genetically modified organisms obtained through the modern
biotechnology techniques, and of the products resulting thereof,
was issued. Two years later, Law no. 214/2002 for the approval
of the GO no. 49/2000, with modifications and completions, was
promulgated, which at the same time also largely transposed the
following Directives: 90/219/EEC, 98/81/EEC and
2001/18/EC.

Romania signed on 11 October, 2000, as a Party to the

Convention on Biological Diversity, the Cartagena Protocol on
Biosafety, which was ratified on 30 June, 2003 by the Law no.
59/2003. The Protocol entered into force on 28 September, 2003,
thus Romania has to implement all its provisions.

It is expected that before Romania's accession to EU, all EU

biosafety regulatory provisions to be transposed in the national
legislation. Thus, in the next period, new legal acts will be
prepared to amend and complete Law 214/2002 addressing
other specific ROMANIAN BIOSAFETY REGULATORY
SYSTEMs. At present, new regulations are to be enforced in
order to strengthen the National Biosafety Framework (NBF) in
accordance with EU Biosafety Policy and the main international
instruments in the field to which Romania is a signatory Party.

7

Romania will enter a new phase with the closing of accession negotiations, which
will facilitate capacity building and ROMANIAN BIOSAFETY REGULATORY
SYSTEM implementation taken from the acquis communautaire during negotiations.
In addition, Romania has to develop a specific Modern Biotechnology Strategy,
following the example of other EU countries, and to include biosafety in this
strategy. However, research in the field of modern biotechnology, which is a
prerequisite for the development of a reliable NBF, has not been developed
adequately, due to the lack of funds necessary for competitive research activities.
This research field is well-developed in Western Europe and in several neighbouring
countries. Modern biotechnology development needs substantial funding, for the
acquisition of equipment and reagents as well as an adequate training of human
resources and a sustainable management.
The current Romanian Government Programme 2005-2008 briefly underlines the
development policy and strategy throughout its 27 chapters, and a short
presentation of chapter 18 will be presented bellow. Other relevant chapters of the
Government Programme are briefly presented in boxes 1-4.
Box 1
“The Romanian Government will grant a special
“Government
Programme 2005- attention to research . innovation sector in order to
2008” help the Romanian economy obtain a durable
Chapter 6 competitive advantage as well to decrease the
“Policies in the field development gaps existing among Romanian
of Research- regions and among these and the regions of other EU
Development and
Innovation” member states”.
Chapter 18 of the Governmental Programme 2005-2008 focuses upon the
Environmental Protection Policy of the Ministry of Environment and Water
Management. It can be considered that one of the main concerns of Romanian
Environmental Policy is biosafety, underlining the importance of implementing the
provisions of the Cartagena Protocol on Biosafety to the CBD. At the same time, it
imposes complying with the provisions of other international conventions with
significant impact upon the conservation of genetic resources and ensuring an
adequate level of environment and human health protection (Espoo Convention
8 9
ROMANIAN BIOSAFETY POLICY
regarding the assessment of the impact on the environment associated with cross-
border movement, Aarhus Convention regarding access to information, public
participation in decision making and access to justice with regards to environmental
issues, Helsinki Convention regarding industrial accidents with significant impact
upon the environment in relation to cross-border movements).
Romania has great concerns in preserving its natural resources as it is well known
that it is possessing one of the richest biodiversity in the region. Thus, development
of this chapter is supported by the numerous conventions and international
Protocols, as well as bilateral and multilateral agreements signed by Romania and
presented in the chapter 2 of the draft.
Box 2 The Ministry of Agriculture, Forests and Rural
“Government Development will observe and promote certain
Programme 2005- democratic principles and values, the most important
2008” to the environment being the following:
[1] sustainable rural development and increase in
Chapter 9
population incomes by capitalization of all potential
“Agricultural and resources in the rural area, diversification of
Rural Development agricultural and non-agricultural economic activities
Policy”
and services, improvement of public rural
infrastructure and of general population welfare; [2]
recognition and orientation towards European
democracy and values. The integration of Romania
into the European Community and integration of
Romanian agriculture into the Common Agricultural
Policy (CAP), while also protecting the interests of
domestic producers; [3] preserving the environment,
the geographic landscape and the spiritual, traditional
and material values from Romanian rural areas;
Having as main objectives, strengthening the administrative structures, as basic
element to build a solid system of environment management and the contribution to
a durable development, the activity of Romanian Government will rely on the
following priorities:
1. Integration of the environment policy within the elaboration and implementation
of sector and regional policies by: [i] Situating the Ministry and the National

Environment Agency in a decision position that would intersect horizontally all
sector policies( industry, energy, transports, agriculture, tourism, regional policies,
local administration and health); [ii] Effective introduction of environment
evaluation as mechanism to integrate the new formulated policies and to issue some
effective assessment indicators of the progress achieved in case of existing strategies
and policies; [iii] Intensification of the actions to integrate the environment policy
within five priority sectors with significant impact on environment, namely:
industry, energy, transport, agriculture and tourism; [iv] Promoting progressively
economic instruments in order to implement environment policies;
Box 3 Among the priority objectives, the following three can
be mentioned:
”Government
Programme 2005-
1. Effective and equal access of citizens to basic medical
2008” care;
2. Increase of life quality by improving the quality and
Chapter 8 the security of medical act;
“Policy in the Health
3. Approach of health and demographic indicators of
Field”
civilized countries, at the same time with decrease of
the pathology specific to underdeveloped countries;
2. Assessment of the actual stage of ecological factors and enforcement of a strategy
of long term development within the environment field, of the regenerative and non
regenerative resources;
3. Strengthening the institutional capacity within the environment field;
4. Improvement of the quality of environment agents within urban and rural areas
Improving the quality of environmental factors within urban and rural areas;
In this context, several objectives are mentioned in relation to the management of
chemical substances, the monitoring of the genetically modified organisms and the
forbidding use of those substances that represent a threat for the population health
on Romania' s territory, as follows: [i] Developing the Biosafety National Framework
in order to implement the Cartagena Protocol (Law 59/2003); [ii] Assuring the
legislative framework upon the transport cross border of genetically modified
organisms, labeling and traceability of food and feed products obtained from
10
ROMANIAN BIOSAFETY POLICY
genetically modified organisms; [iii] Constituting a national Catalogue of genetically
modified organisms accepted on Romanian territory, accessible to population; [iv]
Creating and developing the laboratories specialized in detecting the genetically
modified organisms; [v] Participating at the Mechanism upon the Information
Exchange within the Biosafety field (Biosafety Clearing-House); [vi] transposing and
implementing the legislation on risk assessment and risk control of hazardous
chemicals on human health and the environment.
Box 4 This policy is based on the following general objectives
”Government
in promoting the interest of consumers:[1] achieving a
Programme 2005- high level of consumer protection;[2] effective
2008” enforcement of legislation with regards to consumers'
protection and [3] developing the activities for
Chapter 19
consumers information, counselling and education.
“Policy upon
Consumer
This Governmental strategy, through its objectives
Protection” and priorities, intends to align consumer protection
regulation in Romania with that existing in the
European Union Member States, including consumer
safety, economic interests, information and education,
as well as the development of consumers organizations
for playing an active role in developing consumer
protection policies.
Within the strategy for the period 2005-2008, the
National Authority for Consumers Protection
(NACP) aims at developing a systematic, efficient and
well-organized consumer protection policy,
prevention, a fast response mechanism through the
presence of its representatives all over Romanian
territory, as well as an efficient activity, including
cooperation with other governmental competent bodies
at national and local level. Furthermore,
strengthening the partnership with the civil society, in
general, and with the business sector, in particular,
will lead to a better knowledge and understanding of
consumers' problems and to a better protection of
consumers.
11
5. Extension of the national network of protected areas and natural reservations,
rehabilitation of the coast infrastructure of the Romanian seaside, economic and
ecological resizing of the Danube Delta;

6. Strengthening the cross-border and international partnership with similar

institutions from other countries in order to monitor the implementation stage of
international agreements by: [i] Signing Conventions, Agreements, Bilateral and
multilateral Cooperation within the field of Environment protection at European
and world level for the purpose of capitalizing the opportunities and facilities of
institutional and financial technical financial assistance and identifying some
possibilities to finance the environment reconstruction projects; [ii] Observing the
notice and reporting requests undertaken by Romania as part within different
Conventions, Protocols and International Agreements; [iii] Assuring the
institutional framework established through different bilateral and multilateral
agreements, for the purpose of assuring the implementation of conventions that
settle the cross-border pollution, its prevention and reducing;

7. Elaboration of strategies to protect citizens against natural disasters, ecological

accidents and exposure within areas with ecological risk;

8. Strengthening the partnership with NGOs, in the process of elaboration and

enforcement of public policies within the field, by [i] Granting a priority attention to
the ecological education of population through conceiving and implementing a
national action plan for the public awareness of the environment protection issue; [ii]
Implementation of the Aarhus Convention requests upon access to information,
public participation in decision making and access to justice within the environment
issues, by concluding the legislative framework, introduction of an informed system
at central, regional and local level, upon management of environment information;
[iii] Achieving some yearly campaigns to increase public awareness upon its
participation in decision making process on environment, especially upon its role
within the process of evaluating the environment impact of projects with significant
impact, authorization, environment evaluation for plans and programs; [iv] Media
coverage of some punctual environment protection issues: GMO Genetically Developing the collaboration between Romania
Modified Organisms, POPs Persistent Organic Pollutants, PCBs- Polychlorinated and region countries as well as other Biosafety
Biphenyls, climatic changes, in order to protect not only the environment but also Protocol parties, is essential to implement an
people health from the damaging effect of these substances. international biosafety system

12
 CHAPTER 2

ROMANIAN
BIOSAFETY REGULATORY SYSTEM

In Romania, progress has been made with regards to

environmental legislation, especially after the year 1989. The
new Romanian Constitution was published in the Romanian
Official Journal, Part I, no. 233 on 21 November, 1991, approved
by a national referendum held on 8 December, 1991. Beginning
with the year 1990, environmental protection becomes a major
part of environmental policies through the development of a
legal regime in direct correlation with the major changes in all
sectors of the Romanian economy and also in accordance to
European Policy.

Also, following this period, Romania has become a Party to the

most international environmental conventions and instruments
which require a legal basis and capacity building for their
implementation. Thus, Romania is a signatory Party to the
Convention on International Trade in Endangered Species of
Wild Fauna and Flora (CITES), the European Convention for the
Protection of Animals during International Transport, the
Convention on the Conservation of European Wildlife and
Natural Habitats, the Convention on the Protection and Use of
Transboundary Watercourses and International Lakes, the
Convention on Environmental Impact Assessment in
Transboundary Context, the Convention on Persistent Organic
Pollutants, the Rotterdam Convention on Prior Informed
Consent Procedure for Certain Hazardous Chemicals and
Pesticides in International Trade, the Convention on control of
Transboundary Movements of Hazardous Wastes and their
Disposal, the Kyoto Protocol to the Frame Convention of United

15

Nations on Climate Changes, the Convention on Biological Diversity and the
Cartagena Protocol on Biosafety.
To-date, almost all the countries in the region have ratified, together with the EU, the
Cartagena Protocol on Biosafety; therefore, constituting a Biosafety - related Region
becomes imminent as the national biosafety systems will be developed and
harmonized in connection with systems existing in the countries in this region. The
main Romanian environmental legal acts that are ratifying, accepting or approving
these instruments are presented chronologically in annex 3. Romania has done and is
doing sustainable efforts towards protecting the environment and human health
according to EU Biosafety Policy.
Starting with 1995 Romania is also a signatory Party of WTO and it also signed the
three agreements: SPS, TBT and TRIPSs (Law 133/1994, published in Official Journal
no. 360/1994).
2.1. REGULATORY REGIME RELEVANT
TO GENETICALLY MODIFIED ORGANISMS (GMOs)
Starting with the year 1999, Romania has been developing a pragmatic and
transparent regulatory system and capacity building in the field of genetically
modified organisms by, publishing the GO 49/2000 approved with modifications
and completions by the Law 214/2002. Currently, Romania is one of the few
countries in Europe where approved GMOs are actually commercially grown.
Interfacing regulations are also listed in Annex no 3.
Several authorities are committed to promulgate legislative acts for biosafety
domain and the legal acts described bellow belong to the Ministry of Environment
and Water Management (MEWM), the Ministry of Agriculture Forestry and Rural
Development (MAFRD), the National Sanitary-Veterinary and Food Safety
Authority (NSVFSA) and the National Authority for Consumer Protection (NACP).
GO no. 49/2000 (30 January, 2000) is the first GMO regulation regarding the regime
of obtaining, testing, use and commercialization of genetically modified organisms
obtained through modern biotechnology techniques and also of the products
resulting thereof (published in the Official Journal no. 48/ 2000). After two years,
16
ROMANIAN BIOSAFETY REGULATORY SYSTEM
based on the new experience in the field of EU countries and also of Romania, this
ordinance was completed and amended by the new Law 214/2002.
Law no. 214/2002 (19 April, 2002) for the approval of the GO 49/2000 regarding the
regime for obtaining, testing, use and commercialization of genetically modified
organisms obtained through modern biotechnology techniques and also of the
products resulting thereof was published in the Official Journal no 316/2002.
The purpose of this law is primarily reflected in the contents of Art. 1.”the obtaining,
testing, use and commercialization of genetically modified organisms obtained
through modern biotechnology techniques and products containing gmos”.
Article 1 defines the activities that fall under the provisions of this law: (a) contained
use of genetically modified microorganisms; (b) deliberate release into the
environment of genetically modified organisms, for other purposes than placing on
the market; (c) placing on the market; (d) import.
In the same article the objectives of the law are presented: “activities that involve the
obtaining, testing, use and commercialization of genetically modified organisms
obtained through modern biotechnology techniques are subjected to special
regulatory regime, including authorization and administration, in accordance with
the provisions of the GO 49/2000 and of other legal international acts to which
Romania is a Party. Among these objectives are included: [i] activities regarding the
contained use of genetically modified microorganisms; [ii] definition of terms for the
deliberate release into the environment and placing on the market of genetically
modified organisms and of the products resulting thereof, such that these activities
are carried out in the safest conditions with regards to human health and
environment protection;[iii] definition terms of import/export of genetically
modified organisms and of the products resulting thereof”.
Exemptions from the enforcement of the law are also foreseen: a) organisms obtained
through genetic modification techniques mentioned in annex no.1, part B and in
annex no.2, part A of the present law; b) processed products; c) transport activities,
regardless the mean or way; d) trade, import that are the subject of other normative
acts.
The law regulates: [1] competent authorities, [2] the Biosafety Commission, [3]
procedures (notification procedure, notification contents, authorization process
17

duration, simplified procedures), [4] risk assessment, [5] risk management, [6]
monitoring, [7] labelling, [8] public information and consultation, [9] guarantee on
information confidentiality and publishing rights, [10] accidental situations, [11]
emergency plans, [12] financial mechanisms, [13] entry into force, [14] sanctions, [15]
prejudice, [16] liability, [17] international collaboration in this field, [18] definition of
terms, [19] annexes interfacing GO 49/2000.
Law 214/2002 largely transposes the following EU legislation: Directive
90/219/EEC regarding the use in contained conditions of genetically modified
microorganisms, amended by Directive no. 98/81/EEC; Directive no. 2001/18/EC
that repeals Directive no. 90/220/EEC regarding the deliberate release into the
environment of GMOs and not completely the Cartagena Protocol on Biosafety.
This law is already amended by other legislative acts (MEWM Orders no: 606/2005,
838/2005, 923/2005) and it will be changed and completed in the future, as it is
necessary to improve the clarity and transparency in accordance to international
agreements in this field.
Moreover, law provisions regarding the contained use cover only genetically
modified microorganisms, but does not specifically include plants and animals. In
turn, the concepts of plant and animal cell cultures are included in the definition of
microorganisms, which scientifically is not correct. In this context, the chapter
referring to definitions should be revised in accordance with the definitions foreseen
by the Cartagena Protocol on Biosafety.
The law does not gives details on simplified procedures foreseen in the Cartagena
Protocol on Biosafety. It is necessary to revise the chapters that describe the risk
assessment and management procedures in accordance with the Directive
2001/18/EC. Also, enforcement procedures are not clearly specified.
It is necessary as well to revise the procedure for public participation in decision
making process so that the public participates effectively and not only formally.
MEWM Order no. 684/2002 (5 August, 2002) is the main legal act regarding the
organization and functioning of the members of the Biosafety Commission. It
includes also the names of the Biosafety Commission members related to their
official address (published in the Official Journal, Part I, no. 793/2002
18
ROMANIAN BIOSAFETY REGULATORY SYSTEM
With regards to the functioning of the BC, it is necessary to revise the rights and
obligations of BC members. Also, it is necessary to enforce the financial mechanism,
as currently they are doing voluntary work.
MEWM Order no. 606/2005 (6 July 2005) regarding the approval of the Format for
the results of deliberate release into the environment of genetically modified plants,
for purposes other than placing on the market (published in the Official Journal, Part
I, no. 707/2005).
This order entirely transposes the provisions of the Decision no. 2003/701/EC for
establishing on the basis of Directive no. 2001/18/EC a format for the results of
deliberate release into the environment of genetically modified plants, for purposes
other than placing on the market, published in the EU Official Journal no. 254 /2003.
MEWM Order no. 838/2005 for the approval of Guidelines regarding the application
of the Annex 122 Monitoring Plan belonging to Law 214/2002. This guidelines are
complying with Decision 2002/811/EC for the applying the Annex VII of Directive
2001/18/EC
MEWM Order no. 923/2005 regarding the approval of the Format for notification
summary for placing on the market genetically modified organisms such as or in
products.
Law no. 59/2003 (11 March, 2003) is the legal act for ratification of the Cartagena
Protocol on Biosafety to the Convention on Biological Diversity (the Convention was
signed on 5 June, 1992 in Rio de Janeiro). Cartagena Protocol was adopted in
Montreal on 29 January, 2000 (published in the Official Journal, Part I, no. 192/2003).
This law entered into force on 28 September, 2003.
MAFRD Law no. 266/2002 (15 May, 2002) regarding the production, processing,
control and quality certification, seed and reproductive material commercialization,
and also the registering of plant varieties (published in the Official Journal, Part I,
no.343 /2002).
The Law stipulates that “in the case of genetically modified varieties, all
accompanying labels and documents will clearly indicate that the variety has been
genetically modified”. Also, “interdiction measures can be taken, for the use of a
genetically modified variety on a part or all of Romania's territory if it is ascertained
19

that the variety is harmful to other crop varieties or other species or presents a risk for
the environment or to human health. Also, another important provision strictly
refers to the genetically modified variety that “can not be tested and registered
without the notifier proving that such activities are in accordance with legal
provisions regarding the protection of the environment, to human health and
animals”.
MAFRD Order no. 550/2002 (27 November, 2002) for the approval of the regulations
and technical norms regarding the production, control, quality certification and
commercialization of viticulture breeding material (published in the Official Journal
Part Ino.937/2002).
This order has been issued on the basis of the provisions of Article 12 of Law no.
266/2002 regarding the production, processing, control and quality certification,
commercialization of seeds and reproductive material and also, registration of plant
varieties, taking into consideration the need for harmonizing the Romanian
legislation with the regulations foreseen in Directive no.68/193/CEC of the
European Commission regarding the commercialization of plant (vegetative)
grapevine reproductive material, last amended by the Directive 2002/11/EC, on the
basis of the provisions of GD 362/2002 regarding the organization and functioning
of the MAFRD with subsequent modifications and completions. In this order it is
stipulated that “genetically modified varieties can be approved for testing, breeding
or commercialization only if all necessary measures have been taken to avoid risk to
human health and the environment, according to legal regulations in force.
Genetically modified varieties registered in the catalog will be clearly indicated”.
Moreover, “in the case of reproductive multiplying material derived from a
genetically modified variety, all labels attached or all accompanying official
documents of the supplier must clearly indicate that the variety is genetically
modified”.
MAFRD Order no. 462/2003 (15 July, 2003) regarding the registering of all economic
operators that are cultivating genetically modified plants (published in the Official
Journal, Part I no. 542 /2003). This law is very important for traceability and in
present Ministry of Agriculture Forestry and Rural Development has developed an
archive regarding the number of economic operators, cultivated surfaces and yields.
The order foresees that all economic operators (legal or natural persons, associations
20
ROMANIAN BIOSAFETY REGULATORY SYSTEM
without legal power) are obligated to declare (sign a statement) to the county
departments for agriculture and rural development, respectively, Bucharest
Municipality, the land surface area cultivated with genetically modified plants and
the yield obtained. This statement is completed in two copies one copy is for the
county department for agriculture and rural development and has to be submitted in
maximum ten days from completing sowing (Annex 1 of the Order), and harvesting
(Annex 2 of the Order); one copy is kept by the economic operator for a period of five
years; the information is collected and processed by the county department for
agriculture and rural development and is sent electronically to the central
information centre of the Ministry of Agriculture, Forests and Rural Development
(Record register of all economic operators that cultivate genetically modified plants
in Romania).
Law no 161/2004 (14 May, 2004) for the approval of GO no. 11/2004 regarding the
production, commercialization and use of reproductive forestry material (published
in the Official Journal, Part I no. 466 /2004) stipulates that “the use of genetically
modified reproductive forestry material that is harmful to human health and the
environment is an offence and is punishable with imprisonment from two to five
years or fine” (Article. 442). Moreover, this legal act is stating that stipulates that “not
declaring that any reproductive/breeding forestry material is derived from a
genetically modified seedling is punished with imprisonment from one year to five
years or fine” (Article 443).
MEWM Order no. 727/2003 (29 September, 2003) for the approval of sanitary-
veterinary norms regarding national procedures for authorizing and surveillance of
veterinary medical products (published in the Official Journal no 787/2003) is
presenting the contents of the request for authorizing a genetically modified
veterinary medical product (Article 6).
MAPDR Order no. 117/2002 (28 February, 2002) approving the Sanitation
Regulation Procedures for projects envisaging the location, building, equipping, and
regulating - from the sanitary point of view - the operation of facilities and activities
carried out therein, other than the ones subject to registration with the Trade
Registry, as well as the Sanitation Regulation regarding the market introduction of
substances and products that are either new, or have been imported for the first time
and destined to human use or consumption (published in the Official Journal, Part I
no. 181/2002).
21

This Order lists “substances and product categories that are either new, or have been
imported for the first time, subject to a sanitary regulation before being introduced
into the market”, mentioning, under item 13, the “genetically-modified organisms
and products derived thereof, destined for human use or consumption cleared by
the Clearance Commission”.
GD no.106/2002 (14 October, 2002) regarding the labelling of food products
(published in the Official Journal, Part I, no. 147 /2002). This regulation stipulates
methodological norms regarding labelling in the case of food products obtained
from or contains genetically modified organisms or foodstuffs.
GD no. 1719/2004 (14 October, 2004) for modifying and completing Governmental
Decision no. 106/2002 regarding labelling of food products (published in the Official
Journal, Part I no. 1014/2004).
This Decision transposes: [1] Regulation 1139/98/ECE regarding the obligation for
indicating on the labels of food products obtained from genetically modified
organisms of supplementary information other than that foreseen by Directive
79/112/ECE, published in the Official Journal of the European Commission no.
L159/3 June, 1998, modified by regulation 2000/49/EC, published in the Official
Journal of the European Commission no. L006/11 of January, 2000; [2] Regulation
no. 2000/50/EC regarding the labelling of foods and foodstuff that contains
additives and aromas that have been genetically modified or that have been
produced from genetically modified organisms, published in the Official Journal of
the European Commission no. L006/11th of January, 2000.
Ordinance no. 97/2001 (21 June, 2001) regarding the regulatory regime for the
production, movement and commercialization of food (published in the Official
Journal no. 349/2001).
The Ordinance defines transgenic food as containing “a new combination of genetic
material obtained through biotechnology techniques and/or organisms (as any
biological entity capable to reproduce or to transfer its genetic material) in which the
genetic material has been modified through a process that does not naturally occur
by breeding and/or natural recombination”. In section 9 are presented “the
conditions regarding food designated for special nutritional, nutritive
supplementary, improving food nutritive quality purposes and those genetically
modified”.
22
ROMANIAN BIOSAFETY REGULATORY SYSTEM
Law no. 215/2004 (27 May, 2004) for the approval of Government Ordinance
no.42/2004 (29th of January, 2004, published in the Official Romanian Journal, Part I,
no.94 of the 31st of January, 2004) regarding the organization of veterinary activities
(published in the Official Journal, Part I, no. 531/2004).
According to this Law, the sanitary-veterinary authority “grants scientific advise
and technical and scientific assistance regarding human nutrition, taking into
consideration the provisions of national, community legal documents, issues
scientific permits regarding issues related to health, animal and plant protection, and
also scientific permits regarding products, other than food and feed for animals,
relating to genetically modified organisms as defined by GO no. 49/2000 regarding
the regime for the obtaining, testing, use and commercialization of genetically
modified organisms obtained through modern biotechnology techniques, and also,
of the products resulted thereof, approved with modifications and completions by
Law no. 214/2002”.
GD no. 917/2001 (13 September, 2001) for the approval of methodological norms for
implementing the provisions of EGO 34/2000 (published in the Official Romanian
Journal, Part I, no 172 of the 21st of April 2000) regarding ecological agro-food
products (published in the Official Journal, Part I no. 640 of the 12th of October,
2001). The EGO 34/2000 was abrogated by Law 38/2001 (published in the Official
Romanian Journal, Part I, no.122 /2001).
This act underlines in the methods “for ecological production used for obtaining
non-processed vegetable, animal products and animals, with the exception of seeds
and regenerating material is compulsory not to use genetically modified organisms
and/or products derived from such organisms, with the exception of veterinary
medicine use”. Also, “it is forbidden the use of genetically modified organisms and
of products derived thereof in obtaining feed, prime materials, feed compounds, and
feed additives, auxiliary for producing feed and of other products used in animal
feed”. Moreover, the use of genetically modified microorganisms or products
against pests is excluded.
23
Tradition preserving may influence
the modern biotechnology
development and subsequently the
biosafety system
 CAPITOLUL 3

SYSTEM FOR HANDLING NOTIFICATIONS

AND REQUESTS FOR PERMITS
OR PRODUCT AUTHORIZATIONS

The National Competent Authority for receiving notifications

regarding genetically modified organisms (GMOs), in
conformity with the GO 49/2000 on the obtaining, testing, use
and commercialization of genetically modified organisms
obtained through modern biotechnology techniques as well as
of the products resulting thereof, approved with completions
and modifications by Law 214/2002, is the Ministry of
Environment and Water Management (MEWM). The
organization and functioning of MEWM is regulated by GD no.
408/2004.

3.1. INSTITUTIONAL FRAMEWORK

In Romania the management systems for notifications and

authorization requests are achieved through a specific
institutional framework regulated in accordance with several
legal acts presented in Box no 5.

The institutional framework is provided by several authorities:

a) Ministry of Environment and Water Management (MEWM),

as the Central Public Authority for Environment Protection; this
authority is responsible for issuing import permits,
authorizations for GMOs deliberate release into the
environment and placing on the market and for the enforcement
of the laws;

27

b) Central public authorities from the following sectors agriculture, food, health
with responsibilities in approval/consent and control of activities (they are
regulated by the following legal acts: Law 214/2002 and Law 215/2004):
- Ministry of Health
- Ministry of Agriculture, Forests and Rural Development
- National Sanitary-Veterinary and Food Safety Authority
- National Authority for Consumer Protection
1. GO 49/2000 on the obtaining, testing, use and
Box 5
commercialization of genetically modified
organisms obtained through modern
The legal basis for the
institutional framework biotechnology techniques as well as of the
products resulting thereof, approved with
working in the system for
completions and modifications by Law 214/2002;
handling notifications or
2. MEWM Order 648/2002 on the approval of the
requests for
structure of the Biosafety Commission and of the
authorizations is provided
by the following legal set of rules regarding its organization and
acts: operation;
3. Law 215/2004 for the approval of Government
Ordinance no. 42/2004 on the organization of
veterinary activities: The National Sanitary-
Veterinary and Food Safety Authority
(NSVFSA).
c) Biosafety Commission (BC) as the scientific body with a technical consultative role
in decision-making for the MEWM. Structure, organization and operating rules of
the Biosafety Commission are established by MEWM Order 684/2002. This
commission consists of members belonging to the Romanian Academy (3 members),
the Academy for Agricultural and Forestry Sciences "Gheorghe Ionescu-Sisesti" (3
members), the Academy of Medical Sciences (3 members) and universities and
research institutes in biology, agriculture and health (3 members). The order
nominates the 12 members of the Biosafety Commission, in the exercise of its
attributions having consultative role, while decisions are taken by consensus
agreement.
28
AUTHORIZATION SYSTEM
3.2. AUTHORIZATION PROCEDURES
3.2.1. GMO FOR DELIBERATE RELEASE INTO THE ENVIRONMENT
(Cultivation and commercialization)
This procedure is regulated by articles 1, 11, 24, 25, 49 of the GO 49/2000, approved
with modifications and completions by the Law 214/2002 and follows the scheme
presented in Annex 1.
Box 6 1. Technical specifications (the Dossier) will
include GMO information as follows: [a] General
Content of a GMO information, including data on the personnel
Notification involved and the level of training;[b] information
on genetically modified organisms;[c]
Information on releasing conditions and the
characteristics of the potential recipient
environment;[d] Information on the impact of
genetically modified organism(s) on the
environment;[e] Monitoring plan, in agreement
with the content of Annex 12.2., for the
identification of GMO effects on human health
and environment;[f] Information on the control,
rehabilitation measures, waste management and
action plans in emergency situations;[g]
Summary of the dossier, also in electronic format,
available to the public.
2. Environmental Risk Assessment (ERA)
study, together with any references and
indications regarding the used methods;
3. Information on the results of previous releases
of the same GMOs or GMOs combinations on
Romanian territory and/or outside Romania.
[i] Notification Any legal entity, before releasing into the environment or placing on
the market a GMO or a combination of such organisms, should send a notification to
the MEWM that should contain the information presented in Box no 6. Other
obligations of the Notifier are listed in Box no 7.
29

[ii] Confidential information regime In the notification submitted to the MEWM, the
Notifier may indicate the information that he/she wishes be treated as confidential,
also presenting the appropriate reasons supporting it.
Box 7 [1] Follows the legal authorization procedure,
providing all the necessary data to the competent
Other Notifier's national authority;
Obligations [2] Begins the proposed activity only after
obtaining the authorization issued by the
MEWM and complying with the conditions
established;
[3] Respects and follow other procedures
following the GMO release into the environment.
[iii] Checking notification and additional information The MEWM makes a first
evaluation of the enclosed information and may requests for eventual completions
or clarifications. In the case that the scientific information is incomplete, the MEWM
may ask for additional information and/or apply the precautionary principle
invoked by the Law 214/2002 Annex 121 B and also by the Cartagena Protocol on
Biosafety, and also can ask for specific conditions or even reject import or ban GMO
release into the environment.
[iv] Authorization When the MEWM is considering that the Notification is complete,
based on the information included in notification and other documents, starts the
authorization procedures ranging for a 90 days period (see Annex 6) which consists
in:
a) Informing and consulting the public regarding the notification;
b) Consulting the Biosafety Commission;
c) Requesting the written consents from the central public authorities with
responsibilities in the following fields: agriculture, food, human health and
consumer protection.
The MEWM can not issue any authorization for deliberate release into the
environment of a GMO crop without being tested and homologated at the State
Institute for Variety Testing and Homologation, which is organized and operating
30
AUTHORIZATION SYSTEM
according to Law no. 266/2002. MEWM takes into consideration the conclusions of
the environmental and human health risk assessment studies, included in the
Notification's Dossier, the advice of the BC, written consents from the other involved
authorities as well as public comments. The MEWM should also take into
consideration the socio-economic aspects and verifies the observance of
international obligations in this field, established by bilateral and multilateral
agreements. Permits or approval can only be denied on grounds related to the
protection of the environment and/or human health.
3.2.2. PLACING ON THE MARKET OF GMO
AND PRODUCTS RESULTING THEREOF
[i] Notification Before placing on the market for the first time, a GMO or a GMO
combination as a produce, a notification should be submitted to the MEWM that will
include:
a) recorded data and results obtained during R&D activities;
b) Environmental Risk Assessment (ERA) study;
c) conditions for placing on the market, including the specific use and
handling conditions, as well as a labelling and packaging proposal. The label
should clearly specify whether the product contains GMO. The label reading
„This product contains genetically modified organisms” is compulsory.
d) a monitoring plan;
e) a summary of the notification.
Each new product that contains or consists of the same GMO or of a GMO
combination, intended for a different use, will be separately notified.
[ii] Authorization The product will be placed on the market only after obtaining the
authorization issued by the MEWM and after complying with the established
conditions.
Important The registration in the State Register and the Official List of
Varieties/Cultivars of genetically modified crops will be carried out after obtaining
the authorization for release into the environment for experimental purposes, issued
by the MEWM. In other words, it cannot be possible to give a permit under Law
214/2002 without complying with the variety registration, and also it cannot comply
31
 AUTHORIZATION SYSTEM

with variety registration without a permit issued according to the Law 214/2002.
Box 8
The content of a
notification in the case of
authorization renewal
intended for the activities regulated by GO no. 49/2000, approved with completions
and modifications by Law no. 214/2002, will be based on the data referring to risk
assessment (risk assessment should be based on a scientifically sound information)
a) a copy of the received authorization;
and precautionary principle, taking into consideration the possible adverse effects
b) a report on the monitoring activity results;
on biological diversity, conservation and sustainable use, the risks on human health.
c) any new information that became available
after obtaining the authorization;
The MEWM will inform the Notifier, within the established period, whether: (a) the
d) if appropriate, a proposal for amending the
import can take place without a written permit and in what conditions; and (b) the
conditions specified in the authorization.
import can take place only after the MEWM gives its written permit.

In the case when authorization renewal is requested, the Notifier should address a
new notification to the MEWM within 9 months before the authorization expires.
This time the content of notification is different and is presented in Box. 8.
3.3. IMPORT PERMIT
[i] Notification In accordance with Art. 35. - (1) and GO no. 49/2000, approved with
completions and modifications by Law 214/2002, the importers are obliged to notify
in written form to the MEWM before any import of LMOs or of products resulting
thereof.
The MEWM will establish the notification procedures and will make them available
to interested parties; the Notifiers are responsible for the accuracy of information
provided to MEWM in the notification.
[i] Notification acknowledgment The MEWM acknowledges that it has received the
notification to the Notifier by issuing a written form, within 90 days from its receipt.
According to Law 214/2002, the confirmation contains the following: a) date of
notification receipt; b) whether the notification contains all necessary information for
making a decision; c) other specifications, if appropriate.
3.4. NEW INFORMATION RELEVANT TO BIOSAFETY
Based on any new information provided by the risk assessment and monitoring
studies, the MEWM after consultation with the other central authorities in the field
and the BC may: [1] limits the approval for GMO use or [2] modifies the conditions
for GMO use.
If certain information that might have significant consequences regarding the GMO
potential risks on the environment becomes available after issuing the approval,
MEWM is obliging the notifier to modify conditions for deliberate release and/or
placing on the market, and in case of non-compliance, can suspend or cancel all
activities.
Whenever the user has new, relevant information, or changes the use conditions to
an extent that might have significant consequences as regards risks, he is obliged to
immediately inform the MEWM and consequently modify the notification.
3.5. PUBLIC INFORMATION AND CONSULTATION
IN THE DECISION MAKING PROCESS

Non-compliance with the procedure for receipt acknowledgment of the notification
by the MEWM should not be interpreted as a tacit agreement of the MEWM
regarding the import.
[ii] Import decision The MEWM decision with respect to the approval of an import
The public is consulted during the authorization procedure for GMO deliberate
release into the environment and placing on the market since 2000.
Within 10 days from the date when the MEWM accepts the notification as
appropriate (the notification contains the information stipulated by the legal

32 33
 AUTHORIZATION SYSTEM

provisions), and the authorization procedure is started, it should inform the public The MEWM will not provide to any third party any kind of confidential information
about this notification, specifying the means by which information can be obtained and will protect the copyrights in relation to the received information.
and the deadline for receiving comments.

For this purpose, the MEWM publishes on its own web site (www.mappm.ro) “The Final recommendations of UNEP GEF workshop
Box 9
Notification Summary” as well as the “Risk Assessment Study” and other relevant of 17 November, 2004, Bucharest “Romanian
documents (i.e. monitoring reports) and transmits a press release, through the Romanian Research Research Capacity on Modern Biotechnology “
Directorate for Public Relations within the MEWM which will inform mass media Capacity on Modern The conclusions of the workshop on the
evaluation of the biosafety research capacity are
from Romania. Biotechnology
relevant for this field:
1. No research development strategy has been
At the same time, announcements are transmitted to the Territorial Environment
established in the field of modern biotechnology;
Protection Agencies that belong to the MEWM. 2. There is a regulation system in place for GMO
contained use or testing; however, until 2004 no
Comments of the public can be submitted within 30 days from the date of public research application in this field was notified to
announcement and will be taken into consideration by the MEWM in the decision- the MEWM.
making process for the authorization of the proposed activity. Depending on the 3. At present, Romania has facilities that makes it
received comments, public debates can be organized regarding any aspects related possible to create GMOs only on a collaboration
basis (it can not create transformation vectors);
to scope of the present ordinance.
4. Romania does not have the full capacity to
develop and use modern biotech products;
5. Romania has the scientific competence (human
resources) for research-monitoring activities;
3.6. CONFIDENTIAL DATA REGIME
however, it has not been supported so far to obtain
funds required for facilities acquisition;
In accordance with Art. 491. - (1) of the GO no. 49/2000, approved with completions
6. Romania has no accredited laboratories for
and modifications by Law no. 214/2002, in the notifications sent to the MEWM, the GMO specific tests;
Notifier can indicate the information that should be treated as confidential, while 7. Through the State Institute for Variety Testing
also presenting the reasons for this. and Homologation, Romania has the necessary
capacity and competence to test and register
Furthermore, the MEWM will decide, after consultation with the Notifier, which varieties and hybrids of GM crops.
information is meant to be treated as confidential and will inform the Notifier on its 8. Research in the private sector practically does
decision. not exist.

It is important to underline that according to Romanian legislation the following

information cannot be considered as being confidential: (a) general characteristics of
micro-organisms/genetically modified organisms, name and address of Notifier, If, regardless of reasons, the Notifier withdraws his notification, the MEWM should
purpose and place of activity; (b) the class of contained use and the containment respect the confidentiality of all received information.
measures; (c) conclusions of risk assessment studies on environment and human
health; (d) methods and plans for monitoring and response in case an accident
acquires.

34 35

3.7. GMO FOR CONTAINED USE
[i] Notification The National Competent Authority for contained use activities is the
MEWM, in accordance with GO 49/2000, approved with completions and
modifications by Law 214/2002. This authority will check the notification on the
basis of documentation provided by the user whether the adequate measures have
been taken in order to avoid the adverse effects on human health and environment
(see Annex 2 of the Law 214/2002).
Any public or private research institution, as users, should notify any research
activity that involves GMO contained use. These institutions should present a
contained use assessment study regarding the risks on human health and on
environment, also obliging to keep an assessments record and making them
available to the MEWM. Recent concluding remarks regarding the evaluation of the
modern biotechnology research capacity in Romania are listed in Box no. 9 and the
entire report is available on the web site: www.biosafety.ro
The assessment will be carried out in accordance with the procedure foreseen in
Annex no. 3 of the law and it should lead to the classification of the contained use into
one of the classes presented in Box no 10.
When uncertainty exists in relation to the class of the proposed contained use, more
severe protection measures should be applied except for the situation in which there
are sufficient evidences that justify the application of less severe measures, in joint
agreement with the competent authority.
[ii] Authorization The Notifier may request authorization from the MEWM that will
make a decision within 45 or 90 days from the notification, depending on the risk
class.
The MEWM will analyse the compliance of notification with the provisions of the
GO 49/2000, the accuracy of assessment, as well as the contained use class, the
protection and response measures in emergency cases, as well as waste
management.
The approvals for the activities related to GMO contained use, according to the
provisions of Art. 12-15 (GO 49/2000), are given under the form of an authorization
whose template is established by the MEWM.
36
AUTHORIZATION SYSTEM
The necessary information for notifying is in accordance with the provisions of
Annex no. V to the EU Directive 98/81/EC, on the contained use of genetically
modified organisms.
3.8. RISK ASSESSMENT
The objective of environmental risk assessment is the identification and assessment
of the possible adverse effects that GMOs may have on human health or on
environment as a result of the deliberate release into the environment or placing on
the market; these effects may be direct or indirect and they may appear immediately
or with delay. ERA should be carried out to establish whether it is necessary or not to
develop a risk management plan; in case this proves to be necessary, the best
methods for enforcement should be specified. The procedure is regulated by GO no.
49/2000, approved with its modifications and completions by Law no. 214/2002 that
transposes EU Directive 2001/18/CE.
The general rules, in agreement with the precautionary principle in conducting
environmental risk assessment study, should comply as follows: [1] the identified
GMO characteristics that can induce adverse effects during GMO use should be
compared with the characteristics of the non-genetically modified organism from
which it is derived; [2] should be scientifically-based and transparent, based on
existing data; [3] should be done on a case-by-case basis, as the information may be
different according to the GMO type, the purpose for use and the characteristics of
the environment where it is released; the results of the GMO previous releases into
the environment should be considered as inter alia. [4] When new information
appears regarding to the genetically modified organism and its effects on the
environment, the environmental risk assessment study should be revised to
establish if: a) the risks are modified; b) it is necessary to modify the risk management
plan.
Developing guides for implementing risk assessment is one of the present concerns
(e.g. “Guide for notifications and risk assessment for releases of genetically modified
organisms - Draft 9 November 2005” www.pubresreg.org).
37
 Box 10 class 1: activities with negligible or no risk, i.e.
activities for which containment level 1 is
Contained use adequate for human health and environment
classification protection;
class 2: activities with low risk, i.e. activities
for which containment level 2 is adequate for
human health and environment protection;
class 3: activities with moderate risk, i.e.
activities for which containment level 3 is
adequate for human health and environment
protection;
class 4: activities with high risk, i.e. activities
for which containment level 4 is adequate for
human health and environment protection

3.9. RISK MANAGEMENT

Risk management consists of the establishment and enforcement of a set of risk

mitigation or monitoring measures and intervention measures in case of accident.
The procedure is regulated by GO no. 49/2000, approved with its modifications and
completions by Law no. 214/2002 that transposes EU Directive 2001/18/CE.

During the risk assessment procedure, the risks should be identified for which it is
necessary to elaborate management plans and to establish the adequate plan that has
to be applied.

GMO general risk assessment is carried out taking into consideration each strategy
proposed for the risk management, on a case by case basis.

This procedure is extremely important as it facilitates the management of any

adverse possible impacts on the environment and human health that may emerge
immediately and/or with delay, in a direct or indirect way, as a result of using GMOs
or GMO-based products (contained use, cultivation for commercialization and
placing on the market).
Soyabean Roundup Ready is the only biotech
crop approved for cultivation in Romania
Co-author Ana Maria Comănoiu

38
 CHAPTER 4

MONITORING

GMO import, release into the environment and placing on the

market, as well as contained use are followed by specific
biosafety activities. One of these activities is the monitoring of
GMO effects on the environment and human health and the
identification of unforeseen effects not identified during the risk
assessment studies.

MONITORING ACTIVITY

In accordance with GO no. 49/2000, approved with

modifications and completions by Law 214/2002, GMO
activities will be subjected to the monitoring procedure with
regard to the potential adverse effects on human health and
environment. The monitoring will follow certain procedures,
clearly stipulated in the law, according to a monitoring plan
presented by the Notifier; the scientific information obtained as
a result of the application of this procedure will be used for
future risk assessment procedures as regards the placing on the
market of the same GMO.

The monitoring activity can be carried out for contained use

and/or after obtaining the approval for GMO release into the
environment or placing on the market. The data collected as a
result of the monitoring process should provide new
information on the impact of GMO release into the environment
or on the market, under different conditions. When such new
information appears, this should be automatically considered

41
 MONITORING

when carrying out the following environmental risk assessment studies. The informed on any observed adverse effects on human health and the environment.
experience and information collected through the monitoring of GMO for deliberate Time points and intervals for reports on the results of the monitoring shall be
release in the environment should be the basis for the design of the monitoring indicated); [6] give consideration to the mechanisms for identifying and confirming
system for placing on the market, as such or under the form of different products. any observed adverse effects on human health and environment and enable the
consent holder or the competent authority, where appropriate, to take the measures
necessary to protect human health and the environment.
MONITORING PLAN The MEWM Order no. 606/2005 approves the Format for presenting the results of
The objectives of the monitoring plan stipulated by the law 214/2002 are according deliberate release into the environment of genetically modified crops, for other
to Directive 2001/18/EC [1] confirm that assumptions in the environmental risk purposes than placing on the market. As it has been mentioned in chapter 2, the
assessment regarding the occurrence and impact of potential adverse effects of the Order fully transposes the Commission Decision no. 2003/701/EC, based on
GMO or its use were correct; [2] identify the occurrence of adverse effects of the GMO Directive no. 2001/18/EC. Clear procedures are specified: [1] or each notification
or its use on human health and the environment that were not anticipated in the number, the Notifier submits a final report or a final and intermediary report on
environmental risk assessment. post-release monitoring, according to each case. Both types of reports are elaborated
in accordance with the Report Format; [2] the final report can be transmitted after the
According to the Law, the design of the monitoring plan have comply with Directive last harvesting of genetically modified crops. If for a notification no post-release
2001/18/EC and these requirements are as follows: [1] be detailed on a case by case monitoring is required, no subsequent reports are needed; [3] the final post-release
basis taking into account the results of the environmental risk assessment (ERA); [2] monitoring report is submitted after the completion of the post-release monitoring.
take into account the characteristics of the GMO, the characteristics and scale of its
intended use and the range of relevant environmental conditions where the GMO is
expected to be released; [3] incorporate general surveillance for unanticipated
adverse effects and, if necessary, (case-) specific monitoring focusing on adverse
effects identified in ERA; [i] whereas case-specific monitoring should be carried out
for a sufficient time period to detect immediate and direct as well as, where
appropriate, delayed or indirect effects which have been identified in ERA; [ii]
whereas surveillance could, if appropriate, make use of already established routine
surveillance practices such as the monitoring of agricultural cultivars, plant
protection, or veterinary and medical products. An explanation as to how relevant
information collected through established routine surveillance practices will be
made available to the consent-holder should be provided; [4] facilitate the
observation, in a systematic manner, of the release of a GMO in the receiving
environment and the interpretation of these observations with respect to safety to
human health or the environment; [5] identify who (notifier, users) will carry out the Co-author Ana Maria Comănoiu
various tasks the monitoring plan requires and who is responsible for ensuring that
the monitoring plan is set into place and carried out appropriately, and ensure that
there is a route by which the consent holder and the competent authority will be

42 43
The Romanian arable surface especially
devoted for tradition crop cultivation is
around 9.38 mil ha . Modern Biotechnology is
promising to obtain new cultivars, expressing
new traits, considered as superior compared
to the traditional crops
 CHAPTER 5

LABELLING AND TRACEABILITY

Labelling and traceability are other important elements of the

“follow up” phase of a biosafety system. The main legal act that
covers these activities is GO no. 49/2000, approved with
modifications and completions by Law 214/2002.

Labelling the foodstuffs on the market that are based on GMOs

or that contain additives and flavours that have been genetically
modified or obtained from GMOs, is currently regulated by the
GD 106/2002, Appendix no. 3, initiated by the NACP (the
Minister of Environment and Water Management has no
responsibilities in this field). The label should clearly specify
whether GMOs are present. It is compulsory that the label
should clear specify “This product contains genetically
modified organisms”. GD 106/2002 on food labelling, stipulates
in Appendix no.3 the Methodological Norms on additional
information that should be compulsory specified by labelling in
the case of food obtained from GMOs or that contains
genetically modified additives and flavours that are obtained
from GMOs. This refers to foodstuffs or food ingredients that are
fully or partly obtained from genetically modified soybeans,
tolerant to glyphosate and to genetically modified maize,
tolerant to ammonium glufosinate. The line “product obtained
from genetically modified………” will be clearly specified on
the foodstuff label or in the list that specifies the ingredients. The
products containing more than 1% GMOs will be labelled,
which for the moment is not complying with the EU regulation
(0.9%). Foodstuffs and food ingredients should not be labelled,
according to this decision if they do not contain protein and/or

47

DNA of GMO (i.e. oil, alcohol, starch).
Traceability may be achieved only through appropriate labelling throughout the
chain for example GMO from the laboratory to plant breeders, to seed producers, to
farmers, processors, and importer/exporters. It will be effective after transposing
the Regulation 2003/1830/EC and by ensuring the means of GMO detection and
analysis. This responsibility lies with to the National Sanitary-Veterinary and Food
Safety Authority (NSVFSA) that will collaborate with the MEWM, the Ministry of
Agriculture, Forests and Rural Development (MAFRD), the National Authority for
Consumer Protection (NACP) and the Ministry of Health (MH). The transposing
deadline, established by the Position Document, is the second semester of 2006.
Certain traceability elements have already been introduced by Art. 29, par. 1(c) of the
GO 49/2000, approved with modifications and completions by Law no. 214/2002,
referring to labelling and packaging.
Traceability elements have been also introduced through the MAFRD Order no.
462/2003 regarding the evidence of farmers cultivating GMO crops. It is specified
that in the approval process regarding the deliberate release into the environment
and placing on the market of GMO crops in the year 2005, MAFRD approved the
GMO imports and deliberate release in the environment for testing or cultivation
purposes, only on the condition of complying with the provisions of Order
462/2003, by all the economic operators cultivating GMO crops. The MAFRD, on the
basis of this Order, is the competent national authority for the evidence of economic
operators that cultivate GMOs. The Order stipulates that it is compulsory for all
economic operators (natural or legal persons, non-legal associations) to declare
GMOs cultivated plots with and the yields obtained to the County Directorates for
Agriculture and Rural Development (CDARD), and to the Directorate of Bucharest
Municipality. The statement is filled in two copies: one copy is to be sent to the
CDARD in 10 days maximum after the crop cultivation is completed (Appendix 1),
after the crop harvesting (Appendix 2); and another copy is kept at the central office
of the economic operator for 5 years. Information are collected at the CDARD and
electronically transmitted to the Computing Centre of MAFRD (the Record Register
of Romanian Economic Operators Cultivating GMO crops). In order to ensure the
observance of the Order no. 462/2003 of the MAFRD, the companies provide their
clients with the statement Templates, together with the seed selling documents that
they have to fill in and send to the Agricultural Directorates. At the same time, the
48
LABELLING AND TRACEABILITY
companies should provide information to the MAFRD referring to the client
identification data, sold seed quantities, varieties and biological categories. This
information is necessary for checking the data received through the Agricultural
directorates.
According to Law no. 266/2002, seeds can be imported only after receiving the
import approval issued by the MAFRD. The commodity is packed into bags, and on
the labels and accompanying documents it should be specified that the variety is
genetically modified. For a clear record regarding of the seed distribution, the clients
are obliged to return the empty packages to the respective companies, after the
cultivation season. The MAFRD can forbid the use of a GMO variety in a certain
region of the country or on the whole territory, if it is found that the respective
variety is harmful for other crop varieties (i.e. outcross pollination) or it endangers
the environment or human health. A genetically modified variety cannot be tested or
registered if the applicant does not prove that this complies with the legal conditions
regarding environment and human health protection.
So far, a proper record of the imported quantities of GMO soybean for processing
purposes could not be kept, as there is no distinct tariff line in the Import Schedule for
the genetically modified products. It is necessary to establish, together with the
NCA, a recording system. In the same context, the MAFRD, together with the
NSVFSA, imposed to the notifying companies the obligation to report the accurate
situation of cultivated areas, of the yield obtained and of its use to the MAFRD.
Other traceability elements were also introduced in Romania through food safety
legislation, namely Law no. 412/2004 for the modification and completion of Law
no. 150/2004 on food safety. This law provides for checking the means by which feed
traceability is carried out by all the operators and agents in the food industry. On this
basis, for the year 2005, the notifications of GMO producing companies, regarding
GMO imports and deliberate release into the environment for testing as well as for
cultivation purposes were approved only on the following condition: the economic
operators, authorized natural or legal persons operating in this field, should
demonstrate the destination of the GMO seeds, up to the point of their
commercialization of GMO as food or feed. At the same time, the labelling of
products was imposed. The users of GMO seeds are to be informed by notifiers on
the obligations they have in traceability and labelling.
49
Recommendations

Traceability or the application of the traceability procedure of a GMO from the

laboratory to production, market and then to consumer or into the environment is an
essential condition that is imposed at EU level. The methods and techniques
necessary for certifying the transformation event for traceability purposes are not
regulated by the Law 214/2002. The use of services from an accredited laboratory for
ISO 17025 is compulsory.

Applying the transparency principle is

essential for the credibility of the biosafety
system

Co-authors: Ana Maria Comănoiu, Constantin Sin

50
 CHAPTER 6

ENFORCEMENT

Enforcement is of utmost importance to the credibility of any

biosafety system. The establishment and operation of a biosafety
inspection body, accreditation of a laboratory according to ISO
17025 (performing specific tests along the biosafety chain:
import, contained use, greenhouse, field testing, deliberate
release into the environment and placing on the market), are
essential conditions for organizing a functional system in this
domain, in close correlation with similar issues developed in
countries from sub-region and EU Member States.

INSPECTION AND CONTROL

Several authorities have responsibilities and capacities of

inspection and control. A brief presentation of them will be
given bellow.

6.1. MINISTRY OF ENVIRONMENT

AND WATER MANAGEMENT

THE BIOSAFETY COMMISSION (BC) is the scientific body

established by GO no. 49/2000, approved with completions and
modifications by Law 214/2002, as well as by the MEWM Order
no 684/2002, to participate in control activities organized by the
central public authorities. The BC a) participates in inspections
and checks the compliance with legal provisions with respect to

53

the GMO contained use, deliberate release into the environment, placing on the
market; b) participates in inspection activities and checks the observance of legal
provisions with respect to import operations with GMOs or with products that are
based on, contain or originate from GMOs obtained through modern biotechnology
techniques.
THE NATIONAL ENVIRONMENTAL GUARD (NEG) for public inspection and
control operates as the specialized body of the central public administration under
the MEWM according to Government Decision 440/2005. The Directorate for
Control of Natural Habitats, Biodiversity and Protected Areas is habilitated for
control and inspection activities with respect to biosafety, in accordance with the
MEWM Order 684/2002 (Art 3.2.).
The NEG is a specialized control and inspection body in charge of the effective,
professional, uniform and integrated enforcement of the Government policy for the
enforcement of the EU environment legislation which is transposed into the
Romanian environment legislation. Technical norms regarding the organization and
carrying out of the Control and Inspection activities in the field of environment
protection are designed in accordance with the European Parliament and Council
Recommendation (April 4, 2001) regarding the minimum criteria for environment
inspections in the EU Member States, with the provisions of Art. 65.s and Art.68 of
the Environment Protection Law no. 137/1995, republished with its subsequent
amendments (Appendix 2 of the law).
The NEG has to enforce Government policy so as to prevent, ascertain and sanction
the infringement of legal provisions with respect to environment protection,
including the observance of legal provisions in relation to issuing environment and
water management permits, licenses and authorizations by the competent
authorities, according to the legislation in force, for the regulation of projects,
programs and activities specific to these fields.
Environment inspection is compulsory for those objectives having a significant
impact on the environment and it is exercised by the inspectors (commissioners)
from the NEG structures; the inspection plans should be made available for public
consultation, according to the legislation in force regarding public access to the
environment information.
The Commissariats at regional and county level, the Commissariat from Bucharest
54
ENFORCEMENT
and the Environment Commissariat of the Danube Delta Biosphere Reserve
elaborate the “Territorial Registers of the Controlled Objectives”, containing the lists
of controlled objectives in their respective areas. The regional commissariats collect
and approve the “Territorial Registers of the Controlled Objectives” from their area
and submit them to the General Commissariat of the NEG for the approval.
At national level, the “National Register of Controlled Objectives” is established; this
database is managed and periodically updated by the NEG General Commissariat.
After checking, the NEG General Commissariat will approve and send the
“Territorial Register of Controlled Objectives” to the NEG territorial commissariats.
The environment inspection is an activity consisting of: 1) checking compliance; 2)
investigating the impact on the environment that can result in future inspections
(including the issuing, reviewing, suspending or cancelling of legislative acts) or the
application of sanctions, if appropriate.
The environment inspections can be both scheduled and unannounced. Inspection
preparation is an obligatory step, being necessary for ensuring efficiency and
fulfilling inspection objectives; the inspection activity follows a strict procedure.
The NEG documents available to the public are as follow: [1] “The National Register
of Controlled Objectives”, at the NEG General Commissariat; [2] ”Territorial
Register of Controlled Objectives'', at the NEG territorial commissariats; [3]
”Registers of Inspection Reports'', at the NEG commissariats.
Confidential data (i.e. international relations, national or public security, the course
of justice, the right of a person to benefit from right judgement or the right of a public
authority to conduct a civil or penal investigation) and also the confidentiality of
commercial and industrial information, when this is stipulated in the law for the
purpose of protecting a legitimate economic interest will not be made available to the
general public. In this context, only those information will be available to the public
regarding the emissions with significant effect on the environment; the copy right
compliance.
Recommendations
Presently BC and NEG do not perform GMO-related inspection and control
activities. As NEG is a very specialized structure in inspection and control activities,
55

this capacity should be used for biosafety activities as well. It is necessary to develop
the GMO inspection body specialized in sampling and conducting specialized
inspections and to include it into the national biosafety network.
6.2. MINISTRY OF AGRICULTURE, FORESTS AND RURAL DEVELOPMENT
There are several departments within the MAFRD that enforce the law.
THE INSPECTION DIRECTORATE has the following tasks [1] it control the
enforcement of regulations in wine and grapevine sector, vegetables, fruit, flowers,
as well as in the other activity sectors; [2] it checks the compliance with cultivation
and land clearing norms, with all the technical norms governing agricultural
production; [3] it inspects the way legal provisions are observed with respect to the
activity in agriculture and forestry by the units subordinated to the MAFRD.
THE STATE INSPECTION FOR TECHNICAL CONTROL IN VEGETABLES AND
FRUIT PRODUCTION (SITCVFP) operates within this directorate, established by
the Order of the MAFRD no. 143/2004, on the basis of the provisions of Law on fruit
farming no. 348/2003, Law no. 312/2003 on the production and marketing of field
vegetables and Law no. 469/2003 on the production and marketing of greenhouse'
vegetables, flowers and ornamental plants. At the same time, this directorate checks
up the documentation and approves the cultivation and land clearing authorizations
of the fruit and berry cultures, issued by the agricultural and rural development
directorates at county level and of the municipality of Bucharest; it also checks on a
random basis the application of crop technologies in the commercial farms that
produce fruit, vegetables, melons and mushrooms.
THE STATE INSPECTION FOR TECHNICAL VITICULTURE AND WINE
CONTROL (SITVWC) also operates within this directorate, that was established on
the basis of the provisions of Law no. 244/2002 on grapevine and wine in the system
of joint market organization, providing for [1] the observance of legislation
regarding the establishment and clearing of grapevine plantations; [2] the approval
of applications for the establishment and clearing of grapevine plantations on areas
larger than 0.1 ha per family or economic operator; [3] checking and control the
enforcement provisions on the production, commercial purposes, of grapes, wines
and other vine and wine products, regardless of producer.
56
ENFORCEMENT
NATIONAL INSPECTION FOR SEED QUALITY (NISQ) This Department was
established according to Law no. 266/2002 on the production, processing, quality
control and certification of seeds and reproductive material, as well as the
registration of crop varieties. NISQ is the national authority for seed and
reproductive material quality control and certification, registration, supervision,
monitoring and accrediting of certain activities of producers, processors and traders
that are professionally involved in seeds and reproductive material activities. NISQ
operates in the territory through 30 Territorial Inspectorates for Seed and
Reproductive Material Quality (TISRMQ), with 10 branches and through the Central
Laboratory for Seed and Reproductive Material Quality (CLSRMQ). The National
Inspection for Seed Quality Registers, issues, and withdraw the operation
authorizations for the economic operators that produce, process and/or sell seeds; it
organizes, co-ordinates and controls the activity of territorial inspectorates for seed
and reproductive material quality and of the Central Laboratory for Seed and
Reproductive Material Quality; it ensures the control, for seed quality purposes, for
all biological categories on a pre- and post-control basis. The inspectors from the
TISRMQ check and control the labelling of genetically modified seeds according to
the law.
COUNTY DIRECTORATES FOR AGRICULTURE AND RURAL DEVELOPMENT
(CDARD) These directorates control the GMO crop commercialization according to
the provisions of the MAFRD Order no. 462/2003 on the record of economic
operators cultivating GMO crop. These units collect and send to the MAFRD
information referring to the cultivated areas, origin of seeds, yield obtained and its
destination.
THE STATE INSTITUTE FOR VARIETY TESTING AND HOMOLOGATION
(SIVTH) was established on the basis of Law no. 57/1997, by the reorganization of
the State Commission for Variety Testing and Homologation; it operates according
to Law no. 266/2002 as a specialized body subordinated to the MAFRD. Its purpose
is to investigate from the technical point of view the varieties for which requests have
been made to be registered in the Variety Register and the Official Variety Catalogue.
The institute is subordinating 40 territorial centres, where the varieties are analysed
from the technical point of view; it collaborates with the MAFRD directorates and
specialized departments, with the research institutes and research stations, with the
foreign companies interested in testing the varieties in Romania. At the same time, it
57

collaborates with the National Inspection for Seed Quality from the MAFRD, the
Central Laboratory for Seed and Reproductive Material Quality, the Territorial
Inspectorates for Seed and Reproductive Material Quality, the Central Laboratory
for Phyto-Sanitary Quarantine, agricultural universities and different natural and
legal persons from Romania or from other countries.
SIVTH has the following responsibilities: a) it develops the methodology for
technical examination and presentation of the new varieties, for their registration in
the Variety Register and publication in the Official Catalogue, taking into
consideration the internal and international regulations in force; b) it examines the
varieties for which registration is requested; c) prevents the alienation of biological
material under examination and ensures the information confidentiality, at a request
of breeders; d) ensures the storage of seed samples from the registered varieties; e)
undertakes the annual check of the variety purity belonging to multiplied varieties,
as decided by the control and certification authority; f) keeps the Variety Register, it
edits and publishes the Yearly Official Catalogue; g) provides the linkage with the
international bodies and organizations in the field of variety testing and registration.
In the Official Catalogue of crop varieties cultivated in Romania, from the year 2004,
14 GMO soybean varieties have been registered, but SIVTH, does not function yet in
a transparent manner (i.e. record of field testing available to the public).
Recommendations
The use of services from an accredited laboratory for ISO 17025 is crucial as well as
the organization of a GMO inspection body for all activities related to this Ministry.
Applying the transparency principle is compulsory by developing appropriate
procedures regarding the general public access to relevant information. Traceability
is not implemented yet and it will be necessary to develop appropriate procedures to
track GMO from “farm to the fork” for all MAFRD departments mentioned above.
6.3. MINISTRY OF HEALTH
The Ministry of Health elaborated the inspection procedure in accordance with
Order 861/2003.
58
ENFORCEMENT
SANITARY INSPECTION
The inspection procedure is proposed in the methodology for carrying out the
national synthesis “Monitoring and inspection of GMO food” and it is addressed to
the Public Health Directorates at county level (41) under the subordination of the
Ministry of Health. The implementation of this synthesis encounters difficulties in
the mapping of producing/importing and distribution units of GMO food due to the
lack of the legal bases for horizontal communication between the authorities and
hence the lack of access to information.
Recommendations
No specifications with regards to GMO issues are in place, thus a review of the
legislative system is needed. There are no ISO 17025 accredited laboratories. It is
important to broaden the involvement in gene therapy and GM vaccines into GMO
regulation.
6.4. NATIONAL SANITARY-VETERINARY
AND FOOD SAFETY AUTHORITY
NSVFSA is organized and functions in accordance with GO no 42/2004 with its
subsequent amendments and the GD no 738/2005 (Appendix 3). The enforcement of
Law no 150/2004 on food safety represents the basis for ensuring a high human
health protection level and consumer food interests.
The main tasks of NSVFSA are as follows: [1] designs and implements the strategy
and legislation on food safety; [2] is in charge of the risk assessment and establishes
the measures to be imposed when a serious problem appears that may endanger
human health; [3] coordinates the control activity in food quality and safety
according to the existing EU pattern and [4] supervises and monitors the economic
operators that work in food industry with respect to food safety.
The main objectives of this authority are the following: 1) to protect human health
and life; 2) to protect consumer interests while taking into consideration animal
health and welfare, plant health and environment protection 3) the free movement of
merchandises.
59

The main GMO activities of NSVFSA are regulated by a series of normative acts and
include: [i] issuing scientific consent with respect to issues related to GMO food and
feed and [ii] controlling the application of GMO food and feed traceability
requirements.
Up to date, NSVFSA has carried out the following activities in relation to GMOs: [1]
appointed GMO responsible persons at the level of each county sanitary-veterinary
and food safety directorate, establishing a biosafety network at national level; [2]
training of the involved staff and [3] participation as observer to the meetings of the
Standing Committee for Food Chain and Animal Health, GMO section from the
European Commission, for the elaboration of EU normative acts regulating this
activity field.
Units subordinated to NSVFSA are as follows:
-Institute of Hygiene and Veterinary Public Health
-Institute of Animal Health and Diagnosis
-Institute for the Control of Biological Products and Veterinary Drugs
-42 Sanitary-Veterinary and Food Safety Directorates
In these institutions microbiological analysis are performed (bacteriology, mycology
and virology) as well as physical-chemical, toxicological and residue detection tests.
The Institute of Animal Health and Diagnosis has a section for modern molecular
biology analysis, being provided with equipment and qualified staff for specific
testing in GMO field. The Sanitary-Veterinary and Food Safety Directorates from
Braşov and Constanţa are provided with the necessary equipment for GMO testing.
By accessing funds for ISO 17025 accreditation through SAPARD, NSVFSA has in
view accrediting GMO laboratories.
Recommendations
The use of services from an accredited laboratory for ISO 17025 is crucial as well as
the organization of a GMO inspection body for all activities related to this Authority.
Traceability is not implemented yet and it will be necessary to develop appropriate
procedures to track GMO from “farm to the fork” and clarify responsibilities
towards the other authorities.
60
ENFORCEMENT
6.5. NATIONAL AUTHORITY FOR CONSUMER PROTECTION
NACP coordinates and develops Government strategy and policy with regard to
consumer protection, takes actions for the prevention and control of practices that
endanger consumer health, security or economic interests; evaluates market effects
of the surveillance systems of products and services.
NACP organization and operation is in accordance with GD no. 755/2003. The main
NACP responsibilities are as follow: [1] participates together with other specialized
central and local public administration bodies and the non-governmental
consumers organizations to the establishment of the consumer protection strategy,
ensuring its correlation with that existing in the EU; [2] summits for Government
approval and scientifically approves draft legal acts in the field of consumers
protection with regards to the manufacturing, packaging, labelling, conservation,
storage, transport, import and commercialization of products, as well as to
rendering of services, so that these may not endanger the life of consumers, health or
security or affect their legitimate rights and interests; [3] elaborates, together with
other specialized public administration bodies, procedures regarding the objectives,
conditions and development means for consumer protection activities; [4] carries
out different tests and trials in the accredited laboratories or in its own or agreed
laboratories; [5] carries out activities in relation to consumer information,
counselling and education; edits specialized publications in the field of consumer's
protection; [6] permanently informs the consumers on the products or services that
are hazardous for their health and security or that can affect their economic interests;
[7] periodically reports to the Government and to the interested central public
administration bodies about its own activity regarding the observance of consumers'
rights and interests; [8] controls the observance of legal provisions regarding on
consumers' protection, referring to the safety of products and services, as well as to
the defence of consumers' legitimate rights, by carrying our controls on producers,
importers, distributors, sellers, providers of services or in the customs units, having
access to the premises where products are produced, stored or traded or in which
services are provided, as well as to the documents referring to these; [9] detects
contravention cases and establishes measures to limit the consequences of
manufacturing, import, commercialization, or providing on a free of charge basis of
certain products and services that do not observe the legal provisions in the
Authority scope of activity, by applying the main and complementary contravention
sanctions provided by the law; it informs the legal authorities whenever they find
61

out infringements of the penal law; [10] requests that the issuing bodies suspend or
withdrawal the operation authorization, of the manufacturing licence or
classification certificate, under legal conditions; [11] receives and solves or, if
appropriate, transmits to the competent entities for solving the notifications of
natural or legal persons with regards to violation of consumers' rights, under legal
conditions; [12] checks, according to the law, the legality of publicity for the products
and services intended for consumers.
The main NACP activities regarding GMOs are regulated by GO 49/2000, approved
with completions and modifications by Law 214/2002 and they include: [1] issuing
written consents, within the limits of its competence, according to established
responsibilities; [2] checking enforcement of requirements regarding the labelling of
products so as to ensure correct, complete and accurate information of consumers.
NACP has 42 consumer protection offices in its subordination in all the counties of
the country and in Bucharest, as well as the National Centre for Products Testing and
Expertise LAREX-Bucharest, as an extra-budgetary unit with 9 territorial branches
(i.e. Bucharest, Arad, Baia Mare, Constanţa, Galaţi, Oradea, Satu-Mare, Sibiu and
Iaşi), their operation being regulated by the GD no. 625/1999.
Besides the National Centre for Products Testing and Expertise LAREX-Bucharest,
the laboratory network also includes own-testing and trial county laboratories (i.e.
Bacău, Vrancea, Neamţ, Brăila and Suceava), as well as the Laboratory for Wine and
Spirit Drinks Quality that operates within the structure of the Consumer Protection
Office of the Municipality of Bucharest, laboratories that at the moment do not
contain the necessary equipment for specific GMO tests.
Recommendations
The use of services from an accredited laboratory for ISO 17025 is crucial as well as
the organization of a GMO inspection body, constantly trained in the biosafety
domain.
6.6. NATIONAL CUSTOMS AUTHORITY
According to Law 144/1997, the NCA has the right to enforce customs control of
transport means and commodities, as well as of goods and values belonging to
62
ENFORCEMENT
natural persons, presented at the entry into or exit of the country.
In accordance with Art. 45 of the Regulation on Romania's Import Schedule
application, approved by GD no 1114/2001, it is stipulated that the import custom
statement is submitted to the customs authority together with the following
documents: (1) transport document of commodities or in the absence of this other
documents issued by the transporter including data referring to the transported
commodities; (2) invoice, as original or copy, or another document by which the
value of commodities that reached the custom is declared; (3) customs declaration;
(4) the documents necessary for the application of a preferential tariff regime or of
other derogatory measures to the basic tariff regime; (5) any other document
required for provisions enforcement from the specific legal norms that regulate the
import of declared commodities; (6) titular identification code.
Through Law no. 98/1996, published in the Official Journal no. 234/1996, Romania
joined the International Convention on the Harmonized System of Merchandise
Denomination and Codification signed in Brussels on June 14, 1983. Thus, in
Romania, the classification of commodities in the Import Schedule is in agreement
with the Harmonized System. Romania's Import Tariff Nomenclature is the EU
Combined Nomenclature, with 8 digits. For example, the soybean kernels and also
the crushed kernels, intended for cultivation, are classified in the tariff code
1201.00.10.
Currently, present there are no legal provisions regarding GMO crops in accordance
with the text of the explanatory notes of the Harmonized System, approved by
Decision no. 1783/2002/EC and in conformity with the Emergency Ordinance no.
94/2004, by which Romania's Import Schedule was approved. Furthermore, the
national legislation in force does not include references regarding special customs
regulation on the GMO import/export operations.
In this context, the main legal act on biosafety, GO 49/2000 approved with
modifications and completions by Law 214/2002 does not include the National
Customs Authority in the national biosafety framework and thus its reconsideration
is imposed.
63

Recommendations
The National Customs Authority proposes the improvement of national biosafety
legislation by introducing certain regulations that should include the list of GMOs
and GMO-based products that are the object of biosafety, the procedures to complete
this list, to specify the type of document that should be presented to the customs
office for undertaking the import/export customs operation, as well as the
obligations of economic operators that undertake such operations for facilitating
their traceability on Romania's territory and abroad. In order to facilitate traceability,
the NSVFSA, in collaboration with the customs offices will carry out specific tests, if
it is necessary, to check the compliance of GMO contents. Very important would be
the constant training of the custom officers in biosafety domain.
6.7. THE MINISTRY OF TRANSPORT, CONSTRUCTIONS AND TOURISM
In accordance with the regulations of this authority, transport of GMOs can be
regulated in a similar way as “hazardous goods” if they can affect animals, plants,
microorganisms or ecosystems in a way that cannot occur naturally. The producer of
these goods has the legal obligation to classify them into this category, if appropriate.
If for a road transport for such goods the authorities of the origin, transit and
destination countries have not issued special utilisation authorizations, the
respective transport will take place in conformity with the provisions of the
European Agreement on the International Road Transport of Hazardous Goods
(ADR) signed in Geneva on September 30 1957. If GMOs are classified by ADR as
being hazardous goods, they will bear the identification number UNO 3245, and
their road transport is in this case regulated as follows: [1] international transport by
Law no. 31/1994 for Romania's joining the European Agreement ADR; [2] the
internal transport by GO 48/1999 regarding road transport of hazardous goods,
approved by Law no. 122/2002 and by GD no. 1374/2000 on the approval of norms
for the gradual application in the internal traffic of the provisions of the European
Agreement ADR, that Romania joined by Law no. 31/1994, modified and completed
by GD no. 258/2004. It should be specified that, in conformity with these normative
acts, ADR provisions are applied both to the international and internal transport.
According to the provisions of GD no 1374/2000 with its subsequent improvements
and changes, the coercive measures to apply these regulations are the following: [i]
64
ENFORCEMENT
in-traffic controls, controls at the location of transport operators, at the sites of
loading, unloading, packaging and storage of these goods and at the border control
points by the authorities mentioned in Art. 13; [ii] a severe sanctioning system
ranging from application of fines to vehicle immobilization and even forbidding the
access on Romania's territory of vehicles registered in other countries, that may
endanger traffic, transport and environment safety; [iii] professional training of
“drivers transporting hazardous goods” and of “safety counsellors” for companies
that operate with hazardous goods.
The authorities appointed by GD no. 1374/2000, for the enforcement of regulations
on road transport of hazardous goods and that have responsibilities in GMO
transport are the following: (1) MTCT for transport-related problems, attesting the
drivers of vehicles and safety counsellors, control activities; (2) Ministry of
Administration and Internal Affairs for control activities; (3) Ministry of Economy
and Trade for problems related to packages and control; (4) Ministry of Environment
and Water Management for control issues; (5) General Inspectorate for Emergency
Situations and Interventions, if appropriate.
Recommendations
The introduction of this authority in the National Biosafety Framework and the
introduction of specific regulations on the control of documents for inner traffic are
necessary.
Final recommendations
Capacity building regarding the enforcement of ROMANIAN BIOSAFETY
REGULATORY SYSTEM will be compulsory for the near future in Romania.
Co-authors: Elena Badea, Ana Maria Comănoiu,
Anica Popa, Constantin Sin, Liliana Nistor, Alexandru Petrişor, Monica Neagu,
Felix Nicolescu, Klaus Fabritius
65
 Developing communication between authorities and
all stakeholders is the main pillar in applying the
transparency principle in decision making process

66
 CHAPTER 7

MECHANISMS TO PROMOTE AND

FACILITATE PUBLIC AWARENESS,
EDUCATION AND PARTICIPATION

The public right to information is clearly stipulated in the

Universal Declaration of Human Rights. During the last
decades, instruments have been adopted focusing on human's
rights to information on environment. Furthermore,
international instruments have been adopted that address
public participation in the decision-making process regarding
environmental issues; such issues are no longer unilaterally
treated only by the officials.

While the public participation process is a key-element in

biosafety decision-making, its implementation may represent a
problem not only for Romania but for other countries as well.
Although there is an official recognition in relation to this, there
is no generally accepted consensus on the public participation
modality. The conceptual interpretations of this term allow for a
wide participation range, from physical entities and
empowered communities to political governance systems. Out
of this reason, many international tools referring to public
participation, as well as the national regulations are not
implemented yet, as it is considered that the public participation
process has both potential benefits and complications.

Public participation may be defined as the direct participation in

the decision-making process of the non-governmental players
together with the authorities. This participation includes
comments, public hearings, national referendum, etc. The legal
actions can be also considered as a public participation forum.

69

Public information is a pre-condition for the effective participation of the public in
the decision-making process; for this purpose, its permanent education is needed. At
each level, different methods and mechanisms are used. Often three pillars in public
participation are distinguished: access to information, public participation in the
decision-making and access to justice.
Ideally, the public participation regulations should be simple and easily to
implement, through the development of a sustainable environment. There are also
significant cultural differences concerning implementation of different public
participation tools. These mainly refer to the fundamental values of each nation. That
is why the focus upon national culture is essential for public participation
organization, especially when new methods and techniques are being adopted.
Generally, Romania has easily adopted new strategies and development policies,
which reflects its easy integration into the contemporary European environment.
Box 11 Environmental issues are best handled with the
participation of all concerned citizens, at the relevant
Principle 10 of the level. At the national level, each individual shall have
Rio Declaration on appropriate access to information concerning the
Environment and environment that is held by public authorities,
Development (1992) including information on hazardous materials and
activities in their communities, and the opportunity to
participate in decision-making processes. States shall
facilitate and encourage public awareness and
participation by making information widely available.
Effective access to judicial and administrative
proceedings, including redress and remedy, shall be
provided
Many international tools have been developed worldwide that cover aspects closely
linked to public information and participation in decision making. These tools were
adopted at global level as a result of the unprecedented development of modern
biology and in close correlation with the main conventions on the environment,
highlighting the concern for the environment and human health.
[1] Rio Declaration, adopted during the Earth Summit from Rio de Janeiro, Brazil,
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PUBLIC PARTICIPATION
1992; Principle 10 promotes three pillars of public participation with respect to the
environment: [1] the right of citizens to information; [2] their right to participate in
environmental decision which affect them and [3] their access to mechanisms of
redress and justice when their rights are violated (See Box no 11).
[2] Aarhus Convention on the access to information, public participation to
decision-making and access to justice with respect to environmental issues, signed in
Aarhus on June 25, 1998; this is the most comprehensive and complex international
instrument adopted at Pan-European level.
[3] UNEP “Cartagena Protocol on Biosafety” adopted in 2000 is clearly stipulating
through the Article 23 the need for public information awareness and participation
in decision making process. In fact Article 23 (Box no 12) is best understood in the
context of Principle 10 of the 1992 Rio Declaration on Environment and Development
(Box 1). Article 23 provides for a mix of mandatory and discretionary actions that
Parties to the Protocol are expected to undertake relating to: [i] the provision
information on LMOs; [ii] public participation in LMO-related decision-making
process (Article 23.2); [iii] provision of information to the public about access to the
Biosafety Clearing-House (Article 23.3). It was also adopted in 2003 the guide
entitled: “Public Participation and the Cartagena Protocol Practical Guide”
(www.iucn.org/bookstore) where each Biosafety Protocol's Article is systematically
discussed.
[4] UNECE is acting in the field starting with 1991 and facilitated the organization in
1999 of a working group: UN/ECE Aarhus Convention GMO Working Group that
includes representatives from Europe, 5 countries from Central Asia, Canada, USA,
and Israel. The objective of this working group is to amend the Aarhus Convention
(Art. 6.11) in order to extend the role of the public in the decision-making process
regarding GMO deliberate release into the environment and placing on the market.
The Clearing House Mechanism, established by UNECE, supports the effective
implementation of the Aarhus Convention through the collection, dissemination
and exchange of information on the legislation and good practice in the following
fields: (1) Access of public to information (2) Public participation to decision-making
(3) Public access to justice.
[5] the 1st COP/MOP of Aarhus Convention 2002, detailed application of the
Convention towards GMOs with “Guide on Access to Information, Public
71

Participation and Access to Justice with regard to GMOs”, voluntary instrument
approved at the first Conference of the Parties, Lucca, Italy, 2002. The main objectives
of this guide, that strictly refers to biosafety are the following: 1) Practical application
of the Aarhus Convention provisions; 2) Development of a common approach
regarding the access to information, public participation and access to justice in
decision-making; 3) Guidance provided to Parties for developing the National
Biosafety Framework and practice in this domain; 4) Support to other countries for
the development and extension of the access to information, public participation and
access to justice; 5) Fostering an open, transparent and efficient decision-making
process with regard to GMO activities; 6) Examples of good practice; 7) Promoting
and facilitating the following processes: (a) Education (b) Awareness (c) Public
participation to decision-making.
1. The Parties shall: (a) Promote and facilitate public
Box 12
awareness, education and participation concerning the
Article 23 of safe transfer, handling and use of living modified
Cartagena Protocol organisms in relation to the conservation and
“Public awareness sustainable use of biological diversity, taking also into
and participation” account risks to human health. In doing so, the Parties
shall cooperate, as appropriate, with other States and
international bodies; (b) Endeavour to ensure that
public awareness and education encompass access to
information on living modified organisms identified in
accordance with this Protocol that may be imported.
2. The Parties shall, in accordance with their respective
laws and regulations, consult the public in the
decision-making process regarding living modified
organisms and shall make the results of such decisions
available to the public, while respecting confidential
information in accordance with Article 21.
3. Each Party shall endeavour to inform its public
about the means of public access to the Biosafety
Clearing-House.
[6] the 2nd COP/MOP of Aarhus Convention in Almaty, Kazakhstan (May 25-27
2005) adopted a Decision for the modification of Aarhus Convention, regarding
GMOs by repealing Art. 6 (11) and introducing Art. 6 bis and Annex 1 bis. This
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PUBLIC PARTICIPATION
Conference analyzed the application of the “Guide on the access to information,
public participation and access to justice with regard to GMOs”, based upon the
Report elaborated by the Convention Secretariat, after the consultation of the Parties.
Furthermore, the Parties are encouraged to apply this Guide. At the same time, the
operation of the Clearing House Mechanism of the Aarhus Convention was also
analyzed. Thus, each Party will ensure a prompt and complete information and
public participation, as regards the requests for approval for GMO deliberate release
into the environment and placing on the market, according to Annex 1 bis of the
Aarhus Convention. The requirements imposed to Parties should be mutually
completed with the provisions of NBF, consistent with the provisions of the
Biosafety Protocol (http://aarhusclearinghouse.unece.org).
7.1. PUBLIC INFORMATION AND PARTICIPATION TO DECISION-
MAKING PROCESS ACCORDING TO THE LEGAL PROVISIONS IN
ROMANIA
In Romania public information and participation regarding environmental matters
are ensured through the following legal acts, chronologically listed:
Law no. 86/2000 ratifying the Convention on information access, public
participation in the decision-making, and access to justice for environment-related
issues, signed in Aarhus on June 25, 1998 (published in the Official Journal no. 224,
dated May 22, 2000);
Law no. 137/2000 (MEWM), Environment Protection Law republished with its
subsequent amendments;
Law no. 544/2001 on free access to information of public interest (published in the
Official Journal, Part I, no. 663/2001);
Government Decision no. 1115/2002 on free access to information regarding the
environment (published in the Official Journal, Part I, no. 781/2002);
Government Decision no. 123/2002 to approve implementation Regulations for Law
no. 544/2001 on free access to information of public interest (published in the Official
Journal, Part I, no. 167/2002);
73

Law no. 214/2002 on the approval of GO no. 49/2000 regarding the obtaining,
testing, use and commercialization of genetically modified organisms obtained
through modern biotechnology techniques, as well as of the products resulting
thereof;
MEWM Order no. 1182/2002 approving the Methodology of information
management and dissemination regarding the environment, held by environment
protection public authorities (published in the Official Journal, Part I, no. 331/2003);
Law no. 59/2003 on the ratification of the Cartagena Protocol on Biosafety to the
Convention on Biological Diversity;
Public information and consultation that are specific for biosafety issues are
regulated by Law no. 214/2002 on the approval of GO no. 49/2000 and Law no.
59/2003 on the ratification of the Cartagena Protocol on Biosafety.
Regarding the authorization procedure for GMO deliberate release into the
environment and placing on the market, it is stipulated that any legal entity, before
releasing into the environment or placing on the market a GMO or GMO
combination, should submit a notification to MEWM that should contain the
technical dossier, and the dossier summary that should also be in electronic format as
public information. After the notification acceptance, MEWM, on the basis of
information included in the notification and in other documents, informs and
consults with the public with respect to the received notification.
The approval procedure for the GMO deliberate release into the environment,
placing on the market and contained use, is public. MEWM is in charge of informing
the public through the mass-media about the activities for which authorization is
requested. In 10 days from the Notification receipt MEWM informs and consults the
public. It publishes the notification summary on the site www.mappm.ro under the
chapter “General information”. At the same time, it publishes an announcement in
the mass-media and at the locations of the Environment Protection Agencies (at
regional and local level); depending on the received comments, it can organize
according to the law public debates, but the conditions are not stipulated. The public
comments are received within 30 days and will be considered in the decision-making
process.
The public access to the environment information is ensured by MEWM through [1]
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PUBLIC PARTICIPATION
Mass media: Press Office of MEWM, that produces press releases published on the
internet and transmitted to the Romanian press and [2] Internet:
http://www.mmediu.ro (General information/Informaţii generale), OMG,
http://www.biosafety.ro, http://infoarhus.mmediu.ro.
For an effective involvement of the public in the decision-making process, public
participation in national biosafety legislation should be harmonized with
international standards as well as with the current EU legislation in force.
7.2. PUBLIC EDUCATION AND AWARENESS MECHANISMS
Capacity building
Institutional level
The public education mechanisms with regard to environmental matters should also
be developed for biosafety issues at the MEWM, as competent national authority, in
close relation with the Ministry of Education and Research, other authorities
relevant in the field (Romanian Academy, Academy of Agriculture and Forestry,
Academy of Health, Biosafety Commission), non-governmental organizations
concerned with the environmental issues and mass media. The education process
should cover all generations by using the well recognized methods and tools at
international level.
The Ministry of Education and Research is the main authority with competence in
the education of the youth and to certain extent the adult generation. It is necessary to
introduce curriculum at school and university level that are especially dedicated to
modern biotechnology, biosafety and environmental aspects. At the same time, the
constant review of this curriculum in concordance with the progress in the field is
imposed and human resources constant training is a necessity. However, the
Ministry of Education and Research should take into consideration that the funding
of research projects regarding GMO cannot proceed in the absence of the respective
research notification to MEWM in conformity with Law 214/2002. To note that
between 2000 and 2005 nobody notified MEWM about such projects even some of
them were funded by the Ministry of Education and Research. Furthermore, a
75

stronger focus should be laid on biotech development in Romania, taking into
consideration the great pressure exercised by the development of this sector in the
neighbouring countries and in overall Europe.
The BC, as scientific body the organization and operation of which is authorized by
MEWM Order 684/2002, occasionally informs the public by participation in round
tables, radio and television programs, and publication of articles in different
specialized magazines. The successful initiative at the beginning of its operation was
the publication of an Information Bulletin. However publication of the Bulletin
cannot be continued due to financial reasons.
The establishment of a national environmental education network for biosafety
issues that should function very well at local level (i.e. local communities) and can be
directly/indirectly influenced by the use of modern biotechnology is compulsory. A
central role should be assigned to local authorities, in close collaboration with the
central authorities, other authorities and non-governmental organizations
concerned with the environmental issues. NGOs with a very flexible management
will be able to interconnect all involved stakeholders on a developed legal basis.
Mass media
Mass media can contribute to public information and awareness, through the
development of constant public information and education programmes on the
radio and television, different articles in newspapers and magazines or public
information journals.
So far the National Television has been concerned with the occasional information of
public on GMO issues, organizing round tables on Romanian Television (TVR1) and
(TVR2) channels. National Radio Programs also broadcasted debates, general
information, trying to satisfy the information needs of quite a large public, listening
to the radio broadcasts. The Romanian press was sporadically involved, by several
daily or weekly publications, in providing information, mainly sensational news, on
the genetically modified organisms. These also were concerned with public opinion
polls as regards GMO issues; however, the data obtained as a result of these opinion
polls are not relevant for the education and information level of the interviewed
public.
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PUBLIC PARTICIPATION
Non-governmental organizations
The Non-Governmental Organizations (NGOs) also published a series of
information materials for general public on the GMO issues. It can be considered that
the NGOs involvement in environmental issues became extremely active in
Romania, in particular after 1990, and they can contribute to capacity building
appropriate for the correct information and education of public in biosafety matters.
The NGOs, through their own capacities and by the utilization of flexible
management methods, can consolidate the biosafety communication network
between authorities, mass media and the public from all categories.
Local community' organizations
The development of local community' organizations can have a significant
contribution in the application of appropriate methods and tools for public
education, information and participation in the decision-making process. So far, no
capacities in this field have been developed.
Industry
Interested firms in developing activities related to genetically modified organisms
occasionally organized information events for farmers and producers.
TOOLS AND METHODS
Publications, workshops, seminars, public debates
The Romanian Academy has been funding research projects in this field since the
mid '70s. However, the funds have not been sufficient, in particular after 1990, so as
to manage funding a competitive modern biotech research. Through the institutes in
its subordination, the Romanian Academy organized summer schools dedicated to
modern biology after 1990. The Academy of Agricultural and Forestry Sciences
“Gheorghe Ionescu-Şişeşti“, through the Tempus and Phare Programmes succeeded
in steadily promoting modern biotechnology in Romania, mainly in the agricultural
sector. The Ministry of Education and Research also contributed with funds to this
activity field, however with decreasing amounts, since 1999.
77

[1] The UNEP/GEF project organized different seminars, info days and workshops,
in an attempt to increase public education and awareness in biosafety issues.
[2] Representatives of the MEWM and the UNEP/GEF project also participated to
the seminar for reviewing the draft Biosafety National Framework for Croatia,
Zagreb 2004. In this context, the debates focused for the first time upon the
establishment of a sub-regional biosafety network, the establishment of the Balkan
Region for Biosafety, so that each country from this area should get fast and constant
information on the national biosafety framework development in the other
countries.
[3] The participation to the summer school for the environmental journalists
“Reporting on GMOs in agriculture” from Novi Sad, Serbia, permitted the
UNEP/GEF project to have for the first time contact with the environmental
journalists from the Balkans;
[4] The UNEP GEF project had the occasion for the first time during the summer
school of Novi Sad, to assist to debates on GMO issues and mainly on their potential
to affect human habitats with tradition on a comparative basis with the potential
benefits for economic development.
The NGOs and press from Romania published a series of sensational news and
information on the biotech products, mainly after 1990. Fostering the publication of
scientifically correct information by the authorities is a prerequisite for correct
information of the public, for a correct perception of biosafety issues, as essential
condition for an effective public participation to the decision-making process.
Perspectives
Romanian researchers in biotech or environmental and human health issues should
get involved in transmitting the scientific results in terms that are accessible by the
public they intend to inform.
The scientific research results may be published in different journals, brochures,
posters and on internet; the information can be also disseminated via round tables,
public debates, conferences, workshops, seminars, radio broadcasts, television and
written press, in close collaboration with the authorities and NGOs. Other methods
are the organization of exhibitions associated to conferences. The summary of such
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PUBLIC PARTICIPATION
meetings should be published in the daily newspapers by the environmental
journalists, specially trained in this field, so as to create an objective picture of the
modern biotech issues.
In this context, the training of human resources proves to be necessary in order to
provide information in an accessible format to the different public categories.
Another communication method is the establishment of a telephone hotline, by
which to transmit the current information in this field. Such issues were largely
debated in a workshop organized by UNEP/GEF project.
In the future, the general public should participate in public debates and round
tables within national programs carried out locally with the support of authorities
and NGOs involvement. In the future the public should also effectively participate in
the educational process so as to become a well-informed and educated public, aware
of the importance of modern biotech and biosafety. An educated public represents
the most consistent catalyst of society sustainable development, for successfully
reaching the Millennium Development Goals that Romania joined in September
2000. An important role can be played by the organization of Information Centres in
Modern Biotech that will operate at regional and local level that should be the main
providers of written and virtual information to the interested public that can get
involved in the implementation of all adequate measures for public education,
information, awareness and participation.
It is necessary to establish a Biosafety Scientific Body that is ready to participate in
public debates and in public education and information having in view public
participation in the decision making process.
The ethical aspects themselves represent specific and particular characteristics of the
decision making process belonging to each nationality. In biosafety, the
participation of a Bio-Social Ethics group proves to be necessary that should cover
the following fields: health, environment quality, the preservations of traditions, of
genetic resources implicitly.
Public perception
The investigation of public perception with regard to certain issues is very important
for human society evolution. Thus, as regards modern biotechnology and biosafety
79

in particular, the public perception depends to some extents on the education and
information level, being a consequence of the developments of the above-mentioned
chapters. The concepts of this field are complicated enough to restrict access to
information. Other factors that can influence perception are the mentalities and
traditions. Certain opinion polls conducted in Romania by the National Journal
(Romanian newspaper) during October 2004, that did not reveal the interviewed
public education level, revealed the negative perception on GMO crops cultivation
(80% against). During the UNEP/GEF project such an opinion poll has not been
conducted yet, as it is difficult to distinguish correct perception of different classes in
relation to the education and information level.
Opinion polls should be conducted on a yearly basis and if not at least at 2-3 years
and carried out by professional people; for this purpose, specialized institutions in
this field should be hired. The results of these opinion polls can measure the
evolution of the public information and education level. To date, EU countries
perform highly level polls and it should follow the methods used by Eurobarometer.
7.3. PUBLIC INFORMATION MECHANISMS
Biosafety Clearing-House: BCH
The Cartagena Protocol on Biosafety establishes the mechanism of information
exchange in biosafety: BCH, as part of the clearing-house mechanism of the
Convention, aiming at providing assistance to Parties in Protocol implementation.
The database developed within BCH has a neutral technical basis, accessible to the
general public.
The Focal Point of the Biosafety Clearing House at national level is established at the
level of the Ministry of Environment and Water Management. In this context, the
main focal point (Adriana Baz) and secondary point (Ana Maria Comănoiu) are
found at the level of the Directorate for Nature Protection, Biodiversity Conservation
and Biosafety. The role of this focal point is to collect information in biosafety and to
facilitate the exchange of information between the public and BCH. Among the tasks
of this focal point, it has to be mentioned the publication of specific information on
the BCH website (the Romanian legislation into effect as well as information on the
simplified procedures stipulated in the Cartagena Protocol on Biosafety).
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PUBLIC PARTICIPATION
No regulations have been developed yet for nBCH organization and operation, so
that the institutional capacity is not developed yet. In this context, important
provisions of the Cartagena Protocol on Biosafety, i.e. AIA (advanced informed
agreement) system or the procedure regarding the GM commodities (GMOs
intended for direct use as food, feed or for processing purposes), cannot be
implemented yet.
MEWM has not created yet a web page dedicated to BCH Romania, but it intends to
develop it through the web page of the UNEP/GEF project: www.biosafety.ro. This
web page already includes data on the project, the main chapters of the national
biosafety framework and it intends to publish the reports on project development, as
well as information on GMOs. The publication of biosafety information of public
interest is also envisaged as well as the development of links to web pages in this
field from other foreign information sources. It is worth mentioning that the web
page is already organized in Romanian and in English.
Of particular interest is the organization of the following activities within BCH
Romania:
- GMO recorders, in which the code of GMOs intended for research, release into the
environment and placing on the market can be easily followed up
- list of specialists in the field, roster of experts
- recorders with research projects in the field
- recorders with GMO users
- reports of the Biosafety Commission
- web sites of the GMO use
It is necessary to develop the nBCH mechanism and integrate it in the national and
international BCH network together with other countries of the world. This
desideratum is possible to be reached also by the development of the institutional
capacity building project for the effective participation to the BCH mechanism.
Perspectives
Romania, as a Party of the international instruments providing for public awareness,
education and participation in the decision-making process, has the obligation to
develop the regulatory framework allowing the implementation of these provisions.
Romania's intention to accede the EU in January 2007 represents a further reason to
81
reach these goals.

General and particular mechanisms should be developed for the access of public to
environmental information, in particular for allowing the general public access in
the decision-making process. Thus, it is imperiously necessary to regulate the public
hearing actions in decision-making, considering the general and particular aspects,
the new information in biosafety as well as the capacity building in this field that
should permit the public to express its free opinion in the decision-making process. It
is very important that the access of public to decision-making should be limited (i.e.
for the confidential information regime) but not restrictive.

The development of the BCH mechanism at national level can represent the basis of
capacity building in this particular field and may facilitate the access to information,
preparing the public for its effective participation in the decision-making process.

...developing the research in the field of modern

Co-authors: Ana Maria Comănoiu, Alexandru R. Săvulescu
biotechnology is a prerequisite for the development of
any NBF...

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 CHAPTER 8

ROMANIAN MODERN BIOTECHNOLOGY

DEVELOPMENT STRATEGY

Romanian modern biotechnology development and related to

that the biosafety system development will be based upon the
development of a set of regulatory framework complying with
EU and also with the provisions of Biosafety Protocol (Montreal,
2000). These approaches are the result of collaboration between
all stakeholders working in the biosafety domain during the
development of the UNEP/GEF project.

Modern biotechnology regarding the use of genetically

modified organisms is a relatively new domain at global level
and it was promoted by the significant science results obtained
during the last 20 years. If the classical biotechnology has the
same long history like humanity however, the more recent
modern biotechnology is based on the use of in vitro specific
techniques that are operating at the living organisms level (it
uses methods and techniques specific for the manipulation of
nucleic acids, including the genetic recombination and the direct
injection of nucleic acids within cells or organelles and cell
fusion) which are overcoming the natural reproduction barriers
or for genetic breeding which was not the case for the classical
breeding and amelioration methods (Cartagena Protocol on
Biosafety, 2000).

Biosafety is represented by a set of broad spectrum measures

(biosafety policy, regulatory framework, scientific and technical
measures) applied within a well organized frame, required for
avoiding or mitigating the potential negative effects that the use
of modern biotechnology may produce on the environment or

85
 BIOSAFETY STRATEGY

human health.
The establishment of appropriate biosafety measures has to be taken now when we
are talking about the use of genetically modified organisms. These issues are very
sensitive subjects which are targeting either for maximalizing the potential benefits
offered by the modern biotechnology or for minimizing the potential risks. Such
biosafety measures have to be taken now as modern biotechnology is a new science
domain.
The first international instrument, specifically elaborated to promote biosafety at
global level is Cartagena Protocol on Biosafety to the Convention on Biological
Diversity (2000, Montreal, Canada). The Protocol is a set of procedures and measures
regarding the LMOs transfer over frontiers and was signed in Montreal Canada
2000. Romania signed this Protocol on 11 September, 2000, ratified it by the Law
59/2003 on 28 June, 2003 and the Biosafety Protocol entered into force on 28
September 2003. Biosafety issues exist also in the text of other international
instruments (CBD, WHO, WTO, IPPC, IOE). The Cartagena Protocol and these
instruments should be mutually supportive with a view to achieving sustainable
development..
(fundamental and applied research), it is a prerequisite to orient the research policy
in order to develop this capacity in Romania (human resources constant training,
management, funds, new programmes) at the same level like in sub-region or EU
countries. The need of this capacity development is actually imposed by the pressure
realized by the extraordinary development of this domain in EU countries.
At global level, in the developed countries biosafety is a well organized domain,
rather having a modular structure, which is functioning by the coherent assembly of
“specific modules” belongings to specific capacities, differently positioned in an
hierarchic scale (authorities, non governmental organizations, stakeholders). The
success of this domain establishment consists in the development of interface
capacities between national authorities and all stakeholders identified for the
domain which may contribute directly or indirectly to the full implementation of
Cartagena Protocol on Biosafety.
As biosafety is overcoming the national level interest, being rather of global interest,
its establishment as a domain cannot be realized without the collaboration between
neighbouring countries, and it has to comply with the EU Biosafety Policy and also
other international relevant instruments.

Ensuring the transparency at global level on GMO issues is be possible now by Nevertheless, showing a total transparency in the decision making process towards
setting up the Biosafety Clearing-House mechanism and developing the appropriate the general public cannot be established without capacity building for the fair
capacities. information exchange between authorities and general public.

The establishment of the national biosafety framework for Romania should

generally cover the following issues:
[1] Modern biotechnology policy which is including the biosafety policy;
[2] A specific regulatory framework which is setting up a specific administrative
system as a basis for future capacity building in the domain either at national level or
at regional and global levels;
[3] Notification and decision making systems based on risk assessment and risk
management;
[4] Follow up activities like monitoring, enforcement, traceability, labelling, liability
and redress;
[5] Setting up of mechanisms for public education information awareness and
participation in decision making process.

As the biosafety domain is linked to the modern biotechnology research

86 87

FUTURE PLANS
Required for the development of the Romanian Strategy on Modern Biotechnology
and Biosafety
CAPACITY BUILDING
Setting up in an analytical way the four main pillars of this capacity development
according to the idealistic model envisaged by Heather Baser (2003) may ground the
development of this domain. Thus, external context (regulatory framework), inner
context (resources, facilities, funds) external interventions (the Romanian policy of
EU accession) and stakeholders should be analyzed and make it possible to reveal
the biotechnology and biosafety capacity for Romania.
Any capacity building should be performed according to EU policy in domain and
also respecting all international instruments for which Romanian is a signatory Party
and especially according to Biosafety Protocol procedures.
Romania is preparing to access EU on 1 January 2007 and it will have to comply with
EU demands regarding biosafety. Under these circumstances the national biosafety
framework will develop tightly with the EU regulatory framework and capacity
building before accession is also compulsory.
The Development of the Romanian regulatory framework after transposing the
main EU regulations in the field is a prerequisite. Romania is transposing all EU
regulations regarding biosafety until the second trimester of 2006. Also, the
development of procedures, technical norms, guidelines, guides, checklists is
essential to be introduced in the secondary national legislation to really make
effective the laws.
Administrative system development is compulsory at least by allocating funds and
training human resources. Governmental funds can be supplemented by
performing an appropriate management seeking for funds from other foreign
international organizations (EU PHARE, Dutch project, SAPARD etc). The already
present human resources is valuable for the future development of “biosafety
human resources” and the constant specific training is a necessity.
88
BIOSAFETY STRATEGY
Developing biosafety evaluation systems that have to comply with the EU systems
and will be strictly applied is also compulsory as well as developing biosafety data
bases for each part of the biosafety chain, these data being essential for an
appropriate enforcement and also public information in a transparent manner.
SHORT TERM ACTIVITIES
IMPLEMENTING THE NATIONAL BIOSAFETY FRAMEWORK
Romania is seeking to join the UNEP/GEF NBF implementation project and also to
apply for additional new EU or bilateral funds required for the NBF implementation.
NATIONAL COMPETENT AUTHORITY REGULATION OF COMPETENCE
FOR NOTIFICATION AND AUTHORIZATION SYSTEMS BY DOMAINS
Applying the Protocol through law 214/2002 needs to be evaluated and clarified and
where necessary adjusted.
Biosafety system is very complex covering a broad range of scientific domain and it is
advisable that the National Competent Authority to be nominated according to their
main competency.
[1] Environment: deliberately release into the environment and placing on the
market of living modified organisms (biotech crops), the National Competent
Authority should remain the MEWM which will strictly implement both annexes B
and C of Directive 2001/18/EC and the authorization system will include aside the
MEWM as follows: MAFRD, NSVFSA, NCPA, MH. The general public will actively
participate in the decision making process through several developed mechanisms,
based on new developed regulations.
[2] Modern Biotechnology Contained Use activity linked or not to the research
activity will be ruled under the Ministry of Education and Research as the
Competent Authority in the Field which will tightly cooperate with MEWM and MH
on issues regarding environment and human health.
[3] GMO field testing National Competent Authority will be the MEWM in close
89

collaboration with MEC, MAFRD and MH.
[4] GM products for human health (gene therapy and GM vaccines) National
Competent Authority will be Ministry of Health the decision making institutional
framework remains to be discussed.
[5] GM animals for terrestrial and aquatic environment (GM animal kingdom)
National Competent Authority will be MAFRD and the decision making
institutional framework remains to be discussed.
[6] GM Forestry National Competent Authority will be MAFRD and the decision
making institutional framework remains to be discussed.
[7] GM Food, Feed and FFP National Competent Authority will be NSVFSA and the
decision institutional framework remains to be discussed (MEWM, MAFRD,
NPCA). For this domain are already transposing Regulations 2003/1829/EC and
2003/1830/EC and they have to implemented.
BIOSAFETY COMMISSION
BC is the scientific body that will issue scientific advice after examination of the
technical dossier. It is important to review the functioning mechanisms of the
Commission in order to increase transparency towards the general public on how BC
members are issuing their scientific advices. All their activities should be open to the
public and also should be supported financially. The financial mechanism is not yet
implemented and at present all BC members are doing their work without payment.
IMPLEMENTING THE REGULATORY FRAMEWORK
FOR CONTAINED USE
The general basis of the regulation framework is already in force and this goal may
be achieved by:
[1] Developing containment levels and work procedures. This target issue will be
developed according to Decision 2004/204/EC laying down detailed arrangements
of the operation of the registers for recording information on genetic modification in
90
BIOSAFETY STRATEGY
GM provided by the Directive 2001/18/EC;
[2] Developing specific requirements for different facilities (laboratory, greenhouse,
animal facilities, pilot scale and industrial scale facilities) according to the EU
requirements;
[3] Developing the Institutional Biosafety System for each facility designed for this
biotech domain;
[4] Regulating the required information and the format for each type of notification
and regulate authorization. Developing guidelines for applicants is urgent;
[5] Revising the notification system and institutional capacity should according to
the appropriate competence in the field. Development of check lists, training the
governmental officials in the field and their full access to internal and international
information data basis in the field;
[6] Establishing a uniform system for data base archiving and also for data control;
[7] Developing guidelines for risk assessment;
[8] Developing authorization system and delimiting very strictly each authority
competence. Setting up the financial mechanism for Biosafety Commission
functioning. Drafting official guidelines for dossier evaluation and training the
Biosafety commission members. Review the MEWM order 684/2002.
[9] Developing the electronic application formats.
IMPLEMENTING THE REGULATORY FRAMEWORK FOR DELIBERATELY
RELEASE INTO ENVIRONMENT
The general basis of the regulation framework is already in force and this goal may
be achieved by:
[1] Differentiating between different types of deliberate release depending on GM
(plants, microorganisms, animal), receiver environment and purposes (research
testing and registering testing-also in a scientific manner);
91

[2] Requiring information and an electronic format for notifications. Developing
guidelines for applicants clarify the issue of variety testing (either from laboratory or
for cultivar registration), consider system for fees when a notification is submitted
and add specific clarifications for a notifier (deadlines);
[3] Establishing data base archiving and control rules; Check list development for the
officials and training courses;
[4] Completing the risk assessment procedure; Functioning of the Biosafety
Commission, development of Guidelines for Risk Assessment, training the Biosafety
Commission members, secretary development;
[5] Delineating between involved authorities;
[6] Developing electronic formats for written consents.
IMPLEMENTING THE REGULATORY FRAMEWORK FOR DELIBERATE
RELEASE INTO ENVIRONMENT
CO-EXISTENCE
Developing the regulatory framework and appropriate procedures according to EU
regulation in this field. At the moment no implementing regulations in this domain
are set up.
IMPLEMENTING THE REGULATORY FRAMEWORK FOR PLACING ON
THE MARKET
(commercialization for cultivation)
The general basis of the regulation framework is already in force and this goal may
be achieved by:
[1] Complying the Romanian procedure with the EU procedure;
[2] Requiring information and the format for notification; Obligation for the notifier
to submit requested information. Development of different notification formats (i.e.
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BIOSAFETY STRATEGY
formats for plants, microorganisms, animals) and of Guidance for applicants.
Consider a fee system for applicants, introduce deadlines. Clarify and reconsider the
transition period between now and after EU accession
[3] Establishing data base archiving and control rules;
[4] Developing risk assessment as well as internal biosafety system procedures and
specify the role of consultative body. Functioning of the Biosafety Commission,
development of Guidelines for Risk Assessment, training the Biosafety Commission
members, secretary development
[5] Defining the role of other authorities according to their real competency in the
field for authorization procedure
[6] Developing written consent format according to EU;
[7] Developing deadlines according to EU, labeling and traceability by transposing
the EU Regulations 2003/1829/CE and 2003/1830/CE.
IMPORT / EXPORT
The general basis of the regulation framework is already in force and these activities
may be developed as follows:
[1] Export activity will be regulated according to EU Regulation 2003/1946/EC. The
National Competent Authority will be MEWM which will closely collaborate with
NCA and NSVFSA.
[2] Setting up the institutional framework for export and developing OECD unique
identifier codes for custom, developing guidelines and guidance for authorities,
training courses for authorities.
[3] BCH implementation for custom in direct relation with NSVFSA and MEWM.
[4] Establishment of data base archiving and control rules;
93

MONITORING
The general basis of the regulation framework is already in force and this activity
may be developed as follows:
[1] Monitoring will be realized by properly defining its objectives. In Romanian
regulation are accepted different types of monitoring on a case by case basis, and
should be developed procedures for implementing the general surveillance and
applying the EU obligations and also complying with the Biosafety protocol;
[2] Obligation for the notifier to draw up a monitoring plan in conformity to
Directive 2001/18/EC. Compile the existing methods and methods for monitoring.
Develop check lists for the monitoring plan. Develop accredited laboratory for ISO
17 035 connected to ENGL network of accredited laboratories. Development of the
internal biosafety system for the institutions;
[3] Development of monitoring data base open to the public and establishment of
data base archiving and control rules.
ENFORCEMENT
The general basis of the regulation framework is already in force and this activity
may be developed as follows:
[1] Defining inspection authorities within biosafety domain, training, inspection
prioritization, technical aspects description, GMO detection and identification;
[2] Development of data base archiving and control rules;
[3] Evaluating the system performance, transparency;
[4] Setting up the role of the internal biosafety systems and its implementation at
institutional level according to the new regulations by using guidelines and it will be
developed according to EU;
[5] Training inspectors, development of guidelines and user manuals for inspectors.
Development of plan of inspections, depending on the site to be inspected and
development of literature survey in the field;
94
BIOSAFETY STRATEGY
[6] Training custom personnel by providing them manuals and specific guidelines,
check lists.
BIO ETHIC
Capacity building for all issues regarding the possible wider impact of modern
biotechnology development in Romania including a special focus on human health
(gene therapy and vaccination) will be necessary.
Such capacity do not exists in Romania. The development of this capacity can be
promoted under the Ministry of Health. A major contribution can bring a favourable
political climate for non governmental organizations development in the field. It is
compulsory the evaluation of the needs regarding the development of a general
structure according to the EU.
RESEARCH IN MODERN BIOTECHNOLOGY
A complex capacity evaluation was performed during the project UNEP/GEF on 17
November 2004 in an open meeting and the results are published on the web page
www.biosafety.ro Capacity building in modern biotechnology public research
through:
[1] Regulating and implementing mechanisms, protocols and procedures of
collaboration between MER Romanian Academy, Academy of Agriculture Forestry
Sciences and Academy of Health Sciences regarding biotech project funding. The
indifference regarding the appropriate fund distribution will split more the
discrepancy between Romania and the rest EU countries, and particularly
neighbouring countries;
[2] Regulating and implementing mechanisms, protocols and procedures for
interfacial capacity functioning and organization between research area and
authorities helping orienting the research to strictly domains and also taking into
consideration duration and research theme change according to EU policy in the
field;
95

[3] Developing mechanisms and programs for biotech research according to EU
orientation;
[4] Establishing and developing the national research network in biotech domain,
through the establishment and development of a public data base, facilities, human
resources and a management at EU level.
MODERN BIOTECHNOLOGY AND BIOSAFETY DICTIONARY
PUBLICATION
Modern Biotechnology is a new domain, it uses new principles and new terms and
the development of any kind of capacity within the domain will not be workable
without the use of the same language or the use of the same terminology by
publishing a Dictionary of Biotech Terms. Generally the terminology for this domain
in Romania was set up starting with the 80' and under these circumstances the
present language should use and develop the already existing dictionary of terms.
Why is it so important? When a new legislative act is promulgated it is compulsorily
that the review of the language is to be done using agreed words easily found in a
Biotech Dictionary. This dictionary should be used by all authorities and published
on the web page for the general public.
CAPACITY BUILDING FOR EDUCATION, INFORMATION, AWARENESS
AND PARTICIPATION IN DECISION MAKING PROCESS
[1] Applying transparency principles by developing regulations and capacity
building at local community, county and national levels by properly involving all
stakeholders for accurate information.
[2] Public Education and Information through the involvement of Ministry of
Education and Research and Academies. Development of national info-biotech
programmes necessary to constantly inform and educate general public on
environment and health biotech issues. Active involvement of scientists, authorities
and non governmental organization and professionally trained mass media in
educating and informing people will be a must.
96
BIOSAFETY STRATEGY
[3] Capacity Building in enforcing Aarhus Convention procedures and also
Biosafety Protocol by developing regulatory and administrative systems,
networking authorities with all stakeholders on legal basis by promoting
transparency, promoting flexible and reliable management, training human
resources and ensuring access to funds.
[4] Clarify and implement legal basis;
[5] Developing manuals for public information, a Biotechnology Information Centre
and training the officials.
BIOSAFETY CLEARING-HOUSE MECHANISMS (BCH)
Currently in Romania the MEWM is holding the position of BCH focal point. Once
the nBCH project will be developed a biosafety network between authorities at
national level will be established. This network will include aside MEWM the
Ministry of Agriculture, Forestry and Rural Development, Ministry of Education
and Research, Ministry of Health, National Sanitary Veterinary and Food Safety
Authority, National Consumer Protection Authority and National Custom
Authority. This biosafety network will contribute by sending relevant information
according to Cartagena Protocol to the MEWM. Also, the already established web
page www.biosafety.ro will constitute the basis for the future Ro BCH web page
development serving as a data base for modern biotechnology and particularly for
biosafety. New interfacing capacities - as national biosafety secondary focal points -
will be developed which will connect authorities, stakeholders and the National
Competent Authority for Cartagena Protocol implementation.
CAPACITY BUILDING AT THE SUBREGIONAL LEVEL
Regulating and implementing mechanisms, protocols and procedures of
collaboration between the Romanian authorities and the sub region countries taking
into consideration the Romanian policy of EU accession and also the Biosafety
Protocol procedures which are stipulating that will be compulsory the
implementation of BCH capacities.
97
 GMO NOTIFICATION SYSTEM IN ROMANIA Notification

Yes No

30 days
COMMENTS
Ministry of Environment
10 zile and Water Management 90 days Final
National Competent Authority Decision
Public

Notice Scientific
advice
Notice Biosafety
Notice
Notice Commission
Scientific
Advisory Body
Ministry of National Sanitary
Agriculture, Veterinary and
Forests and Rural Ministry National Authority Food Safety
Development of Health for Consumers Authority
Protection
99
ANNEX I
 ANNEX II

STAKEHOLDERS
Involved in the UNEP/GEF Project
“Development of the National Biosafety Framework for Romania”

AUTHORITIES
Ministry of Environment and Water Management (MEWM)
National Environment Protection Agency
Regional Environment Protection Agencies
County Environment Protection Agencies
National Environment Guard (NEG)
Ministry of Education and Research
Ministry of Foreign Affairs
Ministry of Transport, Constructions and Tourism (MTCT)
Ministry of Agriculture, Forests and Rural Development (MAFRD)
National Customs Authority (NCA)
National Authority for Consumers Protection (NACP)
National Sanitary Veterinary and Food Safety Authority (NSVFSA)
BIOSAFETY SCIENTIFIC ADVISORY BODY
Biosafety Commission (BC)
ACADEMIES, UNIVERSITIES AND INSTITUTES
Romanian Academy
Institute of Biology Bucharest
Academy of Agricultural and Forestry Sciences "Gheorghe Ionescu-Şişeşti" (AAFS)
University of Agricultural Sciences and Veterinary Medicine Cluj-Napoca
University of Agronomy Sciences and Veterinary Medicine Bucharest
Faculty of Biotechnology Bucharest
State Institute for Variety Testing and Homologation Bucharest
Institute of Public Health Bucharest
National Research and Development Institute for Environment Protection Bucharest
Institute of Food Research Bucharest
Agricultural Research and Development Institute Fundulea
National Research and Development Institute for Biotechnology in Horticulture Stefănesti
INTERNATIONAL AGENCIES, ASSOCIATIONS
Environmental Experts Association (EEA)
Romanian Association of Grain Traders
United States Agency for International Development (USAID)
United States Department of Agriculture (USDA), Foreign Agriculture Service
MASS MEDIA
BUSINESS Magazin
Cotidianul
Intermedia Press
National Journal
Romanian Television, European Affairs Department
Rompres
NON-GOVERNMENTAL ORGANIZATIONS-NATIONAL AND INTERNATIONAL
Romanian Environmental Journalist Association
Chamber of Commerce and Industry of Romania and Bucharest Municipality
ECOSENS
Greenpeace
Harding Environment, Agribusiness & FMCG Consulting
National Federation of Ecological Agriculture
Regional Environment Center for Central and Eastern Europe REC Romania
INDUSTRY
Monsanto Europe SA
Pioneer Hi-Bred Seeds Agro SRL
SC CONSENS IMPORT EXPORT SRL

101

OTHER LEGISLATIVE ACTS
1. INTERFACING REGULATIONS
1.1. REGULATORY REGIME REGARDING
ENVIRONMENT PROTECTION
Law no. 137/1995 Environment Protection Law
(published in the Official Journal no. 304 /1995).
Law no. 26/1996 (CSILVIC/1996) Forestry Code
(published in the Official Journal no. 093 /1996).
Article 26: “The conservation of forestry genetic
resources with their fundamental attribute: valuable
genetic pool and intra-specific genetic variability, is
a permanent obligation of the central public
authority that is responsible for forestry
management”.
Law no. 5/2000 regarding the approval of the
National Design Landscape Plan - section III
protected areas (published in the Romanian Official
Journal no. 152 /2000).
Law no. 462/2001 for the approval of Government
Emergency Ordinance no. 236/2000 (24th of
November, 2000) regarding the regime of natural
protected areas, conservation of natural habitats,
wild flora and fauna (published in the Official
Journal, Part I no. 433 /2001).
The law includes a list of plant and animal species [1]
“for the conservation of which it is necessary to
designate special conservation areas and special
aquatic fauna protected areas”; [2] “that need strict
protection”; [3] “of community interest for which
the collection and exploitation are the object of
management measures”.
MEWM Order no. 860/2002 for the approval of the
procedure regarding the environmental impact
assessment and the issuing of the environmental
agreement act (published in the Official Journal, Part
I no. 52/2003).
The objective of this procedure is “regulating the
notification and obtaining conditions of the
environmental agreement act for projects with
significant impact on the environment”.
MEWM Order no. 863/2002 regarding the approval
of the methodological guides applying to the frame
ANNEX III
procedure' stages of environmental impact
assessment (published in the Official Journal, Part I
no. 52/2003).
MEWM Order no. 864/2002 for the approval of the
procedure regarding the environmental impact
assessment associated with transboundary
movement and public participation in the decision
making process regarding projects with
transboundary impact (published in the Official
Journal, Part I no. 397/2003).
Government Decision no. 918/2002 regarding the
establishment of the frame procedure of
environmental impact assessment and for the
approval of the list for public or private sector
projects subjected to this procedure (published in
the Official Journal, Part I no. 686/2002).
MEWM Order no. 421/2003 regarding the approval
of the regulation for organization and functioning of
the Inter-ministerial Committee for built-up
protected areas (published in the Official Journal,
Part I no. 427/2003).
MAFRD Order no. 454/2003 regarding the approval
of the technical norms for protecting forestry and
guidelines regarding the implementation of the
technical norms for forest protection (published in
the Official Journal, Part I no. 564/2003).
MEWM Order no. 552/2003 regarding the approval
for interior spatial planning of national and natural
parks according to the conservation requirement of
biological diversity (published in the Official
Journal, Part I no. 648/2003).
Government Ordinance no. 69/2004 for the
modification and completion of Law no. 192/2001
regarding live aquatic resources, fishing and
aquaculture (published in the Official Journal, Part I
no. 883/2004).
Law no. 120/2004 for the modification and
completion of Governmental Ordinance no. 96/1998
regarding the forestry regulatory regime and the
administration of national forestry (published in the
Official Journal, Part I no. 408 /2004).
“Article 1 The forests, through their ecological,
protective and social-economical functions, are no
103
ANNEX III
matter the form of property, a national interest
heritage from which benefits the entire society. In
this regards, it is necessary to ensure sustainable
management of the forests by establishing adequate
administration, regeneration, exploitation and
housekeeping measures”.
MAFRD Order no. 137/2004 regarding modification
and completion of the provisions of the Order issued
by the Minister of Agriculture, Food and Forestry
no. 84/2003 for approving the regulation regarding
the testing and registering of culture plant varieties
(published in the Official Journal, Part I no.
235/2004).
In Article 1 it is stipulated that: “besides field tests,
where it is necessary, verification of genetic purity
and authenticity of the hybrid parental forms is
carried out through molecular and biochemical
techniques”
Law no. 298/2004 for the modification and
completion of Law no. 192/2001 regarding the
fishery fund, fishing and aquaculture (published in
the Official Journal, Part I no. 593/2004).
The present law regulates the conservation,
administration and exploitation of living aquatic
resources, aquaculture activities, and also, the
processing and commercialization of the products
obtained from fishing and aquaculture.
Law no. 310/2004 for the modification and
completion of the Water Law no. 107/1996
(published in the Official Journal, Part I no.
584/2004).
In Article 1 the following are stipulated: “the water is
part of the state public domain. The conservation,
protection and improvement of aquatic
environment, under sustainable use of water
resources, are based on the precautionary,
prevention, avoiding damage to the source and
polluter pays principles and must take into account
the vulnerability of the aquatic ecosystems of the
Delta Danube and the Black Sea region taking into
account that the equilibrium is strongly influenced
by the quality of catchments”.
MAFRD Order no 312/2004 for the approval of the
quality analysis bulletin template of forest seed
quality (published in the Official Journal, Part I no.
496 /2004).
MAFRD Order no. 494/2004 regarding the approval
104
of the label template that accompanies breeding
forestry material (published in the Official Journal,
Part I no. 713 /2004).
This Order stipulates the labeling of breeding
forestry material if it is or is not genetically modified.
1.2. REGULATORY REGIME REGARDING
PLANT PROTECTION AND PESTICIDES
Law no. 5/1982 regarding crops and forests
protection and pesticide regime (published in the
Official Journal no.105/1982)
Government Ordinance no. 4/1995 regarding the
manufacturing, commercialization and use of
phyto-sanitary products for combating diseases,
pests and weeds in agriculture and forestry
(published in the Official Journal no.18/1995). The
Ordinance was adopted by Law no.85/1995.
The purpose of this Ordinance is stipulated in
Article 1: “For combating diseases, pests and weeds
in agriculture and forestry, on Romanian territory
the phyto-sanitary products that will be
manufactured, commercialized and used only if
homologated by the Inter-ministerial Commission
for Homologating Phyto-sanitary products, named
the Inter-ministerial Commission for Homologation
that is organized and functioning according to the
provisions of the present Ordinance. In Romania,
the protection of crops, forests, pastures and of other
types of useful landscapes and also plant products
stored and safe from disease, pests and weeds is an
issue of national interest and represents an
obligation of the public authorities and for this
purpose a reliable regulatory system has been
developed.
Law no. 85/1995 for the approval of Government
Ordinance no. 4/1995 regarding the manufacturing,
commercialization and use of phyto-sanitary
products for combating diseases, pests and weeds in
agriculture and forestry published in the Romanian
Official Journal, Part I no.18 of the 30th of January,
1995 (published in the Official Journal no. 213
/1995).
MAFRD Order no. 29/1999 regarding the
establishment of the notification procedure in the
case of intercepting a transport or a quarantine
organism during the import of plants, plant
products or of other products subjected to
regulatory regime, in the case of non-observance of
Romanian phyto-sanitary regulation (published in
the Romanian Official Journal no. 486/1999).
Government Ordinance no. 71/1999 regarding the
reorganization of plant protection and phyto-
sanitary quarantine activities, published in the
Official Journal no.232 of the 25th of May, 1999. The
Ordinance was implemented through Law
no.206/2001 for approving the GEO no. 71/1999
regarding the reorganization of plant protection and
phyto-sanitary quarantine activities (published in
the Romanian Official Journal no. 212/2001).
MAFRD Order no. 80/2000 for the approval of
norms regarding the minimal conditions necessary
for carrying out customs phyto-sanitary control
(published in the Official Journal no. 371 of the 10th
of August, 2000).
Through the provisions of this legal act, the
quarantine phyto-sanitary customs inspectorates
are empowered to undertake phyto-sanitary
controls at customs control points.
Government Ordinance no.136/2000 regarding the
protection measures against the introduction and
spreading of quarantine organisms harmful for
plants and plant products in Romania published in
the Romanian Official Journal no. 431/2000).
MAFRD Order no. 199/2000 regarding the people
empowered to issue phyto-sanitary certificates for
plants, plant products and regulated products
designated for export (published in the Romanian
Official Journal no. 614/2000).
Government Ordinance no. 262/2000 regarding the
procedures for establishing the maximum levels of
pesticide residues in plants and vegetable products
(published in the Romanian Official Journal no.
661/2000).
This Ordinance regulates the legal framework
regarding the procedures for establishing the
maximum levels of pesticide residues in plants and
their products. The provisions of this Emergency
Government Ordinance take into consideration
plants and vegetable products destined for import,
export or internal consumption.
Law no. 214/2001 for the approval of Government
Ordinance no. 136/2000 regarding the measures for
protection against the introduction and spreading of
quarantine organisms harmful to plants and plant
products in Romania (published in the Romanian
Official Journal no. 213/2001).
ANNEX III
Law no. 306/2001 for the approval of Government
Emergency Ordinance no. 262/2000 regarding the
procedures for establishing the maximum levels of
pesticide residues in plants and vegetable products
(published in the Official Journal, Part I no.
313/2001).
Government Decision no. 1030/2001 for the
approval of methodological norms for
implementing Government Ordinance no. 136/2000
regarding the measures for protection against the
introduction and spreading of quarantine
organisms harmful to plants and plant products in
Romania (published in the Official Journal, Part I no.
721/2001).
In this legal act it is stipulated that prohibition
measures can be enforced with regards to the
introduction of harmful organisms that are not
subjected to special regulations regarding
genetically modified organisms.
Joint Order of the Ministry of Agriculture, Food
and Forests no. 396/2002, Ministry of Health and
Family no.707/2002, and Ministry of Water and
Environment Protection no. 1944/2002 regarding
the prohibition for the use within the Romanian
territory of phyto-sanitary products containing
certain active substances (published in the Official
Journal, Part I no. 829/2002).
MAFRD Order no 396/2002 takes into consideration
the provisions of Directive 79/117/CEE of the 21st
of December, 1978 for the prohibition of placing on
the market and use of products for plant protection
containing certain active substances.
MAFRD Order no. 502/2002 for the approval of the
written memo template regarding phyto-sanitary
control (published in the Official Journal, Part I no.
61/2002).
MAFRD Order no. 503/2002 regarding the
procedure for recording and registering of
producers, joint storehouses, dispatch centres and of
the importers of plants, vegetable products or
products subjected to a regulatory regime
(published in the Official Journal, Part I no.
61/2002).
MAFRD Order no. 89/2003 regarding the
establishment of the conditions in which certain
harmful organisms, plants, plant products or
products subjected to a regulatory regime, foreseen
105
ANNEX III
in annexes no.1-5 of the methodological norms for
the implementation of Government Ordinance no.
136/2000, approved by Government Decision no.
1030/2001, can be introduced or put in circulation
on Romanian territory or in protected areas of
Romania, for experiments, scientific and
experimental purposes or selection variety purposes
(published in the Official Journal, Part I no.
654/2003).
Joint Order of the Ministry of Agriculture, Food
and Forests no 474/2003 and Order of the Ministry of
Health no. 738/2003 regarding the establishment of
maximum levels of pesticides residues in plants and
vegetable products (published in the Official
Journal, Part I no. 608 /2003).
MAFRD Order no. 1048/2003 regarding the
approval of sampling methods for plants and
vegetable products for carrying out laboratory
analysis for quantifying the level of pesticide
residues (published in the Official Journal, Part I no.
910/2003).
Through this order, the phyto-sanitary inspection is
empowered for sampling, analysis and establishing
clear procedures.
Government Decision no. 1619/2003 for the
modification of methodological norms for
implementing Government Ordinance no. 136/2000
regarding the measures for protection against the
introduction and spreading of quarantine
organisms harmful to plants and vegetable products
in Romania, approved by Governmental Decision
no. 1030/2002 (published in the Official Journal, Part
I no. 54/2004).
Joint Order of the Ministry of Agriculture, Forests,
Water and Environment no. 80/2004 and Ministry
of Health no. 127/2004 for the modification of the
common Order of the Ministry of Agriculture,
Forests, Water and Environment and of the Ministry
of Health no. 474/738/2003 regarding the
establishment of maximum levels of pesticide
residues in plants and vegetable products
(published in the Official Journal, no. 321 bis /2004).
MAFRD Order no. 81/2004 regarding the import
regime of phyto-sanitary product samples
(published in the Official Journal, Part I no.
84/2004).
Joint Order no. 114/2004 of the Ministry of Health
and Family and no.147/2004 of the MAFRD
106
regarding the modification and completion of the
order of the Ministry of Health and Family and of the
MAFRD no. 387/251/2002 for approval of the
norms regarding food intended for special
nutritional purposes (published in the Official
Journal, Part I no. 255/2004).
MAFRD Order no. 205/2004 regarding the
establishment of the procedure for phyto-sanitary
inspection import sampling (published in the
Official Journal, Part I no. 285/2004).
In article 2 it is stipulated that “the Phyto-Sanitary,
Seed and Genetic Material Quality Directorate, the
Central Phyto-Sanitary Quarantine Laboratory and
Phyto-Sanitary Units will carry out the provisions of
the present order” establishing the institutional
framework.
MAFRD Order no. 496/2004 for the approval of the
written memo template as an import document for
phyto-sanitary inspection (published in the Official
Journal, Part I no. 727/2004).
Government Decision no. 1559/2004 regarding the
procedure for homologation of products used for
plant protection intended to be placed on the market
and used within the Romanian territory (published
in the Official Journal, Part I no. 955/2004).
Government Decision no. 1618/2004 regarding the
regime for the import of dangerous products with
impact on population health and the environment
(published in the Official Journal no.48/2004).
1.3. THE REGULATORY REGIME REGARDING
SEED AND BREEDING MATERIAL QUALITY
In Romania the import, multiplication,
conditioning, packaging, labeling, storing and
delivery of seeds and breeding material is carried
out in accordance with internal and international
norms in force, with observance of protection
measures against the introduction and spreading of
quarantine organisms harmful to plants or plant
products.
The Ministry of Agriculture, Forests and Rural
Development (MAFRD) provides the
organizational framework and observance of legal
provisions regarding the production, processing,
control and quality certification for the
commercialization of seeds and breeding material,
and also registering of plant varieties. Seed and
breeding material certification is carried out by the
State Inspection for Seed Quality through the
territorial inspectorates and the Central Laboratory
for Seed and Reproductive Material Quality.
Law no. 57/1997 for the modification and
completion of Law no. 75/1995 regarding the
production, quality control, commercialization and
use of seeds and breeding material, and also, the
registration of agricultural plant varieties
(published in the Official Journal no. 68 /1997).
MAFRD Order no. 31/2002 for the approval of the
regulation regarding the organization of quality and
phyto-sanitary control activities for the import and
export of seeds and breeding material (published in
the Official Journal, Part I no.96/2002).
In chapter III it is stipulated that “imported seeds
and breeding material must be accompanied by
identification and quality certification documents
foreseen by the OECD, ISTA or CE international
organizations regulations, in original or copy, the
origin certificate type EC or EU 1 certificate, for
countries of the European Union, or other
documents, for counties not member to OECD or CE
foreseen in chapter VII”
MAFRD Order no. 350/2002 for the approval of
rules and technical norms regarding the production
for commercial purposes, processing, control and
quality certification, and also, commercialization of
cereal, oleaginous and textile seeds, commodities,
sugar beet, potato, vegetables (published in the
Official Journal, Part I no. 635/2002).
The approval of this order was realized taking into
consideration the need for harmonizing the
Romanian legislation with the regulations of the
European Union Council Directives no.
66/400/CEE regarding the commercialization of
sugar beet seeds, no.66/401/CEE regarding the
commercialization of commodities seeds,
no.66/402/CEE regarding the commercialization of
cereal seeds, no.66/403/CEE regarding the
commercialization of potato tubers for cultivation,
no.69/208/CEE regarding the commercialization of
oleaginous and textile plant seeds, no.70/458/CEE
regarding the commercialization of vegetable seeds,
with subsequent amendments, and also, Directives
and decisions for implementation of the European
Community Commission.
MAFRD Order no. 381/2002 for the approval of the
rules and technical norms regarding the production,
quality control and/or commercialization of
ANNEX III
breeding and vegetable planting material, other
than seeds (published in the Official Journal, Part I
no. 749/2002).
The approval of this order was undertaken taking
into consideration the need for harmonization of the
Romanian legislation with the regulations of the EU
Directive no. 92/33/CEE regarding the
commercialization of breeding and planting
vegetable material, other than seeds.
MAFRD Order no. 382/2002 for the approval of the
rules and technical norms regarding the production,
control, quality certification and/or
commercialization of fruit breeding material
(published in the Official Journal, Part I no.
800/2002).
The approval of the this order was realized taking
into consideration the need for harmonizing the
Romanian legislation with the regulations of the
European Union Council Directives no. 92/34/CEE
regarding the commercialization of fruit plants
breeding material and of fruit plants used for fruit
yield.
MAFRD Order no. 394/2002 for the approval of the
procedure for issuing the phyto-sanitary passport
and phtyo-sanitary substitution passport, used for
the traffic of certain plants, plant products or
products subjected to a regulatory regime on
Romanian territory (published in the Official
Journal, Part I no. 736/2002).
MAFRD Order no. 395/2002 for the approval of the
rules and technical norms regarding the production,
processing, quality control and/or
commercialization of ornamental plant breeding
material (published in the Official Journal, Part I
no.756 /2002).
This order was issued on the basis of Article 12 of
Law no. 26/2002 regarding the production,
processing, control and quality certification,
commercialization of seeds and breeding material,
and also, the registering of plant varieties, taking
into consideration the need for harmonizing the
Romanian legislation with the regulations of the
European Union Directives no. 98/56/CE regarding
the commercialization of ornamental plant breeding
material. The rules and technical norms “are applied
for the production with the purpose of
commercialization, processing, quality control
and/or commercialization of ornamental plant
107
ANNEX III
breeding material belonging to all genus and
species, with the exception of those established by
the European Regulation no. 338/97 of December
1996 regarding spontaneous flora and fauna, and
harmonizes into the Romanian legislation the
European Union Directive no.98/56/CE regarding
the commercialization of ornamental plant breeding
material and European Union Directive no.
93/49/CEE, 93/63/CEE, 99/66/CE and 99/68/CE.
MAFRD Order no. 84/2003 regarding the approval
of the regulation for testing and registering of crop
varieties that transposes specific provisions foreseen
in Directives 2002/53/CE, 2002/55/CE,
92/34/CEE, 68/193/CEE, 98/56/CE, 930/2000/CE
(published in the Official Journal no.138/2003).
MAFRD Order no. 621/2003 regarding the
broadening of the registration procedure for
producers or of joint storehouses or of product
dispatch centers for certain plants not foreseen in
Part A of annex no.5 of the Governmental Decision
no. 1030/2001 (published in the Official Journal, Part
I no. 104/2003).
MAFRD Order no. 977/2003 for the modification
and completion of provisions of the Ministry of
Agriculture, Food and Forestry Order no. 550/2002
for the approval of the rules and technical norms
regarding the production, processing, quality
control and commercialization of grapevine
breeding material (published in the Official Journal,
Part I no. 884/2003).
MAFRD Order no. 101/2004 regarding phyto-
sanitary activities of national interest and means of
financing (published in the Official Journal, Part I
no. 130/2004).
Law no. 161/2004 for the approval of Government
Ordinance no.11 of the 22nd of January, 2004
(published in the Romanian Official Journal, Part I
no.85 of the 30th of January, 2004) regarding the
production, commercialization and use of breeding
forestry material (published in the Official Journal,
Part I no. 466/2004).
MAFRD Order no. 257/2002 for the approval of the
regulation regarding the organization of quality,
phyto-sanitary control for the import and export of
seeds and breeding material that regulates the
import and export in accordance with community
provisions regarding seed and breeding material
quality and that establishes the equivalence
principle according to Decision 95/514 and 97/778
108
(2003/17) and of community provisions regarding
plant health (published in Official Journal no.
563/2002)
MAFRD Order no. 659/2002 regarding the members
and attributes of the technical Council for plant
varieties and seeds as advisory body of the of the
MAFRD (Ministerial Order no. 109/20th of
February, 2003) which analysis and recommends
measures for variety testing, production, processing
and commercialization of seeds, planting and
breeding material. The Council composes of
representatives breeding non-governmental
professional organizations, producers and
merchants, representatives from the scientific
research field and of the Ministry of Agriculture,
Food and Forestry (published in Official Journal No
864/2002)
1.4. REGULATORY REGIME OF PRODUCTS
THAT ARE HAZARDOUS TO HUMAN
HEALTH AND THE ENVIRONMENT
- WASTE MANAGEMENT REGULATIONS -
Order no. 40/1991 regulating the control of exports
of materials, chemicals, biological agents,
technology, equipment and parts thereof, which
may contribute to the proliferation of nuclear,
chemical, and biological weapons, as well as of
rockets equipped with such weaponry (published in
the Official Journal of Romania, no. 141/1991).
Government Decision no. 437/1992 to amend
Government Decision no. 340/1992 regulating
imports of waste and residual of any kind, as well as
of other goods that are hazardous to human health
and the environment (published in the Official
Journal no. 201/1992).
This law stipulates that “imports of waste and
residual of any nature into Romania, whether raw,
or processed form, are forbidden”. Thus, Appendix
2, item 26 stipulates customs tariff position 3808 for
pesticides; Appendix 3, chapter I.3, article 11,
presents the import clearance form; article 12
presents the license; Appendix D, letter C presents
the approval issuance procedure; and Appendix E,
presents the methodology of company licensing.
Government Ordinance no. 200/2000 on the
classification, labeling, and packaging of hazardous
chemicals and chemical preparations, approved
with amendments by Law no. 451/2001 (published
in the Official Journal of Romania, Part I, no.
593/2000).
Law no. 426/2001 for the approval of the
Government Emergency Ordinance 78/2000
regulating waste (published in Official Journal, Part
I, no. 411/ 2001).
Appendix 1 describes the “characteristics of waste
that make it hazardous”, mentioning at point “H11.
mutagens substances and preparations, which, if
inhaled, ingested, or penetrating skin, may produce
hereditary genetic defects, or increase the rate of
occurrence thereof”.
Law no. 451/2001 for the approval of the
Government Emergency Ordinance no. 200/2000 on
the classification, labeling, and packaging of
hazardous chemicals and chemical preparations
(published in the Official Journal, Part I, no.
416/2001).
Government Decision no. 490/2002 for the approval
of the enforcement Regulations for EGO 200/2000
on the classification, labeling, and packaging of
hazardous chemicals and chemical preparations
(published in the Official Journal, Part I, no.
356/2002).
Technical Regulation no. 1070303/2003 regarding
waste storage the building, use, monitoring, and
closure of waste storage facilities (published in the
Official Journal, Part I, no. 150 bis/2003).
Government Decision no. 1618/2004 regulating
imports of products that are hazardous to human
health and the environment (published in the
Official Journal no. 48/2004).
The Decision was issued on the basis of Article 108 in
the Constitution of Romania. It does not contain
specific provisions regarding GMOs or products
thereof, but does specify the regulations that apply
to imports of products that are deemed hazardous to
human health and the environment.
1.5. REGULATORY REGIME REGARDING THE
SUSTAINABLE CONSERVATION AND USE OF
BIODIVERSITY- LIABILITY
Law no. 180/2002 for the approval of the GO 2/2001
regarding the juridical regime of fines (published in
the Official Journal, Part I, no. 268/2002).
Decree no. 484/2002 to enact Law to approve GO
108/1999 to amend Law no. 98/1994 on determining
and sanctioning non-compliance with public health
ANNEX III
and sanitation regulations (published in the Official
Journal, Part I, no. 389/2002).
Government Decision no. 1297/2002 on
determining and sanctioning non-compliance with
sanitary and veterinary regulations (published in
the Official Journal, Part I, no. 837/2002).
Law no. 301/2004, Criminal Code Law (published in
the Official Journal, Part 1, no. 575/ 2004).
Chapter IV, “Crime and Offences Related to Genetic
Manipulation”, stipulates the following: Article 193
Intentional altering of the human genotype, in any
way, is punishable by strict imprisonment of two to
five years. Article 194 Usage of genetic engineering
to produce biological weapons or other mass
destruction weapons is punishable by severe
detention lasting from fifteen to twenty-five years,
as well as by forbidding certain rights.
1.6. REGULATORY REGIME REGARDING
FOOD
Government Ordinance no. 21/1992 regulating
consumer protection, as republished on the basis of
Article 1, point 6, final paragraph in Law no. 11/1994
published in the Official Journal Part I, no. 65/1994
(published in the Official Journal Part I, no.
212/1992).
Government Decision no. 1196/2002 for the
approve General Regulations regarding food
control (published in the Official Journal of Romania
no. 819/ 2002).
Government Decision no. 1198/2002 approving
Food Sanitation Regulations (published in the
Official Journal no. 866/2002).
Government Decision no. 755/2003 regulating the
organization and operation of the National
Authority for Consumer Protection (published in
Official Journal, Part I, no. 490/ 2003).
NSVFSA Order no. 139/2004 for the approval of the
Food Safety and Sanitary-veterinary Regulation on
the approval procedure for the sanitary-veterinary
and food safety activities carried out by legal entities
established according to Article 2, Law 359/2004,
with subsequent amendments (published in the
Official Journal no. 107bis/2005).
NSVFSA Order no. 141/2004 for the approval of the
Food Safety and Sanitary-veterinary Regulation on
contaminants in animal-, and non-animal-, based,
109
ANNEX III
food (published in the Official Journal no.
107/2005).
NSVFSA Order no. 147/2004 for the approval of the
sanitary veterinary and food safety Norms
regarding pesticide residuals from animal-, and
non-animal based food and regarding veterinary
drug residuals in animal-based food (published in
the Official Journal no. 143/2005).
Law no. 150/2004 Food Safety Law (published in the
Official Journal, Part I, no. 462/2004) as amended by
Law 412/2004.
NSVFSA Order no. 55/2005 for the approval of food
safety Norms establishing the procedures for non-
animal products import/export submitted to
surveillance and control safety (published in the
Official Journal no. 528/2005).
Government Decision no. 738/2005 regulating the
organization and operation of the National Sanitary
and Veterinary Authority for Food Safety and of
units subordinated thereto (published in the Official
Journal Part I, no. 673/2005).
2. REGULATORY REGIME REGARDING
HUMAN HEALTH
MHF Order no. 579/2001 on the licensing of units
that may carry out clinical studies on a given drug
(published in the Official Journal, Part I, no.
566/2001).
MHF Order no. 235/2002 to repeal the Health &
Family Minister Order no. 862/2001 to complete
Health Minister Order no. 536/1997 to approve
Sanitation Regulations & Recommendations on the
Living Environment of the Population (published in
the Official Journal, Part I, no. 263/2002).
MHF Order no. 598/2003 on national summaries as
part of sub-programme 1.4 “Assessing Health
Condition and Hazards” (published in the Official
Journal, Part I, no. 557/2003).
MHF Order no. 861/2003 to approve Regulations on
the organisation and operation of government-led
sanitation inspections (published in the Official
Journal, Part I, no. 671/2003).
MH Order no. 859/2004 repealing a number of
articles in Health Minister Order no. 975/1998
approving Food Sanitation Regulations (published
in the Official Journal, Part I, no. 645/2004).
110
MH Order no. 1029/2004 amending Health & Family
Minister Order no. 219/2002 approving the
Technical Regulations on the management of waste
resulting from medical activities and the Data
Collection Methodology for the national database
on waste resulting from medical activities
(published in the Official Journal, Part I, no.
853/2004).
MH Order no. 1030/2004 for modifying the MH
Order no 119/2004for the approval of Norms
regarding the authorization and functioning of
medical analysis laboratory (published in the
Official Journal, Part I, no. 785/2004).
MH Order no. 1688/2004 amending Health & Family
Minister Order no. 598/2003 on the development of
national summaries under sub-programme 1.4
“Assessing Health Condition and Hazards”
(published in the Official Journal no. 89/2005).
MH Order no. 10/2005 to approve health
programmes and sub-programmes funded by the
state budget in 2005 (published in the Official
Journal no. 61/2005).
3. REGULATORY REGIME REGARDING
PUBLIC AWARENESS AND PARTICIPATION
Law no. 86/2000 ratifying the Convention on
information access, public participation in the
decision-making, and access to justice for
environment-related issues, signed in Aarhus on
June 25, 1998 (published in the Official Journal no.
224, dated May 22, 2000).
Law no. 544/2001 on free access to information of
public interest (published in the Official Journal,
Part I, no. 663/2001).
Article 1, “People's free and unhindered access to
any information of public interest, thus defined
herein, constitutes one of the fundamental
principles of the relations between the public and
the public authorities, according to the Constitution
of Romania and the international documents ratified
by the Parliament of Romania.”
Government Decision no. 1115/2002 on free access
to information regarding the environment
(published in the Official Journal, Part I, no.
781/2002).
The above act “establishes the conditions in which
information regarding the environment, held by the
public authorities, is to be made available to the
public, with a view to ensure free access to, and
dissemination of, this information”.
Government Decision no. 123/2002 to approve
implementation Regulations for Law no. 544/2001
on free access to information of public interest
(published in the Official Journal, Part I, no.
167/2002).
Chapter I, entitled “General Provisions”, stipulates
that Law no. 544/2001 is to be applied in compliance
with the following principles: 1) the principle of
transparency; 2) the principle of unitary application;
and 3) the principle of autonomy.
MEWM Order no. 1182/2002 approving the
Methodology of information management and
dissemination regarding the environment, held by
environment protection public authorities
(published in the Official Journal, Part I, no.
331/2003).
Although there are laws on the implementation of
the Aarhus Convention and of the Cartagena
Protocol on Biosafety, it is imperative to develop
capacities that would enable them to make use of
adequate tools and methods. Developing and
applying high-quality management in this field is
essential.
4. REGULATORY REGIME REGARDING
COPYRIGHT AND STANDARDISATION
Law no. 64/1991 - Law on Patents (published in the
Official Journal no. 212/1991).
Law no. 84/1998 Law regarding brands and
geographical landmarks (published in the Official
Journal no. 161/1998).
Government Decision no. 573/1998 on the
organisation and operation of the State Office for
Inventions and Brands (published in the Official
Journal no. 345/1998).
Law no. 285/2004 to amend Law no. 8/1996 on
copyright and related rights (published in the
Official Journal, Part I, no. 587/2004).
Decree no. 310/2002 to enact Law amending Law no.
64/1991 on patents (published in the Official
Journal, Part I, no. 340/2002).
Law no. 355/2002 approving Government
ANNEX III
Ordinance no. 39/1998 on national standardisation
activity in Romania (published in the Official
Journal, Part I, no. 447/2002).
Law no. 585/2002 amending Law no. 129/1992 on
the protection of industrial drawings and designs
(published in the Official Journal, Part I, no.
810/2002).
Decision no. 1587/2002 regarding the measures that
are to be taken to organise and carry out the
information exchange in the field of standards and
technical regulations, as well as rules regarding
services of informational society between Romania
and the EU member states and the European
Commission (published in the Official Journal, Part
I, no. 52/2003).
Government Decision no. 499/2003 approving the
implementation Regulation for Law no. 64/1991 on
patents (published in the Official Journal, Part I, no.
348, /2003).
Government Decision no. 758/2003 regarding the
organisation and operation of the Romanian
Copyright Office and of the arbiter body (published
in the Official Journal, Part I, no. 492/2003).
Government Decision no. 1424/2003 to approve the
National Strategy on Copyright (2003-2007)
(published in the Official Journal, Part I, no.
905/2003).
5. REGULATORY REGIME REGARDING
EDUCATION, RESEARCH, AND
DEVELOPMENT
Law no. 84/1995 “Education Law” (updated on June
25th, 2003). The initial text published in the Official
Journal no. 606/1999.
The updated form until June 25, 2003, with
amendments made by Emergency Ordinance no.
36/1997 amending Education Law no. 84/1995; Law
no. 151/1999; Emergency Ordinance no. 30, dated
April 14, 2000, rejected by Law no. 113 of March 14,
2002; Emergency Ordinance no. 130 of June 30, 2000;
Emergency Ordinance no. 206 of November 15,
2000; Emergency Ordinance no. 295 of December 30,
2000; Emergency Ordinance no. 2 of January 4, 2001;
Emergency Ordinance no. 32 of February 26, 2001;
Law no. 98 of March 26, 2001; Law no. 159 of April 7,
2001; Emergency Ordinance no. 123 of October 8,
2001; Law no. 713 of December 3, 2001; Emergency
Ordinance no. 184 of December 20, 2001; Law no. 345
of June 1, 2002; Law no. 520 of July 17, 2002; Law no.
111
ANNEX III
268 of June 13, 2003.
Government Decision no. 735/1996 approving the
Regulation on Grants for Scientific Research
(published in the Official Journal no. 208/1996).
Order no. 232/2001 approving the Operational
Manual for the competitive grant scheme under the
Agricultural Services Support Project; issuer: the
Ministry of Agriculture, Food, and Forests
(published in the Official Journal no. 565/2001).
This legal act sets out the competitive scheme of
grants destined for applied research and extension.
Law no. 324/2003 approving Government
Ordinance no. 57/2002 on scientific research and
technological development (published in the
Official Journal no. 514/2003).
Law no. 319/2003 on the Status of the Research &
Development Personnel (published in the Official
Journal no. 530/2003).
Decision no. 368/2003 approving Romania's
contribution into the budget of the VI-th Framework
Programme of the European Community, for
Research, Technological Development, and Trial
Activities and of the VIth Framework EC
Programme of Atomic Energy (Euratom), as well as
approving the financial support granted to
Romanian participants, including for incentives to
increase their participation (published in the Official
Journal no. 238/2003).
The Government of Romania has approved this
Decision based on Article 107 in the Constitution
and on Article 2 in EGO no. 206/2002 ratifying the
Memorandum of Agreement between Romania and
the European Communities regarding Romania's
joining the sixth European Community Framework
Programme for research, technological
development, and trial activities, with a view to
contribute to the creation of the European Space for
Research and Innovation (2002-2006), as well as
joining the sixth EC Framework Programme for
Atomic Energy (Euratom), signed in Brussels on
October 29, 2002.
Order no. 7079/2003 approving Regulations on the
protection of classified information in the field of
scientific research and technological development
(published in the Official Journal no. 262/2003).
There are no legislative provisions to ensure the
development of research capacities strictly focused
112
on modern biotechnology. It is necessary to develop
legislative acts that would involve the Ministry of
Education and Research in the national biosafety
framework.
Law no. 206/2004 regarding the good behaviour in
scientific research, technological development, and
innovation (published in the Official Journal no.
505/2004).
Law no. 230/2004 approving Government
Ordinance no. 38/2004, to amend Government
Ordinance no. 57/2002 on scientific research and
technological development (published in Official
Journal no. 506/2004).
Law no. 287/2004 - “Law on Academic Consortia”
(published in the Official Journal no. 614/2004).
Law no. 354/2004 to amend Education Law no.
84/1995 (published in the Official Journal no.
687/2004).
Government Decision no. 1264/2004 on the
organisation and operation of the Programme
Management National Centre (published in the
Official Journal no. 776/2004). According to this act,
the Programme Management National Centre shall
have the following functions: a) running scientific
research, technological development, and/or
innovation, programmes, funded partially or
entirely by the Ministry of Education and Research;
b) running other programmes focusing on research-
development-innovation, funded by sources other
than the Ministry of Education and Research; c)
carrying out related activities.
Decision no. 1265/2004 approving Regulations on
contracting, financing, monitoring, and assessing
programmes, R & D and innovation projects, and
actions laid out in the National Plan for R&D and
Innovation (published in the Official Journal no.
776/2004).
Government Decision no. 1266/2004 approving
Regulations on contracting, funding, monitoring,
and assessing projects that are part of the R&D sector
plans (published in the Official Journal no.
776/2004).
Order no. 3893/2004 laying down instructions on the
equivalence of research & development functions
and titles acquired before the effective date of Law
no. 319/2003 on the Status of Research &
Development Personnel, with the functions
corresponding to the professional degrees of
Research and Development established by Law no.
319/2003 (published in the Official Journal no. 516
/2004).
6. INTER-SECTOR LAWS
Law no. 18/1991 - “Land Law” (published in Official
Journal no. 037/1991).
Law no. 90/1996 - “Labour Protection Law” (as
republished in the Official Journal no. 47/ 2001).
Law no. 106/1996 - “Civil Protection Law”
(published in Official Journal no. 241/1996).
Law no. 171/1997 - “Law To Approve the Land
Management Plan for the National Territory”
Section II, “Water” (published in Official Journal no.
325/1997).
Law no. 255/1998 on New Plant Varieties Protection
(published in Official Journal no. 255/1998).
Government Decision no. 573/2002 approving the
licensing procedures allowing traders to operate
(published in the Official Journal, Part I, no.
414/2002).
7. REGULATORY REGIME REGARDING
CUSTOM AND TRANSPORTATION
Law no. 98/1996 on Romania's adherence to the
International Convention on the Harmonised
System of Designating and Codifying Merchandise,
including its Appendix, signed in Brussels on June
14, 1983 (published in the Official Journal no.
234/1996).
Law no. 141/1997 on Romania's Customs Code
(published in the Official Journal no. 180/1997)
Government Ordinance no. 48/1999 regarding road
transports of hazardous merchandise (published in
the Official Journal no. 401/1999).
Government Decision no. 1114/2001 approving the
application Regulations for Romania's Customs'
Code (published in the Official Journal no.
735/2001).
Law 122/2002 approving Government Ordinance
no. 48/1999 on road transports of hazardous
merchandise (published in the Official Journal, Part
I, no. 198/2002).
ANNEX III
Government Decision no. 1783/2002 laying down
the Technical Regulations for interpreting the
harmonised system of designation and codification
of merchandise, III-rd edition (2002), brought up to
date by updates no. 1 and 2 (published in the Official
Journal, Part I, no. 75/ 2003).
Emergency Ordinance no. 94/2004 for modifying
the name and codes of merchandise from the
Romanian Custom Tariff for Import and custom
taxes related to (published in the Official Journal no.
1115/2004).
8. INTERNATIONAL CONVENTIONS AND
PROTOCOLS
Decree no. 316/1971 regarding the accession of
Socialist Republic of Romania to the International
Convention for plant protection, Roma, 6 Dec 1951
(published in Official Journal no. 117/1971)
Decree no. 187/1990 for acceptance the Convention
on Protection of the World Cultural and Natural
Heritage, adopted in Paris, 16 Nov 1972 (published
in Official Journal No 046/1990).
Law no. 5/1991 regarding Romanian accession to the
Convention on Wetlands of International
Importance especially as Waterfowl Habitat,
Ramsar, 2 Feb 1971, under UNESCO aegis and
amended by the Paris Protocol from 3 Dec 1982
(published in Official Journal No 018/1991).
Law no. 6/1991 for Romanian accession to the Basel
Convention regarding control of Transboundary
Movements of Hazardous Wastes and their
Disposal (published in Official Journal no.
018/1991)
Government Decision no. 267/1991 regarding
Romanian accession to the European Convention for
the Protection of Animals during International
Transport (published in Official Journal no.
111/1991).
Law no. 98/1992 for ratifying the Convention on the
Protection of the Black Sea against Pollution
(Bucharest Convention) Bucharest 21 Apr 1992
(published in Official Journal no. 242/1992).
Law no. 13/1993 for Romania accession to the
Convention on the Conservation of European
Wildlife and Natural Habitats. Bern, 19 Sep 1979
(published in Official Journal no. 062/1993).
113
ANNEX III
Law no. 31/1994, for Romania accession to the
European Agreement concerning the International
Carriage of Dangerous Goods by Road (ADR),
signed in Geneva 30 Sep 1957 (published in Official
Journal no. 136/1994).
Law no. 58/1994. for ratifying the Convention on
Biological Diversity, signed in Rio de Janeiro in 5
June 1992 (published in Official Journal no.
199/1994).
Law no. 69/1994 for Romanian accession to the
Convention on International Trade in Endangered
Species of Wild Fauna and Flora (CITES)
Washington, 3 Mar 1973 (published in Official
Journal no. 211/ 1994).
Law no. 30/1995 for ratifying the Convention on the
Protection and Use of Transboundary Watercourses
and International Lakes (The UN/ECE Water
Convention), Helsinki, 17 Mar 1992 (published in
Official Journal no. 081/1995).
Law no. 4/1999 for the approval of the Government
Ordinance no. 77/1998 for Romania accession to the
Protocol amending of the articles 1 a), 14(1) şi 14(3) b)
of the European Agreement from 30 Sep 1957
referring la Carriage of Dangerous Goods by Road
(ADR), Geneva 28 Oct 1993 (published in Official
Journal no. 4/1999).
Law no. 153/1999 for the approval of the
Government Ordinance no. 8/1999 for ratifying the
Accord between the governments of the participant
States to the Black Sea Economic Cooperation, for
common intervention and emergency answer in the
case of natural and anthropic disasters Soci, 15 Apr
1998 (published in Official Journal no. 491/1999).
Law no. 89/2000 for ratifying the Agreement on the
conservation of African-Eurasian Migratory Water
Birds, Hague, 16 Jun 1995 (published in Official
Journal no. 236/2000).
Law no. 228/2000 regarding the approval of the
Government Ordinance no. 95/2000 for ratifying the
Protocol on Water and Health, adopted to London
17 Jun 1999, to the Convention on the Protection and
Use of Transboundary Watercourses and
International Lakes adopted in Helsinki 17 Mar 1992
(published in Official Journal no. 629/2000).
Government Decision no. 1374/2000 for the
approval of the Norms regarding the faze applying
114
ANNEX III
procedures of the European Agreement concerning 1992, signed in Bled 4 Jul 2003 (published in Official Government Decision no. 258/2004 for the
the International Carriage of Dangerous Goods by Journal no. 877/2003). modification and completions of Norms regarding
Road (ADR) signed in Geneva la 30 Sep 1957, Law no. 261/2004 for ratifying the Convention on the faze applying within the inner traffic of the
enforced by the law no. 31/1994 (published in Persistent Organic Pollutants Stockholm 22 May procedures belonging to the European Agreement
Official Journal no. 11/2001). 2001 (The POP Stockholm Convention) (published concerning the International Carriage of Dangerous
in Official Journal no. 638/2004). Goods by Road (ADR) signed in Geneva la 30 Sep
Law no. 3/2001 for ratifying the Kyoto Protocol to the 1957, enforced by the law no. 31/1994, approved by
Frame Convention of United Nations on Climate
Changes adopted in 11 Dec 1997 (published in
Official Journal No 81/2001).
Law no. 22/2001 for ratifying the Convention on
Environmental Impact Assessment in
Transboundary Context (Espoo Convention)
adopted to Espoo in 25 Feb 1991 (published in
Official Journal No 105/2001).
Law no. 622/2001 for ratifying the Final Blue Print of
the negotiations between Romania and European
Community for the adoption of the Agreement
regarding Romania participation to the European
Environment Agency and to the European network
of environmental information and observance
(EIONET), adopted in Brussels 9 Oct 2000
(published in Official Journal no. 770/2001).
Law no. 53/2002 for the approval of the Government
Ordinance no. 69/2001 for ratifying the Protocol
from 3 Jun 1999 for the modification of the European
Accord on International Carriage by Rail of
dangerous goods (RID), in the Convention
concerning International Carriage by Rail (COTIF),
signed to Berne 9 May 1980 (Protocol 1999), signed to
Vilnius 3 Jun 1999 (published in Official Journal No
45/2002).
Law no. 265/2002 for acceptance of Amendments to
Basel Convention Basel (1989) regarding
Convention on control of Transboundary
Movements of Hazardous Wastes and their
Disposal (published in Official Journal no.
352/2002).
Law no. 451/2002 for ratifying the European
Convention on Landscape, Florence 20 Oct 2000
(published in Official Journal no. 536/2002).
Law no. 91/2003 for Romanian accession to
Rotterdam Convention on Prior Informed Consent
Procedure for Certain Hazardous Chemicals and
Pesticides in International Trade, Rotterdam, 10 Sep
1998 (published in Official Journal no. 199/2003)
Law no. 509/2003 for ratifying the Agreement
regarding the amendment of the Central European
Free Trade Agreement (C.E.F.T.A.), Krakow, 21 Dec
115
 ANNEX IV

NATIONAL COORDINATING COMMITTEE

NATIONAL PROJECT COORDINATOR Phone: +40 21 2239072

Maria-Mihaela ANTOFIE PhD. Fax: +40 21 2219071
Institute of Biology Bucharest E-mail: lucia.dumitru@ibiol.ro
296 Splaiul Independentei St. District 6, 060031
Phone: +40 21 2239072 Institute of Food Research Bucharest
Fax: +40 21 2219071 Gheorghe MENCINICOPSCHI Professor
E-mail: mihaela_antofie@yahoo.com 1D Gârlei Str., 013721, District 6, Bucharest
Phone: +40 21 2331450 /+40 74 4575778
Ministry of Environment and Water Management Fax: +40 21 2331459
NATIONAL EXECUTING AGENCY E-mail: ica@sunu.rnc.ro
Nature Conservation, Biodiversity and Biosafety
Directorate University of Agricultural Sciences and
12 Libertăţii Blvd., 040129, District 5, Bucharest Veterinary Medicine Cluj-Napoca
Doru PAMFIL, Professor
Adriana BAZ, Director 3-5 Mănăstur Str., 400372, Cluj-Napoca County,
Phone/Fax: +40 21 3160531 Romania
E-mail: baz@mappm.ro Phone: +40 74 4779416
Email: dpamfil@usamvcluj.ro
Ana Maria COMĂNOIU, Superior Counsellor
Phone: +40 21 3163382
Fax: +40 21 3160282 Ministry of Agriculture, Forests and Rural
E-mail: comanoiu@mappm.ro Development
Constantin SIN PhD., Counsellor
Romanian Academy 24 Carol I Blvd., 020921, District 2, Bucharest
George ZARNEA Academician Phone: +40 21 3072405 /+40 72 3190825
Head of Biological Science Department Fax: +40 21 3078635
125 Calea Victoriei, 010071, District 1, Bucharest E-mail: c.sin@maa.ro
Phone: +40 21 2128640
Fax: +40 21 2116608 Ministry of Education and Research
Răzvan TEODORESCU, Counsellor
Romanian Biosafety Commission 21-25 Mendeleev Str., 70161, District 1, Bucharest
Elena BADEA Professor Phone/Fax: + 40 21 2109275
296 Splaiul Independenţei, 060031, District 6, E-mail: razvan.teodorescu@rdslink.ro
Bucharest
Phone: +40 21 2239072 National Authority for Consumers Protection
Fax: +40 21 2219071 Anica POPA, Counsellor
E-mail: elena.badea@ibiol.ro 5 Georges Clemenceanu Str., District 1, Bucharest
Phone: +40 21 3156692 /+40 72 4255817
Academy of Agricultural and Forestry Sciences E-mail: anicapopa@anpc.ro
"Gheorghe Ionescu-Sisesti" (AAFS)
Cristian Ioan HERA, Academician, President of National Sanitary Veterinary and Food Safety
AAFS Authority
59 Mărăşti Blvd., 040255, District 1, Bucharest Monica NEAGU, Director
Phone: +40 21 3184478 1B Negustori Str., 023951, District 2, Bucharest
Fax: + 40 21 3184478 Phone: +40 21 3078568
E-mail: asas@customers.digiro.net Fax: + 40 21 3124967
E-mail: neagu@ansv.ro
Institute of Biology Bucharest
Lucia DUMITRU PhD National Federation for Ecological Agriculture
296 Splaiul Independenţei, 060031, District 6, Ion TONCEA PhD.
Bucharest 1Nicolae Titulescu Str., 915200, Fundulea, Călăraşi

117
ANNEX IV ANNEX IV

County, Romania Directorate Eco Counselling Vienna Serbia

Phone: +40 21 3150805 /+40 21 3110722 12 Libertăţii Blvd., 040129, District 5, Bucharest, Present address: Phone: (+38111) 3616278
Fax: +40 24 2642044 Phone: +40 21 3163382 Federal Environment Agency Ltd. E-mail: sandrakojic@sezampro.yu
E-mail: ion_toncea@yahoo.com Fax: +40 21 3160282 Environmental Impact Assessment and Biosafety
E-mail: comanoiu@mappm.ro Spittelauer Laende 5, A-1090 Vienna, Austria Angela LOZAN Professor
Phone: +43-1-31304-3133 Environmental Expert
Romanian Environmental Journalist Association Călina Petruţa CORNEA Professor Fax: +43-1-31304-3700 Ministry of Ecology and Natural Resources
Alexandru R. SAVULESCU, PhD., President University of Agronomy Sciences and Veterinary mail:michael.eckerstorfer@umweltbundesamt.at 9Cosmonauţilor Str., 2005, Chişinău,
CP 45-8, 3 Xenopol Str., S.B, Ap.9, District 1, Medicine Bucharest Republic of Moldova
Bucharest 59 Mărăşti Blvd., 011464, District 1, Bucharest E. Norval Jr. FRANCIS Phone/Fax: (373 22) 22 68 74
Phone: +40 0724864183 Phone: +40 21 2080311 Minister-Counselor for Agricultural Affairs, E-mail: angelalozan@yahoo.com
E-mail: al.r.savulescu@b.astral.ro Fax: +40 21 2080314 United States Department of Agriculture - Foreign
E-mail: pccornea@yahoo.com Agriculture Service Piet van der MEER PhD.
Project Assistant 27 Du Regent Blvd., 1000, Brussels, Belgium HORIZONS Sprl.
Andrei MĂRuŢEscu Ioana ISPAS Phone: 32-2 5082760 Rue de Fichermont 15, B-1380, Lasne, Belgium
Phone: +40 72 2976336 Ministry of Education and Research Fax: 32-2 5110918 Phone: +32 2 652 1240
E-mail: andreimarutescu@yahoo.com 21-25 Mendeleev Str., 010362, Bucharest E-mail: norval.francis@usda.gov Fax: +32 2 652 3570
Phone: +40 21 2127791 E-mail: PietvanderMeer@cs.co
EXPERTS INVOLVED IN SURVEYS FOR Fax: +40 21 2114275 Helmut GAUGITSCH PhD.
DRAFTING THE ROMANIAN NATIONAL E-mail: iispas@mct.ro Federal Environment Agency Ltd. Ivana MILOSEVIĆ
BIOSAFETY FRAMEWORK Head of Unit, Environmental Impact Assessment Inspector, Ministry of Agriculture, Forestry and
Gheorghe MENCINICOPSCHI Professor and Biosafety Water Management
Maria-Mihaela ANTOFIE PhD. Institute of Food Research Bucharest Spittelauer Laende 5, A-1090 Vienna, Division for Analysis and Agrarian Policy
UNEP/GEF National Project Coordinator 1D Gârlei Str., 013721, District 6, Bucharest Austria Department of Agrarian Resources
Institute of Biology Bucharest Phone: +40 21 2331450 /+40 74 4575778 Phone: +43-1-31304-3133 22-26 Nemanjina Str, 11000, Belgrade,
296 Splaiul Independentei St. District 6, 060031, Fax: +40 21 2331459 Fax: +43-1-31304-3700 Republic of Serbia
Bucharest Romania E-mail: ica@sunu.rnc.ro E-mail: helmut.gaugitsch@umweltbundesamt.at Phone: (+38111) 3616278
Phone: +40 21 2239072 Fax: +40 21 2219071
E-mail: mihaela_antofie@yahoo.com Doru PAMFIL, Professor Alexander GOLIKOV PhD.
University of Agricultural Sciences and Veterinary Executive Secretary, Black Sea Biotechnology Patrick RŰDELSHEIM PhD General Partner
Adriana BAZ Medicine Cluj-Napoca Association, BVBA Perseus
Ministry of Environment and Water Management 3-5 Mănăstur Str., 400372, Cluj-Napoca County, Director, Center for Policy in GMO Risk Technologiepark 4
Director of Nature Conservation, Biodiversity and Romania Management B-9052 Gent, Belgium
Biosafety Directorate Phone: +40 74 4779416 B.Sadovaya Str., 1-1-46, 103001,Moscow, Russia Tel/Fex: +32 (0) 93210705
12 Libertăţii Blvd., 040129, District 5, Bucharest Email: dpamfil@usamvcluj.ro Phone: +7 (926) 2028452 Mob: 32 (0) 475457204
Romania Phone/Fax: +7 (095) 2090348 E-mail: patrick.rudelsheim@perseus.be
Phone/Fax: +40 21 3160531 Constantin SIN PhD. E-mail: alexander.golikov@mtu-net.ru
E-mail: baz@mappm.ro Ministry of Agriculture, Forests and Rural alexandergolikov@netscape.net
Development Nemanja VELIMIROVIC
Elena BADEA Professor 24 Carol I Blvd., 020921, District 2, Bucharest Andreas HEISSENBERGER PhD. UNEP/GEF National Project Coordinator
Romanian Biosafety Commission Phone: +40 21 3072405 /+40 72 3190825 Federal Environment Agency Ltd. „Development of the National Biosafety
296 Splaiul Independenţei, 060031, District 6, Fax: +40 21 3078635 Spittelauer Laende 5, A-1090, Vienna Framework for Serbia” Ministry of Agriculture,
Bucharest Romania E-mail: c.sin@maa.ro Austria Forestry and Water Management Division for
Phone: +40 21 2239072 Fax: +40 21 2219071 Phone: +43-1-31304-3032 Analysis and Agrarian Policy Department of
E-mail: elena.badea@ibiol.ro FOREIGN EXPERTS & LECTURERS Fax: +43-1-31304-3700 Agrarian Resources
INVOLVED IN PROJECT WORKSHOPS E-mail: 22-26 Nemanjina Str, 11000 Belgrade,
Dan BRATU PhD. andreas.heissenberger@umweltbundesamt.at Republic of Serbia
Legislation Expert Atanas ATANASSOV Academician Phone: (+38111) 3616278
66 Nicolae G. Caramfil Str., Bl 21H, Sc.A Director of AgroBioInstitute Sandra ÐUKANOVIĆ KOJIĆ E-mail: neca3d@hotmail.com
Bucharest Romania Bld. Dragan Tsankov nr. 8., 1164 Sofia, Bulgaria Associate, Ministry of Agriculture, Forestry and
Phone: +40 723680574 Phone: +359 2 963 54 07 Water Management
Fax: +359 2 963 54 08 Division for Analysis and Agrarian Policy Piet J.M. de WILDT, Biosafety Inspector
Ana Maria COMĂNOIU E-mail: e-mail:atanas_atanassov@abi.bg Department of Agrarian Resources Ministry of Housing, Spatial Planning and
Ministry of Environment and Water Management 22-26 Nemanjina Str., 11000, Belgrade, Republic of Environment
Nature Conservation, Biodiversity and Biosafety Michael ECKERSTORFER PhD.

118 119
ANNEX IV ANNEX IV

VROM - Inspectorate, S&P-GMO Marin FALCĂ Professor

Postbus 1006, 2001 BA HAARLEM, Netherlands Institute of Biology, Romanian Academy
RELEVANT WEB SITES
Phone: +31 (0)23 515 0700, direct (0659) 296 Splaiul Independenţei, 060031, District 6,
Fax: +31 (0)23 515 0777 Bucharest, Romania
Mobile: +31 (0)6113 888 79 Phone: +40 21 2239072
E-mail: piet.dewildt@minvrom.nl Fax: +40 21 2219071 http://www.biodiv.org/biosafety
E-mail: marin.falca@ibiol.ro http://bch.biodiv.org
ROMANIAN LECTURERS & EXPERTS http://www.unep.org
INVOLVED IN PROJECT WORKSHOPS Ioana ISPAS
http://www.unep.ch/biosafety
Ministry of Education and Research
Maria-Mihaela ANTOFIE PhD. http://www.bsbanet.org
21-25 Mendeleev Str., 010362, Bucharest, Romania
UNEP/GEF National Project Coordinator Phone: +40 21 2127791 http://www.pubresreg.org
Present address Fax: +40 21 2114275 http://wwwtwnside.org.sg
Institute of Biology Bucharest E-mail: iispas@mct.ro http://www.biosafety-info.net
296 Splaiul Independentei St. District 6, 060031, http://www.who.int/en/
Bucharest Romania Gheorghe MENCINICOPSCHI Professor http://iucn.org/
Phone: +40 21 2239072 Fax: +40 21 2219071 Institute of Food Research Bucharest http://biosafety.ihe.be/
E-mail: mihaela_antofie@yahoo.com 1D Gârlei Str., 013721, District 6, Bucharest, http://europa.eu.int/comm/environment/biotechnology/index_en.htm
Romania http://europa.eu.int/comm/biotechnology/
Elena BADEA Professor Phone: +40 21 2331450
Romanian Biosafety Commission http://europa.eu.int/comm/food/food/biotechnology/index_en.htm
Fax: +40 21 2331459
Institute of Biology, Romanian Academy http://gmoinfo.jrc.it/default.asp
E-mail: ica@sunu.rnc.ro
296 Splaiul Independenţei, 060031, District 6, http://www.efsa.eu.int/index_en.html
Bucharest, Romania Simona PASCARIU http://www.iaaas.org/
Phone: +40 21 2239072 Programme Coordinator http://www.wto.org/
Fax: +40 21 2219071 Partners Foundation for Local Development http://www.bsbanet.org
E-mail: elena.badea@ibiol.ro 7-9 Amzei Str. Entr D., apt 34, 6 Floor, District 1, http://www.perseus.be/
Bucharest,
Adriana BAZ Phone/Fax: +40 21 3135664 Romanian web sites
Ministry of Environment and Water Management E-mail: fpdl@fdpl.ro
Director, Nature Conservation, Biodiversity and
Biosafety Directorate http://www.gov.ro
Aurel POPESCU PhD.
12 Libertăţii Blvd., District 5, Bucharest, Romania http://www.biosafety.ro
Institute of Biology, Romanian Academy
Phone: +40 21 3160531 296 Splaiul Independentei, 060031, District 6, http://www.mappm.ro
Fax: +40 21 3160531 Bucharest, Romania http://infoaarhus.mappm.ro
E-mail: baz@mappm.ro Phone: +40 21 2239072 http://domino2.kappa.ro/mj/superlex.nsf
Fax: +40 21 2219071
Ana-Maria COMĂNOIU Region biosafety web sites
Ministry of Environment and Water Management Alexandru R. SAVULESCU PhD.
Counsellor, Nature Conservation, Biodiversity and Romanian Journalist Association on Environment Albania http://biosafety.moe.gov.al
Biosafety Directorate CP 45-8, 3 Xenopol Str., S.B, Ap.9, District 1, Armenia http://www.mnpiac.am/biosafety
12 Libertăţii Blvd., District 5, Bucharest, Romania Bucharest
Phone: +40 21 3163382 Belarus http://biosafety.bas-net.by or http://biosafety.org.by
Phone: +40 0724864183
Fax: +40 21 3160282 Croatia http://www.gmo.hr
E-mail: al.r.savulescu@b.astral.ro
E-mail: comanoiu@mappm.ro Czech Republic http://gmo.vscht.cz
Constantin SIN PhD. Estonia http://eelis.ic.envir.ee/w1/
Călina Petruţa CORNEA Professor Ministry of Agriculture, Forests and Rural Latvia http://www.biosafety.lv
University of Agronomy Sciences and Veterinary Development Lithuania http://gmo.am.lt
Medicine Bucharest 24 Carol I Blvd., 020921, District 2, Bucharest, Macedonia http://www.biosafety.org.mk
59 Mărăşti Blvd., 011464, Bucharest, Romania Romania Republic of Moldova http://www.biosafety.md
Phone: +40 21 2080311 Phone: +40 21 3072405 Slovenia http://www.bch.bf.uni-lj.si
Fax: +40 21 2080314 Fax: +40 21 3078635 Slovakia http://www.gmo.sk
E-mail: pccornea@yahoo.com E-mail:c.sin@maa.ro
Ukraine http://www.biosafety.kiev.ua

120 121
 ANNEX VI

ACRONYMS

ADR European Agreement on the International Carriage of Dangerous Goods on Road

AIA Advanced Informed Agreement
BC Biosafety Commission
BCH Biosafety Clearing House
CDARD County Directorates for Agriculture and Rural Development
CEE Central and Eastern Europe
CITES Convention on International Trade in Endangered Species of Wild Fauna and Flora
CLSRMQ Central Laboratory for Seed and Reproductive Material Quality
COP Conference of the Parties
COTIF Convention concerning International Carriage by Rail
DNA Deoxiribo Nucleic Acid
EC European Community
EEC Economic European Community
EGO Emergency Governmental Ordinance
ERA Environmental Risk Assessment
EU European Union
GD Government Decision
GEF Global Environment Facility
GM Genetically Modified
GMOs Genetically Modified Organisms
GO Government Ordinance
IPPC International Plant Protection Convention
ISO International Standardization Organization
ISTA International Seed Testing Association
LMOs Living Modified Organisms
MAFRD Ministry of Agriculture, Forests and Rural Development
MEWM Ministry of Environment and Water Management
MH Ministry of Health
MHF Ministry of Health and Family
MOP Meeting of the Parties
MTCT Ministry of Transport, Construction and Tourism
NACP National Authority for Consumers Protection
nBCH National Biosafety Clearing House

123
ANNEX VI

NBF National Biosafety Framework

NCA National Customs Authority
NCC National Coordinating Committee
NEA National Executing Agency
DISCLAIMER
NEG National Environment Guard
NGOs Non-Governmental Organizations Information contained in this document is provided by the Ministry of Environment and
NISQ National Inspection for Seed Quality Water Management of Romania and the views presented in the document are those of the
NPC National Project Coordinator Ministry of Environment and Water Management. The United Nations Environment
NSVFSA National Sanitary Veterinary and Food Safety Authority
Programme (UNEP) is not responsible for the information provided in this document.
UNEP does not make any warranty of any kind, either express or implied, including, but
OECD Organization for Economic Cooperation and Development
not limited to, warranties of the accuracy, reliability, completeness or content of such
PCBs Biphenyl Polychlorides information in this document. Under no circumstances shall UNEP be liable for any loss,
POPs Persistent Organic Pollutants damage, liability or expense incurred or suffered which is claimed to have resulted from
R&D Research and Development the use of or reliance upon the information contained in this document, including, but
SAPARD Special Accession Programme for Agriculture and Rural Development
not limited to, any fault, error, mistake, omission or defect. Under no circumstances shall
UNEP be liable for any direct, indirect, incidental, special, punitive or consequential
SITCVFP State Inspection for Technical Control in Vegetables and Fruit Production
damages.
SITVWC State Inspection for Technical Viticulture and Wine Control
SIVTH State Institute for Variety Testing and Homologation
SPS Agreement on the Application of Sanitary and Phyto-sanitary Measures
SVFSD Sanitary Veterinary and Food Safety Directorates
TBT Agreement on Technical Barriers to Trade
TISRMQ Territorial Inspectorates for Seed and Reproductive Material Quality
TRIPs Agreement on Trade Related Aspects of Intellectual Property Rights
TVR Romanian Television
UNECE United Nations Economic Commission for Europe
UNEP United Nations Environment Programme
UNFCCC United Nations Framework Convention on Climate Change
UNO United Nations Organization
WHO World Health Organization
WTO World Trade Organization

S.C. Eurografix S.R.L.

Tel.: 021 686 20 29 www.eurografix.ro

124 125
“National Biosafety Framework for Romania”, in conformity with the
Cartagena Protocol provisions, and also under the context of Romania
accession to EU, is a publication which is analyzing the main domains
related to biosafety describing the biosafety policy, regulatory framework
regarding genetically modified organisms and the main activities defining

ISBN 973-87565-2-9