a.

Introduction:
b. Cartagena Protocol: Requirements and Commitment of the Law (Provisions of the
Protocol)

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an

international agreement which aims to ensure the safe handling, transport and use of living
modified organisms (LMOs) resulting from modern biotechnology that may have adverse effects
on biological diversity, taking also into account risks to human health. It was adopted on 29
January 2000 and entered into force on 11 September 2003. Currently, there are 170 parties to
the Cartagena Protocol with the latest addition of Cote d’Ivoire and State of Palestine this year.

The objective of the Protocol is, in accordance with the precautionary approach, “to contribute to
ensuring an adequate level of protection in the field of the safe transfer, handling and use of
LMOs, taking also into account risks to human health, and specifically focusing on
transboundary movement” (Article 1).

The term “living modified organism” is defined in the Protocol (Article 3) as those living
organisms that “possess a novel combination of genetic material” and are “obtained through the
use of biotechnology”.

The Protocol’s general coverage includes the transboundary movement, transit, handling and use
of all LMOs that may have adverse effects on the conservation and sustainable use of biological
diversity, taking into account also risks to human health (Article 4). However, some categories of
LMOs or transboundary movements are excluded. In some cases the exclusions are limited to
specific provisions relating to the AIA procedure, in others they operate as general exclusions
from all of the Protocol’s provisions.

The Protocol establishes a Biosafety Clearing-House as part of the ClearingHouse Mechanism

under Article 18(3) of the CBD. The function of the Biosafety ClearingHouse is to facilitate the
exchange of scientific, technical, environmental and legal information on, and experience with,
LMOs and to assist Parties to implement the Protocol. Article 20(3) sets out certain categories of
information that Parties are to make available to the Biosafety Clearing-House. These include:
Laws, regulations and guidelines for implementation of the Protocol Bilateral, regional and
multilateral arrangements under Article 14 Decisions on import or release of LMOs Summaries
of risk assessments or environmental reviews of LMOs generated by regulatory processes of
Parties.1

The Biosafety Clearing-House (BCH) is a mechanism set up by the Cartagena Protocol on

Biosafety to facilitate the exchange of information on Living Modified Organisms (LMOs) and
assist the Parties to better comply with their obligations under the Protocol. Global access to a
variety of scientific, technical, environmental, legal and capacity building information is
provided in all 6 of the UN languages.
1
http://www.unep.org/chinese/biosafety/files/IUCNGuide%20on%20the%20CPB.pdf
The term "clearing-house" refers to a mechanism or institution that brings together seekers and
providers of goods, services or information, thus matching demand with supply.

Accordingly, with respect to biosafety information, Article 20, paragraph 1, of the Cartagena
Protocol on Biosafety established a BCH as part of the Clearing-House Mechanism (CHM) of
the Convention on Biological Diversity (CBD), in order to:

(1) Facilitate the exchange of scientific, technical, environmental and legal information on, and
experience with, living modified organisms; and
(2) Assist Parties to implement the Protocol, taking into account the special needs of developing
country Parties, in particular the least developed and small island developing States among them,
and countries with economies in transition as well as countries that are centres of origin and
centres of genetic diversity.2

c. Cartagena Protocol in the Philippines: Overview/Legislation/Ratification/Compliance

The Philippines became a party to such protocol on January 3, 2007.

- Discuss NBCP
- National Biosafety Framework EO 514
- Cartagena

Prior to becoming a party to the Cartagena Protocol on Biosafety in 2002, the Philippines have
established, in October 15,1990 its own biosafety regulatory system, the first in Asia. The NCBP
was created by virtue of Executive Order No. 430, to review, develop, and implement procedures
and protocols in the conduct of activities involving genetic engineering of plants and
microorganisms.  The regulations covers activities under contained use (laboratory, screenhouse,
greenhouse, glasshouse), and confined field test.

As research on modern biotechnology continue to grow rapidly in the succeeding years, the
Philippines have continued reviewing the existing policies and issued additional guidelines that
would address the issues and concerns on modern biotechnology. Executive Order No. 514,
issued in 2006  delineated and strengthened the roles and responsibilities of the Competent
National Authorities (CNAs) in handling not only agricultural crops but other types of GMOs as
well. The NCBP’s mandate under the said issuance included, among others, provisions for
compliance with the country’s commitment as party to the Cartagena Protocol on Biosafety.

In the span of 25 years, the Philippines remained committed in ensuring that activities on modern
biotechnology is carried out in a safe and responsible manner. The year 2015 witnessed these
remarkable achievements celebrated by relevant government agencies, private and public
research institutions, academe, industry and other stakeholders.

2
http://www.bic.searca.org/resources/biosafety/cartagena.html
The CNA’s--Departments of Science and Technology, Agriculture, Environment and Natural
Resources, and Health--have also proclaimed their continued dedication in the implementation of
the biosafety on GMOs and the Cartagena Protocol on Biosafety.

In recognition of the fast-pace development in this field in the coming years, the NCBP affirmed
its commitment to uphold its mandate and implement a functional, predictable, and science-
based biosafety regulatory system, while protecting the environment and human health.

Julieta Fe L. Estacio
Project Development Officer
Department of Science and Technology 
National Focal Point, BCH-Pilipinas3

Compliance: Biosafety Clearing House

The BCH Pilipinas is the Philippine node of the Biosafety Clearing-House mechanism
established under Article 20 of the Cartagena Protocol on Biosafety. It is a centralized
operational BCH national system designed to facilitate the exchange of scientific, technical,
environmental and legal information on Living Modified Organisms (LMOs). Similarly,
experiences on the use of LMOs by the participating agencies involved in biosafety regulation
and other biosafety-related organizations are also shared. As a central repository of information,
it serves as a "one-stop shop" where users composed of public research institutions, private
sector and other stakeholders, can readily access biosafety-related information. Thus, BCH
Pilipinas serves as a venue for information exchange for providers and users of biosafety
information in a transparent, accurate and timely manner. The information in the BCH Pilipinas
are provided by the National Committee on Biosafety of the Philippines (NCBP) and the
Competent National Authorities: Department of Agriculture (DA), Department of Environment
and Natural Resources (DENR), Department of Health (DOH) and Department of Science and
Technology (DOST).4

The Philippines, being a party to the Cartagena Protocol on Biosafety, has established the BCH
Pilipinas, the Philippine Biosafety Clearing-House in compliance to Article 20 of the Cartagena
Protocol on Biosafety. The BCH Pilipinas provides access to the country’s information on living
modified organisms (LMOs) / genetically modified organisms (GMOs).

The BCH Pilipinas contains, among others, the National Contacts, Laws and Regulations,
Decisions and Declarations on LMOs, Risk Assessment of Approved Regulated Articles, Unique
Identification of Approved Regulated Articles, Capacity Building, Roster of Experts, and
National Reports. The BCH has established procedures for uploading these informations to the
BCH Central Portal provided by the competent national authorities: National Committee on
3
http://bch.cbd.int/about/news-post/?postid=109157&utm_source=BCH+Central+Portal
4
http://bch.dost.gov.ph/findinginformation1/national-contact/national-biosafety-related-website-or-database
Biosafety of the Philippines (NCBP), Department of Science and Technology (DOST),
Department of Agriculture (DA), Department of Environment and Natural Resources (DENR),
and Department of Health (DOH).5
Profile information and status

Country Philippines

Date of signature 2000-05-24

Date of ratification 2006-10-05

Date of entry into

2007-01-03
force

Profile revision -

Profile status  Published

Profile last updated on -

Type of document Number of records Date of last update

Biosafety Expert 8 2015-05-29

Capacity Building Needs and Priorities 1 2012-06-08

Competent National Authority 5 2012-02-08

Country's Decision or any other Communication 71 2015-08-03

Law, Regulation or Guideline 17 2015-05-28

National Database or Website 3 2011-11-14

National Focal Point 3 2015-05-15

News 10 2015-11-04

Report on Assignment 0 -

Risk Assessment 66 2015-08-03

Reports on Implementation of the Protocol 2 2011-10-28

  Total number of records 186  

What is BCH Mechanism?

The Biosafety Clearing-House (BCH) is an information-exchange mechanism that provides open and easy access to key
information about Living Modified Organisms (LMOs).

What is the role of BCH?

(a) To facilitate the exchange of scientific, technical, environmental and legal information on,
and experience with, living modified organisms; and,

(b) To assist Parties to implement the Cartagena Protocol on Biosafety.

What is the Cartagena Protocol on Biosafety?

5
http://www.bic.searca.org/resources/biosafety/cartagena.html
The Cartagena Protocol on Biosafety is a supplemental agreement of the Convention on
Biological Diversity (CBD) adopted by the Conference of the Parties (COP) on 22 January 2000
to protect biodiversity from the potential risks posed by LMOs resulting from modern
biotechnology.

What is the purpose of BCH and why is it important?

BCH is the only means through which Parties can provide certain information required under the
Protocol, including information provided by Parties for the advance informed agreement
procedure.

The BCH provides the mechanism by which Parties are informed about final decisions regarding
domestic use (including placing on the market) of LMOs that may be subject to transboundary
movement for food, feed or for processing.

How does it work?

Governments need to put in place lines of communication and information exchange to ensure
that information that should be made available through the BCH is placed on the BCH in a
timely and appropriate fashion.

· The development of the BCH is to be guided by the principle of inclusiveness, transparency

and equity, and is to be open to all governments.

· A party must nominate a national focal point for the BCH (or institutional focal point).

What are the benefits from BCH?

Access information about the national laws, regulations and guidelines of other Parties; and
information about the decisions and assessments of other countries relating to specific LMOs.

· Ensure, by posting up-to-date information on the BCH, that all potential exporters of LMOs to
their country, or those who wish to transport LMOs across their territory, are aware of their
national regulatory requirements.

· Access information about capacity-building and other assistance available to support

implementation of the Protocol.

· Ensure that the relevant authorities in other countries can quickly find out who to inform in the
event of an accidental movement of LMOs into their territory.

What is BCH Pilipinas?

It is a central repository of all biosafety related information generated from the NCBP and CNAs (DA, DENR, DOH, DOST).

· It serves as an information exchange venue for providers and users of biosafety information.
What are the CNAs and their roles?

he CNAs are the Government Departments involved in the implementation of the regulation of LMOs.

1. Department of Science and Technology

o Responsible for the review and assessment of LMOs intended for contained use (laboratory, screen house, green house and
confined test).

2. Department of Agriculture

o Responsible for the regulation of plants and plant products derived from the use of modern biotechnology, fisheries and other
aquatic resources, domesticated animals and biological products used for animal husbandry or veterinary purposes and
genetically modified biological control agents.

3. Department of Environment and Natural Resources

o Responsible for the regulation of LMOs intended for bioremediation, the improvement of forest genetic resources, and wildlife
genetic resources, applications of modern biotechnology with potential impact on the conservation and sustainable use of
biodiversity. The DENR ensures that environmental assessments are done and impacts are identified in biosafety decisions.

4. Department of Health

o Responsible for the regulation of food, including drugs (biopharmaceuticals), cosmetics and medical devices derived from
products of modern biotechnology.

The DOH ensures that environmental health impact assessments are reviewed and evaluated for biosafety decisions when
applicable.

What is the clearing mechanism under BCH Pilipinas?

The information coming from the CNAs are submitted to the National Focal Point (NFP) and forwarded to the BCH Central
Portal6

6
http://bch.dost.gov.ph/faqs