Annex 1 - DG SANCO: First working draft of the revised GPSD (13/09/2012)

Please note that the text of this first working draft will be subject to further changes

ANNEX 1

PROPOSAL FOR A REVISED DIRECTIVE ON GENERAL

PRODUCT SAFETY

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Annex 1 - DG SANCO: First working draft of the revised GPSD (13/09/2012)

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CHAPTER I
Objective, scope and definitions
Article 1
Objective
The purpose of this Regulation is to ensure that products placed or made available on
the market are safe.
Article 2
Scope
1.

This Directive shall apply to products defined in Article 3 (1). Each of its provisions
shall apply in so far as there are no specific provisions with the same objective in
rules of Union law governing the safety of the products concerned.

2.

Where products are subject to specific safety requirements imposed by Union

legislation, this Directive shall apply only to the aspects and risks or categories of
risks not covered by those requirements. This means that

3.

(a)

Articles 4 (2) and (3), 4 and 12 shall not apply to those products insofar as
concerns the risks or categories of risks covered by the specific legislation.

(b)

Articles 5 to 11 shall apply except where there are specific provisions

governing the aspects covered by the said Articles with the same objective.

This Directive also applies to the products which appearing to be other than they are
endanger the health and safety of consumers.
Article 3
Definitions

For the purposes of this Regulation the following definitions shall apply:
1.

product shall mean a substance, preparation or good produced through a

manufacturing process other than food, feed, living plants and animals, products of
human origin and products of plants and animals relating directly to their future
reproduction, which is intended for consumers or likely, under reasonably
foreseeable conditions, to be used by consumers even if not intended for them
including in the context of a services and is supplied or made available, whether
for consideration or not, in the course of a commercial activity, and whether new,
used or reconditioned.
This definition shall not apply to second-hand products supplied as antiques or as
products to be repaired or reconditioned prior to being used, provided that the
supplier clearly informs the person to whom he supplies the product to that effect.

2.

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"safe product" shall mean any product which, under normal or reasonably
foreseeable conditions of use including duration and, where applicable, putting into

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Annex 1 - DG SANCO: First working draft of the revised GPSD (13/09/2012)

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service, installation and maintenance requirements, does not present any risk or only
the minimum risks compatible with the product's use, considered to be acceptable
and consistent with a high level of protection for the safety and health of persons,
taking into account the following points in particular:
(i)

the characteristics of the product, including its composition, packaging,

instructions for assembly and, where applicable, for installation and
maintenance;

(ii)

the effect on other products, where it is reasonably foreseeable that it will be

used with other products;

(iii) the presentation of the product, the labelling, any warnings and instructions for
its use and disposal and any other indication or information regarding the
product;
(iv) the categories of consumers at risk when using the product, in particular
children and the elderly,
(v) the appearance of the product, in particular whether it is not a product which,
although not foodstuffs, possesses a form, odour, colour, appearance,
packaging, labelling, volume or size, such that it is likely that consumers,
especially children, will confuse it with foodstuffs and in consequence place it
in their mouths, or suck or ingest it, which might be dangerous and cause, for
example, suffocation, poisoning, or the perforation or obstruction of the
digestive tract.
The feasibility of obtaining higher levels of safety or the availability of other
products presenting a lesser degree of risk shall not constitute grounds for
considering a product to be "dangerous";

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2.

dangerous product shall mean any product which does not meet the definition of
safe product" in (2.);

3.

serious risk shall mean any serious risk, including those the effects of which are not
immediate, requiring rapid intervention by the public authorities;

4.

making available on the market means any supply of a product for distribution,
consumption or use on the Union market in the course of a commercial activity,
whether in return for payment or free of charge;

5.

placing on the market means the first making available of a product on the Union
market;

6.

manufacturer means any natural or legal person who manufactures a product or has
a product designed or manufactured and markets that product under his name or
trademark;

7.

authorised representative means any natural or legal person established in the

Union who has received a written mandate from a manufacturer to act on his behalf
in relation to specified tasks with regard to the latters obligations under the relevant
Union legislation;

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Annex 1 - DG SANCO: First working draft of the revised GPSD (13/09/2012)

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8.

importer means any natural or legal person established in the Union who places a
product from a third country on the Union market;

9.

distributor means any natural or legal person in the supply chain, other than the
manufacturer or the importer, who makes a product available on the market;

10.

economic operator means the manufacturer, the authorised representative, the

importer or the distributor;

11.

'technical specification shall mean a document that prescribes technical

requirements to be fulfilled by a product, process or service;

12.

harmonised standard shall mean a standard adopted by one of the European

standardisation bodies listed in [Annex I to Directive 98/34/EC of the European
Parliament and of the Council of 22 June 1998 laying down a procedure for the
provision of information in the field of technical standards and regulations and of
rules on Information Society services (1) on the basis of a request made by the
Commission in accordance with Article 6 of that Directive];

13.

conformity assessment means the process demonstrating whether specified

requirements relating to a product, process, service, system, person or body have
been fulfilled;

14.

market surveillance means the activities carried out and measures taken by public
authorities to ensure that products do not endanger health, safety or any other aspect
of public interest protection and, in the case of products falling within the scope of
Union harmonisation legislation, that they comply with the requirements set out in
that legislation;

15.

market surveillance authority means an authority of a Member State responsible for

carrying out market surveillance on its territory;

16.

recall means any measure aimed at achieving the return of a product that has
already been made available to the end user;

17.

withdrawal means any measure aimed at preventing a product in the supply chain
from being further made available on the market;

18.

Union harmonisation legislation means any Union legislation harmonising the

conditions for the marketing of products.

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Annex 1 - DG SANCO: First working draft of the revised GPSD (13/09/2012)

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CHAPTER II
OBLIGATIONS OF ECONOMIC OPERATORS
Article 4
General safety requirement
1.

Economic operators shall be obliged to place or make available on the market only
safe products.

2.

A product shall be deemed safe, as far as the aspects covered by the relevant national
legislation are concerned, when, in the absence of specific provisions of Union law
governing the safety of the product in question, it conforms to the specific rules of
national law of the Member State in whose territory the product is marketed, such
rules being drawn up in conformity with the Treaty on the Functioning of the
European Union, and in particular Articles 34 and 36 thereof, and laying down the
health and safety requirements which the product must satisfy in order to be
marketed.
A product shall be presumed safe as far as the risks and risk categories covered by
relevant national standards are concerned when it conforms to voluntary national
standards transposing European standards, the references of which have been
published by the Commission in the Official Journal of the European Union in
accordance with Articles 12, 13 and 14. The Member States shall publish the
references of such national standards.

3.

4.

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In circumstances other than those referred to in paragraph 2, the conformity of a

product to the general safety requirement shall be assessed by taking into account the
following elements in particular, where they exist:
(a)

voluntary national standards transposing relevant European standards other

than those referred to in paragraph 2;

(b)

the standards drawn up in the Member State in which the product is marketed;

(c)

Commission recommendations setting guidelines on product safety

assessment;

(d)

international standards issued by the International Standards Organisation or

International Electrotechnical Commission,

(e)

product safety codes of good practice in force in the sector concerned;

(f)

the state of the art and technology;

(g)

reasonable consumer expectations concerning safety.

Conformity of a product with the criteria designed to ensure the general safety
requirement, in particular the provisions mentioned in paragraphs 2 or 3, shall not bar
the market surveillance authorities of the Member States from taking appropriate
measures to impose restrictions on its being placed on the market or to require its

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Annex 1 - DG SANCO: First working draft of the revised GPSD (13/09/2012)

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withdrawal from the market or recall where there is evidence that, despite such
conformity, it is dangerous.
Article 5
Obligations of manufacturers
1.

When placing their products on the market, manufacturers shall ensure that they have
been designed and manufactured in accordance with the requirements set out in the
relevant Union harmonisation legislation and the general safety requirement.
The presence of warnings does not exempt any person from compliance with the other
requirements laid down in this Directive.

2.

Manufacturers shall ensure that procedures are in place for series production to remain
in conformity with the requirements referred to in paragraph 1. Changes in product
design or characteristics and changes in the harmonised standards or in technical
specifications by reference to which conformity of a product is declared shall be
adequately taken into account.

3.

Within the limits of their respective activities, manufacturers shall provide consumers
with the relevant information to enable them to assess the risks inherent in a product
throughout the normal or reasonably foreseeable period of its use, where such risks are
not immediately obvious without adequate warnings, and to take precautions against
those risks.
When deemed appropriate with regard to the risks presented by
manufacturers shall, to protect the health and safety of consumers, carry
testing of marketed products, investigate, and, if necessary, keep a
complaints, of non-conforming products and product recalls, and
distributors informed of any such monitoring.

4.

a product,
out sample
register of
shall keep

Unless manufacturers have drawn up the required technical documentation under the
Union harmonisation legislation, they shall draw up a technical documentation which
shall include an adequate analysis and assessment of the risk(s) and cover, as far as
relevant for the assessment, the design, manufacture and operation of the product.
The technical documentation shall contain, wherever applicable, at least the following
elements:
a general description of the product,
conceptual design and manufacturing drawings and schemes of components, subassemblies, circuits, etc.
descriptions and explanations necessary for the understanding of those drawings
and schemes and the operation of the product,
a list of the harmonised standards and/or other relevant technical specifications the
references of which have been published in the Official Journal of the European Union
or, if relevant, indications of rules referred to in the first sub-paragraph of Article 3
(2), or other elements referred to in Article 3 (3), applied in full or in part, and

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Annex 1 - DG SANCO: First working draft of the revised GPSD (13/09/2012)

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descriptions of the solutions adopted to meet the requirements of the harmonised
standards, technical specifications or other elements referred to in this paragraph.. In
the event of partly applied harmonised standards, the technical documentation shall
specify the parts which have been applied,
results of design calculations made, examinations carried out, etc., and
test reports.
5.

Manufacturers shall ensure that their products bear a type, batch or serial number or
other element allowing their identification, or, where the size or nature of the product
does not allow it, that the required information is provided on the packaging or in a
document accompanying the product.

6.

Manufacturers shall indicate their name, registered trade name or registered trade mark
and the address at which they can be contacted on the product or, where that is not
possible, on its packaging or in a document accompanying the product. The address
must indicate a single point at which the manufacturer can be contacted.

7.

Manufacturers shall ensure that the product is accompanied by instructions and safety
information in a language which can be easily understood by consumers and other
end-users, as determined by the Member State concerned, except where not to give
such instructions and safety information is justified with regard to the safety properties
of the product.

8.

Manufacturers who know or ought to know, on the basis of the information in their
possession and as professionals, a product which they have placed on the market is not
in conformity with the requirements referred to in Article 4 (1) shall immediately take
the necessary corrective measures to bring that product into conformity, to withdraw it
or recall it, if appropriate and shall immediately inform the competent national
authorities of the Member States in which they made the product available to that
effect, giving details, in particular, of the non-compliance and of any corrective
measures taken.
Recall shall take place as a last resort, where other measures would not suffice to
prevent risks involved, in instances where the producers consider it necessary or where
they are obliged to do so further to a measure taken by the competent authority. It may
be effected within the framework of codes of good practice on the matter in the
Member State concerned, where such codes exist.

9.

Manufacturers shall, further to a reasoned request from a market surveillance

authority, provide it with all the information and documentation necessary to
demonstrate the conformity of the product, in a language which can be easily
understood by that authority.
They shall cooperate with that authority, at its request, on any action taken to eliminate
the risks posed by products which they have placed on the market.

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Annex 1 - DG SANCO: First working draft of the revised GPSD (13/09/2012)

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Article 6
Authorised representatives
1.

A manufacturer may, by a written mandate, appoint an authorised representative.

The obligations laid down in Article 5 (1) and the drawing up of technical
documentation shall not form part of the authorised representative's mandate.

2.

An authorised representative shall perform the tasks specified in the mandate received
from the manufacturer. The mandate shall allow the authorised representative to do at
least the following:
(a) further to a reasoned request from a market surveillance authority, provide that
authority with all the information and documentation necessary to demonstrate the
conformity of a product;
(b) cooperate with the market surveillance authority, at their request, on any action
taken to eliminate the risks posed by products covered by their mandate.
Article 7
Importers

1.

Before placing a product on the market importers shall ensure the manufacturer has
drawn up the technical documentation, that the product bears the required conformity
marking or markings and is accompanied by the required documents, and that the
manufacturer has complied with the requirements set out in Article 5 (7) and (8).
Where an importer considers or has reason to believe that a product is not in
conformity with the requirements referred to in Article 5 (1), he shall not place the
product on the market until it has been brought into conformity and shall inform the
manufacturer and the market surveillance authorities to that effect.

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2.

Importers shall indicate their name, registered trade name or registered trade mark and
the address at which they can be contacted on the product or, where that is not
possible, on its packaging or in a document accompanying the product.

3.

Importers shall ensure that the product is accompanied by instructions and safety
information in a language which can be easily understood by consumers and other
end-users, as determined by the Member State concerned, except where not to give
such instructions and safety information is justified with regard to the safety properties
of the product.

4.

Importers shall ensure that, while a product is under their responsibility, storage or
transport conditions do not jeopardise its compliance with the requirements referred to
in Article 5 (1).

5.

Within the limits of their respective activities, importers shall provide consumers with
the relevant information to enable them to assess the risks inherent in a product
throughout the normal or reasonably foreseeable period of its use, where such risks are
not immediately obvious without adequate warnings, and to take precautions against
those risks.

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When deemed appropriate with regard to the risks presented by a product, importers
shall, to protect the health and safety of consumers, carry out sample testing of
marketed products, investigate, and, if necessary, keep a register of complaints, of
non-conforming products and product recalls, and shall keep distributors informed of
such monitoring.
6.

Importers who know or ought to know, on the basis of the information in their
possession and as professionals, a product which they have placed on the market is not
in conformity with requirements referred to in Article 5 (1) shall immediately take the
corrective measures necessary to bring that product into conformity, to withdraw it or
recall it, if appropriate, and shall immediately inform the competent market
surveillance authorities of the Member States in which they made the product
available to that effect, giving details, in particular, of the non-compliance and of any
corrective measures taken.
Recall shall take place as a last resort, where other measures would not suffice to
prevent risks involved, in instances where the producers consider it necessary or where
they are obliged to do so further to a measure taken by the competent authority. It may
be effected within the framework of codes of good practice on the matter in the
Member State concerned, where such codes exist.

7.

Importers shall, for a period specified in the relevant Union harmonisation legislation
or for a period proportional to the lifecycle of the product and the level of risk, ensure
that the technical documentation can be made available to those authorities, upon
request.

8.

Importers shall, further to a reasoned request from a market surveillance authority,

provide it with all the information and documentation necessary to demonstrate the
conformity of a product in a language which can be easily understood by that
authority.
They shall cooperate with that authority, at its request, on any action taken to eliminate
the risks posed by products which they have placed on the market.
Article 8
Obligations of distributors

1.

When making a product available on the market distributors shall act with due care
in relation to the requirements referred to in Article 5 (1).

2.

Before making a product available on the market distributors shall verify that the
product bears the required conformity marking or markings, that it is accompanied
by the required documents and by instructions and safety information in a language
which can be easily understood by consumers and other end-users in the Member
State in which the product is to be made available on the market, and that the
manufacturer and the importer have complied with the requirements set out in Article
5 (7) and (8) and Article 7 (2).
Where a distributor knows or should have presumed, on the basis of the information
in their possession and as a professional, that a product is not in conformity with the
requirements referred to in Article 5 (1), he shall not make the product available on

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the market until it has been brought into conformity and shall inform the
manufacturer or the importer to that effect as well as the market surveillance
authorities.
Within the limits of their respective activities, distributors shall participate in
monitoring of the safety of products placed or made available on the market. For this
purpose, they shall:
(a) pass on information on product risks,
(b) keep and providing the documentation necessary for tracing the origin of
products,
(c) cooperate in the action taken by other economic operators and competent
authorities to avoid the risks, and
(d) take measures enabling them to cooperate efficiently.
3.

Distributors shall ensure that, while a product is under their responsibility, storage or
transport conditions do not jeopardise its compliance with the requirements referred
to in Article 5 (1).

4.

Distributors who know or should have presumed, on the basis of the information in
their possession and as professional that a product which they have made available
on the market is not in conformity with the requirements referred to in Article 5 (1)
shall make sure that the corrective measures necessary to bring that product into
conformity, to withdraw it or recall it, if appropriate, are taken, and shall
immediately inform the competent national authorities of the Member States in
which they made the product available to that effect, giving details, in particular, of
the non-compliance and of any corrective measures taken.

5.

Distributors shall, further to a reasoned request from a competent national authority,

provide it with all the information and documentation necessary to demonstrate the
conformity of a product.
They shall cooperate with that authority, at its request, on any action taken to
eliminate the risks posed by products which they have made available on the market.
Article 9
Cases in which obligations of manufacturers apply to importers and distributors
An importer or distributor shall be considered a manufacturer for the purposes of this
Directive and he shall be subject to the obligations of the manufacturer under Article
4, where he places a product on the market under his name or trademark or modifies
a product already placed on the market in such a way that compliance with the
applicable requirements may be affected.

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Annex 1 - DG SANCO: First working draft of the revised GPSD (13/09/2012)

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Article 10
Identification of economic operators
Economic operators shall, on request, identify the following to the market
surveillance authorities, for a period specified in the relevant Union harmonisation
legislation or proportional to the lifecycle of the product and the level of risk,
(a) any economic operator who has supplied them with a product;
(b) any economic operator to whom they have supplied a product.
Article 11
Information obligation and dialogue
1.

The information referred to in Articles 8 (2) shall be provided to market surveillance

authorities under the conditions laid down in Annex [], giving details, in particular,
of action taken to prevent risk to the consumer.
The Commission shall adapt the specific requirements relating to the obligation to
provide information laid down in Annex I. Those measures shall be adopted in
accordance with the [].

2.

The procedures for cooperation between economic operators and market surveillance
authorities, including procedures for dialogue with the economic operators concerned
on issues related to product safety, shall be established by the market surveillance
authorities.
Member States shall communicate the rules of these procedures to the other Member
States and the Commission and make them available to the public, by way of
electronic communication and, where appropriate, by other means.
CHAPTER III
PROCEDURES FOR PREPARING EUROPEAN STANDARDS UNDER THIS
DIRECTIVE
Article 12
Procedure for preparing European standards under this Directive

1.

EN

For the purposes of this Directive, the European standards referred to in the second
subparagraph of Article 4 (2) shall be drawn up as follows:
(a)

the Commission inquires with the relevant European standardisation body

whether a relevant European standard or standards developed by this body
which could fulfil the general safety requirement exist;

(b)

if the relevant European standardisation body communicates to the

Commission that no relevant European standard or standards developed by
this body exist, the Commission shall, in accordance with the [Regulation on

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European Standardisation] call on the European standardisation bodies to
draw up standards which satisfy the general safety requirement,
(c)

2.

on the basis of those mandates, the European standardisation bodies shall

adopt the standards in accordance with the principles contained in the general
guidelines for cooperation between the Commission and those bodies.

The Commission shall on its own initiative or upon a request from a Member State
decide in accordance with the procedure laid down in Article [] whether the
standard or standards referred to in paragraph 1 (b) meet the general safety
requirement.
If a standard does not ensure compliance with the general safety requirement, the
Commission shall resubmit the mandate to the concerned European standardisation
body.
If it is decided that a standard ensures compliance with the general safety
requirement, the Commission shall publish in the Official Journal of the European
Union the references of the European standards adopted in this way and drawn up in
accordance with the requirements referred to in paragraph 1.
Article 13
Procedure concerning European standards adopted before this Directive

1.

If a standard adopted by the relevant European standardisation body before the entry
into force of this Directive ensures compliance with the general safety requirement,
the Commission shall decide to publish its references in the Official Journal of the
European Union in accordance with the procedure laid down in Article [].

2.

If a standard does not ensure compliance with the general safety requirement, the
Commission shall withdraw reference to the standard from publication in whole or in
part.
The Commission shall decide to publish or withdraw after consulting the Committee
established by Article [] of Regulation on European Standardisation. The
Commission shall notify the Member States of its decision.
Article 14
Fast-track procedure
If the relevant European standardisation body communicates to the Commission
upon its request under Article 12 (1) (a) that a European standard or standards
developed by this body which could fulfil the general safety requirement exist, the
Commission decides in accordance with the procedure laid down in Article []
whether such standard or standards adopted by the relevant European standardisation
body and subject to the communication under Article 12 (1) (a) fulfil the general
safety requirement.
If it is decided that a standard or the standards in question ensure compliance with
the general safety requirement, the Commission shall publish in the Official Journal
of the European Union the references of the European standards adopted in this way.

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Chapter IV
FINAL PROVISIONS
Article 15
[Implementing/Delegated powers]
Article 16
[Powers to issue Commission recommendations setting guidelines on product safety
assessment]
Article 17
Committee
Article 18
Expert group
Article 19
Review and reporting
Article 20
Amendments
Article 21
This Directive shall enter into force on the [] day following that of its publication in the
Official Journal of the European Union.
Transposition deadline [ ].
Article 22
This Directive is addressed [].
Done at Brussels,

For the European Parliament

The President

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For the Council

The President

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