WORLD TRADE
ORGANIZATIONG/TBT/W/218
30 June 2003
(03-3457)
Committee on Technical Barriers to Trade Original:  English
SUPPLIER’S DECLARATION OF CONFORMITY
Submission by the European Communities
I. INTRODUCTION
1. This note is intended to explain the European Communities’ (EC) system on using “suppliers’
declaration of conformity1”and the EC’s experience in its use.  It examines possible implications for
market surveillance and product liability, as well as associated costs and benefits.
2. The definition of suppliers’ declaration used in this document is the following.  The supplier
himself declares conformity of his product with th e requirements of the applicable legislation without
any mandatory third party intervention – neither in the design phase nor the production phase of the
manufacturing process – that would involve product te sts according to the relevant legislation.  The
Suppliers’ DoC is based on an assessment or test performed by the manufacturer himself or any other
party.
II. THE EUROPEAN COMMUNITIES’ EXPERIENCE
3. EC experience in the use of supplier’s declaration of conformity has been within the
framework of New Approach Directives2.  New Approach Directives are regulations in the field of
technical safety of a wide range of industrial products.  They lay down the essential public interest
requirements for families of products (dealing with  safety, health and environmental protection), the
relevant conformity assessment procedures tailored to the specific risks inherent to the respectiveproduct family and the “CE” marking to be affixed on the products by the manufacturer before
placing them on the market.
                                                     
1 Please note that “supplier’s declaration of conformity” sometimes is called “manufacturer’s
declaration of conformity” or “self-declaration of conformity”.  The underlying concept of the terms is the
same. A supplier, according to the definition in ISO/IE C Guide 22:1996 is a party that supplies the product,
process or service and may be the manufacturer, distributor, importer, assembler, etc.
2 In 1985, the Council Resolution on “A New Approach to technical harmonization and standards”
provided a new framework for the harmonization of national regulations for industrial products. Later, the
Council Resolution of 21 December 1989 on a “Global Approach to conformity assessment”, followed by
Council Decision 93/465/EEC of 22 July 1993 gave more detailed specifications on certification procedures byintroducing the “modules” for the conformity assessment and guidelines for the affixing and use of the CEconformity marking.G/TBT/W/218
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4. Conformity assessment using the supplier’s declaration of conformity is applied in some New
Approach Directives3, covering certain categories of products in the fields of: electrical equipment,
machinery, toys, medical devices, personal protective equipment, recreational crafts, radio and
telecommunication equipment and the equipment for use in potentially explosive atmospheres.  As the
basic model (“Module A”) for conformity assessment in these fields, it also reflects broader EC policyto promote a system based on trust, transparency and competence.  Use of the supplier’s declaration
of conformity is mostly linked to the application of harmonised European standards that are
elaborated by the European standardization bod ies CEN, CENELEC and ETSI following a mandate
by the EC.  They contain technical specifications for the fulfilment of the relevant essential
requirements.  The standardization process offers the possibility to transpose standards and
incorporate international standards from ISO, IEC and ITU-T as they become available.  However, the
use of harmonised European standards remains voluntary and manufacturers are free to choose anytechnical solution to comply with the relevant essential requirements.  Deviation from harmonised
standards may however, depending on the applicable directive, entail mandatory third-party
involvement.
5. For all products intended to be placed on the market, the supplier has to ensure that they
satisfy the relevant legal requirements.  Applying the DoC imposes the supplier to care for the
requirements of documentation and declaration.  The supplier has to establish a technical file
containing the documentation that covers design, manufacture and operational aspects of the product
reflecting the results of an appropriate risk assessment and, if applicable, the test results obtained from
a competent laboratory.  The supplier must also draw up and keep together with the file a copy of thedeclaration of conformity.  The supplier must keep it for a period ending at least 10 years after the last
product has been manufactured and must make it available to the relevant national authorities for
inspection purposes.  The supplier takes full responsibility for placing the product on the market and
must take all measures necessary in order that the manufacturing process ensures compliance of the
manufactured products with the technical documentation and with the relevant legal requirements.
6. For some categories of higher-risk products covered by New Approach Directives, an
additional step is required, which involves the intervention of a third-party certification body.  This
allows for an examination of a product type, the technical file or additional tests to be made prior to
the product being placed on the market.
                                                     
3 Council Directive 73/23/EEC on the harmonization of the laws of Member States relating to electrical
equipment designed for use within certain voltage limits, Council Directive 88/378/EEC on the approximation
of the laws of the Member States concerning the safety of toys, Council Directive 89/336/EEC on the
approximation of the laws of the Member States relating to electromagnetic  compatibility, Directive 98/37/EC
of the European Parliament and the Council on the approximation of the laws of the Member States relating tomachinery, Council Directive 89/686/EEC on the approximation of the laws of the Member States relating topersonal protective equipment, Council Directive 93/ 42/EEC concerning medical devices, Directive 94/25/EC
of the European Parliament and the Council on the approximation of the laws, regulations and administrative
provisions of the Member States relating to recreatio nal craft, Directive 96/57/EC of the European Parliament
and the Council on energy efficiency requirements for household electric refrigerators , freezers and
combinations thereof, Directive 97/23/EC of the Europ ean Parliament and the Council on the approximation of
the laws of the Member States concerning pressure equipment, Directive 98/79/EC of the of the European
Parliament and the Council on in vitro diagnostic medical devices, Directive 1999/5/EC of the EuropeanParliament and the Council on radio equipment and telecommunications terminal equipment and the mutual
recognition of their conformity, Directive 94/9/EC of the European Parliament and the Council on the
approximation of the laws of the Member States concer ning on equipment and protective systems intended for
use in potentially explosive atmospheres.G/TBT/W/218
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III. REQUIREMENTS FOR THE USE OF SUPPLIER’S DECLARATION
7. According to the EC experience supplier's decl aration of conformity can facilitate market
access without prejudice to the fulfilment of legitimate public policy objectives, when it is combined
with well developed market surveillance systems and effective product liability laws.
A. PRODUCT CHOICE
8. Before deciding to apply supplier’s declaration of conformity, several elements should be
taken into consideration.  In particular, issues such as the appropriateness of the supplier’s declaration
of conformity in view of the nature of the risk s involved, the economic infrastructures of the given
sector (e.g. existence or non-existence of certification laboratories) and the production system.
Supplier’s declaration of conformity is the preferred option for product categories presenting risks thatare generally considered to be low.
B. M
ARKET SURVEILLANCE
9. An essential tool for the enforcement of any legislation – and in particular for goods that are
placed on the market following a supplier’s declaration of conformity – is market surveillance.Market surveillance involves monitoring products to ensure they comply with legislation and taking
remedial action when products do not comply.  It also includes penalties for false or misleading
declarations.  In the EC this is the responsibility of national authorities specially nominated or
established by the Member States.  To help ensure the fulfilment of legitimate public policy
objectives, the less involvement by a third party during the conformity assessment before the productis placed on the market, the greater the need for efficient market surveillance.
10. There is a range of market surveillance structures.  The responsible market surveillance
authorities need to have sufficient and appropria te resources, staff and powers to conduct effective
surveillance activities.  Overall, a distinction should be made between conformity assessment
(pre-market), which is a task for the manufacturer or the conformity assessment bodies and marketsurveillance (post-market) which is carried out by market surveillance authorities, and is often
financed from public funds.  Conformity assessment bodies should not be responsible for market
surveillance, as there would be a risk of conflict of interest
C. P
RODUCT LIABILITY
11. In the EC, regardless of the decreed or chosen conformity assessment procedure,
manufacturers and importers are always liable in the case of a product causing damage to an
individual or private property according to the Directive on product liability.4  The Directive covers
all products with a limited number of exceptions.  If the manufacturer or an importer can demonstrate
that the product was not defective when it was placed on the market, the manufacturer or an importer
will not be liable for damages.  The injured party will be paid only if he proves that he has suffered
damage because the product was defective and that the damage was caused under normal conditions
of use including foreseeable misuse.  The injured party does not need to prove that the producer wasnegligent.
12. The defectiveness of the product shall be determined by reference to the lack of the safety,
which the public at large is entitled to expect.  The required risk assessment of the product includes
the foreseeable misuse of the product under the given circumstances.
                                                     
4 Directive 1999/34/EC of the European Parliament and of the Council on the approximation of the
laws, regulations and administrative provisions of the Member States concerning liability for defective products.G/TBT/W/218
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IV. CONCLUSION
13. As mentioned in the EC submission G/TBT/W/ 197, EC experiences are that the introduction
of supplier’s declaration of conformity coupled with ex-post market surveillance and effective product
liability laws works well in certain specific sectors and has not created problems with regard to thefulfilment of the legitimate public policy objectives pursued.
14. Moreover the use of supplier’s declaration of conformity also facilitates imports from third
countries and can be considered to help developing countries fully benefit from the opportunities
offered by the world trading system.  More generally, the supplier’s declaration of conformity holds a
significant potential for effective elimination of barriers to trade in that it is a standards-receptive
model oriented towards the fulfilment of regulatory objectives (like safety, health and environmental
protection) that are globally recognised
5.
15. While the use of supplier’s declaration of conformity implies certain costs for administrations,
in particular higher costs for market surveillan ce, it tends to imply lower costs for industry and
importers, resulting in cheaper products for consumers and possibly, in the long run, higher level ofcompetitiveness and job creation.  An appropriate balance should be struck, taking into account the
imperative objectives of protecting health, safety and the environment, and the constraints on the
resources of administrations.
16. For further details on the suppliers’ declaration of conformity and other conformity
assessment procedures, reference is given to the Guide to the implementation of Directives based on
the New Approach and the Global Approach.  This Guide can be obtained at the URL:
http://europa.eu.int/comm/enterprise/new approach/legislation/guide/legislation.htm
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5 United Nations Economic Commission For Europe, Recommendations on Standardization Policies:
Recommendation “L”: “An International model for technical harmonization based on good regulatory practicefor the preparation, adoption and application of technical regulations via the use of international standards”;http://www.unece.org/trade/tips/wp6/wp6_major.htm