RISK ASSESSMENT AND USE OF FIRST-PARTY CERTIFICATION
IN CONFORMITY ASSESSMENT PROCEDURES

TENTH TRIENNIAL REVIEW

Submission from the European Union

The following submission, dated 30 May 2024, is being circulated at the request of the delegation of the European Union.

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1  BACKGROUND

1.1.  On 19 March 2024, the TBT Committee adopted the Guidelines on Conformity Assessment Procedures, also known as the CAP Guidelines.[1] Building on its previous decisions and recommendations, the TBT Committee developed a set of non-prescriptive practical guidelines to support regulators in the choice and design of appropriate and proportionate conformity assessment procedures.

1.2.  With a view to further promote the CAP Guidelines and the opportunities they offer, the European Union would like to focus this submission on the use of risk assessment and first-party certification in conformity assessment procedures.

1.3.  According to Article 5.1.2 of the TBT Agreement, conformity assessment procedures shall not be stricter or applied more strictly than it is necessary to give the importing Member adequate confidence that products conform to the applicable technical regulations or standards, taking account of the risks non-conformity would create. By referring to the need to consider the 'risks' that non‑conformity would create, the TBT Agreement puts risk assessment at the centre of the Members choice and design of conformity assessment procedures.

1.4.  First-party conformity assessment procedures ― by which manufacturers certify that the product conforms to relevant requirements and assume responsibility for the compliance of the product ― should be considered as the preferred option by regulators for the conformity assessment of product categories presenting risks for the public interests that are generally considered to be low as based on a risk assessment. Indeed, first-party conformity facilitates market access for both domestic and third-country manufacturers while fulfilling legitimate policy objectives.

1.5.  In some Members there are discrepancies between requirements at the federal and sub-federal levels, which adds to the uncertainty in international trade and increases the burden on the manufacturer.

1.6.  More homogenous risk assessment for the same type of products would result in similar level of conformity assessment procedures across the globe. This in turn would facilitate trade and limit trade barriers.

2  PROPOSAL

2.1.  The European Union proposes to hold a thematic session that would examine how different Members approach the issue of risk assessment for the purpose of establishing conformity assessment procedures, with special focus on the determination of degree of risk. The session would also serve to explore how first-party conformity assessment may effectively be used for low-risk products.

2.2.  Topics and areas of focus may include:

a._         Experience sharing in how risk assessment is conducted by different Members with the objective of establishing the level of risk of the product, in view of choosing the most appropriate conformity assessment procedure;

b._         Benefits of using first-party conformity assessment vs. third-party conformity assessment for low-risk products (examples of products for which Members apply different level of conformity assessment procedures, e.g. tiles); and

c._         Discussion on how to improve consistency in design of conformity assessment procedures at central and sub-central level.

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