Internal Market: Orgalim comments on the Draft Guidelines for the practical implementation of Article 4 of Regulation 2019/1020 on market surveillance and compliance of products

Published: 22 April 2020

Policies & Issues: Internal Market - Compliance, Standards & Enforcement

Orgalim thanks the European Commission for the opportunity to comment on the Commission’s Draft Guidelines for the practical implementation of Article 4 and for the recent opportunity to discuss the preliminary text of these guidelines during a stakeholder workshop on the 21 February 2020.

In this position paper, we insist on the need for such guidelines to:

1) Complement without preempting the general Blue Guide on the implementation and application of Union harmonisation legislation, whose general concepts and definitions should be clarified in this Blue Guide rather than in guidelines specific to the application of Article 4 of the Regulation 2019/1020 on market surveillance.

2) Help to ensure a level-playing field between manufacturers established within the EU and those established outside while providing more legal certainty for the responsible economic operator acting on behalf of a non EU-based manufacturer.

3) Refrain from adding unnecessary administrative requirements which would not be specified in sector-specific legislation for the sake of evidencing traceability and compliance requirements, whose digital format should wherever possible be regarded as acceptable as an alternative to the printed format, upon the free choice of the economic operators.

4) Encourage an effective and proportionate enforcement of the application of this Article 4, to contribute to the building of a safer EU single market with a chain of responsible economic operators.

We also encourage the Commission to promote integration of this product compliance culture and accompanying procedures in their bilateral or multi-lateral trade dialogues with other countries in the world.

To read our recommendations in full, please download the position above.


Philippe Portalier
Director - Better Regulation, Compliance and Standards

Related Position Papers

Internal Market: Orgalim response to the European Commission Call for Evidence for an evaluation of Regulation 1025/2012 [28 September 2023]

Internal Market: Join Statement on the Right to Know [11 September 2023]

Internal Market: Enhancing EU manufacturing competitiveness with a future-proof approach to placing products on the Single Market [27 June 2023]

Internal Market: Orgalim Position on the Single Market Emergency Instrument (SMEI) proposal [20 March 2023]

Internal Market: Securing Europe’s industrial competitiveness – An agenda to recommit to the Single Market [15 February 2023]

Digital Transformation: Industry calls on EU legislators to respect principles of the New Legislative Framework in the AI Act [30 September 2022]

Internal Market: Criteria for common specifications [27 September 2022]

Internal Market: Joint industry statement – Feedback on the Standardisation Strategy [6 April 2022]

Internal Market: Orgalim Position paper on the New Legislative Framework [7 March 2022]