Guidance for the application of Regulation (EU) 2019/515 

ID 13055 | 10.03.2021

Guidance document for the application of Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) N° 764/2008

Regulation (EU) 2019/515 on the mutual recognition of goods lawfully marketed in another Member State (‘the Regulation’) started to apply on 19 April 2020 and replaced Regulation (EC) N° 764/2008. The aim of the Regulation is to strengthen the functioning of the single market by improving the application of the principle of mutual recognition and by removing unjustified barriers to trade (Article 1(1) of the Regulation). The purpose of this guidance document is to help businesses and national competent authorities to apply the Regulation. However, only the text of the Regulation itself has legal force. The interpretation of EU legislation is the exclusive competence of the Court of Justice of the European Union (‘the Court’).

The principle of mutual recognition stems from the case-law of the Court on Articles 34 and 36 of the Treaty on the Functioning of the European Union (TFEU). The Regulation lays down rules and procedures for the application of the principle of mutual recognition in individual cases (Article 1(2) of the Regulation).

Articles 34 and 36 TFEU apply in the absence of EU harmonisation rules covering goods or certain aspects of goods.

According to Article 34 TFEU, ‘quantitative restrictions on imports and all measures having equivalent effect shall be prohibited between Member States’.

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Table of Contents
1. INTRODUCTION
2. SCOPE OF THE REGULATION (ARTICLE 2 OF THE REGULATION)
2.1. Goods lawfully marketed in another Member State
2.1.1. Goods
2.1.2. Lawfully marketed in another Member State
2.2. ‘Administrative decisions’ under the Regulation
2.2.1. What is an administrative decision?
2.2.2. First criterion: national technical rules – basis for an administrative decision
2.2.3. Second criterion: the direct or indirect effect of the administrative decision is to restrict or deny market access in the Member State of destination
2.2.4. National technical rules and prior authorisation procedures
2.2.5. Some cases in which Regulation (EU) 2019/515 does not apply
3. HOW DOES MUTUAL RECOGNITION FUNCTION UNDER THE REGULATION?
3.1. Lawful marketing of goods in the Member State of origin
3.2. Selling the goods in another Member State
3.3. Information about the assessment
3.4. The ‘mutual recognition declaration’ (Article 4 of the Regulation)
3.4.1. Content and structure of the declaration
3.4.2. Language of the declaration
3.4.3. Who may draw up the declaration?
3.4.4. What happens if the declaration is only partially complete?
3.4.5. How and when can the declaration be used?
3.4.6. How to submit documents
3.5. Assessment by the competent authority (Article 5(1) of the Regulation)
3.5.1. Legitimate public interest grounds
3.5.2. The principle of proportionality
3.6. Temporary suspension of market access (Article 6 of the Regulation)
3.7. Administrative decision (Article 5(9)-5(13) of the Regulation)
3.8. Notifications to the Commission and the other Member States
3.9. Remedies against the administrative decision
3.10. What is SOLVIT
3.11. SOLVIT and the problem-solving procedure under Article 8 of the Regulation
3.12. The Commission opinion in the context of the problem-solving procedure of Article 8 of the Regulation
3.13. The role of Product Contact Points (Article 9 of the Regulation)
3.14. Administrative cooperation (Article 10 of the Regulation)
4. PRIOR ASSESSMENT OF NATIONAL TECHNICAL RULES – DIRECTIVE (EU) 2015/1535 AND THE SINGLE MARKET CLAUSE
5. RELATIONSHIP BETWEEN REGULATION (EU) 2019/515 AND DIRECTIVE 2001/95/EC
5.1. Measures concerning products posing a risk to consumers’ health and safety
5.2. Measures concerning consumer products posing other risks

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