Mutual recognition of goods
Regulation (EU) 2019/515 on the mutual recognition of goods lawfully marketed in another EU country
WHAT IS THE AIM OF OF THE REGULATION?
It aims to strengthen the internal market by improving the application of the mutual recognition principle* in the field of goods and removing unjustified barriers to trade. It does so by:
defining the principle’s rights and obligations for national authorities and businesses when goods are sold in another EU country;
providing safeguards when mutual recognition would be denied in individual cases;
reinforcing the role of national product contact points as providers of information and points of communication between national authorities and companies.
The legislation replaces Regulation (EC) No 764/2008.
The mutual recognition principle ensures market access for goods that are not, or are only partly, subject to EU harmonisation legislation.
The regulation applies to:
all types of goods lawfully marketed in another EU country, including agricultural and fisheries products, irrespective of the way they are produced and processed;
national administrative decisions that restrict or deny access to that country’s market to such goods.
When a competent authority in the importing country intends to assess the goods, businesses may use a voluntary mutual recognition declaration to demonstrate that the goods are lawfully marketed in another EU country.
National authorities assessing imported goods under the mutual recognition principle must:
immediately contact the business concerned explaining the planned assessment;
allow the goods to be distributed and sold while they make the assessment (unless there is a prior authorisation procedure for the goods in their country or if they temporarily suspend market access);
accept a mutual recognition declaration, together with supporting evidence necessary to verify the information contained in it , as sufficient to demonstrate that the goods are lawfully marketed in another EU country. If no declaration is supplied, the competent authority may request the business concerned to provide documentation and information about both the characteristics of the goods or type of goods in question and the lawful marketing of the goods in another EU country;
take due account of the content of test reports or certificates issued by a conformity assessment body that have been provided by any business as part of the assessment;
notify the business immediately — and the European Commission and EU countries within 20 days — if it decides to deny or restrict market access to the goods;
when adopting a negative administrative decision, set out in a sufficiently detailed and reasoned manner why they restrict or deny market access, including the following
- the national technical rule on which the decision is based
- the legitimate public interest grounds justifying the use of the national technical rule
- the scientific and technical evidence considered
- a summary of the relevant arguments the business concerned put forward
- evidence demonstrating that the decision is proportionate
- the various national remedies open to the business and their time limits, including the possibility to use the free service SOLVIT (which may lead to an Opinion of the Commission).
National authorities assessing imported goods may temporarily suspend their sale or distribution, immediately informing the business, the Commission and EU countries, if:
under normal or reasonably foreseeable conditions of use, the goods pose a serious risk to safety or health of persons or to the environment, including one where the effects are not immediate, which requires rapid intervention by the competent authority; or
the making available of the goods, or of goods of that type, on the market in that EU country is generally prohibited in that EU country on grounds of public morality or public security.
If SOLVIT centres are not able to find a good solution in an individual case using the SOLVIT procedure, the Commission may assist in solving the case at the request of any of the SOLVIT Centres involved by issuing an Opinion. For this, the Commission:
must assess whether the national authority’s decision is compatible with the mutual recognition principle and the requirements of the regulation;
if additional information or documents are needed, must ask the relevant SOLVIT Centre to contact the business or the competent authority, to obtain such additional information or documents;
must issue an Opinion within 45 days;
the opinion must be communicated to the business and the national authority by the relevant SOLVIT Centre. The Commission must notify the Opinion to the EU countries;
where appropriate, the Commission’s Opinion must identify any concerns that should be addressed in the SOLVIT case or must make recommendations to assist in solving the case.
Each EU country must establish and maintain on its territory product contact points, and ensure they have sufficient powers and adequate resources. The product contact points must:
provide online information on
- the mutual recognition principle and the application of the regulation in their country
- contact details of the relevant national authorities, including those of the authorities responsible for supervising the implementation of the national technical rules applicable in their country
- remedies and procedures available in their country in the event of a dispute, including the SOLVIT procedure set out in the regulation;
respond, free of charge, within 15 days to requests from companies or national authorities for further information;
when necessary, help to arrange contacts between national authorities in relation to the assessment procedure of the regulation.
The EU may finance the following activities in support of the regulation:
education and training;
cooperation among product contact points and competent authorities, and the technical and logistic support for this cooperation;
the collection of data related to the functioning of the principle of mutual recognition and its impact on the EU’s single market for goods;
exchange of officials and of best practices.
The Commission must carry out an evaluation of the regulation by 20 April 2025, and every 4 years thereafter, and submit a report to the European Parliament, the Council and the European Economic and Social Committee.
Commission Implementing Regulation (EU) 2020/1668 sets out the details necessary to adapt Information and Communication System for Market surveillance (ICSMS) for the purposes of mutual recognition.
The implementing regulation introduces the use of the ICSMS for:
notifications of administrative decisions (Article 5);
notifications of temporary suspensions (Article 6);
notification of the Commission’s opinion to all EU countries (Article 8);
exchange of information between the competent authorities of the EU countries in charge of verifying data and documents supplied by the businesses during an assessment (Article 10).
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 19 April 2020.
For more information, see:
Mutual recognition principle: a principle of EU law under which EU countries may not prohibit the sale on their territory of goods which are lawfully marketed in another EU country. The only exception is where EU countries have legitimate public interest grounds for restricting or denying market access and the restriction is justified and proportionate.
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) No 764/2008 (OJ L 91, 29.3.2019, pp. 1-18)
Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, pp. 1-44)
Regulation (EU) 2018/1724 of the European Parliament and of the Council of 2 October 2018 establishing a single digital gateway to provide access to information, to procedures and to assistance and problem-solving services and amending Regulation (EU) No 1024/2012 (OJ L 295, 21.11.2018, pp. 1-38)
Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, pp. 1-142)
Successive amendments to Regulation (EU) 2017/625 have been incorporated into the original text. This consolidated version is of documentary value only.
Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, pp. 1-15)
Regulation (EU) No 1306/2013 of the European Parliament and of the Council of 17 December 2013 on the financing, management and monitoring of the common agricultural policy and repealing Council Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008 (OJ L 347, 20.12.2013, pp. 549-607)
See consolidated version.
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, pp. 30-47)
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, pp. 1-24)
See consolidated version.
Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, pp. 4-17)
See consolidated version.
last update 27.11.2020