Subject matter
1. The aim of this Regulation is to strengthen the functioning of the internal market by improving the application of the principle of mutual recognition and by removing unjustified barriers to trade.
2. This Regulation lays down rules and procedures concerning the application by Member States of the principle of mutual recognition in individual cases in relation to goods which are subject to Article 34 TFEU and which are lawfully marketed in another Member State, having regard to Article 36 TFEU and the case-law of the Court of Justice of the European Union.
3. This Regulation also provides for the establishment and maintenance of Product Contact Points in Member States and for cooperation and exchange of information in the context of the principle of mutual recognition.
Scope
1. This Regulation applies to goods of any type, including agricultural products within the meaning of the second subparagraph of Article 38(1) TFEU, and to administrative decisions that have been taken or are to be taken by a competent authority of a Member State of destination in relation to any such goods that are lawfully marketed in another Member State, where the administrative decision meets the following criteria:
(a)
the basis for the administrative decision is a national technical rule applicable in the Member State of destination; and
(b)
the direct or indirect effect of the administrative decision is to restrict or deny market access in the Member State of destination.
Administrative decision includes any administrative step that is based on a national technical rule and that has the same or substantially the same legal effect as the effect referred to in point (b).
2. For the purposes of this Regulation, a ‘national technical rule’ is any provision of a law, regulation or other administrative provision of a Member State which has the following characteristics:
(a)
it covers goods or aspects of goods that are not the subject of harmonisation at Union level;
(b)
it either prohibits the making available of goods, or goods of a given type, on the market in that Member State, or it makes compliance with the provision compulsory, de facto or de jure, whenever goods, or goods of a given type, are made available on that market; and
(c)
it does at least one of the following:
(i)
it lays down the characteristics required of goods or of goods of a given type, such as their levels of quality, performance or safety, or their dimensions, including the requirements applicable to those goods as regards the names under which they are sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures;
(ii)
for the purpose of protecting consumers or the environment, it imposes other requirements on goods or goods of a given type that affect the life-cycle of the goods after they have been made available on the market in that Member State, such as conditions of use, recycling, reuse or disposal, where such conditions can significantly influence either the composition or nature of those goods, or the making available of them on the market in that Member State.
3. Point (c)(i) of paragraph 2 of this Article also covers production methods and processes used in respect of agricultural products as referred to in the second subparagraph of Article 38(1) TFEU, and in respect of products intended for human or animal consumption, as well as production methods and processes relating to other products, where these have an effect on their characteristics.
4. A prior authorisation procedure does not itself constitute a national technical rule for the purposes of this Regulation, but a decision to refuse prior authorisation based on a national technical rule shall be considered to be an administrative decision to which this Regulation applies, if that decision fulfils the other requirements of the first subparagraph of paragraph 1.
5. This Regulation does not apply to:
(a)
decisions of a judicial nature taken by national courts or tribunals;
(b)
decisions of a judicial nature taken by law enforcement authorities in the course of the investigation or prosecution of a criminal offence as regards the terminology, symbols or any material reference to unconstitutional or criminal organisations or offences of a racist, discriminatory or xenophobic nature.
6. Articles 5 and 6 shall not affect the application of the following provisions:
(a)
points (b) to (f) of Article 8(1) and Article 8(3) of Directive 2001/95/EC;
(b)
point (a) of Article 50(3) and Article 54 of Regulation (EC) No 178/2002;
(c)
Article 90 of Regulation (EU) No 1306/2013; and
(d)
Article 138 of Regulation (EU) 2017/625.
7. This Regulation does not affect the obligation under Directive (EU) 2015/1535 to notify draft national technical regulations to the Commission and the Member States prior to their adoption.
Definitions
For the purposes of this Regulation, the following definitions apply:
(1)
‘lawfully marketed in another Member State’ means that goods or goods of that type comply with the relevant rules applicable in that Member State or are not subject to any such rules in that Member State, and are made available to end users in that Member State;
(2)
‘making available on the market’ means any supply of goods for distribution, consumption or use on the market within the territory of a Member State in the course of a commercial activity, whether in return for payment or free of charge;
(3)
‘restricting market access’ means imposing conditions to be fulfilled before goods can be made available on the market in the Member State of destination, or conditions for keeping goods on that market, which in either case require the modification of one or more of the characteristics of those goods, as referred to in point (c)(i) of Article 2(2), or require the performance of additional testing;
(4)
‘denying market access’ means any of the following:
(a)
prohibiting goods from being made available on the market in the Member State of destination or from being kept on that market; or
(b)
requiring the withdrawal or recall of those goods from that market;
(5)
‘withdrawal’ means any measure aimed at preventing goods in the supply chain from being made available on the market;
(6)
‘recall’ means any measure aimed at achieving the return of goods that have already been made available to the end user;
(7)
‘prior authorisation procedure’ means an administrative procedure under the law of a Member State whereby the competent authority of that Member State is required, on the basis of an application by an economic operator, to give its formal approval before goods may be made available on the market in that Member State;
(8)
‘producer’ means:
(a)
any natural or legal person who manufactures goods or has goods designed or manufactured, or who produces goods which were not the result of a manufacturing process, including agricultural products, and markets them under that person's name or trademark,
(b)
any natural or legal person who modifies goods already lawfully marketed in a Member State in a way that might affect compliance with the relevant rules applicable in that Member State, or
(c)
any other natural or legal person who, by putting its name, trademark or other distinguishing feature on goods or on the documents that accompany those goods, presents itself as the producer of those goods;
(9)
‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a producer to act on that producer's behalf with regard to the making available of goods on the market in question;
(10)
‘importer’ means any natural or legal person established within the Union who makes goods from a third country available on the Union market for the first time;
(11)
‘distributor’ means any natural or legal person in the supply chain, other than the producer or the importer, who makes goods available on the market in a Member State;
(12)
‘economic operator’ means any of the following in relation to goods: the producer, the authorised representative, the importer or the distributor;
(13)
‘end user’ means any natural or legal person residing or established in the Union, to whom the goods have been made available or are being made available, either as a consumer outside of any trade, business, craft or profession or as a professional end user in the course of its industrial or professional activities;
(14)
‘legitimate public interest grounds’ means any of the grounds set out in Article 36 TFEU or any other overriding reasons of public interest;
(15)
‘conformity assessment body’ means a conformity assessment body as defined in point 13 of Article 2 of Regulation (EC) No 765/2008.
