7.2 規則（EU）2019/1020の適用範囲

The scope of Regulation (EU) 2019/1020 is defined in its Article 2. Regulation (EU) 2019/1020 regulates market surveillance for most of the Union harmonisation legislation establishing specific requirements on the design, composition and labelling of non-food products, insofar as there are no specific provisions with the same objective in the Union harmonisation legislation. Some categories of products, such as medicinal products or railway equipment, are not covered because they have their own framework for enforcement. Annex I to Regulation (EU) 2019/1020 contains a list of legislation for which the Regulation is relevant. However, additional legislation is also concerned by Regulation 2019/1020, either by amendment to Annex I or through references in that legislation, for example:

—A specific reference to Regulation (EU) 2019/1020, such as in Directive (EU) 2020/2184 on drinking water (278)

—The inclusion of predecessor legislation in Annex I to Regulation (EU) 2019/1020 and a provision that references to the repealed legislation must be construed as references to the new legislation, such as in Regulation (EU) 2019/1009 on EU fertilising products (279).

—Both of the above, such as in Regulation (EU) 2020/740 on the labelling of tyres with respect to fuel efficiency and other parameters (280)

One act explicitly refers to the market surveillance provisions of Regulation (EC) No 765/2008 (without reference to Regulation (EU) 2019/1020): the European accessibility act (281). A number of provisions of Regulation (EU) 2019/1020 apply to this act through its Article 39(2) and the correlation table in Annex III to Regulation (EU) 2019/1020.

Directive (EU) 2019/904 on single use plastics (282) does not contain specific provisions or references for enforcement. Given that its product scope has a significant overlap with the Directive on packaging and packaging waste (included in Annex I of Regulation (EU) 2019/1020), Member States may want to apply at national level the market surveillance provisions of Regulation (EU) 2019/1020.

Delegated and implementing acts adopted under legislation for which Regulation (EU) 2019/1020 is relevant are themselves also covered. Some of the legislation for which Regulation (EU) 2019/1020 is relevant also contains provisions that do not concern the design, composition or labelling of products, such as the recovery and recycling targets laid down in Article 6 of Directive 94/62/EC on packaging and packaging waste. Regulation (EU) 2019/1020 is not relevant for such provisions.

Union harmonisation legislation for which Regulation (EU) 2019/1020 is relevant may also contain rules on market surveillance (283). The provisions of Regulation (EU) 2019/1020 on market surveillance apply to products that are subject to such Union harmonisation legislation in so far as there are no specific provisions with the same objective in the Union harmonisation legislation, which regulate in a more specific manner particular aspects of market surveillance and enforcement (the ‘ lex specialis’ provision in Article 1(1)). This applies, for example, as regards the use of the European database on medical devices (Eudamed) (284) instead of the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020 (285). In many cases, however, the market surveillance provisions in Union harmonisation legislation are complementary and do not render provisions of Regulation (EU) 2019/1020 inapplicable.

Article 4 (‘Tasks of economic operators regarding products subject to certain Union harmonisation legislation’) has its own specific scope specified in the Article. Specific guidance on Article 4 has been issued by the Commission (286).

The provisions regarding controls on products entering the Union (Chapter VII, i.e. Articles 25-28) have a broader product scope than the Union harmonisation legislation listed in Annex I. These provisions apply to products covered by Union law in so far as there are no specific provisions relating to the organisation of controls on products entering the Union market. This includes for example Directive 2001/95 on general product safety.