§4.2.2 Traceability provisions

Union harmonisation legislation is prescriptive as to the ends but not as to the means to achieve those ends. This means that Union harmonisation legislation foresees requirements for the traceability of products made available on the market, without stipulating how to achieve or implement these requirements. Union harmonisation legislation is also technology-neutral, meaning it does not prescribe the technology to be used such as printing or moulding. Manufacturers should choose the traceability system which they deem most appropriate in relation to their products and their manufacturing and distribution system. The indication of the manufacturer’s, and for imported products also the importer’s, name and address on the product is a basic traceability requirement. Products within the scope of application of Article 4 of Regulation (EU) 2019/1020 must indicate the name and address of the economic operator referred to in Article 4 established in the EU. In case of need, it allows market surveillance authorities to quickly get in contact with the economic operator responsible for the placing of an unsafe or non-compliant product on the Union market. There is no explicit obligation that the addresses have to be preceded by the words ‘Manufactured by’, ‘Imported by’ or ‘Represented by’ or ‘Fulfilled by’. This information must however not mislead the end-user and the market surveillance authorities about the place of manufacture and the address of each economic operator (205). If these words are not mentioned, market surveillance authorities will decide what the role of each economic operator is. It is then up to the economic operator to prove that he has a different role. There is no obligation to translate into all necessary languages the English terms ‘manufactured by’, ‘imported by’ or ‘represented by’. These English terms are considered to be easily understandable throughout the EU. Regulation (EU) 2019/1020 on market surveillance and compliance of products and Decision No 768/2008/EC on a common framework for the marketing of products establish the current practices regarding traceability by requiring specific traceability labels. The reference provisions of Decision No 768/2008/EC reflected in Union harmonisation legislation, as well as Regulation (EU) 2019/1020, require: 1. manufacturers to indicate the following elements: their (1) name, registered trade name or registered trade mark (206) and (2) the address at which they can be contacted, on the product or, where that is not possible, on its packaging or in a document accompanying the product. The address must indicate a single point at which the manufacturer can be contacted (207); 2. importers to indicate the following elements: their (1) name, registered trade name or registered trade mark and (2) the address at which they can be contacted, on the product or, where that is not possible, on its packaging or in a document accompanying the product; (208) 3. economic operators referred to in Article 4 of Regulation (EU) 2019/1020, to indicate their (1) name, registered trade name or registered trade mark, and (2) contact details, including the postal address, on the product or on its packaging, the parcel or an accompanying document (209), for products which are included within the scope of Article 4 and placed on the Union market; 4. manufacturers to ensure that their products bear a type, batch, serial or model number or other element allowing their identification, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product (210) and 5. economic operators to identify any economic operator who has supplied them with a product and any economic operator to whom they have supplied a product (211). Unless otherwise specified by Union harmonisation legislation, the information on the name and address of the different economic operators does not need to be affixed indelibly, as opposed to other information on the product such as the CE marking. However, this information should be visible on the product, or on the packaging or accompanying documentation.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07