- Environmental law Overview: Textile Labelling Regulation Regulations for the MedTech industry

Name of the legal act

Regulation (EU) No 1007/2011 of the European Parliament and of the Council of 27 September 2011 on textile fibre names and related labelling and marking of the fibre composition of textile products and repealing Council Directive 73/44/EEC and Directives 96/73/EC and 2008/121/EC of the European Parliament and of the Council.

Status

Consolidated version dated 15 February 2018Externer Link. Öffnet im neuen Fenster/Tab..

Background information

Regulation (EU) No 1007/2011 lays down rules

• for the use of textile fibre names and the associated labelling and marking of the fibre composition of textile products,
• for the labelling or marking of non-textile parts of animal origin,
• for the determination of the fibre composition of textile products by quantitative analysis of binary and ternary textile fibre mixtures.

At German level, the Textile Labelling Act (TextilKennzG)Externer Link. Öffnet im neuen Fenster/Tab. specifies the requirements of Regulation (EU) No. 1007/2011.

There is also the Directive 94/11/ECExterner Link. Öffnet im neuen Fenster/Tab., which regulates the labelling of materials for the main components of footwear products. For example, orthopaedic footwear is subject to this directive (Annex II ix) of Directive 94/11/EC). In Germany, Sec. 10a i.V.m. Annex 11 of the Consumer Goods Ordinance (Bedarfsgegenständeverordnung – BedGgstVExterner Link. Öffnet im neuen Fenster/Tab.) implements these labelling requirements.

Scope of application

Regulation (EU) No 1007/2011 applies in principle to all textile products when they are made available on the Union market. "Textile product" means “any raw, semi-worked, worked, semi-manufactured, manufactured, semi-made-up or made-up product which is exclusively composed of textile fibres, regardless of the mixing or assembly process employed" (Art. 3(1)(a) Regulation (EU) No 1007/2011)

However, it is not mandatory to indicate the names of textile fibres or the fibre composition in the labelling and marking of the textile products listed in Annex V of Regulation (EU) No. 1007/2011. These include, for example, textile products subject to the provisions of the European Pharmacopoeia for which a corresponding note has been included, reusable medical and orthopaedic bandages and general orthopaedic textile material (Art. 17(2) in conjunction with No. 36 of Annex V of Regulation (EU) No 1007/2011).

Roles

Textile labelling law focuses on the manufacturer in accordance with Art. 3(2) Regulation (EU) No 1007/2011 in conjunction with Art. 2(3) Regulation (EC) No 765/2008. This is "any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark".

Distributors are also included in the group of addressees. According to Art. 3(2) Regulation (EU) No 1007/2011 in conjunction with Art. 2(6) Regulation (EC) No 765/2008, the term distributor refers to "any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market". For the purposes of this Regulation, distributor is deemed to be a manufacturer if he places a product on the market under his name or trade mark, affixes the label himself or changes the content of the label (Art. 15(2) Regulation (EU) No 1007/2011).

The relevant point in time for the fulfilment of the obligations is the moment of placing on the market. "Placing on the market" means the first making available of a product on the Union market (Art. 3(2) Regulation (EU) 2019/1020). Distributors must fulfil the obligations incumbent on them in the course of making available, i.e. when continuing to supply the products.

Duties in bullet points

• Requirements for the description of the fibre composition (Art. 5, 7, 8 and 9 Regulation (EU) No 1007/2011)
• Design of labels and labelling (Art. 14 Regulation (EU) No 1007/2011)
• Obligation to label or mark (Art. 15 Regulation (EU) No 1007/2011)
• Labelling and marking of special (textile products listed in Annex IV) (Art. 13 Regulation (EU) No 1007/2011)
• Use of the names of textile fibres and the descriptions of fibre composition referred to in Art. 5, 7, 8 and 9 Regulation (EU) No 1007/2011 in catalogues, brochures, on packaging, labels and markings (Art. 16 Regulation (EU) No 1007/2011)

Violations of the labelling and marking obligations lead to a ban on marketing and may result in the imposition of market surveillance measures (e.g. distribution ban). Breaches of duty may constitute an administrative offence under the German Textile Labelling Act.

Latest news

The EU Commission has launched an initiative to revise European textile labelling legislationExterner Link. Öffnet im neuen Fenster/Tab.. The aim is to introduce comprehensive requirements for the physical and digital labelling of textiles and related goods. Following a consultation phase in Q1/2024, the publication of a draft in this context has currently been announced for Q2/2025. The adoption of the draft by the Commission is expected in Q3/2025Externer Link. Öffnet im neuen Fenster/Tab..

In addition, on 5 July 2023, the EU Commission a presented proposalExterner Link. Öffnet im neuen Fenster/Tab. to revise the EU Waste Framework Directive. The aim of the proposal is to requirements for extended producer responsibility introduce for textiles and footwear, which may also cover medical devices (detailed information can be found in the "fact sheet, such as national registration and responsibility for the collection, return and treatment of end-of-life products “Ongoing initiatives”).

Imprint

© Bundesverband Medizintechnologie e.V. (BVMed), the German MedTech Association, in cooperation with the law firm "Ahlhaus Handorn Niermeier Schucht Rechtsanwaltsgesellschaft mbH" („Produktkanzlei“).

This overview does not replace an individual case assessment.