- Environmental law Overview: REACH Regulation Regulations for the MedTech industry

Name of the legal act

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Text with EEA relevance).

Status

Consolidated version of 22 April 2025.Externer Link. Öffnet im neuen Fenster/Tab.

Background information

National implementation and sanction provisions are contained in the following legal acts:

• Act on Protection against Hazardous Substances (Chemicals Act - ChemGExterner Link. Öffnet im neuen Fenster/Tab.)
• Ordinance on Prohibitions and Restrictions on the Marketing and Distribution of Certain Substances, Mixtures and Products under the Chemicals Act (Chemicals Prohibition Ordinance - ChemVerbotsVExterner Link. Öffnet im neuen Fenster/Tab.)
• Ordinance on the enforcement of sanctions under Community or Union law in the field of Chemical Safety (Chemical Sanctions Ordinance - ChemSanktionsVExterner Link. Öffnet im neuen Fenster/Tab.)

Scope of application

The REACH Regulation applies in principle to all substances (Art. 3 (1) REACH) and mixtures (Art. 3 (2) REACH) and covers the manufacture, placing on the market and use of substances on their own, in mixtures or in articles (Art. 3 (3) REACH) as well as the placing on the market of mixtures. The relevant distinctions between substance/mixture and article are contained in the Guidance on requirements for substances in articles (as of June 2017)Externer Link. Öffnet im neuen Fenster/Tab.. Art. 2 REACH contains numerous exceptions from the entire Regulation or parts of the Regulation. For example, certain radioactive substances and waste are completely exempt. The registration and authorization obligations do not apply, for example, to medicinal products for human and veterinary use or to foodstuffs. The information requirements do not apply, for example, to human and veterinary medicinal products, food and animal feed, cosmetic products and medical devices that are used invasively or in contact with the body, provided that additional requirements are met. There are also narrow exceptions in the areas of research and development.

Roles

The REACH Regulation recognizes different roles with different obligations.

A manufacturer is a "natural or legal person established within the Community who manufactures a substance within the Community" (Art. 3 No. 9 - manufacturing = production or extraction of substances in the natural state).

An importer is a "natural or legal person established within the Community who is responsible for the import" (Art. 3 No. 11 - import = physical introduction into the customs territory of the Community).

A downstream user is a "natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user."

A distributor is a "any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a mixture, for third parties"

Placing on the market is any (not only the first) "supply to third parties or making available to third parties, whether in return for payment or free of charge. Import shall be considered as placing on the market." According to Article 2 (1) lit. (b) REACH, an exemption applies to substances on their own, in mixtures or in articles subject to customs supervision, provided that they are neither treated nor processed and are in temporary storage or in free zones or free warehouses for re-export or in transit.

Duties in bullet points

• Obligation to register substances as such and substances in mixtures if manufacture/import exceeds one tonne/year (Art. 6 REACH) - information from ECHAExterner Link. Öffnet im neuen Fenster/Tab.
• Obligation to register substances in articles in the event of release (Art. 7 (1) REACH - exceptional case)
• Notification obligation for SVHCsExterner Link. Öffnet im neuen Fenster/Tab. over 0.1 % by weight in articles, if over one tonne/year (Art. 7 (2) REACH)
• Safety data sheet for hazardous substances and mixtures (Art. 31 REACH)
• Information requirements for other substances and mixtures (Art. 32 REACH)
• SVHC information b2b and b2c (Art. 33 REACH) - Information from ECHAExterner Link. Öffnet im neuen Fenster/Tab.
• Obligation to retain information (Art. 36 REACH)
• Authorization requirement for manufacturers, importers and downstream users when using or placing on the market for the use of substances from Annex XIVExterner Link. Öffnet im neuen Fenster/Tab. (Art. 55 et seq. REACH) - Information from ECHAExterner Link. Öffnet im neuen Fenster/Tab.
• Ban on the use of substances contrary to restrictions from Annex XVII (Art. 67 et seq. REACH) - Information from ECHA

Breaches of duty are partly criminal offences and partly administrative offences.

On the basis of Art. 9 (1) lit. (j) of the Waste Framework Directive 2008/98/EC, there is an obligation to notify SVHCs to the European Chemicals Agency (ECHA) in accordance with Sec. 16f ChemG if they are contained in an article above 0.1 % by weight (so-called "SCIP notification obligation"). ECHA information portalExterner Link. Öffnet im neuen Fenster/Tab. and FAQsExterner Link. Öffnet im neuen Fenster/Tab..

Comprehensive information on REACH can be found on the ECHA topic pageExterner Link. Öffnet im neuen Fenster/Tab., the FAQsExterner Link. Öffnet im neuen Fenster/Tab. and in the comprehensive guidance documentsExterner Link. Öffnet im neuen Fenster/Tab.. Information is also available from the German HelpdeskExterner Link. Öffnet im neuen Fenster/Tab..

Latest news

A far-reaching revision of the REACH Regulation has been announced at EU level with the chemicals strategy for sustainabilityExterner Link. Öffnet im neuen Fenster/Tab.. A draft has not yet been published, but might be expected this year. The following aspects are being discussed in this context: safe and sustainable by design, material cycles free of substances of concern, extension of enforcement ("zero tolerance"), extension of the regulation of endocrine disruptors and mixtures, registration obligation for polymers, focus on PFAS, strengthening of information obligations, increased assessment of substances on the basis of abstract hazard properties instead of a specific application-related risk assessment and introduction of an "essential use" provison for some of the most worrying substances.

Two legislative procedures are currently underway (Common Data Platform for ChemicalsExterner Link. Öffnet im neuen Fenster/Tab. and enhanced cooperation between authorities on substance evaluationsExterner Link. Öffnet im neuen Fenster/Tab.), both of which will have an impact on REACH. It is not yet possible to predict when these procedures can be expected to be completed.

The proposal to restrict PFASExterner Link. Öffnet im neuen Fenster/Tab., which was submitted by Germany, Denmark, the Netherlands, Norway and Sweden on 13 January 2023, also deserves particular attention. It is expected that the proposal will aim to restrict the manufacture, placing on the market and use of PFAS. The substance group of PFAS according to the OECD definition comprises more than 4,500 substances, so that the restriction is likely to affect a large number of usage, products and sectors. The proposal is still in the internal ECHA evaluation process, whereby a quick decision is not expected due to numerous concerns and impracticability.

On 6 June 2024, Regulation (EU) 2024/1328Externer Link. Öffnet im neuen Fenster/Tab. amending Annex XVII of REACH regarding Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5), and Dodecamethylcyclohexasiloxane (D6) entered into force. However, a transition period until July 6, 2031, applies to medical devices and in vitro diagnostic devices, and certain medical devices are completely exempt or allowed with independent limit values. On September 27, 2023, Regulation (EU) 2023/2055Externer Link. Öffnet im neuen Fenster/Tab. amending Annex XVII of REACH regarding synthetic polymer microparticles (so-called "microplastic restriction") was published in the EU Official Journal. The restriction applies from October 17, 2023, but includes several transition periods. For medical devices in the form of substances and mixtures containing microplastics, a transition period applies until 17 October 2029 (see Paragraph 6 lit. (f)).

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.