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

Name of the legal act

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.

Status

Consolidated version of 1 February 2025Externer 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.)
• Ordinance on Prohibitions and Restrictions on the Marketing and Distribution of Certain Substances, Mixtures and Products under the Chemicals Act (GefStoffVExterner Link. Öffnet im neuen Fenster/Tab.)

Scope of application

The CLP Regulation generally applies to all substances and mixtures and, in exceptional cases, also to articles. Exceptions exist, for example, for certain radioactive substances and waste. Furthermore, the CLP Regulation does not apply to medicinal products, veterinary medicinal products, cosmetic products, medical devices or medical appliances that are invasive or come into contact with the body, as well as food and animal feed, provided that these are substances and mixtures intended for the final consumer in the form of finished products (Art. 1 (2), (3) and (5) CLP).

Roles

The CLP Regulation defines various roles, each with distinct obligations.

A manufacturer is a "natural or legal person established within the Community who manufactures a substance within the Community" (Art. 3 No. 15 - 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 import" (Art. 3 No. 17 - 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 "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) "supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market."

Duties in bullet points

• Basic standard for all obligations (Art. 4 CLP)
• Classification of substances and mixtures (Art. 5 et seq. CLP) - Information by ECHAExterner Link. Öffnet im neuen Fenster/Tab.
• Labelling for hazard communication, in particular with hazard symbols, signal words and hazard/safety statements (Art. 17 et seq. CLP) - Information by ECHAExterner Link. Öffnet im neuen Fenster/Tab.
• Packaging requirements (Art. 35 CLP)
• Requirements for advertising a substance classified as hazardous and certain classified mixtures (Art. 48 CLP)
• Obligation to maintain information (Art. 49 CLP)
• Notifications for emergency health care and preventive measures, including UFI labelling (so-called notification to poison centres - Sec. 16e ChemG in conjunction with Art. 45 CLP and with Annex VIII CLP)

Violations of the CLP Regulation are generally administrative offences.

Comprehensive information on CLP can be found on ECHA's topic pageExterner Link. Öffnet im neuen Fenster/Tab., the FAQsExterner Link. Öffnet im neuen Fenster/Tab. and in the comprehensive guidance documents. Information is also available at the German helpdeskExterner Link. Öffnet im neuen Fenster/Tab..

Latest news

On 20 November 2024, Regulation (EU) 2024/2865 to amend CLP was published in the Official Journal of the EU.

The changes relate in particular to the following topics: extension and adaptation of labeling requirements (e.g. with regard to multilingual folded labels and labeling where space is limited, minimum dimensions, requirements for labels with information from several legal acts, digital labeling options, deadlines for updating labeling), introduction of specific requirements for advertising and online trading and specification of the requirements for notifications to poison centers. The new requirements will apply gradually from 01.07.2026. However, on 8 July 2025, a draftExterner Link. Öffnet im neuen Fenster/Tab. of a further package of measures to amend and postpone these requirements was published.

The Commission Delegated Regulation (EU) 2023/707Externer Link. Öffnet im neuen Fenster/Tab. of 19 December 2022, amending Regulation (EC) No. 1272/2008 regarding hazard classes and the criteria for the classification, labelling, and packaging of substances and mixtures, effective from 20 April 2023, introduced several new hazard classes. Specifically, these include new hazard classes for endocrine disruptors, as well as for persistent, bioaccumulative, and toxic substances (PBT), very persistent and very bioaccumulative substances (vPvB), and persistent, mobile, and toxic substances (PMT), or very persistent and very mobile substances (vPvM).

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.