Legal act:
Regulation (EC) No 1907/2006
Commission Regulation (EU) 2021/2045 of 23 November 2021
Commission Regulation (EU) 2021/2030 of 19 November 2021
European Parliament resolution of 12 February 2020 on the draft Commission regulation - Objection to an implementing act: Lead and its compounds - OJ C 294/2 of 23 July 2021
Commission Regulation (EU) 2020/2081 of 15 December 2020
Commission Regulation (EU) 2020/878 of 18 June 2020
Commission Regulation (EU) 2020/507 of 8 April 2020

Consolidated act:
1/12/2023 of Regulation (EC) No 1907/2006
15/12/2020 of Commission Regulation (EU) 2020/2081 (Language available: NL)
26/06/2020 of Commission Regulation (EU) 2020/878 (Languages available: HU, RO, SK)

Aim and scope

1. The purpose of this Regulation is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation.
2. This Regulation lays down provisions on substances and preparations within the meaning of Article 3. These provisions shall apply to the manufacture, placing on the market or use of such substances on their own, in preparations or in articles and to the placing on the market of preparations.
3. This Regulation is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment. Its provisions are underpinned by the precautionary principle.

Article 2 - Application

1. This Regulation shall not apply to:
   1. radioactive substances within the scope of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation1;
   2. substances, on their own, in a preparation or in an article, which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to re-exportation, or in transit;
   3. non-isolated intermediates;
   4. the carriage of dangerous substances and dangerous substances in dangerous preparations by rail, road, inland waterway, sea or air.
2. Waste as defined in Directive 2006/12/EC of the European Parliament and of the Council2 is not a substance, preparation or article within the meaning of Article 3 of this Regulation.
3. Member States may allow for exemptions from this Regulation in specific cases for certain substances, on their own, in a preparation or in an article, where necessary in the interests of defence.
4. This Regulation shall apply without prejudice to:
   1. Community workplace and environmental legislation, including Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work1 , Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control2 ; Directive 98/24/EC, Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy3 and Directive 2004/37/EC;
   2. Directive 76/768/EEC as regards testing involving vertebrate animals within the scope of that Directive.
5. The provisions of Titles II, V, VI and VII shall not apply to the extent that a substance is used:
   1. in medicinal products for human or veterinary use within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products4 and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use;
   2. in food or feedingstuffs in accordance with Regulation (EC) No 178/2002 including use:
      1. as a food additive in foodstuffs within the scope of Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption;
      2. as a flavouring in foodstuffs within the scope of Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production2 and Commission Decision 1999/217/EC of 23 February 1999 adopting a register of flavouring substances used in or on foodstuffs drawn up in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council;
      3. as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition;
      4. in animal nutrition within the scope of Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition.
6. The provisions of Title IV shall not apply to the following preparations in the finished state, intended for the final user:
   1. medicinal products for human or veterinary use, within the scope of Regulation (EC) No 726/2004 and Directive 2001/82/EC and as defined in Directive 2001/83/EC;
   2. cosmetic products as defined in Directive 76/768/EEC;
   3. medical devices which are invasive or used in direct physical contact with the human body in so far as Community measures lay down provisions for the classification and labelling of dangerous substances and preparations which ensure the same level of information provision and protection as Directive 1999/45/EC;
   4. food or feedingstuffs in accordance with Regulation (EC) No 178/2002 including use:
      1. as a food additive in foodstuffs within the scope of Directive 89/107/EEC;
      2. as a flavouring in foodstuffs within the scope of Directive 88/388/EEC and Decision 1999/217/EC;
      3. as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003;
      4. in animal nutrition within the scope of Directive 82/471/EEC.
7. The following shall be exempted from Titles II, V and VI:
   1. substances included in Annex IV, as sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties;
   2. substances covered by Annex V, as registration is deemed inappropriate or unnecessary for these substances and their exemption from these Titles does not prejudice the objectives of this Regulation;
   3. substances on their own or in preparations, registered in accordance with Title II, exported from the Community by an actor in the supply chain and re-imported into the Community by the same or another actor in the same supply chain who shows that:
      1. the substance being re-imported is the same as the exported substance;
      2. he has been provided with the information in accordance with Articles 31 or 32 relating to the exported substance.
   4. substances, on their own, in preparations or in articles, which have been registered in accordance with Title II and which are recovered in the Community if:
      1. the substance that results from the recovery process is the same as the substance that has been registered in accordance with Title II; and
      2. the information required by Articles 31 or 32 relating to the substance that has been registered in accordance with Title II is available to the establishment undertaking the recovery.
8. On-site isolated intermediates and transported isolated intermediates shall be exempted from:
1. Chapter 1 of Title II, with the exception of Articles 8 and 9; and
2. Title VII.
9. The provisions of Titles II and VI shall not apply to polymers.

Definitions

Placing on the market: means 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.

Distributor: means 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 preparation, for third parties.

Phase-in substance: means a substance which meets at least one of the following criteria:

1. it is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS);
2. it was manufactured in the Community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of this Regulation, provided the manufacturer or importer has documentary evidence of this;
3. it was placed on the market in the Community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, before entry into force of this Regulation by the manufacturer or importer and was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC but does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this.

Notified substance: means a substance for which a notification has been submitted and which could be placed on the market in accordance with Directive 67/548/EEC.

Restriction: means any condition for or prohibition of the manufacture, use or placing on the market.

Supplier of a substance or a preparation: means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a preparation, or a preparation.

Supplier of an article: means any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market.