CHEMICALS
Chemical substances (REACH)
REGULATION (EC) No 1907/2006
Date:
Scope of application
Purpose 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 assessing the risks posed by substances, as well as the free movement of substances within the internal market, while enhancing competitiveness and innovation.
2. This Regulation lays down provisions relating to substances and preparations as defined in Article 3. These provisions shall apply to the manufacture, placing on the market or use of such substances, as such, in the form of preparations or contained in articles, and to the placing on the market of preparations.
3. This Regulation is based on the principle that it is the responsibility of manufacturers, importers, and downstream users to ensure that they only manufacture, place on the market, or use substances that do not adversely affect human health or the environment. Its provisions are based on the precautionary principle.
Exceptions
Application
1. This Regulation shall not apply to:
(a) radioactive substances falling within the scope of Council Directive 96/29/Euratom of 13 May 1996 laying down basic standards for the protection of the health of workers and the public against the risks arising from ionising radiation;
(b) substances, as such or in the form of preparations or contained in articles, which are subject to customs supervision, provided that they are not subject to any type of treatment or transformation and that they are in temporary storage or in a free zone or in a free warehouse for the purpose of re-exportation or in transit;
c) non-isolated intermediates;
d) the transport of dangerous substances and dangerous substances in preparations
dangerous by rail, road, waterway, sea or air.
2. Waste, as defined in Directive 2006/12/EC of the European Parliament and of the Council, does not constitute a substance, preparation or article within the meaning of Article 3 of this Regulation.
3. Member States may, in specific cases, provide for exceptions to this
Regulation for certain substances, as such or in the form of preparations or
contained in articles, if necessary for reasons of defense.
4. This Regulation shall apply without prejudice to:
(a) Community legislation relating to the workplace and the environment, comprising 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 work, Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control, 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 pollution control policy
waters and Directive 2004/37/EC;
b) Directive 76/768/EEC with regard to animal testing
invertebrates within the scope of this Directive.
5. The provisions of Titles II, V, VI and VII shall not apply to the extent that a substance is used:
a) in medicinal products for human or veterinary use within the scope of application
of Regulation (EC) No 726/2004, of Directive 2001/82/EC of the European Parliament
European Union and of the Council of 6 November 2001 establishing a code
Community legislation on veterinary medicinal products and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the
establishes a Community code on medicinal products for human use;
(b) in food or feed in accordance with Regulation (EC) No 178/2002, including when using:
(i) 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 relating to food additives authorised in foodstuffs intended for human consumption
human consumption,
ii) 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 in the field of
flavourings used in foodstuffs and raw materials for their production and Commission Decision 1999/217/EC
February 23, 1999, approving a list of substances
flavourings used in or on foodstuffs prepared in accordance with Regulation (EC) No 2232/96 of the European Parliament and of the Council,
iii) as a feed additive within the scope of Regulation (EC)
No. 1831/2003 of the European Parliament and of the Council of 22 September 2003,
on additives in animal feed,
iv) in animal feed within the scope of Council Directive 82/471/EEC of 30 June 1982 relating to certain products used in animal feed.
6. The provisions of Title IV shall not apply to the following preparations at the stage of
finished product, intended for the end user:
(a) medicinal products for human or veterinary use, within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC and in accordance with
definition of Directive 2001/83/EC;
(b) cosmetic products as defined in Directive 76/768/EEC;
c) medical devices that are invasive or applied in direct contact with the
human body, provided that community measures establish for the
hazardous substances and preparations classification and labeling standards that
guarantee the same level of information and protection as the Directive
1999/45/EC;
(d) food or feed in accordance with Regulation (EC) No 178/2002, including
when used:
(i) as food additives in foodstuffs within the scope of
application of Directive 89/107/EEC,
ii) as flavourings in foodstuffs within the scope of Directive 88/388/EEC and Decision 1999/217/EC,
iii) as feed additives within the scope of Regulation (EC)
No. 1831/2003,
iv) in animal feed within the scope of the
Directive 82/471/EEC.
7. The following are exempt from the provisions of Titles II, V and VI:
a) the substances included in Annex IV, since there is sufficient information
about them and it is considered that, due to their intrinsic properties, they entail minimal risk;
b) substances covered by Annex V, since the registration of these substances is
considered inappropriate or unnecessary and its exemption from the provisions of the titles
mentioned above does not prejudice the objectives of this Regulation;
(c) substances, as such or in the form of preparations, registered in accordance with Title II, exported outside the Community by an operator in the supply chain;
supply and re-import into the Community by another agent in the same supply chain who can demonstrate that:
(i) the re-imported substance is the same as the exported substance,
(ii) information has been provided to him in accordance with Articles 31 or 32 in
relationship with the exported substance;
(d) substances, as such or in the form of preparations or contained in articles, which have been registered in accordance with Title II and which are recovered in the
Community, as long as:
(i) the substance resulting from the recovery process is the same as the
substance registered under Title II, and
(ii) the information required by Article 31 or 32 in relation to the substance that
has been registered in accordance with Title II, is available for the
establishment that carries out the recovery.
8. Intermediates isolated in situ and isolated intermediates
transported are exempt from the provisions of:
a) Chapter 1 of Title II, except for Articles 8 and 9, and
b) Title VII.
9. The provisions of Titles II and VI shall not apply to polymers.
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