Law-ref.org REACH - Registration, Evaluation and Authorisation of Chemicals
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PREAMBLE     [go to this PREAMBLE]
... 10. Substances under customs supervision which are in temporary storage, in free zones or free warehouses with a view to re-exportation or in transit are not used within the meaning of this Regulation and should therefore be excluded from its scope. The carriage of dangerous substances and of dangerous preparations by rail, road, inland waterways, sea or air should also be excluded from its scope as specific legislation already applies to such carriage. ...
... 10. Substances under customs supervision which are in temporary storage, in free zones or free warehouses with a view to re-exportation or in transit are not used within the meaning of this Regulation and should therefore be excluded from its scope. The carriage of dangerous substances and of dangerous preparations by rail, road, inland waterways, sea or air should also be excluded from its scope as specific legislation already applies to such carriage. ...
... 13. This Regulation should apply without prejudice to the prohibitions and restrictions laid down in Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products(9) in so far as substances are used and marketed as cosmetic ingredients and are within the scope of this Regulation. A phase-out of testing on vertebrate animals for the purpose of protecting human health as specified in Directive 76/768/EEC should take place with regard to the uses of those substances in cosmetics. ...
... 75. The possibility of introducing restrictions on the manufacturing, placing on the market and use of dangerous substances, preparations and articles applies to all substances falling within the scope of this Regulation, with minor exemptions. Restrictions on the placing on the market and the use of substances which are carcinogenic, mutagenic or toxic to reproduction, category 1 or 2, for their use by consumers on their own or in preparations should continue to be introduced. ...
... 124. In particular, power should be conferred on the Commission to amend the Annexes in certain cases, to set rules on test methods, to vary the percentage of dossiers selected for compliance checking and to modify the criteria for their selection, and to set the criteria defining what constitutes adequate justification that testing is technically not possible. Since these measures are of general scope and are designed to amend non-essential elements of this Regulation or supplement this Regulation by adding new non-essential elements thereto, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. ...


ARTICLE-1: Aim and scope     [go to this ARTICLE]
... Aim and scope ...


ARTICLE-2: Application     [go to this ARTICLE]
... (a) 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 radiation(1); ...
... (b) Directive 76/768/EEC as regards testing involving vertebrate animals within the scope of that Directive. ...
... (a) 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 products(6)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(7); ...
... (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 concerning food additives authorised for use in foodstuffs intended for human consumption(8); ...
... (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 relating to flavourings for use in foodstuffs and to source materials for their production(9)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(10); ...
... (iii) 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(11); ...
... (iv) in animal nutrition within the scope of Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition(12). ...
... (a) 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; ...
... (i) as a food additive in foodstuffs within the scope of Directive 89/107/EEC; ...
... (ii) as a flavouring in foodstuffs within the scope of Directive 88/388/EEC and Decision 1999/217/EC; ...
... (iii) as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003; ...
... (iv) in animal nutrition within the scope of Directive 82/471/EEC. ...


ARTICLE-14: Chemical safety report and duty to apply and recommend risk reduction measures     [go to this ARTICLE]
... (a) in food contact materials within the scope of Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food(1); ...
... (b) in cosmetic products within the scope of Directive 76/768/EEC. ...


ARTICLE-56: General provisions     [go to this ARTICLE]
... (a) uses in plant protection products within the scope of Directive 91/414/EEC; ...
... (b) uses in biocidal products within the scope of Directive 98/8/EC; ...
... (a) uses in cosmetic products within the scope of Directive 76/768/EEC; ...
... (b) uses in food contact materials within the scope of Regulation (EC) No 1935/2004. ...


ARTICLE-67: General provisions     [go to this ARTICLE]
... 2. Paragraph 1 shall not apply to the use of substances in cosmetic products, as defined by Directive 76/768/EEC, with regard to restrictions addressing the risks to human health within the scope of that Directive. ...


ARTICLE-112: Scope     [go to this ARTICLE]
... Scope ...
... (b) substances within the scope of Article 1 of Directive 67/548/EEC, which meet the criteria for classification as dangerous in accordance with that Directive, and which are placed on the market either on their own, or in a preparation above the concentration limits specified in Directive 1999/45/EC, where relevant, which results in the classification of the preparation as dangerous. ...


ARTICLE-113: Obligation to notify the Agency     [go to this ARTICLE]
... 1. Any manufacturer, producer of articles or importer, or group of manufacturers or producers of articles or importers, who place on the market a substance within the scope of Article 112, shall notify to the Agency the following information in order for it to be included in the inventory in accordance with Article 114, unless submitted as part of the registration: ...


ARTICLE-128: Free movement     [go to this ARTICLE]
... 1. Subject to paragraph 2, Member States shall not prohibit, restrict or impede the manufacturing, import, placing on the market or use of a substance, on its own, in a preparation or in an article, falling within the scope of this Regulation, which complies with this Regulation and, where appropriate, with Community acts adopted in implementation of this Regulation. ...


ARTICLE-138: Review     [go to this ARTICLE]
... 6. By 1 June 2012 the Commission shall carry out a review to assess whether or not to amend the scope of this Regulation to avoid overlaps with other relevant Community provisions. On the basis of that review, the Commission may, if appropriate, present a legislative proposal. ...
... 7. By 1 June 2013 the Commission shall carry out a review to assess whether or not, taking into account latest developments in scientific knowledge, to extend the scope of Article 60(3) to substances identified under Article 57(f) as having endocrine disrupting properties. On the basis of that review the Commission may, if appropriate, present legislative proposals. ...
... 8. By 1 June 2019, the Commission shall carry out a review to assess whether or not to extend the scope of Article 33 to cover other dangerous substances, taking into account the practical experience in implementing that Article. On the basis of that review, the Commission may, if appropriate, present legislative proposals to extend that obligation. ...