COMMISSION REGULATION (EU) No 260/2014
of 24 January 2014
amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to 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 (1), and in particular Article 13(3) thereof,
Whereas:
(1)
Commission Regulation (EC) No 440/2008 (2) contains the test methods for the purposes of the determination of the physico-chemical properties, toxicity and eco-toxicity of substances to be applied for the purposes of Regulation (EC) No 1907/2006.
(2)
It is necessary to update Regulation (EC) No 440/2008 to include with priority new and updated alternative test methods recently adopted by the OECD, in order to obtain a reduction of the number of animals to be used for experimental purposes, in accordance with Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (3) and Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (4).
(3)
The adaptation contains two methods for the determination of physicochemical properties including an update of the water solubility test method and a new partition coefficient test method relevant for the persistent, bioaccumulative and toxic (PBT) assessment; four new and one updated method for the determination of ecotoxicity and environmental fate and behaviour; nine methods for the determination of toxicity and other health effects including four inhalation toxicity test methods, which include an update of three methods and one new method to reduce the number of animals used and to improve assessment of effects, an update of the repeat dose 28-day oral toxicity test method to include parameters for assessment of endocrine activity, an update of the toxicokinetics test method relevant for the design and understanding of toxicological studies and an update of chronic, carcinogenicity and combined chronic and carcinogenicity test methods.
(4)
Regulation (EC) No 440/2008 should therefore be amended accordingly.
(5)
The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006,
HAS ADOPTED THIS REGULATION:
Article 1
The Annex to Regulation (EC) No 440/2008 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 24 January 2014.