COMMISSION REGULATION (EC) No 761/2009
of 23 July 2009
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 COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 1907/2006 of 18 December 2006 of the European Parliament and of the Council 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 changes to certain test methods and to include several new test methods adopted by the OECD. Stakeholders have been consulted on this proposal. Those amendments adapt the methods in question to scientific and technical progress.
(3)
The provisions concerning vapour pressure to include the new effusion method should be revised.
(4)
It is necessary to add a new method to measure length weighted geometric mean diameter of fibres.
(5)
It is appropriate to update Regulation (EC) No 440/2008 to include with priority a new in vitro test method for skin irritation, in order to obtain a reduction of the number of animals to be used for experimental purposes, in accordance with 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 (3). Although a draft in vitro test method for skin irritation is still under discussion within the OECD, it is appropriate in this exceptional case to include method B 46 in this Regulation. Method B 46 should be updated as soon as possible once an agreement has been reached within the OECD or if further information justifying such a revision becomes available.
(6)
The provisions concerning the algal inhibition test need to be revised to include additional species and to meet the requirements for hazard assessment and classification of chemicals.
(7)
It is necessary to add a new method to measure aerobic mineralisation in surface water, by virtue of a simulation biodegradation test and a new method to assess toxicity to the genus Lemna, by virtue of a growth inhibition test.
(8)
Regulation (EC) No 440/2008 should therefore be amended accordingly.
(9)
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 as follows:
1.
Part A is amended as follows:
(a)
Chapter A.4 is replaced by Chapter A.4 as set out in Annex I to this Regulation;
(b)
Chapter A.22 as set out in Annex II to this Regulation is added;
2.
Part B is amended as follows:
Chapter B.46 as set out in Annex III to this Regulation is added;
3.
Part C is amended as follows:
(a)
Chapter C.3 is replaced by Chapter C.3 as set out in Annex IV to this Regulation;
(b)
Chapters C.25 and C.26 as set out in Annexes V and VI to this Regulation are added.
Article 2
This Regulation shall enter into force on the third day following 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, 23 July 2009.