The IATA describes several modules which group information sources and analysis tools, and (i) provides guidance on how to integrate and use existing testing and non-testing data for the assessment of the skin irritation and skin corrosion potentials of chemicals and (ii) proposes an approach when further testing is needed (1). The updated version of OECD TG 404 (originally adopted in 1981, revised in 1992, 20) includes reference to the Guidance Document on Integrated Approaches to Testing and Assessment (IATA) for Skin Irritation/Corrosion (1), proposing a modular approach for skin irritation and skin corrosion testing. In the review of OECD TG 404, special attention was given to possible improvements in relation to animal welfare concerns and to the evaluation of all existing information on the test chemical in order to avoid unnecessary testing in laboratory animals. OECD guidelines for testing of Chemicals are periodically reviewed to ensure that they reflect the best available science. This test method is equivalent to OECD test guideline (TG) 404 (2015). In part B, Chapter B.4 is replaced by the following: The Annex to Regulation (EC) No 440/2008 is amended as follows: 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, Regulation (EC) No 440/2008 should therefore be amended accordingly.
Stakeholders have been consulted on the proposed amendment. Eleven of those test methods relate to in vitro tests for skin and eye irritation/corrosion, skin sensitisation, genotoxicity and endocrine effects. In order to take into account technical progress and, whenever possible, to reduce the number of animals used for experimental purposes in accordance with Article 13(2) of Regulation (EC) No 1907/2006, following the adoption of relevant OECD test guidelines, two new test methods for the assessment of ecotoxicity and nine new test methods for the determination of toxicity to human health should be laid down and seven test methods should be updated. The OECD regularly issues new and revised test guidelines, taking account of scientific progress in this area. The Organisation for Economic Cooperation and Development (OECD) develops harmonised and internationally agreed test guidelines for the testing of chemicals for regulatory purposes. 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(2) thereof,Ĭommission Regulation (EC) No 440/2008 ( 2) contains the test methods for the purposes of the determination of the physicochemical properties, toxicity and ecotoxicity of chemicals to be applied for the purposes of Regulation (EC) No 1907/2006.
Having regard to the Treaty on the Functioning of the European Union, Link Display the Official Journal containing the documentĪmending, for the purpose of its adaptation to technical progress, the Annex to 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) Link Select all documents based on this document Link Select all legislative procedures based on this document Link Select all documents mentioning this document Amendment to: Relation Treaty: Treaty on the Functioning of the European Union Legal basis: 1–508 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV) Commission Regulation (EU) 2019/1390 of 31 July 2019 amending, for the purpose of its adaptation to technical progress, the Annex to 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)