Which Standards are Accepted for New Ecotoxicological and Toxicological Tests?
Article 13(3) of the REACH Regulation requires that new tests shall be carried out in accordance with the test guidelines included in Commission Regulation No. 440/2008 or in accordance with test guidelines recognised by the Commission or the Agency. In addition, in Annexes VII to X on standard information requirements, the use of various OECD test guidelines is required in cases where no EU test method exists (e.g. OECD TG 414, 421 and 422). Article 13(3) also specifies that information may be generated using other methods provided the conditions defined in Annex XI of the REACH Regulation are met. This includes inter alia that the result is sufficient for the purposes of classification and labelling and/or risk assessment, and that adequate and reliable documentation of the applied method is provided (see Annex XI for more information). Moreover, a specific requirement is introduced in Article 13(4) of the REACH Regulation which states that ecotoxicological and toxicological tests an
