of 16 February 2009
amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XI

(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES, Based on experience gained through the development ofguidance for the chemicals safety assessment under Regu­lation (EC) No 1907/2006, three different criteria forexposure-based waiving have been identified. The first Having regard to the Treaty establishing the European criterion requires that it is demonstrated and documented that exposure in all scenarios is well below an appro­priate derived no-effect level (DNEL) or predicted no-effect concentration (PNEC) derived under specificconditions. The second criterion requires that it isdemonstrated and documented that strictly controlled conditions apply throughout the life cycle. The third 18 December 2006 of the European Parliament and of the criterion requires that where the substance is incor­ Council concerning the Registration, Evaluation, Authorisation porated in an article, the substance is incorporated in and Restriction of Chemicals (REACH), establishing a European such a way that no exposure can take place and the Chemicals Agency, amending Directive 1999/45/EC and substance is not released during its life cycle and is repealing Council Regulation (EEC) No 793/93 and Commission handled under strictly controlled conditions during all Regulation (EC) No 1488/94 as well as Council Directive manufacturing and production stages. Consequently, these criteria for justification for the omission of 93/67/EEC, 93/105/EC and 2000/21/EC (1), and in particular testing should be incorporated in Regulation (EC) No Regulation (EC) No 1907/2006 should therefore beamended accordingly.
Regulation (EC) No 1907/2006 establishes registrationobligations of Community manufacturers or importersof substances on their own, in preparations or articles,where, as part of the registration dossier, registrants haveto provide the information required under Annexes VI The measures provided for in this Regulation are in accordance with the opinion of the Committee estab­lished under Article 133 of Regulation (EC) No1907/2006, Annex XI allows registrants, under certain conditions, toomit testing in accordance with sections 8.6 and 8.7 ofAnnex VIII and in accordance with Annex IX and AnnexX to Regulation (EC) No 1907/2006.
For the avoidance of doubt it should be clarified that insection 3.1 the reference to sections 8.6 and 8.7 refers toAnnex VIII only.
Annex XI to Regulation (EC) No 1907/2006 is amended inaccordance with the Annex to this Regulation.
It is necessary to establish the criteria defining whatconstitutes adequate justification for the omission oftesting under sections 8.6 and 8.7 of Annex VIII andin accordance with Annex IX and Annex X to Regulation This Regulation shall enter into force on the third day following (1) OJ L 396, 30.12.2006, p. 1; corrected by OJ L 136, 29.5.2007, p. 3.
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.
Section 3 of Annex XI to Regulation (EC) No 1907/2006 is replaced by the following: ‘3. SUBSTANCE-TAILORED EXPOSURE-DRIVEN TESTING 3.1. Testing in accordance with Sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX and Annex X may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report.
3.2. In all cases, adequate justification and documentation shall be provided. The justification shall be based on a thorough and rigorous exposure assessment in accordance with section 5 of Annex I and shall meet any one ofthe following criteria: (a) the manufacturer or importer demonstrates and documents that all of the following conditions are fulfilled: (i) the results of the exposure assessment covering all relevant exposures throughout the life cycle of the substance demonstrate the absence of or no significant exposure in all scenarios of the manufacture and allidentified uses as referred to in Annex VI section 3.5; (ii) a DNEL or a PNEC can be derived from results of available test data for the substance concerned taking full account of the increased uncertainty resulting from the omission of the information requirement, and thatDNEL or PNEC is relevant and appropriate both to the information requirement to be omitted and for riskassessment purposes (*); (iii) the comparison of the derived DNEL or PNEC with the results of the exposure assessment shows that exposures are always well below the derived DNEL or PNEC; (b) where the substance is not incorporated in an article the manufacturer or importer demonstrates and documents for all relevant scenarios that throughout the life cycle strictly controlled conditions as set out in Article 18(4)(a)to (f) apply; (c) where the substance is incorporated in an article in which it is permanently embedded in a matrix or otherwise rigorously contained by technical means, it is demonstrated and documented that all of the following conditionsare fulfilled: (i) the substance is not released during its life cycle; (ii) the likelihood that workers or the general public or the environment are exposed to the substance under normal or reasonably foreseeable conditions of use is negligible; and (iii) the substance is handled according to the conditions set out in Article 18(4)(a) to (f) during all manufac­ turing and production stages including the waste management of the substance during these stages.
3.3. The specific conditions of use must be communicated through the supply chain in accordance with Article 31 or ___________(*) For the purpose of subparagraph 3.2(a)(ii), without prejudice to column 2 of Section 8.7 of Annexes IX and X, a DNEL derived from a screening test for reproductive/developmental toxicity shall not be considered appropriate toomit a prenatal developmental toxicity study or a two-generation reproductive toxicity study. For the purpose ofsubparagraph 3.2(a)(ii), without prejudice to column 2 of section 8.6 of Annexes IX and X, a DNEL derived from a28-day repeated dose toxicity study shall not be considered appropriate to omit a 90-day repeated dose toxicity study.’


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