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Pending the adoption of those criteria, active substances that are classified in accordance with the provisions of Regulation (EC) 1272/2008 as, or meet the criteria to be classifies as, carcinogen category 2 and toxic for reproduction category 2, shall be considered as having endocrine‐disrupting properties. e. having the same levels of concern as substances identified as C, M, R category 1 or 2, PBT or vPvB substance. •However No internationally agreed methodologies or criteria available for endocrine disrupting properties (ECHA Guidance for SVHC) •Priority of inclusion of EDC substances in Annex XIV be given to substances with a wide dispersive use or are manufactured or imported in high volumes •Decision for inclusion in Annex XIV will be based on available information and a weight of evidence approach will be used 05 January 2012 Paper 4 - Neale Page 14 of 26 pages Endocrine Disruptors 2012 14-15 February 2012 – Munich, Germany Slide 23 EU’s current and future legislative and regulatory REACH – Regulation (EC) No 1907/2006 framework – Pesticides (2) 05 January 2012 Slide 24 Commission Strategy on Regulating EDs • In 1996, the European Commission implemented a policy as to the use and regulation of suspected endocrine disturbing substances, and, in December 1999, it adopted a Community Strategy for Endocrine Disrupters.

Amphibian Metamorphosis Assay. OECD Guideline for the Testing of Chemicals. Test No. 231. Paris, France. OECD (2009). Fish Short Term Reproduction Assay. OECD Guideline for the Testing Chemicals. Test No. 229. Paris, France. S. EPA, 2009. 1100: Amphibian Metamorphosis (Frog). EPA 740-C-09-002. October 2009. S. Environmental Protection Agency. C. S. EPA, 2009. 1350. Fish ShortTerm Reproduction Assay. EPA 740-C-09-007. October 2009. S. Environmental Protection Agency. C. S. EPA, 2011. Endocrine Disruptor Screening Program, Weight-of Evidence: evaluating Results of EDSP Tier 1 Screening to Identify the Need for Tier 2 Testing.

Environmental Protection Agency. C. S. EPA, 2011. Endocrine Disruptor Screening Program, Weight-of Evidence: evaluating Results of EDSP Tier 1 Screening to Identify the Need for Tier 2 Testing. September, 2011. S. Environmental Protection Agency. C. S. EPA, 2011. Endocrine Disruptor Screening Program for the 21 Centruy: (EDSP 21 Work Plan), the incorporation of in silico models and in vitro high throughput assays in the endocrine disruptor screening program (EDSP) for prioritization and screening.

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