Assessment of the Equivalence of Technical Materials - European ...

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6. REFERENCES RELIED ONA. IDENTITY (Annex IIA 1.1-1.11)Author(s)Annexpoint/referencenumberYearTitleSource (where different from company)Company, Report NoGLP or GEP status (where relevant)Published or notOwnerB. METHODS OF ANALYSIS (Annex IIA 4.1.1 & 4.1.2)Author(s)Annexpoint/referencenumberYearTitleSource (where different from company)Company, Report NoGLP or GEP status (where relevant)Published or notOwner4.1. TOXICOLOGY AND METABOLISM (Annex IIA, Point 5)Author(s)Annex point/referencenumberYearTitleSource (where different fromcompany), Report NoGLP or GEP status (where relevant)Published or notOwner4.2. ECOTOXICOLOGY (Annex IIA, Point 8)Author(s)Annex point/referencenumberYearTitleSource (where different fromcompany), Report NoGLP or GEP status (where relevant)Published or notOwner36
SUMMARY OF THE TECHNICAL EQUIVALENCETechnical note:The compilation of the evaluated sources and the results of the assessment provideuseful information for the Member States. In order to facilitate the data input in theexisting table on CIRCA ("Equivalent sources and compliance checks"), therespective data should be provided in the Excel file template(https://circa.europa.eu/Members/irc/sanco/pest/library?l=/technical_evaluation/overview_tables/equivalence_templatexls/_EN_1.0_&a=d).37
Page 1 and 2: EUROPEAN COMMISSIONHEALTH AND CONSU
Page 3 and 4: 1 Implementing scheduleThis amended
Page 5 and 6: Significant impuritiesImpurities th
Page 7 and 8: 7.1.2 Evaluation processThe objecti
Page 9 and 10: If the answer is yes, it might be a
Page 11 and 12: a) Prediction of the expected incre
Page 13 and 14: Bridging across different media (e.
Page 15 and 16: Loewe, S, Muischnek, H. (1926). Üb
Page 17 and 18: 1. Ascertainment of the necessity t
Page 19 and 20: Appendix Ib: Evaluation and decisio
Page 21 and 22: Appendix III, which is based on a l
Page 23 and 24: tests with information provided on
Page 25 and 26: Appendix IV Guideline triggers for
Page 27 and 28: Appendix V How to judge what is an
Page 29 and 30: Appendix VI Example calculations fo
Page 31 and 32: TABLE OF CONTENTS1 STATEMENT OF THE
Page 33 and 34: A.4 MANUFACTURER’S DEVELOPMENT CO
Page 35: XXXXXXAccuracy:XXXXXXPrecisionXXXXX

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