Guidance on identifying endocrine disruptors 

ECHA/NR/18/36

Scientific criteria have been agreed to identify endocrine disruptors under the EU legislation for pesticides and biocides. The criteria for biocides apply from 7 June 2018.

Pre-publication version of the Guidance for Identification of Endocrine Disruptors in the Context of the Biocidal Products and Plant Protection Products Regulations available

This Guidance was developed jointly by ECHA and the European Food Safety Authority (EFSA) with support by the Joint Research Centre (JRC) and describes how to identify endocrine disruptors in the context of the Biocidal Products Regulation (EU) No 528/2012 and the Plant Protection Products Regulation (EC) No 1107/2009 in accordance with the scientific criteria for the determination of endocrine disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100 and Commission Regulation (EU) 2018/605. The final guidance will be published in the EFSA Journal by July 2018. 

Helsinki, 7 June 2018

A drafting group consisting of scientific staff from ECHA and the European Food Safety Authority (EFSA), with the support of the Joint Research Centre (JRC), have developed scientific guidance to enable the identification of endocrine disruptors. The guidance advises applicants and assessors of the competent regulatory authorities on how to identify endocrine disruptors in accordance with the endocrine disruptor criteria.

The European Commission tasked ECHA and EFSA to develop the guidance to ensure harmonised implementation of the endocrine disruptor criteria throughout the EU for the assessment of biocides and plant protection products. The guidance has been consulted with the Agencies’ stakeholders, ECHA’s endocrine disruptor expert group and Member States’ biocides and pesticides competent authorities.

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LEGAL NOTICE
ABBREVIATIONS
GLOSSARY OF TERMS
1. INTRODUCTION
2. SCOPE OF THE GUIDANCE DOCUMENT
3. STRATEGY TO ASSESS WHETHER A SUBSTANCE MEETS THE ENDOCRINE DISRUPTOR CRITERIA
3.1. General overview of the assessment strategy
3.1.1. Grouping of parameters relevant for identification of endocrine disrupting properties
3.1.2. Considerations on non-EATS modalities
3.1.3. The assessment strategy
3.2. Gather all relevant information
3.2.1. Evaluate relevance and reliability of the data
3.2.1.1. Data from standard studies
3.2.1.2. Other scientific data
3.2.2. Extracting and reporting the information
3.3. Assemble and assess lines of evidence for endocrine activity and adversity
3.3.1. Assembling and assessing the line(s) of evidence for adverse effects
3.3.1.1. Effects secondary to other toxicities
3.3.1.2. Low-dose effects and non-monotonic dose response (NMDR)
3.3.1.3. Human relevance
3.3.1.4. Population relevance
3.3.2. Assembling and assessing the line(s) of evidence for endocrine activity
3.3.3. Integration of the lines of evidence for adverse effects and endocrine activity
3.3.4. Reporting the lines of evidence
3.4. Initial analysis of the evidence
3.4.1. Sufficient dataset for EATS-mediated adversity to support a conclusion on absence of EATS mediated adversity
3.4.2. Sufficient dataset for EATS-related endocrine activity to support a conclusion on absence of EATS-related endocrine activity
3.4.3. Considerations on the generation of further data
3.4.4. Scenarios
3.4.4.1. Scenarios based on ‘EATS-mediated’ parameters sufficiently investigated
3.4.4.2. Scenarios based on ‘EATS-mediated’ parameters not sufficiently investigated
3.5. Mode of Action (MoA) analysis
3.5.1. Postulate MoA(s) considering the adversity and/or endocrine activity
3.5.2. Establish the biologically plausible link
3.5.3. Consider which further information could help to clarify the postulated MoA(s)
3.5.4. Additional considerations for non-endocrine or non-EATS mediated MoA(s)
3.5.4.1. Biological plausibility for the key event relationships
3.5.4.2. Empirical support for dose–response/incidence and temporal concordance for the key event relationship
3.5.4.3. Essentiality, consistency, analogy and specificity of the evidence for the association of the KEs with the adverse effect
3.5.4.4. Human relevance
3.5.5. Extent of support for the overall assessment of the MoA analysis
3.5.6. Conclusion on the MoA analysis
3.6. Overall conclusion on the ED criteria
4. INFORMATION SOURCES FOR ENDOCRINE DISRUPTOR IDENTIFICATION
4.1. Non-test methods
4.2. In vitro test methods
4.3. In vivo test methods
4.3.1. Mammalian
4.3.1.1. OECD CF level 3 tests
4.3.1.2. OECD CF level 4 and 5 tests
4.3.2. Non-mammalian
4.3.2.1. Parameters
4.3.2.2. Fish
4.3.2.3. Amphibians
4.3.2.4. Birds
4.4. Epidemiological data, field studies and population models
4.4.1. Epidemiological data
4.4.2. Field studies and monitoring data
4.4.3. Population models
5. RECOMMENDATIONS
5.1. Recommendations for applicants and assessors
5.2. Recommendations for future research
6. REFERENCES
APPENDIX A – ADDITIONAL CONSIDERATIONS ON HOW TO ASSESS THE POTENTIAL FOR THYROID DISRUPTION FOR HUMAN HEALTH
APPENDIX B – RECOMMENDATIONS FOR DESIGN, CONDUCTION AND TECHNICAL EVALUATION OF HORMONAL STUDIES
APPENDIX C – INFORMATION REQUIREMENTS FOR ACTIVE SUBSTANCES UNDER THE BIOCIDAL PRODUCTS AND PLANT PROTECTION PRODUCTS
REGULATIONS, WHICH COULD POTENTIALLY PROVIDE INFORMATION ON ENDOCRINE-DISRUPTING PROPERTIES
APPENDIX D – DATABASES, SOFTWARE TOOLS AND LITERATURE-DERIVED (Q)SARS
APPENDIX E – EXCEL TEMPLATE FOR REPORTING THE AVAILABLE INFORMATION RELEVANT FOR ED ASSESSMENT
APPENDIX F – EXAMPLE ON HOW TO DEVELOP THE SEARCH STRATEGY PROTOCOL
APPENDIX G – EXAMPLE OF MOA FOR NON-TARGET ORGANISMS (FISH)

Fonte: ECHA

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