REGULATORY & COMPLIANCE
Regulation
Water Framework Directive
Plant Protection Product Regulation
Biocidal Product Regulation
EDC criteria & assessment required ?
No
Yes
Yes
General requirements
• First EU legislation to consider EDCs
• EDCs are included in the priority list of substances
• Aim to establish quality standards for several EDCs
• An assessment of EDC properties must be performed before approval or renewal of active substances .
• EDC cannot be cannot be approved if it may cause adverse effects on humans or non-target organisms , unless the exposure is negligible under realistic conditions of use .
• An assessment of EDC properties must be performed before approval or renewal of active substances
• EDC cannot be approved unless :
• Risk from exposure is negligible
• The active substance is essential to prevent or control a serious danger to human health or the environment
• Not approving the active substance would have a disproportionate negative impact on society .
REACH Regulation |
No |
EDCs are considered to represent the same level of concern as carcinogenic , mutagenic or reprotoxic ( CMR ), persistent , bioaccumulative and toxic ( PBT ) or very persistent and very bioaccumulative ( vPvB ) substances . |
Medical Device Regulation
Cosmetic Regulation
Food Contact Regulation
Toy Safety Regulation
N0
No
No
No
• Assessment of EDC properties not required during registration
• Being a potential EDC is one of the initial grounds of concern for evaluation
• As a result of the evaluation , EDCs may :
• Be included in the Candidate List as a Substance of Very High Concern ( SVHC ) and eventually in the Authorisation List ( Annex XIV )
• Be subject to restrictions ( inclusion in Annex XVII )
• Be banned in the EU .
This Regulation identifies EDCs as substances identified as such under REACH and BPR .
For Medical devices containing > 0.1 % w / w of an EDC , a justification must be provided .
• EDC already classified as CMR are banned unless a derogation is granted
• Substances with potential EDC properties may be assessed . As a result , they may be allowed , prohibited or subject to restrictions .
• Substances with potential EDC properties may be assessed as they could represent a risk to human health . As a result , they may be banned or subject to restrictions in food contact materials .
• Substances with potential EDC properties may be assessed as they could represent a risk to human health . As a result , they may be prohibited or their use restricted , or they may be associated with specific limit values
CLP Regulation |
No |
• EU proposes to add two new hazard casses to the |
|
|
CLP Regulation to cover endocrine disruptors |
• Expected concentration limits would be in line with current CMRs .
Figure 2 highlights the rationale for ED grounds of concern . Of these , 12 were associated with additional concerns to justify their inclusion in the CoRAP ; one was included only for its potential ED properties . The Caracal ( the CAs advising on REACH and CLP ) sub-group on endocrine disruptors has been evaluating options to include criteria for endocrine disruption in the CLP and REACH regulations . In July 2020 , the sub-group proposed options to include criteria for endocrine disruption in the CLP Regulation to address the concerns of the public . 4 The new EDC hazard classes are still under discussion , but the general opinion of the industry and other external stakeholders is that the current proposal will result in an excessively strict level of proof for identifying substances as EDCs and potential misclassification of hazardous chemicals . In addition , a classification of the endocrine mode of action is neither appropriate nor necessary when sectoral legislation ( i . e . BPR and PPPR ) allows for the assessment and regulation of substances with ED properties . Also of concern is the position of the EU in relation to the rest of the world . A new classification that is not adopted by the UN Globally Harmonised System would cause confusion and lack of harmonisation .
Identification of EDCs
The approach widely used to identify EDCs is based on the OECD Revised Guidance Document 1505 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption , which is considered the international standard for identifying substances with EDC properties . Both the Scientific Committee on Consumer Safety notes of the guidance document for the Cosmetic Products Regulation and the criteria set out in the BPR and the PPPR are
Table 1 - Endocrine disruptor screening : Overview of EU regulations
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