1. State of play in the EU for criteria to identify endocrine disruptors

2. Adoption of criteria for the identification of substances with endocrine disrupting properties in:
Biocides: Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017
Pesticides: Commission Regulation (EU) 2018/605 of 19 April 2018

3. Biocides:
applicable from 7 of June 2018 to new and on- going applications
Pesticides (plant protection products):
applicable from 10 November 2018 to new and on- going applications

4. What is a substance with ED properties?
1. Scientific criteria according to Regulation (EU) No 2017/2100
2. Article 57(f) and 59(1) of REACH
3. Having intended biocidal mode of action that consists of controlling target organisms via their endocrine system(s) 4

5. 1. Delegated Regulation (EU) 2017/2100 2. CA notes on implementation
3. Secondary legislation
4. Technical and Scientific guidance ED
Criteria

6. State of play CA notes
“Approved active substances”: scheduled for discussion in May 2018 CA meeting
“On- going procedures active substances”: agreed in March 2018 CA meeting
“Already authorised and on- going procedures biocidal products”: agreed in March 2018 CA meeting

7. 2. Secondary legislation and regulatory guidance
ED criteria
2. Secondary legislation and regulatory guidance
Active substances (ASs)
Approval of ASs Technical guidance note (art. 11)
Renewal of ASs Implementing act (art. 16)
Review of approved ASs Implementing act (art. 16)
Biocidal products (BPs)
Authorisation of BPs Technical guidance note (art. 24)
Renewal of BPs Delegated act (art. 40)
Cancellation or amendment of BPs Implementing act (art. 51)
Data requirements
Adaptation of data requirements Delegated act (art. 85)
for ASs and BPs to scientific and
technical progress

8. Implementation of ED scientific criteria - biocidal products on-going procedures
Biocidal product already authorised? No
Yes
Under evaluation by CA**?
AS or coformulant* having ED properties? No
Yes No
Yes
Indications exist that AS or CF may have ED properties?
Different approaches for AS and coformulants No X
Amend authorisation by Art 48 of BPR, or
Apply regulatory consequences at renewal
Yes AS CF X
Condition in the authorisation that applicant has to submit additional data and/or an application
for a change to address the concern of ED properties
The AS identified as having ED*** properties?
Coformulant identified as having ED properties*, ***? No No
Yes
Yes X
Indications exits that CF may have ED properties?
-Comparative assessment
-Regulatory consequences to be set by CA
Yes No X
CA may ask additional information on ED properties and trigger REACH or BPR procedure
*Coformulant/non-active substance having ED properties is considered a Substance of concern
CA concluded in PAR that coformulant has ED properties (REACH or BPR procedure)? No
**In mutual recognition in parallel the phase before the reference MS sent its assessment report to the Member States concerned; for Union authorisations before the evaluating CA sends the PAR to the Agency,
Yes
***In cases for which a procedure to determine ED properties will not be concluded before the legal deadline for product evaluation, the provisions apply for biocidal products for which the evaluation phase is closed
-Regulatory consequences to be set by CA X