EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
C(2016) 3752 projet  
  
DRAFT  
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
setting out scientific criteria for the determination of endocrine -disrupting properties 
pursuant to Regulation (EU) No 528/2012  
(Text with EEA relevance)   EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Regulation (EU) No 528/2012 concerning the making available on the market and 
use of biocidal products sets out regulatory consequences for active substances 
having endocrine -disrupting properties and biocidal products containing these 
substances. Article 5(3) of the Regulation provi des that, by 13  December 2013 at the 
latest, the Commission had to adopt the delegated acts as regards the specification of 
the scientific criteria for the determination of endocrine -disrupting pro perties. In its 
judgement of 16  December 2015 on the Case T -521/14 Sweden versus the 
Commission, the EU General Court ruled that the European Commission breached 
EU law by failing to set criteria to identify endocrine disruptors within the deadline 
indicated in Regulation (EU) No  528/2012. The delegated act provid es scientific 
criteria to identify endocrine disruptors.  
The delegated act provides scientific criteria to identify endocrine disruptors. These 
criteria are based on the definitions for endocrine disruptors   and adverse effects. 
developed by World Health  Organisation through its International Programme for 
Chemical Safety, These criteria reflect the current state of scientific and technical 
knowledge and allow to identify active substances having endocrine disrupting 
properties more accurately.  
On 15 Jun e 2016 the Commission adopted a Communication of the Commission to 
the European Parliament and the Council on endocrine disruptors and the draft 
Commission acts setting out scientific criteria for their determination in the context 
of the EU legislation on  plant protection products and biocidal products  
(XXX/2016). This communication puts the established scientific criteria for biocidal 
products in a broader context, in particular the link with the setting of scientific 
criteria for the determination of end ocrine -disrupting properties in the domain of 
plant protection products, the implication for other regulatory areas and other on -
going activities of the Commission on endocrine disruptors.    
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
A public consu ltation was carried out from September 2014 till January 2015 in the 
context of an impact assessment. The report was published on 24 July 2015. The 
Commission has consulted an expert group (the 'Biocides CA meeting') consisting of 
representatives of Member  States' competent authorities for biocidal products, of the 
European Chemicals Agency, [of the biocides industry and of the civil society ] in 
meetings of XXX  2016 and of XXX 2016. An [updated] draft of the delegated act 
was made public in advance of each of those meetings.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The delegated act specifies scientific criteria for the determination of endocrine -
disrupting properties in accordance with Article 5(3) of Regulation (EU) 
No 528/2012.  EN 3   EN DRAFT  
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
setting out scientific criteria for the determination of endocrine -disrupting properties 
pursuant to Regulation (EU) No 528/2012  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the 
Council of 22 May 2012 concerning the makin g available on the market and use of biocidal 
products1, and in particular the first subparagraph of Article 5(3) thereof , 
Whereas:  
(1) Scientific criteria for the determination of endocrine  disrupting properties  pursuant to 
Regulation (EU) No 528/2012 should be developed taking into account the purpose of 
that Regulation to improve the free movement of biocidal products within the Union 
while ensuring a high level of protection of both human and animal health and the 
environment . 
(2) In 2002, the World Heal th Organisation  (WHO)  through  its International Programme 
for Chemical Safety , proposed a definition for endocrine disruptors2 and in 2009 a 
definition of adverse effects3. Those definitions have by now reached the wide st 
consensus among scientists . The Eu ropean Food Safety Authority ( 'the Authority' ) 
endorsed th ose definitions in its Scientific Opinion on endocrine disruptors adopted on 
28 February 20134 (hereinafter “ The Scientific Opinion of the Authority" ). It is also 
the view of the Scientific Committee on Consumer Safety5. It is therefore appropriate 
to base the criteria for the determination of endocrine  disrupting properties on those 
WHO definitions.  
(3) In order to implement those criteria , weight of evidence should be applied following in 
particular the  methodology provided for in  Regulation (EU) No 528/2012 and in 
                                                 
1 OJ L 167, 27.6.2012, p. 1 .  
2 WHO/IPCS (World Health Organization/International Programme on Chemical Safety), 2002. Global 
Assessment of the State -of-the-science of Endocrine Disruptors. WHO/PCS/EDC/02.2, publicly 
available at http://www.who.int/ipcs/publications/new_issues/endocrine_disruptors/en/.  
3 WHO/I PCS (World Health Organization/International Programme on Chemical Safety), 2009. 
Principles and Methods for the Risk Assessment of Chemicals in Food. Environmental Health Criteria 
240, publicly available at http://www.who.int/foodsafety/chem/principles/en /index1.html.  
4 “Scientific Opinion on the hazard assessment of endocrine disruptors: Scientific criteria for 
identification of endocrine disruptors and appropriateness of existing test methods for assessing effects 
mediated by these substances on human he alth and the environment”, EFSA Journal 2013;11(3):3132, 
doi: 10.2903/j.efsa.2013.3132.  
5 Scientific Committee on Consumer Safety, Memorandum on Endocrine disruptors, 16.12.2014 
(SCCS/1544/14)  EN 4   EN Regulation (EC) No 1272/2008  of the European Parliament and Council6 on the 
weight of evidence . Previous experience with the application of the Guidance 
document on standardised test  guidelines for evaluating chemicals for endocrine 
disruption of OECD7 should be  also considered . In addition, the implementation of the 
criteria  should be based on all relevant scientific evidence, in particular studies based 
on international agreed study  protocol s.  
(4) The criteria for the determination  of endocrine disrupting properties reflect the current 
state of scientific and technical knowledge and allow identifying  active substances 
having endocrine disrupting properties more accurately. Without preju dice to 
Artic le 90(2) of Regulation (EU) No  528/2012 , the new criteria should therefore apply 
as soon as possible, except where the relevant Committee has voted on the draft 
Regulation presented to it without that Regulation having been adopted by the 
Comm ission by [ date of IEF of this Regulation ]. The Commission will consider on a 
case-by-case basis the implications for each pending procedure and, where necessary, 
take appropriate measures with due respect for the rights of the applicants. This may 
include  a request for a revised opinion from the Agency and comments from the 
applicants.  
HAS ADOPTED THIS REGULATION:  
Article 1  
The scientific criteria for the determination of endocrine -disrupting properties referred  to in 
the first subparagraph of Article 5(3)  of Regulation (EU) No 528/2012 shall be as set out in 
the Annex to this Regulation.  
Article 2  
The criteria laid down in the Annex to this Regulation shall apply as of  [date of EIF], except 
for procedures where the Committee  referred to in A rticle 82 of Re gulation (EU) 
No 528/2012  has voted on the draft Regulation presented to it without that draft  Regulation 
having been adopted by  [date of  EIF ]. 
Article 3 
This Regulation shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
                                                 
6 Regulation (EC) No 1272/2008 of the European Parliament and o f the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006  (OJ L 353, 31.12.2008, 
p. 1). 
7 OECD Series on T esting and Assessment No. 150