EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
C(2016) 3751 projet  
  
DRAFT  
COMMISSION REGULATION (EU) …/…  
of XXX  
setting out scientific criteria for the determination of endocrine disrupting properties 
and amending Annex II to Regulation (EC) 1107/2009  
(Text with EEA relevance)   EN 2   EN DRAFT  
COMMISSION REGULATION (EU) …/…  
of XXX  
setting out scientific criteria for the determination of endocrine disrupting properties 
and amending Annex II to Regulation (EC) 1107/2009  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to  Regulation (EC) No 1107/2009 of the  European Parliament and of the 
Council of 21 October 2009 concerning the placing of plant protection products on the market 
and repealing Council Directives 79/117/EEC and 91/414/EEC1, and in particular 
Article  78(1)(a) and second paragraph of point  3.6.5  of Annex II,  thereof,  
Whereas:  
(1) Scientific criteria for the determination of endocrine disrupting properties of active 
substances, safeners and synergists, should be developed taking into account the 
objectives of Regulation (EC) No  1107/2009, which are to ensure a high level of 
protection of both human and animal health and the environment, in particular 
ensuring that substances or products placed on the market have no harmful effect on 
human or animal health or unacceptable effects on the environment, and to improve 
the functioning of the internal market while improving agricultural production.  
(2) In 2002, the World Health 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 European Food Safety Authority ('the Authority') 
endorsed th ose definitions in its Scientific Opinion on endocrine di sruptors 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 
                                                 
1 OJ L 309, 24.11.2009, 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/en docrine_disruptors/en/ . 
3 WHO/IPCS (World Health Organization/International Programme on Chemical Safety), 2009. 
Principles and Methods for the Risk Assessment of Chemicals in Food. Env ironmental Health Criteria 
240, publicly a vailable 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 health and the environment ”, EFSA Journal 2013;11(3):3132, 
doi: 10.2903/j.efsa.2013.3132.  
5  Scientific committee on Consumer Safety, Memorandum on En docrine disruptors , 16.12.2014 
(SCCS/1544/14) . EN 3   EN base the criteria to identify substance s with endocrine disru pting 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 (EC) No 1272/2008  of the 
European Parliament and Council6 on the weigh t of evidence .  Previous experience 
with the Guidance document on standardised test guidelines for evaluating chemicals 
for endocrine disruption of OECD7 should also be considered . In addition, the 
implementation of the criteria should be based on all rele vant scientific evidence , in 
particular studies based on international ly agreed study protocols .  
(4) As the specific scientific criteria laid down by this Regulation reflect the current 
scientific and technical knowledge and are to be applied instead of the criteria 
currently set out in point 3.6.5 of Annex II to Regulation (EC)  No 1107/2009, they 
should be provided for in that Annex . 
(5) In addition, the first subparagraph  of point 3.6.5 and point 3.8.2 of Annex II to 
Regulation (EC) No 1107/2009 currently provi de that substances , safeners and 
synergists  meeting the criteria to be identified as having endocrine disrupt ing 
properties may be  approved in the case the exposure of humans or non -target 
organisms, respectively, to the substances, safeners or synergist i s negligible under 
realistic proposed conditions of use.  
(6) However t he Scientific Opinion of the Authority states that endocrine disruptors may 
be assessed like most other substances of concern for human health and the 
environment, that is to say be subject  to risk assessment and not only to hazard 
assessment . The Authority specifies that the approach concerning substances with  
endocrine disrupt ing properties is to be based on a level of concern and whether or not 
this level of concern is reached, can only b e determined by risk assessment . The 
Scientific Committee on Consumer Safety (SCCS) supports the use of risk assessment 
to assess  endocrine disruptors in their Memorandum8 issued in 2014.  
(7) Experience gained during the application of other Union provisions on endocrine 
disrupting properties of chemical substances which entered into force later than 
Regulation (EC) No 1107/2009 should be also taken into consideration, in particular 
as regards the application of similar criteria set out in Regulation (EU) No 5 28/2012 of 
the European Parliament and of the Council.  
(8) Considering  recital s 6 and 7, it is necessary to ensure that the level of residues of 
active substances having endocrine disrupting properties to be approved or renewed do 
not, taking account of the most recent relevant opinion of the Authority, present an 
unacceptable risk to humans and, where relevant, to animals, and are kept as low as 
possible in accordance with good agricultural practice for each pesticide with a view to 
protecting vulnerable gro ups such as children and the unborn, in accordance with 
Regulation (EC) No 396/2005 of the European Parliament and of the Council . 
                                                 
6 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, am ending 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 Testing and Assessment No. 150 . 
8 Scientific Committee on Consumer Safety (SCCS) Memorandum on Endocrine Disruptors. Retrieved from:  
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_009.pdf . EN 4   EN (9) In order to reflect current scientific and technical knowledge in accordance with 
Article 78(1)(a) of Regulation (EC) No 1107 /2009, points 3.6.5 and 3.8.2 of Annex II 
to Regulation (EC) No 1107/2009 should be amended.  
(10) The criteria for the determination of endocrine disrupting properties reflect the current 
state of scientific and technical knowledge and allow identify ing active substances 
having endocrine disrupting properties more accurately. 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 adopte d by 
the Commission by [Date of EIF ]. The Commission will consider on a case -by-case 
basis the implications for each procedure pending under Regulation (EC) No 
1107/2009 and, where necessary, take appropriate measures with due respect for the 
rights of the  applicants. This may include a request for additional scientific input from 
the Authority and comments from the applicants.  
(11) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1 
Annex II to Regulation (EC) No 1107/2009 is amended in accordance with the Annex to this 
Regulation.   
Article 2 
Point 3.6.5 and point 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by the 
present Regulation, shall apply as of [date of EIF of the Regulation ], except for procedures 
where the Com mittee has voted on the draft Re gulation presented to it without that draft  
Regulation having been adopted by [ date of EIF this Regulation] . 
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  
 Jean -Claude JUNCKER