II 
(Non-legislative acts) 
REGUL ATIONS 
COMMISSION DELEGA TED REGUL ATION (EU) 2017/2100 
of 4 September 2017 
setting out scientif ic criter ia for the deter mination of endocr ine-disr upting proper ties pursuant to 
Regulation (EU) No 528/2012 of the European Parliament and Council 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 
concer ning the making available on the mark et and use of biocidal products (1), and in particular the first subparagraph 
of Article 5(3) thereof, 
Whereas: 
(1)  Scientific criteria for the deter mination of endocr ine-disr upting proper ties pursuant to Regulation (EU) 
No 528/2012 should be developed taking into account the purpose of that Regulation to improve the free 
mov ement of biocidal products within the Union while ensur ing a high level of prot ection of both human and 
animal health and the environment. 
(2)  In 2002, the World Health Org anisation (WHO) through its Internati onal Programme for Chemical Safety , 
proposed a definition for endocr ine disruptors (2) and in 2009 a definition of adverse effects (3). Those definitions 
have by now reac hed the widest consensus among scientists. The European Food Safet y Author ity endorsed those 
definitions in its Scientifi c Opinion on endocr ine disruptors adopt ed on 28 Febr uary 2013 (4). Such is also the 
view of the Scientifi c Committee on Consumer Safety (5). It is theref ore appropr iate to base the criteria for the de­
term ination of endocr ine-disr upting proper ties on those WHO definitions. 
(3)  In order to implement those criteria, weight of evidence should be applied consider ing in particular the approac h 
provid ed for in Regulation (EU) No 528/2012 and in Regulation (EC) No 1272/2008 of the European Parliament 
and Council (6) on the weight of evidence. Previous exper ience with the application of the Guidance document 17.11.2017 L 301/1 Official Jour nal of the European Union EN     
(1)OJ L 167, 27.6.2012, p. 1. 
(2)WHO/IPCS (World Health Organisation/Int ernational Programme on Chemical Safety), 2002. Global Assessment of the State-of-the- 
science of Endocr ine Disr uptors. WHO/PCS/EDC/02.2, publicly avail able at http://www .who.int/ipcs/publications/new_ 
issues/endocr ine_disr uptors/en/ 
(3)WHO/IPCS (World Health Org anisation/Intern ational 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/f oodsaf ety/publications/chemical-f ood/en/ 
(4)‘Scientific Opinion on the hazard assessment of endocr ine disruptors: Scientif ic criteria for identification of endocr ine disruptors and 
appropr iateness of existing test methods for assessing effec ts 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 Safet y, Memorandum on Endocr ine disruptors, 16.12.2014 (SCCS/1544/14). 
(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, 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). on standardised test guidelines for evaluating chemicals for endocr ine disruption of OECD (1) should also 
beconsidered. In addition, the implementation of the criteria should be based on all relevant scientific evidence, 
including studies submitt ed in accordance with the current regulatory data requirements of Regulation (EU) 
No 528/2012. These studies are mostly based on internatio nal agreed study protocols. 
(4)  The deter mination of endocr ine-disr upti ng proper ties with respect to human health should be based on human 
and/or animal evidence, theref ore allowing for the identification of both known and presumed endocr ine- 
disrupti ng substances. 
(5)  One of the charact eristics of endocr ine-disr upti ng substances is their endocr ine mode of action. Several endocr ine 
modes of action exist. Org anisms belonging to differ ent taxonomic phyla differ biologically on essential traits, 
involving different endocr ine modes of action. Theref ore, a certain endocr ine mode of action relevant for 
a specifi c phylum may not be biologically plausible for organisms of a differ ent phylum. Substances whose 
intende d biocidal mode of action, within the meaning of point 6.5, Title 1 of Annex II of Regulation (EU) 
No 528/2012, is to control target organisms other than vertebrat es via their endocr ine system, theref ore present 
a mode of action whic h is not expected to be relevant for vertebrat es. These substances consequently do not 
generally pose a risk via this intende d mode of action to humans and vertebr ates in the environment and are 
theref ore particularly effective and useful in integrat ed pest management. When setting the criteria for the deter­
mination of endocr ine-disr upti ng proper ties that may cause adverse effects on non-target organisms, it is 
appropr iate, in view of the objectives of Regulation (EU) No 528/2012, and the principle of propor tionality , to 
take account of the abov e scientific considerations. Theref ore, where the intended mode of action consists of 
controlling targe t organisms other than vertebr ates via their endocr ine syste ms, the effects caused by that 
intende d mode of action on orga nisms of the same taxonomic phylum as the target ed one should not be 
considered for the purposes of the identification of endocr ine-disr upti ng proper ties with respect to non-target 
organisms. The active substances with such an intended mode of action may however be appro ved only if, 
follo wing a risk assessment, and taking into consideration specific data requirements set by the Regulation (EU) 
No 528/2012, their use does not lead to unaccept able effects on non-target organisms, including on organisms of 
the same phylum as the targe t organism. 
(6)  The Commission should assess, in light of the objectives of Regulation (EU) No 528/2012, the exper ience gained 
from the application of the scientific criteria for the deter mination of endocr ine-disr upti ng proper ties introduced 
by the present Regulation. 
(7)  The criteria for the deter mination of endocr ine-disr upti ng proper ties reflect the current state of scientific and 
technical kno wledge and allow identifying substances having endocr ine-disr upti ng proper ties more accurate ly. 
Without prejudice to Article 90(2) of Regulation (EU) No 528/2012, the new criteria should theref ore apply as 
soon as possible, while taking into account the time necessar y for Member States and the European Chemicals 
Agen cy to prepare for applying those criteria. Theref ore, from 7 June 2018 those criteria should apply excep t 
where the Committ ee refer red to in Article 82 of Regulation (EU) No 528/2012 has voted on a draf t Regulation 
by 7 June 2018. The Commission will consider the implications for each procedure pending under Regulation  
(EU) No 528/2012 and, where necessar y, take appropr iate measures with due respect for the rights of the 
applicants. This may include a request for additional information from the applicant and/or for additional input 
from the regulator y body and/or a revised opinion from the Agen cy, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
The scientific criteria for the deter mination of endocr ine-disr upti ng proper ties pursuant to Regulation (EU) 
No 528/2012 are set out in the Annex to this Regulation. 
Article 2 
The criteria laid down in the Annex to this Regulation shall apply as of 7 June 2018, excep t for procedures where the 
Committ ee referred to in Article 82 of Regulation (EU) No 528/2012 has voted on a draf t Regulation by 7 June 2018. 17.11.2017 L 301/2 Official Jour nal of the European Union EN     
(1)OECD Series on Testing and Assessment No 150. Article 3 
By 7 June 2025, the Commission shall present to the exper t group (the ‘Biocides CA meeting’) consisting of represen ­
tatives of Member State s' compet ent author ities for biocidal products an assessment of the exper ience gained from the 
application of the scientifi c criteria for the determination of endocr ine-disr upti ng proper ties introduced by the present 
Regulation. 
Article 4 
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union. 
It shall apply from 7 June 2018. 
This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 4 Sept ember 2017. 
For the Commission 
The President 
Jean-Claude JUNCK ER  17.11.2017 L 301/3 Official Jour nal of the European Union EN     ANNEX 
A substance shall be considered as having endocr ine-disr upting proper ties with respect to humans or non-target 
organisms, where it meets the criteria set out in section A or section B. 
Section A — Endocr ine-disr upting proper ties with respect to humans 
(1)  A substance shall be considered as having endocr ine-disr upti ng proper ties that may cause adverse effect in humans 
if, based on points (a) to (d) of point (2), it is a substance that meets all of the following criteria, unless there is 
evidence demonstrating that the adverse effects identif ied are not relevant to humans: 
(a)  it shows an adverse effect in an intact orga nism or its progen y, whic h is a chang e in the mor phology , 
physiology , growth, development, reproduction or life span of an organism, system or (sub)population that 
results in an impair ment of functional capacity , an impair ment of the capacity to compensat e for additional 
stress or an increase in suscept ibility to other influences; 
(b)  it has an endocr ine mode of action, i.e. it alter s the function(s) of the endocr ine system; 
(c)  the adverse effect is a consequence of the endocr ine mode of action. 
(2)  The identification of a substance as having endocr ine-disr upti ng proper ties that may cause adverse effect in humans 
in accordance with point (1) shall be based on all of the followi ng points: 
(a)  all available relevant scientifi c data (in vivo studies or adequate ly validat ed alternati ve test syste ms predictive of 
adverse effects in humans or animals; as well as in vivo, in vitro , or, if applicable, in silico studies informing about 
endocr ine modes of action): 
(i)  scientific data generat ed in accordance with internatio nally agreed study protocols, in particular those 
referred to in Annex es II and III of Regulation (EU) No 528/2012; 
(ii)  other scientific data selecte d applying a systemat ic review methodology ; 
(b)  an assessment of the available relevant scientifi c data based on a weight of evidence approach in order to 
establish whether the criteria set out in point (1) are fulfilled; in applying the weight of evidence deter mination, 
the assessment of the scientifi c evidence shall, in particular , consider all of the followi ng factors: 
(i)  both positive and negativ e results; 
(ii)  the relevance of the study designs for the assessment of adverse effects and of the endocr ine mode of action; 
(iii)  the quality and consistency of the data, consider ing the patt ern and coherence of the results within and 
between studies of a similar design and across differ ent species; 
(iv)  the route of exposure, toxicokinetic and metabolism studies; 
(v)  the concept of the limit dose, and international guidelines on maximum recommended doses and for 
assessing conf ounding effects of excessive toxicity ; 
(c)  using a weight of evidence approac h, the link between the adverse effect(s) and the endocr ine mode of action 
shall be established based on biological plausibility , which shall be deter mined in the light of current scientifi c 
kno wledge and under consideration of intern ationally agreed guidelines; 
(d)  adverse effects that are non-specifi c secondar y consequences of other toxic effects shall not be considered for the 
identification of the substance as endocr ine disruptor. 
Section B — Endocr ine-disr upting proper ties with respect to non-t arget organisms 
(1)  A substance shall be considered as having endocr ine-disr upting proper ties that may cause adverse effects on 
non-target organisms if, based on points (a) to (d) of point (2), it is a substance that meets all of followi ng criteria, 
unless there is evidence demonstrating that the adverse effects identif ied are not relevant at the (sub)population level 
for non-target organisms: 
(a)  it shows an adverse effect in non-target orga nisms, which is a change in the mor phology , physiology , growth, 
development, reproduction or life span of an organism, system or (sub)population that results in an impair ment 
of functional capacity , an impairm ent of the capacity to compen sate for additional stress or an increase in sus­
cept ibility to other influences; 17.11.2017 L 301/4 Official Jour nal of the European Union EN     (b)  it has an endocr ine mode of action, i.e. it alter s the function(s) of the endocr ine system; 
(c)  the adverse effect is a consequence of the endocr ine mode of action. 
(2)  The identif ication of a substance as having endocr ine-disr upting proper ties that may cause adverse effects on 
non-target orga nisms in accordance with point (1) shall be based on all of the followi ng points: 
(a)  all available relevant scientifi c data (in vivo studies or adequate ly validat ed alternati ve test syste ms predictive of 
adverse effects in humans or animals; as well as in vivo, in vitro or, if applicable, in silico studies informing about 
endocr ine modes of action): 
(i)  scientific data generat ed in accordance with internatio nally agreed study protocols, in particular those 
referred to in Annex es II and III of Regulation (EU) No 528/2012; 
(ii)  other scientific data selecte d applying a systemat ic review methodology ; 
(b)  an assessment of the available relevant scientifi c data based on a weight of evidence approach in order to 
establish whether the criteria set out in point 1 are fulfilled; in applying the weight of evidence deter mination, 
the assessment of the scientifi c evidence shall consider all of the following factors: 
(i)  both positive and negative results, discr iminating between taxonomic groups (e.g. mammals, birds, fish, 
amphibians) where relevant ; 
(ii)  the relevance of the study design for the assessment of the adverse effects and its relevance at the (sub) 
population level, and for the assessment of the endocr ine mode of action; 
(iii)  the adverse effects on reproduction, growth/development, and other relevant adverse effects which are likely 
to impact on (sub)populations. Adequat e, reliable and representative field or monitori ng data and/or results 
from population models shall as well be considered where available; 
(iv)  the quality and consistency of the data, consider ing the patt ern and coherence of the results within and 
between studies of a similar design and across differ ent taxonomic groups; 
(v)  the concep t of the limit dose and international guidelines on maximum recommended doses and for 
assessing conf ounding effects of excessive toxicity ; 
(c)  using a weight of evidence approac h, the link between the adverse effect(s) and the endocr ine mode of action 
shall be established based on biological plausibility , which shall be deter mined in the light of current scientifi c 
kno wledge and under consideration of intern ationally agreed guidelines; 
(d)  adverse effects that are non-specifi c secondar y consequences of other toxic effects shall not be considered for the 
identification of the substance as endocr ine disruptor with respect to non-target organisms. 
(3)  If the intende d biocidal mode of action of the active substance being assessed consists of controlling target 
organisms other than vertebrates via their endocr ine system s, the effects on organisms of the same taxonomic 
phylum as the targe ted one shall not be considered for the identification of the substance as having endocr ine- 
disrupting proper ties with respect to non-target organisms.  17.11.2017 L 301/5 Official Jour nal of the European Union EN