COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document IMPACT ASSESSMENT DEFINING CRITERIA FOR IDENTIFYING ENDOCRINE DISRUPTORS IN THE CONTEXT OF THE IMPLEMENTATION OF THE PLANT PROTECTION PRODUCTS REGULATION AND BIOCIDAL PRODUCTS REGULATION
Date: 2016-06-15
Institutions: European Commission, Secretariat-General
Subjects: chemical product, dangerous substance, drafting of EU law, endocrine disease, environmental risk prevention, institutional cooperation, protection of plant life, public health

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   EUROPEAN COMMISSION  Brussels, 15.6.2016  SWD(2016) 212 final   COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT  Accompanying the document IMPACT ASSESSMENT DEFINING CRITERIA FOR IDENTIFYING ENDOCRINE DISRUPTORS IN THE CONTEXT OF THE IMPLEMENTATION OF THE PLANT PROTECTION PRODUCTS REGULATION AND BIOCIDAL PRODUCTS REGULATION {COM(2016) 350 final} {SWD(2016) 211 final}  
 
 
Executive Summary Sheet 

Impact  assessment  (IA)  on  defining  criteria  for  identifying  Endocrine  Disruptors  (ED)  in  the  context  of  the 
implementation of the Plant Protection Products Regulation and Biocidal Products Regulation 

A. Need for action 

Why? What is the problem being addressed? Maximum 11 lines 
The  Plant  Protection  Products  Regulation  (EC)  1107/2009  (PPPR)  and  the  Biocidal  Products  Regulation  (EU) 
528/2012  (BPR)  set  the  regulatory  consequences  for  substances  considered  as  having  endocrine-disrupting 
properties. The European Commission is legally required to establish scientific criteria to identify substances with 
endocrine disrupting properties for these two pieces of legislation. The deadline to do so was December 2013.  
The regulatory consequences for substances identified as EDs are already set under the PPPR and BPR. They 
differ as – contrary to the PPR – in the BP limited derogations based on risk and socio-economic considerations 
apply. 

What are these initiatives expected to achieve? Maximum 8 lines 
Scientific  criteria  to  identify  EDs  shall  be  presented.  The  general  objectives  within  the  Treaty  which  are  the 
legal  basis  for  both  the  PPPR  and  BPR  were  guiding  the  IA:  1)  ensuring  a  high  level  of  protection  of  human 
health,  animal  health,  and  the  environment  and  2)  strengthening  the  functioning  of  the  internal  market.  These 
objectives  should  be  considered  while  improving  agricultural  production  (additional  objective  of  the  PPPR). 
Compliance  with  international  obligations  is  also  an  important  consideration.  In  addition  the  following  specific 
objectives were considered: 1) legal clarity, predictability and coherence in the identification of ED, 2) scientific 
criteria that are operational in terms of regulatory decision-making, and 3) the possibility to apply these criteria in 
the PPPR and BPR. 

What is the value added of action at the EU level? Maximum 7 lines  
Defining  scientific  criteria  for  the  identification  of  EDs  is  a  legal  obligation  for  the  Commission,  set  out  in  the 
PPPR  and  BPR,  which  were  both  adopted  through  the  ordinary  legislative  procedure.  The  objectives  can 
therefore not be met through Member State action and an EU action is needed. 

B. Solutions 

What  legislative  and  non-legislative  policy  options  have  been  considered?  Is  there  a  preferred 
choice or not? Why? Maximum 14 lines  
Four options of scientific criteria to identify substances with endocrine disrupting properties under the PPP and 
BP Regulations have been assessed:  

  Option 1: No policy change: interim criteria (baseline);  
  Option 2: WHO/IPCS definition to identify EDs;  
  Option  3:  WHO/IPCS  definition  to  identify  EDs  and  introduction  of  additional  categories  based  on  the 

different strength of evidence;  

  Option  4:  WHO/IPCS  definition  to  identify  EDs  and  inclusion  of  potency  as  an  element  of  hazard 

characterization  

The regulatory consequences of the criteria to identify EDs are already set under the PPP and BP Regulations 
and  differ  in  terms  of  scope  and  implementation,  adding  complexity  to  the  impact  assessment.  In  order  to 
address this complexity, a second set of options for regulatory consequences was developed (Aspect II): 

  Option A: No policy change (Baseline);  
  Option B: Adjustment of the PPP derogations in light of current scientific knowledge;  
  Option C: Alignment of the PPPR with the BPR by introducing further socio-economic considerations,.  

Option C was discarded at a preliminary stage of the impact assessment because it was considered as  going 
beyond the mandate of the Commission but it was maintained in the assessment for analytical purposes. 
The IA report does not identify a preferred option of scientific criteria leaving the political choice to the decision 
makers.  

Who supports which option? Maximum 7 lines  
The majority of the respondents to the public consultation did not support Option 1 (interim ED criteria set in the 
PPPR  and  BPR).  There  is  scientific  consensus  on  the  WHO  definition  for  the  identification  of  endocrine 
disruptors (Option 2). Health, environmental and consumer NGOs call for EU criteria based on hazard (Option A) 
that  would  also  include  additional  categories  based  on  the  different  strength  of  evidence  for  fulfilling  the 
WHO/IPCS  definition  (Option  3).  Third  countries  support  an  option  that  will  identify  EDs  and  takes  regulatory 
decisions under consideration of risk elements (Option B). This is also the position of the chemical industry and 
farmers  who  support  Option  4  (WHO  definition  and  inclusion  of  potency).  EU  MS  are  divided:  some  argue  in 

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favour  of  Option  A  in  combination  with  categories  (Option  3),  while  others  argue  in  favour  of  Option  B  and/or 
including  potency  (Option  4).  Recent  scientific  consensus  made  evident  that  Option  4  could  no  longer  be 
pursued from a scientific point of view, although it is supported by some stakeholders and MS. 

C. Impacts of the best performing combination of options 

What  are  the  benefits  of  the  best  performing  combination  of  options  (if  any,  otherwise  main 
ones)? Maximum 12 lines                                       
All options offer the same high level of protection of human health and environment under the current PPPR and 
BPR because they are all based on the WHO definition (currently recognised by most scientists) and because 
the  Regulations  are  based  on  a  prior  approval  system,  a  high  level  of  data  requirements  and  a  regulatory 
decision making based on thorough risk assessments. 
The  options  which could be  selected  to  define  scientific  criteria  to  identify  EDs  are Option 2  (WHO  definition), 
Option  3  (WHO  definition  +  categories),  and  Option  4  (WHO  definition  +  potency).  In  addition,  Option  B 
(adjustment  of  the  PPP  derogations  in  light  of  current  scientific  knowledge)  could  be  considered  for  the 
implementation of the criteria.  
There is scientific consensus regarding the appropriateness of the WHO definition. Since very recently there is 
also  scientific  consensus  that  potency  should  not  be  used  for  identifying  endocrine  disruptors,  and  that  the 
assessment  of  risks  from  endocrine  disruptors  to  human  health  and  environment  should  consider  hazard 
characterisation (including potency) and exposure.  

What are the costs of the best performing combination of options (if any, otherwise main ones)? 
Maximum 12 lines                                       
Options 2, 3, 4, and B are expected to offer the same high level of protection to human health regarding EDs 
under  the  current  PPP  and  BP  Regulations.  All  options  are  expected  to  affect  the  number  of  substances 
approved for PPP and BP at EU level. This will impact to a different extent human health, environment, sectorial 
competitiveness including agriculture, and trade.  
Regarding Options 2 and 3, Member States, scientists and stakeholders agree that they would correctly identify 
EDs.  If  they  are  implemented  under  the  current  PPP  and  BP  Regulations,  these  options  will  have  the  highest 
impacts on sectorial competitiveness, agriculture, and trade. The implementation of Option 3 may in addition be 
challenging in the context of the PPPR and BPR which are not designed for "categories", may impose additional 
burden to economic sectors, and may reduce harmonisation in the single market.  
Option 4 is contested by some stakeholders, including scientists. The regulatory consequences under the PPP 
derogations would not be in line with current scientific knowledge. Option 4 will affect the same areas as Options 
2 and 3 but to a lesser extent because of a prioritisation of substances based on potency.  
Option  B,  in  combination  with  any  of  the  other  options,  would  be  based  on  science  because  the  derogations 
would be adjusted to current scientific knowledge and applied on a case-by-case basis, while the general hazard 
based  approach  in  the  PPP  Regulation  is  maintained.  Moreover  option  B  would  be  in  line  with  international 
obligations. 

How will businesses, SMEs and micro-enterprises be affected? Maximum 8 lines 
SMEs are affected under all options to a different extent (farmers are mainly SMEs and the biocidal industry is 
represented  mainly  by  SMEs):  it  was  assumed  in  the  IA  that  a  decrease  of  availability  of  PPP  or  BP  would 
negatively  affect  SMEs.  No  derogations  or  special  regimes  for  SMEs  are  foreseen  in  the  PPPR  and  BPR. 
Options 4 and B (in combination with 2 or 4) would lead to the smallest impacts on SMEs. 

Will there be significant impacts on national budgets and administrations? Maximum 4 lines 
The  criteria  to  identify  EDs  will  be  applied  in  the  framework  of  the  PPPR  and  BPR  and  will  thus  not  impact 
national budgets and administrations beyond what is already foreseen in the Regulations mentioned above. 

Will there be other significant impacts? Max 6 lines  
No other impacts than those mentioned under the "costs" section. 

D. Follow up 

When will the policy be reviewed? Maximum 4 lines  
The  legal  acts  will  be  presented  under Regulation  (EC)  No  1107/2009  and Regulation (EU)  No  528/2012.  Any 
review should be done in the context of the reviews of these Regulations. Sufficient time should be allowed after 
the implementation of the ED criteria, in order to be able to evaluate the regulatory consequences. 

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