Doc 23112
10 January 2014
ECPA position paper on Commission impact assessment on criteria for endocrine
disruptors
Summary
Shortly the European Commission will initiate an impact assessment (IA) on the policy
options for the criteria for endocrine disruptors (EDs). This paper makes a number of
suggestions which we believe would support a robust impact assessment.
The paper suggests that:
 The scope of the IA should include all sectors to which the final ED criteria will be
applied (i.e. it should include pesticides, biocides and REACH).
 The impacts on each chemical sector should be assessed separately and individually
and not be aggregated together.
 The IA should be sufficiently detailed to provide a meaningful assessment (i.e. including
sufficiently detailed to an agronomic level) upon which to compare policy options and to
make robust policy decisions.
 All existing information on the impacts of the cut-off criteria in Regulation 1107/2009 as
well as those around the revisions to Directive 91/414, should be used as input.
 The following policy options (scenarios) should be assessed (1) baseline scenario –
interim criteria, (2) DG Environment proposal for the ED criteria, (3) hazard
characterisation scenario, (4) risk assessment scenario.
 Both intended and unintended impacts of the above policy options should be assessed
for the following: agronomic impacts, impacts on human health and environment, socioeconomic impacts, trade impacts and global competitiveness of European agriculture
 To provide a credible evaluation, the IA should be adequately resourced and should be
undertaken by a group of well experienced and independent experts.
Background
In June 2013 DG Environment presented to the other Commission services a draft
recommendation for the criteria for the identification of endocrine disruptors (ED) intended to be
applied to pesticides, biocides, general chemicals and cosmetics. DG Environment and DG Sanco
have since been asked to prepare an impact assessment (IA) comparing possible policy options
for the criteria. Based on the outcome of the IA, DG Environment and DG Sanco are expected to
prepare legislative proposals for the inclusion of the criteria into the regulations for pesticides and
biocides respectively.
This paper describes ECPA’s suggestions on the elements and information that we believe should
be considered by the Commission in preparing and undertaking the IA. The paper uses as a basis
the Commission Impact Assessment Guidelines, SEC (2009) 921.
Scope and level of analysis
ECPA anticipates that the scope of the IA will be constrained by the existing legal obligations and
policy decisions (i.e. it is likely to focus on the decision at stake in relation to the development of
the ED criteria and not on the previous decision to adopt hazard based criteria for ED). The IA
may be limited in scope to pesticides and biocides only or it may be broadened to also consider
REACH and cosmetics. ECPA believes that the IA should include all sectors to which the
1
http://ec.europa.eu/governance/impact/commission_guidelines/commission_guidelines_en.htm
final ED criteria will be applied, i.e. the scope should include pesticides, biocides and
REACH. The impacts on each of these sectors should be assessed separately and
individually and not be aggregated together.
In relation to the level of the analysis, the IA should be sufficiently detailed to provide a
meaningful assessment (i.e. including sufficiently detailed to an agronomic level) upon
which to compare policy options and to make robust policy decisions. However, if due to
possible time constraints, it is not logistically possible to analyse to a sufficient level of detail across
all existing pesticides (and biocides), then alternatives include analysis by chemical class or
selecting a representative selection of substances.
ECPA would strongly recommend that if the Commission does undertake a substance by
substance evaluation on all or a subset of substances, then the results of this assessment should
not be published in way that creates a public list of suspected endocrine disruptors.
Note: the Commission has the general obligation of ensuring a proportionate depth and scope of
analysis linked with the significance of the possible impacts and how politically important the issue
is.
Gathering information and consulting stakeholders
ECPA would encourage the Commission to use existing information on the possible impacts of the
cut-off criteria in Regulation 1107/2009 as an input into the IA. These include the previous and
current reports prepared by various Member State competent authorities (UK, DK, SE) and the
European Parliament around the revisions to Directive 91/414.
As well as information relating to the number of substances concerned, existing data on the
agronomic, trade and socio-economic impacts should also be included as well as information
relating to anticipated health and environmental benefits of policy options. The impact on human
health and the environment should be compared by assessing the overall risk associated with the
different policy options. The list of reports recommended by ECPA to be considered are included
in Attachment 1.
In relation to stakeholder consultation, ECPA would support a public consultation period of at least
3 months (via written, web based procedure). We would also support the option of specific
meetings with targeted groups.
Defining the problem
ECPA believes that the impact assessment process offers an opportunity not only to compare the
different policy options for the criteria, but also to compare hazard-based versus risk-based policy
options. While this is a separate topic in itself, the Commission is required by Regulation
1107/2009 to review the cut-off criteria by the end of 2014. This could be an efficient way to
achieve both goals and to ensure a consistent assessment. To that end, ECPA supports the
inclusion of a risk assessment scenario as one of the policy options.
Defining the policy objective
Consistent with relevant existing EU legislation (e.g. Reg 1107/2009), the overall objective for the
Commission’s policy should be to ensure a high level of protection for human health and the
environment. Within this objective ECPA believes that measures to achieve this should be science
and risk-based and proportionate to the risk.
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Defining policy options
The Commission is expected to define different policy options on which the IA will be performed (in
order to compare the different options). Developing the options does involves consideration of the
proportionality principle.
ECPA would suggest that the following policy options (scenarios) be evaluated in the IA:
(1) baseline scenario – assumes no development of the final ED criteria and the interim criteria
apply (C2 and R2, R2 and toxic to ED organs). Note: this baseline scenario applies only to
pesticides and biocides; REACH and cosmetics will have a different baseline scenario.
(2) DG Environment proposal for the ED criteria – the proposal as prepared during the course
of2013. This scenario assumes that pesticide active substances placed in category 1 are not
authorised, those in category 2 will undergo risk assessment (i.e. no direct impact on ability to
register).
(3) Hazard characterisation scenario – as scenario (2) above but includes the elements of
hazard characterisation (potency, severity, irreversibility, lead toxicity). Inclusion of these elements
in the final ED criteria were supported by some Commission services.
(4) Risk assessment scenario – to assess the historical situation of managing EDs and to
compare the policy options above across different sectors. Currently there is inconsistency
between pesticides, biocides and REACH with regards to the regulation of endocrine disruptors;
some incorporate elements of risk assessment (REACH), while others are purely hazard based
(pesticides, biocides). This scenario would also be useful in relation to a comparison with the
approach employed in other regions of the world (e.g. US), as the EU impact assessment
guidelines explicitly mention considering international standards when conducting an impact
assessment. In addition, this scenario would represent the situation prior to the adoption of Reg
1107/2009 and the inclusion of the hazard based cut-off criteria.
ECPA also believes that as a second step the IA should evaluate the benefits and disadvantages
of a categorisation scheme in order to consider whether it is needed and if it provides any
significant improvements for the protection of human health and the environment.
Assessing economic, social and environmental impacts
We understand that the Commission is expected to assess the likely economic, social and
environmental impacts, both intended and unintended for each policy option. The analysis should
provide information on the impacts of the options as net changes as a basis for comparing them
both against one other and against the ‘no policy change’/baseline scenario.
ECPA believes that the following specific factors and indicators should be evaluated in the IA:
- agronomic impacts such as:
 crop yields
 resistance management
 availability of affordable and effective crop protection alternatives
- impacts on human health (including consideration of food safety) such as:
 occurrence of mycotoxins,
 availability of a balanced diet
- impacts on environment such as:
 availability of effective alternatives,
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


ILUC considerations,
CO2 emissions,
biodiversity
- socio-economic impacts , including consideration of food supply chain, such as :
 food supply index (imports vs exports)
 farm revenue
 rural development
 market value of pesticide/biocides
 prices of products/food
 costs
 employment (including downstream sectors)
 GDP
 impact on innovation
- trade impacts: trade balance, international and within the EU
.
- global competitiveness of European agriculture
Consideration should be given to both intended and unintended impacts and not only to impacts
within the EU but also internationally (e.g. trade). Within the factors mentioned above, the IA
should also consider the consequences occurring as a result of substances being replaced by
others (e.g. possible unintended impacts of substance substitution and/or the ability to find
alternative substances).
The impacts should be assessed within each different piece of concerned legislation (pesticides,
biocides as well as REACH and cosmetics). In making this analysis the Commission will need to
take into account the differences in regulatory consequences of being considered as an endocrine
disruptor between the sectorial legislation. For example, both pesticides and biocides have hazard
based cut-off criteria (REACH and cosmetics do not), however the derogation clauses from these
cut-offs are different between these two regulations. The Commission should also take into
account those substances which may already be captured by the other cut-off criteria (e.g. CMR).
Comparing options
The results of the impact assessment across the different policy options are expected to be
evaluated considering the criteria of effectiveness, efficiency and coherence. A summary overview
of all the positive and negative economic, social and environmental impacts for the options
analysed is expected to be prepared together with a ranking of the options. A cost-benefit analysis
should also be part of this analysis.
Resourcing
In order to provide a credible and meaningful evaluation, ECPA appreciates that significant
resources will be required. As discussed above, it should be undertaken in sufficient detail, but
given the magnitude of the work, we believe that the services of an external expert would be
helpful. A group of experienced and independent experts would be helpful, not only to gather the
necessary information but also to undertake the IA itself.
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Attachment 1 – list of reports recommended to be used as input to the IA
Note: the documents below relate predominately to pesticides only. Further information from the
other chemical sectors will be needed.
Document
ECPA report potential impact of current draft proposal for the
endocrine disruption criteria – March 2013
ADAS report on role of azoles in wheat and potatoes
Comments (or doc.no.)
22658
ADAS-JKI report on role of azoles in OSR
22205
Nomisma report on role of azoles in wheat production
21928
Teagasc ED impact assessment
23203
PSD impact assessment of cut-off criteria – May 2008
22838
Trinity Dublin and IfA Giessen on availability of azoles
22206
Horta study on role of azoles in Italian wheat production
21531
20986
All Member State Competent Authorities impact assessments
on ED (HSE/CRD, BfR, BfR/CRD, DK, FR, ……)
Impact assessment on Revision Dir 91/414– Graham Brookes
15100
Nomisma study Revision Dir 91/414 (socio-economic)
17306-17308
Health Impact study EP on Revision Dir 91/414
All Member State Competent Authorities IAs on revision of Dir
91/414 (, ES, FR – Arvalis, UK – potato council, Cranfield study
etc…)
Member State Competent Authorities IA on Revision Dir 91/414
(NL – Wageningen)
MS IA – HGCA UK
All work linked to ‘loss of products’ during Revision Dir 91/414
Global agricultural trends and their impact on European Union 17608
agriculture (Humboldt-University)
Healthy nutrition and healthy lifestyle- the contribution of plant
protection products.
WRc impact assessment on ED substances
23115
FERA report on agronomic and economic impact of ED criteria
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23116