EUROPEAN COMMISSION Brussels, 15.6.2016 SWD(2016) 211 final COMMISSION STAFF WORKING 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



Main report Accompanying the document COMMUNICATION FROM 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 {COM(2016) 350 final}

{SWD(2016) 212 final}



Contents 1.What is the problem and why is it a problem? 1.1.Introduction 1.2.Endocrine disruptors, background and general regulatory context 1.2.1.Scientific developments which are relevant in the EU regulatory context 1.3.Regulatory context of Plant Protection Products (PPP) and Biocidal Products (BP) 1.3.1.Provisions on endocrine active substances under the PPP and BP Regulation 1.4.Problem identification 1.4.1.Problem definition: Absence of scientific criteria to identify EDs under the PPP and BP legislation – the interim criteria in place are not able to correctly identify EDs according to the latest scientific developments. 1.4.2.Affected parties 1.5.Underlying drivers 1.6.Evaluations 2.Why should the EU act? 3.What objectives should be achieved? 4.What are the options to achieve the objectives? 4.1.Aspect I: Setting scientific criteria to identify EDs based on hazard under the PPP and BP Regulations 4.1.1.Option 1: No policy change (baseline). 4.1.2.Option 2: WHO/IPCS definition to identify EDs 4.1.3.Option 3: WHO/IPCS definition to identify EDs and introduction of additional categories based on the different strength of evidence for fulfilling the WHO/IPCS definition.

4.1.4.Option 4: WHO/IPCS definition to identify EDs and inclusion of potency as an element of hazard characterisation. 4.2.Aspect II: Implementation of the ED criteria / approach to regulatory decision making 4.2.1.Option A: No policy change (baseline). 4.2.2.Option B: Adjustment of the PPP derogations in light of current scientific knowledge. 4.2.3.Option C: Alignment of the PPP with the BP Regulation by introducing further socio-economic considerations. 5.What are the impacts of the different policy options and who will be affected? 5.1.Methodology applied for assessing the impacts 5.1.1.Step 1: Number of substances identified as ED – the screening study 5.1.2.Step 2: Direct and indirect impacts in different policy areas 5.1.3.MCA methodology: selection of the MCA-criteria 5.1.4.MCA methodology: assessment of the options and sensitivity analysis 5.2.Direct impacts on the number of PPP and BP active substances falling under Options 1 to 4 5.3.Direct and indirect impacts in different policy areas expected after implementing the scientific criteria in the current regulatory PPP and BP Regulations (Aspect I) 5.3.1.Achievement of effectiveness and coherence (Annex 8) 5.3.2.Human health (Annexes 9 and 10) 5.3.3.Environment (Annex 11) 5.3.4.Sectorial competitiveness: EU agriculture (Annexes 12 and 13) 5.3.5.Sectorial competitiveness: PPP, BP, and related industries (Annex 14) 5.3.6.International trade (Annex 15) 5.4.Direct and indirect impacts in different policy areas expected under consideration of different implementation of the ED criteria and different approaches to regulatory decision making (Aspect II)

5.4.1.Achievement of effectiveness and coherence (Annex 8) 5.4.2.Human health (Annexes 9 and 10) 5.4.3.Environment (Annex 11) 5.4.4.Sectorial competitiveness: EU agriculture (Annexes 12 and 13) 5.4.5.Sectorial competitiveness: PPP, BP, and related industries (Annex 14) 5.4.6.International trade (Annex 15) 6.How do the options compare? 6.1.Policy ranking of Options 1 to 4 for setting scientific criteria to identify EDs under the current regulatory decision making (Aspect I) - MCA results 6.2.Policy ranking of the options related to different implementation of the ED criteria and different approaches to regulatory decision making (Aspect II) – MCA results 6.3.Summary 7.How would impacts be monitored and evaluated? 8.Bibliography ANNEX 1: PROCEDURAL INFORMATION61 ANNEX 2: STAKEHOLDER CONSULTATION70 ANNEX 3: SCREENING METHODOLOGY TO IDENTIFY ENDOCRINE DISRUPTORS ACCORDING TO DIFFERENT OPTIONS IN THE CONTEXT OF AN IMPACT ASSESSMENT………………………73 ANNEX 4: CHEMICAL SUBSTANCES SCREENED IN THE CONTEXT OF THE IMPACT ASSESSMENT ON CRITERIA TO IDENTIFY ENDOCRINE DISRUPTORS……………………………………………………………86 ANNEX 5: CHEMICAL SUBSTANCES USED IN PPP OR BP, IDENTIFIED AS ENDOCRINE DISRUPTORS UNDER EACH OF THE 4 OPTIONS106 ANNEX 6: ANALYTICAL METHOD USED TO COMPARE AND RANK THE OPTIONS: THE MULTI-CRITERIA ANALYSIS…………...…………127 ANNEX 7: THE MULTI-CRITERIA ANALYSIS: RESULTS……………………….143

ANNEX 8: Achievement of effectiveness and coherence..….......184 Annex 9: Human Health-Hormone related diseases………….……194 Annex 10: Human Health-Transmissible diseases and food safety …241 Annex 11: Environment…………………………………………………………266 Annex 12: Sectorial competitiveness: EU agriculture……………283 Annex 13: Sectorial competitiveness: EU agriculture – CONFIDENTIAL………………………………………………………316 Annex 14: Sectorial competitiveness: PPP, BP and related industries……………………………………………………………324 Annex 15: International Trade……………………………………………348 Annex 16: Glossary and bibliography………………………..…………377



Tables and Figures Figure 1. Regulatory decision making in the PPP and BP Regulations, under consideration of derogations for active substances identified as EDs Figure 2. Potential adjustment of derogations under the PPP Regulation in light of current scientific knowledge (Option B) Figure 3. Relation between the chemical substances used in PPP identified as EDs under Option 1, Option 2 and Option 3 Category I, and Option 4. The circle "ED + cut off" represents substances that are identified as ED and also classified as C1 or R1 and therefore falling under the cut-off criteria in the PPP Regulation. Table 1. MCA-criteria listed by dimension and by impacts they address Table 2. Description and underlying evidence for the MCA-criteria listed by dimension Table 3. Number of active substances used in PPP or BP identified as EDs under the screening study preformed for this impact assessment (substances identified as ED and classified as C1 or R1, thus falling under the "cut-off" criteria, are not included in the PPP numbers). In total, 347 PPP and 98 BP were screened. Table 4. False positives and false negatives identified for Option 1 by the screening.36





1.What is the problem and why is it a problem? 1.1.Introduction In this impact assessment the potential impacts of secondary legislation (implementing and delegated acts), required by Regulations (EC) No 1107/2009 and Regulation (EU) No 528/2012, are evaluated. Under these regulations, there is a legal obligation for the European Commission to set specific scientific criteria to identify substances which have endocrine disrupting properties, hereafter called "endocrine disruptors" (EDs). In particular under the Biocidal Products (BP) Regulation the Commission should adopt a delegated act as regards the criteria by December 2013. The Court judgement on the Case T-521/14 (December 2015) states that the European Commission breached EU law by failing to set criteria to identify endocrine disruptors under the BP Regulation within the legal deadline. The impact assessment is considered important to take a sound decision based on science and evidence, in particular because the EU legislation was the first worldwide to introduce regulatory consequences on EDs and there is also no precedent of setting scientific criteria to identify EDs in a regulatory context. Recent developments have taken place outside of a regulatory context (e.g. World Health Organization;;; (WHO), and Organisation for Economic Co-Operation and Development (OECD)), or in a context of substance prioritisation for further assessment and risk management (e.g. US EPA Endocrine Disruptor Screening Programme). The regulatory consequences for the substances identified as EDs are already defined in the regulations mentioned above with respect to plant protection or biocidal products. Active substances which are identified as ED shall not be approved (they are not allowed on the EU market) unless specific "derogations" could be applied. These derogations have a wider scope under the BP Regulation in comparison to the PPP Regulation, adding a layer of complexity to the analysis of the evidence regarding potential impacts. Because of the regulatory consequences mentioned above (the non-approval of active substances or restricted approval if derogations apply), impacts are expected once the criteria are applied. These impacts may be on human health, environment, sectorial competiveness including agriculture, and trade. They are expected to be higher under the PPP Regulation than under the BP Regulation because of the different scope of the derogations. This was confirmed in the public consultation where respondents expressed diverging views on the expected impacts and on their different preferred options (see more details in Annex 2 and Section 5.2 of this main report). This impact assessment is not concluding on any preferred option for setting scientific criteria to identify endocrine disruptors, but aims at providing additional information to decision makers on the potential implications of these different options under the PPP and BP Regulations. The impact assessment is focused on PPP and BP and not directly related to other EU legislative acts, because only the PPP and BP require by law to set criteria to identify EDs. However, setting the criteria to identify EDs may have potential implications on other legislations which contain specific provisions on EDs (REACH, Cosmetics, and Water Framework Directive). 1.2.Endocrine disruptors, background and general regulatory context EDs are chemicals which can interfere with the endocrine (hormone) systems in animals and humans. Both synthetic as well as naturally-occurring chemicals are known to have endocrine disrupting properties. For instance, it has been found that bisphenol F forms during mustard production from a natural ingredient of mustard grains, at high concentrations which may pose a risk to specific groups of the human population. Exposure to synthetic chemicals can occur from different sources, e.g. from residues of plant protection products or biocidal products, but also from consumer products or articles used in daily life. Knowledge about the potential toxicity of chemicals, including which chemicals may induce certain adverse effects, is available since long time and is already reflected in the EU legislation on chemicals (since the 90'ies for PPP and BP). Compared to this, endocrine disruption is a relatively recent way of looking at the toxicity of chemicals, where first scientific discussions started in the 1990s. Endocrine disruption aims to understand the mode of action, i.e. how exposure to chemicals leads to the adverse effects observed. Although the focus on EDs is recent in a regulatory context, many of the adverse effects which may be caused by EDs (e.g. carcinogenicity or reproductive effects) have already been studied and regulated for many years in the EU chemical's legislation, without detailed knowledge of the potential endocrine mode of action. This resulted in a reduction in general terms of the exposure of humans and the environment to the number of chemicals and to an increase of protection of humans and the environment. In Section 1.3 more details on the regulatory context are given. Focusing on the EU, in 1999 the European Commission's Scientific Committee for Toxicity, Ecotoxicity and the Environment (CSTEE) stated that EDs posed a ‘potential global problem for wildlife' and subsequently the Community Strategy for EDs was adopted. Since then, different specific provisions on EDs have been included in various pieces of EU legislation with the aim of being able to take regulatory decisions based on more detailed knowledge. Although these provisions on EDs are in force, agreed scientific criteria for identifying EDs in a regulatory context are so far lacking, internationally or at EU level. In the context of the PPP and BP Regulations the European Commission has the legal obligation to establish scientific criteria to identify substances with endocrine disrupting properties by December 2013. Further, both the Council of the European Union and the European Parliament have addressed EDs at several occasions during the last years. In particular, in 2000 and 2013 the European Parliament adopted Resolutions on EDs. In 2000, the Environment Council adopted Conclusions on EDs. 1.2.1.Scientific developments which are relevant in the EU regulatory context In 2002 the WHO/International Programme for Chemical Safety (WHO/IPCS) defined an ED as: "an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations". This definition serves as a basis for the options developed for this impact assessment because it reached wide consensus among scientists. Several relevant scientific reports relevant in the EU regulatory context have been published during the last years by EU agencies, EU Scientific Committees, or in the context of activities co-ordinated or commissioned by the European Commission, indicating the advancement of the scientific discussion on some concepts. In particular: -In 2010 the European Food Safety Authority (EFSA) published a scientific report which provides an overview of existing knowledge on endocrine active substances and of the challenges for risk assessment in relation to food and feed, as well as a summary of current initiatives at national, EU and international levels.5

-The report “State of the Art Assessment of Endocrine Disruptors” commissioned by the European Commission summarises advances in the state of the science from 2002 to 2011 and maps ways of addressing EDs in important pieces of EU chemicals legislation (e.g. PPP Regulation, BP Regulation, REACH). -In 2013, two reports published by the Joint Research Centre (JRC) summarise the work of the "Endocrine Disruptors Expert Advisory Group"., The reports indicate that the experts agreed that existing standardised assays are mainly available only for the estrogenic, androgenic, thyroid and steroidogenic modalities (EATS), and that test guidelines are lacking for birds and invertebrates. Agreement was not reached on some elements, e.g. the role of hazard characterisation (potency, severity, lead toxicity, irreversibility) when identifying EDs, whether a threshold approach should be followed in the evaluation of EDs, regarding the evidence for low-dose effects and the relevance of non-monotonic dose-response curves. -Also in 2013, EFSA published a “Scientific Opinion on the Hazard Assessment of Endocrine Disruptors”. The EFSA opinion supports the WHO/IPCS definition for EDs and a case-by-case risk assessment approach to assess EDs for regulatory decision making. Further, EFSA clarifies that issues regarding mixtures, critical windows of susceptibility and non-monotonic dose-response curves were general issues applicable to all chemicals (and not specific to EDs). -Further, the Scientific Committee on Consumer Safety (SCCS) issued a “Memorandum on EDs”, in 2014, in which it supports the EFSA Opinion with respect of the use of risk assessment to assess EDs for decision making. -A recent external scientific report of EFSA (2016) evaluated the evidence for the non-monotonic dose-response (NMDR) hypothesis for substances in the area of food safety. The plausibility of NMDRs was assessed based on a systematic review methodology, which identified over 10'000 potentially relevant scientific studies. From these studies, 142 studies could be selected for the evaluation (49 in-vivo, 91 in-vitro, and 2 epidemiological studies). The report indicates that the empirical evidence for NMDR was limited or weak for most in vivo datasets that were selected for substances in the area of food safety. The report also indicates that evaluation regarding the biological meaning (e.g. dose range studies, adversity of the effects, and toxicity at high doses leading to NMDR) and relevance for risk assessment were not part of this data analysis, thus questioning the relevance of the evidence for the adverse effects. Further, at the occasion of an expert conference organised by the German Federal Institute for Risk Assessment (BfR), held in Berlin in April 2016, a consensus statement on “Scientific principles for the identification of endocrine disrupting chemicals” was signed by 20 internationally renowned scientists present at the conference. This document has been made available via the website of BfR recently, however it has not yet been published in a scientific peer reviewed journal. Among others, the document lists the criteria for identifying the hazard potential of harmful endocrine substances. It also indicates that the assessment of the corresponding risks from EDs on human health and wildlife would require consideration of dose-response relationships, including potency, exposure assessment, and risk characterization, including susceptible sub-populations, severity and reversibility of effects. See for more details Box 1, which quotes from the consensus paper. "… Scientific foundations of regulatory decision-making 19. The various relevant pieces of EU chemicals regulation require both hazard and risk assessment approaches* to enable decision making to be applied in different ways. 20. The identification of a compound as an endocrine disruptor is a hazard identification procedure. Established principles governing disruption of the programming function of hormones mean that hazard identification for endocrine disruption has to take account of the timing of exposure relative to life stage and that transient indices or effects should not necessarily be considered adverse. 21. We recognize that certain adverse outcomes appearing to arise from endocrine disruption can also occur through non-endocrine modes of action. Moreover, adverse effects or modes of action consistent with endocrine disrupting characteristics but demonstrated to be non-specific effects secondary to another toxic effect are not considered appropriate for identification of endocrine disruption. The identification of a chemical as an endocrine disruptor therefore has to rely on weight-of-evidence evaluations of both adversity and mode of action together. We agree that endocrine activity on its own should not trigger a chemical’s identification as an endocrine disruptor. 22. We agree that a chemical’s potency to induce an adverse effect is an important factor for consideration during the characterization of the hazards of endocrine disruptors. However, potency is not relevant for identification of a compound as an endocrine disruptor. However, there may be high doses (e.g. the oral toxicity limit of 1000 mg/kg body weight/day) above which identification as an ED would not be warranted. 23. Criteria for identifying chemicals as endocrine disruptors would need be accompanied by the implementation of relevant test systems in EU regulations. We note that many relevant OECD guidelines exist which have not yet been consistently integrated into the regulatory frameworks. There is lack of validated tests for a number of modes of actions. We recommend that respective EU directives, regulations and other relevant guidance are updated to incorporate validated and internationally agreed test systems for endocrine disruptors. In this context, guidance and scientific advice need to be up-dated to indicate how the outcome of those tests should be evaluated in the regulatory context, and to include endocrine pathways and adverse health effects that are insufficiently explored by current toxicological testing. 24. This document has focused on the identification of endocrine disruptors. However, the assessment of the corresponding risks on human health and wildlife would further require consideration of dose-response relationships, including potency, exposure assessment, and risk characterization, including susceptible sub-populations, severity and reversibility of effects. This emphasizes the importance of the “One Substance – One Toxicological Assessment” philosophy, and has implications for data generation of both regulated and unregulated chemicals. * The WHO IPCS definitions for the four steps in risk assessment: hazard identification, hazard characterization, exposure assessment and risk characterization, have been used throughout this document. …"

In summary, the available relevant reports indicate that: -There is consensus on the WHO/IPCS definition (2002) for identifying ED -There are different endocrine modes of actions. Four modalities (pathways) are relatively well known and internationally agreed tests exist (the estrogen, androgen, thyroid and steroidogen modalities). There are other modalities which are not yet well known and for which no internationally agreed tests exist. For these modalities, still under discussion, science is under development and there is no consensus on the extent of evidence (e.g. diabetes) available. -There is no consensus on the relevance of some scientific aspects for regulatory decision making (e.g. non-monotonic dose response curve, low dose effects and existence of safety thresholds for EDs), but a recent EU review on the empirical evidence and the BfR consensus statement mentioned above indicate that the evidence for this kind of curves is weak for most in vivo data. -There is consensus that the assessment of potential risks from ED on human health and the environment would require consideration of dose-response relationships, exposure assessment, and risk characterisation (risk assessment). 1.3.Regulatory context of Plant Protection Products (PPP) and Biocidal Products (BP) A 'pesticide' prevents, destroys, or controls a harmful organism ('pest') or disease. This expression covers plant protection products and biocidal products. Plant protection products (PPP) protect crops as well as desirable or useful plants. They are used in agriculture, forestry, horticulture, industrial areas (e.g. railways), amenity areas and in gardens. Biocidal products (BP) control unwanted organisms that are harmful to human or animal health, or that cause damage to human activities. BP include products such as insecticides, insect repellents, disinfectants, preservatives for materials and anti-fouling paints for the protection of ship hulls. Both PPP and BP are formulated products (e.g. liquid concentrates, wettable powder, granules) that contain at least one active substance that is responsible for the effect of the PPP or BP, which could be a chemical, a plant extract, a pheromone or a micro-organism (including viruses). In the EU, both PPP and BP have been regulated since the 1990s via Regulation (EC) No 1107/2009 (replacing Directive 91/414/EC) and Regulation (EU) No 528/2012 (replacing Directive 98/8/EC) with the objective of ensuring a high level of protection of human health and the environment, strengthening the functioning of the internal market, and for the PPP Regulation improving agricultural production. As a consequence of the strict legislation in place since the 1990s, a significant number (about 60%) of active substances used in PPP have been taken off the market or have had their use restricted. This resulted in a reduction in general terms of the exposure of humans and the environment to the number of chemicals used in PPP . A recent study on the “Calculation of the Benefits of Chemical Legislation on Human Health and the Environment”, commissioned by the European Commission, concluded that, as a consequence of the EU legislative measures taken over the last years, the exposure to certain substances known to have adverse effects on human health and the environment was reduced. Both the PPP and BP regulations are based on pre-market approval ("positive list") and shift the responsibility for producing scientific evidence (burden of proof) to the industry. Only PPP and BP which contain active substances placed on a "positive list" (via an EU approval process) can be used in PPP or BP in the EU (via authorisation processes at national level), provided the respective uses have been considered not to cause adverse effects on human or animal health or unacceptable effects to the environment. In other words, under the PPP and BP Regulations, no use of a substance – whether the mode of action of the substance is known or not – is authorised in the EU if an unacceptable risk of causing adverse effects to human health or the environment is identified. Further, approvals of active substances and authorisations of PPP or BP are granted only for a limited number of years, after which the approvals need to be renewed following similar processes as for the 1st approvals. The two-step pre-market approval system described above (active substances approval at EU level, product authorisation at national level) is considered as one of the strictest worldwide. The Regulations (and their preceding Directives) also specify comprehensive data requirements; which have to be addressed and fulfilled before any approval of active substance or authorisation of a product can be considered. The data requirements list the experimental studies according to international agreed guidelines which need to be performed, and which results need to be submitted as part of the application dossiers, and already cover studies relevant for EDs. This implies that both PPP and BP are among the most "data rich" regulated product groups in the EU. Besides assessment of toxicological properties of the substance with respect to human health and environment, traces of residues of PPP which may be found on the crop are also considered in the assessment done before any approval or authorisation can be granted. The levels of residues are assessed and maximum residue levels (MRL) are established under Regulation (EC) No 396/2005. MRLs must be respected in commodities produced in the EU or imported into the EU, in order to ensure consumers' safety. In addition, Regulation (EC) No 396/2005 provides that the Community's trading partners should be consulted via the WTO about the MRLs proposed. MRLs set at the international level by the Codex Alimentarius Commission should also be considered when Community MRLs are being set, taking into account the corresponding good agricultural practices. 1.3.1.Provisions on endocrine active substances under the PPP and BP Regulation Both Regulation (EC) No 1107/2009 and Regulation (EU) No 528/2012 have introduced, compared to the previous legislation, specific hazard-based provisions (often referred to as “cut-off criteria") for certain hazardous classes of substances (e.g. mutagens, carcinogens). These provisions include substances identified as EDs, under both pieces of legislation, EDs are not approved unless certain derogations apply. These derogations have a wider scope under the BP Regulation in comparison with the PPP Regulation: while under the PPP Regulation the derogations are mainly hazard based, under the BP Regulation the derogations have a stronger risk component and include also socio-economic provisions (see Figure 1 and a more detailed description under Section 1.5). In cases of approval of active substances under application of these derogations, special conditions apply: the substances are approved as "candidates for substitution". This implies shorter approval periods and the obligation for Member States (MS) to consider safer alternatives when authorising PPP or BP (comparative assessment). In addition, under both Regulations, if a substance is not identified as ED, it will still undergo a full risk assessment. This risk assessment is similar to the one in place in the previous legislations which focused on potential adverse effects irrespectively of the mode of action which causes this adverse effect. In other words, the ED provisions in the PPP and BP Regulations currently act as a "switch (with respect to adverse effects potentially linked to EDs)" which either leads to a non-approval of the active substances identified as ED (subject to derogations), or to a "standard" risk assessment which would cover any potential adverse effect and if appropriate lead to non-approval or restrictions of use of the active substance (this "standard" risk assessment is carried out in any case as all potential adverse effects are assessed). Most of the adverse effects which may be caused by EDs (e.g. carcinogenicity or reproductive effects) are already regulated since many years, without detailed knowledge of their mode of action. For instance, many of the PPP and BP often cited as EDs (atrazine, DDT, lindane, dieldrin, triphenyltin, tributyltin, etc.) have already been banned since years in the EU, as a consequence of the EU regulatory system (see more details in Annex 9 on human health – hormone related diseases).

As the difference between hazard and risk plays an important role in this impact assessment, it needs to be briefly explained: hazard is anything that can cause harm, whereas risk is the potential that a hazard will cause harm. In other words a hazard will not pose any risk unless exposure to that hazard is high enough so that it may cause harm. Risks associated with hazards can be zero, or at least greatly reduced, by reducing exposure. For instance, a knife – a hazardous object per se - would be banned completely if the decision is taken based on hazard, while it would be allowed for certain uses or restricted (e.g. not allowed for small children) if the decision is taken based on risk. Similarly, a substance (e.g. a drug or a pesticide active substance) is banned if the regulatory decision is based on its hazard, while it is allowed for certain uses, under certain (restricted) conditions and doses, if the decision is taken based on risk. 1.4.Problem identification 1.4.1.Problem definition: Absence of scientific criteria to identify EDs under the PPP and BP legislation – the interim criteria in place are not able to correctly identify EDs according to the latest scientific developments. Regulation (EC) No 1107/2009 and Regulation (EU) No 528/2012 both lack scientific criteria to identify EDs, which are needed in order to be able to correctly implement the provisions set in the Regulations concerning these kind of substances (Annex II, Section 3.6.5 of the PPP Regulation and Article 5.2 of the BP Regulation). Both legislations set a legal obligation for the European Commission to establish scientific criteria by December 2013. Until these legal obligations are fulfilled, both Regulations have set the same interim criteria to identify EDs. These interim criteria are not based on the latest scientific developments on endocrine disruption, but they are based on classification of substances that are suspected of being carcinogenic and/or suspected of being toxic to reproduction (C2 and/or R2 according to Regulation (EC) No 1272/2008). They are able to identify some substances with ED properties but may miss some other ED substances (“false negatives”) or identify some substances as having endocrine disrupting properties which are not EDs ("false positives"). In order to protect human health and the environment, it is important to set scientific criteria which are able to identify EDs correctly. For the same reasons, the criteria should be the same for both Regulations. A harmonised definition is also important because it would enhance greater coherence between the regulatory frameworks as some chemical substances are regulated under both Regulations, since they can be used either in PPP or BP. Further, any potential endocrine disrupting property of a chemical substance does not depend on its use, but is an inherent characteristic of the substance. The legal obligation to define criteria is only set under the PPP and BP Regulations. However, it is expected that the new criteria may also influence other EU regulatory areas, where so far no criteria for EDs have been set or requested. In light of the legal obligations, this impact assessment focusses on the PPP and BP Regulations only. 1.4.2.Affected parties Once the criteria to identify EDs are set, they will be applied subsequently to the approvals (or the renewals of approvals) of active substances falling under the PPP and BP Regulations. This is expected to affect – directly and indirectly - society because PPP and BP are used in many ways and play an important role in some economic sectors. The impacts on society are thus driven by the regulatory consequences for the substances which are identified as EDs which are already set under the PPP and BP Regulations. In both cases, these substances shall not be approved unless some specific conditions ("derogations") apply. The derogations and how they are implemented differ between the PPP and BP Regulations (see Figure 1 and Section 1.5 for more details). While the derogations under the BP Regulation consider negligible risk and a wider scope of socio/economic considerations, under the PPP Regulation the derogations are mainly based on hazard (negligible exposure and almost zero exposure via food by lowering the MRLs to the limit of determination) and limited socio-economic considerations (serious danger to plant health). Consequently the impacts under the PPP Regulation are expected to be higher compared to the BP Regulation. In addition, the regulatory consequences set in both the PPP and BP Regulations must be consistent with provisions of international law, such as customary international law and treaties ratified by the EU. The establishment of criteria under the PPP and BP Regulations, following this impact assessment, may have repercussions on other EU-chemical legislation. The BP Regulation can be taken as an illustration of what would happen for sectors where derogations taking into account risk and/or socio economic considerations apply, whereas the PPP Regulation can be taken as an illustration of what would happen for sectors where the decision making is mainly based on hazard. As a consequence of the regulatory context described above, the health of the general population, consumers, and workers exposed to EDs (e.g. professional users) may be affected directly or via the quality of the environment or the safety of the food. However, there may also be indirect impacts for consumers in terms of variation in availability or costs for certain products including agricultural commodities. Economic operators affected may be manufacturers, importers, exporters, traders, industries marketing chemical substances and downstream industries. In particular food chain operators (for instance those using disinfectants), health care facilities, small and medium sized enterprises and professional users like farmers producing plant or animal products are all expected to be affected. Parties may be affected to different extents depending on the type of products they produce and use and the geographical location of their activity. MS and third countries may be affected via international trade through the lowering of the MRLs for food and feed to the default value (limit of determination, i.e. analytical zero) for substances identified as EDs, which have to be applied for EU production but also for imports. International trade is also expected to be impacted via imports of articles, because articles treated with active substances not approved in the EU for BP cannot be imported into the EU. The operability for implementing the criteria may also have an impact on national administrations because of inter alia, shorter approval periods and more complex assessments when applying the derogations.

Since the criteria that the European Commission will present under the PPP and BP Regulations may have repercussions on other EU legislation containing specific provisions governing EDs (e.g. REACH, the Water Framework Directive, the Cosmetics products legislation), parties may also be affected indirectly via these pieces of legislation. 1.5.Underlying drivers The absence of scientific criteria to identify EDs in Regulations (EC) No 1107/2009 and (EU) No 528/2012 is a consequence of the fact that when these Regulations were drafted, the co-legislators felt that it was too early to set scientific criteria in a regulatory context and instead requested the European Commission to set them by December 2013. The interim criteria currently applicable under these Regulations may fail to identify some EDs because: 1) they only refer to certain adverse effects for human health (carcinogenicity and toxicity for reproduction) and do not consider wildlife species and 2) they do not consider the endocrine mode of action of substances. For these reasons, they may identify "false negatives" and "false positives". The scientific criteria to identify EDs are set in a regulatory context (PPP and BP Regulations), which plays a significant role in determining the impacts of the criteria on the approval of active substances and on society in general. Thus, the regulatory consequences for substances identified as EDs are identified as an additional driver which adds complexity to the analysis of the impacts. The regulatory consequences for substances identified as EDs are different between the PPP and BP Regulations. In both cases, substances identified as EDs shall not be approved unless some specific conditions ("derogations") apply. However, these derogations differ in their scope and possibilities of implementation (see Annex II, Section 3.6.5 and Article 4.7 of the PPP Regulation and Article 5 of the BP Regulation for details). This implies that substances identified as EDs will be subject to one of the following regulatory consequences: a non-approval of the active substance (BP for general public, most cases for PPP) approvals limited to situations where negligible exposure is assessed on a case by case basis (some PPP cases) approvals limited to negligible risk assessed on a case by case basis (BP professional uses) approvals limited to socio/economic considerations (PPP to fight a serious danger to plant health; BP professional uses when a substance is needed to prevent or control serious dangers to human health, animal health or the environment or measures would lead to disproportionate negative effects on society). The derogations in the PPP and BP Regulations differ in their scope (exposure vs. risk because of exposure respectively, and socio-economic considerations vs. danger to plant health respectively), but also if they apply sequentially or are assessed in an integrated way, leading to differences in the implementation (see Figure 1 for more details). These differences have consequences for the approval of substances, and hence to the availability of PPP or BP, which is then expected to impact several sectors. The regulatory consequences in the PPP and BP Regulations also differ with respect to the allowed residues. While in the PPP legislation residues (MRLs) of substances identified as EDs will be lowered to the analytical zero, the BP Regulation foresees that a treated article shall not be placed on the EU market unless all active substances contained in the biocidal products that it was treated with or incorporates are approved. These provisions are applicable to commodities and products produced in the EU but also to those imported from non-EU countries. As a consequence the provisions may also have impacts on international trade with consequences for the internal market. 1.6.Evaluations Neither the PPP nor the BP Regulations, adopted in 2009 and 2012 respectively have so far been subject to an ex-post evaluation. However, preparations for the evaluation of Regulation (EC) No 1107/2009 have started under the REFIT programme. Regulation (EC) No 1107/2009 in its Article 82 provides for the issuance of a report which should cover, inter alia, the application of the criteria for approval as set out in Annex II (which includes the provisions on EDs) and their impacts on agriculture, human health, and environment. 2.Why should the EU act? Defining scientific criteria for the identification of EDs is a legal obligation for the European Commission, set out in the PPP and BP Regulations, which were both adopted through the ordinary legislative procedure. The endocrine properties of an active substance to be used in PPP and BP need to be assessed for its approval. Since this approval process is done at EU level, EU action is needed for setting the criteria. Scientific criteria to identify substances which have endocrine disrupting properties are expected to contribute to a more informed regulatory decision making which considers current scientific knowledge. This implies a regulatory decision making which considers in addition to the adverse effects (WHAT question) also the endocrine mode of action (HOW question). Knowledge on the endocrine mode of action is relatively recent and it may further accumulate in the future.

Setting harmonised criteria under the PPP and BP legislation will ensure a consistent level of protection of human health and the environment. A coherent approach with respect to EDs under the PPP and BP legislation will also allow legal coherence and certainty, as well as regulatory consistency and predictability. This is in particular important as some chemical substances (currently around 38 substances, considering only the biocides already assessed under the review programme) fall under both pieces of legislations. 3.What objectives should be achieved? Scientific criteria to identify EDs need to be presented in order to fulfil legal obligations set in the PPP and BP Regulations, with the aim of maintaining the high level of protection of human health and the environment and to provide consistency in these levels of protection across both sets of legislation. The general objectives within the Treaty guide the present impact assessment, as they are the legal basis for both the PPP and BP Regulations: ensuring a high level of protection to human health, animal health and the environment; strengthening the functioning of the internal market. For the PPP Regulation the two objectives mentioned above should be considered while improving agricultural production (see Article 1 of Regulation (EC) No 1107/2009). The compliance with international obligations, notably under the Sanitary and Phytosanitary (SPS) and Technical Barriers to Trade (TBT) agreements under the World Trade Organisation are also important considerations. The following specific objectives for PPP and BP Regulations have also been considered: providing for legal clarity, predictability and coherence in the identification of EDs; providing for scientific criteria that are operational in terms of regulatory decision-making; offering possibility to apply these criteria across the PPP and BP Regulations. 4.What are the options to achieve the objectives? As explained in previous sections, the European Commission is legally required to establish scientific criteria to identify substances with endocrine disrupting properties in the context of the PPP and BP Regulations. Four options, including the current baseline (interim criteria), have been developed. The four options are based on hazard, and consider scientific knowledge. The regulatory consequences (i.e. implementation) of the scientific criteria to identify EDs are already set under the PPP and BP Regulations and are driving the potential impacts of the criteria (see Sections 1 for more details). The regulatory consequences differ in terms of scope and implementation, adding complexity to the impact assessment. In order to address this complexity, a 2nd set of options was developed and presented in the roadmap. Consequently, two separate sets of options were considered along two aspects: Aspect I: setting scientific criteria to identify EDs based on hazard under the PPP and BP Regulations; Aspect II: implementation of the ED criteria / approach to regulatory decision making. The options for each aspect are described below and analysed separately. These analyses are not aimed at concluding on any preferred option for setting scientific criteria to identify endocrine disruptors, but at providing additional information to decision makers on the potential implications of these different options under the PPP and BP Regulations.

4.1.Aspect I: Setting scientific criteria to identify EDs based on hazard under the PPP and BP Regulations All the options considered under this aspect (with exception of the baseline) are based on hazard and on the WHO/IPCS definition, for which there is a wide scientific consensus. They have been all presented in the Roadmap and are representing different views of Member States and stakeholders. These views are explained in the sub-sections below. 4.1.1.Option 1: No policy change (baseline). No scientific criteria are specified and the interim criteria set in the PPP and BP Regulations continue to apply. The interim criteria are based on classification of substances: suspected of being carcinogenic and/or suspected of being toxic to reproduction (C2 and/or R2 according to Regulation (EC) No 1272/2008, respectively). The majority of the respondents to the public consultation that was carried out in the context of the impact assessment did not support Option 1 as it may fail to identify the correct EDs. There is scientific consensus that the interim criteria set in the PPP and BP Regulations are not correctly identifying EDs because they are unable to detect an ED mode of action. The interim criteria may detect "false positives" (the interim criteria identify EDs even when no ED mode of action is present) and "false negatives" (substances which have ED mode of action which cause potential adverse effects are not identified by the interim criteria). 4.1.2.Option 2: WHO/IPCS definition to identify EDs The aim of this option is to identify, based on hazard elements, substances which meet the WHO/IPCS definition (2002). EDs are identified as substances: a) Which show an adverse effect. An adverse effect is defined according to the definition of WHO/IPCS (2009); b) and where there is experimental evidence based on international agreed study protocols (in vivo studies), possibly supported with other information (e.g. (Q)SAR, analogue and category approaches) that the substance has the capacity to cause endocrine-mediated adverse effects in humans or endocrine-mediated adverse effects relevant at the population level on animal species living in the environment. However: This evidence needs to occur in the absence of other toxic effects, or if occurring together with other toxic effects, the endocrine-mediated adverse effects should not be a non-specific secondary consequence of other toxic effects; where there is information demonstrating that the effects are clearly not relevant for humans and not relevant at population level to species living in the environment, then the substance should not be considered an ED. As mentioned before, there is a wide scientific consensus on the WHO/IPCS definition for identifying endocrine disruptors. This was confirmed in the “BfR consensus statement” published on 4 May 2016. However, scientists, MS and stakeholders are divided on whether this definition alone would be the best option in the context of the PPP and BP Regulations. Some of them (most endocrinologists, some MS, health/environmental/consumers NGOs) consider that this option is the most appropriate as it would correctly identify EDs. Others (most toxicologists, some MS, industry and third countries) consider that this option would not correctly identify EDs of actual concern under the current PPP Regulation, i.e. would not correctly assess which EDs pose an actual risk to human health and the environment because the current derogations under the PPP Regulation are mainly hazard based. They believe that many active substances would no longer be approved although they can be used safely, i.e. they would only produce an adverse effect at unrealistic high exposure. They believe that only a subset of the identified EDs should be regulated under the current hazard based "cut-off" criteria set in the PPP, i.e. those substances which produce an adverse effect at realistic doses of exposure. Some of these diverging opinions are also reflected in the public consultation report. 4.1.3.Option 3: WHO/IPCS definition to identify EDs and introduction of additional categories based on the different strength of evidence for fulfilling the WHO/IPCS definition.

The aim of this option is to identify, based on hazard elements, substances which meet the WHO/IPCS definition, and to introduce additional categories based on the strength of the evidence. For the purpose of this impact assessment 3 categories are evaluated, as follows: -Category I: EDs (as defined in Option 2). -Category II: Suspected EDs, which means substances where there is some evidence that endocrine-mediated adverse effects can be produced on humans or on populations living in the environment, but where the evidence is not sufficiently strong or convincing enough to place the substance in Category I. -Category III: Endocrine active substances, which means substances for which there is some in vitro or in vivo evidence indicating an interference with the endocrine system (endocrine activity) but without evidence of an adverse effect in intact organisms. Regulatory consequences are defined in the PPP and BP Regulations for EDs (Category I), while no regulatory consequences are defined in these Regulations for suspected EDs or endocrine active substances (Categories II and III). Therefore, EDs under Option 2 and under Option 3 Category I are identical in terms of substances identified and the impacts related to their regulatory consequences are expected to be the same. Scientists, MS and stakeholders are divided on whether this option would positively contribute to more efficacy and operability of the criteria. Most endocrinologists, some MS, health/environmental/consumers NGOs are generally in favour of this option considering that: the classification system would be consistent with classification under CLP regulation; additional categories would bring further clarity and easier classification by assessors; downstream users would better plan the substances to use in their products. Most toxicologists, some MS and industry are generally against this option considering that it would raise confusion on whether all categories should be subject to regulatory consequences, while the uncertainties on taking regulatory action exclusively based on identification of a substance as an ED are already higher than usual. They believe that: additional categories with no specific regulatory consequences would reduce clarity and predictability; harmonized classification is competence of CLP regulation and not of sectorial legislation; additional categories are likely to lead to "blacklisting" of substances which may negatively affect innovation. Some of these views have also been expressed in the public consultation. The views expressed in the context of Option 2 (see above) need to be also considered. 4.1.4.Option 4: WHO/IPCS definition to identify EDs and inclusion of potency as an element of hazard characterisation. The aim of this option is to identify, based on hazard elements and in the regulatory context of the PPP and BP Regulations, substances which meet the WHO/IPCS definition and to prioritise the substances of greater concern. A prioritisation of substances is supported by farmers, the chemical industry and some EU MS. Third countries are expected to favour this option with respect to options 1 to 3. Therefore, this option was included in the Roadmap and considered in the impact assessment. Under the PPP and the BP Regulations, if a substance is identified as an ED it will not be approved unless certain derogations apply. If a substance is not identified as an ED, it will undergo a full risk assessment focused on potential adverse effects and based on comprehensive data requirements (see Figure 1). Under this regulatory context, a prioritisation of substances of greater concern via hazard characterisation may be considered for the substances which would fall under the "hazard cut off criteria" leading to a non-approval of these substances unless derogations apply, while substances not falling under these "cut off criteria" would still be subject to a full risk assessment and only approved if considered not having adverse effects on human health, animal health or the environment. Thus, Option 4 would identify, based on hazard elements, substances which meet the WHO/IPCS definition and which have a stronger potency, being potency one of the elements of hazard characterisation. Potency is part of hazard characterization and not of hazard identification; however it is neither a full hazard characterisation (hazard characterisation includes e.g. potency, severity, irreversibility) nor a risk assessment (risk assessment is hazard characterisation + exposure assessment). Potency is an inherent characteristic of a chemical substance. It is a scientific measurement (i.e. based on experiments) of the substance’s ability to produce an (adverse) effect. In other words, the higher the potency of a substance, the lower the dose needed to produce a certain adverse effect. For instance artificial sweeteners are more potent than sugar to sweeten a cup of tea, since only a few drops are needed instead of a spoon. Another example is cyanide and table salt: both can be toxic but cyanide is far more toxic than salt. Potency may be considered in several ways. One way would be setting a dose threshold necessary to achieve an adverse effect. For the purpose of this impact assessment potency has been defined as a threshold value based on the STOT-RE Cat 1 trigger values from the Regulation (EC) No 1272/2008 (see Section 5). Considering in particular the regulatory context of the PPP Regulation (i.e. derogations based mainly on hazard) the diverging views of scientists, stakeholders and MS regarding this option are summarized below.

Most endocrinologists, some MS, health/environmental/consumers NGOs believe that: potency should not be part of the criteria for identification of EDs because it is part of hazard characterisation; considering potency in the criteria to identify EDs might reduce protection of human health and environment because EDs are suspected to produce adverse effects at low doses (i.e. EDs are suspected to act via non-monotonic dose-response curves, i.e. a safety threshold might not be identified for EDs); Most toxicologists, some MS, industry and third countries believe that: EDs are chemicals which can be treated like any other chemicals because the available evidence does not confirm the existence of non-monotonic dose-response curves for EDs. This implies that safety thresholds can be set for EDs like for any other chemical and that regulatory decisions can be based on risk considerations. if risk considerations cannot be taken into account in the regulatory decision making because derogations are based mainly on hazard, it would be unscientific not to prioritize the most hazardous substances based on scientific information. The consideration of potency would be a scientific way to achieve this prioritisation. Recent scientific reports, state that assessment of risks from ED on human health and the environment would require consideration of dose-response relationships (which includes potency considerations), exposure assessment, and risk characterisation. There is scientific consensus that Option 4 would not identify correctly all EDs, but that potency should be used when assessing risks of EDs on human health and wildlife. Scientists agree that potency should not be considered at the step of hazard identification, but at the step of hazard characterization needed for a risk assessment of ED. This was confirmed in the “BfR consensus statement” published on the BfR website the 4 May 2016 (see Box 1 for more details) but has not yet been published in a scientific peer reviewed journal (the process for publication is currently on-going). 4.2.Aspect II: Implementation of the ED criteria / approach to regulatory decision making The regulatory consequences (i.e. implementation) of the criteria to identify EDs are already set under the PPP and BP Regulations and are driving the impacts. In addition, the regulatory consequences differ in terms of scope and implementation, adding complexity to the impact assessment. For analytical purposes it was considered important to address this complexity and thus the options presented in the Roadmap were designed in order to address the difference in the derogations between the PPP and the BP Regulations. As a consequence a very comprehensive range of options was developed which covers the entire spectrum of potential policy choices: these include the baseline (current provisions in the BP and PPP Regulations), the possibility to modify an annex of the PPP Regulation under regulatory procedure with scrutiny, and the possibility to modify the PPP Regulation under ordinary legislative procedure. The inclusion of such a wide spectrum of options has been done for analytical purposes and greater transparency, in order to allow greater comparability of the evidence gathered throughout the analysis and facilitate the identification of the most proportionate and fit for purpose policy choice. Some Member States and all third countries replying to the public consultation support an option that will identify EDs and take regulatory decisions based on risk assessment. 4.2.1.Option A: No policy change (baseline). The regulatory consequences under the PPP and BP Regulations remain unchanged. This means that the decision making in the PPP sector is, including the derogations, mainly based on hazard while the decision making in the BP sector considers more risk and socio economic elements (except for consumers). A decision taken based on hazard means that a substance is not-approved based on its inherent properties, while a decision based on risk considers the use of the substance and if there is actually exposure to this substance which leads to a risk. This baseline option (Option A) implicitly applies when evaluating the impacts of the options for setting scientific criteria (Aspect I) because it represents the current regulatory framework. Most endocrinologists, some MS, health/environmental/consumers NGOs call for EU criteria to assess EDs purely based on hazard. Most toxicologists, some MS, industry, farmers and third countries disagree with hazard-based ED criteria and call for EU criteria to assess EDs which consider risk.

4.2.2.Option B: Adjustment of the PPP derogations in light of current scientific knowledge. Option B only applies to the PPP Regulation and takes into account scientific knowledge which is based on scientific consensus. The option aims at updating the derogations foreseen in the PPP legislation while maintaining the essentially hazard-based decision making. It would contribute to increased operability of the derogations currently laid down in the PPPR and would allow implementing the criteria in a consistent manner across the PPP Regulation and the BP Regulation. See below and Figure 2 for more details. The derogations to the non-approval of active substances, currently mainly hazard-based, would be updated in light of current scientific knowledge (e.g. recent scientific opinions of EFSA, Scientific Committee SCCS, expert meeting in Berlin) to derogations which consider risk components. While the general hazard approach for EDs would be maintained, the derogations would be based on a stronger risk component compared to the current regulatory situation. The European Commission is empowered to amend non-essential elements of the Annexes in Regulation (EC) No 1107/2009 taking into account current scientific and technological knowledge via Regulatory Procedure with Scrutiny (RPS) (cf. Article 78 of Regulation (EC) No 1107/2009). This option is therefore feasible within the remit of the mandate of the Commission as it does not imply changes by ordinary legislative procedure to the basic act. By updating the PPP derogations to take into account current scientific knowledge, there would also be a higher alignment of the PPP Regulation to the BP Regulation (see also Section 1.5 and Annex 8 for further details on the exact working of the derogations under the PPP and BP Regulations). Such alignment would provide for more harmonisation of the implementation of the criteria. Thus, this option represents a potential contribution to a clearer and simpler regulatory environment and of an easier implementation of the criteria. It would also contribute to achieving one of the objectives of Better Regulation which is effectiveness of EU action. Third countries replying to the public consultation support this option because it will identify EDs and take regulatory decisions based on a hazard approach which considers derogations based on science and consideration of risk elements, as requested by international obligations (notably Sanitary and Phytosanitary (SPS) and Technical Barriers to Trade (TBT)). Chemical industry, farmers, and some MS are in favour of decision making which considers risk. 4.2.3.Option C: Alignment of the PPP with the BP Regulation by introducing further socio-economic considerations. Option C only applies to the PPP Regulation, as it implies an amendment of the PPP Regulation to introduce measures similar to those in the BP Regulation as regards the derogations for non-approval of substances in case this would have a disproportionate negative impact on society (Art 5.2. of the BP Regulation). This option would require a modification via ordinary legislative procedure of the current PPP Regulation. At a preliminary stage of the analysis it was anticipated that this option goes beyond the mandate given to the Commission for the identification of ED criteria and that it should be discarded. Nevertheless, the option was still considered relevant for analytical purposes and to support the analysis of potential future policy choices. As a consequence, it was maintained for the analysis but not further discussed in the main report. Moreover, it was part of the roadmap which was considered as the basis of this impact assessment. 5.What are the impacts of the different policy options and who will be affected? 5.1.Methodology applied for assessing the impacts Once the criteria to identify EDs are set based scientific considerations, they will be applied subsequently to the regulatory process for the approval or renewal of approval of active substances falling under the PPP and BP Regulations (no derogations for SMEs are foreseen in the Regulations). The impacts are driven by the regulatory consequences foreseen for the substances which are identified as EDs. Regarding the international dimension, the impacts need to be assessed considering provisions set in international law, such as customary international law and treaties ratified by the EU. Due to this situation, the impacts have been assessed in a two-step procedure as described in the subsections below. 5.1.1.Step 1: Number of substances identified as ED – the screening study

In a first instance, the number of substances which would be identified as EDs under the various options has been estimated via a screening study performed by an external contractor (Specific Contract SANTE/2015/E3/001). The study was based on a scientific method developed by the Joint Research Centre (JRC). The JRC monitored and assisted the screening process performed by the contractor. The methodology, the results of the screening, and the contractor’s details will be published once the screening is finalised, which is expected by end June 2016. The screening study served as a case study and constitutes the basis for the assessment of the impacts on different policy areas. It resulted in a quantifiable estimation regarding how many and which chemical substances used in PPP and BP may be identified as EDs under Options 1 to 4. It also gave an estimate of the extent of the overlap between the options allowing a comparison of the options. Further, both the method and the experience applying it might be used at a later state as a starting point for practical guidance to apply the criteria. However, the results of the screening do not constitute evaluations of individual substances to be carried out under the respective chemical legislations [Regulation (EC) No 1107/2009 on plant protection products and Regulation (EU) No 528/2012 on biocidal products] and in no way prejudge future decisions on active substances to be taken pursuant to these two Regulations. The results of the study cannot be used for regulatory purposes because for identifying a substance as ED for taking regulatory decisions a more in depth assessment in line with the provisions of the respective Regulations would be required. 5.1.2.Step 2: Direct and indirect impacts in different policy areas Building on the results of the screening study (i.e. the chemical substances identified as ED under each of the Options 1 to 4) and the regulatory consequences foreseen in the PPP and BP Regulations (non-approval of active substances unless the derogations apply), the direct and indirect impacts in different policy areas have been assessed. The policy areas covered in the assessment were human health, environment, economic operators, users, MS and third countries. For assessing these impacts and because they are multifactorial, the evidence of the screening study was complemented with additional information. However, the availability of reliable and sound data to assess the impacts on agriculture, trade, health and environment was scarce and highly variable. Also the identification of plausible and reliable case studies to be used for assessing the impacts was difficult. In particular: Basic agricultural/trade data were either not available, not ready, or not easy to use (e.g. information on uses of active substances per crop and per pest were not available for all EU MS; yield decreases in crop production due to the absence of a PPP - crucial for any estimation of agricultural and end consumers impacts - could only be estimated with significant uncertainties; extrapolation from case studies based on few Member States to the whole EU was not considered appropriate due to e.g. differences in climate conditions; some agronomic impacts cannot be quantified for example resistance to target organisms). Regarding health data, no active substance identified in the options can be linked directly to hormone related diseases and disorders because of the acknowledged limitations of the reviewed health studies. Also, studies trying to quantify the health cost associated to EDs' exposure rely upon controversial assumptions and models adapted from other sectors. Further, due to the already high protection of health in the PPP and BP legislations (no use of substances that pose a serious health or environmental concern would be authorised), a comparison between Option A and Option B (approaches to regulatory decision making) would be difficult. Assessing environmental impacts, e.g. on biodiversity/ecosystems, is also difficult, in particular because evidence to link environmental data to particular active substances is in general not possible, as confirmed by the recent study on benefits of chemical legislation (RPA, 2015). The preliminary assessment of the evidence concluded that it would not be possible to quantify impacts, as data would neither be of sufficient quality nor reflect reality due to the high level of uncertainties and assumptions made. In addition, some approaches to estimate impacts would - as a consequence of the variable data availability in the different areas – create a strong imbalance between the assessments of the areas. Thus, under consideration of the Better Regulation Guidelines and in light of the complexity of the areas and the potential impacts (including key impacts listed in Tool #16), as well as the evidence and data available, a Multi-Criteria Analysis (MCA, Better Regulation Guidelines' Tool #55) was considered as the most appropriate analytical method to compare and rank the options against the areas considered because: -it is useful when impacts cannot be fully quantified or monetised; -it allows impacts to be reconciled with policy objectives; -it can capture distributional impacts (e.g. in terms of stakeholder types); -it enables to judge the pros and cons of options along the criteria chosen for the comparison; -it allows the selected criteria to determine the results obtained by assigning weights to them. Although a MCA is complex and might be difficult to communicate, it has also many advantages over informal judgement. Advantages are in particular that performance scores and weights are explicit and developed according to established techniques; that a sensitivity analysis can be performed, highlighting how the weights assigned to MCA-criteria and changes in performance of the options influence the final result; and that the scores and weights used provides an audit trail. The performance scores applied in the MCA methodology of this impact assessment for Options 1 to 4 (i.e. the assessment of the impacts for each of the MCA-criteria) are based on the results of the screening combined with the additional evidence available in each of the dimensions analysed (e.g. human health, agriculture, trade). It is assumed that Options 1 to 4 are applied under the current PPP and BP Regulations (Option A). In order to assess the potential impacts of Options B and C (Option C was discarded but kept for methodological reasons, see Section 4.2.3), a 2nd MCA was carried out which compares qualitatively the current regulatory framework with potential different regulatory decision making. Thus, the MCA was carried out in a step-wise approach, as there were two sets of options with the aim to simplify the already very complex analysis: -Step 1: the MCA methodology applied to Options 1 to 4 (Aspect I)

-Step 2: the MCA methodology applied to Options A to C (Aspect II) The same MCA parameters (criteria, weights, performance assessment methods, etc.) were used for both steps. The MCA-methodology is detailed in Annex 6 and includes a sensitivity analysis which considers different scenarios based on the availability of evidence, different priority setting (weight) to the different dimensions (e.g. giving a higher weight / priority to human health), and/or different performance of the options. In the sub-sections below the key steps of the MCA are summarised. 5.1.3.MCA methodology: selection of the MCA-criteria The MCA-criteria need to be operational so that they assess how well each option meets the objectives expressed by the MCA-criteria. The number of MCA-criteria should be kept as low as is consistent with making a well-founded decision. The MCA-criteria were developed as the first MCA-step by the procedure summarised in this section and in more detail in Annex 6: 1)The MCA-criteria were designed so that effectiveness, efficiency and coherence of each option can be assessed, by following Tool #8 of the Better Regulation Guidelines (see below). In particular: a)Link with the objectives (effectiveness): the MCA-criteria were selected considering the objectives described in Section 3 and which are: 1) ensuring of high level of protection of human health, animal health and the environment; and 2) strengthening the functioning of the internal marked while improving agricultural production. Criteria on the social and environmental impacts are linked to the first objective, whereas criteria on the economic, effectiveness and coherence impacts are linked to the second objective. Further, the compliance with international obligations and specific objectives were also considered (see Section 3). b)Areas with significant impacts (efficiency): the MCA-criteria were selected to cover the areas were significant impacts could be expected. This was done by following Tool #16 – “Identification/screening of impacts” for identifying the key economic, social and environmental impacts. c)Consistency with other EU legislation (coherence): the MCA-criteria selected include consideration of international treaties that the EU needs to abide by (WTO and Codex Alimentarius) or the coherence between PPP and BP legislation. Impacts Dimensions and MCA-criteria effectiveness & coherence effectiveness & coherence Legal certainty and proportionality: Operability for regulatory decision making: Coherence between BP and PPP legislation: Compliance with international obligations of the EU: efficiency Economic sectorial competitiveness: EU agriculture Number of PPP affected: Crops affected: Existence of alternatives / risk of resistance of pests: sectorial competitiveness: PPP, BP and related industries Functioning of the single market: Innovation and research: SME's: international trade Import of food: Import of feed: Import of treated articles: Social human health Hormone related diseases and disorders: Transmissible diseases caused by lack of appropriate disinfectants or insecticides: Food safety: Environment environment Chemical quality of water: Wildlife vertebrate populations: Animal welfare: 2)The availability of evidence was crucial for the selection of MCA-criteria in order to be able to use the criteria to assess the performance of the options. As mentioned before, the data availability was highly variable, with some fields benefiting from more detailed data while others being characterised by the prevalence of qualitative data or the lack of data (see Table 2 ). 3)The MCA-criteria were assessed against a range of qualities: completeness, redundancy, operationality and mutual independence. 4)The MCA-criteria were checked against the Public Consultation Report to ensure that all relevant potential impacts mentioned by stakeholders are covered. 5)The MCA-criteria were discussed with the members of the Impact Assessment Steering Group (IASG) at the meeting of 1st February 2016, in order to ensure that all relevant potential impacts are covered.

5.1.4.MCA methodology: assessment of the options and sensitivity analysis In a second MCA-step, the performance of the options was assessed for each of the MCA-criteria. The performances reflect the impacts expected for each criterion. The assessment of the performance (impacts) was based on the outcome of the screening study (number and, where possible, identity of AS identified as EDs under each option). Additional evidence was also considered to the extent possible for the analysis of the impacts and for assessing the performance of the options under the current regulatory framework (Option A). A summary of the evidence used for each criterion is given in Table 2 and described in more detail in the respective Annexes. Some of the impacts (MCA-criteria for EU agriculture and international trade) could be assessed based on case studies which were based on the substance-specific outcome of the screening study (identity of the substance) and additional evidence. For other criteria, where less evidence was available, a more descriptive approach had to be followed so that the evidence compiled via the screening study played a more prominent role because of the assumptions taken during the assessment of the potential impacts. Assumptions played also a prominent role when assessing the potential impacts of Options B and C (Option C was discarded but kept for methodological reasons, see Section 4.2.3). The reason for this is that the comparison of the impacts of these options with those under the current regulatory framework (Option A) could only be done qualitatively. Exact evidence could only be collected once the regulatory process is finalised for each substance, which usually takes 2 to 3 years and is therefore not possible to be assessed in the context of this impact assessment. The impacts described in Sections 5.3 and 5.4 translate into the performance of the options and have been structured the same way as the dimensions used for the MCA: Achievement of effectiveness and coherence (Annex 8) Human Health-Hormone related diseases and disorders (Annex 9) Human Health-Transmissible diseases and food safety (Annex 10) Environment (Annex 11) Sectorial competitiveness: EU agriculture (Annex 12 and 13) Sectorial competitiveness: PPP, BP and related industries (Annex 14) International Trade (Annex 15)



MCA-Criteria additional evidence considered when assessing performance of the options in the MCA description and assumptions of the MCA-criteria effectiveness & coherence Legal certainty and proportionality: degree to which legal certainty is ensured current experience implementing the PPP and BP Regulations and their derogations. Legal certainty would in principle be achieved by all options. However, the application of case-by-case derogations is expected to lead to more uncertainty to applicants and stakeholders. The introduction of categories may decrease legal certainty as AS placed under Category II or III have no regulatory consequences under the PPP and BP Regulations. Operability for regulatory decision making: additional efforts required to public authorities and applicants resulting from implementing derogations and a revision of categories current experience implementing the PPP and BP Regulations and their derogations. The application of derogations for approving substances identified as EDs would decrease operability for regulatory decision making. Additional burden may be expected because of the application of case-by-case derogations. Coherence between BP and PPP legislation current experience implementing the PPP and BP Regulations and their derogations as some substances fall under both legislations. The application of case-by-case derogations (currently different between BP and PPP and currently clearer and easier to implement under BP), is expected to lead to less coherence between the PPP and BP Regulation. An alignment of derogations is assumed to lead to higher coherence and better implementation. Compliance with international obligations: compliance with international obligations (WTO and Codex Alimentarius) Provisions of - The Agreement on Technical Barriers to Trade (TBT Agreement) - The Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement). It is assumed that the more the implementation of criteria is based on risk rather than hazard, the more compliant is the EU with its international obligations. Human Health Hormone related diseases and disorders (potentially ED related diseases and disorders): health risks potentially related to hormonal axes (EATS) - No evidence available to establish a causal link between currently approved AS and potentially ED related diseases. - Incidence of potentially ED related diseases in the EU based on literature review and data from Eurostat, OECD, and WHO. - Current experience implementing the PPP and BP Regulations and their derogations. All options based on the WHO definition are considered to be equally protective. Option 1 is considered not fit for purpose as not able to identify an ED mode of action. i) An active substance is only approved following a risk assessment. As a consequence, it can be assumed that no harmful or unacceptable effects on human health are expected for approved substances. It can be assumed that human health is protected regardless the number of AS identified as ED. ii) exposure zero scenario: it is assumed that only a hazard based approach can protect human health. Thus, it is assumed that any exposure to an AS with ED properties is harmful and the longer the list of relevant AS with ED properties, the higher the protection of human health. Transmissible diseases: health risks caused by lack of appropriate disinfectants (e.g. in hospital settings) or insecticides (e.g. mosquito borne public health treats) - Expert advice on transmissible diseases was provided by the European Centre for Disease Prevention and Control (ECDC). - Current experience implementing the BP Regulation and its derogations. It can be assumed that the expected impact is proportional to the number of BP identified as ED as there is a need for a wide spectrum of disinfectants (there is no single universal disinfectant) and insecticides to control transmissible diseases Food safety: risk of contamination of food (e.g. by mycotoxins) - The Rapid Alert System for Food and Feed (RASFF) data - EFSA database on Collection on Contaminant Occurrence Data - No detailed data is available on the monetary impact of mycotoxins in the EU. The impact on food safety with regards to mycotoxins includes large elements of uncertainty. It can be assumed that the likelihood of having an impact on health will be higher if less PPP relevant for the control of fungi producing mycotoxins are available. environment Chemical quality of water: contamination of ground, surface, and drinking water with ED chemicals used as PPP or BP No direct evidence available to establish a link between the use of PPP and BP and chemical quality of water. This criterion assumes that the quality of the water is inversely proportional to the number of active substances present in it, irrespectively of their levels. It aims at zero exposure from active substances. It is assumed that the higher the number of AS removed from the market or restricted, the higher the likelihood of an improvement in the chemical status of water. Wildlife vertebrate populations: decrease of wildlife vertebrate populations because of ED mediated adverse effects No direct evidence available to establish a link between the use of PPP and BP and the adverse effect on vertebrate populations. All options based on the WHO definition are considered to be equally protective. Option 1 is considered not fit for purpose as not able to identify an ED mode of action. It is assumed that a decision making based on risk assessment is equally protective for wildlife populations as a decision making based on hazard. Differently, the inclusion of socio-economic considerations may consider a risk/benefit analysis and, therefore, it is assumed to protect the environment to a lesser extent. Exposure zero scenario: it is assumed that only a hazard based approach can protect environment. Thus, it is assumed that any exposure to an AS with ED properties is harmful and the longer the list of relevant AS with ED properties, the higher the protection of environment Animal welfare: number of animal tests needed Number of tests required in the application dossiers. All the options perform the same, no matter how many substances they identify as ED. It is however assumed that the inclusion of additional categories under option 3 might trigger additional animal testing, as companies or authorities would wish to verify whether the chemicals classified as Category II or III are actual EDs or not. sectorial competitiveness: EU agriculture Number of PPP affected: number of PPP authorised at national level that will be affected as a consequence of the non-approval of affected AS identified as EDs Data on authorised PPP from 8 MS collected via PPPAMS but evidence is lacking in order to quantitatively assess the impacts in terms of yield losses of the potential disappearance of one single substance. After an AS is approved under the PPP Regulation, MS can authorise products containing this AS. Consequently, if an AS is no longer approved, the PPPs containing this AS will no longer be authorised. Data to assess this, at AS level, were available from 8 MS and were used as case studies. It is assumed that the higher the number of PPP that will disappear from the market, the higher the negative impacts on EU agriculture. Crops affected: number of crops affected by the disappearance of certain AS Data on authorised PPP uses on crops from 8 MS collected via PPPAMS After an AS is approved under the PPP Regulation, MS can authorise products containing this AS which are used on specific crops against specific pests. Data to assess this, at AS level, were available from 8 MS and were used as case studies. It is assumed that the longer the list of crops affected, the higher the negative impacts on EU agriculture. Existence of alternatives / risk of resistance of pests: number of PPP alternatives existing for each crop / risk of appearance of resistance in pests resulting from a lower number of available PPP Eurostat data concerning statistics on pesticides (Regulation (EC) No 1185/2009). The data available in the context of Regulation (EC) No 1185/2009 were used to analyse the percentage of AS (in terms of sales) affected per chemical class and per major group. It is assumed that the higher the percentage of a chemical class affected, the lower the number of alternatives existing. For some crops, only one particular AS is effective/efficient and therefore its loss might lead to higher impacts for the crop production than the data shown in the assessment but the level of detail and of reliability of additional data at the disposal of the Commission did not allow for such a detailed analysis. sectorial competitiveness: PPP, BP and related industries Functioning of the single market (in particular when exceptions apply): Current experience implementing the PPP and BP Regulations and their derogations, in particular the effect on national authorisations and mutual recognitions. Derogations may be applied at MS level where it is necessary and subject to specific conditions that only applies in some MS and not in others. Thus, it can be assumed that the higher the number of AS removed from the market or approved under restricted conditions, the more specific national conditions would apply, which consequently would impact negatively on the functioning of the single market. Innovation and research: change of innovation, research, and technical development in PPP and BP industry, pesticide application industry, food industry, others General information available on the costs to develop and market PPP and BP, but evidence is lacking in order to quantitatively assess the impacts on innovation and research. Considering the current drivers for innovation and the market structure, it can be assumed that the non-approval of an AS will probably not trigger substantial innovation. SME's: Burden to SMEs - Eurostat data on the size of farms, both in terms of hectares and full-time equivalent jobs per holding, in the EU. All agricultural holdings qualify as SMEs. - No data available on SMEs operating in the BP sector. - Not data available on SMEs operating in the PPP industry sector It is assumed that the higher the impacts on farmers, the higher the impacts on SMEs, as all farmers are SMEs – see also impacts for agriculture. Any increase in costs and demand of staff is assumed to negatively affect the market position of SMEs because larger firms have greater financial capacity and are better able to e.g. spread risks. SMEs have in general smaller portfolios of active substances than larger companies and therefore they are relatively more vulnerable to the withdrawal of AS identified as ED. international trade Import of food: volume of imports of food potentially affected by lowering the MRLs at the limit of determination (LOD). - The EU Pesticide Database on MRLs (at AS and crop basis). - COMEXT trade databases from Eurostat for volumes and value of imports of crops from third countries, but evidence is lacking in order to quantitatively assess the impacts on third countries' economies of the possible trade disruption resulting from lowered MRLs The PPP Regulation provides that for AS identified as ED, the MRLs in products imported to the EU is set at the default level (no risk assessment). This implies that some MRLs already set (information available via the EU Pesticide database) will need to be lowered to the default value, i.e. to the limit of determination (LOD). This MCA criterion was evaluated based on information available. For each AS identified as ED and for a sample of the more relevant crops imported in the EU (COMEXT database), it was evaluated how many MRLs would be lowered to the LOD for a crop. It can be assumed that the higher the number of MRLs lowered, the worse the impacts on trade. Also, the higher the value of imports of impacted crops, the worse the impacts on trade. Import of feed: volume of imports of feed potentially affected by lowering the MRLs at the LOD Import of treated articles: volume of imports of goods which may be affected as a consequence of implementing the BP Regulation in relation to treated articles Eurostat COMEXT data used to analyse the country of origin, value and volume of textiles imported to the EU With the non-approval of a BP, it is assumed that manufacturers and importers have to make an effort to adapt to the new requirements. It can therefore be assumed that the more AS identified as ED used in treated articles, the higher the volume of imports may be affected. 5.2.Direct impacts on the number of PPP and BP active substances falling under Options 1 to 4 For determining whether an active substance would be identified as ED under each of the options, a screening study was performed by an external contractor. This study provides evidence regarding which substances and how many of the substances used in PPP and BP may be identified as EDs under each of Options 1 to 4. Please refer to Annex 3 for a method description, Annex 4 for the list of substances screened and Annex 5 for the detailed results of the screening study. The screening study was carried out in the context of this impact assessment to evaluate the impacts associated to options for criteria to identify endocrine disruptors under the regulations on plant protection products and biocidal products. The screening was based on available evidence (no additional testing) and needed to be carried out in a limited time. The screening methodology was developed for the purpose of the screening exercise.

The results of the screening therefore do not constitute evaluations of individual substances to be carried out under the respective chemical legislations [Regulation (EC) No 1107/2009 on plant protection products and Regulation (EU) No 528/2012 on biocidal products] and in no way prejudge future decisions on active substances to be taken pursuant to these two Regulations. It would thus be erroneous to consider that the substances identified in the screening are considered as endocrine disruptors within the meaning of the EU legislation. The screening was based on hazard classification according to Regulation (EC) No 1272/2008, scientific data available in regulatory assessment reports , and information from databases focusing on endocrine effects and including non-regulatory scientific studies (see Annex 3 for a method description). The methodology used was developed by the Joint Research Centre (JRC, European Commission) and was based on the WHO/IPCS definition of an ED and international guidance on assessment of EDs (2012 OECD technical guidance on assessment of EDs ). Considering the internationally validated testing methods available , the methodology only focused on the estrogenic, androgenic, thyroidal and steroidogenic modalities of the endocrine system (EATS modalities) and on population-relevant effects in animal vertebrate species. The screening of chemical substances used in PPP or BP resulted in the same number of active substances identified as EDs under Option 2 and Option 3 Category I, while the number of substances identified under Option 4 is a subset of these (see Table 2 and Figure 2). This trend was expected since it is related to the design of the options and the method used for the screening, however the results indicate the magnitude of the difference between the options and which substances or substance groups are likely to be affected. This information was not available before performing the screening study. All PPP active substances that are currently on the market were screened, with some exceptions (such as the exclusion of micro-organisms) which are explained in Annex 4. In total, 347 PPP active substances were screened. For PPP, Option 1 (interim criteria) identifies almost twice as many substances than Option 2 or Option 3 Category I, but only a small overlap (5 substances) exists between them. A total of 37 substances are identified under Option 1 as ED, but they are not overlapping with the substances identified under options 2, 3 Category I, or 4. Consequently they are considered to be false positives because they are identified as EDs under Option 1 without appearing to have ED properties under Options 2 to 4. This is because the approach followed for Option 1 and Options 2, 3 Category I, and 4 differ: while the interim criteria are based on categorisation of substances as suspected of being carcinogenic (C2) or suspected of being toxic for reproduction (R2), Options 2 to 4 are based on implementation of the WHO definition of EDs (adverse effects, mode of action and causal link). Table 3. Number of active substances used in PPP or BP identified as EDs under the screening study preformed for this impact assessment (substances identified as ED and classified as C1 or R1, thus falling under the "cut-off" criteria, are not included in the PPP numbers). In total, 347 PPP and 98 BP were screened. number of substances identified as EDs option 1 option 2 / option 3 Cat I option 3 Cat II option 3 Cat III option 4 Active substances used in PPP 42 26 82 45 11 Active substances used in BP 16 5 26 8 2 The results also show that Option 1 (interim criteria) did not identify all active substances that were considered ED under Options 2, 3 Category I, or 4. These 21 substances are false negatives because substances identified as ED using the WHO definition are not identified under Option 1 (however this identification is only the 1st step in regulatory decision making). This result confirms that Option 1 is not effective to identify all substances with endocrine-properties. However, it should be kept in mind that most of the adverse effects caused by these "false negatives" would be addressed via the "standard" risk assessment needed in any case under the PPP and BP Regulations, which is focused on potential adverse effects (WHAT question), being the mode of action (HOW question) known or not. It should be noted that the number of substances identified under Option 1 is based on harmonised CLP classification as suspected of being carcinogenic (C2) or suspected of being toxic for reproduction (R2) and in addition on proposals for such classification by the EFSA which are more recent than the harmonised classification. This further increased the number of substances classified as C2 or R2 and therefore as EDs under Option 1. In order to avoid "double-counting" from a regulatory perspective and with respect to potential impacts, substances identified in the screening as EDs and already falling under one of the "cut-off" criteria (R1, C1, and persistent/toxic and bio-accumulative substances), are identified separately (see Annex 5). Although this confirms that some EDs are already regulated via the consideration of the adverse effects, they have been excluded from the analysis of the impacts in the different areas (in particular agriculture and trade). A total of 98 BP active substances were screened. The BP substances selected for the screening were linked to the availability of data at EU level, which is related to the on-going review programme of existing biocidal substances on the market and resulted in different percentages of product groups screened, for instance only 17% of active substances used in disinfectants were screened compared to 52% of the pest control substances. Thus, any result of the screening of BP substances should be cautiously interpreted for the potential impact on all product types on the market. Nevertheless, the overall trend (see Table 3) that Option 1 identifies more substances (16 substances) than Options 2 and 3 Category I (5 substances) is confirmed also for BP, as well as the fact that Option 4 identifies a subset of Option 2 and Option 3 Category I. The number of false positives and false negatives show the same trend for BP as for PPP. A total of 13 substances are identified under Option 1 for BP but not under Option 2 and 3 Cat I (false positives). The interim criteria failed to identify two substances that have endocrine modes of actions (false negatives) that were identified as EDs under Option 2 and 3 Cat I.



Figure 3. Relation between the chemical substances used in PPP identified as EDs under Option 1, Option 2 and Option 3 Category I, and Option 4. The circle "ED + cut off" represents substances that are identified as ED and also classified as C1 or R1 and therefore falling under the cut-off criteria in the PPP Regulation. Table 4. False positives and false negatives identified for Option 1 by the screening.

PPP BP False positives (identified under Option 1 but not under Options 2 to 4) 37 13 False negatives (identified under Options 2 to 4 but not under Option 1) 21 2 5.3.Direct and indirect impacts in different policy areas expected after implementing the scientific criteria in the current regulatory PPP and BP Regulations (Aspect I) Once the new scientific criteria are defined, they will be applied in the context of the review or renewal of approval programmes foreseen in the PPP and BP Regulations for active substances. As a consequence, they are expected to impact the number of active substances which are on the market to be used in PPP and BP. This will then lead to impacts on several areas in particular human health, environment, sectorial competitiveness including agriculture, and trade, as summarised below. The health of the general population, consumers, and workers would be affected directly or indirectly via the occurrence of PPP and BP or their metabolites in food or in the environment, by the availability of PPP or BP (e.g. disinfectants), by the availability of certain products for which production PPP or BP may not be longer available, or by the variation in costs for products including agricultural commodities. Economic operators may also be affected. Besides the chemical industry, impacts are also expected for downstream users of PPP and BP (e.g. food operators, farmers, health facilities) because of availability of PPP and BP. Consumers and international trade may also be affected. Potential impacts of the different options on legal certainty, proportionality and operability for regulatory decision making, coherence between the PPP and the BP legislation, as well as the coherence with international treaties and/or obligations, were also considered in the assessment. The potential impacts are summarised in the subsections below, which reflect the dimensions identified to perform the Multi Criteria Analysis (MCA) (see Table 1 ). More detailed discussion on the respective impacts can be found in the respective Annexes. 5.3.1.Achievem