EUROPEAN COMMISSION Brussels, 25.6.2019 SWD(2019) 199 final COMMISSION STAFF WORKING DOCUMENT FITNESS CHECK

of the most relevant chemicals legislation (excluding REACH), as well as related aspects of legislation applied to downstream industries Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Findings of the Fitness Check of the most relevant chemicals legislation (excluding REACH) and identified challenges, gaps and weaknesses {COM(2019) 264 final}



Table of contents 1 INTRODUCTION 2 BACKGROUND TO THE INTERVENTION 2.1 Description of the initiative 2.2 An overview of the EU chemicals industry and related sectors 2.3 Baseline 3 STATE OF PLAY 3.1 Implementation of the EU chemicals legislation 3.2 Enforcement of the EU chemicals legislation 4 METHODOLOGY 4.1 Description of methodology: quantification and data collection 4.2 Limitations and robustness of findings ANSWERS TO THE EVALUATION QUESTIONS 5 EFFECTIVENESS 5.1 Evaluation question: to what extent does the EU legislative framework for the risk management of chemicals meet its objectives? 5.2 Evaluation question: what factors affect (either positively or negatively) the correct functioning of the EU legislative framework for the hazard identification and risk management of chemicals? What are the consequences or effects that were not originally planned for? 6 EFFICIENCY 6.1 Evaluation question: what are the costs and benefits associated with the implementation of the legislative framework for chemicals? What are the key drivers for those costs and benefits? To what extent are the costs proportionate to the benefits? 6.2 Evaluation question: what aspects of the functioning of the framework are the most efficient and what are the least efficient?

7 COHERENCE 7.1 Evaluation question: to what extent are the legal acts consistent in how they attempt to reach the stated objectives and can differences in the hazard identification and risk management of chemicals be justified? 7.2 Evaluation question: what, if any, are the inconsistencies, contradictions, unnecessary duplication, overlap or missing links between different pieces of legislation? Are these leading to unintended results? 8 RELEVANCE 8.1 Evaluation question: to what extent do the objectives of the legislative framework for chemicals meet the current needs? 8.2 Evaluation question: to what extent does the current legislative framework for chemicals take into account health, environmental, social and economic consequences that are relevant to citizens and stakeholders? 8.3 Evaluation question: to what extent are the current procedures transparent and robust enough to enable decisions related to hazard identification, risk assessment and risk management to be relevant and evidence-based? 9 EU VALUE ADDED 10 CONCLUSIONS A comprehensive and generally well-functioning framework Burden reduction and simplification Needs for improvement 11 LIST OF ANNEXES



1INTRODUCTION Chemicals are everywhere in our modern society. They are an integral part of most human activities and production processes and they are present in most consumer products, be it for food, electronics, toys, clothes or industrial machines. They have contributed to the improvement of human health and life expectancy, and to our societal comfort and wellbeing. They play an important role in the EU industrial competitiveness and creating jobs. On the flipside, however, are the potential and actual human health and environment risks that result from exposures to hazardous chemicals. The overall aim of 50 years of EU policy on chemicals is to promote their safe use with a view to improving their overall sustainability including human health and environment protection, competitiveness, innovation, internal market, growth and jobs. To do so the EU chemicals legislation (what we call today, 'the European Union chemicals acquis') identifies hazardous chemicals and, for those chemicals where the human health and environmental risks require action, establishes measures to manage these risks. The Commission decided to undertake this Fitness Check of chemicals legislation other than REACH ('the Fitness Check') to see what elements of the European chemicals acquis work well and what needs to be improved, both in terms of meeting the policy objectives and in terms of reducing regulatory burden. Unlike most evaluations, the Fitness Check is not an evaluation of one piece of legislation but covers more than 40 different pieces of legislation (see Annex 4 Table 1). It covers legislation that addresses chemical hazard identification, assessment classification and labelling, risk assessment, and risk management, including worker safety, transport, environmental protection, chemical-specific and product-specific legislation. This Fitness Check focuses on how the chemical risk assessment and management processes work across the EU chemicals acquis. This means that in some cases, the focus is on the entire piece of legislation as all of its requirements and, hence, associated regulatory costs relates to chemical hazard/risk assessment and risk management. Examples include the CLP Regulation, the Plant Protection Products Regulation, the Residues of Pesticides Regulation, the Biocidal Products Regulation, the Cosmetics Products Regulation, the Detergents Regulation, the Chemical Agents Directive, and the Carcinogens and Mutagens Directive. For many of the other pieces of legislation only certain requirements were relevant for the purposes of this Fitness Check, for example: the Toy Safety Directive, the water and water-related legislation, the Waste Shipments Directive, the Industrial Emissions Directive and the Seveso III Directive (see Annex 8).

To assess this, the Fitness Check has: ·Mapped out links between hazard identification and consequent risk management in downstream legislation on the basis of generic risk considerations (GRC). ·Mapped out the links between specific risk assessments (SRA) and the consequent risk management. ·Examined the overall effectiveness, efficiency, relevance, coherence and EU added value of the two risk management approaches (GRC and SRA), on their own but also compared to one another, as adopted in the chemicals legislation. Moreover, as announced in the Circular Economy Action Plan, the Commission has assessed the interface between waste, products and chemicals legislations. The Fitness Check takes into consideration the findings presented in the related 'Interface' Communication. This Fitness Check complements the REACH Evaluation. Together, they cover the core EU legislative framework for the risk management of chemicals. The interface between REACH and other legislation is covered by the REACH review. Some REACH-related aspects are also covered under this Fitness Check in particular where REACH is a central consideration in assessing the coherence of different pieces of chemicals legislation (e.g. the identification, assessment and classification of persistent, bioaccumulative and toxic and very persistent, very bioaccumulative substances (PBTs/vPvBs)). Figure 1 presents the intervention logic of the chemicals legislation covered by this Fitness Check. It summarises how the EU chemicals acquis is envisaged to lead to positive impacts on health, the environment and the functioning of the internal market as well as to enhanced competitiveness and innovation. It presents the links between the needs, the objectives, and the actions taken by different actors for each of the key steps in the hazard and risk assessment processes. It also sets out the related output of all these actions and general outcomes of the implementation and application of the EU chemicals acquis (e.g. improved knowledge on substances, hazardous substances identified, etc.).



2BACKGROUND TO THE INTERVENTION 2.1Description of the initiative 2.1.1Objectives of EU chemicals legislation The primary objectives of EU chemicals acquis are: 1.Ensuring a high level of protection of human health from the adverse effects of hazardous chemicals. 2.Ensuring a high level of protection of the environment from the adverse effects of hazardous chemicals. 3.Supporting and enhancing the efficient functioning of the internal market for chemicals and the competitiveness and innovativness of EU industry and business. Specific pieces of legislation may have more specific objectives related to chemicals (see Annex 4 Table 1), such as protecting selected vulnerable groups (e.g. children), encouraging substitution to less hazardous alternatives, reducing the number of animals used for testing chemicals, ensuring the free movement of specific products or encouraging improvements in the occupational safety and health of workers. It is also a general, if not always explicitly stated, objective of the EU chemicals legislation to improve the knowledge of chemical hazards and risks. Furthermore, some of the legislation within the scope of this Fitness Check may also include objectives that concern other policy areas, such as ensuring agricultural productivity and sustainability or promoting products that have a high level of environmental performance. The EU has also played a leading role in the development of, and is committed to, several global objectives related to chemicals. The EU and its Member States, committed to the UN objective of a sound management of chemicals throughout their life cycle in 2002, often referred to as the ‘World Summit of Sustainable Development (WSSD) 2020 goal’. In 2006, governments and stakeholders agreed on the Strategic Approach to International Chemicals Management (SAICM) (UNEP, 2006), a global policy framework to promote safe chemicals management with the explicit aim of implementing the WSSD 2020 Goal on chemicals and waste. In 2015, the EU committed to the United Nations’ 2030 Agenda for Sustainable Development including the Sustainable Development Goals (SDGs) (UN, 2015). Several of the SDGs relate directly or indirectly to chemicals and chemical policy (in particular SDGs 3.9, 6.3, 12.4). It should be noted, however, that apart from some international competitiveness assessment aspects, the Fitness Check scope did not include a detailed assessment of performance against the abovementioned international objectives and commitments. The focus was on the performance of the EU chemicals acquis in delivering against the core policy objectives within the EU context. 2.1.2The Framework of EU Chemicals Legislation

The EU legal framework for chemicals comprises not only chemicals legislation in the strict sense of the word – directly regulating chemical substances and mixtures – but also legislation regulating conditions under which chemicals are manufactured, treated or used (e.g. occupational health and safety or environmental legislation) or regulating products, in which chemicals are used (e.g. toys, medical devices and food contact materials). Furthermore, there are chemicals-related provisions in several pieces of environmental protection legislation such as the Water Framework Directive, the Waste Framework Directive and the Industrial Emission Directive. The development of EU legislation on chemicals started in 1967 with the adoption of a Directive that harmonised the Member States' rules for the classification, packaging and labelling of chemical substances across the then European Economic Community. Since then a multitude of different pieces of legislation have been adopted (see Figure 2 ; see also Annex 4 Table 2) that, to a greater or lesser degree, address the risk management of hazardous chemicals. In 2001 the European Commission adopted a White Paper setting out the strategy for a future chemicals policy, ultimately leading to the adoption of REACH in 2006, the Classification, Labelling and Packaging Regulation ('the CLP Regulation' which repealed the Dangerous Substances and Dangerous Preparations Directives in 2008), and to the establishment of the European Chemicals Agency in Helsinki (ECHA) in June 2007. The EU has also committed to a number of legally binding international agreements related to chemicals, which are implemented through EU chemicals-related legislation, for example, the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and the Basel, Minamata, Rotterdam, and Stockholm Conventions as well as the Convention for the Protection of the Marine Environment of the North-East Atlantic (OSPAR) (see Annex 8 Section 8.1.1 for further detail). The EU chemicals legislation has been a model for policy development in other parts of the world. The knowledge base resulting from the implementation of different pieces of EU legislation is, in many instances, made available to government, industry and stakeholders beyond the EU. 2.1.3Scope of the Fitness Check This Fitness Check focuses on more than 40 pieces of legislation (see Annex 4 Table 1). Those, together with REACH (which is outside the scope of this exercise) form the core of the EU framework of chemicals and chemicals-related legislation. The primary criteria for determining which pieces of legislation to include within the scope of the Fitness Check was the existence of requirements in the legislation relating to hazard/risk assessment and risk management of chemicals. This meant including horizontal legislation that supports the overall process of chemical hazard and risk assessment such as the Test Methods Regulation (440/2008/EC) and the Good Laboratory Practice Directives (2004/9/EC and 2004/10/EC). A meaningful way to categorise these pieces of legislation, given the risk management focus of this Fitness Check, is as follows (see also Annex 8 section 8.1.2): 1)Legislation covering chemical hazard identification and classification: Chemical Agents Directive (98/24/EC), Carcinogens and Mutagens at Work Directive (2004/37/EC), CLP Regulation (1272/2008/EC), Plant Protection Products Regulation (1107/2009/EC), Asbestos Directive (2009/148/EC) and Biocidal Products Regulation (528/2012/EU). 2)Legislation covering chemical risk assessment and risk management measures: a)Worker safety and transport legislation: Pregnant Workers Directive (1992/85/EEC), Young People at Work Directive (1994/33/EC), the Chemical Agents Directive (1998/24/EC) and Carcinogens and Mutagens at Work Directive (2004/37/EC). b)Environmental protection legislation: the Urban Waste Water Directive (91/271/EEC), Water Framework Directive (2000/60/EC) and Industrial emissions (integrated pollution prevention and control) Directive (2010/75/EU). c)Chemicals control legislation: Contaminants in Food and Feed Regulation (315/93/EEC), Persistent Organic Pollutants Regulation (850/2004/EC), and Directive (2002/32/EC), Residues of Pesticides Regulation (396/2005/EC), Plant Protection Products Regulation (1107/2009/EC), Biocidal Products Regulation (528/2012/EU) and Export and Import of Hazardous Chemicals Regulation (649/2012/EU). d)Products control legislation: Medical Devices Directives (93/42/EEC; 90/385/EEC; 98/79/EC), Drinking Water Directive (98/83/EC), General Product Safety Directive (2001/95/EC), Detergents Regulation (648/2004/EC), Toy Safety Directive (2009/48/EC), Cosmetic Products Regulation (1223/2009/EC), Food Contact Materials Regulations (10/2011/EC and 450/2009/EC) and Pressure Equipment Directive (2014/68/EU). 3)Supporting and horizontal legislation: Good Laboratory Practice Directives (2004/9/EC and 2004/10/EC), Test Methods Regulation (440/2008/EC), and Protection of Animals Used For Scientific Purposes Directive (2010/63/EU). This Fitness Check is not an in-depth evaluation of each individual piece of legislation within its scope. Instead, it aims to assess the functioning, performance and coherence of the overall framework with a particular focus on the hazard/risk assessment and risk management of chemicals. In addition and in parallel, the Commission is conducting targeted Better Regulation evaluations of a number of pieces of chemicals legislation within the scope of the Fitness Check, including the Plant Protection Products and the Residues of Pesticides Regulations, the Urban Waste Water Treatment Directive, the Water Framework Directive, the Food Contact Materials legislation and the Detergents Regulation (see Annex 4 Table 4). At the margins, there is some additional legislation that this Fitness Check could have covered e.g. pharmaceuticals legislation (human and veterinary products) and food additives legislation. It was, however, considered that the risk and hazard assessments performed under these pieces of legislation are used slightly differently compared with those performed under the main body of EU chemicals legislation (e.g. an assessment of the risk trade-offs between the health benefits of the medical product versus potential undesired side-effects). REACH is generally outside the scope of this exercise. It is subject to its own legal review deadlines. While the first evaluation of REACH was finished in 2013, the second evaluation had already started when this Fitness Check was launched and was completed by the time that this Fitness Check entered its finalisation phase. Nevertheless, given the importance of hazard identification and classification criteria under this Fitness Check, Annex XIII to REACH covering persistent, bioaccumulative, toxic (PBT) and very persistent and very bioaccumulative (vPvB) criteria was included in the scope of this exercise. In general, where considered relevant from a comparative perspective, links to these pieces of legislation are covered as part of the coherence analysis. 2.1.4Main steps: from hazard identification to risk management measure

Chemical risk assessment involves the analysis of the inherent hazardous properties of a substance or a mixture and the extent of exposure to that substance or mixture. The human health and environmental risks related to exposure to hazardous chemicals are addressed via the hazard and risk assessment procedures and requirements set out in the different key pieces of the EU chemicals legislation such as the CLP, the Plant Protection Products and Biocidal Products Regulations, etc. The main steps of these procedures involve: ·hazard identification (based on toxicity tests and other relevant information); ·dose (concentration) – response (effect) assessment; ·exposure assessment – exposure scenarios (based on models and measurements of the occurrence of the chemical); ·risk characterisation; and ·risk estimation. Risk management measures – which can be policy-based and/or technical in nature - are then decided in light of the identified hazards and/or risks. Risk management measures can range from (and involve a mix of) a total ban to any condition to the manufacture, use or placing on the market of chemicals (such as setting emission/concentration/migration limits, obligations to communicate hazards and risks, labelling requirements, obligations to use personal protection equipment, etc.). 2.1.5Risk management approaches There are two basic approaches to risk management often used in combination, in the EU chemicals acquis: one based on specific risk assessment (SRA) and the other one based on generic risk considerations (GRC) (see Annex 8 Section 8.2.1). The main difference between these two approaches is the point in time when the exposure assessment is considered and the specificity of the exposure assessment. For risk management based on GRC, the potential exposures and risks are considered generically, prior to the adoption of legislation. The GRC-based approach is built into the legislation in the form of an automatic trigger of pre-determined risk management measures (e.g. packaging requirement, communication requirement, restrictions, bans, etc.) based on the hazardous properties of the chemical, without the need or possibility to assess and take into account specific exposure levels for a specific situation or use. For example, under the Cosmetic Products Regulation any substance classified as carcinogenic, mutagenic or toxic for reproduction (CMR) categories 1A/B and 2, shall be banned from use in cosmetics (subject to strict derogations), given the fact that direct exposure of humans is taking place through the application of a cosmetic product on the external parts of the human body (or teeth or mucous membranes of the oral cavity). Similar approaches have been taken for active ingredients in plant protection products and biocides, for substances in toys, etc. The decision to link particular hazard properties (e.g. CMR, persistent bioaccumulative and toxic substances (PBTs), endocrine disruptors (EDs)) to automatic risk management measures without the intervening step of a specific risk assessment is done on the basis of generic risk consideration without prejudice to performing also a full risk assessment for the other properties of the substances which are not linked to the related hazard properties. In the legislation evaluated in this Fitness Check, the generic risk consideration approach is typically applied for the following use applications and the following substances: Use applications: ·when there is a need to obtain and pass on information to enable [further/specific] risk assessment or risk management (e.g. labelling obligations under the CLP, labelling requirements and use instructions under the Plant Protection Products and the Biocidal Products Regulations). ·for use in widely dispersive or open applications which result in a significant exposure of humans or the environment (e.g. plant protection products). ·for use in applications where the exposure is considered to be more difficult to control and monitor (e.g. plant protection products). ·for use in applications resulting in exposure of vulnerable groups (e.g. children). ·for use to prioritise the risk assessment of certain chemicals and under certain conditions (e.g. food contact materials) Substances: ·for substances with hazard properties that result in severe adverse effects on human health or the environment should exposures occur (e.g. CMRs, PBTs, EDs, chemicals with Single Target Organ Toxicity (STOT) properties); and ·for substances where it is difficult/impossible to identify a safe threshold and, therefore, where most specific risk assessments are likely to identify risks that lead to a need for risk management measures (e.g. PBTs, vPvBs, respiratory sensitisers).

On the other hand, in the case of the specific risk assessment approach, the exposure assessment is performed on a case-by-case basis when each substance is risk assessed under a specific legal framework. The risk management measures are triggered based on the outcomes of the specific risk assessment which considers the use of the substances and in which both the hazards and the potential specific exposure scenarios for humans and the environment to the hazardous substance or mixture in question are assessed at the same time. The specific risk assessment approach is used more widely for uses which are not necessarily or obviously going to lead to widespread and difficult to control exposures and/or where the hazard properties of a substance are of less concern. In many instances, individual pieces of chemicals legislation use a combination of both of these approaches. For example, the Cosmetic Products Regulation applies the specific risk management approach to establish lists of authorised substances as well as, where necessary, restrictions on the use of certain substances in certain situations. In addition, for substances identified and classified as a CMRs categories 1A/B and 2, the generic risk management approach is applied (such substances shall be banned and cannot, therefore, be used in cosmetic products subject to strict derogations). 2.1.6Risk assessment and risk management processes and bodies involved The human health and environmental risks from the exposure to hazardous chemicals are addressed via hazard and risk assessment procedures prescribed in the EU chemicals legislation. The main steps of the chemicals risk assessment and management process (i.e. decision making and implementation and enforcement) usually involve: The necessary hazard identification, exposure assessment and risk assessment of chemicals are undertaken through a number of separate (but closely aligned) processes involving EU expert committees/bodies associated (see Annex 8 Section 8.2.2). These committees/expert groups are mainly established in association with different pieces or groups of legislation. Examples include: ·the European Chemicals Agency (ECHA): covering the CLP, the Export and import of hazardous chemicals (PIC) Regulation, the Biocidal Products Regulations) and REACH; ·the European Food Safety Authority (EFSA): covering the Plant Protection Products and Residues of Pesticides Regulations as well as the Food Contact Materials and the Contaminants in Food and Feed legislation; ·the Scientific Committee on Consumer Safety (SCCS): covering the Cosmetic Products Regulation, the Toy Safety Directive and the General Product Safety Directive (GPSD) ·the Scientific Committed on Occupational Exposure Limits (SCOEL): previously covering occupational safety and health legislation; and ·the Scientific Committee on Health, Environment and Emerging Risks (SCHEER): covering health, environmental and emerging risks and broad, complex or multidisciplinary issues that require a comprehensive assessment of risks to consumer safety or public health and related issues not covered by other European Union risk assessment bodies. 2.2An overview of the EU chemicals industry and related sectors The chemicals industry covers five main sectors (petrochemicals, polymers, basic inorganics, specialties and consumer chemicals) broken down into 16 subsectors. Five of these subsectors (paints, varnishes and similar coatings; printing ink and mastics; soap and detergents, and cleaning and polishing preparations; perfumes and toilet preparations; plastics in primary forms; and other organic basic chemicals) account for over 65% of EU chemical companies. The chemicals industry is also characterised by geographical concentration with 85% of the EU turnover in the chemical industry concentrated in seven countries — Germany (30%), France (14%), the Netherlands (10%), Italy (10%), Spain (7%), the United Kingdom (7%), and Belgium (7%). As an "enabling industry", the chemical industry is at the heart of the EU manufacturing industry, supplying two-thirds of its production to other industry sectors. Thus, a large range of downstream sectors rely on the use of chemicals in their everyday activities, such as the automotive and aerospace sectors, the paper and pulp sector, as well as the manufacture of everyday goods such as textiles, cosmetics, toys, etc. Other important links exist with agriculture activities and services. The chemical manufacturing industry is the fifth largest in the EU, accounting for 7% of the EU’s industrial production. With annual EU chemicals sales of EUR 507 billion, the sector comprises over 28 000 companies and it directly employs around 1.2 million people as well as generating additional estimated 3.6 million indirect jobs. SMEs account for around 96% of the number of companies in the sector, approximately one third of the direct employment and one third of the sector's value-added. The EU chemical sector generated a value-added of approximately EUR 115 billion in 2014 representing about 0.8% of EU GDP. In 2016, extra-EU chemicals exports amounted to EUR 146.2 billion and extra-EU imports reached EUR 99 billion (the EU chemicals trade surplus outside the EU being valued at EUR 47.2). In 2017, there was an increase in both exports and imports compared to 2016 (+ 6.5% and + 8.3%). In terms of chemicals sales, the EU chemicals industry represented in 2016 15.1% of the global market, behind China (39.6%) ahead of the United States (14.2%). EU chemical sales increased by more than 50% in 20 years, while its world market share halved (down from 32.5% in 1996 to 15.1% in 2016) due to strong chemical demand growth in China, and other emerging countries and low growth in Europe and North America, where Europe sells most of its chemicals. The main competitive advantage of the EU chemicals manufacturing industry is the high level of technological development, skilled workforce and strong research base. The EU chemicals industry is one of the most research and development intensive manufacturing sectors within advanced economies (behind US and China only). As an input provider for other industries, the chemicals industry is also considered to be at the forefront of innovation and a solution provider for many societal and environmental challenges, with chemical technological breakthroughs spilling over its downstream sectors. The total sold production of chemicals, including pharmaceuticals in the EU in terms of value increased moderately from 2007 to 2016 with an average annual growth of 0.6%. The production of industrial chemicals in the EU-28, increased each year between 2004 and 2007, rising overall by 4.5 % to peak at 371 million tonnes in 2007. The EU chemicals industry was strongly affected by the economic and financial crisis of 2007-2009. In 2009, total sales revenue in the EU chemicals sector lost more than one fifth of its original value compared to 2008. The recovery trend started in 2010 and peaked in 2012 before declining slightly in line with the global economy. It remained relatively stable during the period 2013–2016 but, in production terms, still 40–50 million tonnes below the pre-crisis peak in 2007. In 2017, and especially if compared to the 2012-2016 period, the EU chemical industry resumed strong growth (+7.9%) which continued in first quarter of 2018.

2.3Baseline This is a first comprehensive and cross-cutting assessment of the EU chemicals legislation over its 50 years of existence and the progress made towards the achievement of its core objectives. There was no pre-existing assessment that could have been used as a baseline. The wide scope of the Fitness Check and the selective focus on the hazard and risk assessment and management elements, together with the data limitations and the continuous evolution of EU chemicals legislation led to using for the assessment purposes a number of different points of reference. For the assessment of the effectiveness the following points of reference were used: ·Achieving human health and environmental protection was measured by looking at the achieved exposure reductions since 1970s through implementation of risk management measures such as bans, restrictions, emission limits, concentration limits, etc. In this regard, a range of different timeframes were considered thus reflecting the fact that different pieces of legislation were adopted at different moments in time (see Annex 4 Table 2). The ‘present’ (at the time the studies were undertaken i.e. between 2015-2017) was also a frequently used reference point for assessing the effectiveness of certain processes and aspects of the EU framework of chemical legislation (e.g. communication of chemical hazards and risks to consumers and workers). In terms of on-going exposures and predicted future health and environmental impacts e.g. future cancer fatalities linked to past, present and future exposures, the timeframes used went as far as 2100. ·In terms of meeting the internal market objective, the most practical way to measure change was the level of harmonisation and the growth in intra-EU trade of chemicals. Although there is good data on trade, it is difficult to know what proportion of the growth in intra-EU trade is due to chemicals legislation versus other market forces. Trade was used as a performance indicator but this was not explicitly compared to what might have happened in the absence of EU chemicals legislation given the difficulty of estimating what this baseline might have been. The timeframe considered for this part of the assessment was 2006-2016. ·Eurostat data on the volumes of hazardous chemicals produced and consumed in the EU during the 2004-2016 period was used to provide a rather general point of reference for assessing the progress made in terms of substitution of the most hazardous chemicals. However, lack of clear link between competitiveness and innovativeness and the EU regulatory intervention, as well as lack of specific performance criteria or meaningful points of reference made the assessment difficult. The coherence of the EU chemicals legislation was assessed by comparing different pieces of legislation e.g. are the cut-off criteria under the Plant Protection Products Regulation coherent with the cut-off criteria set out in the Biocidal Products Regulation. For the assessment of costs and benefits, setting a baseline reflecting what would have been the legislation in place in Member State in the absence of the EU legislation since 1970s was not possible. Therefore, a baseline of no legislation in place at the EU or Member State level was used, even though such an assumption also seems hypothetical. For both cost and benefit assessments, the ‘zero counterfactual’ baseline was used except where the costs of transition from older EU legislation to current EU legislation were assessed (for the CLP Regulation). In this case, the counterfactual used for regulatory costs was the pre-existing legislation. The assessed costs represent therefore total costs and not the additional costs of implementing EU legislation i.e. costs above and beyond the costs of assumed Member State legislation that might have already been in place. Even though the ‘zero counterfactual’ baseline was used in a consistent way, cost and benefit figures used are difficult to compare because of the timelines not lining up. As explained above the benefit assessment was backwards looking, i.e. what are the specific exposure level reductions that we can observe 'today’ that can be reasonably attributable to the pieces of legislation within the scope of this Fitness Check and/or other pieces of legislation considered as chemicals related. The cost assessment was limited in time (2004-2016 period). It does not look at what were the costs to achieve the specific exposure level reductions. It looks at what were the costs that specific sub-sectors of the chemicals industry had to bear in order to comply with the legislation existing at that time.



3STATE OF PLAY This section describes the state of play of the EU chemicals legislation and the factors affecting its implementation and enforcement. The following conclusions should be seen as a collection of issues identified under the Fitness Check and related evaluations, without being complete for each of the pieces of legislation within its scope. Moreover, it should be noted that under a number of pieces of the EU chemicals legislation Member States are not required to report information on enforcement or information provided is of poor quality. This was a significant obstacle for the assessment carried out for the purposes of this Fitness Check. The situation is however expected to improve as several of the individual pieces of legislation within the scope of this Fitness Check are currently undergoing their own evaluations (see the list of ongoing evaluation in Annex 4 Table 4). The follow up to the Fitness Check of monitoring and reporting of environmental policy will also contribute to improving the current state of knowledge. 3.1Implementation of the EU chemicals legislation 3.1.1Main actors and roles of each The implementation of the EU chemicals legislation relies increasingly on European harmonised processes in which Member States alone or in cooperation with others and the Commission play important roles. The Commission has been granted delegated and implementing powers, the latter being executed via comitology. Approximately 20 different committees assist the Commission in the chemicals legislation area. Member States are responsible for the correct application of the acquis and the timely and correct transposition of Directives. Regulations do not need to be transposed i.e. they are directly applicable and legally binding across the EU. In the area of chemicals legislation, the use of Regulations over Directives has increased over the past 10-20 years. Directives are mainly used in the occupational safety and health (OSH) legislation and environmental policy (water and waste) areas. For the OSH legislation this reflects the willingness to provide on the one hand a level playing field for business operating within the internal market and on the other, to leave room for Member States to adopt more stringent protective measures when transposing EU Directives into national law. For environmental policies, this allows taking into account the diversity of environmental situations in the various regions of the EU. The implementation of the EU chemicals legislation relies also on the activities of different EU agencies (collection of data, scientific opinions, guidance, helpdesks etc.) such as ECHA or EFSA, and scientific committees providing scientific opinions. 3.1.2State of play

The EU chemicals legislation is relatively mature (2nd or 3rd generation). Some transposition issues related to chemicals legislation (hazard/risk assessment and management aspects) have occurred in the past but the great majority of these have been identified and resolved since then. Moreover, the increasing replacement of Directives by Regulations has contributed to this. Certain stakeholder groups have expressed concern about the Commission's capacity to make risk management decisions in a timely manner. Particular areas of concern include the review programme for the approval of existing active substances under the Biocides Regulation which is closely interlinked with Member States' capacity to carry out assessments, and up in the chain linked to the capacity of industry to deliver good quality dossiers, and authorisation of the use of recycled plastics in food contact materials. 3.2Enforcement of the EU chemicals legislation 3.2.1Main actors and roles of each The Member States, EU Agencies and the Commission all play a role in enforcement. The Member States have the legal powers and obligation to enforce against duty holders. Enforcement activities cover all activities aimed at promoting compliance and achieving general and specific legal objectives e.g. allowing free movement of goods, lowering risks to safety, health and the environment, etc. These activities may include enforcement activities in a broader sense such as providing information, guidance and prevention or in a narrower sense such as data collection and analysis, inspections, warnings, improvement notices, fines, prosecutions, legal actions in case of infringement etc. The Commission's enforcement role is to check the proper application of the legislation. This includes the resort to formal infringement procedures e.g. in case of non-conformity of national transposition law with EU directives or incorrect application of the EU law. The Commission also provides assistance to national authorities through guidance documents, clarifications on interpretation of legal provisions, etc. Some pieces of legislation delegated certain 'enforcement powers' to ECHA or EFSA, for example, in the case of risk assessment dossier evaluation. Guidance to assist national authorities and industry has improved the clarity and consistency of interpretation of legal requirements. National helpdesks for CLP co-operate through the ECHA Helpnet to support companies in understanding their obligations. Although much still needs to be done, networks such as the FORUM and RAPEX and other legislation specific enforcement networks have significantly contributed to improved coherence of enforcement. 3.2.2State of play The Member States have the legal powers to enforce against duty holders. At Member State level, resource (both financial and human) capacity and expertise constraints, particularly following the financial crisis, are resulting in a number of enforcement challenges: ·Capacity of national competent authorities to conduct the necessary market surveillance activities in respect to consumer goods. The General Product Safety Directive (GPSD) created a horizontal framework ensuring the safety of consumer products. To this end, it sets out a number of obligations for manufacturers, importers and distributors as well as certain obligations for Member States as regards the organisation of market surveillance. The GPSD also established a network of authorities of the Member States competent for product safety aimed at facilitating operational collaboration on market surveillance and other enforcement activities. The GPSD applies to all consumer products including the harmonised sectors like toys, cosmetics, etc., in so far as the relevant harmonisation legislation has not itself provided for specific rules with regards to specific safety aspects. While the GPSD contains an obligation for Member States to take part in the cooperation mechanism, the performance of the obligations it imposes on Member States to organise and perform market surveillance depends on the resources available. For this reason differences in the various Member States still continue to persist, leading to a different level of protection and enforcement within the EU. ·In the case of plant protection products, even though controls on retailers were reported to be generally satisfactory, the majority of Member States do not conduct controls on plant protection products stated to be for use in other Member States or in non-European Union countries. This weakness in control systems can be easily exploited to place non-compliant products on the market. ·Capacity to undertake routine inspections and other compliance and enforcement activities, including monitoring and reporting. ·For example, the need to invest additional resources on enforcement activities is recognised in order to ensure that no biocidal product is illegally placed on the market at national level and that these products are properly labelled. ·Regarding the Toy Safety Directive, Member States considered that the low consistency of national approaches to enforcement (both in terms of the number and the type of control procedures) creates a trade barrier. Limited testing capacity of some Member States was also deplored. ·Another example is non-harmonised food contact materials (FCMs) – i.e. specific food contact materials such as inks, adhesives, or paper for which at EU level no harmonised rules exist. Member States highlighted the lack of resources needed for controls (personnel for the inspections, analytical equipment, facilities, etc.). They also reported that local inspection is not adequate for checking compliance with a supply chain spread throughout the world. ·Regarding online chemicals sales, several enforcement surveys show that various non-authorised chemicals and related products are increasingly being offered for sale via the Internet. As chemicals legislation does not distinguish between different types of trade, all provisions regulating chemicals apply in principle also to Internet trade. Currently, however, access to websites and relevant information on transactions, vendors or service providers for monitoring authorities is difficult and therefore hampers their investigations. Verification of compliance with and enforcement of chemicals legislation is in many cases complex and resource-intensive. Some of the differences in the level of enforcement are due to differences in the resources allocated and made available by Member States. Other factors, leading to non-uniform application of the EU law include the national control set ups (planning and frequency of controls, number of inspectors, training and other professional qualifications, etc.), differences in the interpretation of the EU law, differences in or lack of standards, lack of harmonised requirements and guidelines, etc. The following specific examples illustrate these observations: ·Differences in administrative organisation of Member States create differences regarding the frequency of controls and inspections. These differences are notable regarding in particular the occupational safety and health (OSH) legislation and the CLP Regulation. ·Different interpretation by Member States of the legislation and lack of guidance documents and/or harmonised analytical methods for testing impact the implementation of the EU chemicals legislation. This was indicated in particular for the CLP, the FCMs, the Plant Protection Products Regulations, and the Toy Safety Directive. Even though the principle of mutual recognition is one of the means of ensuring the free movement of goods within the EU, whether it is effective in doing so, depends on if and how Member States apply it. In cases where there is an absence of mutual recognition, this leads to duplication of efforts between Member States and exacerbates the existing resource limitations. Because mutual recognition is currently underutilised for plant protection products authorisation, risk assessments are sometimes partially or fully repeated by other Member States thus creating additional costs. The main reasons for this are related to lack of information on how the first Member State reached its conclusion, leading to a lack of confidence. The other major reason is the age of the data, noting that some time may have passed between the first and subsequent assessments.

Where technical standards or detailed harmonised requirements are lacking or are incomplete, or where technical standards do exist but there is no EU-wide shared methodology for assessing them, this can undermine the quality and completeness of the exposure assessments that are needed for conducting the required risk assessments. This issue was highlighted by several Member States regarding the 'safety' (i.e. risk) assessments of toys and their constituent substances, as well as assessing health risks associated with their use. In general, the performance of risk assessment is easier to quality control where there is a requirement to not only document it but also communicate its outcome to the public authorities.



4METHODOLOGY 4.1Description of methodology: quantification and data collection A roadmap was published in 2015 presenting the scope and the key evaluation questions to be addressed by the Fitness Check, as well as a consultation strategy to ensure stakeholders' engagement in the process (see below and the Annex 2). The Fitness Check was accompanied by an interservice steering group covering all Commission services in charge of the legislation under scrutiny plus horizontal services. Priorities for assessment were established on the basis of the main areas of improvement identified by the key studies supporting the Fitness Check, considering the concerns raised by stakeholders. 4.1.1Studies Two key studies and two related studies, carried out by external consultants for the Commission, provide an important part of the evidence base for the Fitness Check. A.Complementarity of the Fitness Check core studies The 1st Fitness Check study (1st FC Study) was completed in January 2017. It focuses on the CLP Regulation and related legislation governing hazard identification, communication and risk management of chemicals. This includes an assessment of costs and benefits associated with the CLP Regulation. The on going costs of the CLP are estimated as ‘present day’ costs generated at the time of the study (2015-2016) using a ‘zero counterfactual’ as the point of reference i.e. against a situation where there is no legislation in place at Member State or the EU level. The transition costs from the previsious Dangerous Substances Directive (DSD) and Dangerous Preparations Directive (DPD) to the CLP Regulation cover the time period from 2009 (when the CLP first came into force) to the 2015 deadline for meeting the CLP requirements applicable to mixtures. The (partial) assessment of human health and environmental benefits of classification, labelling and packaging of chemicals was examined across a timeframe of 2000-2016. This allowed a comparison between the partial estimation of benefits accrued under the pre-CLP legislative situation (the DSD and the DPD) against partial estimation of benefits accrued following implementation of the CLP Regulation. The benefits assessment was also done using a zero counterfactual baseline. The 1st FC Study was complemented by a second study (FC+ study) completed in November 2017. Its focus was pieces of legislation that operate independently of the CLP for chemical hazard identification and classification and pieces of legislation where specific risk assessment procedures form the core part of the risk management process (this was not covered by the 1st FC Study). For the great majority of assessment aspects, including the analysis of cost drivers, the time reference of the FC+ Study was the ‘present day’ situation i.e. situation at the time the study was undertaken (2017). The cost driver analysis was done using a zero counterfactual (i.e. no chemicals legislation in place at Member State and the EU level) as the point of reference. Because in many cases, the EU chemicals legislation is based on the use of both generic and specific risk assessment and more or less direct link to the CLP Regulation (see Annex 4 Table 1), a number of pieces of legislation were covered by both core studies. Examples include the Toy Safety Directive, the Cosmetic Products Regulation, the Plant Protection and the Biocidal Products Regulations, the Industrial Emissions Directive, the Water Framework Directive, the Detergents Regulation, the Food Contact Materials Regulation ( Table 1 ). The REACH Annex XIII and the CLP Regulation were however exclusively covered by the 1st FC study. In line with the Fitness Check methodology, the studies respond to the evaluation criteria and evaluation questions from the roadmap, while also providing a more detailed analysis of relevant themes through study tasks and case studies. B.Additional Fitness Check supporting studies The findings of the two core Fitness Check studies were complemented by a cumulative cost assessment of the chemical industry (CCA1) and a study on the cumulative health and environmental benefits of chemicals legislation (CuBA Study). The CCA1 study provides an estimate of total regulatory costs (i.e. it uses a zero counterfactual as a point of reference which assumes no chemicals legislation at Member State level in the absence of EU chemicals legislation) of the most relevant EU legislation with a bearing on the chemical industry (excluding downstream sectors) during the period 2004-2014. The CuBA study draws together a large body of evidence on the health and environmental improvements achieved since 1970s as a result of hazardous chemical exposure reductions linked to EU chemicals legislation. The CuBA study also assesses the health and environmental impacts and costs associated with on-going exposures to chemical risks. Again, the benefits are estimated using a zero counterfactual as the point of reference. C.Methodology, time and legal scope, and topics covered The main methodologies applied in the context of the abovementioned studies can be described as follows: ·Development of an intervention logic underpinning the rationale for chemicals legislation and the CLP Regulation more specifically, including legal mapping to identify relevant legislation and specific provisions within this. This was then supported by a legal analysis to identify the nature of the obligations for different economic operators, how the legislation was implemented in practice, and areas where there appeared to be inconsistencies, overlaps and incoherence. ·A literature review to pull key information from impact assessments, position papers, academic and scientific research, papers and reports prepared by the relevant scientific bodies, regulatory submissions and other 'grey' literature.

·Development of evaluation questions (see Annex 10) and stakeholder consultation activities (see Annex 2). ·Case study research, which involved a more in-depth examination of some of the most pertinent issues identified as part of initial research (e.g. metals classification and the CLP Regulation, parallel hazard assessments, persistent, bioaccumulative and toxic (PBTs) / very persistent and very Bioaccumulative (vPvBs) substances, carcinogenic, mutagenic or toxic for reproduction substances (CMRs), linkages between the CLP and the occupational safety and health (OSH) legislation and several others), either directly linked to the interface between the CLP and other legislation, the functioning of specific legislation, or examining tools or measures needed to support the legislation. ·Comparative analysis of approaches based on specific risk assessments and generic risk considerations. More generally, the studies have applied the tools set out in the Better Regulation Toolbox in assessing costs and benefits. Figure 3 illustrates the time period covered by each of the Fitness Check studies. Table 1 illustrates the legal scope covered by studies. COVERED BY: LEGISLATION 1st FC FC+ CCA1 CuBA Industrial Emissions Directive Water Framework Directive Biocidal Products Regulation Plant Protection Products Regulation Toy Safety Directive Cosmetic Products Regulation Detergents Regulation Food contact materials Regulations 1st FC CCA1 CuBA CLP Regulation REACH Annex XIII Inland transport of dangerous goods Directive Carcinogens and mutagens at work Directive Chemicals Agents Directive Young People at Work Pregnant Workers Directive Seveso III Directive Waste Framework Directive End of Life Vehicles Directive Fertilisers Regulation 1st FC FC+ CuBA Waste shipments Regulation EU Ecolabel Regulation Pressure equipment Directive General Product Safety Directive FC+ CCA1 CuBA RoHS 2 Directive Batteries Directive Packaging and Packaging Waste Directive Export and import of hazardous chemicals (PIC) Regulation POPs Regulation Explosives Directive 1st FC CCA1 Signs at work Directive FC+ CuBA Asbestos Directive Urban Waste Water Directive Marine Strategy Framework Directive Contaminants in food and feed Regulation and Directive Drinking Water Directive Medical Devices Directives Protection of animals used for scientific purposes Directive 1st FC Aerosol dispensers Directive Test methods Regulation Good Laboratory Practice Directives FC+ Residues of pesticides Regulation Annex 4 Table 1 and Table 3 provides more detailed information about how the Fitness Check supporting studies cover the topics discussed in the remainder of this document. The studies provide evidence for the full scope to a large extent. However, either because of methodological challenges and lack of data or peculiarities of this Fitness Check i.e. focusing on the framework-wide issues rather than on legislation specific issues, some aspects were not assessed in-depth. In order to fill such gaps, other available sources of information were used, including other REFIT supporting studies or interim reports, EU Agencies’ and the Commission’s reports, as well as the other recent chemicals related initiatives and actions (see Annex 4 Table 3). Annex 4 Table 4 provides a list of finished or still ongoing individual evaluations and how these different sources of information were used for the purposes of this Fitness Check (mainly concerning occupational safety legislation, plant protection products legislation, detergents and waste legislation). It should be noted however that where there is no specific reference to these individual evaluations, it is either because they were already used and refered to in the Fitness Check Studies or because the evaluation has just started and therefore evidence is not yet available. 4.1.2Data collection and stakeholder consultation Given the wide scope of the whole exercise and, in some cases, the lack of data (costs, benefits, enforcement, performance monitoring, etc.) on individual pieces of legislation, this Fitness Check put a particular emphasis on stakeholder and expert input. Therefore, some of the issues identified may require further assessment as part of a dedicated evaluation of a specific piece of legislation, as mentioned above. The stakeholder consultation strategy developed for the purpose of this Fitness Check comprised an public consultation (from 4 March to 27 May 2016), an SME panel through the Enterprise Europe Network (from 30 May to 18 July 2016), targeted interviews, stakeholder workshops conducted as part of the two main Fitness Check studies as well as the CCA1 and CuBA studies, and two Eurobarometer surveys (see Annex 2 for more details). In line with the consultation strategy, input from a wide range of stakeholders was collected: ·public authorities, notably competent authorities responsible for the implementation and enforcement activities; ·industry associations covering both the chemicals industry and downstream sectors (manufacturers and importers of chemicals, distributors of substances and mixtures, formulators); ·companies in both the chemicals industry and downstream sectors, focusing in particular on Small and Medium-sized Enterprises (SMEs) (manufacturers and importers of chemicals, distributors of substances and mixtures, formulators);

·civil society organisations – NGOs (e.g. environmental, health, animal welfare); ·consumer associations; ·trade unions ·other interested groups such as academics / research institutes; and ·consumers / workers /citizens. The online public consultation was conducted in English, German and French. The SME panel and the two Eurobarometer surveys were conducted in all EU languages. These different consultation activities and tools allowed receiving feedback from all stakeholder groups. A summary of these views is provided in Annex 2. Information on the Fitness Check is published on the websites of DG GROW and DG ENV. 4.1.3Use of findings from studies and stakeholder views for the purposes of this Fitness Check The two core Fitness Check studies and the two additional Fitness Check studies provide the main evidence for the assessment presented in the remainder of this document. The evidence that these studies provide was used in a combined and complementary way. Each study corresponds to a different evidence gathering phase which was followed by an assessment phase. The 1st FC Study corresponds to the first evidence-gathering phase (March 2015-October 2016; see Figure 4 ) which started with the publication of the Roadmap. It was preceded by the launch of the CCA1 Study. The assessment done during this phase was based on desk research and was followed and complemented by an extensive stakeholder consultation process. This first phase of the assessment provided useful and meaningful input and allowed to identify additional needs in order to cover the full scope of this Fitness Check. The second evidence gathering phase started with the launch of the FC+ Study (see Figure 5 ). Similarly to the 1st FC Study, it also included targeted interviews with stakeholders as well as a stakeholder workshop. During the assessment phase (starting in December 2017), all the evidence and stakeholder input gathered went through a thorough selection process. The purpose was to select those elements that affect (positively or negatively) the functioning of the framework and to identify those aspects that were only affecting the functioning of a specific piece of legislation. Therefore, not all of the findings gathered found their way in the final report. This assessment phase was also necessary in order to reality check the findings and to ensure that the Fitness Check supporting studies were used and combined to their utmost potential. Annex 4 (Table 1 and Table 3) provides more detailed information about how the Fitness Check supporting studies cover the topics discussed in the remainder of this document. 4.2Limitations and robustness of findings Given the wide scope of the exercise and the impacts of chemicals legislation, there were numerous challenges in gathering the data needed to provide a robust evidence base, as well as in providing quantitative estimates of impacts. As far as possible, data was triangulated with evidence collected from multiple sources e.g. literature review, qualitative assessment based on expert input (e.g. Member State Competent Authorities), stakeholder consultation etc. to provide as robust a picture of the evidence as possible. Nevertheless, whilst some legislation and risk assessment processes are well covered by multiple different stakeholder groups and literature/data sources, other pieces of legislation are less well covered.

Where specific obstacles and challenges were encountered, limitations are mentioned and explained in the relevant sections. The evidence and study limitations presented particular challenges with respect to the Fitness Check findings in the following areas: ·Determining and comparing framework-wide costs and benefits and, therefore, assessing the proportionality of the EU chemicals legislation at the framework level. ·Enforcement and implementation of the EU chemicals legislation. ·Determining the actual significance, in practical terms, of some of the coherence issues identified. It was beyond the scope and resources of the Fitness Check to seek primary evidence in order to test the real life significance of coherence issues flagged by one or more stakeholder groups. Care was taken to accurately report different opinions and findings while also ensuring that the evidence and sources can be traced back and that therefore the reliability and robustness are ensured. 4.2.1The First Fitness Check Study (‘1st FC Study’) The key limitations of the 1st FC Study can be described as follows: ·The broad scope of the study and the number of pieces of legislation to be considered. ·The lack of available information on the scale of issues identified (both positive and negative) and the subsequent need to rely on information provided by stakeholders. ·The limited response received from civil society stakeholders. However, further desk-based research of published information from NGOs was undertaken to inform the study. ·The lack of available data to assist in determining the effectiveness and efficiency of the legislative framework (particularly in quantitative terms). ·The inability or unwillingness of companies to provide certain data creating difficulties in quantifying the impacts of the CLP Regulation and other legislation. ·The lack of up-to-date information regarding the effect of the CLP Regulation on consumer behaviour. 4.2.2The Second Fitness Check Study (‘FC+ Study’) The key limitations of the FC+ Study can be described as follows: ·Stakeholders were identified based on their active engagement with specific pieces of legislation. However, involvement in the study was on a voluntary basis. Therefore, those who felt strongly about particular processes or pieces of legislation were more likely to take part. To offset this possible limitation stakeholders included regulators, industry and NGOs, as well as officers of the European Commission and EU agencies responsible for chemicals legislation. ·In a limited number of cases particular stakeholder groups (e.g. industry, regulators, NGOs) dominated the responses for certain aspects of legislation. The study report states where this is the case. ·The stakeholders engaged, while broadly diverse, could still be argued to be a relatively small sub-set compared to the size and scale of the EU chemicals industry. To offset this limitation the work completed under the FC+ Study included a review of the findings of the 1st FC Study to enable a more complete analysis, and evidence was sought wherever possible to back up opinions. Findings from the 1st FC Study (including its public consultation and SME panel) were used to help corroborate findings in the FC+ Study where appropriate. ·The available economic data on costs and efficiency reported in a quantitative fashion was very limited. Literature data, and two stakeholder engagements were used to gather quantitative and qualitative information on the functioning and efficiency aspects of the risk assessment and risk management processes used under the EU legislation. However, it was not possible to provide extensive costed examples related to efficiency. ·The available information on specific pieces of legislation varied, with some legislation and risk assessment processes well covered by multiple different stakeholder groups and literature/data sources. Other pieces of legislation were not as well covered and the analysis relied more on policy guidance documents and review of the legislation to ascertain how the processes function and what potential issues may exist (see Annex 3 Table 6 for a summary of data availability per piece of legislation).

·The FC+ Study also undertook a semi-quantitative assessment of the key cost drivers for six pieces of legislation. 4.2.3The Study on the Cumualative Health and Environmental Benefits of Chemicals Legislation (‘CuBA Study’) With respect to the CuBA Study, key limitations can be described as follows: ·The study focused on “cumulative” health and environmental benefits delivered through the cumulative effect (accumulation) of various different pieces of legislation, each addressing a risk or group of risks. It did not, however, seek to attribute specific impacts to every individual piece of legislation. The study presents a combination of qualitative, quantitative and monetary estimates of these benefits. Neither the socio-economic benefits of chemicals legislation (in terms of accelerated innovation) nor of chemicals themselves (facilitating efficiencies or technologies for example) were part of the study scope. ·It is important to note that this is the first time a study on this scale and scope has been attempted. The work is based on drawing together existing information, though a number of calculations/interpretations were done to derive some of the quantitative figures in the report. In some cases the estimates provided are associated with significant uncertainties. These are discussed at length, but are provided as a starting point for additional research and discussion. Where benefits relate to productivity and/or healthcare treatment (“direct financial”) costs, these are compared to GDP in national accounts to provide context on their significance; others reflect “personal valuation” (willingness to pay to avoid certain medical ailments or for ecosystem services, for example). These costs are no less real than those that are linked to GDP: society places a high value on having a long, healthy and fulfilled life. Where appropriate, they are expressed in monetary terms. 4.2.4The Cumulative Costs Assessment Study (‘CCA1 Study’) The cost estimates provided by the CCA1 Study have to be treated with caution due to differences in scope and in the methodology applied. Firstly, the period covered by the CCA1 Study i.e. 2004-2014, only partially corresponds to the one covered by this Fitness Check. Secondly, the estimated costs relate only to certain subsectors of the EU chemicals industry and not to all the downstream sectors that are also considered by this Fitness Check. Furthermore, regulatory costs were estimated and included in the overall CCA1 estimates for several pieces of legislation that are not in the scope of this Fitness Check while, at the same time, several other pieces of legislation although within the scope of this Fitness Check, were not covered. Finally, the sample size and coverage did not allow for statistically accurate analysis and conclusions. Therefore, additional cost elements were gathered where possible and qualitative assessment is presented instead.



ANSWERS TO THE EVALUATION QUESTIONS The following sections answer the evaluation questions concerning the five central evaluation criteria of effectiveness, efficiency, relevance, coherence and EU added value. A more detailed analysis of effectiveness, efficiency and coherence related issues can be found in annex (Annex 5, Annex 6 and Annex 7 respectively) as well as in the underlying Fitness Check studies. Many of the factors that affect the effectiveness of EU chemicals legislation are also closely linked to its efficiency, coherence, relevance and implementation. Issues identified in the effectiveness section are, therefore, sometimes referred to in other sections where they are evaluated in more detail. 5EFFECTIVENESS 5.1Evaluation question: to what extent does the EU legislative framework for the risk management of chemicals meet its objectives? This section analyses the progress made towards achieving the three core objectives that are shared by nearly all pieces of EU chemicals legislation: 1.Ensuring a high level of protection of human health from the adverse effects of hazardous chemicals. 2.Ensuring a high level of protection of the environment from the adverse effects of hazardous chemicals. 3.Supporting the efficient functioning of the internal market for chemicals and enhancing the competitiveness and innovation of EU industry and business. As the first two objectives are rather different in their nature from the third objective and, therefore, have a different set of performance indicators, they are assessed separately. 5.1.1The objectives of high level of protection of human health and environment A.What's the issue?

EU chemicals legislation aims to achieve a high level of protection of human health and the environment by minimising exposures to hazardous chemicals and by stimulating substitution of hazardous substances by less hazardous chemicals (or alternative non-chemical solutions). The effectiveness of the EU chemicals acquis in achieving these objectives can be assessed by analysing the trends in: ·the production and use of hazardous substances; ·the human and environmental exposures to hazardous chemicals; and, ultimately ·the impacts in the form of the main health and environmental impact parameters associated with exposures to hazardous chemicals, such as trends in the EU incidence rates of certain human diseases, trends in animal population levels, trends in eco-system health/resilience. B.What are the findings? Conclusions For the specific hazardous substances that have been targeted over the last 3-4 decades, the EU chemicals acquis has been quite effective in reducing and minimising human and environmental exposures. This includes some notable reductions in exposures to problematic substances such as lead, mercury, benzene, asbestos, polychlorinated biphenyls (PCBs), and a range of other chemicals with carcinogenic, mutagenic or toxic for reproduction (CMR) and persistent, bioaccumulative and toxic (PBT) / very persistent and very bioaccumulative (vPvB) hazard characteristics. However, a range of on-going and emerging health and environmental concerns related to the exposure to hazardous chemicals remain and require further attention. The analysis finds little evidence of a general shift towards production and/or consumption of less hazardous substances although there are some preliminary positive indications of substitution with respect to substances hazardous to the environment. This may, in part, reflect the effectiveness of risk management measures in reducing exposures and risks, therefore reducing the incentive to substitute to less hazardous substances. Essentially, the share of industrial chemicals hazardous to health and the environment in the total chemicals production has remained relatively unchanged over the last decade. Trends in endpoint human health and environmental impacts (cancers, reproductive diseases, respiratory sensitization, insect and bird populations, etc.) point to a mixed picture but are difficult to use as direct indicators of chemicals policy performance because of the attribution challenge. Most of these trends are linked to multiple causal factors of which exposure to hazardous chemicals might be just one. Moreover, data is generated, including through the regulatory framework, based on substance-by-substance approach. It is therefore difficult to use it to give a picture of the overall level of protection of human health and the environment. The current approach and indicators used in monitoring and assessing human health and environmental impacts could benefit from being more holistic. On a positive note, the reduction in the incidence rates of workplace-related cancers and in lead-related health impacts are good examples of improvements that can be linked to the EU interventions. There are, however, a few trends such as breast cancer, certain reproductive diseases, and decline of insect and bird populations that are a cause for concern. Further research and a strengthened science-policy interface are needed. 1)Production and consumption of hazardous substances Trends in the production and consumption of hazardous substances, either expressed in absolute terms or relative to overall chemicals production and consumption, are one potential indicator of the substitution of hazardous substances by less hazardous substances. While not shared by all the pieces of legislation within the scope, it remains one of the goals of some of them e.g. the Plant Protection Products Regulation and the Biocidal Products Regulation. Eurostat has been producing since 2014 relevant data sets regarding substitution trends for industrial chemicals (please see also Annex 5 Section 5.1.1 A)). The findings of the latest analysis for EU-28 published in December 2017 are: ·The trend in the production of chemicals hazardous to health and the environment followed the trend for the overall chemicals production ( Figure 6 ), reaching a peak in 2007, after which there was a significant decline in production during the financial and economic crisis in 2008, followed by a strong rebound between 2009 and 2010 and a subsequent more stable phase. ·The share of chemicals hazardous to health and the environment was relatively unchanged over the period 2004–2016. The share of chemicals hazardous to the environment fluctuated between 37% and 39%, while the share of chemicals hazardous to health fell from about 66% in 2004 to 62% in 2016. The analysis shows substitution of hazardous substances by less hazardous substances has not yet occurred to any notable extent. Essentially, the share of industrial chemicals hazardous to health and the environment in the total chemicals production has remained relatively unchanged over last decade. This may, in part, reflect the effectiveness of risk management measures in reducing exposures and risks, therefore reducing the incentive to substitute to less hazardous substances. The analysis also shows what might be the beginning of a positive substitution trend. The largest overall decrease in EU-28 production between 2004 and 2016 was recorded for chemicals with severe chronic environmental hazard and for chemicals with significant acute environmental hazard (as the production volume was reduced by about 18 % for both classes over the period under consideration). This may indicate that the substitution for these groups to less hazardous chemicals has started to happen (while it does not seem to be the case yet for chemicals hazardous to health). One could also note that no legislation-specific information is available which could allow the assessment of the pace of substitution once such a need is identified and eventually compare across the legislation. These statistics do not allow to link changes in the share of chemicals hazardous to health and the environment to the EU intervention. In order to do so, more in-depth analysis would be required. Respondents to the public consultation were asked to assign a score of between 1 (no contribution) to 5 (large contribution) to the role of the EU legislative framework in reducing the use of hazardous chemicals and/or substitution with safer alternatives. Scores assigned showed considerable variation among the four groups of respondents. Industry and public authority groups considered the EU chemicals framework to have made the largest contribution to a reduction in number or use of hazardous chemicals and/or an increase in substitution to safer alternatives. In contrast, NGOs and other civil society organisations were considerably less positive. 2)Human and environmental exposures to hazardous chemicals

There is clear evidence that, where targeted EU policy and regulatory action has been taken, human and environmental exposures to a number of well-known individual hazardous chemicals have been successfully reduced or in many cases, minimised. As one example, consumer exposure to lead e.g. in petrol, paints, toys, drinking water, etc., has been reduced by an estimated 89% in the EU between 1990 and 2011, following a variety of risk management measures implemented by Member States, at least in part due to EU legislation. This has resulted in a sustained and significant reduction, on average, in measured levels of lead in blood (see Figure 7 ). From the environmental perspective, similar outcomes have been achieved in the EU between 1990 and 2011 for a number of heavy metals such as mercury (66% emissions reduction), cadmium (64% emission reduction) and arsenic (78% emissions reduction) (see Figure 8 ). Reductions in the concentration of a number of other hazardous chemicals in the environment such as tributyltin, PCBs, dioxins, dichlorodiphenyltrichloroethane (DDT), have also been achieved following EU policy. There are, however, a number of on-going exposure situations that give cause for concern and which point to some shortcomings in meeting the objectives of protecting human health. These reflect both new, emerging issues, as well as existing ones that require further attention in terms of exposure reduction and control. Based on the current evidence, some of the more notable on-going exposure issues in the EU are exposures (see also Annex 5 Section 5.1.1. B)) to: ·carcinogenic substances at the workplace for which occupational exposure limits (OELs) have not yet been set; ·neurotoxic substances; ·chemicals linked to cardiovascular and respiratory (CVR) disease; and ·endocrine disrupting chemicals. On-going environmental exposure situations also give cause for concern, the most notable being: ·Hazardous chemical exposures affecting the quality of surface and ground waters, including marine waters, with implications for their ecosystems (and indirectly for human health via seafood and drinking water consumption), despite considerable progress made in reducing the discharge of pollutants such as nutrients, pesticides, industrial chemicals, and household chemicals into Europe's waters over recent decades. Concern has grown regarding, for example, the widespread occurrence of persistent harmful substances such as polybrominated diphenyl ethers, which pose a risk even at very low concentrations. New (stricter) environmental quality standards have been set for these substances and for some others such as fluoranthene, and these are due to be met by 2021. The results from some Member States, e.g. Sweden, Luxembourg and the Netherlands, indicates the new standard will be difficult to achieve. Concern is also growing that the toxicity of mixtures of chemicals is not sufficiently addressed by the legislation, which focuses largely on individual substances (or small groups). ·Hazardous chemical exposures affecting terrestrial eco-system health/resilience such as neonicotinoid pesticides representing a risk to wild bees and honeybees. Respondents to the public consultation from industry and companies as well as those representing public authorities were overall the most positive about the extent to which the EU legislative framework sufficiently addresses emerging areas of concern while civil society representatives and citizens assigned the lowest scores. 3)Human health and environmental impact evidence and indicators The trends in the main health and environmental impact parameters that are known, or strongly suspected, to be associated with exposures to hazardous chemicals (e.g. trends in the incidence rates of certain cancers, reproductive diseases, sperm count and quality and trends in animal populations and eco-system health/resilience) are important to consider when examining the effectiveness of EU chemicals policy. However, using human health and environmental adverse effects as direct and reliable indicators of chemicals policy performance needs to be treated with caution because of the attribution challenge: many of the observed health and environmental adverse effects may derive from multiple causes (life-style, genetics, habitat destruction/degradation, etc.) and it is difficult to determine to what extent exposure to hazardous chemicals contributes to the observed adverse effects. Complicating things further is the fact that observable adverse effects in human health and the environment often do not materialise immediately after exposure. For example, the latency between exposure to carcinogens and the development of cancer can often be as much as 20 years or more. The available evidence regarding the trends in the main health and environmental impact parameters points to a mixed picture. Some clear improvements have been achieved, for example, in the reduction of cancers related to workplace exposure to a number of targeted carcinogens which has resulted in the estimated prevention of 1 million new cancer cases in the EU over the last 20 years partly through the implementation of the occupational safety and health (OSH) legislation. However, a number of other trends suggest there is still cause for concern, for example: ·The health burdens resulting from most cancers continue to rise in the EU (except for lung cancer) (see Figure 9 for trends for breast cancer). For many cancers, the contributing role of chemical exposures is not yet well understood and defined while at the same time suspected to play a role. As a result, it is often unclear which specific chemical exposures should be targeted by legislation, in an attempt to eliminate preventable disease causes.

·The same is true for neurodevelopment and reproductive health. While both male and female fertility rates are decreasing in Europe and while some neurodevelopmental disorders (e.g. autism) increase, there is no data on how many of these cases are attributable to exposure to hazardous chemicals. However, it is likely that hazardous chemicals play a role in these adverse health outcomes. Substance categories of concern include certain phthalates, dioxins, perfluorinated chemicals, analgesics, etc. These issues are more generally linked to the need to obtain better information about the spectrum of chemicals with relevance to human exposures and diseases. Achieving this include improvments regarding data requirements, toxicological testing and screening methods human biomonitoring as well as better predictive and prioritisation approaches. In the area of the environment, the observed trends also point to a mixed picture: ·Improvements in water quality in some areas may have contributed to some recovery of aquatic ecosystems and the restriction on the use of tributyltin (TBT) as an antifoulant in marine paints has resulted in the recovery of mollusc populations in many ports and coastal areas in Europe. ·Major declines (as high as 50-75%) in the populations of a number of animal species in the EU have been observed over the past 3-4 decades including pollinators, other flying insects (see Figure 10 ), amphibians, and birds. Europe’s wild bee population is in decline with nearly one in ten species facing the threat of extinction and more than a quarter of bumblebee species being currently at risk of dying out. The populations of over 20% of bird species in the EU are in significant decline , with the largest declines (46% between 1990 and 2014) for common farmland birds. The causes of these declines requires further research but are likely to be multiple including exposure to hazardous chemicals, changes in agricultural practices, habitat degradation, climate change, etc. The current approach and indicators used in monitoring and assessing human health and environmental impacts could benefit from being more holistic. For instance, such more holistic impact assessments could feed into exposure indicators (e.g. passive sampling, representative mixtures, human biomonitoring) as well as impact indicators (e.g. (eco)epidemiology, effect based methods as proposed in the Water Framework Directive). 5.1.2The objective of ensuring the efficient functioning of the internal market and of enhancing competitiveness and innovation A.What's the issue? The EU chemicals legislation aims to ensure the efficient functioning of the internal market and to enhance competitiveness and innovation. The effectiveness of the EU chemicals legislation in achieving these objectives can therefore be measured by analysing: ·trends in the development of intra-EU sales of chemicals compared to domestic sales; ·trends in the EU export of chemicals and global market share; ·the role that the legislation plays in boosting the competitiveness of the EU chemicals industry and innovation. B.What are the findings? Conclusions EU chemicals legislation has been instrumental in ensuring the free circulation of chemicals and products within the internal market through the harmonisation of requirements, standards, risk management measures, labelling, and mutual recognition approach that reduce barriers for intra-EU trade. To a large degree, there is a level playing field in Europe, and chemicals legislation has strengthened the internal market and enhanced the competitiveness of EU industry, this being reflected in the growth in intra EU trade. The EU remains the largest chemicals exporting region in the world and, despite the decline of the share (although absolute sales levels have increased) in the global market the EU chemicals industry remains internationally competitive. However, some interpretation, implementation and enforcement issues at Member States level leave room for further improvements. While the EU chemicals industry is often seen as a frontrunner in terms of innovation, there is no evidence that the EU chemicals legislation, as such, is either a major trigger of, or barrier to, innovation for companies in general. EU chemicals legislation has been instrumental in ensuring free circulation of substances, mixtures and articles within the internal market through harmonisation of standards and requirements that reduced barriers for intra-EU trade. There has been a continuous increase of the share of the intra-EU trade of chemicals i.e. EU companies selling in the EU single market rather than in their home country market, in the total sold production of chemicals (from 43% in 2006 to 55% in 2016). For example, the CLP Regulation provides the basis for consistently identifying properties of concern, with this information then used in hazard communication to workers, downstream users and consumers of chemicals. Similar trends have been observed in the fields of cosmetics, detergents, fertilisers, etc., where EU product specific legislation has been adopted. The fact that many Directives have become Regulations contributed to harmonisation across the EU and therefore a better functioning internal market. Nevertheless, there are still areas where divergences in interpretation, implementation and enforcement continue to persist potentially leading to fragmentation of the European market and creating burden and barriers for businesses (see Annex 5 Section 5.1.2).

In terms of international competitiveness, the EU chemical industry in 2016 represented 15.1% of the global market, behind China (39.6%) but ahead of the United States (14.2%). Although the European share of global sales has decreased (32.5% in 1996) the EU chemicals industry remains internationally competitive as evidenced by the trade surplus of EUR 47.2 billion (exports EUR 146.2 billion, imports EUR 99 billion). The decrease in the share of global sales is mainly due to relative growth in other parts of the world, such as China and India, served by their own domestic production. Other potential reasons given for this are high energy prices, currency appreciation, high labour costs, regulatory and tax burdens. Yet the EU remains the largest chemicals exporting region in the world. The main competitive advantage of the EU chemical industry is the high level of technological development, skilled workforce and strong research base. As an input provider for other industries, the chemicals industry is also considered to be at the forefront of innovation and a solution provider for many societal and environmental challenges, with chemical technological breakthroughs spilling over into downstream sectors. As mentioned above, the beginnings of a possible positive trend can be observed concerning substitution to less hazardous or non-hazardous substances for substances hazardous to the environment. In many cases, hazard classification under the CLP alone for example is an incentive for substitution as it triggers a number of legal obligations, including labelling and communication to downstream users as well as consumers. Indeed, increasing consumer awareness of the health risks associated with certain hazard classifications (most notably carcinogens) is a powerful trigger for substitution in the supply chain. In other cases, risk management measures (such as bans and restrictions) triggered by a certain hazard classification provide such incentives. Innovation and substitution are encouraged by many pieces of legislation acting in concert and supported by drivers, such as consumer demands, market circumstances and initiatives such as e.g. the Substitution Support Portal (SUBSPORT) under the European Union’s Life programme. Overall impacts of chemicals legislation on innovation are, however, more complex, as described in the REACH Evaluation. As no specific indicators exist for assessing these and also given that many other factors play a role e.g. intention to develop new applications in order to conquer new markets, it is currently not possible to know whether the EU chemicals legislation has been a major trigger of innovation. The EU chemicals legislation was considered by citizens, industry and companies and public authorities as mostly effective in ensuring a well-functioning internal market while civil society considered it to be moderately effective. Regarding this particular aspect, SME Panel results showed that the EU chemicals legislation is considered to be sufficiently harmonised across Member States for the proper functioning of the European single market. While citizens, industry and companies and civil society considered the legislation moderately effective in stimulating competitiveness and innovation, public authorities were of an opinion that it is mostly effective in reaching this objective. 5.2Evaluation question: what factors affect (either positively or negatively) the correct functioning of the EU legislative framework for the hazard identification and risk management of chemicals? What are the consequences or effects that were not originally planned for? An effective framework of chemicals legislation ensures the timely and sound identification of chemical hazards and risks, the appropriate control of human and environmental exposures to hazardous chemicals and, for hazardous chemicals where the exposures cannot be reliably controlled, a progressive shift towards the use of less hazardous chemicals (substitution) including non-chemical solutions. The basic steps of the risk management procedures and processes applied to chemicals within the EU framework of chemicals legislation (see Section 2.1 and Annex 8 for further detail) are: ·hazard identification (based on toxicity tests and other relevant information); ·dose (concentration) – response (effect) assessment; ·exposure assessment – exposure scenarios for relevant uses of the chemical (based on models and measurements of the occurrence of the chemical); ·risk characterisation; and ·risk estimation. The correct functioning of each of these risk management steps can be affected by one or more key performance factors, including: ·Whether the necessary scientific knowledge (including recognised and accepted test methodologies for hazard identification) and data/information (e.g. on chemical uses and exposure scenarios) are available, are used appropriately and can be shared between different risk assessment regimes to ensure the coherence of findings and to avoid duplication of effort. ·Whether and how the hazard identification and risk assessment process is triggered. ·Whether the overall 'speed' of the hazard identification and classification and risk assessment processes can handle the quantity of existing and newly designed hazardous chemicals placed on the market. This is not simply a question of efficiency but, fundamentally, of effectiveness. If the framework fails to identify and address the hazards and risks of chemicals in a timely manner, its effectiveness is reduced. This also requires further discussion on how to better prioritise and in which areas and/or for which substances such prioritisation would be necessary. ·Whether the necessary competences and resources are available at EU and Member State level to ensure robust and timely hazard identification/assessment/classification, risk assessment and risk management decision-making. ·Whether the use of generic risk considerations (GRC) and specific risk assessment (SRA) based approaches is appropriate and balanced. ·Whether the desired transition to non-animal test methods is happening and is effective. These different factors can affect the performance of one or more of the risk management steps outlined above. For example, poor quality or missing data affects the ability to correctly identify and classify hazards, to determine reliable exposure scenarios, and, therefore, to arrive at a robust risk assessment. The assessment of the effectiveness of the framework of EU chemicals legislation has, therefore, been structured and presented according to these factors. 5.2.1Data, knowledge and information

A.What's the issue? Scientific understanding and the availability of good-quality, reliable data underpins the effective functioning of EU chemicals legislation. It includes, among other things, knowledge and information on chemical properties, data on eco-toxicity of chemicals and on chemical uses and exposures to chemicals (including occurrence in, and release from, articles (consumer products)). Please refer to Annex 5 Section 5.2.1 for a more detailed description of data, knowledge and information related aspects. B.What are the findings? Conclusions Enormous efforts have been made at the EU and Member State level to ensure that the necessary data to take effective chemical risk management decisions is available, comparable and of good quality. Likewise, the scientific understanding of how hazardous chemicals impact human health and the environment has improved significantly over the last two decades. Much of this effort has been resourced and underpinned by industry assuming the responsibility of ensuring the safe use of chemicals placed on the market. This has been helped by significant investment in EU-level capacity for supporting the risk assessment processes under the various chemicals legislation regimes (ECHA, EFSA, and a number of scientific committees). While the existing test guidelines cover the majority of known adverse effects on human health and the environment, they can be further improved. Standardised and internationally recognized test guidelines still need to be developed and/or validated. This is the case for certain environmental adverse effects such as the terrestrial compartments and some specific terrestrial species. This is also the case for neurotoxicity, immunotoxicity and some endocrine disruptors related aspects. The EU has put considerable efforts and resources in promoting the avoidance or reduced use of animal testing. However, there are still barriers to the use and acceptance of alternative (non-animal) test methods for regulatory purposes, partially linked to lack of test guidelines for certain effects or to gaps in the current knowledge. The current state of knowledge regarding exposure scenarios i.e. knowledge of which chemicals and their combinations, and at what concentrations, humans and the environment are being exposed to, needs further attention. The scientific understanding of mechanisms and pathways of how hazardous chemicals interact with organisms has improved considerably over the last two decades with, for example, the support of the Commission's research framework programmes. Much has also been done to improve the quality, reliability and reproducibility of hazard and risk assessment studies and data. Quality standards are prescribed for how hazard and risk analysis is to be conducted, including the testing methodologies. Toxicity studies submitted by chemicals producers or importers need to be performed according to validated test methods and guidelines. In addition, the laboratories that perform chemical hazard and risk assessment studies must comply with the GLP requirements. During the workshops, there was general agreement amongst participants that the GLP requirements help to ensure that the rigorous documentation about how a study was conducted is made available. This is, good to have as it allows comparability and reproducibility but they are not sufficient to ensure high scientific quality. Validated test methods and guidelines help to ensure comparability and reproducibility of data produced and thus increase the reliability and quality of data. International agreement on test guidelines (under OECD) ensures the mutual acceptance of the data among countries and regions, which lowers the technical barriers to trade and reduces also the number of animals used for testing. The existing test guidelines cover the majority of known adverse effects on human health and the environment. However, standardised test methods and guidelines are lacking for certain environmental adverse effects (soil biota, reptiles, and other terrestrial animal species). There is also a need to further improve the existing test methods and guidelines regarding neurotoxicity, immunotoxicity, epigenetics, endocrine disruption as well as how to capture peculiarities of nanomaterials. The policy on the protection of animals used for scientific purposes has streamlined resources and efforts towards the development of alternative methods to replace, reduce, and refine animal testing. To date, this focus has been successful for five human health endpoints, for which tests have been validated and recognised internationally. However, there are still barriers to the use and acceptance of alternative test methods, and no methods are available yet to fully evaluate complex systemic endpoints. The identified gaps in existing test guidelines for endpoints relevant for human health and the environment call for development of new test methods and adequate funding is required for both approaches, non-animal and animal. In addition, there is a need to accelerate the regulatory acceptance of alternative test methods (see also Annex 5