EUROPEAN COMMISSION Brussels, 5.3.2018 SWD(2018) 58 final COMMISSION STAFF WORKING DOCUMENT Accompanying the document COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE

Commission General Report on the operation of REACH and review of certain elements

Conclusions and Actions {COM(2018) 116 final}



Table of Contents GLOSSARY 1. Introduction 1.1. Purpose of the REACH evaluation 1.2. Scope of the REACH evaluation 1.3. Co-ordinated strategy for ensuring chemicals legislation is fit for purpose 2. Background 2.1. Description of the initiative 2.1.1. Objectives 2.1.2. Intervention Logic of the REACH Regulation 2.1.3. REACH elements 2.2. An overview of the chemical industry and related sectors 2.3. Baseline: pre-REACH (extended Impact Assessment) and the 2013 REACH review 3. Evaluation Questions 3.1.1. Effectiveness 3.1.2. Efficiency 3.1.3. Coherence 3.1.4. Relevance 3.1.5. EU added value

4. Methodology 4.1. Evidence collected since 2013 4.1.1. Approach to quantification 4.1.2. Data collection 4.1.3. Limitations and robustness of findings 5. Implementation state of play 5.1. Registration 5.2. Data sharing, test methods and avoidance of unnecessary testing 5.3. Communication of information in the supply chain 5.4. Information on substances in articles 5.5. Substance and dossier evaluation 5.6. Authorisation 5.7. Restriction 5.8. Member State activities other than enforcement 5.9. Enforcement 5.10. Fees and charges 6. Answers to the evaluation questions 6.1. Effectiveness 6.1.1. To what extent does REACH meet its objectives? 6.1.2. What are other effects of REACH?

6.1.3. Which factors influenced effectiveness? 6.1.4. To what extent is REACH contributing to meeting the World Summit Sustainability Development (WSSD) 2020 goals? 6.2. Efficiency 6.2.1. How do costs and benefits of REACH compare? 6.2.2. How are cost distributed between different stakeholders? 6.2.3. What are the costs for public authorities? 6.2.4. What works well, what can be improved? 6.3. Coherence 6.3.1. IS REACH INTERNALLY COHERENT? 6.3.2. IS REACH EXTERNALLY COHERENT? 6.3.3. IS REACH INTERNATIONALLY COHERENT? 6.4. Relevance 6.4.1. Is REACH Technically Relevant? 6.4.2. Is REACH Relevant to EU Citizens? 6.4.3. Are stakeholders properly involved in REACH? 6.5. EU added value 6.5.1. What is the EU Added Value of REACH? 7. Conclusions Annexes Annex 1 – Procedural information concerning the process to prepare the evaluation

Annex 2 – Stakeholder consultation Annex 3 – Methods and analytical models used in preparing the evaluation Annex 4 – Implementation state of play Annex 5 – Horizontal issues Annex 6 – Review of ECHA



GLOSSARY ADCO Administrative Cooperation Groups for European cooperation on market surveillance ANSES French Agency for Food, Environmental and Occupational health and Safety ASO Accredited Stakeholder Organisations ATP Adaptation to Technical Progress BPR Biocidal Products Regulation C&L Classification and Labelling CA Competent Authority CAD Chemical Agents Directive CARACAL Competent Authorities for REACH and CLP CBA Cost-benefit analysis CCA Cumulative cost assessment study CCH Conformity check

CLH Harmonised Classification and Labelling CLP Classification, Labelling and Packaging CMD Carcinogen and Mutagen Directive CMR Carcinogenic, Mutagenic or Toxic for Reproduction CoRAP Community Rolling Action Plan COSME Competitiveness of Small and Medium-sized Enterprises CSR Chemical Safety Report DecaBDE Decabromodiphenyl Ether DMF Dimethylfumarate DNEL Derived No Effect Level ECHA European Chemicals Agency ECJ European Court of Justice ECVAM European Centre for the validation of alternative methods EEA European Environment Agency EEB European Environmental Bureau EEN Enterprise Europe Network EFSA European Food Safety Authority EMA European Medicines Agency ENES Exchange Network on Exposure Scenarios EOGRTS Extended One-Generation Reproductive Toxicity Study

ES Exposure Scenario ESR Existing Substances Regulation EURL-ECVAM European Union Reference Laboratory for Alternatives to Animal Testing FCM Food Contact Materials FORUM Forum for Exchange of Information on Enforcement GHS Globally Harmonized System of Classification, Labelling and Packaging of Chemicals GDP Gross domestic product GPSD General Product Safety Directive HBCDD Hexabromocyclododecane HPVCs High Production Volume Chemicals IATA Integrated Approach to Testing and Assessment ICCM International Conference on Chemicals Management IOELVs Indicative Occupational Exposure Limit Values IOMC Internet-based Toolbox for Decision Making in Chemicals Management IPCS International Programme on Chemical Safety ISO International Organisation for Standardisation IUCLID International Uniform Chemical Information Database JRC Joint Research Centre MS Member State(s) MSC Member State Committee

NGO Non-Governmental Organisation OECD Organisation for Economic Cooperation and Development OEL Occupational Exposure Limit OJEU Official Journal of the European Union OPC Open Public Consultation OSH Occupational Safety and Health PACT Public Activities Coordination Tool PBDEs Polybrominated diphenyl ethers PBDs Polybrominated diphenyls PBT Persistent, Bioaccumulative and Toxic PBTs Persistent, Bioaccumulative and Toxic substances PCB Polychlorinated biphenyl PfAs Proposals for Amendments PFAS Per and Perfluoro Alkyl substances PFOA Perfluorooctanoic acid PFOS Perfluorooctanesulfonic acid PIC Prior Informed Consent Regulation PNEC Predicted No Effect Concentration POPs Persistent Organic Pollutants PPORD Product and Process Oriented Research and Development

PPPR Plant Protection Products Regulation QSAR Qualitative Structure Activity Relationship R&D Research & Development RAAF Read Across Assessment Framework RAC Risk Assessment Committee REACH Registration, Evaluation, Authorisation & Restriction of Chemicals REFIT Regulatory Fitness and Performance Programme RMM Risk management measure RMOA Regulatory Management Options Analysis RoHS Restriction of Hazardous Substances in Electrical and Electronic Equipment ROI Registry of intentions SAICM United Nations Strategic Approach to Chemicals Management SCCPs Short chain chlorinated paraffins SCOEL Scientific Committee for Occupational Exposure Levels SDS Safety Data Sheet SEAC Socio-Economic Analysis Committee SIEF Substance Information Exchange Forum SMEs Small and Medium Sized Enterprises SVHC Substance of Very High Concern t/y Tonnes per year

TSD Toy Safety Directive UN GHS United Nations Globally Harmonized System of Classification, Labelling and Packaging of Chemicals UN United Nations US EPA Environmental Protection Agency of the United States US United States UVCB Substance of Unknown or Variable composition, Complex reaction products or Biological materials vPvBs Very Persistent and Very Bioaccumulative substances WEEE Waste Electrical and Electronic Equipment WHO World Health Organisation WoE Weight of Evidence WTO World Trade Organisation

1.Introduction The Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) came into force in 2007 and aims at improving the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances while promoting alternative methods for the assessment of hazards of substances. This is done by the four processes of REACH, namely the registration, evaluation, authorisation and restriction of chemicals. REACH also aims to enhance innovation and competitiveness of the EU chemicals industry. 1.1.Purpose of the REACH evaluation

The 2017 evaluation of the operation of REACH is part of the regular assessment and reporting by the European Commission on progress in achieving the objectives of the Regulation. This evaluation accompanies the second Commission report on the functioning of REACH pursuant to Article 117(4) and Article 138 of REACH. Regular monitoring and reporting provides information that allows for adjustment to improve the implementation of the Regulation. Being part of the Commission's Regulatory Fitness and Performance Programme (REFIT) , the 2017 REACH evaluation examines to what extent REACH is fit for purpose and looks at what works well and what does not, as well as why this is the case. In line with the Better Regulation Guidelines, the evaluation covers the five compulsory criteria: effectiveness, efficiency, relevance, coherence and EU added value, including the potential for burden reduction and simplification and improving the delivery of the objectives. 1.2.Scope of the REACH evaluation The 2013 REACH review provided a first in-depth assessment of the overall operation of REACH, presenting a broad assessment of what the first five years of REACH had brought about. The 2017 REACH evaluation builds on those findings and examines key developments since then, in particular those that have emerged or developed substantially (e.g. the authorisation process); thus, mainly on the period 2010 - 2016, and assesses REACH's contribution to meeting the World Summit Sustainability Development 2020 goals and the Sustainable Development goals. The 2017 REACH evaluation focuses on assessing the areas where there has been a sufficient level of implementation to allow for a meaningful evaluation at this stage. Some recent developments that are still in early stages of implementation (e.g. implementing regulation on data sharing) or that are being developed (amendment of technical annexes as regards nanomaterials) will be addressed to the extent possible. The evaluation builds on information obtained from Member States, ECHA, a series of thematic studies and other relevant sources, covering the following aspects: I.Main issues resulting from the information obtained from regular reports from Member State Competent Authorities and ECHA submitted in accordance with Article 117 of the Regulation, which cover the implementation of all REACH processes and enforcement. These reports allow monitoring of the practical implementation of REACH and how it contributes to the protection of health and the environment in all Member States. Member State reports provide an overview of the functioning of REACH in the territories of the 28 Member States and the EEA countries. ECHA's reports provide an overview of the operation of REACH, including information on joint submission of information by multiple registrants (Article 11) and the state of use of non-animal testing. Furthermore, Article 138 of the REACH Regulation specifies some elements that are relevant for the general REACH report, namely registration requirements for 1 – 10 tonnes substances, including the CSA and CSR obligation for substances that are carcinogenic, mutagenic or toxic to reproduction - CMRs category 1A or 1B. II.The status of implementation of the work launched as a follow-up to the 2013 REACH review and the actions that the Commission, ECHA, the Member States, and, where relevant, stakeholders have already implemented or are implementing in that context. This includes also other significant legislative and policy developments since 2013, notably: -Implementation of Roadmap on Substances of Very High Concern (SVHC) for 2020 -Streamlining of the restriction procedure -Ongoing implementation work until 2017 on registration (including data sharing) and authorisation requirements with a view to improve effectiveness and lessen the administrative burden stemming from the Regulation. III.Further detailed topics to be covered include: -Assessment of the benefits of chemical legislation on human health and the environment as well as socio-economic benefits -Assessment of the achievements made regarding the use of alternative test methods and non-test methods in REACH and in general -Perception of chemical safety by citizens

-Support measures to assist SMEs (e.g. information concerning the use of EU funding programmes, guidance through the Europe Enterprise Network (EEN)) -Progress in the registration process, results of 2013 registrations and preparations for the 2018 deadline -Review of the obligations on registration requirements for low tonnage (1-10 t/y) substances in relation to the REACH objectives -Review of the obligations on the need, if any, to register certain types of polymers in relation to the REACH objectives -Consideration of substance identity issues -Assessment of the optimisation of substance evaluation -Activities to improve the implementation of the requirements related to extended Safety Data Sheets (eSDS) -Assessment of the costs and benefits of authorisation -Interface with other legislation (including in particular the coherence between REACH and the occupational safety and health – OSH – legislation, coherence with legislation on waste as well as other relevant developments since 2013) - Monitoring of enforcement of REACH via a new indicator system (and a public consultation on enforcement) -Assessment of the impact of REACH on innovation, competitiveness and SMEs -Assessment of the impact of REACH on the international competitiveness of the EU chemicals industry and selected Downstream User sectors -Evaluation of ECHA and its Committees -Information on substances in articles -Review of Regulation (EC) No 340/2008 on the fees and charges payable to the European Chemicals Agency -Ability of REACH to tackle nanomaterials, cumulative effects of chemicals, endocrine disruptors and other emerging issues 1.3.Co-ordinated strategy for ensuring chemicals legislation is fit for purpose The EU legislative framework for the risk management of chemicals comprises a number of interacting and linked legal acts. These range from horizontal chemicals legislation (e.g. the Classification, Labelling and Packaging (CLP) Regulation) to product-specific and sectorial legislation, related to particular uses of chemicals in downstream industries. This is why a fitness check is also being undertaken of the wider legislative framework for the risk management of chemicals in the EU in parallel to the REACH evaluation, scheduled to finish in 2018. The REACH evaluation focuses on the effects of REACH, whereas the fitness check focuses on the interactions between the different pieces of legislation. In contrast to the REACH evaluation, the fitness check does not carry out an evaluation of the individual pieces of legislation but rather focuses on specific elements within the legislation and the interlinkages between the pieces of legislation. In particular it:

·Assesses the consistency, effectiveness and efficiency of the chemicals legislation in applying generic risk and specific risk based risk management decisions; ·Assesses the accessibility of all relevant information available within the group of chemicals legislation when making a decision on a substance; On the basis of a comprehensive impact assessment, the Commission is presently modifying the technical Annexes of REACH on substance identification, information requirements and chemicals safety assessment, to more effectively address nanomaterials when they are subject to registrations. Additionally, the results of this evaluation and the Fitness Check will form the basis of a general stock-taking of the EU's existing legislative framework for chemicals risk management. It will also feed into the Commission's future chemicals strategy for achieving the objective of a non-toxic environment. The obligation to report on the results of the official controls, and other enforcement measures taken under the CLP Regulation will be addressed under the fitness check exercise. 2.Background Increasing concerns that the pre-REACH EU chemicals acquis did not provide sufficient protection led to a debate at the informal Council of Environment Ministers in April 1998, in which it was recognised that a review of the existing policy on chemicals was necessary. The reason for the pre-REACH policy debate was the slow progress of risk assessment under the Existing Substances Regulation (ESR – Regulation (EEC) No 793/93) and the implementation of risk management by e.g. Restrictions Directive (Directive No 76/769/EEC). The policy driver throughout was therefore the need to speed up the risk assessment and risk management of existing chemicals (i.e. those already on the market in 1981), but as the discussions progressed, other drivers and conditions were identified. In line with dissatisfaction with the progress of ESR in 1999, the Joint Research Centre (JRC) published a technical study showing that basic data necessary to carry out a screening level initial risk assessment was only publicly available for a minority of chemicals (less than 20%) and that this situation had not changed compared to what the US National Academy of Sciences had estimated to be the case in the 1980s. This added another, albeit related, policy driver, namely the need to obtain the necessary data for existing substances to enable the risk assessment and risk management of existing chemicals to take place. The assessment of the functioning of the ESR showed that placing the responsibility on authorities to collect and assess the information on priority substances was ineffective. In fact, authorities needed to request industry to provide information to conduct risk assessments and decide on the need for risk management measures. This triggered the conclusion that, in line with the 'polluter pays principle', it should be the responsibility of industry to ensure the safe use of their chemicals and therefore carry out the risk assessment and ensure the risk management of their chemicals, including testing, and the responsibility of authorities to check if this responsibility is properly implemented and, where not, to quickly and efficiently propose measures to manage potential risks appropriately. Thus, the 'reversal of burden of proof' drove much of the design of REACH. Though environment and health concerns related to the marketing and use of existing chemicals were the initial driver of the policy debate, that debate was also shaped by the general EU policy objectives of ensuring a level playing field in the EU (preserving the internal market), ensuring the competitiveness of EU industry and fostering innovation, being non-discriminatory internationally (respecting WTO) and promoting non animal test methods (supporting animal welfare). Furthermore, the legislation contributes to the aim of the EU to achieve the goals agreed at the 2002 World Summit on Sustainable Development. 2.1.Description of the initiative 2.1.1.Objectives The objectives of REACH are to ensure a high level of protection of human health and the environment, including the promotion of alternative methods to animal testing for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing the competitiveness and innovation. In addition, REACH should contribute to the fulfilment of the World Summit on Sustainable Development 2020 goals. Protection of human health and the environment. REACH replaced the previously existing Regulations, Directives, Communications and Recommendations governing so-called new and existing chemicals by one unified systematic registration system, ensuring that the same obligations apply to all chemicals. In line with the polluter pays principle, REACH shifted the burden of proof by making industry responsible for safety, extending responsibility along the supply chain. The registration system introduced requirements to make sufficient information available about the properties of all chemicals including for the previously so-called existing chemicals in order to conduct risk assessments and introduce risk reduction measures where so required for hazardous substances. Health and environment benefits should result from the application of appropriate risk reduction measures. Harmonisation of the internal market. REACH aims at harmonising the general chemicals legislation at Union level for all cases where no more specific product legislation exists that also concerns chemicals. This was implemented by choosing a Regulation based on Article 95 of the EC Treaty (now Article 114 TFEU), which ensures uniform application in all Member States, by establishing a central Agency, the European Chemicals Agency (ECHA) to implement most of the scientific and technical work and by establishing detailed rules for the manufacture, placing on the market and use of substances throughout the EU. Enhancing competitiveness and innovation.

The Regulation was designed to shape the innovative behaviour of firms in the chemical industry as it ended the disadvantages of the previous system for new chemicals by raising the registration threshold to 1 tonne per year per company (compared to 10 kg before for new substances) and by requiring the same amount of data for new and existing chemicals. REACH should therefore promote the competitiveness of the chemical industry and encourage innovation, by facilitating the development of safer chemicals, in particular chemicals aimed at replacing substances of very high concern (SVHCs). Promotion of non-animal testing. Registrants are obliged to systematically collect all available information. Only where this information is insufficient to fulfil the information requirements should a test be considered. Furthermore most testing involving animals needs prior approval by ECHA and legal possibilities to use alternative methods to fill information gaps (e.g. through read across, in vitro testing) were introduced to promote non-animal testing. Separately the Commission has committed itself to stimulating and funding the development of new non-animal test methods. 2.1.2.Intervention Logic of the REACH Regulation The intervention logic summarises how the intervention is envisaged to work. A visual representation is given of the logical links between the needs for the REACH Regulation, the objectives to be pursued, the actions taken by Member States, duty holders, the Commission and ECHA under each REACH process, the related output of these actions (e.g. substances registered or restricted) and general outcomes of the implementation and application of REACH (e.g. improved knowledge on substances, hazardous substances identified) leading to positive impacts on health, the environment and the functioning of the internal market as well as to enhanced competitiveness and innovation. Figure 1: intervention logic of the REACH Regulation 2.1.3.REACH elements The REACH Regulation came into force in 2007 and aims at improving the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. This is done by the four processes of REACH, namely the registration, evaluation, authorisation and restriction of chemicals. REACH also aims to enhance innovation and competitiveness of the EU chemicals industry. The REACH Regulation places responsibility on industry to manage the risks from chemicals and to provide safety information on the substances it manufactures, uses or places on the market. Manufacturers and importers have to gather information on the properties of their chemical substances, which will allow their safe handling, and to register the information in a central database in ECHA in Helsinki, Finland, to be able to manufacture, import or place on the market ("No data no market"). ECHA is the central point in the REACH system: it manages the databases necessary to operate the system, verifies that the data submitted complies with the requirements, and co-ordinates the in-depth evaluation of chemicals suspected to be of concern and is building up a public database in which consumers and professionals can find hazard information. The following section describes each of the main processes in REACH in greater detail and the timing of how they work together is illustrated in Figure 2 below. Figure 2: Timelines for implementation of the main REACH processes. It should be noted that some of the processes were new or had new elements and started immediately (such as registration), whereas others started only later (e.g. evaluation and authorisation); others were a continuation from the pre-REACH system improved by a stronger integration of risk management with the risk identification process (e.g. restriction). Outputs and outcomes were expected to materialise with some delay, starting 10 years after the begin of the REACH implementation, and persisting for another 20 years, in particular actual benefits in terms of improved health and environment protection. Registration, data sharing and avoidance of unnecessary testing Industry has to provide information on all chemicals it places on the market in volumes at or higher than 1 tonne per company per year (t/y); special attention is given to long-term and chronic effects at the higher tonnages. The registration information requirements depend on the proven or suspected hazardous properties, on uses, exposure and volumes of chemicals that are produced or imported.

REACH puts the obligation on economic operators placing on the market hazardous substances and in particular for volumes above 10 t/y to apply a consistent and comprehensive approach to risk management in the chemical safety assessment (CSA) and to document the results in the chemical safety report (CSR) and the safety data sheet (SDS), containing also recommendations regarding the safe use of those chemicals which downstream users then must follow. To ensure proportionality, the system provides for a tiered approach (information requirements depend on volume of substance manufactured or imported) and staggered registration deadlines, where high volume and the most dangerous chemicals had to be registered by the first registration deadline in 2010, followed by medium volume substances in 2013 and lower volume substances will follow in 2018. Furthermore, under certain conditions, producers and importers of articles have to notify to ECHA the Substances of Very High Concern (SVHCs) listed on the candidate list which are present in their articles. To avoid unnecessary testing and reduce costs, data must be shared by companies registering the same substance. This is done in Substance Information Exchange Fora (SIEF) for substances already on the market when REACH entered into force (the so-called phase-in substances) or through the inquiry process for new substances (non phase-in substances). The data sharing obligations aim to ensure that studies, in particular those involving vertebrate animals, which are already available, are shared, as well as their costs. If the information is not available, potential registrants have to agree who will undertake the necessary testing and ensure that the test is carried out only once. Information in the supply chain and downstream users Improving the communication within the supply chain is a central theme of REACH. In the previous legislation, communication was required from the manufacturer or importer down the supply chain to downstream users in the form of Safety Data Sheets (SDS). As under the past legislation there were significant difficulties in obtaining information on the use of substances in the EU, a new requirement was introduced in REACH: Downstream users (DUs) and distributors have to communicate up the supply chain enabling registrants to better understand the uses of their substances for registration and thereby also increasing the knowledge of authorities about all uses of substances. This two-way communication aims at ensuring more transparency and safer use of chemicals in the EU, leading to more innovation and benefits for health and environment. Some elements for this new communication approach are well-known, some have been newly introduced: -SDSs were a well-accepted and effective tool before REACH. One of the major adaptations was the creation of the so-called “extended SDS” which is a SDS containing the relevant exposure scenarios from the CSR. -A new obligation to provide information, interalia enabling appropriate risk management measures also for substances that do not require transmission of a SDS. -The new duty for all suppliers of articles to communicate information on SVHCs present in articles above a concentration threshold of 0.1 % weight by weight to any recipient, including consumers who so request. For the first time in chemical legislation, REACH made DUs a distinct category of duty holders and gave them an important role within its framework. In this respect, it is important to note that in REACH the concept of use is very wide, covering a very broad area of industrial and professional operations and processes extending far beyond the chemical industry. DUs have obligations and rights stemming from many REACH titles: registration (if not covered by their supplier), information in the supply chain, evaluation, authorisation, restrictions. Dossier and Substance Evaluation REACH provides that the ECHA, and the Member States can evaluate the information submitted by companies, examine the quality of the registration dossiers and the testing proposals contained therein. Dossier evaluation covers two different processes: -Examination of testing proposals submitted by registrants, where ECHA – in cooperation with the Member States - decides whether the tests are necessary and if so, under which conditions. -Compliance check, where ECHA – in close cooperation with the Member States verifies and decides whether the information in the technical dossiers submitted by registrants meets the standard information requirements. Under substance evaluation, Member States evaluate substances based on initial concerns to clarify whether their use poses a risk to human health or the environment. Registrants may be required to submit further information on the substance to assist this evaluation. In cooperation with the Member States, ECHA defines prioritisation criteria and then selects the substances that are to be evaluated following the opinion of the Member State Committee. The selected substances are listed by ECHA in the ‘Community rolling action plan’ (CoRAP). An evaluating Member State is designated for each substance on the final CoRAP. Authorisation and restriction REACH also aims at managing the risks from hazardous substances through the authorisation and restriction processes. ·The authorisation requirement aims to ensure the good functioning of the EU internal market while assuring that the risks from SVHCs are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. The authorisation procedure comprises several successive steps:

-SVHC identification and candidate listing (on initiative of a Member State or ECHA on request from the Commission), -prioritisation and recommendation of substances for inclusion into Annex XIV (by ECHA), -inclusion in Annex XIV (by the Commission), thereby subjecting substances to the authorisation requirement. Once included in this Annex, a substance cannot be placed on the market for a use or used after a given date ('sunset date') unless the companies concerned are granted an authorisation for the specific use(s), -application for authorisation (by industry) followed by opinions by the Risk Assessment Committee (RAC) and Socio-economic Analysis Committee (SEAC) and -authorisation decisions (by the Commission following a vote by the Member States in the REACH Committee). Authorisation is a new process introduced by REACH, where operators need to have an authorisation for continued use of a substance based on a dossier prepared by them. ·The restriction process addresses unacceptable risks to human health or the environment posed by any substance that requires Union-wide action. The manufacture, use or placing on the market of those substances on their own, in mixtures or in articles may be restricted or even banned, if necessary. There was already an EU-wide restriction process under the pre-REACH system to address risks at EU level and ensure the proper functioning of the internal market. REACH introduced the possibility for Member States to initiate the restriction process. It sets out clear deadlines and was expected to considerably shorten the time between the moment the risk was identified and the adoption of the restriction. New restrictions may be proposed under different procedures: -the standard procedure, launched on the initiative of a Member State or by ECHA(acting on a request from the Commission), which requires the preparation of an Annex XV dossier, public consultation, opinions by RAC and SEAC and the consultation of the Forum for Exchange of Information on Enforcement (Forum); -the simplified procedure, for CMR substances with consumer uses, where there is no preparation of an Annex XV dossier and no involvement of the Committees; -the procedure for substances subject to authorisation; if, after the sunset date, ECHA considers that the use of the substance in articles presents a risk that is not adequately controlled and ECHA prepares an Annex XV Dossier. The European Chemicals Agency (ECHA) The REACH Regulation set up a central entity for the administration of the system, the European Chemicals Agency . ECHA ensures the effective management of the technical, scientific, and administrative aspects of REACH, providing information on REACH to companies and the general public. It also develops IT tools and guidance documents to support industry and public authorities in fulfilling their obligations under REACH. The organisational structure of ECHA has been adapted to reflect new tasks entrusted to it under the CLP Regulation, Biocidal Products (BPR) and Prior Informed Consent (PIC) Regulation. ECHA's internal structure now comprises: ·A Management Board, responsible for adopting the financial planning, work programme, and annual reporting of ECHA, inter alia. ·An Executive Director: the legal representative of ECHA, responsible for the day to day management and administration of ECHA, including responsibility over its finances. The Executive Director reports to the Management Board. ·A Member State Committee (MSC), responsible for resolving divergences of opinions among Member States and on proposals for the identification of Substances of Very High Concern (SVHCs), it also provides opinions on draft Decisions of ECHA on testing proposals, compliance checks and substance evaluation. If an unanimous agreement is not reached at the MSC, the matter is referred to the European Commission for decision making. The MSC also provides non-binding opinions on ECHA's draft recommendations on priority substances for inclusion into the authorisation list (Annex XIV) and on the draft Community Rolling Action Plans (CoRAP) of substances selected for evaluation. ·A Risk Assessment Committee (RAC), prepares the opinions of ECHA on hazard and risks of substances for human health and the environment in REACH processes, i.e. on applications for authorisation, on proposals for restrictions, and on other questions relating to risk assessment of proposed legislative action (on request of ECHA's Executive Director).The final decisions are taken by the European Commission. The members of RAC are appointed by ECHA's Management Board based on candidates nominated by the Members States. ·A Committee for Socio-economic Analysis (SEAC), prepares the opinions of ECHA related to the socio-economic impact on applications for authorisation, on proposals for restrictions and on other questions relating to the socio-economic impact of possible legislative action (on request of ECHA's Executive Director). The final decisions are taken by the European Commission. The members of SEAC are appointed by ECHA's Management Board based on candidates nominated by the Members States.

·A Forum for Exchange of Information on Enforcement to coordinate a network of Member State competent authorities responsible for enforcement. The Forum is composed of one representative from each Member State. ·A Secretariat, under the leadership of the Executive Director, to support the Committees and Forum, and to undertake work on registration and evaluation processes as well as the preparation of guidance, maintenance of databases and provision of information. ·A Board of Appeal, to decide on appeals against certain decisions taken by ECHA. Member States Member States have established national helpdesks to provide advice to duty holders concerning their obligations under REACH. National helpdesks are part of the HelpNet network, hosted by ECHA that promotes the provision of uniform advice to companies. Member States have also appointed the Competent Authorities responsible for performing the tasks stipulated in the Regulation, in particular concerning evaluation, restrictions and authorisation, as well as for cooperating with the Commission and ECHA in its implementation. The Member States have to ensure that the Competent Authorities are sufficiently resourced to support their ECHA Committee Members and can fulfil their duties to prepare restrictions, identification of substances as SVHC, or proposals for harmonised classification and labelling. Member States’ authorities are responsible for enforcement by conducting official controls and establishing penalties for non-compliance. They exchange information and coordinate their enforcement activities through the Forum for Exchange of Information on Enforcement. European Commission The Commission has the ultimate responsibility to take decisions on risk management measures (such as restrictions and authorisations), and takes decisions under the evaluation process, where ECHA does not succeed to decide due to lack of unanimity in its Member States Committee. The Commission has the right of initative related to risk management measures: it can initiate the restriction process (either directly or via ECHA), and it can request ECHA to initiate the process for the identification of substances of very high concern. Furthermore, the Commission oversees activities to ensure the harmonised implementation of REACH by organising regular meetings of the competent authorities where all issues requiring agreements among the authorities, such as interpretative questions, are discussed. Lastly, the Commission has to monitor the operation of the Regulation and is empowered to adopt amendments to its Annexes for adaptation to technical progress. The Commission is also empowered to adopt regulations to supplement the REACH Regulation (e.g. through Regulations on test methods, fees and charges) and implementing Regulations (e.g. data sharing). 2.2.An overview of the chemical industry and related sectors The chemical industry is one of Europe's largest manufacturing sectors, with annual EU chemical sales estimated at EUR 519 billion, equivalent to around 14.7% of global sales. While absolute sale figures remained relatively stable over the last ten years, EU production has fallen strongly as a percentage of the global market as a result of the growth of emerging markets, especially China. The sector comprises over 28,000 companies, who employ around 1.13 million persons. Around 96% of European chemical companies are SMEs. They provide more than one third of all the industry’s employment and generate about one third of the sector’s value added. The sector generates a value added of about EUR 115 billion (representing about 0.8% of EU GDP) and has a trade surplus of over EUR 40 billion per year. In 2016, extra-EU chemicals exports were EUR 146.3 billion and extra-EU imports reached EUR 98.6 billion. Besides the chemical industry described above, one of the manufacturing sectors considered to be most directly affected by REACH is metal manufacturing. Altogether, those two sectors (chemical industry and metal manufacturing) account for a comparable proportion of GDP, contribute roughly EUR 126 billion in Gross Value Added, and account for around 1.5 million jobs. As an "enabling industry", the chemical industry is at the heart of the EU manufacturing industry, supplying two-thirds of its production to other sectors within the manufacturing industry. 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. It should be noted that REACH does not only affect the chemicals industry, but also all of these downstream user industries. 2.3.Baseline: pre-REACH (extended Impact Assessment) and the 2013 REACH review In order to assess the progress of REACH over its full 10 years this second REACH evaluation uses the pre-REACH situation and the expectations foreseen in the original extended impact assessmentor the estimates for ECHA annual workload as the baseline. At the time, estimations were made on the costs of REACH, the number of substances that would be registered and the timing and the subsequent regulatory REACH measures

That baseline has already been considered, through the first assessment of the implementation of REACH that was carried out after five years of operation of the Regulation and published in 2013 – the "REACH Review 2013". The Commission undertook a broad assessment based on Member State and ECHA reports, as well as thematic studies carried out by external consultants under the supervision of the relevant units of the Commission. The REACH Review 2013 concluded that REACH functioned well and delivered on all objectives that could be assessed at that time. Some needs for adjustment were identified, but balanced against the interest of ensuring legislative stability and predictability, the Commission concluded that changes to the enacting terms of REACH would not be necessary. The Commission noted however, a need to reduce the impact of REACH on SMEs and set out measures that would contribute to that goal. Many other opportunities for improvement at all levels were set out in the Commission Report and were further described in a Staff Working Document. Where relevant, the state of play of implementation of the different REACH chapters at the time of the REACH Review 2013 is also taken into account for this REFIT evaluation. 3.Evaluation Questions The Commission services will examine the effectiveness, efficiency, proportionality, coherence, relevance and EU added value of the provisions of the REACH Regulation, focusing on the elements set out in the previous sections. The evaluation will be guided by the following questions: 3.3.1.Effectiveness 1. To what extent does REACH meet its objectives? 2. What have been the effects of REACH (whether socio-economic, environmental or health-related, both positive and negative), including also effects not originally planned? 3. What factors (including external ones) influenced the observed effects and to what extent? 4. To what extent is REACH contributing to meeting the World Summit Sustainability Development 2020 goals? 3.3.2.Efficiency 1. What are the costs and benefits associated with the implementation of REACH? To what extent are the costs proportionate to the benefits achieved? 2. What are the key drivers for those costs and benefits? What factors influenced the efficiency with which the accomplishments of REACH were attained? 3. Was the distribution of costs proportionate between the different stakeholders (e.g. larger companies vs. SMEs, or among different industrial sectors)? To what extent are there unnecessary burdens on stakeholders? 4. How are costs distributed among public authorities at EU and national levels? 5. What aspects of REACH (including procedural aspects) are the most efficient and what are the least efficient (including the development of scientific opinions, work of scientific committees, urgency procedures, etc.)? Are there case studies demonstrating highly efficient or inefficient working of REACH processes? Are there differences in efficiency between Member States (both in terms of delivery of objectives and the costs of doing so)? 3.3.3.Coherence 1. To what extent are the different work processes, including their output, in REACH interacting in a coherent manner? 2. The REACH review 2013 examined the coherence of REACH with other chemical legislation. To what extent have inconsistencies, contradictions or missing links with other EU chemical legislation been addressed through REACH implementation after 2013?

3. To what extent is REACH coherent with international efforts, including chemical legislation in third countries? 3.3.4.Relevance 1. To what extent is REACH capable of adapting to evolving needs (e.g. through adaptations to technical and scientific progress)? 2. To what extent is REACH relevant to the EU and its citizens? 3. To what extent is REACH capable of taking into account health, consumer and environmental concerns, and social and economic consequences that are relevant to citizens and stakeholders (e.g. through stakeholder information, consultation or involvement)? 3.3.5.EU added value 1. What is the additional value of regulating the risk management of chemicals at EU rather than at Member State level? 4.Methodology 4.1.Evidence collected since 2013 The first REACH review concluded that more information was necessary to determine whether to review information requirements for the registration of substances produced in low tonnages and of certain polymers. In addition, the Commission proposed a more systematic approach concerning the collection of information and reporting on Member States’ activities, including their enforcement activities, as well as work to address difficulties in relation to substance identity and sameness. Moreover, there was a need to improve the methodology to assess and quantify the benefits arising from the implementation of REACH. The need to monitor regularly the effects of the implementation of REACH was also highlighted in the REACH review 2013, in particular as regards industry preparedness for the 2013 and 2018 registration deadlines, and effects on innovation, SMEs and international competitiveness. A number of thematic studies were launched in those areas as a follow-up to the REACH review 2013 (overview in Annex 3). As well as those thematic studies, extensive evidence on the functioning of REACH is periodically reported to the Commission by Member States and ECHA in accordance with the requirements of Article 117 of the Regulation. Member States submitted their latest reports in 2015, while ECHA submitted its report on the functioning of REACH in 2016 and two reports on the use of alternative methods to animal testing (in 2014 and in 2017). In addition, ECHA published reports and other relevant documents on particular areas of REACH implementation that present additional evidence for this REFIT evaluation. A wide range of stakeholders (companies, associations, NGOs, trade unions, MSs etc) exchange views regularly with the Commission services, highlighting key issues in relation to the implementation of REACH. In this context, the Commission has underlined the importance of presenting data to describe and possibly quantify the issues raised when providing input for the REACH evaluation process. Several thematic studies were launched in the course of 2015 and 2016 in order to further develop the knowledge and evidence base for the second REACH review. Those studies aimed to enable the Commission services to undertake a systematic analysis, address information gaps and monitor progress towards achievement of the REACH objectives. In particular, studies were designed to monitor reduction of risks and improvement of the quality of data available for chemical risk assessment, to review the performance of ECHA and to assess the impacts of the authorisation process. All relevant details can be found in Annex 3. A roadmap was developed and published presenting the key questions to be addressed by the evaluation, as well as a consultation strategy to ensure stakeholders' engagement in the evaluation process. The Commission Services involved in the development of REACH and its implementation over the last 10 years have accumulated significant experience and insights to the implementation and functioning of REACH. This experience and insights are also used in this evaluation to draw conclusions and identify key findings to prioritise for immediate action. Priorities were established on the basis of the main shortcomings with the implementation of REACH in the last five years, considering also the concerns raised by stakeholders. 4.1.1.Approach to quantification The REACH Regulation provides a comprehensive regulatory system expected to deliver short term benefits but also long-term benefits, such as positive effects on human health, which were expected to materialise 10 years after the start of REACH implementation. On the other hand, other effects such as the costs and resources necessary for companies and public authorities to adapt to the requirements of REACH materialise immediately. In spite of the experience gained so far, the implementation of REACH is still in a relatively early stage and benefits are only starting to materialise and cannot yet be quantified; accordingly, at this stage, the evaluation does not (and cannot) aim for a full quantitative comparison of benefits with costs. The evaluation thus focuses on monitoring progress, assessing the outcomes of the intervention so far and comparing those results with expectations. A first strand of work is comparing the costs (to the extent that relevant costs can be quantified) with the expectations stated in the Impact Assessment for the REACH proposal. Moreover, attempts to qualify and quantify benefits have been carried out, while keeping in mind the present limitations. In addition, the evaluation seeks to identify key issues and opportunities for improvement in all areas of REACH implementation.

4.1.2.Data collection Several thematic studies (see Annex 3 for the details of the 16 studies) have been carried out by external consultants for the Commission services. The main methodologies applied in the context of those studies are described below: ·Desk research was conducted in the early stages of most thematic studies in order to review existing literature, gather available data and identify information gaps that would need to be filled. Reports from Member States and ECHA were also analysed to extract key issues and data. Results from ECHA meta-analysis studies were also used to derive costs and benefits for the authorisation and restriction processes ·Surveys were conducted in several studies in order to gather information available from particular stakeholders (e.g. costs information from companies) as well as to get a systematic collection of stakeholders' views on specific areas (e.g. performance of ECHA). ·Interviews have been conducted in several studies to complement surveys and obtain in-depth insights into issues raised by stakeholders in the context of surveys. ·Workshops and ad hoc focus groups were arranged in the context of several studies to discuss the early findings and obtain feedback and additional expert opinions on the topics addressed by the studies. According to the objectives stated in the consultation strategy for the REACH evaluation, stakeholder consultation is a key component to gather evidence, data and information on REACH implementation. Thus, a structured approach was developed to collect information from stakeholders. Feedback from all the categories of stakeholders identified in the consultation strategy has been obtained through the consultation activities carried out. Table 1: Feedback collected through consultation activities by stakeholder group Public authorities Industry associations Companies / SMEs Civil society (NGOs) Consumer associations Trade unions Consumers / workers / citizens Third countries Online public consultation √ √ √ √ √ √ √ √ SME panel √ Stakeholder questionnaires √ √ √ √ √ √ Stakeholder interviews √ √ √ √ √ √ Stakeholder workshop √ √ √ √ √ Expert group √ √ √ √ Eurobarometer Survey √ Annex 2 to this report provides a detailed summary of the consultation activities and results obtained, including the online public consultation and SME consultation that ran between the end of October 2016 and the end of January 2017. 4.1.3.Limitations and robustness of findings Despite best efforts, there are a number of challenges in the analysis: ·While extensive information on the functioning of REACH is available, it is often rather general, based on individual appreciations and it is difficult to say how representative these views or examples are. Thus, one of the difficulties for the evaluation was to extract relevant, robust and reliable evidence from a "large pool of information" that would allow a qualitative and quantitative description of the effects of REACH. Therefore great care was taken to accurately report the context and relevance of reported information. ·The relatively early stage of implementation mentioned above is one of the challenges for a comprehensive evaluation of REACH and in particular its benefits. It is acknowledged that some benefits will still manifest in the next 10 years. ·The complexity and far-reaching effects of REACH, affecting society and a broad range of sectors well beyond the chemical industry as well as the environment make it difficult to provide a systematic and detailed account of all the effects. Therefore the evaluation concentrates on the main objectives of REACH. ·Verified data are difficult to obtain. Efforts were made to estimate costs using a statistically robust sample of respondents and, where possible, to crosscheck with findings of previous studies on the implementation of REACH or additional sources of data. However, cost estimates often rely on data collected through company surveys with limited possibilities to establish whether questions have been understood in the same way, and whether the data are representative, or to compare and validate them. ·Finally, assessing causality between REACH and the effects observed on the ground is not straightforward. REACH in itself is complex but it is also designed to complement obligations stemming from a multiplicity of other EU legislation and national rules. An economic operator therefore often does not clearly understand if an obligation actually stems from another piece of legislation or from REACH. In addition REACH replaced a significant number of directives and regulations and therefore the assessment of REACH needs to disentangle the baseline (continuation of the pre-REACH legislation) from the additions coming from REACH. In addition, there are a large number of intervening factors at play (e.g. economic cycles, evolution of chemical markets worldwide) making it very difficult to attribute the parts of an observed effect to REACH. 5.Implementation state of play

This section provides an overview of the state of implementation of REACH, presenting key findings on the main chapters of the Regulation. A detailed analysis and evaluation of the technical dimension of the implementation of each chapter is presented in Annex 4. 5.1.Registration A key chapter of REACH is the requirement for registration of substances. The main aim of registration under REACH is to ensure that industry adequately manages the risks from its substances by obtaining adequate data, by performing chemical safety assessments, by implementing appropriate risk management measures and by submitting a registration to ECHA which documents all of these. The first registration deadline in 2010 was assessed as part of the 2013 REACH Review, which drew a number of conclusions on, for example, compliance of registration dossiers. The second registration deadline was in 2013 (after adoption of the REACH Review) and the third deadline is in 2018. Since the 2013 REACH Review progress can be observed on how industry fulfils its obligations as regards submission of dossiers and how more data are becoming available for the risk assessment of chemicals. Generally, the system is working well and as envisaged; however, some issues have been identified in particular in relation to the quality of dossiers. The costs of registrations are dealt with in Annex 4 - part of registration and in efficiency questions. Key findings on the implementation of registration include: ·Registration is taking place. By December 2017, ECHA had received and disseminated more than 65 000 dossiers for approximately 17 000 unique registered substances since REACH came into operation, which is broadly in line with the original estimates of the Commission. The ‘one substance, one registration’ principle is largely respected, and is being further promoted. ·The availability of data for risk management (through registration dossiers) is improving as seen in the quality scores. In particular availability of exposure scenarios has improved. This is making more information available to manage the risks from substances. ·Work is still needed to rectify important data gaps or inappropriate adaptations in registration dossiers for specific endpoints and for information on uses and exposure. The data gaps or data quality issues in dossiers hamper the identification of priority substances for SVHC identification or other regulatory action. ·The update of registration dossiers by companies is still a weak point, only 25% of dossier owners conduct a regular routine review of their REACH data and 50% of updates were requested by ECHA. ECHA concluded in 2016 that stronger incentives may be needed for companies to stimulate updates of registration dossiers, especially on the use, exposure and tonnage information. The only incentive working in practice might be enforcement actions by the Member State Competent Authorities on dossiers which updates are overdue. ·REACH provisions concerning the registration of intermediates are not fully coherent and have caused uncertainty for both registrants and regulators. ·A review of the Commission Recommendation on the definition of a nanomaterial is ongoing. Work is also ongoing for the amendment of Annexes to the REACH Regulation to clarify the registration requirements for nanoforms of substances. ·Further work is needed for the development of a useful system for the possible registration of polymers of concern for human health and/or environment, taking account of competitiveness and innovation. ·Two changes to the registration requirements in the low tonnage band (1-10t) are being considered by the Commission to improve risk management of hazardous substances due for registration by 2018; increasing standard information requirements and obliging the Chemical Safety Report for the CMR 1A or 1B. Both need further study to assess the affordability for SMEs. ·In the light of data-sharing obligations that will continue to apply for registration and evaluation, the consequences of the time limitation of the obligation for SIEFs to stay operational until 1 June 2018 as stated in Article 29 of REACH need further consideration. ·There is work ongoing to improve the completeness and compliance of registration dossiers and to support the 2018 registration deadline, which is expected to involve a large number of SMEs. 5.2.Data sharing, test methods and avoidance of unnecessary testing The hazardous properties of chemicals cannot be sufficiently determined using currently available in vitro (non-animal) testing methods. As REACH requires information to be gathered, the implication would be an increased use of laboratory animals. To minimise animal testing, REACH requires companies to share data and obtain approval in advance for certain tests. The Commission is also active in the field of developing, validating and promoting the regulatory use of alternative test methods, for example through the Framework Programme for Research and the European Union Reference Laboratory for Alternatives to Animal Testing (EURL-ECVAM). Key findings on the implementation of data sharing, test methods and the avoidance of unnecessary testing include:

·Since the 2013 REACH Review, the data sharing process has been further improved, and is the most important contributor to avoiding animal testing. ·The REACH principles of sharing and joint submission of data on intrinsic properties of a substance generally work well. Data sharing between structurally similar substances suitable for read across and categorisation purposes has the potential to further avoid animal testing and also to identify hazards earlier and thereby manage risks faster, but is hampered by the absence of obligatory data sharing between structurally similar substances in REACH. ·Amendments to the standard information requirements have introduced test methods that lead to a reduction or replacement of testing on vertebrate animals, such as the requirement for the extended one-generation reproductive toxicity study (EOGRTS). However, test methods containing optional modulation, as in the case of EOGRTS, cause difficulties in implementation and may lead to re-testing should conditions change. ·38 new (alternative) test methods have been introduced in Regulation (EC) No 440/2008 and 24 methods have been updated in the last 5 years via Adaptations to Technical Progress (ATPs); these methods were first endorsed by the OECD Test Guidelines Programme. ECHA and the Commission's Joint Research centre provide initial advice on new OECD Test Guidelines and their possible use for the purpose of REACH, while inclusion in the Regulation provides legal clarity but only after a time- and resource-intensive process. Further assessment is needed to determine whether the current process can be improved, in particular in terms of regulatory readiness and regulatory acceptance of alternative methods and whether the process could be further optimised while retaining scientific soundness and legal certainty. ·Information from the third ECHA report on the use of alternatives to testing on animals for the REACH Regulation confirms that the main source of experimental data for low tier endpoints are studies performed before REACH came into force. Endpoints outlined in REACH Annexes VII and VIII are considered as low-tier endpoints, while endpoints listed in REACH Annexes IX and X are considered as high tier endpoints. Less experimental data is available for high tier human health endpoints. For high tier environmental endpoints adaptations (such as QSAR or read across) are much more common than experimental data. This report also shows a continued high use of the adaptation possibilities offered in Annex XI, in particular read-across. This confirms that many registrants seriously implement the legal requirements to propose testing on animals only as a last resort. However, the adaptations used by registrants have often been found to be insufficiently justified, especially when the conclusion is the absence of a given hazard and in case of non-compliance, further testing is requested. ECHA has recently increased efforts to provide improved information and guidance to registrants, in order to improve the quality of adaptations. Consequently, less vertebrate animals than initially predicted have been used for testing, but on the other hand, hazard information has not been generated to the extent predicted. ·Although validated and accepted alternative test methods are available for certain endpoints (notably skin and eye irritation), and these methods are frequently used in REACH Registration dossiers, there are still a significant number of recent in vivo tests submitted for those endpoints. The reasons for this need to be further explored in detail, but limited analyses point to regulatory requirements in third countries as an important driver for animal testing, highlighting the need to further work towards the international acceptance of alternative methods. ·The Commission makes significant and sustained financial efforts to support the research on alternative methods, as well as the subsequent steps (e.g. validation and test guideline development) leading to regulatory acceptance. During the period 2012-2016, Commission expenditure has been around EUR 40 million per annum. However, there are still gaps in terms of alternatives for some endpoints. 5.3.Communication of information in the supply chain Communication within the supply chain is a central theme in REACH, as it ensures the passing on of information on hazards of substances, risks associated with their use and the necessary risk management measures down the supply chain to ensure safe use. In addition, downstream users need to pass information on how they use chemicals up the supply chain. Since the 2013 REACH Review efforts have been made to improve communication along the supply chain. Companies are increasingly engaged in the elaboration and transmission of extended safety data sheets (SDSs), with the support of different activities launched by ECHA (see Annex 4, paragraphs 3.1.1 and 3.1.2 for more details), resulting in improved communication promoting safer use of chemicals including complying with the requirements of occupational safety and health legislation. However, information flows do not always work well. Key findings on information in the supply chain include: ·The introduction of extended SDS has led to improvements in communication and more transparency in the supply chain. Around a half of companies have adopted changes in risk management measures on the basis of information received via extended SDS. However, in a significant number of cases, the information communicated is too lengthy and technical, or does not provide enough practical information to implement appropriate risk management measures. ·Responding to the problems identified in the 2013 REACH Review, a number of tools have been put in place to support downstream users in meeting their obligations, especially as regards communication in the supply chain and the development of SDS. These appear to be having a positive effect, but could be more fully used. ·Many companies, and in particular SMEs, consider extended SDS as burdensome and too technical to be fully understood mainly due to lack of in-house expertise. This prevents SMEs from using the information on the properties and use of substances in order to manage risks at their workplaces. In some cases the lack of information or the poor quality of particular exposure scenarios was underscored as an obstacle for formulators to prepare good quality SDS for their mixtures. The costs associated with the obligation to transmit information in the supply chain (which includes management of extended SDS and their translation) was also raised as problematic, in particular as most of the transmission is currently done manually (i.e. on paper). 5.4.Information on substances in articles Producers and importers have to notify to ECHA the substances listed on the Candidate list which are present in their articles, under certain conditions: ·The substance is present in their relevant articles above a concentration of 0.1% weight by weight. ·The substance is present in these relevant articles in quantities totalling over one tonne per year.

The notification information can be used together with other sources (e.g. registration information) to support identification of further needs for risk management. If there are grounds for suspecting that the substance is released from the articles under normal or reasonably foreseeable conditions of use and such a release presents a risk to human health or the environment, then the producer or importer of articles may be required to submit a registration. Since the 2013 REACH Review progress can be observed as to how industry fulfils its obligations as regards substances in articles, and how this information is communicated and used. However, whilst the situation may be improving, it is still not working as well as originally envisaged. Key findings on substances in articles include: ·Divergence between Member States in the interpretation of the 0.1% threshold limit regarding notifications to be submitted to ECHA (Article 7(2)) and regarding communication in the supply chain and to consumers (Article 33) of REACH has been resolved by a ruling of the European Court of Justice. This provides a common basis for the harmonised implementation of the requirements related to SVHCs in articles, and for increased and coordinated enforcement activities. ·The amount and adequacy of information in registrations dossiers for the safe use of substances in articles is still very limited. Fewer than expected notifications to ECHA have been provided, because of: a lack of awareness; difficulties to get the information needed, especially from third country suppliers; descriptions of uses in articles in registration dossiers being too broad; costs of communication for example due to complexity; a lack of methods to assess the safety of substance uses in articles (e.g. release and exposure estimation methods); a lack of methods to measure the content and release of SVHCs in articles. This limits the usefulness of such information for the identification of appropriate regulatory measures. ·The obligations to communicate the presence of SVHCs in articles allows operators along the supply chain to implement appropriate risk management measures as well as enabling operators and consumers to make informed purchasing decisions. This is happening, as information flows improve, but slower than foreseen reflecting perhaps the costs of managing the information flows and the need to learn from experience. ·Efficient functioning of supply chain communication is necessary for economic operators to implement appropriate risk management measures and to make informed purchasing decisions as well as for the ability of suppliers to respond to consumer requests. The communication requirement in Article 33 has triggered the development and potential use of information management tools by companies promoted by EU-projects or activities of some Member States. However, it remains difficult for actors in the supply chain to retrieve, verify and communicate information on SVHCs in articles. The transfer of information to the consumer greatly depends on a well-functioning communication in the supply chain as well as on the awareness and understanding of consumers about their "right to know". ·Better tracking of chemicals of concern in products would facilitate recycling and improve the uptake of secondary raw materials, as part of the Circular Economy. However, this would require transfer of information on the chemical content of end-of-life articles to the waste management sector. 5.5.Substance and dossier evaluation Evaluation is a set of processes in which ECHA and the Member States evaluate the information submitted by companies in registration dossiers to (1) under dossier evaluation, check compliance of the registration dossiers and examine the registrant's testing proposals for higher tier studies that require the use of vertebrate animals , and to (2) clarify under substance evaluation if the use of a given substance constitutes a risk to human health or the environment. The evaluation processes often result in legally binding decisions whereby registrants are required to update their dossier(s) with further information on the substance within a specified deadline. Further regulatory risk management action(s) may be initiated by the authorities as a follow-up of the evaluation conclusions. Both dossier and substance evaluation processes are operational and contributing to an important extent to the generation of relevant data on chemicals. Both processes are continuously evolving as challenges are identified and addressed on the basis of experience. This however requires time and resources from ECHA, the Member States and the industry. Further modifications to the existing procedures could be considered to improve the level of efficiency and effectiveness. Key findings on the implementation of dossier and substance evaluation include: The integrated regulatory strategy developed by ECHA provides an adequate framework to identify and prioritise "substances that matter". ·By the end of 2016, in terms of dossier evaluation, 748 testing proposal examination decisions had taken place. Around 220 compliance checks a year were taking place. Follow up to dossier evaluation decisions is an increasingly important part of ECHA's work. There are technical challenges, such as the changes in the reproductive testing approach. These need to be addressed given that dossier evaluation is the main means to ensure the required information is being gathered in registration, which has a direct impact on ensuring REACH delivers its objectives. ·Fewer substance evaluations have taken place than predicted, with 82 decisions by ECHA on substance evaluation adopted so far. This falls far short of expectations of 448 substances evaluated by 2016. If more substances would be evaluated by the Member States, this would benefit the implementation of the integrated regulatory strategy conducted by ECHA. ·The administrative processes associated to dossier and substance evaluation and the time needed to generate information is taking a lot of time. An effort needs to be made to speed up the processes by: improving choices about whether to initiate dossier evaluation or substance evaluation; whether to run substance evaluation and compliance checks in parallel; whether to start substance evaluation in parallel to restrictions or authorisation. ·Dossier and substance evaluation processes are working but need to be improved so that they can deliver faster and better, and do not represent the bottleneck in the 'pipeline' of the integrated regulatory strategy. Over half of the registration dossiers have been found non-compliant, suggesting that industries have to generate further information. ·Modifications of individual steps in the formal evaluation procedure may also be considered to further improve its efficiency and effectiveness in particular with regard to the third party and the two-step registrant consultation, but also the roles of the Member State competent authorities and the MSC.

·With compliance checks limited to 5% of dossiers and a comparatively even much smaller number of substance evaluations, the formal evaluation processes cannot be the main data-gap filling solution. The compliance check target linked to individual tonnage bands seems ineffectual in light of the evolution of the integrated regulatory strategy, the common screening which already now combs through all registrations and the possibility of addressing groups of substances. Therefore the compliance check target should be revised accordingly. ·In the longer-term, evaluation will need to move from successfully addressing dossier deficiencies and concerns of high volume substances (due to some specific endpoints such as carcinogenicity, reproductive toxicity), to the assessment and improvement of other endpoints. Evaluation should eventually reduce to monitoring the continuous compliance of all the dossiers in light of technological development and registration of new substances. ·Evaluation decisions are an important driver to generate new information; also in the recent decision of the European Ombudsman concerning the delay by the European Commission in processing files on reproductive toxicity of chemicals, the lack of incentives for registrants to spontaneously update their registration files despite their obligation is, together with the enforcement difficulties, have been identified as the main cause of the delay to generate new information. 5.6.Authorisation Substances with specific hazard effects on human health and the environment can be identified as substances of very high concern (SVHCs) and added in a Candidate List for possible inclusion in the Authorisation List (Annex XIV) and thus be subject to authorisation. Manufacturers, importers or downstream users need to have an authorisation for the placing on the market or the use of a substance on the Authorisation List. Authorisations are granted if the applicant can demonstrate that the risk from the use of the substance is adequately controlled. If not, an authorisation may still be granted if it is proven that the socio-economic benefits of using the substance outweigh the risk to human health or the environment and that there are no suitable alternative substances or technologies. There is some evidence that the objectives of authorisation are being achieved through the progressive substitution of SVHCs by suitable alternatives and the reduction of the risks through controlled use. Key findings on the way in which substances of SVHCs are identified and added to the Candidate List, and subsequently prioritised and included in the Authorisation List (Annex XIV) include: ·The SVHC Roadmap is proving an effective tool through setting out priority criteria and a methodology to ensure that, by 2020, all known relevant SVHCs are included in the Candidate List. It is improving regulatory coherence, transparency and predictability. For more information see annex 4 paragraph 6.1.2 and 6.2. ·The work under the SVHC Roadmap is progressing beyond expectations. More than 600 substances have been screened and for the relevant ones (159) a Regulatory Management Options Analysis (RMOA) has been prepared. All the substances with confirmed SVHC properties have been assessed. Further work is on-going for 500 cases where data are being assessed or further information and data generation is needed before analysing the most appropriate regulatory action. The focus should now move to identifying new SVHCs, generating information on hazard properties and speeding up the process through addressing similar substances together in groups. ·Encouraging as many companies as possible to substitute SVHCs early enough so that they do not have to apply for authorisation at all is one of the main challenges in the implementation of REACH authorisation. Inclusion of substances in the Candidate List works as a driver for the companies concerned to look at the possibilities of substitution (more information can be found in annex 4 paragraph 6.2) ·Between 2013 and 2017, 36 substances were included in the Candidate list, meaning that in total 174 substances were listed. The rate of inclusion has slowed down compared with the period of 2007-2012 where 138 substances were included in the candidate list. This is due to the fact that, since 2012, more complex cases, such as Persistent, Bioaccumulative and Toxic (PBT), very Persistent, very Bioaccumulative (vPvB) substances and substances of equivalent level of concern , were screened out, requiring more detailed RMOAs and, in some cases, generation of new data. ·The Authorisation List (Annex XIV) contains 43 substances by June 2017, less than estimated in the baseline (approximately 120 substances by 2016). As announced in the Commission REFIT Communication in 2014 , the Commission has introduced some measures to improve the authorisation process and is considering further measures to improve the authorisation process and make it more predictable. These measures include reducing the frequency of amendments of the Authorisation list (done), simplifying the authorisation process for some specific low-risk cases (ongoing) and consideration of socio-economic impacts when including new substances in the Authorisation list (done). ·ECHA had received by March 2016 applications for authorisation for only 21 out of the 31 substances included in Annex XIV. This may be an indication that substitution is taking place for all or at least part of the remaining 10 substances. The authorisation process is leading to substitution even from the early point of inclusion in the candidate list. ·The implementation of the new authorisation application process has met numerous challenges; being a new process, the general working procedures still have significant margin for improvement. Although important efforts have been made such as in the case of use in low volume or in the case of use of legacy spare parts by the Commission services to make the process clearer and simpler. ·There is still room for improvement in particular for applications submitted by upstream operators in the supply chain and a guidance document has been recently published on How to apply to authorisation to help companies to be more precise on the description of uses, on the representative exposure scenarios, on the socio-economic analysis. ·The costs of applying for authorisation remain high for individual companies, even though they have decreased (i.e. from EUR 230 000 on average per substance, use and applicant for the first applications in 2013 to EUR 120 000 in 2016). More details are included in the Annex 4, paragraph 6.7 ·Recent efforts to clarify the required information for applications for a wide scope of uses or covering many different operators should be assessed as soon as sufficient evidence becomes available to see whether they have led to good quality applications. Such improvement will be key in making the process work efficiently, and will make it less controversial to subject new substances to authorisation in the future. ·When substitution is not possible, there is evidence that authorisation has led to an improvement in the risk management of SVHCs, reducing workers’ exposure and emissions to the environment. This was proved by several applications for authorisation prepared by the companies. Companies are actively seeking to substitute and investing in substitution related activities.

·Feedback from applicants, the ECHA Committees, Member States and interested stakeholders will continue to be necessary for identifying and resolving remaining challenges. Ongoing activities such as Commission workshops and ECHA dialogues with the applicants will help to reinforce such improvement. ·As an example, for non-threshold substances applicants should describe the remaining risk quantitatively/semi-quantitatively assuring that the exposure levels are as low as technically and practically possible which then has to be assessed by RAC. This information on the remaining risk is an input to the socio-economic analysis of the applicant to be assessed by SEAC in order to consider if the benefits of continued use outweigh the health and environmental impact. ·In relation to the competitiveness and innovation of EU industry both negative effects (possible relocation and competitive disadvantage for EU industry as a result of imported articles not being subject to authorisation) and positive effects (development of alternatives) have been raised by industry. Those are further described in section 6.1.1.3. and annex 5 paragraph 2.4.2. 5.7.Restriction Restrictions limit or ban the manufacture, placing on the market or use of a substance on its own, in a mixture or in an article, including imports. A Member State, or ECHA on request of the European Commission, can propose restrictions if they find that the risks need to be addressed on a Union wide basis. ECHA can also propose a restriction on articles containing substances that are in the Authorisation list (Annex XIV). Anyone can comment on a proposal to restrict a substance. Those most likely to be interested are companies, organisations representing industry or civil society, individual citizens, as well as public authorities. Since the 2013 REACH Review, new restrictions have been proposed but at a slower pace than expected. This seems to be driven by a number of factors including lack of information to identify good candidates, and a demanding process that puts Member States off from proposing restrictions. A number of efforts are being made to improve the efficiency of the process. Key findings on the implementation of the restriction process include: ·During the period between January 2011 and December 2016, the Commission adopted 13 restrictions under Article 68(1). Overall, the number of restrictions initiated per year is about the same as in the final years of the pre-REACH system. This falls far short of expectations at the time of adoption of REACH of 11 restrictions per annum. ·A barrier to effectiveness is that it is difficult for Member States to find and invest resources in the preparation of Annex XV dossiers, which are demanding in terms of their technical/economic content. One Member State estimated the costs of preparing a proposal for restrictions under REACH to be between EUR 0.5 -1 million. Other barriers include high demands by the ECHA Committees during their opinion-making process. ·The evaluation has shown that EU companies are at a competitive disadvantage in relation to imported articles containing CMR substances because they are generally not used in the EU in consumer articles. In these cases, a restriction can be enacted to prevent the introduction of articles containing these CMR substances in the EU market via the simplified procedure envisaged in article 68(2). This would provide a level playing field between EU and non-EU companies. The competitive disadvantage of economic operators in EU should also be considered when introducing a restriction by advancing the start of the restriction process initiated by ECHA (see Annex 4 paragraph 7.3) for substances subject to authorisation and present in articles (Article 69(2)). ·The efficiency of the REACH restriction process has so far not met original expectations, but it has been improved since 2013 on the basis of the recommendations of the Restriction Task Force and of the enhanced cooperation of authorities (Commission services, ECHA and Member States eg through common screening and regulatory management option analysis) in the preparation of new proposals for restrictions. (Further information is provided in annex 4 paragraph 7.4.1). ·There is room for further improvement in the restriction process. The implementation of the recommendations of the Task Force is "work in progress". The activities will continue on the basis of experience gained in the preparation of Annex XV dossiers, ECHA should review the requirements for the conformity check and continue its efforts to obtain a maximum of information through the public consultation. RAC and SEAC should diligently scrutinise the information submitted in the dossier and via the public consultation, including in particular requests for exemptions. Finally, the Commission services intend to provide guidance to RAC and SEAC as to how to adopt opinions when, despite all efforts, information is lacking. 5.8.Member State activities other than enforcement Every five years, Member States submit to the Commission a report on the operation of this Regulation in their respective territories. These Member State reports provide information on issues such as Competent Authorities activities, work of the helpdesks, and the Member State involvement in many of the different REACH activities (evaluations, restrictions, SVHC dossiers, etc.). Member States authorities submitted reports on their activities in 2015 that had improved in terms of completeness and consistency compared to the 2010 reports. These reports provide part of the evidence base for this evaluation and the conclusions from the report include: ·There are 45 REACH Competent Authorities (CAs) operating in the 28 Member States and the 3 EEA countries. 6 Member States have more than one CA. Competent Authorities are generally satisfied with their technical expertise, while some consider their financial and human resources too limited to achieve all activities required under REACH. ·CAs generally expressed a high level of satisfaction with the cooperation between CAs at EU and national levels and with ECHA and the Commission. However, there are concerns about the resources available for fulfilling the REACH tasks.

·The Commission underlines the crucial role of Member States to support duty-holders and facilitate the fulfilment of their obligations by providing guidance through national helpdesks and awareness-raising activities. Two third of Member States have targeted SMEs for such activities. Most common awareness raising activities include the production of easily accessible information content, (leaflets and newsletter), organisation of seminars, development of websites and use of social media. ·The next version of the Member States' questionnaire will be re-evaluated with the view to being further streamlined. 5.9.Enforcement The Member States, ECHA and the Commission all play a role in enforcement. The Member States have the legal powers to enforce against duty holders. However, REACH delegated some 'enforcement powers' to ECHA, for example, in the case of dossier evaluation. Moreover, ECHA hosts information (e. g. registration dossiers), which in case of non-compliance, needs enforcement action by Member States' enforcement authorities. The Commission's enforcement role is to check the proper application of REACH, making sure Member States and ECHA apply and enforce REACH. To improve enforcement, new procedures and communication channels have been developed between Member States and ECHA in specific FORUM enforcement projects and also between Member States. Particularly relevant is the Forum for Exchange of Information on Enforcement (Forum), which is a network of authorities responsible for the enforcement of the REACH, CLP and PIC regulations. Since the 2013 REACH Review, an effort has been made to improve enforcement and progress can be seen in a number of areas, but it is clear that enforcement is still weak in some aspects and in some Member States. Key conclusions on enforcement include: ·The amount of work carried out by Member States authorities, progress towards common enforcement strategies and the increase of activities of the Forum have provided good results but improvements are needed. ·In response to the 2013 REACH Review, the Commission developed enforcement indicators in cooperation with Forum members. 50 enforcement indicators were proposed at three levels (EU, Forum and Member States). This is the first time that such an approach has been developed in the field of enforcement of chemicals legislation in the EU. It is still premature to draw final conclusions on the reliability of the first quantitative results of the indicators. ·The average level of REACH compliance reported by the Member States and ECHA has varied from 79 % to 89 % in the period from 2007 to 2014. In this period, the areas with lower level of compliance are the ones related to control of imports and supply chain obligations (e.g. 52% non-compliance for safety data sheets). ·The indicators show differences among Member States (i.e. some tend to systematically report higher compliance than the EU average whereas others keep to the lower end). These findings may be influenced by substantial differences in enforcement culture between Member States. ·Enforcement activities are complex since they are carried out at different levels. The Member States have the main role in enforcing the Regulation but ECHA, and in particular the Forum, play important roles by supporting enforcement activities in small Member States. ·Enforcement activities have increased over time: Member States are now reporting close to 100 000 controls per year, and there is some prioritisation of these (eg reflecting risks). Member States should carry out further activities in order to increase the harmonisation of enforcement across the EU as also requested by industry during the public consultation (more information in annex 4 paragraph 9.2). REACH is of direct application in all Member States and further implementation efforts are needed to create a level playing field among Member States and all the actors involved in particular from those Member States which are not particularly active in the enforcement projects developed by the Forum. ·The result of the open public consultation shows that there is negative perception with regard to the question if REACH is uniformly enforced across the EU . Stakeholders identified particular shortcomings with regard to imported goods. Mostly businesses and industry organisations stated that Member States should significantly increase controls in this area. This was seen of such importance because the lack of controls puts at risk Member States' enterprises competitiveness in a globalised trade system. ·The effectiveness of national enforcement activities could be further improved (e.g. in the areas of safety data sheets and imported goods), and also needs to be better communicated (e.g. by publishing Member State level enforcement indicators, developing and communicating national enforcement strategies and broadening national capabilities). ·The Commission services, the Forum and the Member States should further refine the enforcement indicators in the light of experience gained with their implementation. This system allows progress to be monitored (e.g. comparing different years) to better inform enforcement authorities, duty holders and the public in general. 5.10.Fees and charges ECHA undertakes work related to REACH and other chemicals legislation (CLP, Biocides, etc). For REACH, it receives income from fees and charges for work that ECHA does on registration and authorisation. This income covers only part of the costs of the services provided by ECHA, and so there is a balancing EU subsidy.

Key findings include: ·The fees and charges revenue was foreseen to amount to EUR 510 million over the period 2007-2016 and the total REACH budget over the same period to EUR 757 million (implying a balancing subsidy of around EUR 247 million). ·Revenue has been higher than expected, which has had an impact on the level of the EU subsidy. In practice, the fees and charges revenue over the period 2007-2016 was EUR 581 million (14% higher than expected) and the EU balancing subsidy was EUR 225 million for this period. ·The amount of fees and charges collected allowed ECHA to be self-financed for the period 2013-2015. Income from registration will be significantly less for the upcoming period (as all 'old' chemicals have been registered now, and only new ones will incur fees). From 2016 on, a significant EU contribution is needed to balance ECHA's budget. ·Half of the registrations over 2013-2016 relate to substances produced outside the EU. ·In line with the conclusions of the 2013 REACH Review, the Commission introduced in March 2013 fee reductions in favour of small and medium enterprises (SMEs) for both registration and authorisation; the reduction reaches up to 95% for micro-enterprises. For the period 2013-2016 the additional total fee reduction for SMEs represented a total amount of EUR 1.7 million. ·Stakeholders generally perceive registration fees and charges as adequate, but for authorisation they are generally considered too high. The Commission services are considering the possibility to abolish the additional fee per applicant in a joint application and increase the fee (to 90% of the base fee) for each additional use of a substance. This should contribute to reduce significantly the authorisation costs since companies will have an incentive to introduce joint applications. 6.Answers to the evaluation questions 6.1.Effectiveness 6.1.1.To what extent does REACH meet its objectives? The evaluation of effectiveness looks at the extent to which REACH fulfils the objectives it is meant to achieve. Based on the intervention logic, the main objectives are: 1)to achieve a high level of protection of human health and the environment 2)to promote alternative methods for assessment of hazards of substances 3)to achieve the free circulation of substances in the internal market 4)while enhancing competitiveness and innovation Assessment question: "To what extent does REACH meet its objectives?" Progress has been made towards the REACH objectives. The impact on protection of human health and the environment will take a number of years to become visible. However, evidence indicates that the outcomes defined in the intervention logic are being delivered in line with expectations. Information on substances is generated, passed to some extent along the supply chain and used to better assess and manage chemical risks, implying that REACH is being effective in terms of protecting human health and the environment to some extent. The development and consideration of alternative methods have greatly improved during the last ten years, although this may have been at the expense of delivering (hazard) information. In fact, alternative methods are not yet available for high-tier endpoints but registrants tended to avoid animal testing.

Regarding the free circulation of substances on the internal market, it can be concluded that REACH is delivering towards this objective. No clear effects are seen on the competitiveness and innovation as those depend on other more important factors that influence the market. What is the issue? The Intervention Logic sets out the sequencing from actions to outputs to outcomes to impacts, with the impacts relating directly to the objectives of the legislation. This question considers the degree to which the objectives are being met through an assessment of how effective the different actions envisaged in the intervention logic are proving. As such, answering the question leans heavily on the state of implementation as discussed in Section 5, considering also details set out in Annexes 4 and 5. However, the answer stops short of an assessment of the costs and benefits, which is instead considered under the efficiency questions. 6.1.1.1.Protection of human health and environment The high level of protection of human health and the environment can be reached via improved knowledge on substances and their uses and properties as such knowledge allows reducing risks through improved risk management measures. This requires registration and evaluation to work well. This in turn can result in improved risk management measures through the passing of information along the supply chain and the operation of the restrictions and authorisation processes. This section looks first at the evidence on the effectiveness of the actions as indicated in the intervention logic, and then at the evidence on the end impacts. 6.1.1.1.1.Availability of information on substance properties and uses The results of the 10-year update of the REACH baseline study show that 81% of the registered chemicals have a Chemical Safety Report and most (75%) of those contain worker exposure information; this is a clear increase in the availability of data compared to 2012 and especially 2007. Given that the baseline for the study was the situation before REACH, it suggests as a result of REACH, there has been progress in the generation of information on chemical substances and significant progress on making available information on chemical substances. This has led to a constant increase in the number of hazardous substances identified, controlled, restricted or substituted. Exposure limits (Derived No-Effect Levels (DNELs)) are available for more substances compared with the pre-REACH situation. This means more and better data are available to perform chemical risk assessments . REACH has also enhanced the knowledge within companies on the properties and uses of the chemicals including