Concept of REACH and impact on evaluation of chemicals

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1 Human & Experimental Toxicology (2008) 27: and impact on evaluation of chemicals H Foth 1 and AW Hayes 2 1 Medical Faculty, Institute of Environmental Toxicology, Martin Luther University, Halle, Germany; and 2 Department of Environmental Health, Harvard School of Public Health, Boston, MA 02115, USA Industrial chemicals have been in use for many decades and new products are regularly invented and introduced to the market. Also for decades, many different chemical laws have been introduced to regulate safe handling of chemicals in different use patterns. The patchwork of current regulation in the European Union is to be replaced by the new regulation on industrial chemical control, REACH. REACH stands for registration, evaluation, and authorization of chemicals. REACH entered force on June 1, REACH aims to overcome limitations in testing requirements of former regulation on industrial chemicals to enhance competitiveness and innovation with regard to manufacture safer substances and to promote the development of alternative testing methods. A main task of REACH is to address data gaps regarding the properties and uses of industrial chemicals. Producers, importers, and downstream users will have to compile and communicate standard information for all chemicals. Information sets to be prepared include safety data sheets (SDS), chemical safety reports (CSR), and chemical safety assessments (CSA). These are designed to guarantee adequate handling in the production chain, in transport and in use and to prevent the substances from being released to and distributed within the environment. Another important aim is to identify the most harmful chemicals and to set incentives to substitute them with safer alternatives. On one hand, REACH will have substantial impact on the basic understanding of the evaluation of chemicals. However, the toxicological sciences can also substantially influence the workability of REACH that supports the transformation of data to the information required to understand and manage acceptable and non acceptable risks in the use of industrial chemicals. The REACH regulation has been laid down in the main document and 17 Annexes of more than 849 pages. Even bigger technical guidance documents will follow and will inform about the rules for application and work out of dossiers. The following article gives a comprehensive overview on the concept of REACH to give deeper insight into this document. Members of the scientific community will have to define their own position as researchers, teachers, and experts to support the efforts to protect human health and the environment. The concept of REACH as well as new approaches to adapt standard testing regimes to foster a risk oriented approach in required work load to decrease animal based tests and to strengthen weight of evidence are explained in detail in this article. Key words: adaptation; authorization; evaluation; impact on science; REACH concept; registration Introduction Progress in technology and lifestyle is linked with a broad use of chemicals. There is almost no activity in public or private life that does not involve equipment containing, for example, plastics, surface coatings, dyes, liquids, liquid crystals or cooling agents, grease, and flame retardants. Chemicals are also widely used in agriculture (e.g., for pest control and treatment of farm animals) and food production to guarantee that food and feed are available and, Correspondence to: Heidi Foth, Medical Faculty, Institute of Environmental Toxicology, Martin Luther University, Franzosenweg 1a, D Halle/Saale, Germany. heidi.foth@medizin.uni-halle.de Part of the review is content of a special report from the Advisory Council on the environment of the Federal Republic of Germany to the government and has been published as Stellungnahme Nr 8, Die Registrierung von Chemikalien unter dem REACH Regime Prioritätensetzung und Untersuchungstiefe. It can be downloaded from ostensibly, appetizing. It is also inconceivable that diagnosis, treatment, and prophylaxis of diseases can be achieved without synthetic drugs. Our existing knowledge of the long-term effects of chemicals on humans and the environment is very different between these fields of application. Medicinal drugs and compounds for pest control are intensively tested for their effects and their underlying mechanisms before they are licensed to be put on the market, whereas food ingredients must also be rigorously evaluated. These data provide a systematic and comprehensive basis to evaluate acceptable use patterns and to help recognize risks in advance. The same has not, however, been true for other chemicals in use. Industrial chemicals are used because of technical features, economical reasons, chemical reactivity or physico-chemical stability. They are not generally designed for use on humans and also not, or at least not primarily, for release and distribution in the environment. Accordingly, the testing regime 2008 SAGE Publications /

2 6 during the development of industrial chemicals has focused on parameters other than biological effects. The time has come for further development of knowledge and a wider view of the above. Within the European Union (EU), the existing strategies to regulate chemicals divide responsibilities for safe use of chemicals between, on the one hand, the generation and interpretation of data and the evaluation of the effects and assessment of the risks. Furthermore, existing chemical safety programs focus on compounds manufactured or imported in quantities above 1000 t/annum. The regulatory process is thorough for these compounds and various issues are integrated into the assessment. However, the existing systems cannot provide the capacity or flexibility needed to eliminate the various deficits that are recognized as currently inherent within the process. The new chemical legislation of the European Union (EU), Registration, Evaluation, and Authorization of Chemicals (REACH), Regulation No 907/2006 came into force in 2007 and aims to address these deficits. 1 REACH aims to establish a fully functional and transparent procedure that reorganizes the primary responsibilities for chemical safety between the various stakeholders. The main task of REACH as expressed in the REACH regulation on page 2 1 is to ensure a high level of protection of human health and the environment as well as the free movement of substances, on their own, in preparations and in articles, while enhancing competitiveness and innovation. This regulation should also promote the development of alternative methods for assessment of hazards of substances. Under REACH, the database to evaluate the effects of chemicals on humans and on the environment should be considerably broadened and the safety associated with the use of chemicals and products increased significantly. REACH replaces about 40 directives and regulations on industrial chemicals and erases the regulatory distinction between new notified substances (NNS) and existing chemical substances (ECS) formerly introduced under the 6th Amendment to Directive 67/548. REACH does not touch the special regulations for drugs, pesticides, biocides, radioactive compounds, food, and feed additives. This fact may be read to be irrational, but it should not be forgotten that these special regulations have a higher force to deal with the basic problems because they are designed according to the needs for safe handling and require a much broader data set to prove when and how these chemicals may be safely used. In the following section, the rationale behind REACH will be given. The concept of REACH will be summarized and related areas of further focus and development for the toxicological sciences needed to support the workability of REACH in the future will be drawn. This text is focused on the description of facts, time lines and responsibilities for actions under REACH and to trace to the articles and paragraphs within the 849 pages of the REACH document. The new approaches to decrease the workload from standard testing regimes by adaptation of the test strategy are presented. Opinions of actors and politically motivated promises and biased opinions of interested groups were omitted. The need to address the interests of toxicologists toward REACH is more important than ever. To understand the roots of REACH, experiences gained with regard to existing chemicals legislation need to be thoroughly reviewed and this background of REACH will be presented separately. Also, the role of alternative methods to safety studies in experimental animals in the risk assessment of chemicals under REACH needs in depth discussion and will be presented on other occasions. Rationale for REACH from experience on existing regulations The evaluation of chemical substances has been focused to high-production volume that was already identified as having potentially dangerous effects. The work in the evaluation program of chemical substances has identified many dangerous substances. A high number of non evaluated chemical substances had to be postponed in the evaluation processes although these substances are produced in high amounts and widely distributed. According to the directive regulating consumer products, dangerous substances may be present only in small amounts in consumer products. However, this regulation could not prevent products containing carcinogenic, mutagenic, and reproductive toxic substances from being imported to and used by consumers within the EU. The power to regulate is not sufficient even for some identified dangerous substances. The systematic evaluation of substances produced or imported in the EU for the last 20 years has indicated that some substances have been widely distributed within the production chain. The information provided to end users setting out the relevant aspects of the safe use of chemical products and appropriate precautionary measures to protect against health and environmental damage is not sufficient. The distribution of chemical sub-

3 stances across the production chain is not taken into consideration by present regulations. All existing programs on chemical regulation were generated from the concept that the priority is the identification of hazards associated with chemicals that may affect human health. It is increasingly important to take into consideration exposure of man to chemical substances, which results from their distribution in the general environment, considering air, water, soil, and the food chain as a consequence of the production, processing, and end use of chemical substances. The consideration of the impact of production and use of chemical substances on the environment and on exposures of consumers is too weak. The regulation on existing chemicals is based on a trustful cooperation between the state authorities and industry. Thus, the regulating authorities and the regulated manufacturers are mutually dependent on each other within systems of co-operative chemical policy. The authorities do not have the power to generate all the information needed for the risk assessment on their own. As a consequence of cooperation, manufacturers are entitled to have an influence on evaluation and the outcome of decisions that are drawn from that process. Existing procedures are time consuming and cannot accelerate the risk evaluation process. Main outline The new EC Regulation No 907/2006 on the Registration, Evaluation, and Authorisation of Chemicals (REACH) published in the official Journal of the European Union on 30th December 2006 came into effect on 1st June The new regulatory framework for REACH aims to improve the protection of human health and the environment through a more inclusive and focused system for the identification and assessment of the properties and uses of chemical substances being produced or imported in Europe with provisions also for substances that are intended to be released from products. This includes provision for the collection of at least a basic data set for those chemical substances that had not been sufficiently covered by existing regulations. In particular, information with which to evaluate the need for measures to protect men and the environment is lacking for chemical substances produced or imported in volumes exceeding 1 t but below 1000 t/year. At the same time, a strong motivation for REACH has been to enhance the innovative capability and competitiveness of the EU chemicals industry. The EU Commission proposed the concept of REACH on 29th October 2003, 2003/0256(COM). 2 The concept sought to adopt and build on a number of underlying principles and goals. These include the need to expand the responsibility of manufacturers within the process. Procedures and methods prescribed under REACH aim to be transparent and the resources required to successfully implement REACH shall be proportionate to the problem that it aimed to resolve. The data sets resulting from the REACH process are expected to provide relevant information about hazardous properties and behavior in the environment, and the most appropriate strategies to manage associated risks are asked to be evaluated with reference to the intended use of the substances. All data about intrinsic properties and safety measures shall be registered and communicated to all enterprises using these substances within the supply chain. The evaluation of substances should also enable the protection of consumers, where robust, relevant information is needed to identify those areas where protection is required and those where the risk can be regarded as tolerable. The focus on protection of the environment should be improved, and the data should also, therefore, enable conclusions and inform decisions regarding this aspect. Use of chemicals with dangerous properties should be restricted or banned, as has been the case previously, although known and prevailing deficits in this area should be reduced under REACH. For these purposes, therefore, the technical use of some chemicals must be re-evaluated within a broader scope, where consideration of all relevant aspects of the risks associated with the use of substances are integrated to identify measures to protect both man and the environment as soon as possible. The main elements of REACH are pre-registration, registration, evaluation, and authorization, including restriction. The concept and the contents of these elements are explained in the following paragraphs (see Figures 1 and 2). Preregistration REACH came into force on June 1, All manufacturers or importers of chemical substances in volumes exceeding 1 t/year/enterprise will need to register these substances at the European Chemicals Agency (ECHA) in Helsinki (see Figure 1). This requirement will extend to existing, as well as newly developed, substances manufactured and/or marketed in Europe; non-registered substances may not be produced in or imported to Europe (Article 5 no data no market ). Substances which have been notified as new substances (NNS) in accordance with Directive 67/548/EEC and its amendments (i.e., substances marketed in the EU after September 18, 1981) are 7

4 8 Figure 1 Registration of chemical substances under REACH. The EU regulation REACH targets all produced or imported substances of 1 t/annum and above. By this all EINECS and ELINCS listed substances as well as isolated intermediates (not EINECS listed) or new substances are covered. A new regulatory body is formed: the European Chemical Agency (ECHA) which is responsible for all administrative work during registration, evaluation, and authorization including management of contact between the agency and enterprises, competent authorities of member states and non-profit organizations, or other interested parties. Substances that were already produced before REACH have a transition period to fill the requirements (phase-in substances). SIEF, Substance Information Exchange Forum; EINECS, European Inventory of Existing Chemical Substances; ELINCS, European List of Notified Chemical Substances; CMR, carcinogenic mutagenic, toxic for reproduction; PBT, persistent and bioaccumulative and toxic; vpvb, very persistent, very bioaccumulative. regarded as already registered for the purpose of REACH. The notification procedure already included classification on the basis of standard testing following Good Laboratory Practices (GLP) protocols and risk assessment as laid down in Council Directive 93/67/EEC for NNS. Special provisions have been included to facilitate the phased transition of other chemical substances already in the marketplace into the REACH regime over an 11- year period (Article 23). These substances, termed phase-in substances, include (a) EINECS (European Inventory of Existing Chemicals Substances) listed substances produced or marketed in the EU between January 1, 1972, and September 18, 1981, (b) substances placed on the market before June 1, 2007, that were considered notified under Directive 67/548/EEC but do not meet the definition of polymers set out within REACH, and (c) substances that have been manufactured, but not marketed, in the EU at least once since June A postponed schedule for registration under REACH applies to these phase-in substances, as long as manufacturers pre-register the substances with the European Chemicals Agency in accordance with the regulation. Preregistration for all phase-in substances must be completed between June 1, 2008, and December 1, In practical terms, this means that, assuming preregistration is completed, phase-in substances may be produced or imported until the end of the relevant registration window. About 30,000 of EINECS listed chemicals substances are candidates for preregistration under REACH. 3 Failure to preregister phase-in substances means that a manufacturer or importer cannot take advantage of these transitional arrangements; in this event, the manufacturer or importer must complete the registration process before it can recommence production or import. In all other cases (i.e., for non phase-in substances that are not otherwise exempt from REACH, see Registration below), chemical substances may be produced or imported after June 1, 2007, only if registration has been completed beforehand. Preregistration requires the manufacturer, importer, or their representative to provide the name and head office of the applicant, the name and EINECS or CAS (chemical abstracts service reg-

5 9 Figure 2 Evaluation and authorization of substances under REACH. Evaluation of dossiers is done by European Agency (ECHA) by two different steps: dossier evaluation (compliance check of technical requirements and evaluation of proposed tests) and substance evaluation. Candidates for substance evaluation will be complied in candidate lists. The first draft rolling plan on these candidates will be published 1 year after end of the registration. Authorization is started by compiling 7 working lists over the years from which substances to enter the formal authorization approval are indexed in Annex XIV. ECHA, European Chemical Agency; CA MS, Competent Authorities of EU Member States. istry) numbers of the substance to be preregistered, the annual tonnage and likely deadline for registration. These preregistration statements are collected by the EU Chemical Agency and will be implemented in a special database that is designed to support the exchange of information between enterprises in the Substance Information Exchange Forum (SIEF). This approach is meant to foster co-operation between competitors as well as enterprises throughout the supply chain and to reduce the number of tests on animals. Furthermore, co-operation should also help to reduce the workload and resources required to implement REACH. Information regarding substances which it is envisaged may be used within structure activity relationships and grouping and read-across methods, and this is fully given into the decision of enterprises. The rules for application and the criteria of justification have not yet been decided by the commission. Registration For registration, a specified data set for each substance must be collected or generated and necessary technical dossiers compiled (Article 5 and Title II of the document). Table 1 contains a comprehensive overview on the outline of dossier preparation and requirements to be filled according to Article 10 and Annex VI. The scope and detail of the required information is dependent on the production or import volume and is highest for HPV (high production volume) substances (Article 12). The substances are divided into bands according to production or import volumes of (A) between 1 and 10 t/year/enterprise, (B) between 10 and 100 t/year/enterprise, (C) between 100 and 1000 t/year/enterprise, and (D) 1000 t or more per year/enterprise. Tables 2 5 give details about the data needed for registration of substances, including tests to establish toxicological and ecotoxicological properties. The contents of Tables 2 5 are comprehensive versions of Annexes VII XI of the document where the exemptions from testing as described in column 2 were left out. Where scientifically justified, exceptions to the testing regime will be tolerated, and the acceptability of such a proposal depends on factors including the intrinsic properties of the compound as well as on the nature and extent of possible exposure (see Adaptation of standard testing regime). Phase-in substances in the import of production volume A (1 10 t/annum) will have to fill the required information of Annex VII only when it is likely that they meet one or both criteria of Annex III. These criteria focus on (a) predicted carcinogencity, mutagenicity (class 1 and 2), reproductive toxicity (class 1, 2 and 3) and (b) on dispersive of diffuse use particularly where substances are used in consumer products. Annex

6 10 Table 1 Registration, evaluation, and duty of care under REACH Required general information for all chemical substances >1 t/annum (article 10) Information 1 General registrant information Information 2 Identification of the substances Information 3 Information on the manufacture and use(s) of the substances Information 4 Classification (Directive 67/548 EEC) Article 4 intrinsic properties categories (explosive(s), oxidizing properties, flammable very toxic, toxic, harmful corrosive, irritant, sensitizing carcinogenic, mutagenic, toxic for reproduction dangerous for the environment ) Article 6 obligations to carry out investigations Articles 23, 24, 25 (Directive 67/548 EEC) labeling Information 5 Guidance on safe use (measures in accidents, handling and storage, transport, exposure control, disposal) Information 6 Information on exposure (use categories, human exposure, environmental exposure) Guidance notes given in Annex VI on fulfilling the requirements Article 10 information for general registration Article 12 information depending on tonnage Article 13 generation of information in intrinsic properties Step 1 Gather and share existing information Collect all available and relevant information to identify presence or absence of hazardous properties Step 2 Consider information needs (specified in Annexes VI IX) Information depending on tonnage (article 12) Step 3 Identify information gaps Step 4 Generate new data (variations from standard testing are specified in Annex XI) Propose testing strategy to fulfill requirements for substances >100 t/annum (testing an vertebrates only when all other sources have been exhausted) Table 2 Information required for chemical substances 1 t/year under REACH All non phase in substances in quantities of 1 10 t Phase in substances meeting the criteria of Annex III: Classified as carcinogens class 1 and 2 Classified as PBT or vpvb (specified in Annex XIII) dispersive use in consumer products QSAR prediction for classification according to Directive 67/548/EEC General rules from adaptation of testing regime are specified in Annex XI (1. use of existing data, weight of evidence, QSAR, in-vitro methods, grouping of substances; 2. testing is technically not possible) Information 7 Information 8 Information 9 Standard information on physicochemical properties 7.1 State of the substance 7.2 Melting/freezing point 7.3 Boiling point 7.4 Relative density 7.5 Vapor pressure 7.6 Surface tension 7.7 Water solubility 7.8 Partition coefficient n-octanol/water 7.9 Flash point 7.10 Flammability 7.11 Explosive properties 7.12 Self-ignition temperature 7.13 Oxidizing properties 7.14 Granulometry Toxicological information 8.1 Skin irritation or corrosion (assessment of available information or in-vitro studies) 8.2 Eye irritation (as mentioned for 8.1) 8.3 Skin sensitization (assessment of available information and consecutively to outcome invivo testing) 8.4 Mutagenicity In-vitro gene mutation, bacteria 8.5 Acute toxicity Oral route Ecotoxicological information 9.1 Aquatic toxicity Short-term test on daphnia Growth inhibition test on algae 9.2 Degradation Biotic degradation Source: Regulation (EC) 1907/2006, pp Specific rules for adaptation and exemptions to conduct studies are given

7 Table 3 Information required for chemical substances 10 t/year under REACH 11 All substances in quantities of 10 t or more (Article 12 (1) c) General rules from adaptation of testing regime are specified in Annex XI (1. use of existing data, weight of evidence, QSAR, in-vitro methods, grouping of substances; 2. testing is technically not possible) Information 7 Standard information on physicochemical properties Specific rules for exemptions to conduct studies are Information 8 Information (see Table 2) Toxicological information 8.1 Skin irritation (in-vivo study) 8.2 Eye irritation (in-vivo study) 8.3 Skin sensitization (assessment of available information and consecutively to outcome invivo testing) 8.4 Mutagenicity In-vitro gene mutation, bacteria In-vitro cytogenicity study in mammalian cells or in vitro micronucleus assay In-vitro gene mutation in mammalian cells, if and are negative 8.5 Acute toxicity Oral route By inhalation By dermal route 8.6 Repeated dose toxicity day test one species, most appropriate route for human exposure 8.7 Reproductive toxicity Screening test OECD 421 or 422, if there is no evidence from other sources 8.8 Toxicokinetics (assessment from relevant available information) Ecotoxicological information 9.1 Aquatic toxicity Short-term test on daphnia, Growth inhibition test on algae Short-term test on fish Activated sludge respiration inhibition testing 9.2 Degradation Biotic degradation Abiotic degradation 9.3 Fate and behavior in the environment Adsorption/desorption screening Source: Regulation (EC) 1907/2006, pp given in Annex VII In-vivo mutagenicity studies, if any of in vitro genotoxicity studies is positive Testing in section 8.6 and 8.7 may be omitted based on exposure scenarios = Annex XI, 3 substance-tailored, exposure-driven testing III (b) includes also substances for which it is predicted that they are likely to meet the classification criteria for any human health or environmental end points under Directive 67/548/EEC. The source for information may be quantitative structure activity relationship (QSAR) or other evidence. It is important to note that Annex III focus on predicted properties, whereas substances that are already classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) class 1 or 2 or persistent, bioaccumulative, and toxic (PBT), very persistent, very bioaccumulative (vpvb) need to be registered in the first group together with HPV substances. However, each company must register all of the products it places on the EU market after June 1, In effect, this is likely to lead to the multiple registration of identical CAS number substances because many chemical substances are manufactured and marketed by many different companies, often, for a range of uses. A particular problem may arise from the fact that chemical products having identical CAS numbers are marketed with different impurities and concentrations, and the production or import volume may vary between enterprises. These circumstances will result in differences in both the registration dossiers, for example, concerning physico-chemical or toxicity data and the time lines for registration. Hence, at least some conflicting information in the databases submitted under REACH is to be expected. Within REACH, it is appreciated that enterprises should co-operate for registration and should jointly submit documents as far as possible. The registration fee and cost of data sharing will then be divided among them. The Substance Information Exchange Forum (SIEF) developed following the preregistration phase should facilitate the organization of consortia through which joint registrations can be prepared. Ideally, this would lead to a one substance one registration (OSOR) outcome for each substance,

8 12 Table 4 Information required for chemical substances 100 t/year under REACH All substances in quantities of 100 t or more (Article 12 (1) d) General rules from adaptation of testing regime are specified in Annex XI (1. use of existing data, weight of evidence, QSAR, in-vitro methods, grouping of substances; 2. testing is technically not possible, and 3. substance-tailored, exposure driven testing) Information 7 Information 8 Information 9 Standard information on physicochemical properties (see Table 2) 7.15 Stability in organic solvents 7.16 Dissociation constant 7.17 Viscosity Toxicological information 8.1 Skin irritation (in-vivo study) 8.2 Eye irritation (in vivo study) 8.3 Skin sensitization (assessment of available information and consecutively to outcome invivo testing) 8.4 mutagenicity In-vitro gene mutation, bacteria In-vitro cytogenicity study in mammalian cells or in vitro micronucleus assay In-vitro gene mutation in mammalian cells if and are negative 8.5 Acute toxicity Oral route By inhalation By dermal route 8.6 Repeated dose toxicity day test one species, most appropriate route for human exposure Subchronic toxicity study (90 days) 8.7 reproductive toxicity Screening test OECD 421 or 422, if there is no evidence from other sources Prenatal developmental toxicity study Two generation toxicity study, if repeated toxicity study indicates adverse effects on reproductive organs 8.8 Toxicokinetics (assessment from relevant available information) Ecotoxicological information 9.1 Aquatic toxicity Short-term test on daphnia Growth inhibition test on algae Short-term test on fish Activated sludge respiration inhibition testing Long-term toxicity on daphnia Long-term toxicity on fish 9.2 Degradation Biotic degradation, simulation testing on ultimate degradation in surface, water, soil simulation test, sediment, simulation test Abiotic degradation Identification of degradation products 9.3 fate and behavior in the environment Adsorption/desorption screening Bioaccumulation in aquatic species Further information on adsorption desorption test) 9.4 Effects on terrestrial organisms Short-term toxicity to invertebrates Effects on soil microorganisms Short-term toxicity to plants Source: Regulation (EC) 1907/2006, pp Specific rules for exemptions to conduct studies are given in Annex VII In-vivo somatic cell genotoxicity if in-vitro genotoxicity studies are positive Germ cell mutagenicity including toxicokinetic evidences if in-vivo cell genotoxicity is positive Tests in 8.6, 8.7, 9.1, 9.2, 9.3, 9.4 marked in italic can be omitted based on exposure scenarios Annex XI 3 substance-tailored, exposure-driven testing which will get the special support of the Chemical Agency. This is still an option within REACH but not likely a demand as it has been previously implemented into the consolidated version of commission document 2003/0256(COM). The technical dossier comprises a variety of different documents to distribute information in the sup-

9 Table 5 Information required for chemical substances 1000 t/year under REACH 13 All substances in quantities of 1000 t or more (article 12 (1) e) General rules from adaptation of testing regime are specified in Annex XI (1. use of existing data, weight of evidence, QSAR, in-vitro methods, grouping of substances; 2. testing is technically not possible, and 3. substance-tailored, exposure-driven testing) Information 7 Information 8 Information 9 Standard information on physicochemical properties (see Table 2) 7.15 Stability in organic solvents 7.16 Dissociation constant 7.17 Viscosity Toxicological information 8.1 Skin irritation (in-vivo study) 8.2 Eye irritation (in-vivo study) 8.3 Skin sensitization (assessment of available information and consecutively to outcome invivo testing) 8.4 Mutagenicity In-vitro gene mutation, bacteria In-vitro cytogenicity study in mammalian cells or in vitro micronucleus assay In-vitro gene mutation in mammalian cells if and are negative 8.5 Acute toxicity Oral route By inhalation By dermal route 8.6 Repeated dose toxicity day test one species, most appropriate route for human exposure Subchronic toxicity study (90 days) 8.7 Reproductive toxicity Screening test OECD 421 or 422 if there is no evidence from other sources Prenatal developmental toxicity study Two generation toxicity study, if repeated toxicity study indicates adverse effects on reproductive organs 8.8 Toxicokinetics (assessment from relevant available information) 8.9 Carcinogenicity study Ecotoxicological information 9.1 Aquatic toxicity Short-term test on daphnia Growth inhibition test on algae Short term test on fish Activated sludge respiration inhibition testing Long-term toxicity on daphnia Long-term toxicity on fish 9.2 degradation Biotic degradation, simulation testing on ultimate degradation in surface, water, soil simulation test, sediment, simulation test Abiotic degradation Identification of degradation products 9.3 fate and behavior in the environment Adsorption/desorption screening Bioaccumulation in aquatic species Further information on adsorption desorption test Further information on the environmental fate and behavior of the substance and/or degradation products 9.4 Effects on terrestrial organisms Short-term toxicity to invertebrates Effects on soil microorganisms Short-term toxicity to plants Source: Regulation (EC) 1907/2006, pp Specific rules for exemptions to conduct studies are given in Annex VII In-vivo somatic cell genotoxicity if in vitro genotoxicity studies are positive Germ cell mutagenicity including toxicokinetic evidence if in-vivo cell genotoxicity is positive Tests in 8.6, 8.7, 8.9, 9.1, 9.2, 9.3, 9.4 marked in italic can be omitted based on exposure scenarios Annex XI 3 substance-tailored, exposure driven testing

10 14 ply chain. The required information is listed in the documents of REACH and its Annexes. 1 The safety data sheet (SDS) should inform downstream users about all dangerous properties (hazards) associated with the substance and should set out advice concerning the appropriate precautions and safety measures to prevent harm (Article 31 and Annex II). This document will need to provide information where a substance or preparation (a) meets the criteria of classification as dangerous, which are irritation, corrosion, sensitization, toxicity, and class 1 or 2 carcinogenic, mutagenic, or toxic for reproduction properties; (b) is persistent and bioaccumulative according to the PBT, vpvb criteria (see Authorization), or (c) where other reasons (Article 57) are given, such as endocrine disrupting properties or scientific evidence of probable serious effects on human health or the environment, which did not fill the criteria of classification as CMR class 1 or 2 and PBT, vpvb substance or preparation. The procedure to identify such cases is described in Article 59. SDS will not give information on the height of exposure but on measures to limit exposure, to monitor exposure or on safety measures and personal protection aids. The outline of SDS is very close to previous directives and will be provided to all enterprises involved in downstream processing or use of substances or preparation above 1 t/annum. The information given in SDS needs to be in accordance with the information and data in safety documents laid down in chemical safety assessment (CSA) and chemical safety report (CSR). A CSR is needed for substances exceeding production or import volumes of 10 t/year/enterprise (Articles 14, 38; Annex I). The CSR contains more detailed information about the type and quality of data for testing of effects, for classification and for evaluation of risks. The CSR has to present information on the most appropriate measures for risk reduction. It forms part of the technical dossier submitted to the ECHA and will be implemented in an aggregated form into databases that will be available for information perhaps needed in the production chain. Some but not all information of the CSR will be implemented in data bases with wider access. The CRS effectively documents the chemical safety assessment, described below. The third dossier, the CSA is an extensive compilation of all data and information regarding the effects of substances exceeding 10 t/year/enterprise (Articles 14, 37). The assessment dossier will present information on all risks associated with shortterm or long-term use of the compound as well as measures to minimize these risks. It also will have to inform about methods to detect effects and about uncertainties concerning the interpretation of data that still remain once the evaluation process is complete. This document will remain in the hands of the enterprise (i.e., is not submitted to the ECHA) but should be made available when sudden events or otherwise unexpected situations occur, and authorities need information about associated risks and the measures available to prevent or limit damage. The CSA will be the principle reference document for decisions on risk management in case of sudden events such as incidents during production, spillage during transport, or other unintended and unforeseeable distribution and exposure. The window for submission of all registration applications and associated dossiers will end on November 30, 2010, which is 3.5 years after the start of REACH, for all HPV phase-in substances. Also all phase-in substances that have already been classified as category 1 or 2 CMR substances and which will be produced or imported in volumes exceeding 1 t/year and those phase-in substances classified as very toxic to aquatic organisms that may cause long-term adverse effects in the aquatic environment and are manufactured or imported in quantities exceeding 100 t/year have to be registered, alongside all associated dossiers, within this time scale. Phase-in substances with a production or import volume between 100 and 1000 t/year have a deadline for registration until May 31, 2013, which is 6 years after start of REACH. Finally, all phase-in substances produced or imported in volumes exceeding t/year/enterprise will have to be registered by May 31, Chemical substances which are already adequately regulated by other EU Directives are not candidates for registration under REACH. These include components of human or veterinary drugs because they are extensively tested before authorization as drugs. Also, food additives and feed additives or substances used in cosmetics or in products for personal hygiene are effectively regulated and the risks for human health are minimized. Similarly, the data sets from tests on toxicity and ecotoxicity of biocides or plant protection products before they are authorized for use and may be set on EU market are comprehensive, and active substances registered as biocides or plant protection products are regarded as registered under REACH. Non-isolated intermediates used on site (Article 2) are also currently exempt from the duty to be registered under REACH. Polymers and on-site and transported isolated intermediates are exempt from certain requirements under REACH. Intermediates may be short lived and remain within the reactor

11 vessel. In other cases, intermediates are relatively stable and may be transported from the site of manufacture to other facilities for further synthesis. Any concept to test non-isolated intermediates would be expected to rapidly become non-workable because they are part of complex mixtures. Furthermore, by definition, intermediates are chemically reactive and this implies that they have also substantial potential to induce harmful effects in biological systems. However, the transport and handling pattern of on-site intermediates is well known and may be strictly controlled. Accordingly, the chances for exposure can be minimized and safety measures to prevent damage in case of sudden events established. Intermediates in production volumes exceeding 1000 t/year which are planned to be transported to other sites of production or to other enterprises must submit a basic data set for registration under REACH (Article 18). For this use pattern, it can be expected that measures are undertaken to prevent unexpected losses during transport and that safety rules apply to prevent exposure and damage. Finally, substances or products which are newly generated during processing by downstream enterprises or during recycling of chemical products are also exceptions from the duty to be registered under REACH. Examples are galvanic processes, paints, or any complex mixtures, where chemical reactions are likely to occur during final processing. REACH is designed to regulate chemical substances not products. However, any emission of substances out of products is covered by regulation under REACH. Any producer or importer of products is also required to register substances present in those products in quantities of over 1 t/producer or importer per annum if that substance is intended to be released under normal or reasonably foreseeable circumstances and if that use has not already been registered. Evaluation Registered dossiers will undergo evaluation by ECHA, which will undertake two different types of evaluation: the technical dossier evaluation and the substance evaluation (see Figure 3). Five percent of the registration dossiers will be evaluated by the European Chemical Agency for completeness with respect to the required information (compliance check, Article 41). All proposals for experiments on animals for phase-in substances under Annexes IX and X for substances exceeding 100 t/year will be checked. Special attention is required for these cases to ascertain whether the proposed tests can be omitted because the data are available by other sources. The time lines for this part of technical evaluation are December 1, 2012, for the first phase of registration and December 1, 2016, and December 1, 2022, for the second and third phase of registration. Proposed test on vertebrate animals have to be published for 60 days by ECHA announcing the type of test planned and the CAS number of substances to invite interested parties to commend within a time line of 45 days. The ECHA or competent authorities of member states may also require tests of the required standard test regime if the approval of the dossiers indicates a gap and adaptation according to Annex XI seems not to be justified. However, generally, a detailed review of the quality of the data and whether the conclusions are supported by the data submitted will not be completed in the technical dossier evaluation. The enterprises themselves are solely responsible for ensuring that the evaluation of data and risk assessment is appropriate. 4 However, within the substance evaluation, ECHA and the authorities of the member states may perform Figure 3 Adaptation of standard test regime (Annex XI). Under the force of REACH substances can only be produced when they are tested for dangerous properties. Every registration document needs general information according to items 1 6. Additional information on the properties of the substance is needed depending on the volumes of production and/or import. The data sets required are laid down in Annexes VII X. These annexes formulate a standard test regime and give advice in column 2 as to how the test has to be adapted according to the results obtained. However, every test regime can be adapted by decision of the registrant. The criteria are described in Annex XI. For every registration general adaptation of the regime can be done when other reliable source of information are available as described by items 1 and 2 of general adaptation. Substancetailored, exposure-driven testing of the general adaptation rule (option 3) can be applied only for substances of 100 t/annum and above. 15

12 16 their own evaluation of the data in cases where concerns arise (Article 44). Substances selected for substance evaluation are indexed by ECHA in candidate lists. A draft rolling plan of the candidate lists will be published December 1, 2011, which is one year after end of the first registration phase. This phase will contain all substances of 1000 t/annum/manufacturer or importer, all CMR class 1 and 2 substances, PBT and vpvb of 1 t/annum and beyond. The substance evaluation should result in identification of the need for further information and identification of substances with very high concern. Any additional test program which may result from the evaluation process should be agreed with the enterprise and the national authorities co-ordinating the decision finding. The outcome of the evaluation process may lead national authorities to the conclusion that the process of authorization should be initiated for a substance. The European Chemical Agency will have the key role in organizing and coordinating the evaluation process. In particular, the agency will have to establish a list of evaluation criteria that would guarantee that the process will be managed equally, regardless of which national authority is involved. Authorization Substances of very high concern that are produced or imported by more than 1 t/year are candidates for authorization under REACH. The authorization phase is initiated by selection of the substance for the authorization lists, which will be published in a series of seven lists scheduled from June 1, 2009 (first list), to June 1, 2021 (seventh list). The criteria under which an evaluation of the need for authorization is required are specified in Article 57 of REACH. These criteria include categories 1 and 2 CMR substances (but not those classified as class 3 of CMR) as well as very persistent, very bioaccumulative substances (vpvb substances), persistent, bioaccumulative and toxic substances (PBT substances), and substances of equivalent concern, such as those with endocrine active properties or allergic potential. The definition of these criteria is further clarified in Annex XIII of the REACH document. For example, the half-life of substances in specific environmental media is compared with maximum values to allow an evaluation of its persistence. A substance fulfils the bioaccumulative and very bioaccumulative criterion when the bioconcentration factor (BCF) for aquatic species exceeds 2000 and 5000, respectively. The PBT classification requires that a compound has all three properties of persistence (P), bioaccumulation (B), and toxicity (T). The authorization process aims to clarify whether use of these substances of very high concern should be restricted to prevent dispersive distribution or whether the risks are substantial and further use should be banned to prevent harm to man and/or to the environment, and results in a decision as to whether measures to restrict the use of a substance is necessary (Article 53). Substances included in Annex XIV (the list of substances subject to authorization) may not be banned by other regulations before the authorization process is finalized. In most cases, the first driver for identifying a substance as a candidate for Annex XIV inclusion is expected to come from the evaluation process and will be initiated by national authorities. A committee comprising Member States and EU Commission representatives will decide whether candidate substances should be listed in Annex XIV, taking into account comments from interested parties that may be made during a 3 month consultation period earlier to the decision. The process will be co-ordinated by the European Chemical Agency, which will also have to oversee communications between all actors. The decision to ban or restrict the use of a substance will be made by the Commission. Presently, about 1000 substances within the EINECS list fulfils the criteria of Annex XIII for substances of concern (PBT, vpvb). The PBT criteria are fulfilled when a substance has a half-life above 40 days in water (above 60 days in marine water), above 120 days in fresh water and estuarine sediment and soil (above 180 days in marine sediment) and a bioconcentration factor above 2000 and is toxic. The criteria for toxic are NOEC (No Observed Effect Concentration) for water organisms below 0.01 mg/l or carcinogenic (class 1 and 2), mutagenic (class 1 and 2), or toxic for reproduction (class 1, 2 and 3) and are classified as toxic because of severe health damage after repeated contact (risk phrases T, R48 or Xn R48; tests by oral route, by inhalation, by dermal route) according to Directive 67/548/EEC. The vp criterion is fulfilled when the half-life of a substance is above 60 days in water and 180 days in sediment or soil. The vb criterion is fulfilled when the bioconcentration factor is above vpvb means that vp and vb are fulfilled. Because other candidate substances will be detected in the course of the evaluation process, the overall number of substances expected to be listed in Annex XIV is currently expected to approach Annex XIV listed substances have to be fully evaluated for their risk that will need time and expertise. The time lines needed for risk assessment and peer review of the data in previous initiatives are about full substance evalua-

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