Annex I

02006R1907-20191030 → 02006R1907-20200101

ANNEX I GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS 0. INTRODUCTION 0.1. The purpose of this Annex is to set out how manufacturers and importers are to assess and document that the risks arising from the substance they manufacture or import are adequately controlled during manufacture and their own use(s) and that others further down the supply chain can adequately control the risks. The chemical safety report shall also describe whether and which different nanoforms of substances as characterised in Annex VI are manufactured and imported, including an adequate justification for each information requirement describing when and how information on one form is used to demonstrate safety of other forms. The requirements speof the following hazard classes or categories setcific to nanoforms of a substance in this Annex apply to all nanoforms covered by the registration and without prejudice to requirements applicable to other forms of that substance. This Annex shall also apply adapted as necessary to producers and importers of articles required to make a chemical safety assessment as part of a registration. 0.2. The chemical safety assessment shall be prepared by one or more competent person(s) who have appropriate experience and received appropriate training, including refresher training. 0.3. The chemical safety assessment of a manufacturer shall address the manufacture of a substance and all the identified uses. The chemical safety assessment of an importer shall address all identified uses. The chemical safety assessment shall consider the use of the substance on its own (including any major impurities and additives), in a mixture and in an article, as defined by the identified uses. The assessment shall consider all stages of the life-cycle of the substance resulting from the manufacture and identified uses. The assessment shall address all nanoforms that are covered by the registration. The justifications and conclusions drawn from the assessment shall be relevant to these nanoforms. The chemical safety assessment shall be based on a comparison of the potential adverse effects of a substance with the known or reasonably foreseeable exposure of man and/or the environment to that substance taking into account implemented and recommended risk management measures and operational conditions. 0.4. Substances whose physicochemical, toxicological and ecotoxicological eco-toxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or category of substances. If the manufacturer or importer considers that the chemical safety assessment carried out for one substance is sufficient to assess and document that the risks arising from another substance or from a group or category of substances are adequately controlled then he can use that chemical safety assessment for the other substance or group or category of substances. The manufacturer or importer shall provide a justification for this. Where any of the substances exists in one or more nanoforms and data from one form are used in demonstration of the safe use of other forms, in accordance with the general rules set out in Annex XI, a scientific justification shall be given on how, applying the rules for grouping and read-across, the data from a specific test or other information (e.g. methods, results or conclusions) can be used for the other forms of the substance. Similar considerations apply to exposure scenarios and risk management measures. 0.5. The chemical safety assessment shall be based on the information on the substance contained in the technical dossier and on other available and relevant information. Manufacturers or importers submitting a proposal for testing in accordance with Annexes IX and X shall record this under the relevant heading of the chemical safety report. Available information from assessments carried out under other international and national programmes shall be included. Where available and appropriate, an assessment carried out under Community legislation (e.g. risk assessments completed under Regulation (EEC) No 793/93) shall be taken into account in the development of, and reflected in, the chemical safety report. Deviations from such assessments shall be justified. Thus the information to be considered includes information related to the hazards of the substance, the exposure arising from the manufacture or import, the identified uses of the substance, operational conditions and risk management measures applied or recommended to downstream users to be taken into account. In accordance with section 3 of Annex XI in some cases, it may not be necessary to generate missing information, because risk management measures and operational conditions which are necessary to control a well-characterised risk may also be sufficient to control other potential risks, which will not therefore need to be characterised precisely. If the manufacturer or importer considers that further information is necessary for producing his chemical safety report and that this information can only be obtained by performing tests in accordance with Annex IX or X, he shall submit a proposal for a testing strategy, explaining why he considers that additional information is necessary and record this in the chemical safety report under the appropriate heading. Where considered necessary, the proposal for a testing strategy may concern several studies addressing respectively different forms of the same substance for the same information requirement. While waiting for results of further testing, he shall record in his chemical safety report, and include in the exposure scenario developed, the interim risk management measures that he has put in place and those he recommends to downstream users intended to manage the risks being explored. The exposure scenarios and interim risk management measures recommended shall address all nanoforms that are covered by the registration. 0.6. Steps of a chemical safety assessment 0.6.1. A chemical safety assessment performed by a manufacturer or an importer for a substance shall include the following steps 1 to 4 in accordance with the respective sections of this Annex: 1. Human health hazard assessment. 2. Human health hazard assessment of physicochemical properties. 3. Environmental hazard assessment. 4. PBT and vPvB assessment. 0.6.2. In the cases referred to in point 0.6.3 the chemical safety assessment shall also include the following steps 5 and 6 in accordance with Sections 5 and 6 of this Annex: 5. Exposure assessment. 5.1. The generation of exposure scenario(s) (or the identification of relevant use and exposure categories, if appropriate). 5.2. Exposure estimation. 6. Risk characterisation. 0.6.3. Where as a result of steps 1 to 4 the manufacturer or importer concludes that the substance or, when applicable, nanoforms thereof fulfils the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008 or is assessed to be a PBT or vPvB, the chemical safety assessment shall also include steps 5 … 474 unchanged words … the safety data sheet. 0.11. When assessing the risk of the use of one or more substances incorporated into a special mixture (for instance alloys), the way the constituent substances are bonded in the chemical matrix shall be taken into account. 0.11.bis When nanoforms are covered by the chemical safety assessment, an appropriate metric for the assessment and presentation of the results in steps 1-6 of the chemical safety assessment under 0.6.1 and 0.6.2 shall be considered, with the justification included in the chemical safety report and summarised in the safety data sheet. A multiple metric presentation, including mass metric information, is preferable. When possible, a method for reciprocal conversion shall be indicated. 0.12. Where the methodology described in this Annex is not appropriate, details of alternative methodology used shall be explained and justified in the chemical safety report. 0.13. Part A of the chemical safety report shall include a declaration that the risk management measures outlined in the relevant exposure scenarios for the manufacturer's or importer's own use(s) are implemented by the manufacturer or importer and that those exposure scenarios for the identified uses are communicated to distributors and downstream users in the safety data sheet(s). 1. HUMAN HEALTH HAZARD ASSESSMENT 1.0. Introduction 1.0.1. The objectives of the human health hazard assessment shall be to determine the classification of a substance in accordance with Regulation (EC) No 1272/2008; and to derive levels of exposure to the substance above which humans should not be exposed. This level of exposure is known as the Derived No-Effect Level (DNEL). 1.0.2. The human health hazard assessment shall consider the toxicokinetic profile (i.e. absorption, metabolism, distribution and elimination) of the substance and the following groups of effects: (1) acute effects such as acute toxicity, irritation and corrosivity; (2) sensitisation; (3) repeated dose toxicity; and (4) CMR effects (carcinogenity, germ cell mutagenicity and toxicity for reproduction). Based on all the available information, other effects shall be considered when necessary. 1.0.3. The hazard assessment shall comprise the following four steps: Step 1 Evaluation of non-human information. Step 2 Evaluation of human information. Step 3 Classification and Labelling. Step 4 Derivation of DNELs. The assessment shall address all nanoforms that are covered by the registration. 1.0.4. The first three steps shall be undertaken for every effect for which information is available and shall be recorded under the relevant section of the Chemical Safety Report and where required and in accordance with Article 31, summarised in … 538 unchanged words … and Articles 4 to 7 of Directive 1999/45/EC shall be presented and, if they are not included in Part 3 of Annex VI to Regulation (EC) No 1272/2008, justified. The assessment should always include a statement as to whether the substance or, when applicable, nanoforms thereof fulfils or does not fulfil the criteria given in Regulation (EC) No 1272/2008 for classification in the hazard class carcinogenicity category 1A or 1B, in the hazard class germ cell mutagenicity category 1A or 1B or in the hazard class reproductive toxicity category 1A or 1B. 1.3.2. If the information is inadequate to decide whether a substance or, when applicable, nanoforms thereof should be classified for a particular hazard class or category, the registrant registrants shall indicate and justify the action or decision he has taken as a result. 1.4. Step 4 Identification of DNEL(s) 1.4.1. Based on the outcomes of steps 1 and 2, (a) DNEL(s) shall be established for the substance, reflecting the likely route(s), duration and frequency of exposure. For some hazard classes, especially germ cell mutagenicity and carcinogenicity, the available information may not enable a toxicological threshold, and therefore a DNEL, to be established. If justified by the exposure scenario(s), a single DNEL may be sufficient. However, taking into account the available information and the exposure scenario(s) in Section 9 of the Chemical Safety Report it may be necessary to identify different DNELs for each relevant human population (e.g. workers, consumers and humans liable to exposure indirectly via the environment) and possibly for certain vulnerable sub-populations (e.g. children, pregnant women) and for different routes of exposure. A full justification shall be given specifying, inter alia, the choice of the information used, the route of exposure (oral, dermal, inhalation) and the duration and frequency of exposure to the substance for which the DNEL is valid. If more than one route of exposure is likely to occur, then a DNEL shall be established for each route of exposure and for the exposure from all routes combined. When establishing the DNEL, the following factors shall, inter alia, be taken into account: (a) the uncertainty arising, among other factors, from the variability in the experimental information and from intra- and inter-species variation; (b) the nature and severity of the effect; (c) the sensitivity of the human (sub-)population to which the quantitative and/or qualitative information on exposure applies. 1.4.2. If it is not possible to identify a DNEL, then this shall be clearly stated and fully justified. 2. PHYSICOCHEMICAL HAZARD ASSESSMENT 2.1. The objective of the hazard assessment for physicochemical properties shall be to determine the classification of a substance in accordance with Regulation (EC) No 1272/2008. 2.2. As a minimum, the potential effects to human health shall be assessed for the following physicochemical properties: explosivity, flammability, oxidising potential. If the information is inadequate to decide whether a substance or, when applicable, nanoforms thereof should be classified for a particular hazard class or category, the registrant shall indicate and justify the action or decision he has taken as a result. 2.3. The assessment of each effect shall be presented under the relevant heading of the Chemical Safety Report (Section 7) and where required and in accordance with Article 31, summarised in the Safety Data Sheet under headings 2 and 9. 2.4. For every physicochemical property, the assessment shall entail an evaluation of the inherent capacity of the substance to cause the effect resulting from the manufacture and identified uses. 2.5. The appropriate classification developed in accordance with the criteria in Regulation (EC) No 1272/2008 shall be presented and justified. 3. ENVIRONMENTAL HAZARD ASSESSMENT 3.0. Introduction 3.0.1. The objective of the environmental hazard assessment shall be to determine the classification of a substance in accordance with Regulation (EC) No 1272/2008 and to identify the concentration of the substance below which adverse effects in the environmental sphere of concern are not expected to occur. This concentration is known as the Predicted No-Effect Concentration (PNEC). 3.0.2. The environmental hazard assessment shall consider the potential effects on the environment, comprising the (1) aquatic (including sediment), (2) terrestrial and (3) atmospheric compartments, including the potential effects that may occur (4) via food-chain accumulation. In addition, the potential effects on the (5) microbiological activity of sewage treatment systems shall be considered. The assessment of the effects on each of these five environmental spheres shall be presented under the relevant heading of the Chemical Safety Report (Section 7) and where required and in accordance with Article 31, summarised in the Safety Data Sheet under headings 2 and 12. The assessment shall address all nanoforms that are covered by the registration. 3.0.3. For any environmental sphere, for which no effect information is available, the relevant section of the chemical safety report shall contain the sentence: This information is not available. The justification, including reference to any literature research carried out, shall … 433 unchanged words … shall be presented and justified. Any M-factor resulting from the application of Article 10 of Regulation (EC) No 1272/2008 shall be presented and, if it is not included in Part 3 of Annex VI to Regulation (EC) No 1272/2008, justified. The presentation and justification is applied to all nanoforms covered by the registration. 3.2.2. If the information is inadequate to decide whether a substance or, when applicable, nanoforms thereof should be classified for a particular hazard class or category, the registrant shall indicate and justify the action or decision he has taken as a result. 3.3. Step 3 Identification of the PNEC 3.3.1. Based on the available information, the PNEC for each environmental sphere shall be established. The PNEC may be calculated by applying an appropriate assessment factor to the effect values (e.g. LC50 or NOEC). An assessment factor expresses the difference between effects values derived for a limited number of species from laboratory tests and the PNEC for the environmental sphereIn general, the more extensive the data and the longer the duration of the tests, the smaller is the degree of uncertainty and the size of the assessment factor. An assessment factor of 1000 is typically applied to the lowest of three short term L(E)C50 values derived from species representing different trophic levels and a factor of 10 to the lowest of three long-term NOEC values derived from species representing different trophic levels.. 3.3.2. If it is not possible to derive the PNEC, then this shall be clearly stated and fully justified. 4. PBT AND VPVB ASSESSMENT 4.0. Introduction 4.0.1. The objective of the PBT and vPvB assessment shall be to determine if the substance fulfils the criteria given in Annex XIII and if so, to characterise the potential emissions of the substance. A hazard assessment in accordance with Sections 1 and 3 of this Annex addressing all the long-term effects and the estimation of the long-term exposure of humans and the environment as carried out in accordance with Section 5 (Exposure Assessment), step 2 (Exposure Estimation), cannot be carried out with sufficient reliability for substances satisfying the PBT and vPvB criteria in Annex XIII. Therefore, a separate PBT and vPvB assessment is required. 4.0.2. The PBT and vPvB assessment shall comprise the following two steps, which shall be clearly identified as such in Part B, Section 8 of the Chemical Safety Report: report. The assessment shall address all nanoforms that are covered by the registration: Step 1 : Comparison with the Criteria. Step 2 : Emission Characterisation. The assessment shall also be summarised in the Safety Data Sheet under heading 12. 4.1. Step 1: Comparison with the criteria This part of the PBT and vPvB assessment shall entail the comparison of the available information with the criteria given in Section 1 of Annex XIII and a statement of whether the substance fulfils or does not fulfil the criteria. The assessment shall be conducted in accordance with the provisions laid down in the introductory part of Annex XIII as well as Sections 2 and 3 of that Annex. 4.2. Step 2: Emission Characterisation If the substance fulfils the criteria or it is considered as if it is a PBT or vPvB in the registration dossier an emission characterisation shall be conducted comprising the relevant parts of the exposure assessment as described in Section 5. In particular it shall contain an estimation of the amounts of the substance released to the different environmental compartments during all activities carried out by the manufacturer or importer and all identified uses, and an identification of the likely routes by which humans and the environment are exposed to the substance. The estimation shall address all nanoforms that are covered by the registration. 5. EXPOSURE ASSESSMENT 5.0. Introduction The objective of the exposure assessment shall be to make a quantitative or and qualitative estimate of the dose/concentration of the substance to which humans and the environment are or may be exposed. The assessment shall consider all stages of the life-cycle of the substance resulting from the manufacture and identified uses and shall cover any exposures that may relate to the hazards identified in Sections 1 to 4. The assessment shall address all nanoforms that are covered by the registration. The exposure assessment shall entail the following two steps, which shall be clearly identified as such in the Chemical Safety Report: Step 1 Generation of exposure scenario(s) or the generation of relevant use and exposure categories. Step 2 Exposure Estimation. Where required and in accordance … 555 unchanged words … resulting from identified uses cover, where relevant, the service-life of articles and the waste stage. The emission estimation shall be performed under the assumption that the risk management measures and operational conditions described in the exposure scenario have been implemented. When nanoforms are covered by the registration, the emission estimation for these shall, where relevant, take account of situations when the conditions outlined in Annex XI section 3.2 point (c) are fulfilled. 5.2.3. A characterisation of possible degradation, transformation, or reaction processes processes, and an estimation of environmental distribution and fate shall be performed. When nanoforms are covered by the registration, a characterisation of the dissolution rate, the particle aggregation, the agglomeration and of the particle surface chemistry changes shall be included. 5.2.4. An estimation of the exposure levels shall be performed for all human populations (workers, consumers and humans liable to exposure indirectly via the environment) and environmental spheres for which exposure to the substance is known or reasonably foreseeable. Each … 787 unchanged words … humans via the environment 10.2.2. Environment 10.2.2.1. Aquatic compartment (including sediment) 10.2.2.2. Terrestrial compartment 10.2.2.3. Atmospheric compartment 10.2.2.4. Microbiological activity in sewage treatment systems (etc.) 10.x. Overall exposure (combined for all relevant emission/release sources) 10.x.1. Human health (combined for all exposure routes) 10.x.1.1. 10.x.2. Environment (combined for all emission sources) 10.x.2.1.