[ANNEX I U.K. GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS
0. INTRODUCTION U.K.
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. 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. U.K.
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. U.K.
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 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. U.K.
0.4. Substances whose physicochemical, toxicological and ecotoxicological 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. U.K.
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. U.K.
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. 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.
0.6. A chemical safety assessment performed by a manufacturer or an importer for a substance shall include the following steps in accordance with the respective sections of this Annex: U.K.
1.
Human health hazard assessment.
2.
Human health hazard assessment of physicochemical properties.
3.
Environmental hazard assessment.
4.
PBT and vPvB assessment.
If as a result of steps 1 to 4 the manufacturer or importer concludes that the substance or the [mixture] meets the criteria for classification as dangerous according to Directive 67/548/EEC or Directive 1999/45/EC or is assessed to be a PBT or vPvB, the chemical safety assessment shall also consider the following steps:
5.
Exposure assessment
5.1.
The generation of exposure scenario(s) or the generation of relevant use and exposure categories if appropriate.
A summary of all the relevant information used in addressing the points above, shall be presented under the relevant heading of the Chemical Safety Report (Section 7).
0.7. The main element of the exposure part of the chemical safety report is the description of the exposure scenario(s) implemented for the manufacturer's production, the manufacturer or importer's own use, and those recommended by the manufacturer or importer to be implemented for the identified use(s). U.K.
An exposure scenario is the set of conditions that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment. These sets of conditions contain a description of both the risk management measures and operational conditions which the manufacturer or importer has implemented or recommends to be implemented by downstream users.
If the substance is placed on the market, the relevant exposure scenario(s), including the risk management measures and operational conditions shall be included in an annex to the safety data sheet in accordance with Annex II.
0.8. The level of detail required in describing an exposure scenario will vary substantially from case to case, depending on the use of a substance, its hazardous properties and the amount of information available to the manufacturer or importer. Exposure scenarios may describe the appropriate risk management measures for several individual processes or uses of a substance. An exposure scenario may thereby cover a large range of processes or uses. Exposure scenarios covering a wide range of processes or uses may be referred to as Exposure Categories. Further mention of Exposure Scenario in this Annex and Annex II includes Exposure Categories if they are developed. U.K.
0.9. Where information is not necessary in accordance with Annex XI, this fact shall be stated under the appropriate heading of the chemical safety report and a reference shall be made to the justification in the technical dossier. The fact that no information is required shall also be stated in the safety data sheet. U.K.
0.10. In relation to particular effects, such as ozone depletion, photochemical ozone creation potential, strong odour and tainting, for which the procedures set out in Sections 1 to 6 are impracticable, the risks associated with such effects shall be assessed on a case-by-case basis and the manufacturer or importer shall include a full description and justification of such assessments in the chemical safety report and summarised in the safety data sheet. U.K.
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. U.K.
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. U.K.
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).] U.K.