Without affecting the obligations of downstream users laid down in Article 35 of this Regulation, the part of the registration number referring to the individual registrant of a joint submission may be omitted by a supplier who is a distributor or a downstream user provided that: (a) this supplier assumes the responsibility to provide the full registration number upon request for enforcement purposes or, if the full registration number is not available to him, to forward the request to his supplier, in line with point (b); and (b) this supplier provides the full registration number to the Member State authority responsible for enforcement (the enforcement authority) within 7 days upon request, received either directly from the enforcement authority or forwarded by his recipient, or, if the full registration number is not available to him, this supplier shall forward the request to his supplier within 7 days upon request and at the same time inform the enforcement authority thereof. A single safety data sheet may be provided to cover more than one substance or mixture where the information in that safety data sheet fulfils the requirements of this Annex for each of those substances or mixtures. Other means of identification Other names or synonyms by which the substance or mixture is labelled or commonly known, such as alternative names, numbers, company product codes, or other unique identifiers may be provided. Relevant identified uses of the substance or mixture and uses advised against At least the identified uses relevant for the recipient(s) of the substance or mixture shall be indicated. This shall be a brief description of what the substance or mixture is intended to do, such as ‘flame retardant’, ‘antioxidant’. The uses which the supplier advises against and the reasons why shall, where applicable, be stated. This need not be an exhaustive list. Where a chemical safety report is required, the information in this subsection of the safety data sheet shall be consistent with the identified uses in the chemical safety report and the exposure scenarios from the chemical safety report set out in the annex to the safety data sheet. Details of the supplier of the safety data sheet The supplier and/or only representative shall be identified. The full address and telephone number of the supplier shall be given as well as an e-mail address for a competent person responsible for the safety data sheet. For registrants, the information shall be consistent with the information on the identity of the manufacturer or importer provided in the registration.
For a mixture meeting the criteria for classification in accordance with By-law on Classification, Labelling and Packaging of Substances and Mixtures, the following substances shall be indicated, together with their concentration or concentration range in the mixture: a) substances presenting a health or environmental hazard within the meaning of By-law on Classification, Labelling and Packaging of Substances and Mixtures, if those substances are present in concentrations equal to or greater than the lowest of any of the following: ia) the generic cut-off values set out in Table 1.1 of Annex I to By-law on Classification, Labelling and Packaging of Substances and Mixtures; ib) the generic concentration limits given in parts 3 to 5 of Annex I to By-law on Classification, Labelling and Packaging of Substances and Mixtures, taking into account the concentrations specified in the notes to certain tables in part 3 in relation to the obligation to make available a safety data sheet for the mixture upon request, and for aspiration hazard (Section 3.10 of Annex I to same By-law) ≥ 10 %; List of hazard classes, hazard categories and concentration limits for which a substance shall be listed as a substance in a mixture in subsection 3.2 1.1 Hazard class and category Concentration limit (%) Acute toxicity, category 1, 2 and 3 ≥ 0,1 Acute toxicity, category 4 ≥ 1 Skin corrosion/irritation, category 1, sub-categories 1A, 1B, 1C and category 2 ≥ 1 Serious damage to eyes/eye irritation, category 1 and 2 ≥ 1 Respiratory/skin sensitisation ≥ 0,1 Germ cell mutagenicity category 1A and 1B ≥ 0,1 Germ cell mutagenicity category 2 ≥ 1 Carcinogenicity category 1A, 1B and 2 ≥ 0,1 Reproductive toxicity, category 1A, 1B, 2 and effects on or via lactation ≥ 0,1 Specific target organ toxicity (STOT) — single exposure, category 1 and 2 ≥ 1 Specific target organ toxicity (STOT) — repeated exposure, category 1 and 2 ≥ 1 Aspiration hazard ≥ 10
9.1.3. Short-term toxicity testing on fish: the registrant may consider long-term toxicity testing instead of short-term. 9.1.4. Activated sludge respiration inhibition testing 9.1.3. The study does not need to be conducted if: — there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes, or — a long-term aquatic toxicity study on fish is available. Long-term aquatic toxicity testing as described in Annex IX shall be considered if the chemical safety assessment according to Annex I indicates the need to investigate further effects on aquatic organisms. The choice of the appropriate test(s) will depend on the results of the chemical safety assessment. 9.1.4. The study does not need to be conducted if: — there is no emission to a sewage treatment plant, or — there are mitigating factors indicating that microbial toxicity is unlikely to occur, for instance the substance is highly insoluble in water, or — the substance is found to be readily biodegradable and the applied test concentrations are in the range of concentrations that can be expected in the influent of a sewage treatment plant. The study may be replaced by a nitrification inhibition test if available data show that the substance is likely to be an inhibitor of microbial growth or function, in particular nitrifying bacteria. 9.2. Degradation 9.2.1. Abiotic 9.2. Further degradation testing shall be considered if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance. The choice of the appropriate test(s) will depend on the results of the chemical safety assessment. 9.2.1.1. Hydrolysis as a function of pH. 9.2.2.1. The study does not need to be conducted if: — the substance is readily biodegradable, or — the substance is highly insoluble in water. 9.3. Fate and behaviour in the environment 9.3.1. Adsorption/desorption screening 9.3.1. The study does not need to be conducted if:
on the basis of all available data, including toxicokinetic evidence. If no clear conclusions about germ cell mutagenicity can be made, additional investigations shall be considered. 8.6.3. A long-term repeated toxicity study (≥ 12 months) may be proposed by the registrant or required by the Ministry in accordance with Articles 36 or 37 if the frequency and duration of human exposure indicates that a longer term study is appropriate and one of the following conditions is met: — serious or severe toxicity effects of particular concern were observed in the 28-day or 90-day study for which the available evidence is inadequate for toxicological evaluation or risk characterisation, or — effects shown in substances with a clear relationship in molecular structure with the substance being studied were not detected in the 28-day or 90-day study, or — the substance may have a dangerous property that cannot be detected in a 90-day study. 8.7. Reproductive toxicity 8.6.4. Further studies shall be proposed by the registrant or may be required by the Ministry in accordance with Articles 36 or 37 in case of: — toxicity of particular concern (e.g. serious/severe effects), or — indications of an effect for which the available evidence is inadequate for toxicological evaluation and/or risk characterisation. In such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity), or — particular concern regarding exposure (e.g. use in consumer products leading to exposure levels which are close to the dose levels at which toxicity is observed). 8.7. The studies need not be conducted if: — the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented, or
ANNEX XIV LIST OF SUBSTANCES SUBJECT TO AUTHORISATION Entry Nr Substance Intrinsic referred to in Article 47 Transitional arrangements Exempted (categories of) uses Review periods Latest application date Sunset date Note: List of Substances subject to Authorisation shall be published in the Ministry’s website.
wood placed on the market is individually labelled ‘For professional and industrial installation and use only, contains arsenic’. In addition, all wood placed on the market in packs shall also bear a label stating ‘Wear gloves when handling this wood. Wear a dust mask and eye protection when cutting or otherwise crafting this wood. Waste from this wood shall be treated as hazardous by an authorised undertaking’. (ç) Treated wood referred to under point (a) shall not be used: — in residential or domestic constructions, whatever the purpose, — in any application where there is a risk of repeated skin contact, — in marine waters, — for agricultural purposes other than for livestock fence posts and structural uses in accordance with point (b), — in any application where the treated wood may come into contact with intermediate or finished products intended for human and/or animal consumption. 5. Wood treated with arsenic compounds that was in use before 01 January 2014, or that was placed on the market in accordance with paragraph 4 may remain in place and continue to be used until it reaches the end of its service life. 6. Wood treated with CCA type C that was in use before 01 January 2014, or that was placed on the market in accordance with paragraph 4: — may be used or reused subject to the conditions pertaining to its use listed under points 4(b), (c) and (ç), — may be placed on the market subject to the conditions pertaining to its use listed under points 4(b), (c) and (ç). 7. Wood treated with other types of CCA solutions that was in use before 01 January 2014 shall be permited to be used in the following conditions: — to be used or reused subject to the conditions pertaining to its use listed under points 4 (b), (c) and (ç), — to be placed on the market subject to the conditions pertaining to its use listed under points 4(b), (c) and (ç). 20. Organostannic compounds 1. Shall not be placed on the market, or used, as substances or in mixtures where the substance or
EXAMINATION SUBJECTS AND SCORING Examination shall consist of 25 multiple-choice question (with at least 4 choices) and 5 classic questions. Number of questions and scoring of the multiple-choice and classic questions according to subject headings is given in Table-1. In scoring, only right answers shall be taken into account, wrong answers will not affect the scoring of the right answers. Table-1. Number of Competency examination test questions per subject heading and scoring. Subject headings of test questions Number of questions Score Total score Legislation 15 2 30 Chemicals management 2 2 4 Classification knowledge 8 2 16 Classic: Human health risk assessment Environmental risk assessment Exposure scenarios CSA/CSR Preparation of SDS Preparation of registration dossier 1 1 1 1 1 1 10 10 10 10 5 5 10 10 10 10 5 5 6 50 TOTAL SCORE 100