Annex II - List of enforceable provisions of REACH and CLP

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1 Annex II - List of enforceable provisions of REACH and CLP The provisions below are listed according to the sections of the main report, together with the Titles of the Regulation in the case of REACH. Table 1 - Section Title II Registration of substances Key Provisions 5 Prohibition on manufacture or placing on the market of substances on their own, in mixtures or in articles unless they have been registered 6 (1) Requirement on a manufacturer or importer of a substance, either on its own or in one or more mixture(s), in quantities of one tonne or more per year to submit a registration to the Agency. 6(2) Obligation to register for monomers that are used as on-site intermediates or transported isolated intermediates 6(3) Requirement on a manufacturer or importer of a polymer to submit a registration to the Agency for the monomer substance(s) or any other substance(s) that have not already been registered by an actor up the supply chain (under conditions). 7(1) Requirement on a producer or importer of articles to submit a registration to the Agency for any substance contained in those articles (under conditions). 7(2) and Requirement on a producer or importer of an article to notify the Agency of information provided in (4) 7(4). 7(3) Requirement on a producer or importer to supply appropriate instructions to the recipient of the article. 7(5) A registration shall be submitted if the Agency takes this decision based on the criteria set in 7(5). 10 The information to be submitted for registration shall contain the technical dossier and the CSR. 12(1) Requirement to include in the technical dossier all physicochemical, toxicological and ecotoxicological information that is relevant and available to the registrant. 12(2) Requirement on a manufacturer and importer to notify ECHA with additional information where it reaches the next tonnage threshold 14(1), (3) and (4) A CSA shall be performed and a CSR completed for all substances subject to registration in accordance with this Chapter in quantities of 10 tonnes or more per year per registrant. The CSA shall follow the steps described in 14(3) and the additional steps of 14(4) if the substance is classified as dangerous according to D.67/548/EEC or is a PBT or vpvb 14(6) Requirement on a registrant to identify and apply the appropriate measures to adequately control the risks identified in the CSA and where suitable recommend them in SDS. 14(7) The CSR shall be kept available and up to date. 17(1) and (2) Requirement on a manufacturer to register on-site isolated intermediate manufactured in quantities of one tonne or more per year. Registration shall include information as listed in 17(2). 18(1), (2) and (3) Requirement on a manufacturer to register transported isolated intermediate manufactured or imported in quantities of one tonne or more per year. Registration shall include information as listed in 18(2). Requirements on manufacturers registering transported isolated intermediate manufactured or imported in quantities of more than 1000 tonnes per year to include information specified in Annex VII. 20(2) Requirement to complete the registration and to submit it to ECHA within the deadline set in case of incomplete registration. 21(1) Prohibition to start or continue the manufacture or import of a substance or production or import of an article within three weeks of the registration submission date, if ECHA so indicates 21(2) If ECHA has informed the registrant that he is to submit further information and further information has been submitted, prohibition to start the manufacture or import of a substance or production or import of an article, if ECHA so indicates 22(1) Requirement on a registrant to update its registration whenever needed. 22(2) Requirement on a registrant to submit ECHA an updated registration providing information as required by a decision. 24(2) Requirement on a registrant to notify, in accordance with articles 10 and 12, where the quantity of a notified substance reaches the next tonnage threshold. Inspections requirements for REACH and CLP/1

2 Table 2 Section Title VI Evaluation Key Provisions 40(4) Requirement on a downstream user and the registrant to submit information required regarding testing proposals to ECHA. 41(4) Requirement on a registrant to submit information required after compliance check of registrations by ECHA to the Agency. 46(2) Requirement on a registrant to submit further information in accordance with the decision prepared by the competent authority during a substance evaluation. Table 3 Section Classification , 9.2 and Key Provisions (CLP) Requirement that manufacturers, importers and downstream users ( MIDs ) classify substances before placing them on the market Requirement that manufacturers, producers and importers classify those substances not placed on the market where Regulation 1907/2006 provides for their registration or notification. Requirement to classify a substance subject to harmonised classification and labelling through an entry in Part 3 of Annex VI in accordance with that entry. Where the substance also falls within one or more hazard classes or differentiations not covered by an entry in Part 3 of Annex VI, requirement to classify under Title II (hazard classification) for those hazard classes or differentiations. Prohibition to place on the market mixtures referred to in Part 2 of Annex II containing any substances classified as hazardous, unless they are labelled in accordance with Title III (hazard communication in the form of labelling). Requirement to classify, label and package articles referred in section 2.1 of Annex I (explosives) in accordance with the rules for substances and mixtures before being placed on the market. Requirement that MIDs of a substance identify the relevant available information to determine whether the substance entails a physical, health or environmental hazard; in addition, requirement that they ascertain whether such information is adequate, reliable and scientifically valid for the purpose of the evaluation. Requirement that MIDs identify relevant available information on the mixture itself or the substances contained in it for the purpose of determining whether the mixture entails a physical, health or environmental hazard.. For the evaluation of mixtures in relation to germ cell mutagenicity, carcinogenicity and reproductive toxicity hazard classes, and in relation to the biodegradation and bioaccumulation properties within the hazardous to the aquatic environment hazard class, MIDs shall only use this information. Where no or inadequate test data on the mixture itself are available, MIDs shall use other available information on individual substances and similar tested mixtures.. Requirement to undertake tests on animals only where no other alternatives are possible; Prohibition of tests on on non-human primates; Prohibition of tests on humans. Requirement that the information identified with regards to a substance or mixture in the form it is placed on the market be evaluated so as to ascertain the hazards associated with the substance or mixture. When the criteria cannot be applied directly to the identified information MIDs shall carry out an evaluation by applying a weight of evidence determination using expert judgment, thus weighing all available information having a bearing on the determination of the hazards. Requirement to apply the bridging principles when, due to the absence of relevant data or inadequateness of the already existing data, they revert to other available information on individual substances and similar tested mixtures. Requirement to set specific concentration limits where adequate and reliable information shows that the hazard of a substance is evident when the substance is present in a mixture at certain levels. Requirement to establish M-factors for substances classified as hazardous to the aquatic environment, acute category 1 or chronic category 1. Requirement to take cut-off values into account for the purposes of classification where a substance or mixture contains another substance classified as as hazardous. Requirement to take into account further information which reveals that the information on which the classification was based is incorrect. Inspections requirements for REACH and CLP/2

3 Key Provisions (CLP) If a substance or mixture meets the criteria for classification in one or more hazard classes or differentiations, requirement to classify the substance or mixture by assigning (a) one or more hazard 13 categories for each relevant hazard class or differentiation; and (b) one or more hazard statements corresponding to each hazard category assigned in accordance with (a). 14 Specific rules for the classification of mixtures Requirement that MIDs take reasonable steps to become aware of new scientific or technical 15.1 information that may affect the classification of the substances or mixtures they place on the market, and to carry out a new evaluation when new and reliable information becomes available Requirement that MIDs carry out a new evaluation when introducing changes to a mixture classified as hazardous and to adapt its classification in accordance with the results of the new evaluation unless there is valid scientific justification that this change will not result in a change of classification. Requirement that MIs of (a) substances subject to REACH registration and (b) substances within the scope of 1 which meet criteria for classification as hazardous and are placed on the market to notify and update the Agency concerning certain information regarding such substances/mixtures to be included in the classification and labelling inventory. Table 4 Section Title IV Information in the supply chain Key Provisions 31(1) Requirement on a supplier of a substance or a mixture to provide recipient with a SDS compiled in accordance with Annex II. 31(2) Requirement on any actor in the supply chain who has been requested to perform a CSA to ensure that information in the SDS is consistent with the information in the assessment. 31(3) Requirement on a supplier to provide a SDS when requested for a mixture which falls within paragraph 3. 31(5) The SDS shall be provided in the language of the Member State concerned. 31(6) The SDS shall contain the information listed in article 31(6). 31(7) Requirement on actors in the supply chain to place the relevant exposure scenarios in an annex to the SDS. Requirement on a downstream user to include the exposure scenarios in their own SDS for identified uses. Requirement on a distributor to pass on relevant exposure scenarios and use other relevant information from the SDS when compiling his own safety data sheet. 31(8-9) The SDS shall be provided free of charge either electronically or on paper. Requirement on a supplier to update the SDS and provide it free of charge to all former recipients. 32 (1) Requirement on a supplier of a substance or a mixture who does not have to supply a SDS to provide the recipient with the information in paragraph (1). 33(1 and Requirement on a supplier of an article containing substances on the candidate list to provide the 2) recipient with sufficient information to allow safe use, including as a minimum the name of that substance. Requirement on a supplier of an article containing substances on the candidate list to provide a consumer on request with sufficient information to allow safe use, including as a minimum the name of that substance, free of charge and within 45 days of the request 34 Requirement on every actor (including distributor) in the supply chain to communicate new information on hazardous properties, regardless of the uses concerned, or any other information that might call into question the appropriateness of the risk management measures identified in the SDS communicated for identified uses to the next actor or distributor up the supply chain. 35 Requirement on an employer to provide workers and their representatives with access to information received in accordance with articles 31 and 32 in relation to substances or mixtures which they may use or be exposed to in the course of their work. Table 5 Section Title VII Authorisation and Title VIII Restrictions Key Provisions 56(1) Requirements on manufacturers, importers or downstream users not to place a substance on the market for a use or use it itself if that substance is included in Annex XIV unless sub-paragraph (a), (b), (c), (d) Inspections requirements for REACH and CLP/3

4 Key Provisions or (e) are satisfied. 65 Requirement on a holder of an authorisation and downstream users to include the authorisation number on the label before they place the substance or mixture on the market for an authorised use. 67(1) Prohibition on the manufacture, placing on the market or use of a substance on its own, in a mixture or in an article for which Annex XVII contains a restriction unless the manufacture, placing on the market or use of a substance on its own complies with the conditions of that restriction. Table 6 Section Labelling & packaging requirements under CLP Key Provisions (CLP) 4.4 Requirement that suppliers ensure that hazardous substances are labelled and packaged in accordance with Titles III and IV before placing them on the market. 4.9 Requirement that suppliers in a supply chain cooperate to meet the requirements for classification, labelling and packaging of this Regulation Substances and mixtures may not be placed on the market unless they comply with CLP General rules on the content of the label, including the requirement that substances or mixtures classified as hazardous must bear a label with the information specified, and the label must be in the official language(s) of the Member State(s) where the substance is placed on the market. Requirement to include specific details on labels to enable the identification of the substances and mixtures. Requirement to include the hazard relevant pictograms on the label of packages containing hazardous substances/mixtures to convey specific information on the hazards concerned. Requirement to include on labels the relevant signal words in accordance with the classification of the hazardous substance or mixture. Requirement to include on labels the relevant hazard statements in accordance with the classification of the hazardous substance or mixture following the rules set in Annexes I and III. 22 Requirement to include on labels precautionary statements in accordance with Annexes I and IV Obligation to include supplemental information on the label when (a) a hazardous substance or mixture has specific physical or health properties or (b) when the substance or mixture classified as hazardous falls within the scope of the Plant Protection Products Directive. The supplier may include other supplemental information as long as such additional information does not make it more difficult to identify the label elements and does not contradict or casts doubt on the validity of the information. Obligation not to include in the supplemental information section statements that are inconsistent with the classification of the substance or mixture. Where a mixture contains a substance classified as hazardous it shall be labelled in accordance with Part 2 of Annex II on Special rules for labelling and packaging of certain substances and mixtures, and any statements will be placed in the supplemental information section; in addition, the label shall contain the product identifier and the contact information of the supplier. Specific principles of precedence for hazard pictograms, hazard statements and precautionary statements. Requirement that suppliers ensure that the label is updated following any change to the classification and labelling of that substance or mixture where the new hazard is more severe or new supplemental elements are required considering the nature of the change as regards the protection of human health and the environment. General rules regarding the presentation of the label and the elements it contains as well as its affixation on the packaging. 32 Specific rules regarding the location of the information required to appear on the label Specific rules for labelling of outer packaging, inner packaging and single packaging 33.3 Single packages that meet the labelling requirements of the rules on the transport of dangerous goods shall be labeled in accordance with this Regulation and the rules on the transport of dangerous goods. 35 Specific requirements for packages containing hazardous substances or mixtures. Inspections requirements for REACH and CLP/4

5 Table 7 Section Title V Downstream users Key Provisions 39 states that downstream users shall comply with the 37 obligations at the latest months after receiving a registration number. Requirement on downstream user to identify and apply appropriate measures to adequately control risks identified in (a) an SDS supplied to it: (b) its own chemical safety assessment or (c) any information 37(5) received in accordance with article 32. Requirement on downstream user to recommend, where suitable, measures to adequately control the risks identified in (a) an SDS supplied to it; (b) its own chemical safety assessment or (c) any information received in accordance with article 32. Right of a downstream user to make a use known in writing to his manufacturer, importer, downstream 37(2) user or distributor with the aim of making it an identified use. Requirements on distributors to pass on such information to the next actor up the supply chain. Requirement on a downstream user to prepare a CSR in accordance with Annex XII for any use outside 37(4) either the conditions described in an exposure scenario or a use and exposure category in a SDS or for any use his supplier advises against. Requirement on a downstream user to identify and apply appropriate risk management measures needed 37(6) to ensure that the risks to human health and the environment are adequately controlled. 37(7) Requirement on downstream users to keep their chemical safety report up to date and available. 39 states that downstream users shall comply with the 38 obligations at the latest 6 39 months after receiving a registration number. Requirement that downstream user, in the cases specified in this paragraph report information in article 38(1) 38(2) to ECHA before commencing or continuing with a particular use of a substance that has been registered by an actor up the supply chain. 38(2) Non-exhaustive list of information to be provided by the downstream user under 38(1) Requirement that downstream user update the information provided in article 38(2) without delay in the 38(3) event of a change in information. Requirement that a downstream user report to ECHA if its classification of a substance is different to 38(4) that of its supplier. Table 8 - Section Title VII Authorisation Key Provisions 55 Requirement on all manufacturers, importers and downstream users applying for authorisations to analyse the availability of alternatives and consider their risks, and the technical and economic feasibility of substitution. 56(1) Requirements on manufacturers, importers or downstream users not to place a substance on the market for a use or use it itself if that substance is subject to authorisation unless it is (a) authorised, (b) exempted from authorisation, (c) and (d) subject to certain transitional arrangements or (e) placed on the market and authorisation has been granted to the immediate downstream user. 56(2) Requirements on downstream users not to use a substance otherwise than in accordance with the conditions of an authorisation granted to an actor up his supply chain for that use. 60(8) Requirement to ensure the respect of the conditions linked to the authorisation. 60(10) Requirement on a holder of an authorisation to ensure that the exposure is reduced to as low a level as is technically and practically possible. 66(1) Requirement on a downstream user using a substance in accordance with article 56(2) to notify ECHA within three months of the first supply. Table 9 Section Labelling & packaging requirements under CLP Key Provisions (CLP) 4.1 Requirement that MIDs classify substances before placing them on the market Suppliers must ensure that hazardous substances are labelled and packaged in accordance with Titles III and IV before placing them on the market. Downstream users, in fulfilling their responsibilities under 4.1 and 4.4 may use the classification of a substance or mixture derived by an actor in the supply chain, provided that they do not change the composition of the substance or mixture. Inspections requirements for REACH and CLP/5

6 Inspections requirements for REACH and CLP/6