... (d) persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment. ...

... 4. If, as a result of carrying out steps (a) to (d) of paragraph 3, the registrant concludes that the substance meets the criteria for classification as dangerous in accordance with Directive 67/548/EEC or is assessed to be a PBT or vPvB, the chemical safety assessment shall include the following additional steps: ...

... 1. The Agency shall examine any testing proposal set out in a registration or a downstream user report for provision of the information specified in Annexes IX and X for a substance. Priority shall be given to registrations of substances which have or may have PBT, vPvB, sensitising and/or carcinogenic, mutagenic or toxic for reproduction (CMR) properties, or substances classified as dangerous according to Directive 67/548/EEC above 100 tonnes per year with uses resulting in widespread and diffuse exposure. ...

... (a) PBT or vPvB properties; or ...

... 4. PBT and vPvB assessment. ...

... If as a result of steps 1 to 4 the manufacturer or importer concludes that the substance or the preparation 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: ...

... 4. PBT AND VPVB ASSESSMENT ...

... 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. ...

... 4.0.1. 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. ...

... 4.0.1. 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: ...

... This part of the PBT and vPvB assessment shall entail the comparison of the available information, which is submitted as part of the technical dossier, with the criteria given in Annex XIII and a statement of whether the substance fulfils or does not fulfil the criteria. ...

... If the technical dossier contains for one or more endpoints only information as required in Annexes VII and VIII, the registrant shall consider information relevant for screening for P, B and T properties to decide whether further information needs to be generated to fulfil the objective of the PBT and vPvB assessment. In case the generation of further information is necessary and would require testing on vertebrate animals, the registrant shall submit a testing proposal. However, such further information does not need to be generated if the registrant implements or recommends sufficient risk management measures and operational conditions that enable derogation according to Section 3 of Annex XI from testing relevant for PBT and vPvB assessment. ...

... If the technical dossier contains for one or more endpoints only information as required in Annexes VII and VIII, the registrant shall consider information relevant for screening for P, B and T properties to decide whether further information needs to be generated to fulfil the objective of the PBT and vPvB assessment. In case the generation of further information is necessary and would require testing on vertebrate animals, the registrant shall submit a testing proposal. However, such further information does not need to be generated if the registrant implements or recommends sufficient risk management measures and operational conditions that enable derogation according to Section 3 of Annex XI from testing relevant for PBT and vPvB assessment. ...

... For substances satisfying the PBT and vPvB criteria, the manufacturer or importer shall use the information as obtained in Section 5, Step 2 when implementing on its site, and recommending for downstream users, risk management measures which minimise exposures and emissions to humans and the environment, throughout the lifecycle of the substance that results from manufacture or identified uses. ...

... 8. PBT AND VPVB ASSESSMENT ...

... 3.4. The classification (derived either from Articles 4 and 6 of Directive 67/548/EEC, from Annex I to Directive 67/548/EEC or from an agreed entry in the classification and labelling inventory established under Title XI of this Regulation) of the above substances shall be given, including the symbol letters and R phrases which are assigned in accordance with their physicochemical, human health and environmental hazards. The R phrases do not need to be written out in full here: reference shall be made to heading 16, where the full text of each relevant R phrase shall be listed. If the substance does not meet the classification criteria, the reason for indicating the substance in section 3 shall be described, such as "PBT-substance "or "substance with a Community workplace exposure limit". ...

... 12.5. Results of PBT assessment ...

... Where a Chemical Safety Report is required, the results of the PBT assessment as set in the Chemical Safety Report shall be given. ...

... If the downstream user considers the hazard and PBT assessments reported in the Safety Data Sheet supplied to him to be appropriate, then no further hazard assessment or PBT and vPvB assessment is necessary. In this case he shall use the relevant information reported by the supplier for the risk characterisation. This shall be stated in the Chemical Safety Report. ...

... If the downstream user considers the hazard and PBT assessments reported in the Safety Data Sheet supplied to him to be appropriate, then no further hazard assessment or PBT and vPvB assessment is necessary. In this case he shall use the relevant information reported by the supplier for the risk characterisation. This shall be stated in the Chemical Safety Report. ...

... (i) persistent, bioaccumulative and toxic substances (PBT-substances), and ...

... A substance is identified as a PBT substance if it fulfils the criteria in Sections 1.1, 1.2 and 1.3. A substance is identified as a vPvB substance if it fulfils the criteria in Sections 2.1 and 2.2. This annex shall not apply to inorganic substances, but shall apply to organo-metals. ...

... 1. PBT-SUBSTANCES ...

... A substance that fulfils all three of the criteria of the sections below is a PBT substance. ...

... 2. Dossier for the identification of a substance as a CMR, PBT, vPvB or a substance of equivalent concern according to Article 59 ...

... The proposal shall include the identity of substance(s) concerned and whether it is proposed to be identified as a CMR according to Article 57(a), (b) or (c), a PBT according to Article 57(d), a vPvB according to Article 57(e), or a substance of equivalent concern according to Article 57(f). ...

... A comparison of the available information with the criteria in Annex XIII for PBT according to Article 57(d), and vPvBs according to Article 57(e), or an assessment of the hazards and a comparison with Article 57(f), according to the relevant parts of Sections 1 to 4 of Annex I shall be completed. This shall be documented in the format set out in Part B of the Chemical Safety Report in Annex I. ...

... 23.CadmiumCAS No 7440-43-9EINECS No 231-152-8and its compounds | 1.Shall not be used to give colour to finished articles manufactured from the substances and preparations listed below:(a)polyvinyl chloride (PVC) [3904 10] [3904 21] [3904 22] [74],polyurethane (PUR) [3909 50] [74],low-density polyethylene (ld PE), with the exception of low-density polyethylene used for the production of coloured masterbatch [3901 10] [74],cellulose acetate (CA) [3912 11] [3912 12] [74],cellulose acetate butyrate (CAB) [3912 11] [3912 12] [74],epoxy resins [3907 30] [74],melamine — formaldehyde (MF) resins [3909 20] [74],urea — formaldehyde (UF) resins [3909 10] [74],unsaturated polyesters (UP) [3907 91] [74],polyethylene terephthalate (PET) [3907 60] [74],polybutylene terephthalate (PBT) [74],transparent/general-purpose polystyrene [3903 11] [3903 19] [74],acrylonitrile methylmethacrylate (AMMA) [74],cross-linked polyethylene (VPE) [74],high-impact polystyrene [74],polypropylene (PP) [3902 10] [74];(b)paints [3208] [3209] [74].However, if the paints have a high zinc content, their residual concentration of cadmium shall be as low as possible and shall at all events not exceed 0,1 % by mass.In any case, whatever their use or intended final purpose, finished articles or components of articles manufactured from the substances and preparations listed above coloured with cadmium shall not be placed on the market if their cadmium content (expressed as Cd metal) exceeds 0,01 % by mass of the plastic material.2.However, paragraph 1 does not apply to articles to be coloured for safety reasons.3.Shall not be used to stabilise the finished articles listed below manufactured from polymers or copolymers of vinyl chloride:packaging materials (bags, containers, bottles, lids) [3923 29 10] [3920 41] [3920 42] [74],office or school supplies [3926 10] [74],fittings for furniture, coachwork or the like [3926 30] [74],articles of apparel and clothing accessories (including gloves) [3926 20] [74],floor and wall coverings [3918 10] [74],impregnated, coated, covered or laminated textile fabrics [5903 10] [74],imitation leather [4202] [74],gramophone records [8524 10] [74],tubes and pipes and their fittings [3917 23] [74],swing doors [74],vehicles for road transport (interior, exterior, underbody) [74],coating of steel sheet used in construction or in industry [74],insulation for electrical wiring [74].In any case, whatever their use or intended final purpose, the placing on the market of the above finished articles or components of articles manufactured from polymers or copolymers of vinyl chloride, stabilised by substances containing cadmium shall be prohibited, if their cadmium content (expressed as Cd metal) exceeds 0,01 % by mass of the polymer.4.However, paragraph 3 does not apply to finished articles using cadmium-based stabilisers for safety reasons.5.Within the meaning of this Regulation, "cadmium plating "means any deposit or coating of metallic cadmium on a metallic surface.Shall not be used for cadmium plating metallic articles or components of the articles used in the sectors/applications listed below:(a)equipment and machinery for:food production [8210] [8417 20] [8419 81] [8421 11] [8421 22] [8422] [8435] [8437] [8438] [8476 11] [74],agriculture [8419 31] [8424 81] [8432] [8433] [8434] [8436] [74],cooling and freezing [8418] [74],printing and book-binding [8440] [8442] [8443] [74];(b)equipment and machinery for the production of:household goods [7321] [8421 12] [8450] [8509] [8516] [74],furniture [8465] [8466] [9401] [9402] [9403] [9404] [74],sanitary ware [7324] [74],central heating and air conditioning plant [7322] [8403] [8404] [8415] [74].In any case, whatever their use or intended final purpose, the placing on the market of cadmium-plated articles or components of such articles used in the sectors/applications listed in points (a) and (b) above and of articles manufactured in the sectors listed in point (b) above shall be prohibited.6.The provisions referred to in paragraph 5 are also applicable to cadmium-plated articles or components of such articles when used in the sectors/applications listed in points (a) and (b) below and to articles manufactured in the sectors listed in (b) below:(a)equipment and machinery for the production of:paper and board [8419 32] [8439] [8441] [74],textiles and clothing [8444] [8445] [8447] [8448] [8449] [8451] [8452] [74];(b)equipment and machinery for the production of:industrial handling equipment and machinery [8425] [8426] [8427] [8428] [8429] [8430] [8431] [74],road and agricultural vehicles [chapter 87] [74],rolling stock [chapter 86] [74],vessels [chapter 89] [74].7.However, the restrictions in paragraphs 5 and 6 do not apply to:articles and components of the articles used in the aeronautical, aerospace, mining, offshore and nuclear sectors whose applications require high safety standards and in safety devices in road and agricultural vehicles, rolling stock and vessels,electrical contacts in any sector of use, on account of the reliability required of the apparatus on which they are installed.Owing to the development of knowledge and techniques in respect of substitutes less dangerous than cadmium and its compounds, the Commission shall, in consultation with the Member States, assess the situation at regular intervals in accordance with the procedure laid down in Article 133(3) of this Regulation. | ...