Registration, Evaluation, Authorisation and Restriction of Chemicals

02006R1907-20210101 → 02006R1907-20210215

ANNEX XIV LIST OF SUBSTANCES SUBJECT TO AUTHORISATION Date referred to in Article 58(1)(c)(ii) of Regulation (EC) No 1907/2006.Date referred to in Article 58(1)(c)(i) of Regulation (EC) No 1907/2006.1 September 2021 for the use of the substance in the production of spare parts as articles or as complex products for the repair of articles or complex products, the production of which ceased or will have ceased before the sunset date indicated in the entry for that substance, where that substance was used in the production of those articles or complex products and these cannot function as intended without that spare part and the spare part cannot be produced without that substance, and for the use of the substance (on its own or in a mixture) for the repair of such articles or complex products where that substance on its own or in a mixture was used in the production of those articles or complex products and they cannot be repaired otherwise than by using that substance.1 March 2023 for the use of the substance in the production of spare parts as articles or as complex products for the repair of articles or complex products the production of which ceased or will have ceased before the sunset date indicated in the entry for that substance, where that substance was used in the production of those articles or complex products and these cannot function as intended without those spare parts and the spare part cannot be produced without that substance, and for the use of the substance (on its own or in a mixture) for the repair of such articles or complex products, where that substance on its own or in a mixture was used in the production of those articles or complex products and they cannot be repaired otherwise than by using that substance.Does not meet the criteria for identification as a carcinogen if it contains < 0,005 % (w/w) benzo[a]pyrene (Einecs No 200-028-5). 200-028-5).Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176). Entry Nr Substance Intrinsic property(ies) referred to in Article 57 Transitional arrangements Exempted (categories of) uses Review periods Latest application date Sunset date 1. 5-tert-butyl-2,4,6-trinitro-m-xylene (Musk xylene) EC No 201-329-4 CAS No 81-15-2 vPvB 21 February 2013 21 August 2014 — — 2. 4,4’-Diaminodiphenylmethane (MDA) EC No 202-974-4 CAS No 101-77-9 Carcinogenic (category 1B) … 753 unchanged words … — — 41. Pitch, coal tar, high temp. EC No 266-028-2 CAS No 65996-93-2 Carcinogenic (category 1B), PBT, vPvB 4 April 2019 4 October 2020 — — 42. 4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated (covering well-defined substances and UVCB substances, polymers and homologues) EC No — CAS No — Endocrine disrupting properties (Article 57(f) — environment) (a) 4 July 2019 2019; (b) by way of derogation from point (a), 22 June 2022 for uses as follows: for the research, development and production of medicinal products falling within the scope of Directive 2001/83/EC or medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746 of the European Parliament and of the Council, in view of their use for the diagnosis, treatment or prevention of the coronavirus disease (COVID-19), in medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, for the diagnosis, treatment or prevention of COVID-19. (a) 4 January 2021 2021; (b) by way of derogation from point (a), 22 December 2023 for uses as follows: for the research, development and production of medicinal products falling within the scope of Directive 2001/83/EC or medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, in view of their use for the diagnosis, treatment or prevention of COVID-19, in medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, for the diagnosis, treatment or prevention of COVID-19. — — 43. 4-Nonylphenol, branched and linear, ethoxylated (substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homologues, which include any of the individual isomers and/or combinations thereof) EC No — CAS No — Endocrine disrupting properties (Article 57(f) — environment) 4 July 2019 4 January 2021 — — 44. 1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear EC No: 271-093-5 CAS No: 68515-50-4 Toxic for reproduction (category 1B) 27 August 2021 27 February 2023 — — 45. Dihexyl phthalate EC No: 201-559-5 CAS No: 84-75-3 Toxic for reproduction (category 1B) 27 August 2021 27 February 2023 — — 46. 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0,3 % of dihexyl phthalate (EC No 201-559-5) EC No: 271-094-0; 272-013-1 CAS No: 68515-51-5; 68648-93-1 Toxic for reproduction (category 1B) 27 August 2021 27 February 2023 — — 47. Trixylyl phosphate EC No: 246-677-8 CAS No: 25155-23-1 Toxic for reproduction (category 1B) 27 November 2021 27 May 2023 — — 48. Sodium perborate; perboric acid, sodium salt EC No: 239-172-9; 234-390-0 CAS No: - Toxic for reproduction (category 1B) 27 November 2021 27 May 2023 — — 49. Sodium peroxometaborate EC No: 231-556-4 CAS No: 7632-04-4 Toxic for reproduction (category 1B) 27 November 2021 27 May 2023 — — 50. 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof] EC No: - CAS No: - vPvB 27 February 2022 27 August 2023 — — 51. 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328) EC No: 247-384-8 CAS No: 25973-55-1 PBT, vPvB 27 May 2022 27 November 2023 — — 52. 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327) EC No: 223-383-8 CAS No: 3864-99-1 vPvB 27 May 2022 27 November 2023 — — 53. 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350) EC No: 253-037-1 CAS No: 36437-37-3 vPvB 27 May 2022 27 November 2023 — — 54. 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320) EC No: 223-346-6 CAS No: 3846-71-7 PBT, vPvB 27 May 2022 27 November 2023 — —

02006R1907-20210101 → 02006R1907-20210215

compared line by line: this provision is too large to compare word by word, so a marked line is a line that changed somewhere

ANNEX XVII RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, MIXTURES AND ARTICLES For substances which have been incorporated in this Annex as a consequence of restrictions adopted in the framework of Directive 76/769/EEC (Entries 1 to 58), the restrictions shall not apply to storage, keeping, treatment, filling into containers, or transfer from one container to another of these substances for export, unless the manufacture of the substances is prohibited. OJ L 256, 7.9.1987, p. 42.OJ L 147, 9.6.1975, p. 40.OJ L 37, 13.2.2003, p. 19.OJ L 263, 9.10.2007, p. 1.OJ L 171, 9.7.2003, p. 1.OJ L 124, 9.5.2002, p. 1.OJ L 24, 29.1.2008, p. 8.OJ L 104, 8.4.2004, p. 1.OJ L 399, 30.12.1989, p. 18.OJ L 304, 21.11.2003, p. 1.OJ L 121, 15.5.1993, p. 20.OJ L 270, 21.10.2003, p. 1.OJ L 365, 31.12.1994, p. 10.OJ L 326, 29.12.1969, p. 36.Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1).Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88).Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17).Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OL L 60, 2.3.2013, p. 1).Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (OJ L 79, 19.3.2008, p. 1).Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, p. 1). OJ L 256, 7.9.1987, p. 42.OJ L 147, 9.6.1975, p. 40.OJ L 37, 13.2.2003, p. 19.OJ L 263, 9.10.2007, p. 1.OJ L 171, 9.7.2003, p. 1.OJ L 124, 9.5.2002, p. 1.OJ L 24, 29.1.2008, p. 8.OJ L 104, 8.4.2004, p. 1.OJ L 399, 30.12.1989, p. 18.OJ L 304, 21.11.2003, p. 1.OJ L 121, 15.5.1993, p. 20.OJ L 270, 21.10.2003, p. 1.OJ L 365, 31.12.1994, p. 10.OJ L 326, 29.12.1969, p. 36.Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1).Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88).Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17).Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OL L 60, 2.3.2013, p. 1).Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (OJ L 79, 19.3.2008, p. 1).Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, p. 1).Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59). Column 1 Designation of the substance, of the group of substances or of the mixture Column 2 Conditions of restriction 1. Polychlorinated terphenyls (PCTs) Shall not be placed on the market, or used: as substances, in mixtures, including waste oils, or in equipment, in concentrations greater than 50 mg/kg (0,005 % by weight). 2. Chloroethene (vinyl chloride) CAS No 75-01-4 EC No 200-831-0 Shall not be used as propellant in aerosols for any use. Aerosols dispensers containing the substance as propellant shall not be placed on the market. 3. Liquid substances or mixtures which are regarded as dangerous in accordance with Directive 1999/45/EC or are fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008: (a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F; (b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10; (c) hazard class 4.1; (d) hazard class 5.1. 1. Shall not be used in: ornamental articles intended to produce light or colour effects by means of different phases, for example in ornamental lamps and ashtrays, tricks and jokes, games for one or more participants, or any article intended to be used as such, even with ornamental aspects, 2. Articles not complying with paragraph 1 shall not be placed on the market. 3. Shall not be placed on the market if they contain a colouring agent, unless required for fiscal reasons, or perfume, or both, if they: can be used as fuel in decorative oil lamps for supply to the general public, and, present an aspiration hazard and are labelled with R65 or H304, can be used as fuel in decorative oil lamps for supply to the general public, and present an aspiration hazard and are labelled with H304. 4. Decorative oil lamps for supply to the general public shall not be placed on the market unless they conform to the European Standard on Decorative oil lamps (EN 14059) adopted by the European Committee for Standardisation (CEN). 5. Without prejudice to the implementation of other Community provisions relating to the classification, packaging and labelling of dangerous substances and mixtures, suppliers shall ensure, before the placing on the market, that the following requirements are met: (a) lamp oils, labelled with R65 or H304, intended for supply to the general public are visibly, legibly and indelibly marked as follows: Keep lamps filled with this liquid out of the reach of children; and, by 1 December 2010, Just a sip of lamp oil — or even sucking the wick of lamps — may lead to life-threatening lung damage; (b) grill lighter fluids, labelled with R65 or H304, intended for supply to the general public are legibly and indelibly marked by 1 December 2010 as follows: Just a sip of grill lighter may lead to life threatening lung damage; (c) lamp oils and grill lighters, labelled with R65 or H304, intended for supply to the general public are packaged in black opaque containers not exceeding 1 litre by 1 December 2010. 5. Without prejudice to the implementation of other Union provisions relating to the classification, labelling and packaging of substances and mixtures, suppliers shall ensure, before the placing on the market, that the following requirements are met: (a) lamp oils, labelled with H304, intended for supply to the general public are visibly, legibly and indelibly marked as follows: Keep lamps filled with this liquid out of the reach of children; and, by 1 December 2010, Just a sip of lamp oil – or even sucking the wick of lamps – may lead to life-threatening lung damage; (b) grill lighter fluids, labelled with H304, intended for supply to the general public are legibly and indelibly marked by 1 December 2010 as follows: Just a sip of grill lighter fluid may lead to life threatening lung damage; (c) lamps oils and grill lighters, labelled with H304, intended for supply to the general public are packaged in black opaque containers not exceeding 1 litre by 1 December 2010. 6. No later than 1 June 2014, the Commission shall request the European Chemicals Agency to prepare a dossier, in accordance with Article 69 of the present Regulation with a view to ban, if appropriate, grill lighter fluids and fuel for decorative lamps, labelled R65 or H304, intended for supply to the general public. 7. Natural or legal persons placing on the market for the first time lamp oils and grill lighter fluids, labelled with R65 or H304, shall by 1 December 2011, and annually thereafter, provide data on alternatives to lamp oils and grill lighter fluids labelled R65 or H304 to the competent authority in the Member State concerned. Member States shall make those data available to the Commission. 4. Tris (2,3 dibromopropyl) phosphate … 340 unchanged lines … mineral oil products intended for use as fuel in mobile or fixed combustion plants, fuels sold in closed systems (e.g. liquid gas bottles); (d) artists’ paints covered by Regulation (EC) No 1272/2008; (e) the substances listed in Appendix 11, column 1, for the applications or uses listed in Appendix 11, column 2. Where a date is specified in column 2 of Appendix 11, the derogation shall apply until the said date. (e) the substances listed in Appendix 11, column 1, for the applications or uses listed in Appendix 11, column 2. Where a date is specified in column 2 of Appendix 11, the derogation shall apply until the said date; (f) devices covered by Regulation (EU) 2017/745. 31. (a) Creosote; wash oil CAS No 8001-58-9 EC No 232-287-5 … 394 unchanged lines … (iv) Directive 2011/65/EU of the European Parliament and of the Council 9. By 1 July 2019, the Commission shall re-evaluate paragraphs 7 and 8(e), (f), (i) and (j) of this entry in the light of new scientific information, including the availability of alternatives and the migration of lead from the articles referred to in paragraph 7, including the requirement on coating integrity, and, if appropriate, modify this entry accordingly. 10. By way of derogation paragraph 7 shall not apply to articles placed on the market for the first time before 1 June 2016. 11. Doing either of the following acts after 15 February 2023 in or within 100 metres of wetlands is prohibited: (a) discharging gunshot containing a concentration of lead (expressed as metal) equal to or greater than 1 % by weight; (b) carrying any such gunshot where this occurs while out wetland shooting or as part of going wetland shooting. For the purposes of the first subparagraph: (a) within 100 metres of wetlands means within 100 metres outward from any outer boundary point of a wetland; (b) wetland shooting means shooting in or within 100 metres of wetlands; (c) if a person is found carrying gunshot in or within 100 metres of wetlands while out shooting or as part of going shooting, the shooting concerned shall be presumed to be wetland shooting unless that person can demonstrate that it was some other type of shooting. The restriction laid down in the first subparagraph shall not apply in a Member State if that Member State notifies the Commission in accordance with paragraph 12 that it intends to make use of the option granted by that paragraph. 12. If at least 20 % in total of the territory, excluding the territorial waters, of a Member State are wetlands, that Member State may, in place of the restriction laid down in the first subparagraph of paragraph 11, prohibit the following acts throughout the whole of its territory from 15 February 2024: (a) the placing on the market of gunshot containing a concentration of lead (expressed as metal) equal to or greater than 1 % by weight; (b) the discharging of any such gunshot; (c) carrying any such gunshot while out shooting or as part of going shooting. Any Member State intending to make use of the option granted by the first subparagraph shall notify the Commission of this intention by 15 August 2021. The Member State shall communicate the text of the national measures adopted by it to the Commission without delay and in any event by 15 August 2023. The Commission shall make publicly available without delay any such notices of intention and texts of national measures received by it. 13. For the purposes of paragraphs 11 and 12: (a) wetlands means areas of marsh, fen, peatland or water, whether natural or artificial, permanent or temporary, with water that is static or flowing, fresh, brackish or salt, including areas of marine water the depth of which at low tide does not exceed 6 metres; (b) gunshot means pellets used or intended for use in a single charge or cartridge in a shotgun; (c) shotgun means a smooth-bore gun, excluding airguns; (d) shooting means any shooting with a shotgun; (e) carrying means any carrying on the person or carrying or transporting by any other means; (f) in determining whether a person found with gunshot is carrying gunshot as part of going shooting: (i) regard shall be had to all the circumstances of the case; (ii) the person found with the gunshot need not necessarily be the same person as the person shooting. 14. Member States may maintain national provisions for protection of the environment or human health in force on 15 February 2021 and restricting lead in gunshot more severely than provided for in paragraph 11. The Member State shall communicate the text of those national provisions to the Commission without delay. The Commission shall make publicly available without delay any such texts of national provisions received by it. 64. 1,4-dichlorobenzene CAS No 106-46-7 EC No 203-400-5 Shall not be placed on the market or used, as a substance or as a constituent of mixtures in a concentration equal to or greater than 1 % by weight, where the substance or the mixture is placed on the market for use or used as an air freshener or deodoriser in toilets, homes, offices or other indoor public areas. … 182 unchanged lines … (c) national exposure limits for diisocyanates, if there are any; (d) information about enforcement activities related to this restriction. 10. This restriction shall apply without prejudice to other Union legislation on the protection of safety and health of workers at the workplace. 75. Substances falling within one or more of the following points: (a) substances classified as any of the following in Part 3 of Annex VI to Regulation (EC) No 1272/2008: carcinogen category 1A, 1B or 2, or germ cell mutagen category 1A, 1B or 2, but excluding any such substances classified due to effects only following exposure by inhalation reproductive toxicant category 1A, 1B or 2 but excluding any such substances classified due to effects only following exposure by inhalation skin sensitiser category 1, 1A or 1B skin corrosive category 1, 1A, 1B or 1C or skin irritant category 2 serious eye damage category 1 or eye irritant category 2 (b) substances listed in Annex II to Regulation (EC) No 1223/2009 of the European Parliament and of the Council (c) substances listed in Annex IV to Regulation (EC) No 1223/2009 for which a condition is specified in at least one of the columns g, h and i of the table in that Annex (d) substances listed in Appendix 13 to this Annex. The ancillary requirements in paragraphs 7 and 8 of column 2 of this entry apply to all mixtures for use for tattooing purposes, whether or not they contain a substance falling within points (a) to (d) of this column of this entry. 1. Shall not be placed on the market in mixtures for use for tattooing purposes, and mixtures containing any such substances shall not be used for tattooing purposes, after 4 January 2022 if the substance or substances in question is or are present in the following circumstances: (a) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as carcinogen category 1A, 1B or 2, or germ cell mutagen category 1A, 1B or 2, the substance is present in the mixture in a concentration equal to or greater than 0,00005 % by weight; (b) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as reproductive toxicant category 1A, 1B or 2, the substance is present in the mixture in a concentration equal to or greater than 0,001 % by weight; (c) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as skin sensitiser category 1, 1A or 1B, the substance is present in the mixture in a concentration equal to or greater than 0,001 % by weight; (d) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as skin corrosive category 1, 1A, 1B or 1C or skin irritant category 2, or as serious eye damage category 1 or eye irritant category 2, the substance is present in the mixture in a concentration equal to or greater than: (i) 0,1 % by weight, if the substance is used solely as a pH regulator; (ii) 0,01 % by weight, in all other cases; (e) in the case of a substance listed in Annex II to Regulation (EC) No 1223/2009, the substance is present in the mixture in a concentration equal to or greater than 0,00005 % by weight; (f) in the case of a substance for which a condition of one or more of the following kinds is specified in column g (Product type, Body parts) of the table in Annex IV to Regulation (EC) No 1223/2009, the substance is present in the mixture in a concentration equal to or greater than 0,00005 % by weight: (i) Rinse-off products; (ii) Not to be used in products applied on mucous membranes; (iii) Not to be used in eye products; (g) in the case of a substance for which a condition is specified in column h (Maximum concentration in ready for use preparation) or column i (Other) of the table in Annex IV to Regulation (EC) No 1223/2009, the substance is present in the mixture in a concentration, or in some other way, that does not accord with the condition specified in that column; (h) in the case of a substance listed in Appendix 13 to this Annex, the substance is present in the mixture in a concentration equal to or greater than the concentration limit specified for that substance in that Appendix. 2. For the purposes of this entry use of a mixture for tattooing purposes means injection or introduction of the mixture into a person’s skin, mucous membrane or eyeball, by any process or procedure (including procedures commonly referred to as permanent make-up, cosmetic tattooing, micro-blading and micro-pigmentation), with the aim of making a mark or design on his or her body. 3. If a substance not listed in Appendix 13 falls within more than one of points (a) to (g) of paragraph 1, the strictest concentration limit laid down in the points in question shall apply to that substance. If a substance listed in Appendix 13 also falls within one or more of points (a) to (g) of paragraph 1, the concentration limit laid down in point (h) of paragraph 1 shall apply to that substance. 4. By way of derogation, paragraph 1 shall not apply to the following substances until 4 January 2023: (a) Pigment Blue 15:3 (CI 74160, EC No 205-685-1, CAS No 147-14-8); (b) Pigment Green 7 (CI 74260, EC No 215-524-7, CAS No 1328-53-6). 5. If Part 3 of Annex VI to Regulation (EC) No 1272/2008 is amended after 4 January 2021 to classify or re-classify a substance such that the substance then becomes caught by point (a), (b), (c) or (d) of paragraph 1 of this entry, or such that it then falls within a different one of those points from the one within which it fell previously, and the date of application of that new or revised classification is after the date referred to in paragraph 1 or, as the case may be, paragraph 4 of this entry, that amendment shall, for the purposes of applying this entry to that substance, be treated as taking effect on the date of application of that new or revised classification. 6. If Annex II or Annex IV to Regulation (EC) No 1223/2009 is amended after 4 January 2021 to list or change the listing of a substance such that the substance then becomes caught by point (e), (f) or (g) of paragraph 1 of this entry, or such that it then falls within a different one of those points from the one within which it fell previously, and the amendment takes effect after the date referred to in paragraph 1 or, as the case may be, paragraph 4 of this entry, that amendment shall, for the purposes of applying this entry to that substance, be treated as taking effect from the date falling 18 months after entry into force of the act by which that amendment was made. 7. Suppliers placing a mixture on the market for use for tattooing purposes shall ensure that, after 4 January 2022, the mixture is marked with the following information: (a) the statement Mixture for use in tattoos or permanent make-up; (b) a reference number to uniquely identify the batch; (c) the list of ingredients in accordance with the nomenclature established in the glossary of common ingredient names pursuant to Article 33 of Regulation (EC) No 1223/2009, or in the absence of a common ingredient name, the IUPAC name. In the absence of a common ingredient name or IUPAC name, the CAS and EC number. Ingredients shall be listed in descending order by weight or volume of the ingredients at the time of formulation. Ingredient means any substance added during the process of formulation and present in the mixture for use for tattooing purposes. Impurities shall not be regarded as ingredients. If the name of a substance, used as ingredient within the meaning of this entry, is already required to be stated on the label in accordance with Regulation (EC) No 1272/2008, that ingredient does not need to be marked in accordance with this Regulation; (d) the additional statement pH regulator for substances falling under point (d)(i) of paragraph 1; (e) the statement "Contains nickel. Can cause allergic reactions." if the mixture contains nickel below the concentration limit specified in Appendix 13; (f) the statement "Contains chromium (VI). Can cause allergic reactions." if the mixture contains chromium (VI) below the concentration limit specified in Appendix 13; (g) safety instructions for use insofar as they are not already required to be stated on the label by Regulation (EC) No 1272/2008. The information shall be clearly visible, easily legible and marked in a way that is indelible. The information shall be written in the official language(s) of the Member State(s) where the mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise. Where necessary because of the size of the package, the information listed in the first subparagraph, except for point (a), shall be included instead in the instructions for use. Before using a mixture for tattooing purposes, the person using the mixture shall provide the person undergoing the procedure with the information marked on the package or included in the instructions for use pursuant to this paragraph. 8. Mixtures that do not contain the statement Mixture for use in tattoos or permanent make-up shall not be used for tattooing purposes. 9. This entry does not apply to substances that are gases at temperature of 20 °C and pressure of 101,3 kPa, or generate a vapour pressure of more than 300 kPa at temperature of 50 °C, with the exception of formaldehyde (CAS No 50-00-0, EC No 200-001-8). 10. This entry does not apply to the placing on the market of a mixture for use for tattooing purposes, or to the use of a mixture for tattooing purposes, when placed on the market exclusively as a medical device or an accessory to a medical device, within the meaning of Regulation (EU) 2017/745, or when used exclusively as a medical device or an accessory to a medical device, within the same meaning. Where the placing on the market or use may not be exclusively as a medical device or an accessory to a medical device, the requirements of Regulation (EU) 2017/745 and of this Regulation shall apply cumulatively. Appendices 1 to 6 FOREWORD Explanations of column headings … 39 unchanged lines … Note R: The classification as a carcinogen need not apply to fibres with a length weighted geometric mean diameter, less two standard errors, greater than 6μm. Appendix 1 Entry 28 — Carcinogens: category 1A (Table 3.1)/category 1 (Table 3.2) Entry 28 – Carcinogens: Category 1A Substances Index No EC No CAS No Notes Chromium (VI) trioxide 024-001-00-0 215-607-8 1333-82-0 E Zinc chromates including zinc potassium chromate 024-007-00-3 Nickel monoxide; [1] 028-003-00-2 215-215-7 [1] 1313-99-1 [1] Nickel oxide; [2] 234-323-5 [2] 11099-02-8 [2] … 400 unchanged lines … 77536-66-4 77536-68-6 77536-67-5 Appendix 2 Entry 28 — Carcinogens: category 1B (Table 3.1)/category 2 (Table 3.2) Entry 28 – Carcinogens: Category 1 B Substances Index No EC No CAS No Notes Beryllium 004-001-00-7 231-150-7 7440-41-7 Beryllium compounds with the exception of aluminium beryllium silicates 004-002-00-2 Beryllium oxide 004-003-00-8 215-133-1 1304-56-9 E Sulfallate (ISO); 2-chlorallyl diethyldithiocarbamate 006-038-00-4 202-388-9 95-06-7 Dimethylcarbamoyl chloride 006-041-00-0 201-208-6 79-44-7 Diazomethane 006-068-00-8 206-382-7 334-88-3 O-isobutyl-N-ethoxy carbonylthiocarbamate 006-094-00-X 434-350-4 103122-66-3 O-hexyl-N-ethoxycarbonylthiocarbamate 006-102-00-1 432-750-3 — Hydrazine 007-008-00-3 206-114-9 302-01-2 E … 1,262 unchanged lines … Refractory Ceramic Fibres, Special Purpose Fibres, with the exception of those specified elsewhere in this Annex; [Man-made vitreous (silicate) fibres with random orientation with alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+ MgO+BaO) content less or equal to 18 % by weight] 650-017-00-8 — — A, R Appendix 3 Entry 29 — Mutagens: category 1A (Table 3.1)/category 1 (Table 3.2) Entry 29 – Germ cell mutagens: Category 1 A Appendix 4 Entry 29 — Mutagens: category 1B (Table 3.1)/category 2 (Table 3.2) Entry 29 – Germ cell mutagens: Category 1 B Substances Index No EC No CAS No Notes O-isobutyl-N-ethoxy carbonylthiocarbamate 006-094-00-X 434-350-4 103122-66-3 O-hexyl-N-ethoxycarbonylthiocarbamate 006-102-00-1 432-750-3 — Hexamethylphosphoric triamide; hexamethylphosphoramide 015-106-00-2 211-653-8 680-31-9 Mixture of: dimethyl(2-(hydroxymethylcarbamoyl)ethyl)phosphonate; Diethyl(2-(hydroxymethylcarbamoyl)ethyl)phosphonate; … 982 unchanged lines … Aromatic hydrocarbons, C8-10; Low boiling point naphtha - unspecified 649-403-00-9 292-695-4 90989-39-2 P Appendix 5 Entry 30 — Toxic to reproduction: category 1A (Table 3.1)/category 1 (Table 3.2) Entry 30 – Reproductive toxicants: Category 1 A Substances Index No EC No CAS No Notes Carbon monoxide 006-001-00-2 211-128-3 630-08-0 Lead hexafluorosilicate 009-014-00-1 247-278-1 25808-74-6 Slimes and sludges, copper electrolyte refining, decopperised 028-015-00-8 305-433-1 94551-87-8 Silicic acid, lead nickel salt 028-050-00-9 — 68130-19-8 Lead compounds with the exception of those specified elsewhere in this Annex 082-001-00-6 A, E Lead alkyls 082-002-00-1 A, E Lead azide 082-003-00-7 236-542-1 13424-46-9 Lead chromate 082-004-00-2 231-846-0 7758-97-6 Lead di(acetate) 082-005-00-8 206-104-4 301-04-2 Trilead bis(orthophosphate) 082-006-00-3 231-205-5 7446-27-7 Lead acetate 082-007-00-9 215-630-3 1335-32-6 Lead(II) methanesulphonate 082-008-00-4 401-750-5 17570-76-2 C.I. Pigment Yellow 34; (This substance is identified in the Colour Index by Colour Index Constitution No C.I. 77603.) 082-009-00-X 215-693-7 1344-37-2 C.I. Pigment Red 104; (This substance is identified in the Colour Index by Colour Index Constitution No C.I. 77605.) 082-010-00-5 235-759-9 12656-85-8 Lead hydrogen arsenate 082-011-00-0 232-064-2 7784-40-9 Lead powder; [particle diameter < 1 mm] 082-013-00-1 231-100-4 7439-92-1 Lead massive: [particle diameter ≥ 1 mm] 082-014-00-7 231-100-4 7439-92-1 1,2-Dibromo-3-chloropropane 602-021-00-6 202-479-3 96-12-8 2-bromopropane 602-085-00-5 200-855-1 75-26-3 E Warfarin (ISO); 4-hydroxy-3-(3-oxo-1- phenylbutyl)-2H-chromen-2-one; [1] (S)-4-hydroxy-3-(3-oxo- 1-phenylbutyl)-2-benzopyrone; [2] (R)-4-hydroxy-3-(3-oxo- 1-phenylbutyl)-2-benzopyrone [3] 607-056-00-0 201-377-6 [1] 226-907-3 [2] 226-908-9 [3] 81-81-2 [1] 5543-57-7 [2] 5543-58-8 [3] Brodifacoum (ISO); 4-hydroxy-3-(3-(4′-bromo-4-biphenylyl)-1,2,3,4-tetrahydro-1-naphthyl)coumarin 607-172-00-1 259-980-5 56073-10-0 Lead 2,4,6-trinitroresorcinoxide, lead styphnate 609-019-00-4 239-290-0 15245-44-0 Appendix 6 Entry 30 — Toxic to reproduction: category 1B (Table 3.1)/category 2 (Table 3.2) Entry 30 – Reproductive toxicants: Category 1 B Substances Index No EC No CAS No Notes Dibutyltin hydrogen borate 005-006-00-7 401-040-5 75113-37-0 Boric acid; [1] 005-007-00-2 233-139-2 [1] 10043-35-3 [1] Boric acid, crude natural, containing not more than 85 % of H3BO3 calculated on the dry weight; [2] 234-343-4 [2] 11113-50-1 [2] Diboron trioxide; … 244 unchanged lines … Entry 43 — Azocolourants — List of testing methods List of testing methods European standardisation organisation Reference and title of the harmonised standard Reference of the superseded standard CEN EN ISO 17234-1:2010 Leather — Chemical tests for the determination of certain azo colorants in dyed leathers — Part 1: Determination of certain aromatic amines derived from azo colorants CEN ISO/TS 17234:2003 CEN EN ISO 17234-1:2015 Leather – Chemical tests for the determination of certain azo colorants in dyed leathers – Part 1: Determination of certain aromatic amines derived from azo colorants EN ISO 17234-1:2010 CEN EN ISO 17234-2:2011 Leather — Chemical tests for the determination of certain azo colorants in dyed leathers — Part 2: Determination of 4-aminoazobenzene CEN ISO/TS 17234:2003 CEN EN 14362-1:2012 Textiles — Methods for determination of certain aromatic amines derived from azo colorants — Part 1: Detection of the use of certain azo colorants accessible with and without extracting the fibres EN 14362-1:2003 EN 14362-2:2003 CEN EN 14362-3:2012 Textiles — Methods for determination of certain aromatic amines derived from azo colorants — Part 3: Detection of the use of certain azo colorants, which may release 4-aminoazobenzene Appendix 11 Leather – Chemical tests for the determination of certain azo colorants in dyed leathers – Part 2: Determination of 4-aminoazobenzene CEN ISO/TS 17234:2003 CEN EN ISO 14362-1:2017 Textiles – Methods for determination of certain aromatic amines derived from azo colorants – Part 1: Detection of the use of certain azo colorants accessible with and without extracting the fibres EN 14362-1:2012 CEN EN ISO 14362-3:2017 Textiles – Methods for determination of certain aromatic amines derived from azo colorants – Part 3: Detection of the use of certain azo colorants, which may release 4-aminoazobenzene EN 14362-3:2012 Appendix 11 Entries 28 to 30 — Derogations for specific substances OJ L 104, 8.4.2004, p. 1. Substances Derogations … 39 unchanged lines … 4-methoxy-m-phenylene diammonium sulphate; 2,4-diaminoanisole sulphate 612-200-00-0 39156-41-7 254-323-9 30 mg/kg 2,4,5-trimethylaniline hydrochloride 612-197-00-6 21436-97-5 — 30 mg/kg Quinoline 613-281-00-5 91-22-5 202-051-6 50 mg/kgAppendix 13 Entry 75- List of substances with specific concentration limits: Soluble. ‡Chromium VI. Substance name EC No CAS No Concentration limit (by weight) Mercury 231-106-7 7439-97-6 0,00005 % Nickel 231-111-4 7440-02-0 0,0005 % Organometallic tin 231-141-8 7440-31-5 0,00005 % Antimony 231-146-5 7440-36-0 0,00005 % Arsenic 231-148-6 7440-38-2 0,00005 % Barium 231-149-1 7440-39-3 0,05 % Cadmium 231-152-8 7440-43-9 0,00005 % Chromium‡ 231-157-5 7440-47-3 0,00005 % Cobalt 231-158-0 7440-48-4 0,00005 % Copper 231-159-6 7440-50-8 0,025 % Zinc 231-175-3 7440-66-6 0,2 % Lead 231-100-4 7439-92-1 0,00007 % Selenium 231-957-4 7782-49-2 0,0002 % Benzo[a]pyrene 200-028-5 50-32-8, 63466-71-7 0,0000005 % Polycyclic-aromatic Hydrocarbons (PAH), classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as carcinogen or germ cell mutagen category 1A, 1B or 2 0,00005 % (individual concentrations) Methanol 200-659-6 67-56-1 11 % o-Anisidine 201-963-1 90-04-0 0,0005 % o-toluidine 202-429-0 95-53-4 0,0005 % 3,3'-dichlorobenzidine 202-109-0 91-94-1 0,0005 % 4-methyl-m- phenylenediamine 202-453-1 95-80-7 0,0005 % 4-chloroaniline 203-401-0 106-47-8 0,0005 % 5-nitro-o-toluidine 202-765-8 99-55-8 0,0005 % 3,3'-dimethoxybenzidine 204-355-4 119-90-4 0,0005 % 4,4'-bi-o-toluidine 204-358-0 119-93-7 0,0005 % 4,4'-Thiodianiline 205-370-9 139-65-1 0,0005 % 4-chloro-o-toluidine 202-441-6 95-69-2 0,0005 % 2-naphthylamine 202-080-4 91-59-8 0,0005 % Aniline 200-539-3 62-53-3 0,0005 % Benzidine 202-199-1 92-87-5 0,0005 % p-toluidine 203-403-1 106-49-0 0,0005 % 2-methyl-p-phenylenediamine 202-442-1 95-70-5 0,0005 % Biphenyl-4-ylamine 202-177-1 92-67-1 0,0005 % 4-o-tolylazo-o-toluidine 202-591-2 97-56-3 0,0005 % 4-methoxy-m- phenylenediamine 210-406-1 615-05-4 0,0005 % 4,4'-methylenedianiline 202-974-4 101-77-9 0,0005 % 4,4'-methylenedi-o-toluidine 212-658-8 838-88-0 0,0005 % 6-methoxy-m-toluidine 204-419-1 120-71-8 0,0005 % 4,4'- methylene-bis-[2-chloro aniline] 202-918-9 101-14-4 0,0005 % 4,4'-oxydianiline 202-977-0 101-80-4 0,0005 % 2,4,5-trimethylaniline 205-282-0 137-17-7 0,0005 % 4-Aminoazobenzene 200-453-6 60-09-3 0,0005 % p-Phenylenediamine 203-404-7 106-50-3 0,0005 % Sulphanilic acid 204-482-5 121-57-3 0,0005 % 4-amino-3-fluorophenol 402-230-0 399-95-1 0,0005 % 2,6-xylidine 201-758-7 87-62-7 0,0005 % 6-amino-2-ethoxynaphthaline 293733-21-8 0,0005 % 2,4-xylidine 202-440-0 95-68-1 0,0005 % Pigment Red 7 (PR7)/CI 12420 229-315-3 6471-51-8 0,1 % Pigment Red 9(PR9)/CI 12460 229-104-6 6410-38-4 0,1 % Pigment Red 15 (PR15)/CI 12465 229-105-1 6410-39-5 0,1 % Pigment Red 210(PR210)/CI 12477 612-766-9 61932-63-6 0,1 % Pigment Orange 74 (PO74) 85776-14-3 0,1 % Pigment Yellow 65 (PY65)/CI 11740 229-419-9 6528-34-3 0,1 % Pigment Yellow 74 (PY74)/CI 11741 228-768-4 6358-31-2 0,1 % Pigment Red 12 (PR12)/CI 12385 229-102-5 6410-32-8 0,1 % Pigment Red 14 (PR14)/CI 12380 229-314-8 6471-50-7 0,1 % Pigment Red 17 (PR17)/CI 12390 229-681-4 6655-84-1 0,1 % Pigment Red 112 (PR112)/CI 12370 229-440-3 6535-46-2 0,1 % Pigment Yellow 14 (PY14)/CI 21095 226-789-3 5468-75-7 0,1 % Pigment Yellow 55 (PY55)/CI 21096 226-789-3 6358-37-8 0,1 % Pigment Red 2 (PR2)/CI 12310 227-930-1 6041-94-7 0,1 % Pigment Red 22 (PR22)/CI 12315 229-245-3 6448-95-9 0,1 % Pigment Red 146 (PR146)/CI 12485 226-103-2 5280-68-2 0,1 % Pigment Red 269 (PR269)/CI 12466 268-028-8 67990-05-0 0,1 % Pigment Orange16 (PO16)/CI 21160 229-388-1 6505-28-8 0,1 % Pigment Yellow 1 (PY1)/CI 11680 219-730-8 2512-29-0 0,1 % Pigment Yellow 12 (PY12)/CI 21090 228-787-8 6358-85-6 0,1 % Pigment Yellow 87 (PY87)/CI 21107:1 239-160-3 15110-84-6, 14110-84-6 0,1 % Pigment Yellow 97 (PY97)/CI 11767 235-427-3 12225-18-2 0,1 % Pigment Orange 13 (PO13)/CI 21110 222-530-3 3520-72-7 0,1 % Pigment Orange 34 (PO34)/CI 21115 239-898-6 15793-73-4 0,1 % Pigment Yellow 83 (PY83)/CI 21108 226-939-8 5567-15-7 0,1 % Solvent Red 1 (SR1)/CI 12150 214-968-9 1229-55-6 0,1 % Acid Orange 24 (AO24)/CI 20170 215-296-9 1320-07-6 0,1 % Solvent Red 23 (SR23)/CI 26100 201-638-4 85-86-9 0,1 % Acid Red 73 (AR73)/CI 27290 226-502-1 5413-75-2 0,1 % Disperse Yellow 3/CI 11855 220-600-8 2832-40-8 0,1 % Acid Green 16 603-214-8 12768-78-4 0,1 % Acid Red 26 223-178-3 3761-53-3 0,1 % Acid Violet 17 223-942-6 4129-84-4 0,1 % Basic Red 1 213-584-9 989-38-8 0,1 % Disperse Blue 106 602-285-2 12223-01-7 0,1 % Disperse Blue 124 612-788-9 61951-51-7 0,1 % Disperse Blue 35 602-260-6 12222-75-2 0,1 % Disperse Orange 37 602-312-8 12223-33-5 0,1 % Disperse Red 1 220-704-3 2872-52-8 0,1 % Disperse Red 17 221-665-5 3179-89-3 0,1 % Disperse Yellow 9 228-919-4 6373-73-5 0,1 % Pigment Violet 3 603-635-7 1325-82-2 0,1 % Pigment Violet 39 264-654-0 64070-98-0 0,1 % Solvent Yellow 2 200-455-7 60-11-7 0,1 %