Registration, Evaluation, Authorisation and Restriction of Chemicals

02006R1907-20231201 → 02006R1907-20240606

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).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).Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43).Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (OJ L 170, 25.6.2019, p. 1).Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16).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).Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117 5.5.2017, p. 1).Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, 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).Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43).Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (OJ L 170, 25.6.2019, p. 1).Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16).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).Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117 5.5.2017, p. 1).Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (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 … 948 unchanged lines … 69. Methanol CAS No 67-56-1 EC No 200-659-6 Shall not be placed on the market to the general public after 9 May 2019 in windscreen washing or defrosting fluids, in a concentration equal to or greater than 0,6 % by weight. 70. Octamethylcyclotetrasiloxane (D4) CAS No 556-67-2 EC No 209-136-7 70. Octamethylcyclotetrasiloxane (D4) CAS No 556-67-2 EC No 209-136-7 Decamethylcyclopentasiloxane (D5) CAS No 541-02-6 EC No 208-764-9 1. Shall not be placed on the market in wash-off cosmetic products in a concentration equal to or greater than 0,1 % by weight of either substance, after 31 January 2020. 2. For the purposes of this entry, wash-off cosmetic products means cosmetic products as defined in Article 2(1)(a) of Regulation (EC) No 1223/2009 that, under normal conditions of use, are washed off with water after application. CAS No 541-02-6 EC No 208-764-9 Dodecamethylcyclohexasiloxane (D6) CAS No 540-97-6 EC No 208-762-8 1. Shall not be placed on the market (a) as a substance on its own; (b) as a constituent of other substances; or (c) in mixtures; in a concentration equal to or greater than 0,1 % by weight of the respective substance after 6 June 2026. 2. Shall not be used as a solvent for the dry cleaning of textiles, leather and fur after 6 June 2026. 3. By way of derogation: (a) for D4 and D5 in wash-off cosmetic products, paragraph 1, point (c), shall apply after 31 January 2020. For the purposes of this point, wash-off cosmetic products means cosmetic products as defined in Article 2(1), point (a), of Regulation (EC) No 1223/2009 of the European Parliament and of the Council that, under normal conditions of use, are washed off with water after application; (b) for all cosmetic products other than the ones mentioned in paragraph 3(a), paragraph 1 shall apply after 6 June 2027; (c) for devices as defined in Article 1(4) of Regulation (EU) 2017/745 of the European Parliament and of the Council and in Article 1(2) of Regulation (EU) 2017/746 of the European Parliament and the Council, paragraph 1 shall apply after 6 June 2031; (d) for medicinal products, as defined in Article 1, point 2, of Directive 2001/83/EC, and for veterinary medicinal products, as defined in Article 4(1) of Regulation (EU) 2019/6, paragraph 1 shall apply after 6 June 2031; (e) for D5 as a solvent in the dry cleaning of textiles, leather and fur, paragraphs 1 and 2 shall apply after 6 June 2034. 4. By way of derogation, paragraph 1 shall not apply to the: (a) placing on the market of D4, D5 and D6 for the following industrial uses: as a monomer in the production of silicone polymer, as an intermediate in the production of other silicon substances, as a monomer in polymerisation, in the formulation or (re)packing of mixtures, in the production of articles, in non-metal surface treatment; (b) placing on the market of D5 and D6 for use as devices, as defined in Article 1(4) of Regulation (EU) 2017/745, for the treatment and care of scars and wounds, the prevention of wounds and the care of stoma; (c) placing on the market of D5 for professional use in the cleaning or restoration of art and antiques; (d) placing on the market of D4, D5 and D6 for use as laboratory reagent in research and development activities carried out under controlled conditions. 5. By way of derogation, paragraph 1, point (b), shall not apply to the placing on the market of D4, D5 and D6: as a constituent of a silicone polymer on its own, as a constituent of a silicone polymer in a mixture derogated under paragraph 6. 6. By way of derogation, paragraph 1, point (c), shall not apply to the placing on the market of mixtures that contain D4, D5 or D6 as residues from silicone polymers, under the following conditions: (a) D4, D5 or D6 in a concentration equal to or less than 1 % by weight of the respective substance in the mixture, for use in adhesion, sealing, gluing and casting; (b) D4 in a concentration equal to or less than 0,5 % by weight, or D5 or D6 in a concentration equal to or less than 0,3 % by weight of either substance in the mixture for use as protective coatings (including marine coatings); (c) D4, D5 or D6 in a concentration equal to or less than 0,2 % by weight of the respective substance in the mixture, for use as devices as defined in Article 1(4) of Regulation (EU) 2017/745 and in Article 1(2) of Regulation (EU) 2017/746, other than the devices referred to in paragraph 6(d); (d) D5 in a concentration equal to or less than 0,3 % by weight in the mixture or D6 in a concentration equal to or less than 1 % by weight in the mixture, for use as devices as defined in Article 1(4) of Regulation (EU) 2017/745, for dental impression; (e) D4 in a concentration equal to or less than 0,2 % by weight in the mixture, or D5 or D6 in a concentration equal to or less than 1 % by weight of either substance in the mixture for use as silicone insoles for horses, or as horseshoes; (f) D4, D5 or D6 in a concentration equal to or less than 0,5 % by weight of the respective substance in the mixture, for use as adhesion promoters; (g) D4, D5 or D6 in a concentration equal to or less than 1 % by weight of the respective substance in the mixture, for use in 3D-printing; (h) D5 in a concentration equal to or less than 1 % by weight in the mixture or D6 in a concentration equal to or less than 3 % by weight in the mixture, for rapid prototyping and mould making, or high performance uses stabilised by quartz filler; (i) D5 or D6 in a concentration equal to or less than 1 % by weight of either substance in the mixture, for use in pad printing, or manufacturing of printing pads; (j) D6 in a concentration equal to or less than 1 % by weight of the mixture, for professional use in the cleaning or restoration of art and antiques. 7. By way of derogation, paragraphs 1 and 2 shall not apply to the placing on the market for use, or to the use, of D5 as a solvent in strictly controlled closed dry cleaning systems for textile, leather and fur, where the cleaning solvent is recycled or incinerated. 71. 1-methyl-2-pyrrolidone (NMP) CAS No 872-50-4 … 98 unchanged lines … 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 skin cworrosive 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 … 3,429 unchanged lines … Loading: 10 g/1000 mL Test time: 24 h Pass criterion: solubility > 2 g/L.