Registration, Evaluation, Authorisation and Restriction of Chemicals

02006R1907-20240606 → 02006R1907-20241010

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).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). 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).Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on the control of major-accident hazards involving dangerous substances, amending and subsequently repealing Council Directive 96/82/EC (OJ L 197, 24.7.2012, p. 1, ELI: http://data.europa.eu/eli/dir/2012/18/oj).Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (OJ L 169, 25.6.2019, p. 45, ELI: http://data.europa.eu/eli/reg/2019/1021/oj). Column 1 Designation of the substance, of the group of substances or of the mixture Column 2 Conditions of restriction … 1,241 unchanged lines … 15. Manufacturers, importers and industrial downstream users of products containing polymers claimed to be excluded from the designation of synthetic polymer microparticles on grounds of degradability or solubility shall provide, without delay, information proving that those polymers are degradable in accordance with Appendix 15 or soluble in accordance with Appendix 16, as applicable, to competent authorities upon their request. 16. Paragraph 1 shall not apply to placing on the market of synthetic polymers microparticles, on their own or in mixtures, placed on the market before 17 October 2023. However, the first subparagraph shall not apply to the placing on the market of synthetic polymers microparticles for uses listed in paragraph 6. 79. Undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances: (a) having a linear or branched perfluoropentyl group with the formula C5F11- directly attached to another carbon atom as one of the structural elements; or (b) having a linear or branched perfluorohexyl group with the formula C6F13-. The following substances are excluded from this designation: (a) C6F14; (b) C6F13-C(=O)OH, C6F13-C(=O)O-X′ or C6F13-CF2-X′ (where X′ = any group, including salts); (c) any substance having a perfluoroalkyl group C6F13- directly attached to an oxygen atom at one of the non-terminal carbon atoms. 1. Shall not, from 10 October 2026 be placed on the market, or used, in a concentration equal to or greater than 25 ppb for the sum of PFHxA and its salts, or 1 000 ppb for the sum of PFHxA-related substances, measured in homogeneous material, in the following: (a) textiles, leather, furs and hides in clothing and related accessories for the general public; (b) footwear for the general public; (c) paper and cardboard used as food contact materials within the scope of Regulation (EC) No 1935/2004; (d) mixtures for the general public; (e) cosmetic products as defined in Article 2(1), point (a), of Regulation (EC) No 1223/2009. 2. Shall not, from 10 October 2027 be placed on the market, or used, in a concentration equal to or greater than 25 ppb for the sum of PFHxA and its salts, or 1 000 ppb for the sum of PFHxA-related substances, measured in homogeneous material, in textiles, leather, furs and hides, other than in clothing and related accessories referred to in paragraph 1, for the general public. 3. Paragraphs 1 and 2 shall not apply to the following: (a) personal protective equipment intended to protect users against risks within the scope of risk category III, points (a), (c) to (f), (h), and (l) of Annex I to Regulation (EU) 2016/425; (b) devices within the scope of Regulation (EU) 2017/745; (c) devices within the scope of Regulation (EU) 2017/746; (d) textiles used as construction textiles. 4. Shall not, from 10 April 2026 be placed on the market, or used, in a concentration equal to or greater than 25 ppb for the sum of PFHxA and its salts, or 1 000 ppb for the sum of PFHxA-related substances, in: (a) firefighting foams and firefighting foam concentrates for training and for testing, except functional testing of the firefighting systems provided that all releases are contained; (b) firefighting foams and firefighting foam concentrates for public fire services, except where those services intervene at industrial fires at establishments covered by Directive 2012/18/EU of the European Parliament and of the Council and they use the foams and the equipment for that purpose only. 5. Shall not, from 10 October 2029 be placed on the market, or used, in firefighting foams and firefighting foam concentrates for civil aviation (including in civilian airports) in a concentration equal to or greater than 25 ppb for the sum of PFHxA and its salts, or 1000 ppb for the sum of PFHxA-related substances. 6. Paragraphs 1, 2, 4 and 5 shall not apply to substances having a perfluoroalkyl group C6F13- directly attached to a sulphur atom that are prohibited in Annex I to Regulation (EU) 2019/1021 of the European Parliament and of the Council. 7. By way of derogation from paragraph 1, that paragraph shall not apply to articles and mixtures which were placed on the market before 10 October 2026. 8. By way of derogation from paragraph 2, that paragraph shall not apply to articles which were placed on the market before 10 October 2027. 9. For the purposes of this entry, PFHxA-related substances are substances that, based on their molecular structure, are considered to have the potential to degrade or be transformed to PFHxA. Appendices 1 to 6 FOREWORD Explanations of column headings … 3,289 unchanged lines … Loading: 10 g/1000 mL Test time: 24 h Pass criterion: solubility > 2 g/L.