Registration, Evaluation, Authorisation and Restriction of Chemicals

02006R1907-20250422 → 02006R1907-20250623

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. … 1,201 unchanged lines … (a) polymers that are the result of a polymerisation process that has taken place in nature, independently of the process through which they have been extracted, which are not chemically modified substances; (b) polymers that are degradable as proved in accordance with Appendix 15; (c) polymers that have a solubility greater than 2 g/L as proved in accordance with Appendix 16; (d) polymers that do not contain carbon atoms in their chemical structure. 1. Shall not be placed on the market as substances on their own or, where the synthetic polymer microparticles are present to confer a sought-after characteristic, in mixtures in a concentration equal to or greater than 0,01 % by weight. (d) polymers that do not contain carbon atoms in their chemical structure. 1. Shall not be placed on the market on their own or, where the synthetic polymer microparticles are present to confer a sought-after characteristic, in mixtures in a concentration equal to or greater than 0,01 % by weight. 2. For the purposes of this entry, the following definitions apply: (a) particle means a minute piece of matter, other than single molecules, with defined physical boundaries; (b) solid means a substance or mixture other than a liquid or gas; (c) gas means a substance or mixture which at 50 °C has a vapour pressure greater than 300 kPa (absolute), or is completely gaseous at 20 °C at a standard pressure of 101,3 kPa; (d) liquid means a substance or mixture that meets any of the following conditions: (i) the substance or mixture at 50 °C has a vapour pressure of not more than 300 kPa, is not completely gaseous at 20 °C and at a standard pressure of 101,3 kPa, and has a melting point or initial melting point of 20 °C or less at a standard pressure of 101,3 kPa; (ii) the substance or mixture fulfils the criteria in the American Society for Testing and Materials (ASTM) D 4359-90 Standard Test Method for Determining Whether a Material Is a Liquid or a Solid; (iii) the substance or mixture passes the fluidity test (penetrometer test) described in chapter 2.3.4 of Part 2 of Annex A to the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) concluded at Geneva on 30 September 1957; (e) make-up product means any substance or mixture intended to be placed in contact with specific external parts of the human body, namely the epidermis, eye brows and eye lashes, with a view to, exclusively or mainly, changing their appearance; 3. Where the concentration of synthetic polymer microparticles covered by this entry cannot be determined by available analytical methods or accompanying documentation, in order to verify the compliance with the concentration limit referred to in paragraph 1, only the particles of at least the following size shall be taken into account: (a) 0,1 μm for any dimension, for particles where all dimensions are equal to or smaller than 5 mm; (b) 0,3 μm in length, for particles that have a length that is equal to or smaller than 15 mm and a length to diameter ratio greater than 3. 4. Paragraph 1 shall not apply to the placing on the market of: (a) synthetic polymer microparticles, as substances on their own or in mixtures, for use at industrial sites; (a) synthetic polymer microparticles on their own or in mixtures, for use at industrial sites; (b) medicinal products within the scope of Directive 2001/83/EC and veterinary medicinal products within the scope of Regulation (EU) 2019/6 of the European Parliament and of the Council; (c) EU fertilising products within the scope of Regulation (EU) 2019/1009 of the European Parliament and of the Council; (d) food additives within the scope of Regulation (EC) No 1333/2008 of the European Parliament and of the Council; (e) in vitro diagnostic devices, including devices within the scope of Regulation (EU) 2017/746 of the European Parliament and of the Council; (f) food within the meaning of Article 2 of Regulation (EC) No 178/2002, not covered by point (d) of this paragraph, and feed as defined in Article 3(4) of that Regulation. 5. Paragraph 1 shall not apply to the placing on the market of the following synthetic polymer microparticles, as substances on their own or in mixtures: 5. Paragraph 1 shall not apply to the placing on the market of the following synthetic polymer microparticles on their own or in mixtures: (a) synthetic polymer microparticles which are contained by technical means so that releases to the environment are prevented when used in accordance with the instructions for use during the intended end use; (b) synthetic polymer microparticles the physical properties of which are permanently modified during intended end use in such a way that the polymer no longer falls within the scope of this entry; (c) synthetic polymer microparticles which are permanently incorporated into a solid matrix during intended end use. 6. Paragraph 1 shall apply as follows regarding the following uses: (a) from 17 October 2029 to synthetic polymer microparticles for use in the encapsulation of fragrances; (b) from 17 October 2027 for rinse-off products as defined in point (1)(a) of the Preamble to Annexes II to VI to Regulation (EC) No 1223/2009 unless such products are covered by point (a) of this paragraph or contain synthetic polymer microparticles for use as an abrasive, i.e. namely to exfoliate, polish or clean (microbeads); (c) from 17 October 2035 for lip products as defined in point (1)(e) of the Preamble to Annexes II to VI to Regulation (EC) No 1223/2009, nail products as defined in point (1)(g) of the Preamble to Annexes II to VI to that Regulation, and make-up products within the scope of that Regulation, unless such products are covered by points (a) or (b) of this paragraph or contain microbeads; (d) from 17 October 2029 for leave-on products, as defined in point (1)(b) of the Preamble to Annexes II to VI to Regulation (EC) No 1223/2009, unless such products are covered by points (a) or (c) of this paragraph; (e) from 17 October 2028 for detergents, as defined in Article 2(1) of Regulation (EC) No 648/2004, waxes, polishes and air care products, unless those products are covered by point (a) of this paragraph or contain microbeads; (f) from 17 October 2029 for devices, within the scope of Regulation (EU) 2017/745 of the European Parliament and of the Council, unless those devices contain microbeads; (g) from 17 October 2028 for fertilising products, as defined in Article 2, point (1), of Regulation (EU) 2019/1009, which do not fall within the scope of that Regulation; (h) from 17 October 2031 for plant protection products within the meaning of Article 2(1) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council and seeds treated with those products, and biocidal products as defined in Article 3(1), point (a), of Regulation (EU) No 528/2012 of the European Parliament and of the Council; (i) from 17 October 2028 for products for agricultural and horticultural uses not covered by points (g) or (h); (j) from 17 October 2031 for granular infill for use on synthetic sports surfaces. 7. From 17 October 2025 suppliers of synthetic polymer microparticles referred to in paragraph 4, point (a), shall provide the following information: (a) instructions for use and disposal explaining to industrial downstream users how to prevent releases of synthetic polymer microparticles to the environment; (b) the following statement: The synthetic polymer microparticles supplied is subject to conditions laid down by entry 78 of Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council; (b) the following statement: The synthetic polymer microparticles supplied are subject to conditions laid down by entry 78 of Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council; (c) the information on quantity or, as applicable, concentration of synthetic polymer microparticles in the substance or mixture; (d) generic information on the identity of the polymers contained in the substance or mixture that enables manufacturers, industrial downstream users and other suppliers to comply with their obligations laid down in paragraphs 11 and 12. 8. From 17 October 2026 suppliers of products containing synthetic polymer microparticles referred to in paragraph 4, point (e), and from 17 October 2025 suppliers of products containing synthetic polymer microparticles referred to in paragraph 4, point (d), and paragraph 5, shall provide instructions for use and disposal explaining to professional users and the general public how to prevent releases of synthetic polymer microparticles to the environment. … 45 unchanged lines … 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. 80. N,N-dimethylacetamide (DMAC) CAS No 127-19-5 EC No 204-826-4 1. Shall not be placed on the market as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers, importers and downstream users have included in the relevant chemical safety reports and safety data sheets, derived no-effect levels (DNELs) relating to exposure of workers of 13 mg/m3 for long-term exposure by inhalation and 1,8 mg/kg bw/day for long-term dermal exposure. 2. Shall not be manufactured, or used, as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers and downstream users take the appropriate risk management measures and provide the appropriate operational conditions to ensure that exposure of workers is below the DNELs specified in paragraph 1. 3. By way of derogation from paragraphs 1 and 2, the obligations laid down therein shall apply from 23 June 2029 in relation to placing on the market for use, or use, as a solvent in the production of man-made fibres. 81. 1-ethylpyrrolidin-2-one (NEP) CAS No 2687-91-4 EC No 220-250-6 1. Shall not be placed on the market as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers, importers and downstream users have included in the relevant chemical safety reports and safety data sheets, derived no-effect levels (DNELs) relating to exposure of workers of 4,0 mg/m3 for long-term exposure by inhalation and 2,4 mg/kg bw/day for long-term dermal exposure. 2. Shall not be manufactured, or used, as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers and downstream users take the appropriate risk management measures and provide the appropriate operational conditions to ensure that exposure of workers is below the DNELs specified in paragraph 1. 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.