Registration, Evaluation, Authorisation and Restriction of Chemicals

02006R1907-20230629 → 02006R1907-20230806

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). 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). Column 1 Designation of the substance, of the group of substances or of the mixture Column 2 Conditions of restriction … 1,106 unchanged lines … EC. No 200-679-5 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 12 December 2023 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 6 mg/m3 for exposure by inhalation and 1,1 mg/kg/day for 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 12 December 2023 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 12 December 2024 in relation to placing on the market for use, or use, as a solvent in direct or transfer polyurethane coating processes of textiles and paper material or the production of polyurethane membranes, and from 12 December 2025 in relation to placing on the market for use, or use, as a solvent in the dry and wet spinning processes of synthetic fibres. 77. Formaldehyde CAS No 50-00-0 EC No 200-001-8 and formaldehyde-releasing substances 1. Shall not be placed on the market in articles, after 6 August 2026, if, under the test conditions specified in Appendix 14, the concentration of formaldehyde released from those articles exceeds: (a) 0,062 mg/m3 for furniture and wood-based articles; (b) 0,080 mg/m3 for articles other than furniture and wood-based articles. The first subparagraph shall not apply to: (a) articles in which formaldehyde or formaldehyde releasing substances are exclusively naturally present in the materials from which the articles are produced; (b) articles that are exclusively for outdoor use under foreseeable conditions; (c) articles in constructions, that are exclusively used outside the building shell and vapour barrier and that do not emit formaldehyde into indoor air; (d) articles exclusively for industrial or professional use unless formaldehyde released from them leads to exposure of the general public under foreseeable conditions of use; (e) articles for which the restriction laid down in entry 72 applies; (f) articles that are biocidal products within the scope of Regulation (EU) No 528/2012 of the European Parliament and of the Council; (g) devices within the scope of Regulation (EU) 2017/745; (h) personal protective equipment within the scope of Regulation (EU) 2016/425; (i) articles intended to come into contact directly or indirectly with food within the scope of Regulation (EC) No 1935/2004; (j) second-hand articles. 2. Shall not be placed on the market in road vehicles after 6 August 2027 if, under the test conditions specified in Appendix 14, the concentration of formaldehyde in the interior of those vehicles exceeds 0,062 mg/m3. The first subparagraph shall not apply to: (a) road vehicles exclusively for industrial or professional use unless the concentration of formaldehyde in the interior of those vehicles leads to exposure of the general public under foreseeable conditions of use; (b) second-hand vehicles. Appendices 1 to 6 FOREWORD Explanations of column headings … 3,131 unchanged lines … 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 %Appendix 14 1. Measurement of formaldehyde released to indoor air from articles referred to in paragraph 1, first subparagraph, of entry 77 The formaldehyde released from articles referred to in paragraph 1, first subparagraph of entry 77 shall be measured in the air of a test chamber under the following cumulative reference conditions: (a) the temperature in the test chamber shall be (23 ± 0,5) 0C; (b) the relative humidity in the test chamber shall be (45 ± 3) %; (c) the loading factor, expressed as the ratio of the total surface area of the test piece to the volume of the test chamber, shall be (1 ± 0,02) m2/m3. This loading factor corresponds to the testing of wood-based panels; for other material or products, if such a loading factor is clearly not realistic under foreseeable conditions of use, loading factors in accordance with Section 4.2.2 of EN 16516EN 16516: Construction products – Assessment of release of dangerous substances – Determination of emissions into indoor air. may be used; (d) the air exchange rate in the test chamber shall be (1 ± 0,05) h-1; (e) an appropriate analytical procedure for measuring the formaldehyde concentration in the test chamber shall be used; (f) an appropriate method for sampling of the test pieces shall be used; (g) the formaldehyde concentration in the air of the test chamber shall be measured at least twice per day throughout the test with a time interval between two consecutive samplings of 3 hours at a minimum; the measurement shall be repeated until sufficient data are available to determine the steady state concentration; (h) the duration of the test shall be sufficiently long to allow the determination of the steady state concentration and shall not exceed 28 days; (i) the steady state concentration of formaldehyde measured in the test chamber shall be used to verify the compliance with the limit value of formaldehyde released from articles referred to in paragraph 1, first subparagraph, of entry 77. If data from a test method using the reference conditions specified above are not available or suitable for the measurement of the formaldehyde released from a specific article, data obtained from a test method using non-reference conditions may be used, where there is a scientifically valid correlation between the results of the test method used and the reference conditions. 2. Measurement of formaldehyde concentration in the interior of vehicles referred to in paragraph 2, first subparagraph, of entry 77 For road vehicles, including trucks and buses, the formaldehyde concentration shall be measured in ambient mode in accordance with the conditions specified in ISO 12219-1ISO 12219-1: Interior air of road vehicles – Part 1: Whole vehicle test chamber – Specification and method for the determination of volatile organic compounds in cabin interiors. or ISO 12219-10ISO 12219-10: Interior air of road vehicles – Part 10: Whole vehicle test chamber – Specification and methods for the determination of volatile organic compounds in cabin interiors – Trucks and buses., and the concentration measured shall be used to verify the compliance with the limit value referred to in paragraph 2, first subparagraph, of entry 77.