Registration, Evaluation, Authorisation and Restriction of Chemicals

02006R1907-20181201 → 02006R1907-20190107

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). 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). Column 1 Designation of the substance, of the group of substances or of the mixture Column 2 Conditions of restriction … 566 unchanged lines … 6. Toys, including activity toys, and childcare articles, shall not be placed on the market, if any of their rubber or plastic components that come into direct as well as prolonged or short-term repetitive contact with the human skin or the oral cavity, under normal or reasonably foreseeable conditions of use, contain more than 0,5 mg/kg (0,00005 % by weight of this component) of any of the listed PAHs. 7. By way of derogation from paragraphs 5 and 6, these paragraphs shall not apply to articles placed on the market for the first time before 27 December 2015. 8. By 27 December 2017, the Commission shall review the limit values in paragraphs 5 and 6 in the light of new scientific information, including migration of PAHs from the articles referred to therein, and information on alternative raw materials and, if appropriate, modify these paragraphs accordingly. 51. The following phthalates (or other CAS and EC numbers covering the substance): (a) Bis (2-ethylhexyl) phthalate (DEHP) CAS No 117-81-7 EC No 204-211-0 (b) Dibutyl phthalate (DBP) CAS No 84-74-2 EC No 201-557-4 (c) Benzyl butyl phthalate (BBP) CAS No 85-68-7 EC No 201-622-7 1. Shall not be used as substances or in mixtures, in concentrations greater than 0,1 % by weight of the plasticised material, in toys and childcare articles. 2. Toys and childcare articles containing these phthalates in a concentration greater than 0,1 % by weight of the plasticised material shall not be placed on the market. 3. The Commission shall re-evaluate, by 16 January 2010, the measures provided for in relation to this entry in the light of new scientific information on such substances and their substitutes, and if justified, these measures shall be modified accordingly. 4. For the purpose of this entry childcare article shall mean any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children. 51. Bis(2-ethylhexyl) phthalate (DEHP) CAS No.: 117-81-7 EC No.: 204-211-0 Dibutyl phthalate (DBP) CAS No.: 84-74-2 EC No.: 201-557-4 Benzyl butyl phthalate (BBP) CAS No.: 85-68-7 EC No.: 201-622-7 Diisobutyl phthalate (DIBP) CAS No.: 84-69-5 EC No.: 201-553-2 1. Shall not be used as substances or in mixtures, individually or in any combination of the phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % by weight of the plasticised material, in toys and childcare articles. 2. Shall not be placed on the market in toys or childcare articles, individually or in any combination of the first three phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % by weight of the plasticised material. In addition, DIBP shall not be placed on the market after 7 July 2020 in toys or childcare articles, individually or in any combination with the first three phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % by weight of the plasticised material. 3. Shall not be placed on the market after 7 July 2020 in articles, individually or in any combination of the phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % by weight of the plasticised material in the article. 4. Paragraph 3 shall not apply to: (a) articles exclusively for industrial or agricultural use, or for use exclusively in the open air, provided that no plasticised material comes into contact with human mucous membranes or into prolonged contact with human skin; (b) aircraft, placed on the market before 7 January 2024, or articles, whenever placed on the market, for use exclusively in the maintenance or repair of those aircraft, where those articles are essential for the safety and airworthiness of the aircraft; (c) motor vehicles within the scope of Directive 2007/46/EC, placed on the market before 7 January 2024, or articles, whenever placed on the market, for use exclusively in the maintenance or repair of those vehicles, where the vehicles cannot function as intended without those articles; (d) articles placed on the market before 7 July 2020; (e) measuring devices for laboratory use, or parts thereof; (f) materials and articles intended to come into contact with food within the scope of Regulation (EC) No 1935/2004 or Commission Regulation (EU) No 10/2011; (g) medical devices within the scope of Directives 90/385/EEC, 93/42/EEC or 98/79/EC, or parts thereof; (h) electrical and electronic equipment within the scope of Directive 2011/65/EU; (i) the immediate packaging of medicinal products within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC or Directive 2001/83/EC; (j) toys and childcare articles covered by paragraphs 1 or 2. 5. For the purposes of paragraphs 1, 2, 3 and 4(a), (a) plasticised material means any of the following homogeneous materials: polyvinyl chloride (PVC), polyvinylidene chloride (PVDC),polyvinyl acetate (PVA), polyurethanes, any other polymer (including, inter alia, polymer foams and rubber material) except silicone rubber and natural latex coatings, surface coatings, non-slip coatings, finishes, decals, printed designs, adhesives, sealants, paints and inks. (b) prolonged contact with human skin means continuous contact of more than 10 minutes duration or intermittent contact over a period of 30 minutes, per day. (c) childcare article shall mean any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children. 6. For the purposes of paragraph 4(b), aircraft means one of the following: (a) a civil aircraft produced in accordance with a type certificate issued under Regulation (EC) No 216/2008 or with a design approval issued under the national regulations of a contracting State of the International Civil Aviation Organisation (ICAO), or for which a certificate of airworthiness has been issued by an ICAO contracting State under Annex 8 to the Convention on International Civil Aviation, signed on December 7, 1944 , in Chicago; (b) a military aircraft. 52. The following phthalates (or other CAS- and EC numbers covering the substance): (a) Di-isononyl phthalate (DINP) CAS No 28553-12-0 and 68515-48-0 … 3,306 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/kg