Registration, Evaluation, Authorisation and Restriction of Chemicals

02006R1907-20170102 → 02006R1907-20170302

ANNEX VII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MOREThis Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are … 1,705 unchanged words … vitro/in chemico test method(s) recognised according to Article 13(3), addressing each of the following key events of skin sensitisation: (a) molecular interaction with skin proteins; (b) inflammatory response in keratinocytes; (c) activation of dendritic cells. The(se) test(s) do not need to be conducted if if: an in vivo study according to point 8.3.2 is available, or the available in vitro/in chemico test methods are not applicable for the substance or are not adequate for classification and risk assessment according to point 8.3. If information from test method(s) addressing one or two of the key events in column 1 already allows classification and risk assessment according to point 8.3, studies addressing the other key event(s) need not be conducted. 8.3.2. Skin sensitisation, in vivo An in vivo study shall be conducted only if in vitro/in chemico test methods described under point 8.3.1 are not applicable, or the results obtained from those studies are not adequate for classification and risk assessment according to point 8.3. The murine local lymph node assay (LLNA) is the first-choice method for in vivo testing. Only in exceptional circumstances should another test be used. Justification for the use of another in vivo test shall be provided. In vivo skin sensitisation studies that were carried out or initiated before 11 October 2016, 10 May 2017, and that meet the requirements set out in Article 13(3), first subparagraph, and Article 13(4) shall be considered appropriate to address this standard information requirement. 8.4. Mutagenicity 8.4. Further mutagenicity studies shall be considered in case of a positive result. 8.4.1. In vitro gene mutation study in bacteria 8.5. Acute toxicity 8.5. The study/ies do(es) not generally need to be conducted if: the substance is classified as corrosive to the skin. 8.5.1. By oral route The study need not be conducted if a study on acute toxicity by the inhalation route (8.5.2) is available. 9. ECOTOXICOLOGICAL INFORMATION COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 9.1. Aquatic toxicity 9.1.1. Short-term toxicity testing on invertebrates (preferred species Daphnia) The registrant may consider long-term toxicity testing instead of short-term. 9.1.1. The study does not need to be conducted if: there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes, or a long-term aquatic toxicity study on invertebrates is available, or adequate information for environmental classification and labelling is available. The long-term aquatic toxicity study on Daphnia (Annex IX, section 9.1.5) shall be considered if the substance is poorly water soluble. 9.1.2. Growth inhibition study aquatic plants (algae preferred) 9.1.2. The study does not need to be conducted if there are mitigating factors indicating that aquatic toxicity is unlikely to occur for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes. 9.2. Degradation 9.2.1. Biotic 9.2.1.1. Ready biodegradability 9.2.1.1. The study does not need to be conducted if the substance is inorganic. Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided.

02006R1907-20170102 → 02006R1907-20170302

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). 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). Column 1 Designation of the substance, of the group of substances or of the mixture Column 2 Conditions of restriction … 751 unchanged lines … 66. Bisphenol A CAS No 80-05-7 EC No 201-245-8 Shall not be placed on the market in thermal paper in a concentration equal to or greater than 0,02 % by weight after 2 January 2020. 67. Bis(pentabromophenyl)ether (decabromodiphenyl ether; decaBDE) CAS No 1163-19-5 EC No 214-604-9 1. Shall not be manufactured or placed on the market as a substance on its own after 2 March 2019. 2. Shall not be used in the production of, or placed on the market in: (a) another substance, as a constituent; (b) a mixture; (c) an article, or any part thereof, in a concentration equal to or greater than 0,1 % by weight, after 2 March 2019. 3. Paragraphs 1 and 2 shall not apply to a substance, constituent of another substance or mixture that is to be used, or is used: (a) in the production of an aircraft before 2 March 2027. (b) in the production of spare parts for either of the following: (i) an aircraft produced before 2 March 2027; (ii) motor vehicles within the scope of Directive 2007/46/EC, agricultural and forestry vehicles within the scope of Regulation (EU) No 167/2013 of the European Parliament and of the Council or machinery within the scope of Directive 2006/42/EC of the European Parliament and of the Council, produced before 2 March 2019. 4. Subparagraph 2(c) shall not apply to any of the following: (a) articles placed on the market before 2 March 2019; (b) aircraft produced in accordance with subparagraph 3(a); (c) spare parts of aircraft, vehicles or machines produced in accordance with subparagraph 3(b); (d) electrical and electronic equipment within the scope of Directive 2011/65/EU. 5. For the purposes of this entry aircraft means one of the following: (a) a civil aircraft produced in accordance with a type certificate issued under Regulation (EU) No 216/2008 of the European Parliament and of the Council 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; (b) a military aircraft. Appendices 1 to 6 FOREWORD Explanations of column headings … 2,939 unchanged lines … (b) Perboric acid (H3BO2(O2)), monosodium salt trihydrate; perboric acid, sodium salt, tetrahydrate; perboric acid (HBO(O2)), sodium salt, tetrahydrate; sodium peroxoborate hexahydrate CAS No 13517-20-9; 37244-98-7; 10486-00-7 EC No 239-172-9; 234-390-0; 231-556-4 Detergents as defined by Regulation (EC) No 648/2004 of the European Parliament and of the Council. The derogation shall apply until 1 June 2013.