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Appendix 11


Entries 28 to 30 — Derogations for specific substances

Substances

Derogations

1.  

(a)  Sodium perborate; perboric acid, sodium salt; perboric acid, sodium salt, monohydrate; sodium peroxometaborate; perboric acid (HBO(O2)), sodium salt, monohydrate; sodium peroxoborate

CAS No 15120-21-5; 11138-47-9; 12040-72-1; 7632-04-4; 10332-33-9

EC No 239-172-9; 234-390-0; 231-556-4

(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 (1). The derogation shall apply until 1 June 2013.

(1)   OJ L 104, 8.4.2004, p. 1.

( 1 ) OJ L 159, 29.6.1996, p. 1.

( 2 ) OJ L 114, 27.4.2006, p. 9.

( 3 ) OJ L 183, 29.6.1989, p. 1. Directive as amended by Regulation (EC) No 1882/2003.

( 4 ) OJ L 257, 10.10.1996, p. 26. Directive as last amended by Regulation (EC) No 166/2006 of the European Parliament and of the Council (OJ L 33, 4.2.2006, p. 1).

( 5 ) OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).

( 6 ) OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, p. 58).

( 7 ) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regulation (EC) No 1901/2006.

( 8 ) OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003.

( 9 ) OJ L 184, 15.7.1988, p. 61. Directive as last amended by Regulation (EC) No 1882/2003.

( 10 ) OJ L 84, 27.3.1999, p. 1. Decision as last amended by Decision 2006/253/EC (OJ L 91, 29.3.2006, p. 48).

( 11 ) OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).

( 12 ) OJ L 213, 21.7.1982, p. 8. Directive as last amended by Commission Directive 2004/116/EC (OJ L 379, 24.12.2004, p. 81).

( 13 ) OJ L 124, 20.5.2003, p. 36.

( 14 ) OJ L 338, 13.11.2004, p. 4.

( 15 ) Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1). Directive as last amended by Commission Directive 2006/136/EC (OJ L 349, 12.12.2006, p. 42).

( 16 Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (OJ L 366, 15.12.1992, p. 10). Regulation as last amended by Regulation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 27).

( 17 Commission Regulation (EC) No 703/2001 of 6 April 2001 laying down the active substances of plant protection products to be assessed in the second stage of the work programme referred to in Article 8(2) of Council Directive 91/414/EEC and revising the list of Member States designated as rapporteurs for those substances (OJ L 98, 7.4.2001, p. 6).

( 18 Commission Regulation (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (OJ L 224, 21.8.2002, p. 23). Regulation as last amended by Regulation (EC) No 1744/2004 (OJ L 311, 8.10.2004, p. 23).

( 19 Commission Decision 2003/565/EC of 25 July 2003 extending the time period provided for in Article 8(2) of Council Directive 91/414/EEC (OJ L 192, 31.7.2003, p. 40).

( 20 ) OJ L 123, 24.4.1998, p. 1. Directive as last amended by Commission Directive 2006/140/EC (OJ L 414, 30.12.2006, p. 78).

( 21 ) OJ L 307, 24.11.2003, p. 1. Regulation as last amended by Regulation (EC) No 1849/2006 (OJ L 355, 15.12.2006, p. 63).

( 22 ) OJ L 350, 28.12.1998, p. 58. Directive as amended by Regulation (EC) No 1882/2003.

( 23 ) OJ L 189, 20.7.1990, p. 17. Directive as last amended by Regulation (EC) No 1882/2003.

( 24 ) OJ L 169, 12.7.1993, p. 1. Directive as last amended by Regulation (EC) No 1882/2003.

( 25 ) OJ L 331, 7.12.1998, p. 1. Directive as last amended by Regulation (EC) No 1882/2003.

( 26 ) OJ L 158, 30.4.2004, p. 7, corrected in OJ L 229, 29.6.2004, p. 5. Regulation as amended by Council Regulation (EC) No 1195/2006 (OJ L 217, 8.8.2006, p. 1).

( 27 ) OJ L 248, 16.9.2002, p. 1. Regulation as amended by Regulation (EC, Euratom) No 1995/2006 (OJ L 390, 30.12.2006, p. 1).

( 28 ) OJ L 136, 31.5.1999, p. 1.

( 29 ) OJ L 136, 31.5.1999, p. 15.

( 30 ) OJ 17, 6.10.1958, p. 385/58. Regulation as last amended by Council Regulation (EC) No 920/2005 (OJ L 156, 18.6.2005, p. 3).

( 31 ) OJ L 63, 6.3.2003, p. 1. Regulation as last amended by Commission Regulation (EC) No 777/2006 (OJ L 136, 24.5.2006, p. 9).

( 32 ) In general, the more extensive the data and the longer the duration of the tests, the smaller is the degree of uncertainty and the size of the assessment factor. An assessment factor of 1 000 is typically applied to the lowest of three short term L(E)C50 values derived from species representing different trophic levels and a factor of 10 to the lowest of three long-term NOEC values derived from species representing different trophic levels.

( 33 ) Marpol — Consolidated edition 2006, London, IMO 2007, ISBN 978-92-801-4216-7.

( 34 ) IBC Code, 2007 edition, London, IMO 2007, ISBN 978-92-801-4226-6.

( 35 ) Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40).

( 36 Commission Decision 2014/113/EU of 3 March 2014 on setting up a Scientific Committee on Occupational Exposure Limits for Chemical Agents and repealing Decision 95/320/EC (OJ L 62, 4.3.2014, p. 18).

( 37 ) Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (OJ L 399, 30.12.1989, p. 18).

( 38 ) Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).

( 39 ) United Nations, Economic Commission for Europe, version applicable as from 1 January 2015, ISBN-978-92-1-139149-7.

( 40 ) Annex 1 to Appendix B (Uniform Rules concerning the Contract for International Carriage of Goods by Rail) of the Convention concerning International Carriage by Rail, version with effect from 1 January 2009.

( 41 ) Version as revised as of 1 January 2007.

( 42 ) Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p. 13).

( 43 ) International Maritime Organisation, 2006 edition, ISBN 978-92-8001-4214-3.

( 44 ) IATA, 2007-2008 edition.

( 45 ) MEPC.2/Circular, Provisional categorisation of liquid substances, version 19, effective 17 December 2013.

( 46 ) Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer (OJ L 286, 31.10.2009, p. 1).

( 47 ) Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (OJ L 158, 30.4.2004, p. 7).

( 48 ) Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (OJ L 201, 27.7.2012, p. 60).

( 49 ) Council Directive 96/82/EC of 9 December 1996 on the control of major-accident hazards involving dangerous substances (OJ L 10, 14.1.1997, p. 13).

( 50 ) This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are required to carry out tests under this Regulation adapted as necessary.

( 51 ) Note: conditions for not requiring a specific test that are set out in the appropriate test methods in the Commission Regulation on test methods as specified in Article 13(3) that are not repeated in column 2, also apply.

( 52 ) This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are required to carry out tests under this Regulation adapted as necessary.

( 53 ) Note: conditions for not requiring a specific test that are set out in the appropriate test methods in the Commission Regulation on test methods as specified in Article 13(3) that are not repeated in column 2, also apply.

( 54 ) This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are required to carry out tests under this Regulation adapted as necessary.

( 55 ) Note: conditions for not requiring a specific test that are set out in the appropriate test methods in the Commission Regulation on test methods as specified in Article 13(3) that are not repeated in column 2, also apply.

( 56 ) This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are required to carry out tests under this Regulation adapted as necessary.

( 57 ) Note: conditions for not requiring a specific test that are set out in the appropriate test methods in the Commission Regulation on test methods as specified in Article 13(3) that are not repeated in column 2, also apply.

( 58 ) For the purpose of subparagraph 3.2(a)(ii), without prejudice to column 2 of Section 8.7 of Annexes IX and X, a DNEL derived from a screening test for reproductive/developmental toxicity shall not be considered appropriate to omit a prenatal developmental toxicity study or a two-generation reproductive toxicity study. For the purpose of subparagraph 3.2(a)(ii), without prejudice to column 2 of section 8.6 of Annexes IX and X, a DNEL derived from a 28-day repeated dose toxicity study shall not be considered appropriate to omit a 90-day repeated dose toxicity study.