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FOOTNOTES: | List of Footnotes |
[1] OJ C 112, 30.4.2004, p. 92 and OJ C 294, 25.11.2005, p. 38.
[2] OJ C 164, 5.7.2005, p. 78.
[3] Opinion of the European Parliament of 17 November 2005 (OJ C 280 E, 18.11.2006, p. 303), Council Common Position of 27
June 2006 (OJ C 276 E, 14.11.2006, p. 1) and Position of the European Parliament of 13 December 2006 (not yet published in
the Official Journal). Council Decision of 18 December 2006.
[4] OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission Directive 2004/73/EC (OJ L 152, 30.4.2004, p. 1). Corrected
in OJ L 216, 16.6.2004, p. 3.
[5] OJ L 262, 27.9.1976, p. 201. Directive as last amended by Commission Directive 2006/139/EC (OJ L 384, 29.12.2006, p. 94).
[6] OJ L 200, 30.7.1999, p. 1. Directive as last amended by Commission Directive 2006/8/EC (OJ L 19, 24.1.2006, p. 12).
[7] OJ L 84, 5.4.1993, p. 1. Regulation as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1).
[8] OJ L 158, 30.4.2004, p. 50, corrected in OJ L 229, 29.6.2004, p. 23.
[9] OJ L 131, 5.5.1998, p. 11.
[10] OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2007/1/EC (OJ L 25, 1.2.2007, p. 9).
[11] OJ L 358, 18.12.1986, p. 1. Directive as amended by Directive 2003/65/EC of the European Parliament and of the Council
(OJ L 230, 16.9.2003, p. 32).
[12] OJ L 50, 20.2.2004, p. 44.
[13] OJ L 357, 31.12.2002, p. 72.
[14] OJ L 136, 30.4.2004, p. 1. Regulation as amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1).
[15] OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 575/2006 (OJ L 100, 8.4.2006, p.
3).
[16] OJ C 218, 13.9.2003, p. 1.
[17] OJ L 41, 14.2.2003, p. 26.
[18] OJ L 145, 31.5.2001, p. 43.
[19] OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).
[20] Commission Directive 91/155/EEC of 5 March 1991 defining and laying down the detailed arrangements for the system of
specific information relating to dangerous preparations in implementation of Article 10 of Directive 88/379/EEC (OJ L 76,
22.3.1991, p. 35). Directive as last amended by Directive 2001/58/EC (OJ L 212, 7.8.2001, p. 24).
[21] Commission Directive 93/67/EEC of 20 July 1993 laying down the principles for assessment of risks to man and the environment
of substances notified in accordance with Council Directive 67/548/EEC (OJ L 227, 8.9.1993, p. 9).
[22] Commission Directive 93/105/EC of 25 November 1993 laying down Annex VII D, containing information required for the technical dossier referred to in Article 12 of the seventh amendment of Council
Directive 67/548/EEC (OJ L 294, 30.11.1993, p. 21).
[23] Commission Directive 2000/21/EC of 25 April 2000 concerning the list of Community legislation referred to in the fifth
indent of Article 13(1) of Council Directive 67/548/EEC (OJ L 103, 28.4.2000, p. 70).
[24] Commission Regulation (EC) No 1488/94 of 28 June 1994 laying down the principles for the assessment of risks to man and
the environment of existing substances in accordance with Council Regulation (EEC) No 793/93 (OJ L 161, 29.6.1994, p. 3).
[25] OJ C 364, 18.12.2000, p. 1.
[26] OJ L 159, 29.6.1996, p. 1.
[27] OJ L 114, 27.4.2006, p. 9.
[28] OJ L 183, 29.6.1989, p. 1. Directive as amended by Regulation (EC) No 1882/2003.
[29] 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).
[30] 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).
[31] 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).
[32] OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regulation (EC) No 1901/2006.
[33] OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003.
[34] OJ L 184, 15.7.1988, p. 61. Directive as last amended by Regulation (EC) No 1882/2003.
[35] 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).
[36] 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).
[37] 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).
[38] OJ L 124, 20.5.2003, p. 36.
[39] OJ L 338, 13.11.2004, p. 4.
[40] 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).
[41] 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).
[42] 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).
[43] 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).
[44] 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).
[45] 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).
[46] 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).
[47] OJ L 350, 28.12.1998, p. 58. Directive as amended by Regulation (EC) No 1882/2003.
[48] OJ L 189, 20.7.1990, p. 17. Directive as last amended by Regulation (EC) No 1882/2003.
[49] OJ L 169, 12.7.1993, p. 1. Directive as last amended by Regulation (EC) No 1882/2003.
[50] OJ L 331, 7.12.1998, p. 1. Directive as last amended by Regulation (EC) No 1882/2003.
[51] 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).
[52] 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).
[53] OJ L 136, 31.5.1999, p. 1.
[54] OJ L 136, 31.5.1999, p. 15.
[55] 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).
[56] 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).
[57] 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 1000 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.
[58] Where the person responsible for placing the preparation on the market can demonstrate that the disclosure in the safety data sheet of the chemical identity of a substance which is exclusively classified as irritant with the exception of those assigned
R41 or irritant in combination with one or more of the properties mentioned in point 2.3.4 of Article 10 of Directive 1999/45/EC,
or harmful or harmful in combination with one or more of the properties mentioned in point 2.3.4 of Article 10 of Directive
1999/45/EC presenting acute lethal effects alone, will put at risk the confidential nature of his intellectual property, he
may, in accordance with the provisions of Part B of Annex VI to Directive 1999/45/EC, refer to that substance either by means
of a name that identifies the most important functional chemical groups, or by means of an alternative name.
[59] OJ L 399, 30.12.1989, p. 18. Directive as last amended by Regulation (EC) No 1882/2003.
[60] OJ L 100, 19.4.1994, p. 1. Directive as amended by Regulation (EC) No 1882/2003.
[61] This information cannot be given for the preparation because it is substance specific. It should therefore be given,
where available and appropriate, for each constituent substance in the preparation which is required to be listed in the Safety Data Sheet according to the rules under Section 3 of this Annex.
[62] OJ L 319, 12.12.1994, p. 7. Directive as last amended by Commission Directive 2004/111/EC (OJ L 365, 10.12.2004, p. 25).
[63] OJ L 235, 17.9.1996, p. 25. Directive as last amended by Commission Directive 2004/110/EC (OJ L 365, 10.12.2004, p. 24).
[64] 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.
[65] 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.
[66] 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.
[67] 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.
[68] 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.
[69] 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.
[70] 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.
[71] 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.
[72] OJ L 377, 31.12.1991, p. 20. 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).
[73] Chrysotile has two CAS Nos, confirmed by ECB.
[74] Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs
Tariff (OJ L 256, 7.9.1987). Regulation as last amended by Regulation (EC) No 426/2006 (OJ L 79, 16.3.2006, p. 1).
[75] OJ L 147, 9.6.1975, p. 40. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).
[76]
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.’
[] ESO: European standardisation organisations:
- CEN: rue de Stassart 36, B-1050 Bruxelles; tel. (32-2) 550 08 11, fax (32-2) 550 08 19. http://www.cenorm.be
- CENELEC: rue de Stassart 36, B-1050 Bruxelles; tel. (32-2) 519 68 71, fax (32-2) 519 69 19. http://www.cenelec.org
- ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis; tel. (33) 492 94 42 00, fax (33) 493 65 47 16. http://www.etsi.org