COM(2003)644-1 - Registration, Evaluation, Authorisation and Restriction of Chemicals (Reach), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC)
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Contents
official title
Proposal for a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (Reach), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC)Legal instrument | Regulation |
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Decision making procedure | ordinary legislative procedure (COD) |
reference by COM-number490 | COM(2003)644 ![]() |
Additional COM-numbers | SEC(2003)1171; SEC(2006)924; COM(2006)375; COM(2006)842 |
procedure number492 | 2003/0256(COD) |
CELEX number493 | 52003PC0644(01) |
Document | 29-10-2003 |
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Online publication | 29-10-2003 |
Decision | 18-12-2006; Verordening 2006/1907 |
Publication in Official Journal494 | 30-12-2006; Special edition in Romanian: Chapter 13 Volume 060,Special edition in Bulgarian: Chapter 13 Volume 060,Special edition in Croatian: Chapter 13 Volume 023,OJ L 396, 30.12.2006 |
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- 1.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 2.COM(2001) 428 final, 25.7.2001.
- 3.COM(2002) 718 final, 11.12.2002.
- 4.COM(2002) 718 final, 11.12.2002.
- 5.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 6.COM(2002) 718 final, 11.12.2002.
- 7.COM(2001) 428 final, 25.7.2001.
- 8.COM(2001) 428 final, 25.7.2001.
- 9.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 10.OJ C
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- 14.OJ 196, 16.8.1967, p. 1. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).
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- 16.OJ L 200, 30.7.1999, p. 1. Directive as amended by Commission Directive 2001/60/EC (OJ L 226, 22.8.2001, p. 5).
- 17.OJ L 84, 5.4.1993, p. 1.
- 18.OJ L 262, 27.9.1976, p. 201. Directive as last amended by Directive 2003/53/EC of the European Parliament and of the Council (OJ L 178, 17.7.2003, p. 24).
- 19.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 20.OJ L196, 26.7.1990, p. 1. Directive as last amended by Directive 1999/38/EC (OJ L 138, 1.6.1999, p. 66).
- 21.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).
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- 23.OJ L 357, 31.12.2002, p. 72.
- 24.OJ L 214, 24.8.1993, p. 1. Regulation as last amended by Regulation (EC) No 1647/2003 (OJ L 245, 29.9.2003, p. 19).
- 25.OJ L 31, 1.2.2002 p. 1. Regulation as amended by Regulation (EC) No 1642/2003 (OJ L 245,29.9.2003, p. 4).
- 26.OJ C 218, 13.9.2003, p. 1.
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- 28.OJ L 78, 26.3.1991, p. 38. Directive as amended by Commission Directive 98/101/EC (OJ L 1, 5.1.1999, p. 1).
- 29.OJ L 227, 8.9.1993, p. 9.
- 30.OJ L 294, 30.11.1993, p. 21.
- 31.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 32.OJ L 103, 28.4.2000, p. 70.
- 33.OJ L 161, 29.6.1994, p. 3.
- 34.OJ L
- 35.OJ C 364, 18.12.2000, p. 1.
- 36.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 37.As set out in the Communication from the Commission on the precautionary principle, COM(2000) 1 final.
- 38.OJ L 159, 29.6.1996, p. 1.
- 39.OJ L 183, 29.6.1989, p. 1.
- 40.OJ L 131, 5.5.1998, p. 11.
- 41.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 42.OJ L 259, 15.10.1979, p. 10.
- 43.OJ L 154, 5.6.1992, p. 1.
- 44.OJ L 311, 28.11.2001, p. 1.
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- 47.OJ L 84, 27.3.1999, p. 1.
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- 49.OJ L 213, 21.7.1982, p. 8.
- 50.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 51.COM(2002) 718 final, 11.12.2002.
- 52.COM(2002) 718 final, 11.12.2002.
- 53.OJ L 230, 19.8.1991, p. 1.
- 54.OJ L 366, 15.12.1992, p. 10.
- 55.OJ L 98, 7.4.2001, p. 6.
- 56.OJ L 224, 21.8.2002, p. 23.
- 57.OJ L 192, 31.7.2003, p. 40.
- 58.OJ L 123, 24.4.1998, p. 1.
- 59.OJ L
- 60.COM(2001) 428 final, 25.7.2001.
- 61.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 62.OJ C
- 63.COM(2002) 718 final, 11.12.2002.
- 64.OJ L 40, 11.2.1989, p. 38.
- 65.OJ L 262 , 27.9.1976, p. 169.
- 66.COM(2002) 718 final, 11.12.2002.
- 67.COM(2001) 428 final, 25.7.2001.
- 68.OJ C
- 69.COM(2001) 428 final, 25.7.2001.
- 70.COM(2001) 428 final, 25.7.2001.
- 71.OJ C
- 72.OJ C
- 73.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 74.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 75.COM(2001) 428 final, 25.7.2001.
- 76.COM(2001) 428 final, 25.7.2001.
- 77.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 78.COM(2001) 428 final, 25.7.2001.
- 79.OJ C
- 80.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 81.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 82.COM(2002) 718 final, 11.12.2002.
- 83.COM(2001) 428 final, 25.7.2001.
- 84.COM(2001) 428 final, 25.7.2001.
- 85.COM(2001) 428 final, 25.7.2001.
- 86.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 87.COM(2001) 428 final, 25.7.2001.
- 88.COM(2002) 718 final, 11.12.2002.
- 89.COM(2001) 428 final, 25.7.2001.
- 90.COM(2002) 718 final, 11.12.2002.
- 91.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 92.COM(2002) 718 final, 11.12.2002.
- 93.COM(2002) 718 final, 11.12.2002.
- 94.COM(2001) 428 final, 25.7.2001.
- 95.OJ 196, 16.8.1967, p. 1. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).
- 96.COM(2001) 428 final, 25.7.2001.
- 97.COM(2001) 428 final, 25.7.2001.
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- 99.OJ L 377, 31.12.1991, p. 20.
- 100.OJ L 350, 28.12.1998, p. 58.
- 101.COM(2002) 718 final, 11.12.2002.
- 102.COM(2002) 718 final, 11.12.2002.
- 103.COM(2002) 718 final, 11.12.2002.
- 104.COM(2002) 718 final, 11.12.2002.
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- 106.COM(2002) 718 final, 11.12.2002.
- 107.OJ L 327, 22.12.2000, p. 1.
- 108.OJ L 189, 20.7.1990, p. 17.
- 109.OJ L 169, 12.7.1993, p. 1.
- 110.OJ L 331, 7.12.1998, p. 1.
- 111.OJ C
- 112.COM(2001) 428 final, 25.7.2001.
- 113.COM(2002) 718 final, 11.12.2002.
- 114.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 115.COM(2002) 718 final, 11.12.2002.
- 116.OJ C
- 117.OJ C
- 118.OJ C
- 119.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 120.COM(2001) 428 final, 25.7.2001.
- 121.COM(2001) 428 final, 25.7.2001.
- 122.COM(2001) 428 final, 25.7.2001.
- 123.COM(2002) 718 final, 11.12.2002.
- 124.COM(2002) 718 final, 11.12.2002.
- 125.OJ C
- 126.COM(2002) 718 final, 11.12.2002.
- 127.COM(2002) 718 final, 11.12.2002.
- 128.COM(2002) 718 final, 11.12.2002.
- 129.COM(2002) 718 final, 11.12.2002.
- 130.COM(2002) 718 final, 11.12.2002.
- 131.COM(2002) 718 final, 11.12.2002.
- 132.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 133.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 134.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 135.COM(2002) 718 final, 11.12.2002.
- 136.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 137.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 138.COM(2001) 428 final, 25.7.2001.
- 139.OJ C
- 140.COM(2001) 428 final, 25.7.2001.
- 141.OJ C
- 142.COM(2001) 428 final, 25.7.2001.
- 143.OJ L 248, 16.9.2002, p. 1.
- 144.OJ L 136, 31.5.1999, p. 1
- 145.OJ L 136, 31.5.1999, p. 15.
- 146.OJ C
- 147.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 148.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 149.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 150.OJ C
- 151.COM(2002) 718 final, 11.12.2002.
- 152.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 153.COM(2001) 428 final, 25.7.2001.
- 154.COM(2001) 428 final, 25.7.2001.
- 155.OJ L 145, 31.5.2001, p. 43.
- 156.OJ C
- 157.OJ L 41, 14.2.2003, p. 26.
- 158.OJ C
- 159.OJ C
- 160.COM(2001) 428 final, 25.7.2001.
- 161.OJ L 63, 6.3.2003, p. 1.
- 162.COM(2002) 718 final, 11.12.2002.
- 163.COM(2001) 428 final, 25.7.2001.
- 164.COM(2002) 718 final, 11.12.2002.
- 165.COM(2002) 718 final, 11.12.2002.
- 166.COM(2002) 718 final, 11.12.2002.
- 167.COM(2002) 718 final, 11.12.2002.
- 168.OJ C
- 169.COM(2002) 718 final, 11.12.2002.
- 170.COM(2002) 718 final, 11.12.2002.
- 171.COM(2002) 718 final, 11.12.2002.
- 172.COM(2002) 718 final, 11.12.2002.
- 173.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 174.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 175.COM(2001) 428 final, 25.7.2001.
- 176.COM(2002) 718 final, 11.12.2002.
- 177.OJ C
- 178.OJ C
- 179.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 180.COM(2001) 428 final, 25.7.2001.
- 181.COM(2002) 718 final, 11.12.2002.
- 182.OJ C
- 183.OJ C
- 184.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.
- 185.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 186.COM(2001) 428 final, 25.7.2001.
- 187.COM(2002) 718 final, 11.12.2002.
- 188.OJ L131, 5.5.1998, p.11
- 189.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 190.COM(2002) 718 final, 11.12.2002.
- 191.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:
- 192.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 193.OJ L399 30.12.1989 p 18
- 194.OJ L100 19.4.1994 p. 1
- 195.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 heading 2 of this Annex.
- 196.OJ C
- 197.OJ C
- 198.OJ C
- 199.COM(2001) 428 final, 25.7.2001.
- 200.COM(2001) 428 final, 25.7.2001.
- 201.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 202.OJ C
- 203.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 204.Note: conditions for not requiring a specific test that are set out in the appropriate test methods in Annex X itself that are not repeated in column 2, also apply
- 205.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 206.Note: conditions for not requiring a specific test that are set out in the appropriate test methods in Annex X itself that are not repeated in column 2, also apply
- 207.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 208.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 209.Note: conditions for not requiring a specific test that are set out in the appropriate test methods in Annex X itself that are not repeated in column 2, also apply
- 210.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 211.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 212.Note: conditions for not requiring a specific test that are set out in the appropriate test methods in Annex X itself that are not repeated in column 2, also apply
- 213.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 214.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 215.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 216.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 217.OJ C
- 218.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 219.COM(2001) 428 final, 25.7.2001.
- 220.COM(2002) 718 final, 11.12.2002.
- 221.COM(2002) 718 final, 11.12.2002.
- 222.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 223.COM(2002) 718 final, 11.12.2002.
- 224.COM(2001) 428 final, 25.7.2001.
- 225.COM (2002) 1605 of 25 June 2002
- 226.COM(2001) 88 Final
- 227.Article 51 of the Regulation stipulates Obligations for Member States to report to the Agency - In the interests of ensuring that the burden is fairly shared, every Member States shall prepare a report annually on the dossier evaluations of testing proposals conducted over the previous year.
- 228.Article 123 of the Regulation stipulates Report - This requires Member States to report on their enforcement activities and the sanctions imposed for non-compliance over the previous calendar year. This information will be useful to the Forum in identifying any action that might usefully be taken at Community level.
- 229.Persistent, bioaccumulative and toxic substances
- 230.very persistent and very bioaccumulative substances
- 231.Carcinogenic, mutagenic and reprotoxic substances
- 232.Product and Process Oriented Development
- 233.Qualitative structure activity relationships (alternative testing method)
- 234.Technical barriers to trade
- 235.
- 236.
- 237.See Feasibility study on resource requirements for a Central Entity, Commission financed study carried-out by Deloitte
- 238.Past experiences of creating other Agencies have shown that without a transitional period it is very difficult to hire staff and to become operational before an Executive Director is in place.
- 239.In year 11 the staff requirements peak due to an additional
- 240.COM(2002) 718 Final
- 241.Normal operational and financial indicators will be monitored and reported by the Agency
- 242.The Commission will carry responsibility for evaluating the indicators related to the impact assessment and Member States will produce their reports as indicated in 8.2.
- 243.COM(2001) 428 final, 25.7.2001.
- 244.COM(2001) 428 final, 25.7.2001.
- 245.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 246.COM(2001) 428 final, 25.7.2001.
- 247.COM(2002) 718 final, 11.12.2002.
- 248.COM(2002) 718 final, 11.12.2002.
- 249.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 250.COM(2002) 718 final, 11.12.2002.
- 251.COM(2001) 428 final, 25.7.2001.
- 252.COM(2001) 428 final, 25.7.2001.
- 253.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 254.OJ C
- 255.OJ C
- 256.OJ C
- 257.Commission Working Document SEC(1998) 1986 final, referred to in White paper Strategy for a future Chemicals Policy, COM(2001) 88 final, 27.2.2001.
- 258.OJ 196, 16.8.1967, p. 1. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).
- 259.OJ L 187, 16.7.1988, p. 14.
- 260.OJ L 200, 30.7.1999, p. 1. Directive as amended by Commission Directive 2001/60/EC (OJ L 226, 22.8.2001, p.
5).
- 261.OJ L 84, 5.4.1993, p. 1.
- 262.OJ L 262, 27.9.1976, p. 201. Directive as last amended by Directive 2003/53/EC of the European Parliament and of the Council (OJ L 178, 17.7.2003, p. 24).
- 263.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 264.OJ L196, 26.7.1990, p. 1. Directive as last amended by Directive 1999/38/EC (OJ L 138, 1.6.1999, p. 66).
- 265.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).
- 266.OJ L 15, 17.1.1987, p. 29. Directive as amended by Commission Directive 1999/11/EC (OJ L 77, 23.3.1999, p.
8).
- 267.OJ L 357, 31.12.2002, p. 72.
- 268.OJ L 214, 24.8.1993, p. 1. Regulation as last amended by Regulation (EC) No 1647/2003 (OJ L 245, 29.9.2003, p. 19).
- 269.OJ L 31, 1.2.2002 p. 1. Regulation as amended by Regulation (EC) No 1642/2003 (OJ L 245,29.9.2003, p.
4).
- 270.OJ C 218, 13.9.2003, p. 1.
- 271.OJ L 184, 17.7.1999, p. 23.
- 272.OJ L 78, 26.3.1991, p. 38. Directive as amended by Commission Directive 98/101/EC (OJ L 1, 5.1.1999, p.
1).
- 273.OJ L 227, 8.9.1993, p. 9.
- 274.OJ L 294, 30.11.1993, p. 21.
- 275.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 276.OJ L 103, 28.4.2000, p. 70.
- 277.OJ L 161, 29.6.1994, p. 3.
- 278.OJ L
- 279.OJ C 364, 18.12.2000, p. 1.
- 280.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 281.As set out in the Communication from the Commission on the precautionary principle, COM(2000) 1 final.
- 282.OJ L 159, 29.6.1996, p. 1.
- 283.OJ L 183, 29.6.1989, p. 1.
- 284.OJ L 131, 5.5.1998, p. 11.
- 285.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 286.OJ L 259, 15.10.1979, p. 10.
- 287.OJ L 154, 5.6.1992, p. 1.
- 288.OJ L 311, 28.11.2001, p. 1.
- 289.OJ L 311, 28.11.2001, p. 67.
- 290.OJ L 40, 11.2.1989, p. 27.
- 291.OJ L 84, 27.3.1999, p. 1.
- 292.OJ L 270, 14.12.1970, p. 1.
- 293.OJ L 213, 21.7.1982, p. 8.
- 294.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 295.COM(2002) 718 final, 11.12.2002.
- 296.COM(2002) 718 final, 11.12.2002.
- 297.OJ L 230, 19.8.1991, p. 1.
- 298.OJ L 366, 15.12.1992, p. 10.
- 299.OJ L 98, 7.4.2001, p. 6.
- 300.OJ L 224, 21.8.2002, p. 23.
- 301.OJ L 192, 31.7.2003, p. 40.
- 302.OJ L 123, 24.4.1998, p. 1.
- 303.OJ L
- 304.COM(2001) 428 final, 25.7.2001.
- 305.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 306.OJ C
- 307.COM(2002) 718 final, 11.12.2002.
- 308.OJ L 40, 11.2.1989, p. 38.
- 309.OJ L 262 , 27.9.1976, p. 169.
- 310.COM(2002) 718 final, 11.12.2002.
- 311.COM(2001) 428 final, 25.7.2001.
- 312.OJ C
- 313.COM(2001) 428 final, 25.7.2001.
- 314.COM(2001) 428 final, 25.7.2001.
- 315.OJ C
- 316.OJ C
- 317.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 318.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 319.COM(2001) 428 final, 25.7.2001.
- 320.COM(2001) 428 final, 25.7.2001.
- 321.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 322.COM(2001) 428 final, 25.7.2001.
- 323.OJ C
- 324.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 325.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 326.COM(2002) 718 final, 11.12.2002.
- 327.COM(2001) 428 final, 25.7.2001.
- 328.COM(2001) 428 final, 25.7.2001.
- 329.COM(2001) 428 final, 25.7.2001.
- 330.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 331.COM(2001) 428 final, 25.7.2001.
- 332.COM(2002) 718 final, 11.12.2002.
- 333.COM(2001) 428 final, 25.7.2001.
- 334.COM(2002) 718 final, 11.12.2002.
- 335.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 336.COM(2002) 718 final, 11.12.2002.
- 337.COM(2002) 718 final, 11.12.2002.
- 338.COM(2001) 428 final, 25.7.2001.
- 339.OJ 196, 16.8.1967, p. 1. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).
- 340.COM(2001) 428 final, 25.7.2001.
- 341.COM(2001) 428 final, 25.7.2001.
- 342.OJ L 194, 25.7.1975, p. 39.
- 343.OJ L 377, 31.12.1991, p. 20.
- 344.OJ L 350, 28.12.1998, p. 58.
- 345.COM(2002) 718 final, 11.12.2002.
- 346.COM(2002) 718 final, 11.12.2002.
- 347.COM(2002) 718 final, 11.12.2002.
- 348.COM(2002) 718 final, 11.12.2002.
- 349.OJ L 257, 10.10.1996, p. 26.
- 350.COM(2002) 718 final, 11.12.2002.
- 351.OJ L 327, 22.12.2000, p. 1.
- 352.OJ L 189, 20.7.1990, p. 17.
- 353.OJ L 169, 12.7.1993, p. 1.
- 354.OJ L 331, 7.12.1998, p. 1.
- 355.OJ C
- 356.COM(2001) 428 final, 25.7.2001.
- 357.COM(2002) 718 final, 11.12.2002.
- 358.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 359.COM(2002) 718 final, 11.12.2002.
- 360.OJ C
- 361.OJ C
- 362.OJ C
- 363.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 364.COM(2001) 428 final, 25.7.2001.
- 365.COM(2001) 428 final, 25.7.2001.
- 366.COM(2001) 428 final, 25.7.2001.
- 367.COM(2002) 718 final, 11.12.2002.
- 368.COM(2002) 718 final, 11.12.2002.
- 369.OJ C
- 370.COM(2002) 718 final, 11.12.2002.
- 371.COM(2002) 718 final, 11.12.2002.
- 372.COM(2002) 718 final, 11.12.2002.
- 373.COM(2002) 718 final, 11.12.2002.
- 374.COM(2002) 718 final, 11.12.2002.
- 375.COM(2002) 718 final, 11.12.2002.
- 376.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 377.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 378.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 379.COM(2002) 718 final, 11.12.2002.
- 380.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 381.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 382.COM(2001) 428 final, 25.7.2001.
- 383.OJ C
- 384.COM(2001) 428 final, 25.7.2001.
- 385.OJ C
- 386.COM(2001) 428 final, 25.7.2001.
- 387.OJ L 248, 16.9.2002, p. 1.
- 388.OJ L 136, 31.5.1999, p. 1
- 389.OJ L 136, 31.5.1999, p. 15.
- 390.OJ C
- 391.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 392.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 393.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 394.OJ C
- 395.COM(2002) 718 final, 11.12.2002.
- 396.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 397.COM(2001) 428 final, 25.7.2001.
- 398.COM(2001) 428 final, 25.7.2001.
- 399.OJ L 145, 31.5.2001, p. 43.
- 400.OJ C
- 401.OJ L 41, 14.2.2003, p. 26.
- 402.OJ C
- 403.OJ C
- 404.COM(2001) 428 final, 25.7.2001.
- 405.OJ L 63, 6.3.2003, p. 1.
- 406.COM(2002) 718 final, 11.12.2002.
- 407.COM(2001) 428 final, 25.7.2001.
- 408.COM(2002) 718 final, 11.12.2002.
- 409.COM(2002) 718 final, 11.12.2002.
- 410.COM(2002) 718 final, 11.12.2002.
- 411.COM(2002) 718 final, 11.12.2002.
- 412.OJ C
- 413.COM(2002) 718 final, 11.12.2002.
- 414.COM(2002) 718 final, 11.12.2002.
- 415.COM(2002) 718 final, 11.12.2002.
- 416.COM(2002) 718 final, 11.12.2002.
- 417.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 418.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 419.COM(2001) 428 final, 25.7.2001.
- 420.COM(2002) 718 final, 11.12.2002.
- 421.OJ C
- 422.OJ C
- 423.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 424.COM(2001) 428 final, 25.7.2001.
- 425.COM(2002) 718 final, 11.12.2002.
- 426.OJ C
- 427.OJ C
- 428.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.
- 429.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 430.COM(2001) 428 final, 25.7.2001.
- 431.COM(2002) 718 final, 11.12.2002.
- 432.OJ L131, 5.5.1998, p.11
- 433.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 434.COM(2002) 718 final, 11.12.2002.
- 435.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:
- 436.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 437.OJ L399 30.12.1989 p 18
- 438.OJ L100 19.4.1994 p. 1
- 439.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 heading 2 of this Annex.
- 440.OJ C
- 441.OJ C
- 442.OJ C
- 443.COM(2001) 428 final, 25.7.2001.
- 444.COM(2001) 428 final, 25.7.2001.
- 445.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 446.OJ C
- 447.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 448.Note: conditions for not requiring a specific test that are set out in the appropriate test methods in Annex X itself that are not repeated in column 2, also apply
- 449.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 450.Note: conditions for not requiring a specific test that are set out in the appropriate test methods in Annex X itself that are not repeated in column 2, also apply
- 451.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 452.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 453.Note: conditions for not requiring a specific test that are set out in the appropriate test methods in Annex X itself that are not repeated in column 2, also apply
- 454.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 455.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 456.Note: conditions for not requiring a specific test that are set out in the appropriate test methods in Annex X itself that are not repeated in column 2, also apply
- 457.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 458.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 459.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 460.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 461.OJ C
- 462.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 463.COM(2001) 428 final, 25.7.2001.
- 464.COM(2002) 718 final, 11.12.2002.
- 465.COM(2002) 718 final, 11.12.2002.
- 466.See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).
- 467.COM(2002) 718 final, 11.12.2002.
- 468.COM(2001) 428 final, 25.7.2001.
- 469.COM (2002) 1605 of 25 June 2002
- 470.COM(2001) 88 Final
- 471.Article 51 of the Regulation stipulates Obligations for Member States to report to the Agency - In the interests of ensuring that the burden is fairly shared, every Member States shall prepare a report annually on the dossier evaluations of testing proposals conducted over the previous year.
- 472.Article 123 of the Regulation stipulates Report - This requires Member States to report on their enforcement activities and the sanctions imposed for non-compliance over the previous calendar year. This information will be useful to the Forum in identifying any action that might usefully be taken at Community level.
- 473.Persistent, bioaccumulative and toxic substances
- 474.very persistent and very bioaccumulative substances
- 475.Carcinogenic, mutagenic and reprotoxic substances
- 476.Product and Process Oriented Development
- 477.Qualitative structure activity relationships (alternative testing method)
- 478.Technical barriers to trade
- 479.
- 480.
- 481.See Feasibility study on resource requirements for a Central Entity, Commission financed study carried-out by Deloitte
- 482.Past experiences of creating other Agencies have shown that without a transitional period it is very difficult to hire staff and to become operational before an Executive Director is in place.
- 483.In year 11 the staff requirements peak due to an additional
- 484.COM(2002) 718 Final
- 485.Normal operational and financial indicators will be monitored and reported by the Agency
- 486.The Commission will carry responsibility for evaluating the indicators related to the impact assessment and Member States will produce their reports as indicated in 8.2.
- 487.COM(2001) 428 final, 25.7.2001.
- 488.COM(2001) 428 final, 25.7.2001.
- 489.This legally binding act of the European Union is directly applicable in all member states of the European Union. The regulation is similar to national legislation in terms of the impact and direct effect it generates. As such the regulation is the most pervasive of all the legal instruments of the EU.
- 490.De Europese Commissie kent nummers toe aan officiële documenten van de Europese Unie. De Commissie maakt onderscheid in een aantal typen documenten door middel van het toekennen van verschillende nummerseries. Het onderscheid is gebaseerd op het soort document en/of de instelling van de Unie van wie het document afkomstig is.
- 491.De Raad van de Europese Unie kent aan wetgevingsdossiers een uniek toe. Dit nummer bestaat uit een vijfcijferig volgnummer gevolgd door een schuine streep met de laatste twee cijfers van het jaartal, bijvoorbeeld 12345/00 - een document met nummer 12345 uit het jaar 2000.
- 492.Het interinstitutionele nummer is een nummerreeks die binnen de Europese Unie toegekend wordt aan voorstellen voor regelgeving van de Europese Commissie.
Binnen de Europese Unie worden nog een aantal andere nummerseries gebruikt. Iedere instelling heeft één of meerdere sets documenten met ieder een eigen nummering. Die reeksen komen niet overeen met elkaar of het interinstitutioneel nummer.
- 493.Deze databank van de Europese Unie biedt de mogelijkheid de actuele werkzaamheden (workflow) van de Europese instellingen (Europees Parlement, Raad, ESC, Comité van de Regio's, Europese Centrale Bank, Hof van Justitie enz.) te volgen. EURlex volgt alle voorstellen (zoals wetgevende en begrotingsdossiers) en mededelingen van de Commissie, vanaf het moment dat ze aan de Raad of het Europees Parlement worden voorgelegd.
- 494.Als dag van bekendmaking van een Europees besluit geldt de dag waarop het besluit in het Publicatieblad wordt bekendgemaakt, en daardoor in alle officiële talen van de Europese Unie bij het Publicatiebureau beschikbaar is.