Regulation 2006/1907 - Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency

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This page contains a limited version of this dossier in the EU Monitor.

Contents

  1. Current status
  2. Key information
  3. Key dates
  4. Legislative text
  5. Chapter 1
  6. Aim, scope and application
  7. Chapter 2
  8. Definitions and general provision
  9. Chapter 1
  10. General obligation to register and information requirements
  11. Chapter 2
  12. Substances regarded as being registered
  13. Chapter 3
  14. Obligation to register and information requirements for certain types of isolated intermediates
  15. Chapter 4
  16. Common provisions for all registrations
  17. Chapter 5
  18. Transitional provisions applicable to phase-in substances and notified substances
  19. Chapter 1
  20. Objectives and general rules
  21. Chapter 2
  22. Rules for non-phase-in substances and registrants of phase-in substances who have not pre-registered
  23. Chapter 3
  24. Rules for phase-in-substances
  25. Chapter 1 Dossier evaluation
  26. Chapter 2
  27. Substance evaluation
  28. Chapter 3
  29. Evaluation of intermediates
  30. Chapter 4 Common provisions
  31. Chapter 1
  32. Authorisation requirement
  33. Chapter 2
  34. Granting of authorisations
  35. Chapter 3
  36. Authorisations in the supply chain
  37. Chapter 1 General issues
  38. Chapter 2 Restrictions process
  39. TITLE XI
  40. CLASSIFICATION AND LABELLING INVENTORY
  41. TITLE XIV
  42. ENFORCEMENT
  43. Original proposal
  44. Sources and disclaimer
  45. Full version
  46. EU Monitor

1.

Current status

This regulation has been published on December 30, 2006 and entered into force on June  1, 2007.

2.

Key information

official title

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC
 
Legal instrument Regulation
Number legal act Regulation 2006/1907
Original proposal COM(2003)644 EN
CELEX number489 32006R1907

3.

Key dates

Document 18-12-2006
Publication in Official Journal 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
Effect 01-06-2007; Entry into force See Art 141.1
01-06-2008; Partial application See Art 141.2
01-08-2008; Partial application See Art 141.3
01-06-2009; Partial application See Art 141.4
Deadline 31-12-2023; See Art 41.5
31-12-2027; See Art 41.5
End of validity 31-12-9999

4.

Legislative text

30.12.2006 EN Official Journal of the European Union L 396/1

I

(Acts whose publication is obligatory)

REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT

AND OF THE COUNCIL

of 18 December 2006

concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee1,

Having regard to the opinion of the Committee of the Regions2,

Acting in accordance with the procedure laid down in Article 251 of the Treaty1,

OJ C 112, 30.4.2004, p. 92 and OJ C 294, 25.11.2005, p. 38. OJ C 164, 5.7.2005, p. 78.

Whereas:

  • (1) 
    This Regulation should ensure a high level of protection of human health and the environment as well as the free movement of substances, on their own, in preparations and in articles, while enhancing competitiveness and innovation. This Regulation should also promote the development of alternative methods for the assessment of hazards of substances.
  • (2) 
    The efficient functioning of the internal market for substances can be achieved only if requirements for substances do not differ significantly from Member State to Member State.
  • (3) 
    A high level of human health and environmental protection should be ensured in the approximation of legislation on substances, with the goal of achieving sustainable development. That legislation should be applied in a non-discriminatory manner whether substances are traded on the internal market or internationally in accordance with the Community's international commitments.
  • (4) 
    Pursuant to the implementation plan adopted on 4 September 2002 at the Johannesburg World Summit on sustainable development, the European Union is aiming to achieve that, by 2020, chemicals are produced and used in ways that lead to the minimisation of significant adverse effects on human health and the environment.

Opinion of the European Parliament of 17 November 2005 (not yet published in the Official Journal), Council Common Position of 27 June 2006 (OJ C 276E, 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.

  • (5) 
    This Regulation should apply without prejudice to Community workplace and environment legislation.
  • (6) 
    This Regulation should contribute to fulfilment of the Strategic Approach to International Chemical Management (SAICM) adopted on 6 February 2006 in Dubai.
  • (7) 
    To preserve the integrity of the internal market and to ensure a high level of protection for human health, especially the health of workers, and the environment, it is necessary to ensure that manufacturing of substances in the Community complies with Community law, even if those substances are exported.
  • (8) 
    Special account should be taken of the potential impact of this Regulation on small- and medium-sized enterprises (SMEs) and the need to avoid any discrimination against them.
  • (9) 
    The assessment of the operation of the four main legal instruments governing chemicals in the Community, i.e. Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances1, Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of...

More

This text has been adopted from EUR-Lex.

43.

Original proposal

 

44.

Sources and disclaimer

For further information you may want to consult the following sources that have been used to compile this dossier:

This dossier is compiled each night drawing from aforementioned sources through automated processes. We have invested a great deal in optimising the programming underlying these processes. However, we cannot guarantee the sources we draw our information from nor the resulting dossier are without fault.

 

45.

Full version

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46.

EU Monitor

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    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. 
    europa.eu.int/comm/enterprise/ chemicals/chempol/bia/index.htm

     
  • 236. 
    europa.eu.int/comm/enterprise/ chemicals/chempol/whitepaper/whitepaper.htm

     
  • 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. 
    europa.eu.int/comm/enterprise/ chemicals/chempol/bia/index.htm

     
  • 480. 
    europa.eu.int/comm/enterprise/ chemicals/chempol/whitepaper/whitepaper.htm

     
  • 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. 
    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.
     
  • 490. 
    EUR-lex provides an overview of the proposal, amendments, citations and legality.