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Volumn 17, Issue 1, 2008, Pages 107-125

Registration: The cornerstone of reach

Author keywords

[No Author keywords available]

Indexed keywords

CHEMICAL POLLUTANT; ENVIRONMENTAL PLANNING; ENVIRONMENTAL PROTECTION; EUROPEAN COMMISSION; WASTE MANAGEMENT;

EID: 42149167873     PISSN: 09628797     EISSN: 14679388     Source Type: Journal    
DOI: 10.1111/j.1467-9388.2008.00588.x     Document Type: Article
Times cited : (7)

References (109)
  • 1
    • 42149179244 scopus 로고    scopus 로고
    • In the European Parliament, the REACH second reading deal was passed by 529 votes in favour, 98 against and 24 abstentions. See 'Parliament adopts REACH - new EU chemicals legislation and new chemicals agency', press release (13 December), available at
    • In the European Parliament, the REACH second reading deal was passed by 529 votes in favour, 98 against and 24 abstentions. See 'Parliament adopts REACH - new EU chemicals legislation and new chemicals agency', press release (13 December 2006), available at .
    • (2006)
  • 2
    • 42149147357 scopus 로고    scopus 로고
    • Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization 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, [2006] OJ L396/1, available at
    • Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization 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, [2006] OJ L396/1, available at .
  • 3
    • 42149160074 scopus 로고    scopus 로고
    • European Parliament, (P6_TAPROV 0434, 17 November 2005), available at
    • European Parliament, 'First reading opinion on REACH' (P6_TAPROV (2005) 0434, 17 November 2005), available at .
    • (2005) 'First Reading Opinion on REACH'
  • 4
    • 42149132714 scopus 로고    scopus 로고
    • Common position adopted by the Council on 27 June 2006 with a view to the adoption of a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC of the European Parliament and of the Council 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 (7524/8/06 REV 8, 27 June 2006), available at
    • Common position adopted by the Council on 27 June 2006 with a view to the adoption of a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC of the European Parliament and of the Council 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 (7524/8/06 REV 8, 27 June 2006), available at .
  • 5
    • 42149126710 scopus 로고    scopus 로고
    • Communication from the Commission to the European Parliament pursuant to the second subparagraph of Article 251(2) of the EC Treaty concerning the Common Position of the Council on the adoption of a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC; and a Directive of the European Parliament and of the Council amending Council Directive 67/548/EEC in order to adapt it to Regulation (EC) No ... 2006 (REACH) COM 375 final, available at
    • Communication from the Commission to the European Parliament pursuant to the second subparagraph of Article 251(2) of the EC Treaty concerning the Common Position of the Council on the adoption of a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC; and a Directive of the European Parliament and of the Council amending Council Directive 67/548/EEC in order to adapt it to Regulation (EC) No ... 2006 (REACH) COM (2006) 375 final, available at .
  • 6
    • 42149188238 scopus 로고    scopus 로고
    • note
    • Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, [1967] OJ 196/1, as amended by Commission Directive 2004/73/EC, [2004] OJ L152/ 1, corrected in [2004] OJ L216/3.
  • 7
    • 42149085664 scopus 로고    scopus 로고
    • In the European Parliament, the REACH second reading deal was passed by 529 votes in favour, 98 against and 24 abstentions. See 'Parliament adopts REACH - new EU chemicals legislation and new chemicals agency', press release (13 December), available at
    • In the European Parliament, the REACH second reading deal was passed by 529 votes in favour, 98 against and 24 abstentions. See 'Parliament adopts REACH - new EU chemicals legislation and new chemicals agency', press release (13 December 2006), available at .
    • (2006)
  • 8
    • 42149170596 scopus 로고    scopus 로고
    • note
    • Council Regulation (EEC) 793/93 of 23 March on the evaluation and control of existing chemical substances, [1993] OJ L84/1, as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council, [2003] OJ L 284/1.
  • 9
    • 42149117820 scopus 로고    scopus 로고
    • note
    • Council Directive 76/769/EEC of 27 July 1976 on the approximation of laws, regulations and administrative provisions relating to restrictions on the marketing and use of certain dangerous substances and preparations, [1976] OJ L262/201, as last amended by Directive 2005/90/ EC of the European Parliament and of the Council, [2006] OJ L33/28.
  • 10
    • 42149192570 scopus 로고    scopus 로고
    • EINECS (European Inventory of Existing Chemical Substances, [1990] OJ C146, Annex) was drawn up by the European Commission in application of Article 13 of Directive 67/548/EEC, n. 6 above. It is a registry for each chemical substance commercially available in the EU between 1 January 1971 and 18 September 1981, based on industry submissions, and contains 100,204 substances. In terms of Article 1(4) of Directive 67/548/EEC, as amended, these are substances to which the new substance notification provisions of the Directive do not apply. See European Chemical Substances Information System (European Chemicals Bureau, undated), available at which is a database of the substances included on EINECS
    • EINECS (European Inventory of Existing Chemical Substances, [1990] OJ C146, Annex) was drawn up by the European Commission in application of Article 13 of Directive 67/548/EEC, n. 6 above. It is a registry for each chemical substance commercially available in the EU between 1 January 1971 and 18 September 1981, based on industry submissions, and contains 100,204 substances. In terms of Article 1(4) of Directive 67/ 548/EEC, as amended, these are substances to which the new substance notification provisions of the Directive do not apply. See European Chemical Substances Information System (European Chemicals Bureau, undated), available at , which is a database of the substances included on EINECS.
  • 11
    • 42149106242 scopus 로고    scopus 로고
    • note
    • The information required is dependent on the tonnage placed on the market or imported, but at the 1 tonne level it is equivalent to the 10 tonnes level (Annexes VII and VIII) of REACH (see n. 2 above).
  • 12
    • 42149157775 scopus 로고    scopus 로고
    • note
    • In the European Parliament, the REACH second reading deal was passed by 529 votes in favour, 98 against and 24 abstentions. See 'Parliament adopts REACH - new EU chemicals legislation and new chemicals agency', press release (13 December 2006), available at .
  • 13
    • 42149170025 scopus 로고    scopus 로고
    • The information required is equivalent to the 10 tonnes level (Annexes VII and VIII) of REACH, n. 2 above
    • The information required is equivalent to the 10 tonnes level (Annexes VII and VIII) of REACH, n. 2 above.
  • 14
    • 42149126112 scopus 로고    scopus 로고
    • The information required was limited to all available data
    • The information required was limited to all available data.
  • 15
    • 42149140066 scopus 로고    scopus 로고
    • note
    • Article 8 of Regulation (EEC) 793/93 (n. 8 above) states that the Commission, in consultation with the Member States, will regularly draw up lists of priority substances that require immediate attention because of their potential effects to people or the environment. Since 1994, four such priority lists have been published. Substances on priority lists must undergo an in-depth risk assessment covering the risks posed by the priority chemical to people (covering workers, consumers and man exposed via the environment) and the environment (covering the terrestrial, aquatic and atmospheric ecosystems and accumulation through the food chain).
  • 16
    • 42149184730 scopus 로고    scopus 로고
    • 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, [1994] OJ L161/3, available at
    • 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, [1994] OJ L161/3, available at .
  • 17
    • 42149095355 scopus 로고    scopus 로고
    • Where a risk assessment concludes that a substance is of concern and that further risk reduction measures - beyond those already in place - are required, then a risk reduction strategy must be developed. The elaboration of such a strategy is done utilizing the Technical Guidance Documents on Risk Reduction. See European Commission, Technical Guidance Documents on Risk Reduction (European Commission, January 1998), available from This guidance is not legally binding but represents a common commitment by the Commission, Member States and participating non-governmental organizations (NGOs) on how risk reduction recommendations pursuant to Regulation 793/93 could be framed
    • Where a risk assessment concludes that a substance is of concern and that further risk reduction measures - beyond those already in place - are required, then a risk reduction strategy must be developed. The elaboration of such a strategy is done utilizing the Technical Guidance Documents on Risk Reduction. See European Commission, Technical Guidance Documents on Risk Reduction (European Commission, January 1998), available from . This guidance is not legally binding but represents a common commitment by the Commission, Member States and participating non-governmental organizations (NGOs) on how risk reduction recommendations pursuant to Regulation 793/93 could be framed.
  • 18
    • 33751581603 scopus 로고    scopus 로고
    • 'REACH: A Step Change in the Management of Chemicals'
    • B.G. Hansen and M.A. Blainey, 'REACH - An Update', 3:5 JEEPL (2006), 446
    • B.G. Hansen and M.A. Blainey, 'REACH: A Step Change in the Management of Chemicals', 15:3 RECIEL (2006), 270-280; B.G. Hansen and M.A. Blainey, 'REACH - An Update', 3:5 JEEPL (2006), 446.
    • (2006) RECIEL , vol.15 , Issue.3 , pp. 270-280
    • Hansen, B.G.1    Blainey, M.A.2
  • 19
    • 9944261759 scopus 로고    scopus 로고
    • available at Commission White Papers are documents containing proposals for Community action in a specific area and where it is favourably received by the Council, it can lead to action in the area concerned
    • Commission of the European Communities, White Paper on a Strategy for a Future Chemicals Policy COM (2001) 88 final, available at . Commission White Papers are documents containing proposals for Community action in a specific area and where it is favourably received by the Council, it can lead to action in the area concerned.
    • (2001) Commission of the European Communities, White Paper on a Strategy for a Future Chemicals Policy COM 88 Final
  • 20
    • 42149188236 scopus 로고    scopus 로고
    • note
    • To assist the Commission in implementation of the White Paper proposals, a number of technical expert working groups were convened by the Commission from October 2001 to February 2002. The working groups were made up of stakeholder experts from authorities in the Member States, industrial associations and NGOs.
  • 21
    • 42149114062 scopus 로고    scopus 로고
    • note
    • A 'top-down' approach means that a larger set of information is in principle needed, but waiving would reduce the required information if it is not necessary. The 'bottom-up' approach is one where a minimum data set is required and then on a case-by-case basis further information needs may be identified. The Commission Working Group on Testing, Registration and Evaluation concluded that ideally both approaches should result in the same information being generated, but the former (the 'top-down') was easier to enforce.
  • 23
    • 42149104460 scopus 로고    scopus 로고
    • See White Paper on a Strategy for a Future Chemicals Policy n. 19 above
    • See White Paper on a Strategy for a Future Chemicals Policy n. 19 above.
  • 24
    • 42149146142 scopus 로고    scopus 로고
    • See Regulation 1907/2006, n. 2 above, Title II
    • See Regulation 1907/2006, n. 2 above, Title II.
  • 25
    • 42149132712 scopus 로고    scopus 로고
    • Ibid., Title III
    • Ibid., Title III.
  • 26
    • 42149098748 scopus 로고    scopus 로고
    • Ibid., Title IV
    • Ibid., Title IV.
  • 27
    • 42149167955 scopus 로고    scopus 로고
    • Ibid., Title V
    • Ibid., Title V.
  • 28
    • 42149126708 scopus 로고    scopus 로고
    • Ibid., Title VI
    • Ibid., Title VI.
  • 29
    • 42149175999 scopus 로고    scopus 로고
    • Ibid., Title VII
    • Ibid., Title VII.
  • 30
    • 42149181224 scopus 로고    scopus 로고
    • Ibid., Title VIII
    • Ibid., Title VIII.
  • 31
    • 42149162255 scopus 로고    scopus 로고
    • Ibid., Title IX
    • Ibid., Title IX.
  • 32
    • 42149158302 scopus 로고    scopus 로고
    • Ibid., Title XI
    • Ibid., Title XI.
  • 33
    • 42149087720 scopus 로고    scopus 로고
    • In REACH speak, 'safe' means 'adequately controlled' (see ibid., Annex I, para. 6.4) or minimized (see ibid., Annex I, para. 6.5)
    • In REACH speak, 'safe' means 'adequately controlled' (see ibid., Annex I, para. 6.4) or minimized (see ibid., Annex I, para. 6.5).
  • 34
    • 42149097185 scopus 로고    scopus 로고
    • See nn. 5-9 above
    • See nn. 5-9 above.
  • 35
    • 42149114536 scopus 로고    scopus 로고
    • Only two substances out of 3,500-odd notified substances have been restricted: Ugilec 141 and Ugilec 121 were developed as safe alternatives for PCBs but after their commercial introduction, concentrations were found in fish and sediments in the same order as PCBs and were assessed to constitute a potentially high risk to man and environment. See M. Herrmann, Ugilec (undated), available at
    • Only two substances out of 3,500-odd notified substances have been restricted: Ugilec 141 and Ugilec 121 were developed as safe alternatives for PCBs but after their commercial introduction, concentrations were found in fish and sediments in the same order as PCBs and were assessed to constitute a potentially high risk to man and environment. See M. Herrmann, Ugilec (undated), available at .
  • 37
    • 42149145535 scopus 로고    scopus 로고
    • Base-set means the tests required under Directive 67/548/EEC for a new substance that is manufactured or imported
    • Base-set means the tests required under Directive 67/548/EEC for a new substance that is manufactured or imported.
  • 38
    • 42149156044 scopus 로고    scopus 로고
    • note
    • High Expected Regulatory Outcome (HERO) substances are those for which the application of regulation will result in a high probability of a regulatory outcome, i.e. identification of a carcinogen, mutagen or a substance toxic to reproduction and subsequent restriction.
  • 39
    • 42149193720 scopus 로고    scopus 로고
    • See n. 21 above, for an explanation of the top-down approach
    • See n. 21 above, for an explanation of the top-down approach.
  • 40
    • 42149148724 scopus 로고    scopus 로고
    • note
    • REACH, n. 2 above, Annex XI(3) on substance-tailored, exposuredriven testing provides a possibility to waive testing in accordance with sections 8.6 and 8.7 of Annex VIII, Annex IX and Annex X based on exposure scenarios. Also for specific endpoints, column 2 provides that exposure considerations and/or results of the Chemical Safety Assessment may be used to justify waiving of testing for the endpoint.
  • 41
    • 42149195019 scopus 로고    scopus 로고
    • note
    • These were the Environment Committee; Industry Committee; Internal Market and Consumer Protection Committee; Economic and Monetary Affairs Committee; Employment and Social Affairs Committee; Budgets Committee; Women's Rights Committee; Legal Affairs Committee; International Trade Committee; and Petition Committee.
  • 42
    • 42149125536 scopus 로고    scopus 로고
    • note
    • European Parliament legislative resolution on the proposal for a regulation of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) No.../... (on Persistent Organic Pollutants) (COM (2003) 0644 - C5-0530/2003 - 2003/0256 (COD)) (P6_TA-PROV (2005) 0434, 17 November 2005).
  • 43
    • 42149174953 scopus 로고    scopus 로고
    • See Common Position, n. 4 above
    • See Common Position, n. 4 above.
  • 44
    • 42149109701 scopus 로고    scopus 로고
    • note
    • The Chemical Safety Report (CSR) documents the Chemical Safety Assessment (CSA) undertaken for substances manufactured or imported in quantities starting at 10 tonnes. The CSA is in effect a combined risk assessment/risk reduction strategy carried out by the registrant for all the identified uses of their substance.
  • 45
    • 42149114063 scopus 로고    scopus 로고
    • Committee on the Environment, Public Health and Food Safety, Recommendation for Second Reading on the Council Common Position for Adopting a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC of the European Parliament and of the Council 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 (7524/8/2006 - C6-0267/2006 - 2003/0256 (COD)) (A6-0352/2006, 13 October 2006), available at
    • Committee on the Environment, Public Health and Food Safety, Recommendation for Second Reading on the Council Common Position for Adopting a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC of the European Parliament and of the Council 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 (7524/8/2006 - C6-0267/2006 - 2003/0256 (COD)) (A6-0352/2006, 13 October 2006), available at .
  • 46
    • 42149104461 scopus 로고    scopus 로고
    • note
    • 'Trialogues' are normally discussions during conciliation between the co-decision actors, the Council and the Parliament, with the Commission in attendance to decide on issues surrounding the particular dossier being discussed. In the case of a second reading deal, any trialogues are termed informal as they do not have a specific standing in the rules of procedure.
  • 47
    • 42149132715 scopus 로고    scopus 로고
    • See Regulation 1907/2006, n. 2 above, Articles 3(4), 3(33), 3(20), 3(37) and 3(38) respectively
    • See Regulation 1907/2006, n. 2 above, Articles 3(4), 3(33), 3(20), 3(37) and 3(38) respectively.
  • 48
    • 42149096579 scopus 로고    scopus 로고
    • Ibid., Articles 9, 11, 14, 21, 22, and 23
    • Ibid., Articles 9, 11, 14, 21, 22, and 23.
  • 49
    • 42149186434 scopus 로고    scopus 로고
    • Ibid., Article 3(22)
    • Ibid., Article 3(22).
  • 50
    • 42149095989 scopus 로고    scopus 로고
    • Ibid., Article 9(7)
    • Ibid., Article 9(7).
  • 51
    • 42149154486 scopus 로고    scopus 로고
    • Ibid., Article 13
    • Ibid., Article 13.
  • 52
    • 42149164938 scopus 로고    scopus 로고
    • Ibid., Article 23
    • Ibid., Article 23.
  • 53
    • 42149145269 scopus 로고    scopus 로고
    • Ibid., Article 138
    • Ibid., Article 138.
  • 54
    • 42149100550 scopus 로고    scopus 로고
    • CEFIC, (MD/PRESS/1806, 8 October), available at UNICE, An EU Industry recommendation to improve the efficiency and workability of REACH (UNICE, 2005), available at
    • CEFIC, 'Revised REACH proposals: The right direction on "scope" but no progress on "workability"' (MD/PRESS/1806, 8 October 2003), available at ; UNICE, An EU Industry recommendation to improve the efficiency and workability of REACH (UNICE, 2005), available at .
    • (2003) 'Revised REACH Proposals: The Right Direction on "scope" But No Progress on "Workability"'
  • 55
    • 11144342941 scopus 로고    scopus 로고
    • The Royal Commission on Environmental Pollution's Twenty-Fourth Report, (June), available at L. Bergkamp and J.C. Hanekamp, 'The draft REACH regime: costs and benefits of precautionary chemical regulation', 5 Env. Liability (2003), 167
    • The Royal Commission on Environmental Pollution's Twenty-Fourth Report, Chemicals in Products, Safeguarding the Environment and Human Health, Cm 5827 (June 2003), available at ; L. Bergkamp and J.C. Hanekamp, 'The draft REACH regime: Costs and benefits of precautionary chemical regulation', 5 Env. Liability (2003), 167.
    • (2003) Chemicals in Products, Safeguarding the Environment and Human Health, Cm 5827
  • 57
    • 42149157212 scopus 로고    scopus 로고
    • Draft Opinion of the Committee on the Internal Market and Consumer Protection for the Committee on the Environment, Public Health and Food Safety on the proposal for a regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) (on Persistent Organic Pollutants), COM 0644 - C6-0531/2003 - 2003/0256 (COD)
    • Draft Opinion of the Committee on the Internal Market and Consumer Protection for the Committee on the Environment, Public Health and Food Safety on the proposal for a regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) (on Persistent Organic Pollutants), COM (2003) 0644 - C6-0531/2003 - 2003/ 0256 (COD).
    • (2003)
  • 58
    • 42149158871 scopus 로고    scopus 로고
    • note
    • Industrial use (workers with a high standard of competence, qualifications and skills, a high standard of supervision and control and a high standard for technical measures), commercial use (workers with various/different competences, qualifications and skills lower or varying standard of supervision and control and a lower standard for technical measures) or consumer use (no expertise/fewer skills for implementing measures, no technical measures (except for certain products), no individual protection (except for gloves or protective glasses in certain cases), sensitive group).
  • 59
    • 42149116317 scopus 로고    scopus 로고
    • In the EU classification system, CMR substances are placed in one of three categories, with category one indicating the substances that are most likely to cause the relevant effect
    • In the EU classification system, CMR substances are placed in one of three categories, with category one indicating the substances that are most likely to cause the relevant effect.
  • 60
    • 42149173800 scopus 로고    scopus 로고
    • Criteria for high toxicity: high toxicity is indicated for substances that are very toxic, toxic, corrosive, sensitizing. CMR Category 3, aquatic toxicity less than 1 mg/l
    • Criteria for high toxicity: High toxicity is indicated for substances that are very toxic, toxic, corrosive, sensitizing. CMR Category 3, aquatic toxicity less than 1 mg/l.
  • 61
    • 42149110884 scopus 로고    scopus 로고
    • note
    • Criteria for high exposure: High exposure is indicated for repeated, long-term exposure of human beings, or repeated, longterm exposure of the environment. High exposure is not indicated for substances that break down easily in the environment, are bound into a matrix, are used in preparations in concentrations of less than 1% or are used in products in concentrations of less than 0.1%. These are covered, with regard to their use, by other regulated areas excluded from REACH.
  • 62
    • 42149150446 scopus 로고    scopus 로고
    • See Regulation 1907/2006, n. 2 above, Annex VIII, Parts 8.6 and 8.7
    • See Regulation 1907/2006, n. 2 above, Annex VIII, Parts 8.6 and 8.7.
  • 63
    • 84869613933 scopus 로고    scopus 로고
    • The Commission has estimated that 80,000 dossiers will be registered for 30,000 substances; see European Commission, (European Commission, July), available at
    • The Commission has estimated that 80,000 dossiers will be registered for 30,000 substances; see European Commission, Questions and Answers on REACH (European Commission, July 2007), available at .
    • (2007) Questions and Answers on REACH
  • 64
    • 42149101160 scopus 로고    scopus 로고
    • 'REACH: Industry's meltdown predictions groundless but fierce lobbying goes on'
    • See n. 36 above, for example. (June 2005), available at E. Forsberg, 'Editorial' (KEMI, 14 March 2006), available at . World Wide Fund for Nature (WWF), WWF Factsheet: Hazard information, risk assessment and REACH (WWF, undated), available at
    • See n. 36 above, for example. T. Musu, 'REACH: Industry's meltdown predictions groundless but fierce lobbying goes on', 27 HESA Newsletter (June 2005), 5, available at . E. Forsberg, 'Editorial' (KEMI, 14 March 2006), available at . World Wide Fund for Nature (WWF), WWF Factsheet: Hazard information, risk assessment and REACH (WWF, undated), available at .
    • 27 HESA Newsletter , vol.5
    • Musu, T.1
  • 65
    • 34547682459 scopus 로고    scopus 로고
    • 'Note on the Further Work Concerning the Impact Assessment of REACH'
    • F. Leone, 'Note on the Further Work Concerning the Impact Assessment of REACH', 2:3 JEEPL (2005), 195.
    • (2005) JEEPL , vol.2 , Issue.3 , pp. 195
    • Leone, F.1
  • 66
    • 42149121458 scopus 로고    scopus 로고
    • Presented, discussed and reviewed at the Luxembourg Presidency Workshop on REACH, 10-11 May 2005. See Luxembourg Presidency Workshop on REACH, available at
    • Presented, discussed and reviewed at the Luxembourg Presidency Workshop on REACH, 10-11 May 2005. See Luxembourg Presidency Workshop on REACH, Presidency Report (Government of Luxembourg, undated), available at .
    • Presidency Report (Government of Luxembourg, Undated)
  • 67
    • 42149108525 scopus 로고    scopus 로고
    • note
    • The following physicochemical hazards were assessed by the initiators of the proposal as being essential for computer-based assessment of the substance as potentially exposing human beings or environmental spheres: state of the substance at 20°C and 101.3 kPa; vapour pressure; water solubility; partition coefficient n-octanol/water; flash point; flammability; explosive properties; granulometry (if applicable).
  • 68
    • 42149137933 scopus 로고    scopus 로고
    • note
    • These are: Main use category (industrial use, professional use or consumer use); specification for industrial and professional use (use in closed system, use resulting in inclusion into or onto matrix, non-dispersive use or dispersive use); significant route(s) of exposure (human exposure (oral, dermal, environmental exposure through water, air, solid waste)); pattern of exposure accidental/infrequent, occasional, continuous/frequent.
  • 69
    • 42149119006 scopus 로고    scopus 로고
    • Structural activity relationships and quantitative structural activity relationships, collectively referred to as (Q)SARs, are theoretical models that can be used to predict the physicochemical, biological and environmental fate properties of molecules. In the hazard and risk assessment process, (Q)SARs are generally used in combination with other sources of information on chemicals, either to prioritize chemicals for further assessment, or to replace testing. See Joint Research Centre (JRC), (JRC, undated), available at
    • Structural activity relationships and quantitative structural activity relationships, collectively referred to as (Q)SARs, are theoretical models that can be used to predict the physicochemical, biological and environmental fate properties of molecules. In the hazard and risk assessment process, (Q)SARs are generally used in combination with other sources of information on chemicals, either to prioritize chemicals for further assessment, or to replace testing. See Joint Research Centre (JRC), Computational Toxicology (JRC, undated), available at .
    • Computational Toxicology
  • 70
    • 42149108062 scopus 로고    scopus 로고
    • note
    • The tests that were added are found in Annex VII, para. 6.5.1 on acute toxicity (oral route), para. 7.1.2 on growth inhibition study aquatic plants (algae preferred), and para. 7.2.1.1 on ready biodegradability of Regulation 1907/2006, n. 2 above.
  • 71
    • 42149120165 scopus 로고    scopus 로고
    • The Commission supported the full Malta/Slovenia proposal as it only prioritized 5 percent of substances, as did certain Member States
    • The Commission supported the full Malta/Slovenia proposal as it only prioritized 5 percent of substances, as did certain Member States.
  • 73
    • 42149093208 scopus 로고    scopus 로고
    • See Opinion of the Committee, n. 57 above
    • See Opinion of the Committee, n. 57 above.
  • 74
    • 42149088305 scopus 로고    scopus 로고
    • note
    • Opinion of the Committee on the Industry, Research and Energy for the Committee on the Environment, Public Health and Food Safety on the proposal for a regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) (on Persistent Organic Pollutants).
  • 77
    • 42149148723 scopus 로고    scopus 로고
    • Proposal for a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) (on Persistent Organic Pollutants) (SEC 1171) COM/2003/0644 final - COD 2003/0256 (2003). Article 10 related to the joint submission of data by members of consortia. Manufacturers and importers of the same substance may form a consortium for the purposes of registration and each member would pay onethird of the registration fee
    • Proposal for a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) (on Persistent Organic Pollutants) (SEC (2003) 1171) COM/2003/0644 final - COD 2003/0256 (2003). Article 10 related to the joint submission of data by members of consortia. Manufacturers and importers of the same substance may form a consortium for the purposes of registration and each member would pay onethird of the registration fee.
    • (2003)
  • 78
    • 42149128852 scopus 로고    scopus 로고
    • Core data in this case consists of the physicochemical, toxicological and ecotoxicological data in Annexes VII-X of REACH, n. 2 above, the classification and labelling of the substance and any proposals for testing
    • Core data in this case consists of the physicochemical, toxicological and ecotoxicological data in Annexes VII-X of REACH, n. 2 above, the classification and labelling of the substance and any proposals for testing.
  • 80
    • 42149152717 scopus 로고    scopus 로고
    • Commission Staff Working Paper of 29 October 2003 on Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restrictions of Chemicals (REACH), establishing a available at
    • Commission Staff Working Paper of 29 October 2003 on Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restrictions of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/ EC and Regulation (EC) (on Persistent Organic Pollutants): Extended Impact Assessment, COM (2003) 644, available at .
    • (2003) European Chemicals Agency and Amending Directive 1999/45/EC and Regulation (EC) (on Persistent Organic Pollutants): Extended Impact Assessment, COM 644
  • 81
    • 42149183568 scopus 로고    scopus 로고
    • See Regulation 1907/2006, n. 2 above, Article 11
    • See Regulation 1907/2006, n. 2 above, Article 11.
  • 82
    • 42149119007 scopus 로고    scopus 로고
    • See n. 44 above
    • See n. 44 above.
  • 83
    • 42149195018 scopus 로고    scopus 로고
    • note
    • See Proposal for a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), n. 77 above, Annex I, para. 5.1.1, which states: 'These exposure scenarios may be as wideranging or specific as necessary...'.
  • 84
    • 42149193157 scopus 로고    scopus 로고
    • See n. 47 above
    • See n. 47 above.
  • 85
    • 42149083296 scopus 로고    scopus 로고
    • Amendment 413 of the first reading in Parliament sets out a new section in Annex IV containing explanations on how to determine the main use category for a substance (including categorization as industrial/professional/consumer use and significant routes of exposure). See n. 42 above
    • Amendment 413 of the first reading in Parliament sets out a new section in Annex IV containing explanations on how to determine the main use category for a substance (including categorization as industrial/ professional/consumer use and significant routes of exposure). See n. 42 above.
  • 86
    • 42149146144 scopus 로고    scopus 로고
    • See Regulation 1907/2006, n. 2 above, Annex I, para
    • See Regulation 1907/2006, n. 2 above, Annex I, para. 0.5.
  • 88
    • 34548409780 scopus 로고    scopus 로고
    • Commission Services, (European Commission, November 2007), available at V.J. Brown, 'REACHing for Chemical Safety', 111:14 Environmental Health Perspectives 767, available at
    • Commission Services, REACH in Brief (European Commission, November 2007), available at . V.J. Brown, 'REACHing for Chemical Safety', 111:14 Environmental Health Perspectives (2003) 767, available at .
    • (2003) REACH in Brief
  • 89
    • 42149156648 scopus 로고    scopus 로고
    • Report on the operation of 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 substances, Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations, Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations and Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances, available at . SEC 1986 final (1998)
    • Report on the operation of 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 substances, Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations, Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations and Council Regulation (EEC) No 793/ 93 of 23 March 1993 on the evaluation and control of the risks of existing substances, available at . SEC (1998) 1986 final (1998).
    • (1998)
  • 91
    • 42149166116 scopus 로고    scopus 로고
    • CEFIC, (CEFIC, undated), available at See also 'Two Decades of Responsible Care: Credible response or comfort blanket?', 360 ENDS Report (January 2005), available at
    • CEFIC, Health, Safety and Environment: Responsible Care (CEFIC, undated), available at . See also 'Two Decades of Responsible Care: Credible response or comfort blanket?', 360 ENDS Report (January 2005), available at .
    • Health, Safety and Environment: Responsible Care
  • 92
    • 42149169093 scopus 로고
    • The Toxic Substances Control Act (TOSCA) of 1976, 15 USC s/s 2601 et seq
    • The Toxic Substances Control Act (TOSCA) of 1976, 15 USC s/s 2601 et seq. (1976).
    • (1976)
  • 97
    • 84996585819 scopus 로고    scopus 로고
    • 'Chemicals management may be getting tougher' (1 November), available at
    • 'Chemicals management may be getting tougher' Environmental Science and Technology (1 November 2006), available at .
    • (2006) Environmental Science and Technology
  • 98
    • 42149117819 scopus 로고    scopus 로고
    • ENGO Delegation to the Parliamentary Review of CEPA Burden of Proof, (October), available at
    • ENGO Delegation to the Parliamentary Review of CEPA Burden of Proof, Reverse Onus CEPA 1999 (October 2005), available at .
    • (2005) Reverse Onus CEPA 1999
  • 99
    • 42149126709 scopus 로고    scopus 로고
    • Notification G/TBT/N/EEC/52 of 30 January 2004 on COM 644 Final Proposal for a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) (on Persistent Organic Pollutants); Proposal for a Directive of the European Parliament and of the Council amending Council Directive 67/548/EEC in order to adapt it to Regulation (EC) of the European Parliament and of the Council concerning the registration, evaluation, authorization and restriction of chemicals, available at
    • Notification G/TBT/N/EEC/52 of 30 January 2004 on COM (2003) 644 Final Proposal for a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) (on Persistent Organic Pollutants); Proposal for a Directive of the European Parliament and of the Council amending Council Directive 67/548/EEC in order to adapt it to Regulation (EC) of the European Parliament and of the Council concerning the registration, evaluation, authorization and restriction of chemicals, available at .
    • (2003)
  • 100
    • 42149178458 scopus 로고    scopus 로고
    • note
    • Thirteen sets of comments were received from the USA, Japan, Canada, China, Brazil, Australia, Chile, Singapore, Taiwan, Thailand, Cuba, the American Chemistry Council (ACC) and the Asia-Pacific Economic Co-operation Chemical Dialogue (APEC).
  • 101
    • 42149147962 scopus 로고    scopus 로고
    • Notification G/TBT/N/EEC/52/Add.2 of 17 August 2006 on COM 644 final, Proposal for a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) (on Persistent Organic Pollutants); Proposal for a Directive of the European Parliament and of the Council amending Council Directive 67/548/EEC in order to adapt it to Regulation (EC) of the European Parliament and of the Council concerning the registration, evaluation, authorization and restriction of chemicals, available at
    • Notification G/TBT/N/EEC/52/Add.2 of 17 August 2006 on COM (2003) 644 final, Proposal for a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) (on Persistent Organic Pollutants); Proposal for a Directive of the European Parliament and of the Council amending Council Directive 67/548/EEC in order to adapt it to Regulation (EC) of the European Parliament and of the Council concerning the registration, evaluation, authorization and restriction of chemicals, available at .
    • (2003)
  • 102
    • 42149096575 scopus 로고    scopus 로고
    • Notification G/TBT/N/EEC/52/Add.3.Rev 1 of 9 February 2007 on COM 644 final, Proposal for a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) (on Persistent Organic Pollutants); Proposal for a Directive of the European Parliament and of the Council amending Council Directive 67/548/EEC in order to adapt it to Regulation (EC) of the European Parliament and of the Council concerning the registration, evaluation, authorization and restriction of chemicals, available at
    • Notification G/TBT/N/EEC/52/Add.3.Rev 1 of 9 February 2007 on COM (2003) 644 final, Proposal for a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) (on Persistent Organic Pollutants); Proposal for a Directive of the European Parliament and of the Council amending Council Directive 67/548/EEC in order to adapt it to Regulation (EC) of the European Parliament and of the Council concerning the registration, evaluation, authorization and restriction of chemicals, available at .
    • (2003)
  • 103
    • 42149169713 scopus 로고    scopus 로고
    • 'REACH: Substances in Articles - A Step in the Right Direction'
    • M. Blainey, C. de Avila and P. van der Zandt, 'REACH: Substances in Articles - A Step in the Right Direction', 6 JEEPL (2007), 424.
    • (2007) JEEPL , vol.6 , pp. 424
    • Blainey, M.1    de Avila, C.2    van der Zandt, P.3
  • 104
    • 42149136826 scopus 로고    scopus 로고
    • Response from the European Communities to Comments Submitted by WTO Members under G/TBT/N/EEC/52 Regulation concerning the registration, evaluation and authorization of chemicals (known as REACH), (European Commission, undated), available at
    • Response from the European Communities to Comments Submitted by WTO Members under G/TBT/N/EEC/52 Regulation concerning the registration, evaluation and authorization of chemicals (known as REACH), COM (2003) 644 final (European Commission, undated), available at .
    • (2003) COM 644 Final
  • 105
    • 0013371016 scopus 로고
    • The main WTO issues that have been raised by the countries who commented (see n. 100 above) relate to Article 2.1 of the TBT Agreement that requires 'domestic regulations to accord treatment no less favourable than that accorded to like products of national origin'. In addition, Article 2.2 of the TBT Agreement requires all WTO members to 'ensure their technical regulations are not more trade restrictive than necessary to fulfil a legitimate objective, taking account of the risks non-fulfilment would create'. See (Marrakesh, 15 April), Articles 2.1 and 2.2
    • The main WTO issues that have been raised by the countries who commented (see n. 100 above) relate to Article 2.1 of the TBT Agreement that requires 'domestic regulations to accord treatment no less favourable than that accorded to like products of national origin'. In addition, Article 2.2 of the TBT Agreement requires all WTO members to 'ensure their technical regulations are not more trade restrictive than necessary to fulfil a legitimate objective, taking account of the risks non-fulfilment would create'. See Agreement on Technical Barriers to Trade (Marrakesh, 15 April 1994), Articles 2.1 and 2.2.
    • (1994) Agreement on Technical Barriers to Trade
  • 106
    • 42149103843 scopus 로고    scopus 로고
    • 'REACH Reviewed under WTO Law'
    • M. Bronkers and P. Charro, 'REACH Reviewed under WTO Law', 3 JEEPL (2005), 184.
    • (2005) JEEPL , vol.3 , pp. 184
    • Bronkers, M.1    Charro, P.2
  • 107
    • 77950936329 scopus 로고    scopus 로고
    • AMCHAM EU, CEFIC, FECC, (AMCHAM EU, CEFIC, FECC, 30 November), available at
    • AMCHAM EU, CEFIC, FECC, Discussion paper on the trade impact of REACH (AMCHAM EU, CEFIC, FECC, 30 November 2004), available at .
    • (2004) Discussion Paper on the Trade Impact of REACH


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