PBT assessment using the revised annex XIII of REACH: A comparison with other regulatory frameworks

Integrated Environmental Assessment and Management

Volumn 8, Issue 2, 2012, Pages 359-371

  Moermond, Caroline T A ^a   Janssen, Martien P M ^a   de Knecht, Joop A ^a   Montforts, Mark H M M ^a   Peijnenburg, Willie J G M ^a   Zweers, Patrick G P C ^a   Sijm, Dick T H M ^a  

^a NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

Author keywords

Bioaccumulation criteria; Legislation; PBT assessment; Persistence criteria; REACH

Indexed keywords

ARTICLE; CHEMISTRY; CLASSIFICATION; DECISION MAKING; ENVIRONMENTAL EXPOSURE; ENVIRONMENTAL MONITORING; ENVIRONMENTAL PLANNING; EUROPEAN UNION; GOVERNMENT REGULATION; LEGAL ASPECT; POLLUTANT; POLLUTION; RISK ASSESSMENT;

DECISION MAKING; ENVIRONMENTAL EXPOSURE; ENVIRONMENTAL MONITORING; ENVIRONMENTAL POLICY; ENVIRONMENTAL POLLUTANTS; ENVIRONMENTAL POLLUTION; EUROPEAN UNION; GOVERNMENT REGULATION; RISK ASSESSMENT;

EID: 84863852470     PISSN: 15513793     EISSN: None     Source Type: Journal    
DOI: 10.1002/ieam.1248     Document Type: Article

References (28)

1. [EC] European Commission. 1991. Directive 91/414/EC. Luxembourg: Publications Office of the European Union. [cited 2011 October 7]. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri1/4CELEX:31991 L0414:EN: HTML
2. [EC] European Commission. 1998. Directive 98/8/EC. Luxembourg: Publications Office of the European Union. [cited 2011 October 7]. Available from: http://eurlex. europa.eu/LexUriServ/LexUriServ.do?uri1/4OJ:L:1998:123:0001:0063:EN:PDF
3. [EC] European Commission. 2003. Technical Guidance Document on risk assessment in support of Commission Directive 93/67/EEC on Risk Assessment for new notified substances, Commission Regulation (EC) No 1488/94 on Risk Assessment for existing substances and of Directive 98/8/ EC of the European Parliament and of the Council concerning the placing of biocidal products on the market. Ispra (IT): European Chemicals Agency. Report no. EUR 20418 EN/2.
4. [EC] European Commission. 2004a. Regulation (EC) No 850/2004. Luxembourg: Publications Office of the European Union. [cited 2011 October 7]. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri1/4OJ:L:2004:158: 0007:0049:EN:PDF
5. [EC] European Commission. 2004b. Directive (EC) No 2004/27/EC. Luxembourg: Publications Office of the European Union. [cited 2011 October 7]. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri1/4OJ:L:2004:136: 0034:0057:EN:PDF
6. [EC] European Commission. 2004c. Directive (EC) No 2004/28/EC. Luxembourg: Publications Office of the European Union. [cited 2011 October 7]. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri1/4OJ:L:2004:136:0058: 0084:EN:PDF
7. [EC] European Commission. 2006. Regulation (EC) No 1907/2006. Luxembourg: Publications Office of the European Union. [cited 2011 October 7]. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri1/4CELEX:32006 R1907:EN:NOT
8. [EC] European Commission. 2009. Regulation (EC) No 1107/2009. Luxembourg: Publications Office of the European Union. [cited 2011 October 7]. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri1/4OJ:L:2009:309: 0001:0050:EN:PDF
9. [EC] European Commission. 2010. Proposal for a Regulation concerning the placing on the market and use of biocidal products. Document number 6564/5/10; 5th revision, November 2010. Luxembourg: Publications Office of the European Union. [cited 2011 October 7]. Available from http://www.europa-nu.nl/9353000/1/j4nvgs5kjg27kof_j9vvikqpopjt8zm/viki7rtjv4xh
10. [EC] European Commission. 2011. Commission Regulation (EU) No 253/2011. Luxembourg: Publications Office of the European Union. [cited 2011 October 7]. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri1/4OJ:L:2011:069:0007:0012:EN:PDF
11. [ECB] European Chemical Bureau. 2002. TNsG on Annex I inclusion. Technical Notes for Guidance in Support of Directive 98/8/EC of the European Parliament and the Council Concerning the Placing of Biocidal Products on the Market. Principles and Practical Procedures for the inclusion of active substances in Annexes I, IA and IB. [cited 2011 October 7]. Available from: http://ihcp.jrc.ec.europa.eu/our_activities/health-env/risk_assessment_of_Biocides/guidancedocuments
12. [ECHA] European Chemicals Agency. 2008. Guidance on information requirements and chemical safety assessment. Helsinki (FI): European Chemicals Agency. [cited 2011 October 7]. Available from: http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm
13. [EMA] European Medicines Agency. 2000. Guideline on environmental impact assessment (EIAs) for veterinary medicinal products, Phase I. VICH Topic GL6. London (UK): EMA. Report no. CVMP/VICH/592/98-FINAL.
14. [EMA] European Medicines Agency. 2005. Guideline on environmental impact assessment for veterinary medicinal products, Phase II. VICH GL38. London (UK): EMA. Report no. CVMP/VICH/790/03-FINAL.
15. [EMA] European Medicines Agency. 2006. Guideline on the environmental risk assessment of medicinal products for human use. London (UK): EMA. Report no. EMEA/CHMP/SWP/4447/00.
16. [EMA] European Medicines Agency. 2008. Revised guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38. London (UK): EMA. Report no. EMEA/CVMP/ERA/418282/2005-Rev.1.
17. [EMA] European Medicines Agency. 2010a. Concept paper on assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicine. London (UK): EMA. Report no. EMA/CVMP/ERAWP/389867/2010.
18. [EMA] European Medicines Agency. 2010b. Q&A on the Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. London (UK): EMA. Report no. EMA/CHMP/SWP/44609/2010.
19. [IMO] International Maritime Organization. 2004. International Convention for the control and management of ships' ballast water and sediments (BWM). London (UK): IMO. [cited 2011 October 7]. Available from http://www.imo.org/About/Conventions/ListOfConventions/Pages/International-Convention-for-the- Control-and-Management-of-Ships%27-Ballast-Water-and-Sediments-(BWM). aspx
20. [MEPC] Marine Environment Protection Committee. 2008. Procedure for approval of ballast water management systems that make use of active substances (G9). London (UK): IMO. [cited 2011 October 7]. Available from http://www.imo.org/OurWork/Environment/BallastWaterManagement/Pages/BWMGuidelines.aspx
21. [OSPAR] Oslo Paris Convention. 2002. Guidance on how to apply the safety net procedure for the inclusion of substances in the list of substances of possible concern. London (UK): OSPAR. [cited 2011 October 7]. Available from http://www.ospar.org/documents/dbase/decrecs/agreements/02-10e_Safety%20net%20procedure.doc
22. [OSPAR] Oslo Paris Convention. 2003. OSPAR Hazardous Substances Strategy. London (UK): OSPAR. [cited 2011 October 7]. Available from http://www.ospar.org/html_documents/ospar/html/Revised_OSPAR_Strategies_2003.pdf#nameddest1/4hazardous_substances
23. [OSPAR] Oslo Paris Convention. 2005. Cut-off values for the selection criteria of the OSPAR dynamec selection and prioritisation mechanism for hazardous substances. London (UK): OSPAR. [cited 2011 October 7]. Available from http://www.ospar.org/documents/DBASE/DECRECS/Agreements/05-09e_Cutoff-value%20agreement.doc
24. [OSPAR] Oslo Paris Convention. 2006. Dynamic selection and prioritisation mechanism for hazardous substances (new DYNAMEC manual). London (UK): OSPAR. [cited 2011 October 7]. Available from http://www.ospar.org/documents/DBASE/Publications/p00256_New%20DYNAMEC%20Manual.pdf
25. Rorije E, Verbruggen EMJ, Hollander A, Traas TP, Janssen MPM. 2011. Identifying potential POP and PBT substances. Development of a new Persistence/Bioaccumulation score. Bilthoven (NL): RIVM. Report 601356001/2011. [cited 2011 October 7]. Available from http://www.rivm.nl/bibliotheek/rapporten/601356001.html
26. Stockholm Convention. 2001. Geneva (Switzerland): UNECE. [cited 2011 October 7]. Available from http://chm.pops.int/Convention/tabid/54/language/en-US/Default.aspx
27. [UNECE] United Nations Economic Commission for Europe. 1998a. Protocol to the 1979 convention on long-range transboundary air pollution on persistent organic pollutants. Geneva (Switzerland): UNECE. [cited 2011 October 7]. Available from http://www.unece.org/env/lrtap/full%20text/1998.POPs.e. pdf
28. [UNECE] United Nations Economic Commission for Europe. 1998b. Executive body decision 1998/2 on information to be submitted and the procedure for adding substances to annexes I, II or III to the protocol on persistent organic pollutants. Geneva (Switzerland): UNECE. [cited 2011 October 7]. Available from http://www.unece.org/env/documents/2000/ece/eb/ece%20eb%20air.60.e.pdf