Environment
This article was originally published in SRA
Executive Summary
EU members oppose threshold policy for REACH high concern chemicals
EU members oppose threshold policy for REACH high concern chemicals
Six European member states have formally rejected a European Commission policy under which the limit placed on chemical substances of very high concern applies only to finished products1,2. The dissenting views issued by Austria, Belgium, Denmark, France, Germany and Sweden say that the threshold level for these substances (eg carcinogens, mutagens or those toxic to reproduction) should apply to a product's homogeneous materials or individual components, and not to the complex product itself3.
The threshold level for substances of very high concern was determined under the provisions of REACH, the European regulation concerning the registration, evaluation, authorisation and restriction of chemicals4,5. A preliminary candidate list published by the European Chemicals Agency (ECHA) identified 15 chemicals within that category6.
Incorporation of a high concern substance in a product in a concentration of above 0.1% weight by weight (ie 1 gram/kg or 1,000 ppm) faces special requirements under REACH. The contentious issue was how the threshold levels should be applied - whether to the finished product or to each component individually. After much discussion, the commission voted in favour of the finished product option. The six member states, however, do not agree with the commission's interpretation.
Review project
As such, the dissenting member states, along with Finland and Norway, have launched a project to come up with an alternative interpretation that they say would have “fewer negative implications” compared with the commission's interpretation. REACH requires information on substances of very high concern in products to be made systematically available to consumers in the supply chain so that they can use the products safely. According to the Belgian government, the commission's interpretation defeated REACH's objectives as it would result in:
- information on substances of very high concern being rendered superfluous in case of complex products;
- serious enforcement problems;
- competitive disorders and arbitrary discrimination; and
- inconsistencies with other EU legislation such as the Restriction of Hazardous Substances (RoHS) Directive.
The project is being led by Sweden and is expected to be completed before the end of 2009.
If any enforcement action takes place in Belgium before the finalisation of the project, the Belgian government has said that it would apply its own interpretation of the matter while dealing with the cases and not that of the commission.
ECHA reviewing guidance
The ECHA too is reviewing its existing guidance on the issue in light of the differences in interpretation. In order to reach consensus, the Belgian government said the dissenting member states would co-ordinate their project with the ECHA's work.
References
1. Federal Public Service press release, 9 December 2008, https://portal.health.fgov.be/portal/page?_pageid=56,512448&_dad=portal&_schema=PORTAL&ITEM_ID=15812547&SITE_ID=56&PAGE_ID=512545&isportlet=true&p_security=ON
2. Federal Public Service, Belgian interpretation concerning the obligations for Substances of Very High Concern (SVHCs) in articles, 9 December 2009, https://portal.health.fgov.be/portal/page?_pageid=56,15812534&_dad=portal&_schema=PORTAL
3. Dissenting views on the Guidance on requirements for substances in articles, May 2008, https://portal.health.fgov.be/pls/portal/docs/PAGE/INTERNET_PG/HOMEPAGE_MENU/MILIEU1_MENU/CHEMISCHESTOFFEN1_MENU/REACH1_MENU/REACH1_DOCS/DISSERTING%20VIEWS%20ON%20THE%20GUIDANCE%20ON%20REQUIREMENTS%20FOR%20SUBSTANCES%20IN%20ARTICLES_1.PDF
4. European Chemicals Agency, Guidance on requirements for substances in articles, May 2008, https://portal.health.fgov.be/pls/portal/docs/PAGE/INTERNET_PG/HOMEPAGE_MENU/MILIEU1_MENU/CHEMISCHESTOFFEN1_MENU/REACH1_MENU/REACH1_DOCS/GUIDANCE%20ON%20REQUIREMENTS%20FOR%20SUBSTANCES%20IN%20ARTICLES_1.PDF
5. Regulation (EC) No 1907/2006, OJ, 30 December 2006, L396, 1-849, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:396:0001:0849:EN:PDF
6. The Regulatory Affairs Journal - Pharma, 2008, 19(12), 828-829