Abstract
REACH is intended to increase the speed and efficiency of the risk assessment process and to make producers and importers of chemicals responsible for this process. In this contribution, the REACH data requirements are evaluated against the background of accepted data requirements and criteria for hazard assessment, classification and warning labelling. It is concluded that REACH will lead to increased availability of toxicological data, but not to the extent that would be needed to achieve a sound scientific basis for hazard assessment of all individual substances covered by the legislation. Amendments are proposed that would improve priority-setting and testing strategies in the REACH system.
This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsNotes
- 1.
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), Official Journal L396/17:1–849.
- 2.
- 3.
Then the following tests would be relevant: acute toxicity test, subacute/28-d study or a subchronic/90-d test, skin and eye irritation, corrosivity, skin sensitization, carcinogenicity, mutagenicicity, reproductive toxicity (2-gen study), ecotoxicity tests in fish, algae and Daphnia, evaluation of the potential for (or actual) bioaccumulation through the determination of log Pow (or BCF), and degradability.
- 4.
For a summary of these efforts, see Philipson, Lloyd L (1983) Risk Acceptance Criteria and Their Development. Journal of Medical Systems 7(5):437–456.
- 5.
The analyses are performed using the criteria in the European classification and labelling directive (67/548). These criteria will be replaced by a new directive that is based on the Globally Harmonized System (GHS) for classification and labelling developed by the United Nations (Reg. 1272/2008). The new rules will be implemented stepwise from June 2010 to June 2015.
- 6.
The major deviations from this orderly structure are the test requirements concerning mutagenicity and carcinogenicity, that form a special tiered approach, and the provisions for waiving certain test requirements.
- 7.
Council Directive 92/32/EEC of 30 April 1992 amending for the seventh time Directive. 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances Official Journal L 154, 05/06/1992 (Annex VIIA).
- 8.
See the newsletter of the existing substances programme on the homepage of the European Chemicals Bureau (ecb.jrc.it/existing-chemicals).
- 9.
The so called “base-set” included data on mutagenicity (in vitro), acute toxicity, skin and eye irritation, skin sensitization, a sub-acute/28-day toxicity study, acute toxicity tests on fish, Daphnia and algae and degradation data (Annex VII A of directive 92/32).
- 10.
I.e. prioritization criteria according to REACH Annex III: “Indications” that the substance is classifiable as a carcinogen, mutagen or reproductive toxicant in categories 1or 2, substances with at least one classifications according to 67/548, substances that are PBT or vPvB (according to the REACH criteria).
- 11.
According to REACH, results from in vitro testing of eye and skin irritation are also required for substances produced in 1 tonne per year or more. However no such standardized in vitro tests are currently available in the OECD test guidelines. Furthermore, a standardization or validation process has not been initiated for any such test in the guidelines.
- 12.
Or if they are categorized as PBT or vPvB, or identified as a SVHC (REACH, vol. I article 29, Annex XI).
References
Allanou, R., Hansen, B.G., and van der Bilt, Y. (1999) Public Availability of Data on EU High Production Volume Chemicals. European Commission EUR 18996 EN, Institute for Health and Consumer Protection, Ispra.
Bicevskis, A. (1982) Unacceptability of acceptable risk. Search 13(1–2): 31–34.
Breitholtz, M., Rudén, C., Hansson, S. and Bengtsson (2006) Ten challenges for improved ecotoxicological testing in environmental risk assessment. Ecotoxicology and Environmental Safety 63: 324–335.
Clausen, J., Hansson, S.O. and Nilsson, F. (2006) Generalizing the safety factor approach. Reliability Engineering and System Safety 91: 964–973.
European Commission (2001) White Paper – Strategy for a Future Chemicals Policy. Brussels 27.2.2001, COM(2001)88 final.
Hansson, S.O. (1997) Can we reverse the burden of proof? Toxicology Letters 90: 223–228.
Hansson, S.O. (1999) The moral significance of indetectable effects. Risk 10: 101–108.
Hansson, S.O. and Rudén C. (2003) Improving the incentives for toxicity testing. Journal of Risk Research 6: 3–21.
Hansson, S.O. and Rudén C. (2007) Towards a theory of tiered testing. Regulatory Toxicology and Pharmacology 48(1): 35–44.
Harremoës, P. et al. (2001) Late lessons from early warnings: The precautionary principle 1896–2000. European Environment Agency, Luxembourg.
National Research Council (1984) Toxicity testing – strategies to determine needs and priorities. National Academy Press, Washington, DC.
Ong, E.K. and Glantz, A.S. (2001) Constructing ‘sound science’ and ‘good epidemiology’: Tobacco, lawyers, and public relations firms. American Journal of Public Health (91): 1749–1757.
Philipson, Lloyd L. (1983) Risk acceptance criteria and their development. Journal of Medical Systems 7(5): 437–456.
Roe, D., Pease, W., Florini, K., and Silbergeld, E. (1997) Toxic Ignorance. Environmental Defense Fund (EDF), New York, USA.
Rudén C. and Hansson S.O. (2008) Evidence-based toxicology – ‘sound science’ in new disguise. International Journal of Occupational and Environmental Health 14: 299–306.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2010 Springer Science+Business Media B.V.
About this chapter
Cite this chapter
Hansson, S.O., Rudén, C. (2010). REACH: What Has Been Achieved and What Needs To Be Done?. In: Eriksson, J., Gilek, M., Rudén, C. (eds) Regulating Chemical Risks. Springer, Dordrecht. https://doi.org/10.1007/978-90-481-9428-5_5
Download citation
DOI: https://doi.org/10.1007/978-90-481-9428-5_5
Published:
Publisher Name: Springer, Dordrecht
Print ISBN: 978-90-481-9427-8
Online ISBN: 978-90-481-9428-5
eBook Packages: Earth and Environmental ScienceEarth and Environmental Science (R0)