toxics use reduction institute chemicals policy in europe: new directions rachel massey policy...
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Toxics Use Reduction Institute
Chemicals Policy in Europe: New Directions
Rachel Massey
Policy Analyst
April 2006
REACH
Registration
Evaluation
and
Authorization
of
Chemicals
REACH: The Basics
New regulatory structure for chemicals
Replaces or incorporates about 40 pieces of existing legislation
Creates a centralized European Chemicals Agency
What Problems does REACH Solve?
Lack of data on health and environmental effects of chemicals
Artificial historical distinction between “new” and “existing” chemicals
Incentives against testing chemicals
REACH: Who is Regulated?
European chemical manufacturers
Some European downstream users of chemicals
Importers of chemicals and some products containing chemicals
REACH vs. EU Baseline
How does REACH compare with the baseline of current EU legislation?
More stringent for “existing” (pre-1981) chemicalsLess stringent for “new” (post-1981) chemicals– Fewer tests required at low volume tiers– Requirements start at 1 ton per year
Legislative Process in the EU
European Commission: the executive branch, responsible for proposing and implementing legislation.
European Parliament: elected by EU citizens
Council of the European Union, or Council of Ministers: includes ministers of the governments of each EU member state
New Chemical Policy
2001
2007
Cardiff Council meeting
Council Conclusions
Parliament’s Opinion
Proposal DG Env DG ENT
Council Common Position
Parliament’s 1st reading
WHITE PAPER
1998
COMMISSION PROPOSAL
Internet consultation
Stakeholder consultation
We are here
Opinion Commission
July 2003
Parliament’s 2nd reading
FINAL LEGISLATIVE
ACTSConsiliation process
Member state implementation
Oct 03
Source: International Chemical Secretariat
REACH
Registration
Evaluation
and
Authorization
of
Chemicals
REGISTRATION
Manufacturers and importers must submit information on health and environmental effects of the chemicals they sell.
Companies can form consortia to share testing costs.
Testing requirements depend on annual production volume per company.
REGISTRATION: Time Line
Source: International Chemical Secretariat
EVALUATION
National authorities evaluate registration data on selected chemicals, and may ask for data gaps to be filled. – Dossier evaluation: applies > 100 tons per
year. – Substance evaluation: applies when there is
reason to believe a substances presents a risk to health or the environment.
AUTHORIZATION
Substances of Very High Concern (SVHC) cannot be sold without an authorization.
Applicant must show “adequate control,” or
Socioeconomic value that outweighs the risks.
An authorization applies to specific uses.
AUTHORIZATION
Substances of Very High Concern include:
Carcinogenic, Mutagenic, Reproductive toxicity (CMR) 1 & 2
Persistent, Bioaccumulative, and Toxic (PBT)
Very Persistent, very Bioaccumulative (vPvB)
Substances of “equivalent concern,” e.g. endocrine disrupting chemicals
RESTRICTION
Safety net
Incorporates current restrictions
Can include conditions for use, or prohibition
Dossier must show risk to health or the environment that needs to be addressed at the European Community level, and explore options for managing risk.
Substances in Articles – Still Subject to Debate
For substances present at more than 1 tpa per producer or importer, the Council version requires registration for substances that are intended to be released, plus
“notification” of substances that constitute more than 0.1% of the article by weight. Does not apply if company can exclude exposure.
REACH Exemptions
Radioactive materials
Pharmaceuticals
Polymers
Pesticides
Some byproducts
Some minerals, ores, and fuels
Some familiar, commonly used substances
Costs of REACH
Testing
Registration
Withdrawals
Authorization
Costs of REACH
Extended Impact Assessment by the European Commission: REACH will cost companies €2.3 billion over 11 years.Cost of chemicals will increase 1/50 of 1%, or at most 1/10 of 1%. (Joan Canton and Ch. Allen, “A Microeconomic Model to
Assess the Economic Impacts of the EU’s New Chemicals Policy,” DG Enterprise, November 2003, pp. 27-31.)
Commission partnership with industry groups: – Registration requirements will not lead to significant
withdrawal of low-volume chemicals– REACH will have limited impacts on downstream
users (Source: KPMG study, summarized in ChemSec, Surviving REACH.)
Benefits of REACH
Access to information
Less risk of future liability
Lower worker protection and compensation costs
Cleanup costs avoided
Innovation encouraged
Benefits of REACH
Health benefits over 30 years estimated at €50 billion (European Commission - order of magnitude estimate) (Commission’s Extended Impact
Assessment (October 2003).
Estimated savings of €3.5 billion over ten years from occupational skin and respiratory diseases avoided (Simon Pickvance et al., “The
Impact of REACH on Occupational Health with a Focus on Skin and Respiratory Diseases,” September 2005, http://hesa.etui-rehs.org/uk/newsevents/files/reach-sheffield-complet.pdf.)
RESOURCES
Lowell Center for Sustainable Production– Chemicals Policy Initiative:
• http://chemicalspolicy.org
International Chemical Secretariat• http://www.chemsec.org/
* Interactive walk-through of REACH
* Publications
Surviving REACH