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