Explanatory Memorandum to COM(2005)618 - Restrictions on the marketing and use of perfluorooctane sulfonates (amendment of Council Directive 76/769/EEC) - Main contents
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| dossier | COM(2005)618 - Restrictions on the marketing and use of perfluorooctane sulfonates (amendment of Council Directive 76/769/EEC). |
|---|---|
| source | COM(2005)618  |
| date | 05-12-2005 |
Perfluorooctane sulfonates (PFOS) are anions that are commercially available in the form of salts, derivatives and polymers. The major uses for PFOS-related substances were in providing grease, oil and water resistance to materials such as textiles, carpets, paper and in general coating. The substances used in these areas were largely PFOS-polymers for fabrics and PFOS-substances for paper treatment and coatings. Other smaller volume uses are in chromium plating, photography, photolithography, fire fighting foams and in hydraulic fluids for aviation.
The proposal is primarily based on the following studies:
- An OECD hazard assessment was endorsed at the 34th Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology(5-8 November 2002). According to this assessment PFOS is persistent in the environment, bio accumulative and toxic to mammalian species.
- A risk evaluation report and a risk reduction strategy which includes an impact assessment have been prepared by the United Kingdom in accordance with the principles of Council Regulation (EEC) 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances i.
- The Scientific Committee on Health and Environmental Risks (SCHER) examined the scientific aspects of the above mentioned risk reduction strategy and confirmed in its opinion adopted on 18 March 2005 that the data indicate that PFOS was very persistent, very bio-accumulative and toxic.
Estimates of emissions from each use area have been made. The risk assessment identified a need for reducing the risks to health and the environment from PFOS. The risk reduction strategy recommended marketing and use restrictions for certain uses. The proposed Directive would cover the great part of the exposure risks by preventing the use of PFOS in carpets, textiles, upholstery, leather, apparel, paper, packaging and other applications. These uses seem already to be phased out and the proposal would prevent their reintroduction. There are some further smaller and specific uses in chromium plating, photography, photolithography, fire fighting foams and in hydraulic fluids for aviation. The volumes used in these limited areas, and the emissions into the environment, would need to be further assessed, but they are currently expected to be very small. The advantages and disadvantages of regulating these uses would have to be subject to impact assessment.
An ongoing research project PERFORCE ( www.science.uva.nl/perforce/ ) which is financed by the Research Framework Programme is generating new data, e.g. on exposures, sources and routes and physico-chemical parameters of PFOS.
Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations i should therefore be amended accordingly.
The objective of the Directive would be to introduce harmonised provisions with regard to PFOS, thus preserving the internal market whilst ensuring a high level of protection of human health and the environment, as required by Article 95 of the Treaty.
2. JUSTIFICATION FOR PROPOSAL
What are the objectives of the proposal in relation to the Community’s obligations?
Due to the fact that certain uses of chemicals cannot be controlled under certain conditions, safety for health and the environment can only be ensured by prohibiting such uses of the substances and preparations concerned.
The aim of the proposal is to preserve the Internal Market. When Member States adopt national provisions restricting the marketing and use of dangerous substances and preparations there will be obstacles to trade because of differences in legislation between Member States. The Draft Proposal aims to improve the conditions for the functioning of the Internal Market to the benefit of the protection of health and the environment.
What are the courses of action available to the Community?
The only course of action available is to make a proposal for an amendment to Directive 76/769/EEC providing for harmonised rules on the use of PFOS.
Are uniform rules necessary? Is it not sufficient to establish targets to be implemented by Member States?
The proposed Directive would establish uniform rules for the circulation of PFOS. It also guarantees a high level of protection of health and the environment. The proposed amendment to Directive 76/769/EEC is the only way to meet these goals. Targets would be insufficient.
3. RATIONALE OF THE PROPOSAL
The proposed Directive would extend Annex I to Directive 76/769 by adding the substance PFOS. Marketing and use of this substance would thus be restricted.
4. COSTS AND BENEFITS
4.1. Costs
The proposed Directive should pose only minor problems to the industry or trade, as the uses of PFOS are declining in the concerned cases, and companies have already developed alternatives.
4.2. Benefits
The benefits of the proposal are to establish an Internal Market as well as to protect human health and the environment. The proposed restriction will ensure that for certain uses which pose a risk to human health or the environment PFOS are no longer on the market.
5. PROPORTIONALITY
The proposed Directive would yield benefits in terms of protecting human health and the environment. This will be achieved at little cost.
PERFORMED IN PREPARING THE DRAFT AMENDMENT
Advice on the preparation of the proposal was sought through meetings involving experts from Member States and the European Chemical Industry Council (CEFIC), the outcome of which is reflected in the proposal. The European Consumers’ Organisation BEUC has also been invited to give comments.
7. CONFORMITY WITH THE TREATY
This proposal is intended to preserve the Internal Market and at the same time ensure a high level of protection of human health and the environment. It is therefore in conformity with Article 95 i of the Treaty.
8. EUROPEAN PARLIAMENT AND EUROPEAN ECONOMIC AND SOCIAL COMMITTEE
In compliance with Article 95 of the Treaty, the Codecision Procedure with the European Parliament is applicable. The European Economic and Social Committee has to be consulted.