09 July 2003 17:34 [Source: ICIS news]
LONDON (CNI)--Cefic, the European chemical industry council, called on Wednesday for a fundamental review of the European Commission's (EC) new chemicals policy and the Reach chemicals registration and authorisation procedure.
The EC’s proposed system is unworkable, Cefic said in its response to the Commission's Reach Internet consultation. It will have a negative impact on the competitiveness of the European chemical industry in the global market, its contribution to the economic well-being of the European Union (EU) and its ability to finance innovation, added Cefic.
As expected, Cefic has objected to the apparent unworkability of Reach, its extent and some of the legal aspects of the new chemicals control system. It calls for the creation of a workable system that is focused and targeted on areas of highest concern. A methodology and tools for prioritisation for such a system would have to be developed, it said, but the system could be developed along the lines of the ECETOC’s (European Centre for Ecotoxicology and Toxicology of Chemicals) targeted risk assessment proposal.
There is a need for a manageable and enforceable legislation, Cefic said, that can be applied both by industry and by the authorities, and which is able to fulfil the expectations of society. However, European industry, including the chemical industry, must not be a test laboratory for a bureaucratic regulatory experiment, it asserted.
Cefic suggested that the scope of the proposals be limited as well as the scope of the duty of care on manufacturers and importers to report. It wants to see polymers and intermediates exempted from the scope of Reach, the latter because potential worker exposure is controlled by current legislation.
The industry council also believes that the scope of authorisation needs to be limited to substances with properties of high concern, namely category 1 and 2 carcinogens, mutagens and reproductive toxicants. If the system is not confined to these substances it will be overloaded from the start, Cefic claimed. Other groups have called for a much broader scope of authorisation covering suspected carcinogenic, persistent and bioaccumulative chemicals.
The Reach information requirements are too burdensome and go beyond the proposals of the original chemicals white paper published in 2001, and current regulatory requirements for the notification of new substances, Cefic added.
The industry council said it supported a bottom up approach in terms of the information requirements depending on the use and exposure of a substance. Redundancy is built into the system, it suggested, because of the existence of chemicals safety data sheets which should be used to communicate information. The proposed chemical safety reports would lead to additional bureaucracy and potential inconsistencies between documents, it contended.
Cefic suggested tight management control of the system with more responsibility given to a central agency, once again to limit bureaucracy. The system has to function with the available and existing resources it said. The proposed system will be very costly, Cefic believes, and SMEs (small to medium sized enterprises) will be hardest hit but the large chemical companies too will be forced to de-select products that cannot justify the increased costs.
Cefic member companies and associations are also clearly worried about the confidentiality of the proposed system which, it said, erodes the principle of protection of intellectual property and threatens the confidentiality of data protected by other laws.
Legal remedies are not sufficiently developed it said, and rights of hearing, second opinion or appeal need to be included. The future legislation needs to be reviewed in regard to the principle of proportionality developed in the case law of the European Court of Justice (ECJ), Cefic argued. Under these rules, regulators are required to ensure that measures proposed be proportionate to the benefits desired to be achieved.
The EC has commissioned some work on the expected costs and benefits of Reach but Cefic said that the claimed occupational health benefits must be verified. Occupational exposures to known chemical carcinogens are decreasing, it said, and this should lead to a measurable decrease in occupational cancer cases in future.
The majority of current occupational cancers (between 67% and 85%) in Europe are due to asbestos which falls under separate regulations from those covering chemicals, it said.
Cefic is clearly focused on the competitiveness of the industry in Europe which, it said, the new chemicals legislation should support. The new chemical policy must deliver a cost-effective system that is consistent with the EU’s international commitments. The unintentional development of ‘fortress Europe’ must be avoided, it urged.
Open questions remain as to whether the new legalisation would violate World Trade Organisation (WTO) rules, it said.
Cefic’s 314 pages of comment on the EC’s chemicals policy and Reach proposals are posted on the internet today to join submissions from interested and affected individuals, companies, governments, trade associations, and NGOs (non-governmental organisations). The internet consultation period closes tomorrow (10 July).
For background and further details, see: http://www.europa.eu.int/comm/enterprise/chemicals/chempol/whitepaper/contributions.htm
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