Select Committee on Science and Technology Sixth Report



107. The role of the ECA is set out in Title IX of the Proposals. Its principal functions will be to:

The ECA will be based on the European Agency for the Evaluation of Medicinal Products, whose functions it will most resemble.[154] It will be sited in Finland with a planned annual budget of €30 million, funded mainly through fees charged for Registrations and Authorisations, and will have a staff of about 200.

108. Article 71 explains that the ECA has been set up with a coordinating function and not as a regulatory body, based on the principle of subsidiarity. There is widespread support for a stronger body, however. The Government says it would like to see the European Chemicals Agency taking more of a central role than that envisaged in the European Commission's proposal, in particular:

a)  To act as arbitrator in disputes when setting up consortia for data sharing;

b)  To carry out a screening of the Registration information in order to prioritise for further action under evaluation; and

c)  To take responsibility for Evaluations to ensure they are carried out.

109. This view has support from industry, The CIA thinks the ECA should have full responsibility for all aspects of prioritisation, decision-making and management of the system. Currently this is just at the Registration phase. This would help, it says, to ensure consistency of enforcement and timely decision-making.[155] The British Cement Association agrees, concluding that the lack of a strong central ECA threatens "distortions in the internal market".[156] WWF wishes to see the ECA take on a stronger role in checking the accuracy of Registration dossiers and insisting on a minimum number of Evaluations to be undertaken by Member States.[157]

Structure and administration

110. The structure of the ECA is set out in Article 72. It will comprise:

111. The Government says the Proposals for the ECA have been improved but is considering whether its administration could be further streamlined. One option would be to combine the committees for risk assessment and socio-economic analysis, which would have the benefit of ensuring that issues concerning substitution were not dealt with in isolation. The CBI is concerned about the proposed structure of the ECA, suggesting that there are too many decision-making bodies, which will lead to inefficiencies.[158] We agree with the suggestion that the European Chemicals Agency's committees for risk assessment and socio-economic analysis should be merged. As well as streamlining its work, the move would ensure that these issues are not dealt with in isolation.

112. The Royal Society of Chemistry has concerns about the resources and expertise needed by the ECA. A particular concern is that harmful chemicals could be classified into categories not intended for rapid Evaluation and slip through because the data are not properly scrutinised. The ECA, it says, will need considerable expertise "to counter the ability of registrants to finesse a dossier that could hide issues requiring more careful scrutiny".[159] It had originally been envisaged that the ECA would be based at Ispra in the Italian Lakes, the site of the European Chemicals Bureau and ECVAM. For reasons that seem to be political rather than rational, the ECA went to Helsinki as part of a deal which gave Parma the European Food Safety Authority. We hope that locating the European Chemicals Agency at Helsinki rather than Ispra in Italy with the European Chemicals Bureau and the European Centre for the Validation of Alternative Methods does not affect its access to the necessary chemicals expertise. Without the necessary skills and experience, the EU's new chemical regulation cannot be fully effective. It is also vital that European Chemicals Agency attains the confidence of all stakeholders. To achieve this, it must operate in a transparent fashion and decisions must be consistent.

113. The European Chemicals Agency needs to be a powerful and authoritative body. While much of the Evaluation should be dealt with by Member States to make use of existing expertise and avoid unnecessary bureaucracy, strong direction and oversight will be required from the Agency to ensure that the Evaluation of substances is carried out promptly and rationally by Member States.

154   REACH Proposals, Volume 1, Section 1.9, p 16 Back

155   Ev 67 Back

156   Ev 89 Back

157   Ev 56, 78 Back

158   Ev 95 Back

159   Ev 86 Back

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