The main elements of the proposals below. The letter also enclosed two documents to help provide a broader understanding of the issues: the record of the last meeting of national delegations (the Committee of Experts) (document RD39REC); and the record of the meeting of the ad-hoc group on safety evaluation (RD4-39#REC). This latter group has produced the draft guidelines.
In essence, the Council of Europe's proposals for the safety evaluation of food contact materials and articles are built around a system based on the same criteria and data requirements applied by the European Commission's Scientific Committee on Food. However, there is one significant digression from the Scientific Committee's guidelines in that the Council of Europe has agreed a set limit of exposure of 0.5 micrograms per kilogram of food for substances known to be non-carcinogenic and that do not contain structural alerts indicative of carcinogenicity. The system requires safety assessments that combine toxicological data indicating potential hazard with data on likely human exposure. The human exposure data will continue to use the assumption that a person may consume up to 1 kg of food per day that has been in contact with the material in question. This recognises that other ways of assessing human exposure have yet to be accepted by the Scientific Committee.
The proposal contains a general principle that greater exposure through migration leads to more toxicological information being required. The consequence of this is that the cost of the evaluation of a substance more likely to migrate is greater. Early cost indications are as follows:
The safety evaluation is a precursor to a substance being entered on an agreed list. Only substances actually used in manufacture will be listed and there will be two lists: one of substances approved by the Council of Europe Committee of Experts; the other of substances not yet approved by that Committee. These lists are further elaborated on page 12 of the ad-hoc group's proposals.
Generally, substances can become approved by the submission of an application letter that has to be accompanied by a technical dossier and a separate summary data sheet. The quality of the submissions and the numbers submitted for approval will determine the time taken to gain approval, but early estimations put the time at 6 to 12 months.
The proposals include the establishment of a Safety Evaluation Working Group under the auspices of the Committee of Experts. This Group will be made up of 6 to 10 toxicologists and analysts from member countries nominated by the competent authorities (the Food Standards Agency for the United Kingdom). The Group will be trained to work to the same standards as the European Commission's Scientific Committee on Food. Other national experts may be called upon as required and industry experts may be invited to give limited assistance to the Group. The submission to the Working Group would follow evaluation of the case by a national agency who would complete a summary datasheet.
Confidentiality will be assured and based on agreement if necessary. Priority will be given to the evaluation of potential toxic substances and new substances already used or to be used in food contact materials. To maintain independence of those involved in the evaluation, industry's fees will be paid into a special account of the Council of Europe. The Council would be responsible for payments to evaluators and agencies.
For more information on the Council of Europe's activities in this area, see their web pages at: http://www.coe.fr/soc-sp/sante/contact_eng.htm