Approach for safety assessment of glass fibre-sizing agents in glass fibre-reinforced plastics for food contact
Following a request from the European Commission, EFSA was asked to review Commission proposals for classification of the substances used as sizing agents and provide an opinion on whether or not the proposed classifications could imply an unacceptable risk to human health. Glass fibre-reinforced plastics are composite materials made of a polymer matrix reinforced with glass fibres. The glass fibres therein are coated with a surface treatment (‘sizing agent’) to hold individual filaments together and to promote adherence to the polymer matrix. Glass fibre-reinforced plastic is covered by Regulation (EU) No 10/2011, which stipulates that substances used for its manufacture should be listed in the Union List. From January 2016, the Plastics Regulation will also apply to glass fibre-sizing agents, and these substances shall be included in the Union List. On the basis of the low migration from glass fibre-reinforced plastics and the low consumer exposure expected, the CEF Panel does not expect any particular health risks from sizing agents compared with other plastics. For substances classed as coupling agents and for the substances considered polymer production aids, aids to polymerisation or solvents used to make plastics, any use of glass fibre-reinforced plastics does not seem to merit deviation from risk management decisions that were taken earlier. For the reactive polymers used for sizing the glass fibres, two possibilities are presented: evaluation of these polymers by EFSA and then specific authorisation via the Union List or regulation through the starting materials, if already listed, in accordance with the derogation in Article 6(3) of Regulation (EU) No 10/2011. In either case, the data required and the risk assessment process used should be the same or equivalent. The difference will be in the data that are presented to EFSA, and this is a decision in the remit of the Commission.