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Parliamentary questions
3 February 2011
Answer given by Mr Dalli on behalf of the Commission

1. The classification of formaldehyde by the International Agency for Research on Cancer (IARC) as carcinogen class 1 is related to exposure via inhalation and is therefore not relevant to oral exposure through ingestion of food. The Commission is not planning an assessment of exposure of formaldehyde through food and food contact materials. Formaldehyde is currently authorised as monomer and additive in plastic food contact materials(1) with a specific migration limit of 15 mg/kg food based on the risk assessment by the Scientific Committee on food. Formaldehyde is not authorised as food additive at EU level. Formaldehyde is naturally occurring in some foodstuffs e.g. in certain fruits and vegetables in concentrations between 3-60 mg per kg food. For cosmetics, formaldehyde is currently authorised as a preservative with very low concentration limits and for other purposes than preservation in nail hardeners. The use of formaldehyde is under re-evaluation, in particular to ensure the safety of cosmetic products containing formaldehyde releasing substances.

2. In line with the procedures of Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures(2), the initiative to change the classification of a substance rests with the EU Member States and can start only if a Member State submits a proposal to the European Chemicals Agency (ECHA) to this effect. As set out in the regulation, such dossier will then be discussed by ECHA's Risk Assessment Committee (RAC). RAC has to adopt an opinion within 18 months of receipt of the proposal giving parties concerned the opportunity to comment. Based on the RAC opinion, and where the Commission finds that harmonisation of the classification and labelling of the concerned substance is appropriate, the Commission will, without undue delay, submit a draft decision concerning the inclusion of the substance together with the relevant classification and labelling elements in Annex VI to Regulation (EC) No 1272/2008. France submitted a dossier based on data obtained by the inhalation route to classify formaldehyde as carcinogen Category c (among other hazardous properties) in September 2010 to ECHA. The dossier is under accordance check in ECHA. If the dossier is in accordance then the procedure described above will be followed to update the classification.

3. Harmonised legislation on food additives exists in the EU. Formaldehyde is not authorised as food additive.

(1)Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs, OJ L 220, 15.8.2002.
(2)Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, OJ L 353, 31.12.2008.

OJ C 265 E, 09/09/2011
Last updated: 2 March 2011Legal notice