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Parliamentary questions
29 May 2017
E-002399/2017
Answer given by Ms Thyssen on behalf of the Commission

Formaldehyde is classified as a carcinogen Category cB according to Regulation (EC) No 1272/2008(1) on classification, labelling and packaging of substances and mixtures. Based on that classification, the substance falls within the scope of Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work(2). Consequently, employers are obliged to protect workers from exposure to this substance in accordance with the provisions laid down in that directive.

With regard to workers' protection, a recent recommendation from the Scientific Committee on Occupational Exposure Limits(3) refers to the following effects that may result from exposure to Formaldehyde:

(a) The potential of the substance to produce respiratory irritation and chemosensory effects, both in humans and animals, and
(b) The local carcinogenicity in studies with experimental animals exposed by inhalation.

Nevertheless, the measures to be taken in accordance with Directive 2004/37/EC are intended precisely to protect workers who may be exposed to that substance, including pathology laboratory workers, from the risks related to such exposure.

The Commission is not intending to ban the use of formalin/formaldehyde, therefore the quality of laboratory activities and medical services should not be affected.

Because the Commission is not intending to ban the use of formalin/formaldehyde, it can also not foresee any exception for the use of formalin in pathologic analysis.

(1)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 (Text with EEA relevance), OJ L 353 31.12.2008, p. 1.
(2)Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work , OJ L 158, 30.4.2004, p.50
(3)SCOEL Recommendation 125 on Formaldehyde, adopted 30 June 2016.

Last updated: 30 May 2017Legal notice