On 15 October 2020, Italian Member of the European Parliament (MEP) Eleonora Evi of the Group of the Greens/European Free Alliance posed a written parliamentary question to the European Commission:
“Formaldehyde has been reclassified since 2016 under Regulation (EU) No 605/2014 as a category 1B carcinogenic substance, with hazard statement H350 and H350i, meaning it can cause cancer, including if inhaled.
In Viadanese in Milan province, where 12 % of Europe’s formaldehyde is produced, epidemiological surveys and health authority reports have found statistically significant excess levels of respiratory, tumour and cardiovascular pathological conditions that can be ascribed to exposure to formaldehyde.
Notwithstanding that it would be better to replace formaldehyde with substances that do not harm human health, while encouraging the development of industrial processes for this purpose, the Commission has chosen to launch the ECHA procedure to restrict the use of formaldehyde and formaldehyde releasers in mixtures and articles for consumer use, in accordance with Annex XV to Regulation (EC) No 1907/2006 (REACH).
Can the Commission therefore say:
How will its decision to launch the REACH Regulation Annex XV procedure ensure that the public’s health, and in particular the health of people residing in the vicinity of the Viadana industrial district, will be properly protected?
In light of the serious effects exposure to this substance has on people’s health, would it not be more appropriate to include formaldehyde in Annex XIV to the REACH Regulation, where substances subject to authorisation on account of being carcinogenic, persistent and bioaccumulative are listed?”
On 1 February 2021, Internal Market Commissioner Thierry Breton responded on behalf of the European Commission stating: “Formaldehyde is not listed in the candidate list of substances of very high concern, a prior step for its eventual inclusion in Annex XIV to the REACH Regulation. The Commission is not aware of any intention of Member States to prepare a dossier for its inclusion into the candidate list, nor does it plan to request such a dossier from the European Chemicals Agency (ECHA).
However, to reduce consumer’s exposure to formaldehyde, the Commission asked ECHA in December 2017 to prepare a restriction dossier on formaldehyde and formaldehyde releasers in articles for consumer use. A restriction will also cover imported articles.
In addition, under the Industrial Emissions Directive (IED), emissions of formaldehyde are addressed in the Commission implementing decisions establishing Best Available Techniques (BAT) conclusions for industry sectors where such emissions are relevant (e.g., production of wood-based panels). The ongoing revision of the IED will examine its interaction with the EU’s Chemicals Strategy for Sustainability, for example, via potentially incorporating a Chemicals Management System into the revised primary legislation and/or relevant sectoral BAT conclusions.
Finally, Directive 2019/983 lays down a binding occupational exposure limit value for formaldehyde. Together with the comprehensive EU occupational safety and health acquis, it aims to improve the protection of workers from the exposure to this substance.”
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