On the 25th of November 2020 the European Commission has approved the active substance-product types (PT’s) combinations Formaldehyde PT2, PT3 and has published the implementing regulation identifying as the approval deadline the 1st of February 2022.

As concluded by ECHA, formaldehyde meets the criteria for classification as Carcinogen Category 1B and as Skin Sensitiser Category 1 in accordance with Annex I to the CLP Regulation (EC) No 1272/2008, therefore formaldehyde meets the conditions laid down in point (a) of Article 10(1) of the CLP Regulation and it should thus be considered a candidate for substitution with the period of approval of three years.

The competent authorities of the Member States should therefore perform a comparative assessment as part of the evaluation of an application for authorisation of a biocidal product containing formaldehyde.

Considering these restrictions there is still enough time to prepare the Biocidal Product dossier for PT2 (Disinfectants and algaecides not intended for direct application to humans or animals) and PT3 (Veterinary hygiene) uses.

TEAM mastery has a broad experience in the biocidal product dossier and it usually takes about 6 months for the definition of the authorization strategy and the preparation of the product dossier.

Should you be interested, you can contact us in the following e-mail address:

stefanotortelli@team-mastery.eu; Stefano Tortelli, Regulatory Affairs Specialist for TEAM mastery biocides division.

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