Marketing authorisation applications for the biocidal products contained in embalming fluids
French decree No. 2021-145 of 10 February 2021 transfers competence from the Ministry of Health to ANSES, as of 1 March 2021, for marketing authorisations for biocidal products (or embalming fluids) used in the preservation of human corpses.
Products used for the preservation of corpses (or embalming fluids) are type 22 biocidal products, governed by Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products. Article 89 of this Regulation allows Member States to continue implementing pre-existing national regulations during the transitional period for the assessment of biocidal active substances.
These national provisions are therefore applied, alongside the provisions of the above-mentioned Regulation, to any embalming fluid in which the biocidal active substance is undergoing assessment.
The notice to producers, distributors, importers and users of products for the preservation of corpses (or embalming fluids) published in the Official Journal of the French Republic No. 0051 of 28 February 2021, sets out the administrative and technical requirements to be satisfied by the entity responsible for placing the biocidal product on the market in compliance with the above-mentioned European and national provisions applicable to biocidal products.
Applications for authorisation should be sent by email to the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) at the following address: firstname.lastname@example.org.
Scientific information can be in French or English. For original documents in languages other than French or English, applicants are required to provide a detailed summary in French and a full translation of the conclusions.