As we informed you earlier this year, Regulation 528/2012 on the making available on the market and use of biocidal products (hereinafter ‘Biocidal Products Regulation') defines the concept of 'biocidal product' broadly. This broad definition, supported by the Court of Justice of the European Union, has important implications, as only duly registered or authorised biocidal products can be made available on the market and used (article 17 of the Biocidal Products Regulation).
On 23 March 2020, the Belgian competent authorities have decided to proceed with the grant of temporary authorisations for certain biocidal product types, hence applying article 55 (1), first paragraph of the Biocidal Products Regulation:
"By way of derogation from Articles 17 and 19, a competent authority may permit, for a period not exceeding 180 days, the making available on the market or use of a biocidal product which does not fulfil the conditions for authorisation laid down in this Regulation, for a limited and controlled use under the supervision of the competent authority, if such a measure is necessary because of a danger to public health, animal health or the environment which cannot be contained by other means."
Only products used for human hygiene purposes, especially hydroalcoholic gels or solutions (product type 1 of Annex V to the Biocidal Products Regulation) or products used for the disinfection of surfaces (product type 2 of the same annex) are eligible for temporary authorisation. Such temporary authorisation is:
- valid for 180 days (which can be extended);
- free of charge; and
- can be requested via email (‘email@example.com’). This email must include certain information, e.g. the complete composition of the product, a draft label of the product and the safty data sheet of the product.
In addition, both public and hospital chemists are granted an exceptional and temporary (six months) authorisation for the production of their own hydroalcoholic solutions (alcohol-based hand sanitisers), which qualify as biocidal products in the sense of the Biocidal Products Regulation, given the difficulties that pharmacies are currently facing with obtaining such hydroalcoholic solutions.
The temporary authorisation procedure for certain biocidal products that can be of use in the current coronacrisis significantly facilitates and speeds up the regular authorisation or registration procedure.
We support that Belgian authorities were alert and decided to proceed with the grant of these temporary authorisations, hence applying article 55 (1), first paragraph of the Biocidal Products Regulation, to help tackle the current crisis. Unusual times call for unusual measures.
Do not hesistate to reach out to any of our contact persons below should you have any questions or need help regarding these temporary authorisations.