The coronavirus (COVID-19) pandemic has increased the need for access to disinfectant products for healthcare professionals and EU citizens. To increase the manufacture and supply of these products, the European Chemicals Agency (ECHA) and the European Commission are supporting EU Member States and the UK Health and Safety Executive (HSE) to apply derogations from the normal authorisation requirements of biocidal products in product-type (PT) 11, PT 22 and PT 43.
Companies that wish to place biocidal products on the market that contain already-approved active substances should apply for an emergency permit from a relevant national authority using the ‘derogation from the requirements’ system under Article 55 of the European Biocidal Products Regulation (BPR). The conditions of an emergency permit vary depending on the Member State. These include providing derogations for pharmacies or companies producing disinfectants, product-specific derogations and general derogations for products that meet nationally agreed requirements.
For companies already having a product that is authorised under the BPR, but require additional sources for their active substance, there is the option of applying to the ECHA for a technical equivalence decision for the new source. There are accelerated procedures in place for propan-1-ol and propan-2-ol that have been selected by Member States for emergency permits as they are approved active substances for PT1, PT2 and PT4.
Some Member States stated that the Article 95 requirements of the BPR are not applicable to disinfectants at this time and ECHA has since accelerated the evaluation procedure for Article 95 applications for disinfectants.
NCEC is closely tracking developments in relation to Article 55 of the BPR. Should you require advice on your options with regards to placing disinfectants on the market in response to COVID-19 or for any other regulatory query, please contact us.
1PT1 – products in this group are biocidal products used for human hygiene purposes, applied on or in contact with human skin or scalps
2PT2 – products in this group are disinfectants and algaecides not intended for direct application to humans or animals
3PT4 – products in this group are used for disinfecting equipment and containers associated with the production, transportation, storage or consumption of food or feed