National Authorisation

In order to make a biocidal product available on the market in an EU Member State, the product must be authorised. The most common way in which an authorisation will be granted is by applying to a Member State Competent Authority for a National authorisation, in a process carried forward from the Biocidal Products Directive.

If a product has already been authorised by a Member State, or an application is in the process of being evaluated, then applications for a National authorisation in another Member State will not be accepted. Where an organisation wishes to make a biocidal product available on the market in multiple Member States they need to use the process of ‘mutual recognition’ to validate a National authorisation in other Member States. Applications for mutual recognition of an authorisation in other Member States may be made at the time of applying for a national authorisation, or subsequent to the authorisation being granted. For certain products, it may also be possible to apply to ECHA for a Union authorisation.

If the application for authorisation is for a biocidal product containing an active substance which is a candidate for substitution, then the Competent Authority of the Member State in which authorisation is sought will undertake a comparative assessment of other authorised products. If this assessment identifies other products which may be used in the specified application, which present a lower risk to health or the environment, the application for authorisation may not be approved. Such a comparative assessment will be conducted at each renewal of an authorisation as well.

You can call our Helpdesk number on +44 (0) 20 7901 1444. Or e-mail us on enquiries@reachready.co.uk.