Marketing authorisations of biocides

The marketing authorisation of a biocidal product is issued only if the active substances forming the product have all been approved for the product type (PT) of interest. Therefore, if the active ingredient has been approved for a PT relative to a different use of the biocidal preparation, it is not possible to request the authorisation of that biocidal product.

All biocides must be authorised before being placed on the market. There are several authorisation procedures depending on the characteristics of the product and the number of countries where it should be marketed.

National authorisation

It can be requested in the event the product is to be marketed in a single EU country. The applicant must submit the request through the R4BP, an information platform created and managed by the European Chemicals Agency (ECHA).

Where an active substance is identified that is a candidate for substitution, the Member State shall carry out a comparative evaluation to determine whether there are other approved biocidal products, or methods of non-chemical control or prevention which have a significantly lower risk for human and animal health and the environment.

In case these exist and are sufficiently effective and have no other significant economic and practical disadvantages and do not alter the probability to cause resistance of the target organism, the use of the new product will be limited or prohibited.

Mutual recognition

This can apply in the event one wish a marketing authorisation of the biocidal product in more EU countries.

There are two types of mutual recognition:

• mutual recognition in sequence: it applies in the case where the biocidal product has already been authorised in one Member State and the holder intends to extend the authorisation in other countries. In this case, the holder must request to those Member States that they recognize the authorisation;
• mutual recognition in parallel: it applies in the cases where the owner wishes to authorise a biocidal product which has not previously been authorised in any other Member State in more Member States. The application, including a list of all the Member States where authorisation has been requested is submitted to the “Reference Member State”.

In both options, applications must be submitted via the R4BP.

Union authorisation

This is a procedure to obtain a single authorisation valid throughout Europe for specific types of biocidal products with similar conditions of use throughout the European Union.

This authorisation provides the same rights and obligations in all Member States, such as those provided by national authorisations.

The Union authorisation may be granted only to biocides with similar conditions of use throughout the European Union, with the exception of those containing active substances that meet the criteria of exclusion and those belonging to PT 14, 15, 17, 20 and 21.

Simplified authorisation

This authorisation is intended to encourage the use of biocides that are less harmful to the environment as well as to human and animal health.

In order to be eligible for the simplified authorisation procedure, biocidal products must comply with the following conditions:

• all the active substances contained in the biocidal product are listed in Annex I of the Biocide Regulation and comply with the specified limits;
• the biocidal product does not contain any potentially dangerous substance;
• the biocidal product does not contain nanomaterials;
• the biocidal product is sufficiently effective;
• the management of the biocidal product and its intended use do not require personal protective equipment.

If all these conditions are met, the applicant must submit a request to the ECHA via the R4BP, indicating the competent authority of the Member State that will assess the application.

Di Renzo Regulatory Affairs has a dedicated unit made up of regulatory experts in the field of biocides and PMCs. We can therefore assist companies in all required activities, including:

• assessment of the preliminary documentation
• preparation of the authorisation dossier
• submission of the biocide authorisation dossier
• assistance during the whole authorisation procedure.