Biocidal products are only authorised if they comply with Article 19(1) of the Biocidal Products Regulation, which means that a biocidal product must be effective, must not have any harmful effects on human or animal health, and must not have any unacceptable environmental effects. Nevertheless, in exceptional cases, authorisation may be granted where the unavailability of the product would result in significant disadvantages for society that outweigh the risks associated with its use. In such an instance, authorisation may be granted on the grounds of public interest, in accordance with Article 19(5) of the Biocidal Products Regulation.

In 2023, the Commission determined that a biocidal product family may only include uses that comply with Article 19(1) of the BPR, or uses authorised on the basis of Article 19(5). If, during the assessment, it transpires that a biocidal product family includes both types of use, it must be split.

Following the assessment of PT21 products and other ongoing assessments, the Coordination Group, the Competent Authorities and the Commission have further examined the application of Article 19(5) in relation to mutual recognition. The Coordination Group has also further developed the approach to splitting biocidal product families.

Splitting of biocidal product families

If, following the assessment of a biocidal product family, it transpires that one or more of the uses, products or meta-SPCs do not comply with Article 19(1), these may still be authorised under Article 19(5), subject to certain conditions. This involves each Member State weighing up for itself whether the benefits of combating the ‘pest’ outweigh the risks posed by the biocide.

Applications, products or meta-SPCs authorised under Article 19(5) must be classified within a new biocidal product family. The applicant must submit a new application for this.

In such an instance, the reference Member State may choose how to deal with the assessment reports:

  • A new PAR is drawn up for the applications, products or meta-SPCs authorised under Article 19(5); in this case, the information relating to Article 19(1) must be removed from the PAR.
  • All the information is contained in a single PAR. This PAR is then twice submitted for peer review: once for authorisation under Article 19(1), and once for authorisation under Article 19(5). In the case of a renewal application, the PAR must still be split.

Antifouling products (PT21) – applications with regional scenarios

For antifouling products (PT21), there are eight core scenarios that cover the range of environmental conditions across Europe. It has been agreed that, when assessing an antifouling product, all scenarios must be taken into account, regardless of which Member States are involved. If one or more of those scenarios reveal that an application is not safe, it will be considered to not meet the requirements of Article 19(1) of the BPR. In that case, authorisation will only be possible under Article 19(5).

Authorisation in the refMS required for mutual recognition by the cMS

It is important for the applicant to ascertain, prior to the peer review, whether the conditions for authorisation under Article 19(5) apply in the refMS.  Only if these conditions apply in the Member State may the refMS authorise the biocidal product, and the other Member States concerned may then assess for themselves whether they too wish to make use of Article 19(5) for that application. If the refMS does not grant authorisation pursuant to Article 19(5), the other Member States do not have that option. This is because no reference authorisation would then be established that could be adopted through mutual recognition.

The same applies where, pursuant to Article 37, the refMS deviates from the harmonised assessment and does not permit application on national grounds. In that case, too, there is no reference authorisation that can be mutually recognised by other Member States.

This is described in CG-64_e-c Authorisation of pleasure craft uses in PT21.