Biocides regulation: application problems for SMEs

Foreward
The Biocidal Products Directive n. 98/8/EC (also known as the BPD) entered into force on 14th May 2000 and was the first EU wide scheme under which biocides (active substances and products) were regulated and assessed for their safety to people, animals and the environment. The BPD introduced for the first time the concept of the mutual recognition of authorisations within the Community. A fundamental aim of the BPD was to establish a positive list of actives substance which may be used in biocidal products. Once a biocidal product was authorized under the Directive in one EU Member State, authorization could then be easely granted in all other Member States.
Since the BPD was written as a ‘Directive’, each EU Member State was then responsible for implementing the BPD into their national law. This caused some discrepancies between Member States within the first year of application.
Annex I of the BPD contained all the biocidal active substances that had been assessed and approved for use in biocidal products. The ultimate target of companies submitting active substance BPD dossiers was to gain ‘Annex I inclusion’.
The biocides review program under the BPD Biocidal active substances which were on the market before the BPD entered into force (14th May 2000) were referred to as “existing active substances”. New biocidal active substances are those which were not on the EU market prior to the 14th May 2000. New active substances need to be assessed and approved before biocidal products containing them can be placed on the EU market. From the date of entry into force, it was optimistically expected that the BPD review program would last for 10 years and that by 2010 all the existing biocidal actives would have been approved. When it became obvious that this was not possible, the deadline was extended to 14th May 2014. Under the BPR, the deadline to approve all actives was then extended even further to 31st December 2024. By the end of 2023 45% of the review program was completed, so it is clear that the deadline of 31st December 2024 will not be achieved. The proposal of the commission is to extend the review program until the 31st December 2030. The delegated act amending BPR has not yet been published. The review program for existing active substances was governed by many additional EU Commission review regulations and guidelines.

The Biocidal Product Regulation (BPR)
In 2012, the long-awaited Biocide Product Regulation (BPR) was, in the end, published as EU n. 528/2012.
The equivalent Annex I under the BPR is referred to as the ‘Union list of approved active substances’ but it’s important not to confuse Annex I of the BPD with Annex I of the BPR. Annex I of the BPR refers to the list of active substances that can be used in products eligible for the ‘simplified authorization procedure’.
Manufactures/importers (suppliers) of biocidal active substances that are not involved in the approval process, must either submit an application for review of a novel active substance or participate in the existing active substance procedure by applying for inclusion on the Art. 95 list. In first case, the biocidal product can only be placed on the market after the Commission decision on the active substance, in the second case, the BPR provides for a transitional arrangement that grants biocidal products marketability at least until the decision on the inclusion of the existing active substance has been taken. After approval of a given active substance at EU level, all biocidal products containing such a substance are subject to authorization. Furthermore, BPR explicitly defines treated articles, “in situ” generated actives setting specific provision for all these. Furthermore, it changed consistently the definition of “product family” which comes from the old “frame formulation“ definition in BPD.
The BPR confirmed that a product authorization can be done by different procedures: first authorization in a selected Member State, mutual recognitions procedure, same biocide approach, family approach and Union Authorization (when multiple national markets are of interest).