Complex Legislation - Art. 5 of the Biocidal Products Directive (BPD, 98/8/EC) lays down the procedure for the main authorization and registration of a biocidal product. Art. 16/1 provides that member states who had a system or practice in place for the marketing of biocidal products at the time Directive 98/8/EC came into force can prolong this extra system until the review of the active substances (transition period) has been completed (which was supposed to be 2010 but was prolonged until 2014).

Only a minority of member states have only minor or no real extra regulation besides the one based on the EU regime. Most member states cover the full range of product types as listed in the BPD and others only cover a part or have exceptions in certain product type categories.

A Big Mix

With 27 member states in the EU, most having also different approaches in the several national schemes, this creates a great mix of different, non-harmonized regulations for one and the same purpose. This of course leads to a variety of misunderstandings and marketing problems for companies, and it requires lots of resources from industry as well as from the national competent authority (CAs) in the member states.
The situation has become even more complex since the EU made its first BPD Annex I/IA inclusion decisions and first authorizations according to Art. 3-8 of the BPD have been granted in member states. That's because there is a strong interaction of these decisions with these national - extra - procedures.

It is essential not only for the industry but also for the CAs of other member states to understand and learn from each other in regards to the handling of national product authorizations in the "transition period" between publication of an Annex I decision in the Official Journal of the European Union and the formal inclusion date two years later. They should also take lessons from each other during the transition between Annex I inclusion and the BPD product authorization.

Having currently about 4,000-5,000 entries in the Community Register for Biocidal Products (R4BP) system for product authorizations, registration or mutual recognition under the BPD regime, it is a struggle to find the way through and keep track of the various systems and requirements of the several national procedures in addition.

Authorization Process under the BPD

Primarily, industry needs to understand member states' opinions on any cut-off date for receipt of product applications (for the purposes of evaluation and decision making) under their current national schemes and whether member states will still allow administrative changes to existing products during the BPD evaluation. If this leads to discouragement of applications for authorization under national rules or even to archiving of applications within the system in this transitional period, it would only double efforts on both sides with less or no gain in the field of product safety or time spent.

The Commission has developed a note for guidance that outlines the product authorization process under the BPD. This note sets out guidance on procedures and timescales for action following decisions on Annex I or IA inclusion (or non-inclusion) but unfortunately it doesn't reflect the subject of national authorization in this time period as this is a national task. So there are particular concerns on how industry can or should act under existing national schemes, in advance of the formal Annex I inclusion date for an active substance.

As the main requirements to fully implement the BPD do not really start until an active substance is formally included into Annex I (date of inclusion) of the Directive for potential use for that specific product type, this is the date on which any existing national scheme is in principle superseded by the requirements of the BPD and some implementing legislation in the MS implicitly states this.

The formal Annex I inclusion date (for that specific product type) is also the very last date for the receipt of an application for the BPD authorization of a biocidal product already existing on the national market of the member states.

Up to the date of Annex I inclusion, a CA of a member state could be working on the evaluation of a biocidal product containing the active substance in question (in the same product type for its future Annex I entry) for potential authorization under its existing national scheme.
Given that the evaluation of a biocidal product sometimes takes some considerable time (and that the timescale for evaluation and an authorization decision varies from one member state to another), it is unlikely that any such application would be submitted just on the day before the formal Annex I inclusion.

Staying in the Dark Detrimental to Markets

However one of the main questions is to clarify the interaction with the BPD regime and the "cut off" date for such applications to be submitted and accepted by a CA under its current national authorization schemes. Not speaking of the need of any amendments to the authorizations of existing products during the evaluation period of the BPD product dossier.
Staying in the dark in these issues could lead to "freezing" markets or a "no launch" of new products or even to a lack of substantially needed products.

Therefore the Austrian Ministry of Environment - supported by several other CAs and stakeholders - initiated a two-day symposium systematically focusing on the details of existing national systems or practices in place for marketing biocidal products in certain member states (see infobox). But also the experiences gained and the interaction with the main Authorization/registration procedures according to Art. 3 to 8 of the BPD (98/8/EC) will be a major issue as well as some aspects of letters of access and data protection.

Infobox:
Symposium by the Austrian Ministry of Environment on National Schemes and Practices in place for Biocidal Products
When: May 19-20
Where: Vienna, Hotel Modul

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