The Biocidal Products Directive

08/2008

The Biocidal Products Directive 98/8/EC (BPD) seeks to establish a high level of protection for humans and the environment, and to eliminate barriers to trade by harmonizing the processes involved in placing biocidal products on the European market. But it will also dramatically transform the biocidal industry, since it will have far-reaching effects on those who produce, distribute and use active substances. The BPD describes biocides as chemical preparations containing one or more active substances that are intended to control harmful organisms by either chemical or biological means.

The classification of biocides is broken down into 23 Product Types (i.e. application categories), with several comprising different subgroups. Under the BPD, the system of approval requires two regulatory submissions before a biocidal product can be marketed: the first on the active substances, and the second on the formulated biocidal products. Each requires a dossier per product type that contains information on its biocidal efficacy, toxicological and ecotoxicological properties, etc. .

The First Review Regulation

In this review of existing active substances (i.e. already on the market), applicants must indicate their support for the active substance by submitting marketing data per product type and, in summary form, the data required. After evaluation, authorization for the continuous marketing of the active substance will be granted only in those product types, for which the substance is notified and approved. 

The Second Review Regulation

This second review was established by Commission regulation (EC) 2032/2003. It comprises the list of notified existing active substances and the product types in which they were notified.

The Third Review Regulation

This Regulation has been amended by Commission Regulation (EC) 1048/2005. This so-called Third Review Regulation introduced the following amendments:

  • It extended the 1 September 2006 deadline for certain substances, under the condition that a complete dossier will have been submitted to the competent authorities of a Member State by March 1st, 2006 at the latetst. These substances are  substances that were only identified and notified substances, for product types not notified.
  • It updates among others the list of notified existing active substances and the product types in which they were notified, taking into account all withdrawals and cases where no dossier was submitted.
  • It allocates Rapporteur Member States for the substances of the 3rd and 4th priority lists.

The Biocides Strategy Group

Since the first drafts of the First Review Regulation, Euro Chlor has decided to work on a joint notification of the active substances that would be of interest to its Members. For this purpose, a Biocides Strategy group has been created uniting experts from member companies. This group has been focussing on the different practical aspects and submission requirements. A list of possible substances to notify was drafted and a questionnaire sent to all Members seeking information of the products they want to support under the BPD. Members were asked to detail sales quantities within the European biocides market for each product type.

For certain active substances, the application fields are precisely defined and well understood by the producers. But for other substances, the usage is diverse. Therefore, we have urged our members to seek further clarification from their clients and distributors on the different biocidal product types in which the substances are used. It is important to validate and consider both the scientific justification and economic merits of notifying an active substance.

After having succeeded the notification procedure the names of existing active substances have been published in the Official Journal of the European Communities in the Second Review Regulation on the Annexes I, II, III and V. It has to be emphasized that these Annexes ARE NOT the so-called positive lists! At the next step the full dossier including all test reports should be submitted to the Rapporteur Member State in agreed Data Formats including the risk assessment of the active substance.

The Biocides Strategy group has also finished a first assessment of the available scientific data for the substances that are planned for support. When all information from Euro Chlor members has been collected, more specific task forces will be created for each active substance in order to prepare the actual notification dossier to be submitted for evaluation.

Following steps

At the next step the full dossier including all test reports should be submitted to the Rapporteur Member State in agreed Data Formats including the risk assessment of the active substance.

The Biocides Strategy group has also finished the assessment of the available scientific data for the substances that are supported for an Annex I entry. Specific task forces were created for each active substance in order to prepare the actual technical dossier to be submitted for evaluation to the Italian Competent authorities.  Product types of the 3rd priority list were submitted by the 31st of July 2007 to the Rapporteur Member State. Assessments of two PTs (11 and 12) of the 4th priority list will be submitted by end October 2008.

Italy Rapporteur Member State has carried out a completeness check on the submitted product types and hazard dossier.

At the last step the Rapporteur Member State in co-operation with all other Member States will decide whether the active substance will be entered onto the so-called positive lists (Annexes I, IA and IB of the Directive 98/8/EC).

On the agency website you can follow the annex I entries by clicking on these links:

http://ec.europa.eu/environment/biocides/

http://ec.europa.eu/environment/biocides/annexi_and_ia.htm