Biocidal Product Directive, BPD
The Biocidal Product Directive, (98/8/EC,BPD) was put in place in Europe in May 2000. Part of the implementation is the evaluation of all existing active substances (active substances already on the EU market before May 2000) during a transition period of 10 years. This transition period started in 2000. After evaluation only products which appear in Annex 1 of the BPD will be allowed in biocidal formulations in the European Union. New active substances (active substances not on the EU market before May 2000) do not fall under the transition period but are only allowed when first Annex 1 registered.
A directive and several regulations have been published in the past years. The principles are given in the directive 98/8/EC.
Regulation EC 1896/2000, also called 1st Review Regulation (1st RR), explains the identification and notification procedures.
Regulation EC 1687/2002 gives details on the extension of the notification period for identified substances not notified or not notified for certain application areas.
Regulation EC 2032/2003, also called the 2nd Review Regulation (2nd RR), is giving details on the second phase of the 10-year working program.
The first phase of the process started with an evaluation of all existing active substances by the European Union represented by the ECB (European Chemicals Bureau). The implementation of the 1st RR resulted in an overview of identified and/or notified active substances. At that moment all active substances with biocidal claims were known. The lists with identified and notified active substances are published in the 2nd RR. At the date of first publication of the 2nd RR (November 2003),all active substances not identified and not notified had to withdraw from the market. This resulted in a significant decrease in the number of active substances.
The dossiers for the biocides used by Unico have been submitted for notification by the suppliers and the European Union have accepted all submitted notifications. The notified biocidal active substances are available during the evaluation period for use in limited application areas.
Under the BPD, the application areas are called Product Types (PTíS). The 23 categories are listed in Annex V of the BPD. Unico uses biocides in the product types notified by the suppliers.
If a biocide has been evaluated and placed on Annex 1 or 1A of the BPD, in order for the products containing that biocide to remain on the market, they will require Product Authorisation or Product Registration.
Product Authorisation or Product Registration requires a letter of access to the active substance dossier used for supporting its Annex 1 inclusion. It is possible to provide your own dossier but this must meet the requirements set out in Annex IIB of the BPD.
If the source of the active is changed from that used in the active substance dossier then you must provide evidence to show that the substance being changed to is technically equivalent to that being used.
Claims for microbiological efficacy on biocidal products will require proof. Test results may be in triplicate but this is yet to be confirmed.
As biocides are evaluated the BPD directive will list inclusions of active substances to Annex 1. Product Authorisation should be applied for within 2 years of that active being formally included in Annex 1.