RICHARD ELSMORE*, SAMANTHA WRIGHT
*Corresponding author
JSC International Limited, The Exchange, Station Parade, Harrogate, North Yorkshire, HG1 1TS, United Kingdom

Abstract

With the entry into application of the Biocidal Products Regulation (BPR) on 01 September 2013 companies which were previously not involved with supporting active substances they supply now have the opportunity to become engaged in the regulatory process and must do so to remain in the market. This article looks at some of the options open to companies and the benefits and drawbacks of supporting an active substance through the EU biocides system.

INTRODUCTION

Under the Biocidal Products Directive (BPD)(1) companies could legally supply active substances into the EU market without having to be involved in the support of these active substances through the BPD Review programme, as long as another company or group of companies were doing so. These non-involved companies were termed somewhat pejoratively as “free riders” by companies who had invested in the EU review programme by supporting active substances either individually or as part of consortia. Under the BPD it was recognised that following evaluation of the active substance and its inclusion on Annex I of the BPD, any subsequent product authorisations would require formulating companies to seek letters of access (LoA) to the active substance dossier or to submit their own active substance dossier (called a third party dossier) to allow their products to remain on the market. As companies not involved in supporting active substances would not be able to issue these LoAs then this was considered to be the end of the road for any free rider companies.
With the introduction of the new Biocidal Products Regulation (2) companies which ...