Why choose our Biocide lawyers?
The team provides legal advice on data protection, data sharing, dossier submission and evaluation, regulatory requirements under the Biocidal Products Regulation (BPR) as well as overlap with other legislation, such as the REACH Regulation and legislation on medicinal products, cosmetics or medical devices.
The Biocides team frequently provides expert advice on the national Member State regulations of biocidal active substances/product type combinations during the review programme. Its expertise encompasses all EU Member States. It also helps and provides advice on making biocidal product authorisation applications in the Member States. The team has broad experience in providing expert advice on data sharing/compensation agreements, as such or in the context of distribution/purchasing or other arrangements. It has an in-depth knowledge of the free-rider and EU competition law issues at stake. The Biocides team is also guiding a number of active substance/ product type combinations through the EU review programme for existing active substances, including counselling and representation before the European Commission and ECHA.
The team has also represented clients in numerous litigation proceedings with ECHA, Members States Courts and EU Courts.
- We have several cases pending before the European Courts on complex issues like data sharing, data protection, inclusion on the list of authorised suppliers and competition issues. We represent members of the Alcohol Task Force in these litigations.
- We are actively involved in the establishment and running of several biocidal product consortia for biocidal products containing permethrin, sodium hypochlorite, salt, peracetic acid and hydrogen peroxide. The consortia involve competing companies coming together to share costs in the development of biocidal products dossiers, and membership numbers typically range from 4-35 companies. In drafting the consortium agreement and running the consortia, our team has to pay particular attention to avoid commercially sensitive information exchange, while at the same time addressing the varying perspectives of individual member companies.
- We manage and serve as legal secretary several biocide task forces, among which is the EU Silver Task Force. The silver dossier is commonly known as the most complex dossier in the EU review programme, comprising 8 different silver forms and 13 participating companies.
- Through our legal consultancy, we succeeded in having the European Commission change the dossier submission deadlines for several active substance/ product type combinations in the review programme to the great relief of its clients. One example is the active substance Terbutryn.
- We were involved, with ECHA and the European Commission, in the drafting of guidance documents for SME’s on data sharing, letters of access and consortia formation for product authorisation purposes.