Biocides Regulation

 

RegisGate: Your partner for bringing
your biocidal products to market

 

Biocide use in Europe is regulated by the EU Biocidal Products Regulation (the BPR or Regulation (EU) No 528/2012) which came into effect on September 1, 2013.
 
The BPR lays down rules for:

Article 95 ‘Transitional measures concerning access to the active substance dossier’ of the Biocidal Products Regulation (EU) No 528/2012 (BPR)


The objective of Article 95 is to ensure that substance manufacturers or importers that are not actively involved in the review program for existing active substances but are benefiting from it (these companies are known as ‘alternative suppliers’) will share the costs of the approval process. These alternative suppliers will have a chance to purchase access to the data generated by the main notifier(s) of an active substance.


According to the BPR, biocidal products cannot be made available on the EU market if the supplier is not on the approved list of suppliers (known as the Article 95 list). This list is maintained by the European Chemicals Agency (ECHA) and is updated frequently. Entry onto the list will be automatic for those companies that are supporting active substances through the review programme but alternative suppliers have to submit an Article 95 application.

 

 

Other relevant legislation, such as the General Product Safety Directive (2001/95/EC), ‘REACH’ and ‘CLP’ also play an important role in the legislation of Biocides. In addition to EU Regulations and Directives, other specific national, or Member State, implementing regulations should also be taken into consideration.

 

Post-approval obligations are also regulated by the BPR, for example, the claims made in advertisements, record keeping, the level of the annual fees levied by Member States (known as the General Industry Charge) and what information should be provided to local National Poisons Information Services.

 

 

RegisGate is experienced in submitting applications under the BPR and able to support you in gaining authorisation of your biocidal products in Europe. RegisGate is a partnership of 4 companies all of whom have considerable experience in submitting applications under the BPR.


The four partners that make up RegisGate are…

 

 

This combined expertise allows RegisGate partners to provide you with a complete support package for authorisation of your biocidal products in Europe

 

RegisGate provides you with an “all-inclusive” service comprising:

 

 

Experts in comprehensive data preparation

Our capabilities and experienced consultants will add value during the dossier compilation process and at pre- submission meetings with the Authorities. We can draw on our in-depth experience derived from previous projects for the successful approval of active substances and biocidal products; e.g. in the area of disinfectants, pest control products and in situ-generated active substances.

RegisGate provides: 

We can advise you on specific information requirements and on the most suitable testing strategy as well as information gathering concerning the specific active substance properties and product type combination to develop waiving strategies. Other areas of expertise include Summary of Product Characteristics (SPC), Technical Equivalence (TE) and Chemical Similarity (CS) and Complete Technical IUCLID 6 dossier work, including preparation of comprehensive study summaries and details of product characteristics, risk assessment and testing justifications.