We are pleased to announce that KAELTIA has developed an IT System, called KBC (KAELTIA Biocide Consortium) that facilitates manufacturers/formulators/distributors of biocidal products to work together and to cooperate in the preparation of EU authorisation dossiers under the Regulation 528/2012.
We invite you to visit KBC website http://consortium.kaeltia.com/ and to check teh User Guide of this System.
For the purposes of the EU registration of biocidal products under the BPR and in order to facilitate manufacturers, formulators and distributors to work together and to cooperate in the preparation of biocidal dossiers for authorisation, KAELTIA has developed the KBC System for cooperation where the parties can express their interest to achieve an agreement to support jointly their products by establishing a voluntary agreement.
The new concepts under BPR such as “biocidal product family” and “same biocidal product” have been developed to facilitate the process of applying for product authorisations for companies such as SMEs and to reduce cost and administration issues for both applicants and regulators. Therefore, if you have biocidal products in the EU market that you want to support under the BPR, please express your interest for cooperation by listing these products in this IT System.
The use of this IT System is free of charge.
KAELTIA will be in charge of the formation of each potential “Registration Group” and will communicate to the parties interested for cooperation that a potential “Registration Group” has been formed. This service is subject to an initial fee that will be deducted from the final cost of the EU registration dossier/s that will be managed by KAELTIA.
This process is structured in 5 phases as follows:
- Phase 1: User Registration on the IT System, where a Service Provider/Confidentiality Agreement will be signed before entering any product/s data into the system and where each user will be assigned with a confidential user name and password.
- Phase 2: Creating the list of products of interest to each user. In this phase, each user must provide the relevant information for each biocidal product.
- Phase 3: “Registration Group” Formation. Once a “Registration Group” is formed, KÆLTIA will inform all group members. If members agree to cooperate together, a voluntary agreement between the parties will be signed.
- Phase 4: Registration Strategy Design. KÆLTIA will design the EU registration strategy based on the information provided by each member of the “Registration Group” about their products and will discuss the strategy with the Group.
- Phase 5: Preparation, submission and follow-up of European registration dossier/s. Once the registration strategy is agreed within the “Registration Group”, KÆLTIA will prepare the European registration dossier/s for their submission to the relevant Member States of the EU.
Please be aware that all the information provided in this IT System will be managed by KAELTIA and treated as strictly confidential and that the members of each “Registration Group” will not be publicly available in this IT System as it is considered confidential.