The BPR Regulation (EU Regulation 528/2012 on biocidal products), which entered into force on 1 September 2013 repealing Directive 98/8/EC, regulates the placing on the market and use of biocidal products and ensures a high level of protection for human health and the environment.
In order to place a biocidal product on the market under the BPR Regulation, it must be authorised in each of the Member States where it is to be placed on the market (national authorisation) or throughout the European Union (EU authorisation).
Active substances must be approved before a biocidal product containing them is authorised. To this end, a review programme for active substances has been set up and is being evaluated by the Member States before they are approved by the European Commission and included in the List of Approved Active Substances.
However, active substances included in the review programme and biocidal products containing them may be placed on the market pending a final decision on approval if they have the relevant permits to be placed on the market in accordance with the regulations applicable in each country of the European Union.
Within the chemical sector, different solutions have been proposed to address the application for authorisation in the most affordable way. One of the most attractive options is the creation of consortia, in which the companies jointly prepare the documentation and share the testing costs, substantially reducing the economic outlay involved in submitting an application for individual authorisation.
ServiREACH offers you the necessary support to comply with the regulations applicable to the marketing of biocidal products in all the member states of the European Union.
"ServiREACH has always provided us with fast and professional solutions."
The active substance is the chemical ingredient that acts against harmful organisms, while the biocidal product is the final formulation sold to the user. According to Regulation (EU) 528/2012 (BPR), active substances must first be approved by the European Commission. Only once the active substance has been approved can the biocidal product containing it be authorized. ServiREACH helps you in both stages: from the inclusion of substances on the approved list to the application for authorization of your final product for its commercialization.
Yes, it is possible under certain conditions. Si tu producto contiene sustancias activas que aún están siendo evaluadas en el “Programa de Revisión”, puedes comercializarlo cumpliendo con las national transitional regulations de cada país (en España, por ejemplo, el registro según el Real Decreto 3349/1983 ante el Ministerio de Sanidad). We manage these transitional procedures (“Applicable legislation before approval”) so that you can sell your product without waiting years for final approval of the active substance at the European level or for the granting of the BPR dossier.
It depends on the strategy we choose at the BPR level (if the active substance is already approved). There are several routes:
At ServiREACH, we analyze your target market and define the most efficient strategy, managing the documentation for the route that best suits your commercial expansion.
Yes, one of the most effective options is participation in Consortia.. This allows several companies interested in the same type of biocide to join together to share the high costs of the tests and the preparation of the technical documentation. ServiREACH advises you on the possibility of joining existing consortia or helps you manage this collaboration, substantially reducing your regulatory investment.
The risk is withdrawal from the market and severe penalties. To avoid this, we offer a service of Compliance Study service. We evaluate each of your biocidal products against the current regulation, verify if their active substances are approved or under review for the correct use (Product Type), and propose a list of corrective actionslista de acciones correctivas immediate. This ensures that your catalog remains legal and operational in the market without interruption.
If you place biocidal products into the EU market we can help you to comply with the applicable regulations. Interested?
