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."
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The active substance is the chemical ingredient that exerts the action against harmful organisms, while the biocidal product is the final formulation that is 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 is 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. If your product contains active substances that are still being evaluated in the “Review Programme,” you can market it by complying with the national transitional regulations of each country (in Spain, for example, that may be a registration according to Royal Decree 3349/1983 before the Ministry of Health or a different kind of procedure). We handle these transitional procedures (“Applicable legislation before approval”) so you can sell your product without waiting years for the definitive approval of the active substance at the European level or 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 market withdrawal and severe sanctions. To avoid this, we offer a 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 immediately. This way, we ensure that your product portfolio remains compliant and available in the market uninterruptedly.
If you place biocidal products into the EU market we can help you to comply with the applicable regulations. Interested?
