We assess the regulatory path for your biocidal product, prepare authorisation applications, analyse costs and address compliance gaps to operate in the European market.
Regulation (EU) No 528/2012 (BPR) governs the placing on the market and use of biocidal products. It requires that both the active substance and the final product are properly authorised before being marketed in the European Union.
We assess the impact of the BPR, define the most appropriate regulatory pathway for your case, and prepare a complete authorisation strategy and execution.
We manage your inclusion in Article 95, support LoA (Letter of Access) acquisition,
and prepare all required documentation and lab assays.
We review your substances and product types to identify risks of penalties or market withdrawal.
Strategy to market products before the final approval of the active substance under BPR
Cost assessment and financial feasibility analysis of the authorisation project.
We audit your products on the market to prevent risks of withdrawal or official penalties.
Assessment of the regulatory strategy for your case.
Detailed breakdown of stages, deliverables and timelines.
Transparent commercial conditions.
We work with clearly defined phases, deliverables and priorities from the outset.
"Working with ServiREACH, we’ve found the solutions that best suited our needs, and they have always provided the trust, rigor, and reliability you look for in a consultant."
"Trust and satisfaction are the words that define our experience with ServiReach. A young, dynamic, and professional company, adapted to the present times where a service provider must become a true partner, aligning with the client’s real needs."
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. 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.
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