If your company is located outside the European Union and you wish to market biocidal products in Europe, you will need to appoint an EU Representative who complies with regulatory requirements. ServiREACH offers this Representation service to all companies with sales in the European market.
The commercialization of active substances and biocidal products in Europe is strictly regulated by Regulation (EU) No. 528/2012 (BPR Regulation). This regulation mandates that all active substances and biocidal products must be approved and authorized, respectively, prior to their commercialization in the European Union, ensuring the protection of human, animal, and environmental health.
If your company is based outside the European Union and you wish to export biocides to Europe in compliance with the BPR Regulation, you will need to appoint a legal representative within the European Union (EU Representative) to act on your behalf. This representative is essential for managing the authorization procedures of your biocidal products and will help ensure that the products meet all the regulatory requirements for sale within the EU.
At ServiREACH, we understand the complexity of these regulatory processes and help businesses streamline it. As your EU Representative, we will take care of:
Our experience in the European regulatory landscape allows us to offer a personalized service, tailored to your company’s specific needs. We help you minimize risks and optimize the time-to-market for your products in the European market.
"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."
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Companies located outside the EU cannot register biocides directly. To comply with the BPR Regulation (EU) 528/2012, it is mandatory to appoint a Legal Representative in the European Union to act on your behalf. ServiREACH offers this legal representation service, managing all authorization procedures and ensuring that your biocide products comply with regulatory requirements to be sold legally in the European market.
The Article 95 list includes the suppliers of active substances approved by ECHA. Being on this list is crucial because, according to the regulation, a biocide product cannot be marketed in the EU if the supplier of the active substance is not on it. We are responsible for carrying out the registration of your active substances on this list of authorized suppliers, which validates your supply chain and maximizes your business opportunities against competitors who are not included.
Yes. As your representatives in the EU, we handle the entire cycle: from the preparation and submission of authorization applications to the follow-up with the competent authorities. We prepare all the necessary technical documentation to demonstrate that your products are safe for human, animal, and environmental health, guaranteeing the total compliance required by the regulation.
European bureaucracy can be complex and prone to errors that cause long delays. We offer expert regulatory advice and strategy from the outset. By designing an appropriate strategy before submitting the application, we anticipate possible obstacles and ensure that your biocidal dossier complies with all legal requirements from the start, thus optimizing the time-to-market for your products.
They are two distinct but connected obligations. Active substance registration refers to the approval of the chemical ingredient that performs the biocidal action (and its inclusion in Art. 95). Product authorization refers to the permit to sell the final product (the formulated mixture) that reaches the customer and is used by it. ServiREACH manages both processes: we ensure that your active substance is correctly registered and process the authorization so that the final product can be sold on European shelves.
Contact us today to find out how we can help you comply with the BPR Regulation and ensure your products’ compliance in the European Union.
