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EU biocidal product registration service

We take care of the complete Biocidal Product Registration (BPR) process from scratch or certain parts of it based on your needs.

We handle for example the biocide dossier preparation and biocide product authorization to ensure your biocide regulatory compliance in the EU.

Our biocide consultants make sure that you can focus on your own productive business while leaving all biocidal regulatory compliance matters to us on a turnkey basis.

Rebecca Karjalainen

Customer inquiries
Phone +358 44 974 0601
rebecca.karjalainen@chementors.fi
Finnish | English | French

    EU biocidal product registration service

    Chementors is your trusted provider of EU biocidal product registration services, offering expert guidance and support to companies seeking to comply with the EU Biocidal Products Regulation (BPR) (EU) No 528/2012 by registering their biocidal products for sale in the European Union. 

    Why Register Your Biocides?

    Under EU Biocidal Products Regulation (BPR) No. 528/2012, all biocidal products must have authorization (i.e., registration) before being placed on the EU market. Companies can register their biocidal products after the European Chemicals Agency (ECHA) has approved the biocidal active substance contained in the product.

    In short, in the EU, biocidal product registration is a legal obligation.

    Registering biocides in the European Union (EU) is crucial for ensuring compliance with EU regulations which are designed to protect humans and the environment.

    By registering biocidal products with the appropriate regulatory authorities, companies demonstrate that the product meets the required safety and efficacy criteria and that experts in the field approve it.

    It gives European consumers and businesses the confidence to trust the products.

    Fulfilling the biocidal product registration obligation helps companies rest assured that the product fulfills the EU regulations and can legally access the EU market.

    Failure to register the biocides can result in costly fines and legal penalties, therefore harming the company’s credibility. It also could forbid companies from selling biocidal products in the EU market.

    Why choose Chementors:

    Biocidal regulatory consultants: Our team of biocidal regulatory experts has extensive experience in navigating fulfilling the complex requirements of the BPR Regulation, providing international companies with the guidance and support they need to stay compliant with all relevant regulations.

    Comprehensive data collection, biocides dossier preparation, and submission: We collect and submit all the required data for the biocidal product authorization application, including safety, efficacy, and environmental impact data for a compliant and efficient application process.

    Application submission and management: We submit the authorization application and follow up on the application outcome for prompt actions.

    Labeling and reporting compliance: We handle the labeling and reporting requirements under the BPR, including hazard pictograms and adverse incident reporting, to help maintain compliance with relevant regulations.

    Continuous support: According to regulation, the compliance status of a biocide must be kept at all times. We provide continuous support and guidance during and after the registration process so that companies remain fully compliant with all relevant regulations and achieve continued success in the EU market.

    At Chementors, we are committed to providing you with comprehensive and expert support for your EU biocidal product registration needs, ensuring that the products meet all necessary regulatory requirements and can be marketed and sold legally in the European Union.

    Take the first step towards compliance and market success by partnering

    with Chementors for your EU biocidal product registration needs.

    Our EU Biocide registration services

    According to the Regulation, biocidal products must be registered. The products can contain only biocidal active substances that are either already approved for use or which are under evaluation. Suppliers of the active substances have to be included in the Article 95 List of compliant suppliers.

    Biocidal active substances which are included in the European Commission’s Review Programme can be manufactured and used in biocidal products during their evaluation period according to transitional rules. If the active substance was not included in the Review Programme it has to be approved before using in biocidal products.

     

    Chementors offers a large range of biocidal product authorization services to help international manufacturers fulfill the complex EU regulatory system. We assist companies with

    • Article 95 List compliance
    • new product registrations
    • existing product renewals

    To register the biocidal products:

    • The active substance must be approved
    • The supplier of the active substance must be included in the Article 95 List
    Chementors experts are experienced in handling all requirements regarding the registration of biocidal products including active substance approval and Article 95 inclusion in a compliant and fast procedure.   

    Chementors can handle the registration of different biocidal product types, including

     

    • Disinfectants for home and industrial use, for example
      • Human hygiene products for disinfecting the skin or scalp
      • Veterinary hygiene products such as disinfectants, disinfecting soaps, oral or corporal hygiene products or with anti-microbial function
      • Disinfectants for food and feed areas for humans and animals i.e., disinfection of equipment, containers, consumption utensils, surfaces, or pipework
      • Disinfectants for drinking water for humans and animals
    •  
    • Preservatives for manufactured and natural products, for example
      • Preservatives for products during storage
      • Film preservatives
      • Wood preservatives
      • Fibre, leather, rubber, and polymerized materials preservatives
      • Construction material preservatives
      • Preservatives for liquid-cooling and processing systems
      • Slimicides
      • Working or cutting fluid preservatives
    • Pest control products, for example
      • Rodenticides
      • Avicides
      • Piscicides
      • Molluscicides, vermicides, and products to control other invertebrates
      • Insecticides, acaricides, and products to control other arthropods
      • Repellents and attractants
    • Other specialist biocidal products, for example
      • Antifouling products
      • Embalming and taxidermist fluids

    Our Biocide expert consultants

    Our team of experts will work closely with companies to make sure that the biocidal products are classified and registered according to the relevant EU regulations. A detailed and clear roadmap regarding the process, data requirements, and other relevant regulations will be customized based on each project’s needs and characteristics. 

    Jan Nylund

    COO, Senior Specialist

    Phone +358 40 747 3393
    jan.nylund@chementors.eu
    Finnish | Swedish | English | German

    Mi Nguyen

    REACH & Vietnam chemical regulation Specialist

    Phone +84 39 6169 628
    mi.nguyen@chementors.eu
    English | Vietnamese

    Prasanna Sakha

    Senior Toxicologist, REACH & BPR Specialist

    Phone +358 50 375 88 79
    prasanna.sakha@chementors.fi
    English | Nepalese

    Contact us today to learn more about how we can help you

    navigate the regulatory landscape and register your products.

    Biocidal Product Registration Process In Europe

    Registering biocidal products in the EU is a complex process that requires several mandatory steps.

    The prospective applicant should note that preparation of the biocide dossier takes time, especially if there is a need for new tests or data. The application dossier needs the Letter of Access (LoA) of the active substance.

    4 authorization options are available: 

    • National authorization
    • Union authorization
    • Simplified authorization and 
    • Same biocidal product authorization 

    The national authorization entitles the company to sell the product in the member state where the authorization was granted. 

    You can also extend the market by applying for mutual recognition in other member states. Union authorization permits the sale of the product in all EU member states. 

    There is a possibility for a simplified authorization procedure for products that meet certain criteria specified in the regulation.

    An application for the same biocidal product authorization is possible for products which is either identical to an already authorized biocidal product or identical to a biocidal product for which an application for authorization is ongoing.

    You can apply for authorization for a single product or a product family. If the company’s product portfolio contains many similar products, the family approach can be more cost-effective.

    It should be noted that EU member states can have their own legislation for biocides which is applied during the transitional period.

    It is also possible to apply for the product or product family authorization with other companies as a product consortium. This can decrease registration fees dramatically for the applicant.

    Chementors can assist you with all issues and questions regarding the Biocidal Product Regulation. Let us help you with active substance or biocide authorization dossier preparation and submission, Article 95 List inclusion application, and consortium management. Besides experiences, our specialists keep updated about the interpretation of the BPR Regulation to customize a cost-effective roadmap for each specific project in achieving biocidal regulatory compliance. 

    We handle the full registration process including these mandatory steps:

    • product data collection
    • biocides dossier preparation
    • risk assessment
    • submission of the biocides dossier to the relevant regulatory authorities

    The registration dossier must include detailed information for example 

    • the product’s composition
    • manufacturing process
    • safety
    • and environmental impact

    The EU and/or national authorities will review the application and might request additional information before final approval. Once the application is approved, the sales of the registered product can start in the country where it was applied. 

    Note that the authorization may be subject to certain restrictions, such as limitations on use or labeling requirements. 

    Once the product is authorized, you or the importer must ensure continuous compliance with EU regulations, which may involve periodic reporting, monitoring, and testing.

    Our team of experienced consultants can take care of the registration and other compliance obligations applied to your biocides.

    This is what the process looks like:

    1. Determine the product type and active substance

    The first step is determining the type of biocidal product manufactured or imported and the status of the active substances in the product (Article 95 List approval). Also, consider the option to do a product family registration.

    2. Collect data and conduct testing

    Next, we collect data on the product's composition, manufacturing process, efficacy, safety, and environmental impact. It includes for example buying the Letter of Access of active substance data, and possibly conducting laboratory tests and field trials to demonstrate the product's effectiveness and safety.

    3. Biocides dossier preparation

    Based on the collected data, we prepare a biocides dossier that includes a summary of the product's properties, information on the active substances, details on the product formulation and use, and an assessment of the product's safety and efficacy.


    6. Authorization and conditions

    If the product is deemed safe and effective, the authorities will permit it to be used within the EU or within the member state where the registration application was submitted. However, the approval may be subject to certain conditions or restrictions, such as limitations on use or labeling requirements. European Chemicals Agency (ECHA) and national officials have specific fees for authorizing the product.


    5. Review and evaluation

    The respective regulatory authority will review the dossier and may request additional data or clarification before deciding on the product's safety and efficacy.


    4. Submit the biocides dossier

    We submit the dossier to the relevant regulatory authority in the EU member state where you market the product. The submission will be made by using the R4BP software of ECHA.

    7. Compliance monitoring

    Once the product is authorized, the manufacturer or importer must ensure ongoing compliance with EU regulations, which may involve periodic reporting, monitoring, and testing.

    About Chementors

    We are a leading provider of regulatory compliance services for the chemical and biocide industries. Our team of experts has extensive experience in biocidal product registration, and we specialize in assisting companies with navigating the complex chemical regulatory system in the European Union.

    Our team includes highly qualified regulatory professionals with chemistry, toxicology, and regulatory affairs backgrounds. We deeply understand and have practical experience in the EU Biocidal Products Regulation and other relevant regulations. 

    Chementors strives to provide customized service and build long-term relationships with our clients. We work closely with you to understand the project-specific needs and develop customized solutions for a fast and smooth registration process.

    If you need help with EU biocides registration or any other regulatory compliance issue, contact Chementors to learn more about our services and how our experts can assist you.

    FAQs

    Frequently asked questions

    Biocides are subject to REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation in the European Union (EU). REACH is a regulation that requires companies to register substances produced or imported into the EU in quantities of one tonne or more per year. Biocidal active substances and certain biocidal products fall under the scope of REACH and must be registered accordingly, except for those active substances which are in the Article 95 list and only used in biocidal products.

    The REACH registration process involves submitting a dossier that includes information on the properties, uses hazards, risks of the substance, and guidance on safe handling and use. They use the information to evaluate the substance’s potential risks to human health and the environment and to determine appropriate risk management measures.

    Companies that manufacture or import biocidal active substances or biocidal products into the EU must stay compliant with REACH regulation. Failure to comply with REACH can result in penalties, fines, and even product recalls. Working with experienced regulatory experts is essential to ensure smooth and successful registration.

    Biocidal product regulations are laws and guidelines that regulate the manufacture, marketing, and use of biocidal products within the European Union (EU). Biocidal products are substances or mixtures intended to destroy, deter, render harmless, or control any harmful organism by chemical or biological means. Various industries use these products, including agriculture, healthcare, and consumer products.

    Biocidal product regulations aim to protect both the consumers and the environment by ensuring your products are safe.

    To comply with the BPR (528/2012) you must fully understand the local regulation requirements. 

    This is how you can comply with the BPR

    Determine if your product is biocidal: The first step is to determine if your product falls under the scope of the BPR. Biocidal products control harmful organisms, such as disinfectants, insecticides, and preservatives.

    Determine if your product is authorized: All biocidal products require authorization before being placed on the EU market. If your product still needs approval, you must apply for permission.

    Prepare the biocides dossier: The authorization process requires significant data on the product’s safety, efficacy, and environmental impact. You must collect and submit all the data needed for the application process.

    Comply with labeling requirements: Biocidal products must comply with specific labeling requirements, including product identification, active substance information, and hazard pictograms.

    Comply with data-sharing requirements: If your product contains an active substance already approved for biocidal products, you may be required to share data with other companies seeking approval for products containing the same substance.

    Comply with reporting requirements: You must report any adverse effects or incidents related to your product to the relevant authorities.

    Stay up-to-date with regulatory changes: The BPR is subject to ongoing updates and amendments, so staying informed about changes affecting your product is essential.

    The authorization holder for biocides is usually the manufacturer or the importer of the product. The authorization holder is responsible for ensuring that the biocidal product complies with all EU biocide regulations. 

    The authorization holder must have a legal entity within the EU or have an EU representative.

    Biocides are generally classified under the HS code 3808.

    HS code 3808 includes various products with different purposes.

    The EU Biocidal Products Regulation (EU) No 528/2012 (BPR) is a regulation that sets out the rules for the placing on the market and use of biocidal products in the European Union. The BPR replaced the previous Biocidal Products Directive (BPD) and became fully applicable in September 2013.

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