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We are your trusted provider of EU biocides registration services, offering expert guidance and support to companies seeking to comply with the EU Biocidal Products Regulation (BPR) (EU) No 528/2012 and register their biocidal products for sale in the European Union.
Rebecca Karjalainen
Customer inquiries
Phone +358 44 974 0601
rebecca.karjalainen@chementors.fi
Finnish | English | French
We are a leading provider of regulatory compliance services for the chemical and biocide industries. Our team of experts has extensive experience in biocides registration, and we specialize in helping companies navigate the complex regulatory landscape in the European Union.
Our team includes highly qualified regulatory professionals with backgrounds in chemistry, toxicology, and regulatory affairs. We deeply understand the EU Biocidal Products Regulation and other relevant regulations.
We strive to provide personalized service and build long-term relationships with our clients. We work closely with you to understand your unique needs and develop customized solutions to ensure a fast and smooth registration process.
Chementors
Our team of Biocide regulatory experts has extensive experience navigating the complex regulatory landscape of the BPR, providing international companies with the guidance and support they need to secure compliance with all relevant regulations.
We help companies collect and submit all the required data for their biocidal product authorization application, including safety, efficacy, and environmental impact data, to make sure a smooth and efficient application process.
We assist with submitting and managing the authorization application, ensuring that you provide all required documentation and that the application process is streamlined and efficient.
We make sure that your company complies with all labeling and reporting requirements under the BPR, including hazard pictograms and adverse incident reporting, to help ensure ongoing compliance with relevant regulations.
We provide ongoing support and guidance throughout the registration process and beyond, helping 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, expert support for your EU biocides registration needs, ensuring that your products meet all necessary regulatory requirements and can be marketed and sold confidently in the European Union.
If you’re ready to start the EU biocides registration process and want to confirm your products comply with all relevant regulations, Chementors is here to help.
Take the first step towards compliance and market success by partnering with Chementors for your EU biocides registration needs!
According to the Regulation biocidal products need authorization. The products can contain only active substances which are either already approved for use or which are under evaluation. Suppliers of the active substances have to be included in Article 95 list the 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.
We offer a large range of biocidal product authorization services to help international manufacturers navigate the complex EU regulatory system. We help you with
“We help your company with the full submission process, making sure your company complies with the strict EU regulations.”
We can help you to register various biocides, including
Our team of experts will work closely with you to make sure your biocide products are classified and registered according to the relevant EU regulations.
We will provide a clear and detailed explanation of the authorization process, data requirements, and other relevant regulations to ensure that you are fully compliant and can confidently sell your products in the EU.
We help manufacturers succeed in the EU market by providing complete biocidal product authorization services.
Customer inquiries
Phone +358 44 974 0601
Address: Chementors Oy, Smart Chemistry Park, Raisionkaari 55, FI-21200, Raisio, Finland
Email: rebecca.karjalainen@chementors.fi
Finnish | English | French
To begin with, all biocidal products need authorization. Companies can apply for authorization after the European Commission has decided to approve the active substance contained in the product.
Registering your biocide in the European Union (EU) is crucial for ensuring compliance with EU regulations designed for local consumers and the environment.
By registering your biocide with the appropriate regulatory authorities, you demonstrate that your product meets the necessary safety and efficacy criteria and that experts in the field approve it.
It gives European consumers and businesses the confidence to trust your products.
Failure to register your biocide can also result in costly fines and legal penalties. It can also forbid you from selling your product within the EU.
By registering your biocide, you make certain that your product complies with strict EU regulations and can access the EU market.
Registering your biocidal product in the EU is a complex process that requires several mandatory steps.
The prospective applicant should remember that preparation of the product 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.
Four authorization options are available: National, Union, Simplified, 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 your market by applying for mutual recognition in other member states. Union authorization gives permission to sell the product in all EU member states.
There is a possibility of a simplified procedure for products that meet certain criteria specified in the regulation.
An application for the same biocidal product authorization is possible for products that are either identical to an already authorized biocidal product or identical to a biocidal product for which an application for authorization has been submitted.
You can apply the 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.
Note 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 costs dramatically for applicants.
We can assist you with all problems and questions regarding Biocidal Product Regulation. Let us help you with active substance or product authorization dossier compilation and submission, Article 95 inclusion application, and consortium management. Our specialists have up-to-date information on the interpretation of the BPR. We can help your company to find the most cost-effective way to achieve compliance.
The regulators want to keep both the consumers and the environment safe.
The EU and/or national authorities will review your application and might request additional information before the final approval. If your product is approved, the sales can begin in the area it was applied for.
Note that the authorization may be subject to certain restrictions, such as limitations on use or labeling requirements.
Once your product is authorized, you or the importer must confirm ongoing compliance with EU regulations, which may involve periodic reporting, monitoring, and testing.
This is what the process looks like:
The first step is determining the kind of biocidal product manufactured or imported and the situation with active substances in the product (Article 95 list approval). Think also about the option to do a product family registration,
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, possibly conducting laboratory tests and field trials to demonstrate the product's effectiveness and safety.
Based on the collected data; we prepare a 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.
We submit the dossier to the relevant regulatory authority in the EU member state where you market the product. The submission will be done by using the R4BP software of ECHA.
The respective regulatory authority will review the dossier and may request additional data or clarification before deciding on the product's safety and efficacy.
If the product is deemed safe and effective, the authorities will permit it to use within the EU or within the applied member state. 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 authorize the product.
Once the product is authorized, the manufacturer or importer must ensure ongoing compliance with EU regulations, which may involve periodic reporting, monitoring, and testing.
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 confirm compliance 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 secure a 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.
Collect and submit required data: 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 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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