COO, Senior Specialist
Phone +358 10 504 5861
jan.nylund@chementors.eu
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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.
