Biocides
Biocides are developed and used to deter or eliminate harmful organisms. They have diverse active substances and applications, such as disinfection, preservatives, or pest control.
Active substances and biocide products are strictly regulated by legislators. The EU Biocidal Products Regulation (EU) No 528/2012 requires manufacturers to meet specific criteria for market access: Biocidal active substances must be approved, and biocide products require authorization – this is the core requirement of the Biocidal Products Regulation.
Extensive data requirements and substantial background knowledge must be met solely to include a biocidal active substance in the list of approved substances. Similarly, obtaining authorization for a biocide product under the Biocidal Products Regulation (BPR) necessitates a complex dossier and comprehensive testing.
Our goal is to assist you in ensuring that your product can enter or remain on the market in a cost-optimized manner.
Active Substances
Since September 2015, it has been mandatory for suppliers of active substances or manufacturers of products to be listed on the so-called Article 95 list for biocidal products. This change also affects biocide manufacturers or distributors who registered their biocidal products before September 1, 2015. Ensure now that you have the necessary evidence to comply with Article 95(2) requirements! We are here to advise you.
Approval of a Biocidal Active Substance
Are you seeking to include your biocidal active substance in the list of approved substances? Together, we develop the optimal approach to meet the extensive data requirements.
Product Authorisation
Do you want to bring a biocide product to market with your own data? Together, we develop the optimal approach to obtain your authorization in Europe or individual European Member States.
Options for cost optimization in the authorization of a biocide product
The high requirements and associated costs of biocide product authorization under the BPR can be critical for manufacturers, such as SMEs (small and medium-sized enterprises), in remaining competitive in the market. However, the BPR also offers opportunities for cost optimization and savings in the authorization process of a biocide product. We are happy to research how your product can remain cost-optimized under the BPR while staying competitive in the market.
Transitional Arrangement
Your biocide product’s active substance is not yet approved? Do you want to market your biocide product in certain EU countries already? We are here to assist you in marketing your products in the countries of the EU, EEU, and Switzerland.
Product registration under the transitional arrangement is not uniformly regulated. Requirements vary between countries depending on the active substances and the type of product you intend to market as a biocide.
We conduct research to determine in which countries registration would be beneficial for you and devise a cost-effective strategy. This service is offered in collaboration with partners across various EU member states.
Labelling and Advertising
We are here to assist you in creating labels and verifying the compliance of existing product labels.
Article 69 of the BPR regulates the classification and, importantly, labelling of biocidal products, requiring not only specified information but also labelling according to Regulation (EC) No 1272/2008 (CLP). It is expected that compliance with classification and labelling obligations will be rigorously enforced. Furthermore, the CLP Regulation imposes sanctions for non-compliance with labelling requirements. Depending on the nature or packaging size of your product, compliance with BPR and CLP labelling can pose significant challenges.
Please note: CFCS-Consult GmbH does not create or review safety data sheets. Please consult a specialized service provider.
Advertising for Biocidal Products and Mixtures
Every word matters.
We are ready to advise you on legally compliant advertising and claims for your biocidal products.
Certain terms related to advertising biocidal products have been prohibited by authorities. Seek advice in advance! For example, many biocidal products are advertised using terms like ‚natural‘ or ‚non-toxic,‘ which is not permissible.
Authorities rigorously enforce regulations on advertising and claims. Often, violations of advertising regulations for biocidal products are reported by competitors or result in a costly warning to the manufacturer.
Treated Articles
We are here to assist you in classifying your product and inform you about measures for legally compliant marketing.
Is your product a biocidal product or a treated article under Regulation (EU) No 528/2012? The distinction is often not trivial, and the respective requirements for legal marketing in the EU can differ significantly. Often, a statement from an authority is necessary. Special regulations also apply to the distribution of treated articles within the EU.