Negotiating the biocide regulations

Independent testing of biocide performance offers transparency and reassurance

European Union Regulation No. 528/2012 is set to replace the EU’s current legislation concerning the “making available on the market and use of biocidal products”, reports Lesley Taylor, regulatory & technical manager for Stafford-based Biomaster.

 The new regulation aims to lay down clear, detailed and directly applicable rules for companies dealing with biocides within their products.

Currently there is no universal standard for regulation. Each country therefore employs its own standards and countless businesses are unsure of the correct procedures to follow. The new legislation will attempt to harmonise these matters and enforce legal requirements.

This news does not immediately affect companies dealing with biocidal products, but the new regulations will eventually direct how manufacturers are required to register and sell their products. It is prudent to get ahead by partnering with an expert additive company.

Silver antimicrobial additives are still being reviewed, but initial findings have encouraged additive companies such as Biomaster to complete registration of their biocidal products. Pre-emptive registration will ensure a smoother transition for our customers using biocides in their products.

While the new regulations will standardise the EU’s treatment of biocides within products, the US regime will remain as it is. Only biocides listed under the new regulation will be allowed for sale within the European Union, thus completely removing unregulated biocides from the market.

Within the US the current Treated Article Exemption register will remain in effect. For manufacturers this means that claims can be made in relation to products containing a biocide as long as two conditions are fulfilled. Firstly, that the biocide is registered with the US Environmenal Protection Agency, and secondly that the claims meet certain criteria. Essentially, no health-related claims can be made, only claims regarding the protection of the treated product.

To comply with the new EU regulation, claims regarding treated products will need to be convincingly substantiated, eliminating the over-selling of current products and helping the consumer to understand more clearly what is being bought. One example is antibacterial spray products which eradicate 99.99% of bacteria rather than all of them. It has long been known that total eradication is not possible, though this has never been made clear to the consumer.

Independent testing is a transparent way of ensuring that regulatory requirements are met, and is an important factor when seeking an additive supplier. Biomaster offers testing by an independent laboratory to ISO standards. This can include customer-specific testing – for instance of biocidal efficacy against a specific organism, or of end-of-life performance.

To grow and develop their business within the new regulations, it is crucial that manufacturers choose a suitable additive company well poised to help them navigate the requirements soon to be imposed. With current monetary and time pressures, ensuring that a partner is expert in terms of both the current and impending regulations is imperative if businesses are to survive against tough market competition.

Biomaster can confidently substantiate any claims made by its customers, providing full supporting documentation. We are expert on both European Union regulation and the stricter and more complex US regime – we have registered US offices and a team of US lawyers.

With these combined resources, Biomaster has successfully helped business partners with regulatory issues worldwide.

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