Regulatory Landscape of Biocides in Europe

30.12.2015
Nolla Antimicrobial’s Nolla™ silver polymer technology has been developed to match the strictest safety and regulatory requirements.

Regulatory affairs of biocides are in transition in Europe. Many biocidal products and active substances will be withdrawn from the market due to concerns over health and environmental issues.

The active substance of Nolla™ silver polymer technology is silver chloride, which is one of the safest options available in the market. Nolla Antimicrobial is committed to offer safe and sustainable biocides that will meet regulatory requirements in Europe and elsewhere now and in the future.

Regulation improves safety

Biocides are substances used to prevent the development of harmful or unwanted micro-organisms like bacteria, molds, viruses, and fungi. Biocides have become a common part of everyday life as they are used in disinfectants and preservatives. Their use is essential for a high standard of health and hygiene.

As biocides are intended to control a wide variety of harmful or unwanted organisms, it is important to ensure their safe use. All biocidal products must be authorized before they can be placed on the market.

In Europe, the authorization procedure is laid down in the Biocidal Products Regulation (EU) No 528/2012 (commonly referred as BPR). This regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment.

The BPR came into force September 2013 and had a transition period until September 2015. The BPR repealed and replaced the Biocidal Products Directive 98/8/EC (commonly referred as BPD), in place since May 2000.

Approval process of active substances

One objective of the BPD/BPR was the evaluation of all existing active substances in the market. The review programme of active substances has been laid down in the European Commission Regulation (EC) No 1451/2007.

There are almost 300 active substances to evaluate. The assessment work proved to be so laborious that the original deadline of 2010 was extended up until December 2024.

Sweden’s competent authority, KEMI, is working on the assessment of silver substances within the review programme.

KEMI is working on the assessment of 8 different silver substances, including silver chloride. It is expected to take several years to complete the evaluation.

Nolla Antimicrobial has notified silver chloride in several product-types that cover all biocidal uses of Nolla technology in Europe. The notification of these product-types means that biocidal products containing Nolla as an active substance can be currently marketed in EU.

Within the next two years, Nolla Antimicrobial will submit the full dossier for the final evaluation and approval of silver chloride by KEMI.

After the approval, Nolla Antimicrobial will appear in the Article 95 list maintained by European Chemical Agency (ECHA).

Product authorization

The product authorization according to BPR can begin only after the active substance is evaluated and its use has been approved. Pursuant to Article 89 of BPR, biocidal products containing non-evaluated active substances may still be placed on the market without authorization until a decision on approval of the active substance has been made.

Once the inclusion decision has been made, the biocidal product is authorized for a specific product-type in which its use is approved. There are 22 product-types including disinfectants, preservatives, pest control and other biocidal products.

Summary

The biocide market is in transition in Europe. The new biocide regulation will increase the safety of biocidal products and the protection of health and the environment.

Nolla Antimicrobial is committed to taking action to guarantee that all our biocide products can be used safely and according to current regulations in Europe.

For more information about regulatory issues, please contact Nolla Antimicrobial.