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Impact of the Next Phase of the Biocidal Products Regulation (BPR) Explained
With the impending legal requirements about to affect the life science and healthcare sectors, a leading decontamination expert has developed a quick overview to help explain the impact from the next phase of the Biocidal Products Regulation (BPR).
This new white paper written by John Chewins, director of the scientific & regulatory affairs at Bioquell, highlights that the introduction of the second phase of the BPR will mean some biocidal products currently legally placed on the market may no longer be legal.
Manufacturers using hydrogen peroxide in an automated disinfectant system have to submit a technical dossier to a European Competent Authority (CA) by February 2017. This technical dossier is to include evidence for supporting the use, risk, toxicity and efficacy claims and must also indicate the process parameters used to support such claims – including where applicable the application equipment used and contact times. The efficacy data supplied in the technical dossier is to be produced using the standard NF T 72-281 (2014).
This follows on from the first phase of the BPR (1st September 2015), where a biocidal products consisting of or containing a relevant ‘active’, cannot be made available on the EU market, if the active substance supplier is not included on the Article 95 list for the product type(s) to which the product belongs.
Applying to all biocidal products, EU regulation 528/2012 Biocidal Products Regulation (BPR) came into force in September 2013. The regulation is designed to control the selling or ‘placing on the market’ of biocidal products. These are used to protect humans, animals, materials or articles against harmful organisms, like pests or bacteria, by the action of the active substances contained in the biocidal product. This regulation includes details on the analysis of a biocidal product’s performance (efficacy), toxicity, environmental fate and risk during use.
Overall, the goal of the BPR is 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 text was adopted on 22 May 2012 and was applicable from 1st September 2013, repealing the Biocidal Products Directive (Directive 98/8/EC).
Speaking about the new white paper, John said, “Is your supplier placing on the market or sourcing biocidal products where the active substance is listed on the approved Article 95 list of the BPR? Are you ready for the new impact that the latest phase in the BPR will have? I have tried to cover some of the key background and impact that all users of decontamination products and systems should be aware of, especially with the February 2017 deadline on all hydrogen peroxide decontamination systems. I can also confirm that Bioquell already adheres to the stringent NF T 72-281 (2014) standard.”