EU Biocidal Products Regulation - A Quick Guide
What is the Biocidal Products Regulation (BPR)?
The EU Biocidal Products Regulation (528/2012) covers any biocide which is marketed in Europe, and is designed to ensure a high level of protection for humans, animals and the environment by ensuring recognised standards are met.
The regulation is particularly important where ozone products are being considered, especially in the current climate for deep cleaning during the Coronavirus (COVID-19) crisis – in that anyone marketing an ozone generator for a biocidal application within the EU must have their product authorised in line with the BPR.
Ozone and the Biocidal Products Regulation
Ozone is an effective natural disinfectant which has been used safely for many years. In addition to disinfecting our drinking water it has been found to be effective in a diverse range of applications from laundry, swimming pools and hydroponics to dentistry, air fumigation and surface disinfection.
All disinfectant products are subject to European regulations. The BPR covers both off-the-shelf disinfectants as well as those which generate chemicals in situ. The regulation exists, in simple terms, to ensure that a product's performance meets recognised standards to prove that the product is safe and that no dangerous contaminants are being produced during its use.
The BPR and EUOTA
The process of validating ozone products for the BPR is both time-consuming and expensive, with potential costs well in excess of £100k for an individual product. Such a steep financial commitment deters many businesses from achieving the necessary standards for legally marketing and supplying ozone products. However, JLA is not only supporting its OTEX range of products but has played an active role in establishing a dedicated 03 trade body, the European Ozone Trade Association (EUOTA) - with leading ozone equipment manufacturers and suppliers collaborating to meet the BPR.
The European Ozone Trade Association (EUOTA) is the trade body set up to collectively deal with regulatory requirements for the ozone industry in Europe and forms one of the two registration groups with a submission to the EU BPR. Further information about EUOTA can be found at www.euota.org where its advisable to check the list of members. If an equipment provider is not on the list, their products are currently not being supported to meet the BPR. It's also important to point out that being a member of EUOTA does not necessarily guarantee participation in the BPR.
Please note, following the exit from the UK’s exit from the EU (1st January 2021) these regulations will be replaced by a similar framework, but will reflect the current EU BPR. The Health & Safety Executive (HSE) will act as the competent authority for Great Britain. Ireland will still be governed by EU BPR.
COVID-19 and ozone products - buyer beware
If you purchase from, or enter into a long-term contract with a company who isn't actively supporting the BPR, you run the risk of owning a product which will essentially be illegal to use in the near future.
The current COVID-19 crisis has led to mass promotion of ozone as a disinfectant, notably including activity from companies who had previously shown no interest or credibility in 03. Many of these companies do not have any supporting data to either demonstrate their efficacy, nor that they actually produce ozone to the levels claimed in their advertising and marketing.
Before buying or leasing ozone equipment, ask your potential supplier:
- Are they aware of the Biocidal Products Regulation?
- Are they a EUOTA Task Force member?
- Can they show you any disinfection efficacy data?
- How long have they been supplying ozone products?
- Does their product have safety features?
- Have they had their own data published?
- Can they claim NHS RRP1 for their ozone product?
JLA's ozone solutions – supported under the EU Biocidal Products Regulation
Our OTEX ozone laundry system was launched back in 2004 and was recognised by the Depaartment of Health/NHS in 2009 under the Rapid Review Panel, receiving a recommendation 1. We then went on to co-develop an airborne ozone room disinfection sanitiser which has been used successfully in a number of healthcare settings.