05.07.23

BPR Compliance: what does it mean for your Hydrogen Peroxide Disinfection System?

EU regulation 528/2012 Biocidal Products Regulation (BPR) applies to all biocidal products. The regulation is designed to control the selling or “placing on the market” of biocidal products and involves the analysis of a products performance (efficacy), toxicity, environmental fate and risk during use. The manner in which a product is intended to be used is an important factor in BPR product assessment and products must be authorised for use in accordance with specific categories called Product Types (PTs). There are 22 different PTs ranging from PT1 “Human hygiene” through to PT22 “Embalming fluids”.

Verordnung Über Biozid Produkte

Ecolab’s Bioquell hydrogen peroxide vapour (HPV) disinfectant – Bioquell HPV-AQ – and associated vaporisation systems have received a Union Authorisation from the European Chemicals Agency (ECHA) approval number EU-0027469-0000, which has been written into European Law under implementing regulation 2022/1226. The authorisation covers the use of the Bioquell technology in PTs 2 (Public Area), 3 (disinfection of animal cages / racks in biomedical and research facilities) and 4 (Food & Feed Areas). Biocidal products must be authorised for use within a specific PT to be marketed and used for that application – for example if a product is authorised solely for use in PT1 (Human Hygiene) applications, it cannot be used as a disinfectant for hospital surfaces, which requires a PT2 authorisation. Users should ensure that a disinfectant product or system is authorised for their specific intended use.

The BPR is a two-step process. Firstly, biocidal active ingredients must be authorised as “Actives”. Hydrogen peroxide was given an authorisation in 2015 for a range of PTs. Once an active has been authorised, manufacturers of biocidal products containing that active are required to submit a technical dossier to a European Competent Authority (CA) by a specified deadline. In the case of hydrogen peroxide this deadline was the 1st February 2017. If a anufacturer of a product did not submit their dossier by the specified deadline, the product is considered an unauthorised biocidal product and it is illegal to use or market that product.

In January 2021, the United Kingdom left the European Union through the Brexit process. The UK Health and Safety Executive (HSE) established the Great Britain Biocidal Products Regulation (GB BPR) based on the EU BPR. Disinfectant products authorised under EU BPR on the UK market prior to the 31st December 2020 retain their UK authorisation as long as the authorisation holder is established in the UK. Disinfectant products produced using EU BPR authorised active substances, on the UK market without EU BPR authorisations, had to submit dossiers to the HSE prior to the 29th June 2021. Failure to submit a dossier meant the disinfectant product had to be removed from the market within 6 months. Ecolab submitted an application for Bioquell HPV-AQ to the HSE on 16th June 2021.

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