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Biocide product regulations

The Biocidal Product Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which 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.

Ozone, and other in situ generated biocides, now comes under the scope of the BPR. This legislation requires that the active substance (ozone) is authorised which involves the writing of an Active Substance Dossier and the subsequent evaluation of that dossier by the European Chemicals Agency (ECHA) and a Competent Authority (CA), for example the HSE in the UK. On approval of the Active Substance dossier the “products” containing the active substance must be authorised which involves the assessment by EHCA and the CA of specific Product Authorisation dossiers. The Product Dossiers must contain full specific efficacy data for the product/application and full risk assessments.

Arrow Lake AB are members of the European Ozone Trade Association (EuOTA). This organisation was formed with the sole purpose of bringing responsible ozone companies together in order to compile an Active Substance Dossier for ozone. This dossier was validated by the Dutch CA (the Ctgb) in 2017 and is now undergoing a full assessment. Subsequent to this EuOTA will be preparing a series of product dossiers to enable its members to continue to sell compliant products in the future.

To use your ozone system for biocidal purposes in after July1st 2024 you must ensure that the product you use is being put through the BPR authorisation process. Further information can be found at:

Euota: https://www.euota.org
ECHA: https://echa.europa.eu/regulations/biocidal-products-regulation
HSE: http://www.hse.gov.uk/biocides/eu-bpr/in-situ-generation.htm

REACH REGULATION
All chemicals which are used in quantities greater than 1.000 kg per year and that are not Biocides, must comply with the REACH Regulations. EuOTA is assisting its members to comply with this legislation.