Ozone Regulation in the EU and UK: BPR and REACH Compliance

Ozone as a Regulated Substance

Ozone, like all chemicals, is now regulated across many of its applications in both the European Union and the United Kingdom. Whether used as a biocidal agent or for other industrial purposes, ozone falls under strict legal frameworks to ensure human and environmental safety.

Ozone Under the Biocidal Products Regulation (BPR)

The Biocidal Products Regulation (EU) 528/2012 (BPR) came into effect on 1 September 2013, replacing the Biocidal Products Directive (Directive 98/8/EC). From this date, ozone was officially classified as an "active substance" under the BPR.

Despite the UK's departure from the EU, the core principles of the BPR continue to apply in the UK. The UK has implemented its own version of the BPR, and ozone remains regulated under this framework. Details can be found via the UK HSE website.

Key Regulatory Requirements

To market an ozone generator for biocidal use in the EU or UK, companies must follow a two-step regulatory process:

1. Submission of an active substance dossier

   • For ozone in the EU, this was due by September 2016.

   • In the UK, dossier submission is required by 2025.

2. Product authorisation application

   • After approval of the active substance dossier, a product-specific application must be submitted before marketing the product.

Failure to comply will result in the withdrawal of unregistered products from the market.

Ozone Dossier Submission and Industry Collaboration

To meet these requirements, Ozone Industries Ltd. is a proud member of the European Ozone Trade Association (EuOTA). EuOTA, along with Euro3zon, submitted the ozone dossier within the EU deadline. The EU ozone dossier was officially approved in July 2023, triggering the product application deadline of 1 July 2024.

• After July 1, 2025, only companies that have submitted a product application will be allowed to continue supplying ozone products while assessments are underway.

• Ozone Industries Ltd. is also submitting the dossier to the UK Health and Safety Executive to ensure compliance with UK BPR regulations.

The regulatory process is especially complex for ozone due to its in-situ generation and non-traditional chemical behavior, making compliance both technically and financially demanding. As a result, industry consortiums like EuOTA have been formed to share resources and streamline the approval process.

Ozone for Non-Biocidal Applications – REACH Regulation

For non-biocidal uses of ozone, the appropriate framework is the UK REACH regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals). UK REACH aims to:

• Ensure high-level protection of human health and the environment

• Make manufacturers and importers responsible for chemical safety and risk management

• Promote alternative testing methods such as QSARs and "read-across" approaches

Companies using ozone outside of biocidal contexts must ensure compliance with REACH, which complements BPR in regulating the safe use of chemicals in the UK.

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Complying with ozone regulation under BPR and REACH is essential for any company operating in the UK or EU markets. Whether you're using ozone as a biocide or for industrial applications, understanding your regulatory responsibilities is crucial.