The use of ozone in biocidal products
Ozone generated from oxygen has been approved for use in biocidal products falling within product types 2, 4, 5 and 11.
The use of ozone in biocidal products in categories 2, 4, 5 and 11:
- Category 2: disinfectants and algicides not intended for direct application to humans or animals
- Category 4: products used in the food and feed industry
- Category 5: products intended for the treatment of drinking water
- Category 11: preservatives for cooling and liquid treatment systems
Ozone, a gas composed of three oxygen atoms, is a powerful natural oxidant with the ability to destroy harmful organisms such as bacteria, viruses and yeasts. Its use as a micro-organism control agent offers a number of advantages. Firstly, ozone is generated from atmospheric oxygen by ozone generators, eliminating the need to use potentially harmful chemicals. What's more, ozone rapidly decomposes into oxygen, leaving no toxic residue in the treated environment.
Conditions of approval and monitoring of the use of ozone generated from oxygen
The approval of ozone generated from oxygen is subject to specific conditions set out in the Annex to the Regulation. These conditions include:
- maintenance of a minimum degree of purity for the active substance,
- a required oxygen purity of at least 90% in volume fraction
- a hydrocarbon content reported in methane equivalents not exceeding a volume fraction of 50 ppm.
In addition, particular attention must be paid to the exposures, risks and efficacy associated with the use of biocidal products containing ozone generated from oxygen.
Period of validity of the authorisation to use ozone generated from oxygen
The authorized use of ozone generated from oxygen will be valid from 1 July 2024 to 30 June 2034. During this period, manufacturers and users of biocidal products must comply with the conditions set out in the regulation.
It is important to note that the assessment of any biocidal product containing oxygen-generated ozone should give priority to the assessment of exposures, risks and efficacy associated with specific applications not covered by the EU risk assessment for the active substance. This includes consideration of the impact on professional users and potential secondary exposure of the general public.
EcoMundo supports you every step of the way as you bring your product to market. We guarantee you personalised support that respects your deadlines and confidentiality.
A. Submission of dossiers in accordance with national procedures during the transitional period
Until the date of approval of the active substance "ozone generated from oxygen" (end 2024), companies can register their products during the transitional period.
B. Marketing authorisation
1. Strategic diagnosis and cost assessment
EcoMundo takes stock of your obligations and suggests the best strategies for your products and markets, in order to minimise your costs.
2. Biocidal product risk assessment
- Consideration of competent authority reports on active substances
- Identification of substances of concern
- Exposure modelling
- Risk assessment for human health and the environment
- Follow-up of approval with the Competent Authorities
3. Dossier preparation and submission
EcoMundo accompanies you from the creation to the submission of your dossier:
- Determining the costs applied to the size of your company.
- Drawing up the "data gap" for the toxic and ecotox data to be supplied (read-accross, QSAR, etc.).
- Help with drafting the scientific argument
- Help collect the relevant data: analytical, efficacy, toxicology, eco-toxicology, residue analysis, etc.
- Complete the dossier in IUCLID format and generate the dossier.
- Submit the dossier via R4BP
4. Intermediary role
EcoMundo defends your interests with :
- Competent Authorities, ECHA and BPC (Biocidal Product Committee)
- Working groups and consortia
- Data owners to negotiate the costs of LoAs
- Member States to validate submission authorisation and manage exchanges in the event of requests for additional information.
For more information, please contact Jeanne Pontisso or one of our other experts!