Commission Implementing Regulation (EU) 2023/1078
of 2 June 2023
approving ozone generated from oxygen as an active substance for use in biocidal products of
product-types 2, 4, 5 and 11 in accordance with Regulation (EU) No 528/2012 of the European
Parliament and of the Council
According to the Draft Commission Implementing Regulation ozone (ozone generated from oxygen) will be approved on 1 July 2024 as an active substance for use in biocidal products of producttypes 2, 4, 5 and 11 in accordance with Regulation EU No 528/2012 of the European Parliament and of the Council.
During the IOA International Conference Ozone and Advanced Oxidation in Toulouse, France, 28-30 Nov. 2022, EurO3zon had the opportunity to give a presentation with the title ‘Bromate in Ozone Treatment - a new avenue’ covering new risk evaluation concepts for Bromate health risks. More information can be read in presentation which is accessible on EurO3zon’s ‘Documents’ webpage.
On 1 December 2021, the Biocidal Products Committee (BPC) adopted the opinions on EurO3zon’s application for approval of the AS ‘ozone generated from oxygen’ for Product Types 2, 4, 5 and 11 by consensus. The four opinions are published on the ECHA website. More information can be read in the article Ozone News Vol 50, No 1, p24-27, which is accessible on EurO3zon’s ‘Documents’ webpage.
EurO3zon UK Ltd has, as a next step, uploaded the original Active Substance dossier of ‘Ozone generated from Oxygen’ (Ozone; CAS 10028-15-6; EC 233-069-2) of EurO3zon ivzw using the secured link provided by HSE. More updates will follow in due time.
EurO3zon UK Ltd has submitted the completed form which is necessary as first step for the resubmission of the pending active substance dossiers for Ozone generated from Oxygen (Ozone; CAS 10028-15-6; EC 233-069-2).
On November 30, 2020, EurO3zon UK Ltd (United Kingdom) has been established by the founding members of EurO3zon ivzw (Belgium) in order to have a UK foothold allowing to be prepared and to avoid any risk of market disruption for ‘Ozone generated from oxygen’ (further called ‘ozone’) as biocide as well as REACH substance after the Brexit.
Indeed on 31 December 2020, the so-called transition period (TP) took an end, requiring companies that operate in the UK market to comply with the new local requirements set by the UK authorities.
So EurO3zon UK Ltd has been established with, among others, the objectives to advise its Members about initiatives to be taken to ensure compliance with relevant legislation in the UK and to assist with authorisations to be obtained on behalf of its Members, which may benefit other companies.
As Northern Ireland (NI) continues following European (chemicals) legislations, such as BPR and REACH, the focus of EurO3zon UK Ltd is on Great Britain (GB), covering England, Scotland and Wales.
Address: EurO3zon UK Ltd, 1 St James Court, Whitefriars, Norwich, Norfolk NR3 1RU, United Kingdom | Mobile: +32475331361 | Telephone: +3215615111 | E-mail (Secr.): email@example.com | Web: www.euro3zon.uk
EurO3zon ivzw has obtained in Switzerland via its consultant PAB Management Services GmbH transitional phase authorisations for ozone. This is required for continuous legal operation of ozone devices under the BPR in Switzerland as long the approval process of the active substance ‘Ozone generated from oxygen’ is not completed. The authorisations cover ozone generated from air, ozone generated from oxygen and ozone generated from water by electrolysis
The draft assessment report (also called Competent Authority Report or CAR) for the active substance ‘Ozone generated from oxygen’ (PT 2, 4, 5 and 11) of EurO3zon passed ECHA’s accordance check. The further treatment of the assessment report of the active substance has now been assigned to ECHA’s Process Flow 39. The deadlines for the further steps of the review process are specified in the ‘Timelines for the peer review of active substance evaluations’, which can be downloaded from the website of the BPC (More information: https://echa.europa.eu/documents/10162/4221979/revised_timeline_as_app_en.pdf/ba57583d-b081-4b6e-8632-3d8a5bfe0028)
On 2 October 2020 EurO3zon has become one of ECHA’s accredited stakeholders. In this role EurO3zon seeks to be further involved in the development of the guidance on in situ generated active substances under the BPR. EurO3zon will participate in bodies and networks such as the Biocidal Products Committee (BPC), Forum for Exchange of Information on Enforcement, and for Updating of guidance documents related to REACH, CLP and Biocides.
The draft Competent Authority Report (CAR) of the active substance dossiers for ‘ozone generated from oxygen’ of EurO3zon has been completed by the German authority BAuA covering the following product types: PT 2 Disinfectants and algaecides (not intended for direct application to humans or animals), PT 4 Food and feed area, PT 5 Drinking Water, and PT 11 Preservatives for liquid- cooling and processing systems. The CAR is forwarded to ECHA for an accordance check.
EurO3zon granted on 8 June 2020 Associate Membership to three LoA holder companies, including Hydro-Elektrik GmbH (Germany), Industrie De Nora SpA (Italy) and Primozone Production AB (Sweden). These companies join forces with the Founding Members of EurO3zon for completing the Biocidal Product Authorisation dossiers that are in progress since early 2019.
On behalf of its members EurO3zon started already early 2019 the work on the ozone Biocidal Product Authorisation dossier. A data gap analysis and testing planning was worked out and a pre-submission meeting with the German Competent Authority (BAuA) was already held on 20 February 2020. EurO3zon is working together with selected partners and research facilities on further efficacy testing, covering all uses and target organisms. The ozone Biocidal Product Authorisation dossier will be completed and submitted to the authorities well ahead the approval of ozone as Active Substance.
On 9 December 2019 the new statutes of EurO3zon were published allowing Associate Membership within EurO3zon, a service that is available for LoA holders to cooperate easily for Biocidal Product Authorisation. Membership is reserved to and limited to entities having legal personality, being producers of devices generating or using Ozone (O3) or having developed methods based on the use of Ozone (O3), and to Research institutes, federations and to individuals having an interest in the ‘in situ’ generation of Ozone (O3). On 20 December 2019 all necessary documentation for Associate Membership and BP authorisation cooperation was available.
In this CA meeting document ‘CA-July19-Doc.4.1’ was approved taking into account the points that were agreed during the meeting. In situ systems are divided over the case-types 1, 2, 3 and 4. For case type 4 (ozone) it was agreed that a single biocidal product authorisation could be granted instead of a Biocidal Product Family (BPF) authorisation because the generated active substance concentration(s) is/are not intended and rather depend(s) on environmental conditions. When applying for single biocidal product authorisation, a concentration range of the active substance can be accepted.
The main topic of this expert meeting was to reflect on the concept for the authorisation of in situ generated Biocidal Products (BP). More specific, the target of the meeting was to solve openstanding discussion points for the four case-types of in situ systems. This was helpful for the endorsement of the document ‘CA-May19-Doc.4.6.a_in situ’ on the 84th Competent Authority of 4 July 2019.
Hofstade, Belgium 19th March 2018 – EurO3zon is driving the regulative requirements for ozone under Biocidal Products Regulation (Regulation (EU) No 528/2012) since 2012. One milestone was the filing of the dossier outlining the characteristics of the active substance “ozone“ on the 27th July in 2015.
The progress and developments of the dossier evaluation can be found on the website of EurO3zon (www.euro3zon.org) as well as on the ECHA website listing the inclusion of ozone in the review process.
Throughout the process the active substance dossier has been renamed by ECHA and is now listed under “Ozone generated from oxygen”.
Links: ECHA Website – “List of active substances and suppliers “https://echa.europa.eu/information-on-chemicals/active-substance-suppliers"
At the August 15, 2017 General Assembly of the IOA in Washington, DC, Mr. Bernhard Paolini was confirmed as IOA President for 2018-2019.
The International Ozone Association (IOA) is a non-profit educational and scientific organization dedicated to the collection and dissemination of information on, and to promote research in, any and all aspects of ozone and related oxygen species technologies
Members coming from science, industries and municipalities
Platform for exchange of knowhow, good practise and the safe use of ozone between the members
Publish the highly scientific and technical journal "Science and Engineering“
Note: Other founding members of EurO3zon are also members of IOA
Following the approval of ozone as an active substance, all ozone applications need to be authorized as “biocidal product”. It is unlikely that (end-)users of ozone equipment will be able to complete the authorization procedure by own means. This is mainly due to detailed specialist know-how being required and the high cost associated with the process. Manufacturers of ozone equipment will have effectively the duty to take care about the authorization process based on the LoA-ownership of an approved active substance dossier. The product authorizations have to start directly after approval of the active substance, which is expected 2017/2018. Based on the detailed know-how gathered in the approval process of the BPR, EurO3zon decided to make a product authorization, which can cover also the biocidal products of EurO3zon LoA-owners and avoiding huge extra-costs for individual product authorizations. Negotiations with the authorities on this subject are in process and ongoing.
In the Competent Authority (CA) meeting of September 2015 in Brussels the Dutch CA offered to develop a guidance document to specify information requirements for in situ generated free radicals for substance approval and for product authorisation in the context of the BPR. EurO3zon was invited to participate in this workshop allowing us to represent the interests of the European ozone industries.
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