As an operator of an in-situ ozone system you are responsible for your particular activity. This is resulting that you need to demonstrate that you are using an approved active substance (e.g. ozone). At first you need to obtain a so called Letter of Access (LoA). EurO₃zon is offering LoAs for ozone. Subsequently you need to authorize the biocidal product you are producing. The members of EurO₃zon believe that it is in the best interest of downstream users (end-users of ozone equipment) to approach their system manufacturer if they can support the authorization process for ozone.

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Modified Date: 15.05.2020

For legal operation of your ozone generation system you need to seek authorization of your operations under the BPR Regulation (EU) No 528/2012. Please consult your ozone system supplier or national authority for more information.

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Modified Date: 15.05.2020

Please consult EurO₃zon in case your ozone system supplier is not supporting you under the BPR Regulation (EU) No 528/2012.

In case your ozone system manufacturer does not exist anymore (orphaned ozone system) you are required to undertake the product authorization on your own. Prior to the authorization you need to get access to an ozone active substance dossier by purchasing a Letter of Access (LoA). However in such a case you might can easier replace the ozone equipment with a unit that is or will be supported under the BPR. Alternatively, you might contact your national authority to find out if there is someone else taking over this responsibility for you.

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Modified Date: 15.05.2020

EurO₃zon is an international non-profit organization under Belgian law and was established as of May 7, 2015 and has filed Active Substance Dossiers as of June 5, 2015 for the product types 2, 4, 5 and 11. EurO₃zon makes LoAs available to these AS Dossiers and is also offering to participate in its BP authorization dossier for LoA holders via an ‘associate membership’.

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Modified Date: 15.05.2020

This is a list managed by ECHA. The active substance / product-type combinations listed are all those for which an application for approval has been submitted under Directive 98/8/EC or Regulation (EU) No 528/2012, including "existing" active substances included in the Review Programme and "new" active substances. You can find the list here.

No there is not. The BPR applies to everyone producing ozone in the EU for biocidal uses, even if it concerns small quantities. Non-biocidal uses of ozone are principally falling under REACH.

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Modified Date: 15.05.2020

EurO₃zon is offering ‘associate membership’ to LoA holders who are also participating in the product authorization dossier under the BPR. So, the first step in this process remains obtaining an Letter of Access from EurO₃zon. See also the FAQs under the chapter Associate Membership for more details.

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Modified Date: 15.05.2020

You need to have an office or representative in the EU and then you can obtain an LoA from EurO₃zon for the approval of your in-situ generated ozone in the EU.

You can obtain an LoA from EurO₃zon, for supporting a BP dossier but Article 95 compliance prior to authorization is not required for Article 93 products, including ozone.

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Modified Date: 15.05.2020

No, the ozone generators themselves are not regulated, but the substances generated with them do (in our case this is "ozone generated from oxygen").

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Modified Date: 15.05.2020

Yes. Industrial oxygen was not placed on the market by the supplier with the intention that it is used for a biocidal purpose. When you generate the active substance ozone from this oxygen and use it with the intention to have a biocidal effect, then this produced ozone gas can be regarded as the biocidal product, which must be authorized before use. End-users with equipment manufactured by an EurO₃zon-member and used for biocidal applications need not to apply themselves for an authorization under the BPR. More details and also advice for other end-users can be found under the FAQ above “Who is affected by the new regulation and who needs or can solve this?” and under other FAQ’s below.

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Modified Date: 15.05.2020

Firstly, a derogation applies to products and active substances that did not fall under the authorization requirement of Directive 98/8/EC (the Biocidal Products Directive), but are now subject to the Biocidal Products Regulation, such as ozone. This derogation is described in Article 93 of the Regulation. For active substances (AS) and biocidal products (BP) that fall under Article 93 of the Regulation, a substance dossier must have been submitted before 1 September 2016. Secondly, after approval of the AS ozone (expected earliest by 2021) you need to have a LoA giving access to an ozone AS dossier and need to submit an ozone biocidal product authorization dossier, separate or together with EurO₃zon. Without this BP authorization dossier your product can now longer stay on the market.

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Modified Date: 15.05.2020

The coronavirus SARS-CoV-2 causing COVID-19 belongs to the so-called enveloped viruses. As enveloped viruses are surrounded by a lipid host cell membrane, which is not robust, the coronavirus is very likely more sensitive to oxidizing disinfection processes than other viruses such as adenovirus, norovirus, rotavirus and hepatitis A virus. It shall be noted that ozone is the strongest oxidizing active substance used in drinking water treatment, pool water treatment, evaporative cooling systems, and many other kinds of water treatment. In order to proof virucidal efficacy, the European Chemical Agency (ECHA) has defined representative viruses suitable to demonstrate efficacy against all pathogenic viruses. According to ECHA Guidelines a set of indicator viruses including Bacteriophage MS2 has to be used for virucidal efficacy proof of drinking water disinfectants (PT 5) in simulated use tests. As part of the active substance approval EurO₃zon has executed multiple successful tests proofing the excellent activity of ozone against the viruses required by the Guidelines in particular the Bacteriophage MS2. The results of our tests are suited to describe the efficacy of ozone against pathogenic viruses in general. Following the concept of testing with indicator viruses and taking into account the already known properties of coronaviruses, the applicability of our test results to describe the efficacy of ozone in particular against coronavirus SARS-CoV-2 is realistic, although the efficacy of ozone against SARS CoV-2 was not tested yet. The EurO₃zon statement on COVID-19, including references, can also be downloaded here.

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Modified Date: 01.06.2020

Four (4) active substance dossiers were filed 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.

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Modified Date: 15.05.2020

The active substance dossier is under evaluation by the Competent Authority BAuA, Germany (BAuA Federal Institute for Occupational Safety and Health).

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Modified Date: 15.05.2020

The evaluating competent authority BAuA is expected to complete the draft review earliest by mid of 2020. Hereafter the active substance dossier is under discussion at ECHA with all other competent authorities (CA's) in the EU. This part of the evaluation and approval process takes about 1 year, in other words the approval of the active substance ozone could be expected in the best case by end 2021.

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Modified Date: 15.05.2020

The letter of intent is defining your needs for obtaining an LoA. This is a requirement for EurO₃zon to invest time in your case so we can find out in details about your dossier requirements.

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Modified Date: 15.05.2020

Everyone, bringing ozone to the EU market, could until 1 September 2016 submit their own active substance dossiers - a very costly and laborious process - which is since that date no longer possible. By purchasing a LoA to existing active substance dossiers the submission of own active substance dossiers are not needed. Although a LoA does not give you the right for direct access, EurO₃zon makes the non-confidential content of the dossier available by using a so called "Information Corner". Here you or your specialized consultant can access the dossier in person, but cannot make copies. Moreover, we can always support you in creating the authorization dossier for your biocidal products, or even more easy, just join the EurO₃zon biocidal product authorization dossier. In other words, there is no disadvantage at all when you are a LoA holder and not the owner of an active substance dossier.

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Modified Date: 15.05.2020

The LoA is available from now. To date (March 2018) there are eight LoAs sold.

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Modified Date: 30.03.2018

The LoA grants the authority the right to use the information of the active substace dossier for the evaluation of your product dossier. This results in the authorization of your ozone biocidal product.

As ozone is falling under Article 93 you do not need to comply with Article 95 as long you obtain an LoA and submit an ozone BP authorization dossier before approval of the active substance ozone.

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Modified Date: 15.05.2020

You can access the ozone active substance dossier by a so-called information corner. This is a terminal that does not allow making copies, but you can review the non-confidential data of the dossier. Nobody, except the dossier consultants and the authorities, has access to confidential data in the dossier.

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Modified Date: 15.05.2020

All LoAs are valid for 10 years from the approval date of the active substance ozone and must be extended by the authorities thereafter. Hence there is a 10-year validity. The extension of that period, with again 10 years, will be under preparation well in advance prior the due date.

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Modified Date: 15.05.2020

Yes, everyone in need can obtain a LoA from EurO₃zon.

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Modified Date: 15.05.2020

EurO₃zon will resubmit the dossier to ECHA, allowing to extend the approval with 10 years.

The active substance dossier is only one part of the steps to be carried out under the Regulation (EU) No 528/2012. You still need to authorize the ozone produced locally with your in-situ ozone system. This process can be streamlined by participating in a so-called biocidal product or biocidal product family dossier. Such a dossier is already in progress at EurO₃zon since 2019 and will be completed before the approval of ozone by the European Commission. However all LoA owners waive all requirements until that date!

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Modified Date: 15.05.2020

The LoA can be obtained at different cost level depending on your needs. This is starting at 1, 3, 5 and all EU countries. The more countries the LoA needs to cover the higher the costs.

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Modified Date: 09.04.2019

EurO₃zon has prepared a document in the download section for this purpose "Procedure to get a LoA".

The LoA can be obtained at different cost level depending on your needs. This is starting with one (1) country. Alternatively, you can also choose for 3, 5 or all EU countries. The more countries you select the higher the costs.

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Modified Date: 15.05.2020

The biocidal product dossier of EurO₃zon will be evaluated by the Competent Authority BAuA, Germany (BAuA Federal Institute for Occupational Safety and Health).

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Modified Date: 15.05.2020

The biocidal product dossier will be submitted before the approval date of the active substance ‘ozone generated from oxygen’, this can be expected earliest by the end of 2021. Then the evaluation of this dossier by the Competent Authority BAuA can start. The BPR foresees that the whole process from AS approval date till BP authorization date can take 3 years.

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Modified Date: 15.05.2020

Yes, the letter of access (LoA) to the ozone active substance dossier is still needed. The letter is issued by owner of the data (in casu EurO₃zon) and gives the evaluating authority the right to use the study reports of the active substance dossier when evaluating your biocidal products dossier.

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Modified Date: 15.05.2020

Yes, an important part of the biocidal product dossier is the efficacy testing against target organisms. EurO₃zon is actually working with its members on proving ozone’s efficacy against numerous test organisms (including microorganisms such as bacteria, fungi and viruses, but also protozoa, etc.). This work started already in 2019 and is now further completed in cooperation between Founding and Associated Members.

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Modified Date: 15.05.2020