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). You can write an AS dossier for ozone by yourself or obtain an 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 it is in the best interest of downstream users (end-users of ozone equipment) to approach their system manufacturer if they can help with the approval and subsequent authorization process for ozone.

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 a 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.

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 ECHA for more information.

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

Everyone can write their own active substance dossiers. However this is a very costly and laborious process. It might be easier to obtain a LoA to an existing dossier (e.g. EurO₃zon). In case your are "only" obtaining an LoA you have no direct access. However, EurO₃zon makes available the non-confidential content of the dossier by a so called "Information Corner". Here you can access the dossier in person, but can not make a copy. Moreover we can always support you in creating the biocidal product authorisation dossier for your products.

In case your ozone system manufacturer does not exist anymore you are required to undertake the approval as a substance supplier on your own. 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. You might contact ECHA to find out if there is someone else taking over this responsibility for you.

EurO₃zon is an international non-profit organization under Belgian law and was established as of May 7, 2015 and has filed an Active Substance Dossier as of June 5, 2015. EurO₃zon will make LoAs available to this AS Dossier.

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. Non-biocidal uses of ozone are principally falling under REACH.

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Modified Date: 30.03.2018

No you can not join neither the ORG nor EurO₃zon. This is not necessary as the ozone dossier has already been filed. Therefore a membership does not create any value. However in case you need to get access to the active substance dossiers for ozone, this can be achieve by obtaining an Letter of Access from EurO₃zon.

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

Firstly, a derogation applies to products and active substances that did not fall under the authorisation 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 and biocidal products that fall under Article 93 of the Regulation, a substance dossier have been given derogation until 1 September 2016. Therefore, the requirement for inclusion of these substances and products on the Article 95 list has also been postponed until then. From then on you need to comply with Article 95. Secondly, after approval of the AS ozone (expected after 2018) you need to have a LoA giving access to an ozone AS dossier and to submit an ozone biocidal product authorisation dossier, separate or together with EurO₃zon, without this authorisation dossier your product can now longer stay on the market.

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Modified Date: 30.03.2018

PT 2 Disinfectants and algaecides not intended for direct application to humans or animals, PT 4 Food and feed area, PT 5 Drinking Water, PT 11 Preservatives for liquid- cooling and processing systems.

The dossier is under evaluation by the competent authority BAuA, Germany (BAuA Federal Institute for Occupational Safety and Health).

The evaluating competent authority BAuA is expected to complete the draft review earliest by end of 2018. Hereafter the dossier is under discussion by all other competent authorities (CA's) in the EU, this part of the evaluation and approval process takes about 1 year.

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Modified Date: 30.03.2018

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.

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

The fairness clause will actually make sure that EurO₃zon does not make excessive profit with the LoA. If the value of all ordered LoA before the inclusion of ozone into the EU List of Approved Active Substances is exceeding 2.25 MEUR (total dossier cost actually estimated at 2.25 MEUR), all surplus money will be paid back and thus distributed between all LoA-owners. So the more LoAs are sold above the actually estimated total dossier cost of 2.25 MEUR, the lower the final price will be per sold LoA. In practice this means that you can get a refund from the fee you paid to EurO₃zon towards the LoA. In case you require an LoA for all of Europe this would costs you initially €350,000. However in case the payments from all LoA owners is exceeding the money spend in the registration process by EurO₃zon you will be refunded any surplus amount dived by the number of LoA owners. In an ideal situation this will bring down the costs for each LoA to the minimum. Assume that 100 companies require an LoA, this would result, if obtained before the inclusion of ozone into the EU List of Approved Active Substances, to an amount less than €23,000. EurO₃zon does not seek making profit with LoAs. The main reason is that EurO₃zon is not prepared to pre-finance the LoA price to a theoretical maximum - in such a case the LoA costs would look minute, but the risk is with EurO₃zon.

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Modified Date: 30.03.2018

You can obtain an LoA or write your own AS dossier.

You can access the ozone AS 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 has access to confidential data in the dossier.

The LoA is valid for 10 years and must be revalidated thereafter.

Yes, everyone in need.

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

The 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 a so-called biocidal product family. This will be made available by EurO₃zon after the successful approval of ozone by ECHA. Unfortunately this can not be made earlier due to regulative constraints. However all LoA owners waive all requirements until that date!

The LoA can by obtained at different cost level depending on your needs. This is starting at 1, 3, 5 and all EU countries. The more country the higher the costs. Please also see the fairness clause by EurO₃zon.

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

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

Modified date: 30/03/2018

The LoA can by obtained at different cost level depending on your needs. This is starting at 1, 3, 5 and all EU countries. The more country the higher the costs. Please also see the fairness clause by EurO₃zon.