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    BPR

    FAQs

    Biocidal Products Regulation (EU) No 528/2012 related topics

    Why is ozone regulated by Regulation (EU) No 528/2012 ?

    On May 22, 2012 a new text was adopted by the European Parliament and the European Council called the Biocidal Products Regulation (BPR, Regulation (EU) No 528/2012, which repeals and replaces the BPD (Directive 98/8/EC) and henceforth regulate all biocidal products placed on market of the European Union. The BPR introduces new procedures for all EU countries for the authorization of biocidal products. A system of mutual recognition among EU member states is instigated, as is the possibility of Union authorization, the latter giving market access in all member states.
    Modified Date: 15.05.2020

    Who is affected by the new regulation and who needs or can solve this?

    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.
    Modified Date: 15.05.2020

    Can you please advise how the current legislation (BPR Regulation (EU) No 528/2012) affects me or will affect me in the near future?

    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.
    Modified Date: 15.05.2020

    How do we get involved?

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

    How to comply if a ozone system is still in use by a company that no longer exist?

    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.
    Modified Date: 15.05.2020

    What is the role of EurO3zon?

    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’.
    Modified Date: 15.05.2020

    What is the List of approved active substances?

    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.

    Is there an exemption for small quantities of ozone?

    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.
    Modified Date: 15.05.2020

    Can my company join EurO3zon?

    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.
    Modified Date: 15.05.2020

    We are a "foreign" ozone manufacturer which are the steps to comply with Regulation (EU) No 528/2012?

    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.

    We have in our plant Ozone generating equipment installed; Do we need to assure the legal compliance with the Article 95 list of biocidal active substance and product suppliers?

    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.
    Modified Date: 15.05.2020

    Is the equipment (ozone generator) regulated?

    No, the ozone generators themselves are not regulated, but the substances generated with them do (in our case this is "ozone generated from oxygen").
    Modified Date: 15.05.2020

    We feed our ozone generator with industrial oxygen that we buy as a commodity. Can we comply with the BPR?

    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.
    Modified Date: 15.05.2020

    What are the deadlines in the coming into force due to the BPR?

    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.
    Modified Date: 15.05.2020

    COVID-19

    Is ozone effective to kill coronavirus in water?

    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.
    Modified Date: 01.06.2020

    Ozone Active Substance dossier

    General

    When did you file the dossiers for the approval of ozone as active substance?

    The 4 active substance dossiers covering the product types 2, 4, 5 and 11 have been filed on the 5th of June 2015 being valid for 'ozone generated from oxygen'.
    Modified Date: 15.05.2020

    Could you please confirm which Product Types (PT) you are supporting?

    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.
    Modified Date: 15.05.2020

    Who is doing the evaluation of the active substance dossier?

    The active substance dossier is under evaluation by the Competent Authority BAuA, Germany (BAuA Federal Institute for Occupational Safety and Health).
    Modified Date: 15.05.2020

    What is your timetable for the process?

    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.
    Modified Date: 15.05.2020

    What is that letter of intent (LoI)?

    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.
    Modified Date: 15.05.2020

    I have heard it is a disadvantage not to be the owner of an active substance dossier.

    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.
    Modified Date: 15.05.2020

    Letters of Access

    When is the LoA available?

    The LoA is available from now. To date (March 2018) there are eight LoAs sold.
    Modified Date: 30.03.2018

    What is the benefit of a LoA?

    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.

    Do I have to comply with Article 95?

    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.
    Modified Date: 15.05.2020

    Can we access the content of the active substance dossier?

    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.
    Modified Date: 15.05.2020

    For how long is the LoA valid?

    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.
    Modified Date: 15.05.2020

    Are you still offering LoAs to "everyone"?

    Yes, everyone in need can obtain a LoA from EurO3zon.
    Modified Date: 15.05.2020

    What happens after 10 year?

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

    After purchasing your LoA, can we produce and sell right away or need to do extra paper work regarding this new biocidal products regulation?

    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!
    Modified Date: 15.05.2020

    I’m interested in investigating the cost of this LoA

    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.
    Modified Date: 09.04.2019

    Can you please explain the procedure for obtaining a LoA?

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

    Please provide information on the cost for small businesses to obtain 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.
    Modified Date: 15.05.2020

    Ozone Biocidal Product dossier

    General

    When do you plan to file the dossier for the biocidal product ozone?

    This requires at first the approval of the active substance ozone ('ozone generated from oxygen'). This can be as early as end 2021. The ozone AS dossier of EurO3zon is actually in the end-phase of its evaluation by the German Competent Authority, resulting in a draft Competent Authority Report (CAR). Then the dossier of the active substance ozone will go through some further steps coordinated by ECHA and more specific the Biocidal Products Committee (BPC) which will deliver an opinion through a peer review assessment and which will submit its opinion on approval of the substance, after which the substance will be finally considered for approval by the European Commission (https://echa.europa.eu/nl/regulations/biocidal-products-regulation/approval-of-active-substances/existing-active-substance/evaluation-process-for-active-substances-under-the-review-programme). As determined by the BPR the review of the CAR can take 270 days.
    Modified Date: 15.05.2020

    Who is doing the evaluation of the biocidal product ozone?

    The biocidal product dossier of EurO3zon will be evaluated by the Competent Authority BAuA, Germany (BAuA Federal Institute for Occupational Safety and Health).
    Modified Date: 15.05.2020

    What is your timetable for the biocidal product dossier?

    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.
    Modified Date: 15.05.2020

    I want to join the ozone biocidal product dossier but do I still need a letter of access?

    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.
    Modified Date: 15.05.2020

    Efficacy testing

    I have heard that the efficacy of a biocidal product needs to be proven?

    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.
    Modified Date: 15.05.2020

    Associate Membership

    I have read a news flash on the EurO3zon website, in which Associate Membership is announced, what is the benefit?

    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 (BP) authorization. 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 authorization cooperation was available. Among others the biggest benefit of becoming an Associate Member is the ability to join the ozone BP authorization dossier supported by EurO3zon resulting in an obvious saving of time, efforts and budgets. All costs for BP authorization are equally shared between all members of EurO3zon.
    Modified Date: 15.05.2020
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