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 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 a single EU-wide approval, which will be in force immediately in all member states.
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.
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.
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 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.
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.
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.
Biocidal Product Regulation related topics (EU 528/2012)
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.
Modified Date: 30.03.2018
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 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!
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