In short, the BPR requires manufacturers to demonstrate that their products are safe to use and do what is claimed. When the application is for a Biocide.

A biocidal claim is when you are claiming an effect on any microorganism: bacteria, virus, yeast or meld.

As an in-situ generated substance ozone falls within the scope of the regulation of Biocidal products. Contrary to many marketing promotions Ozone is a chemical and as such is now regulated.

Details can be found at the European Chemicals Agency (ECHA) web site

https://echa.europa.eu/regulations/biocidal-products-regulation/in-situ-generated-active-substances

Most National authority web sites also have details of the regulation. There are also helplines.

There is much confusion over this point as many companies refer to their ozone generator as a product. For the purpose of the BPR, the generator is referred to as the device which produces the product: ozone.

However, the regulation requires a complete description of what is produced ie all the substances which are produced by the device. This is referred to as specificity.

As a manufacturer supplying ozone for Biocidal purposes to the European Union it is compulsory to comply with this regulation. A regulation is a Law. To apply a CE mark to a product you must comply with all regulations associated with that product.

As a supplier, you should check your manufacturer is seeking compliance with the regulation especially if the manufacturer is outside the EU (Liability). It is possible for a supplier to put a product through the BPR.

As a user, you should understand if your product is going through the approval process. The consequence of being in possession of a non approved products is withdrawal from the market.

As a regulation compliance to the regulation is required. Unlike normal CE marking the BPR will provide a registration number that is part of the CE mark. Applying the CE mark with a false registration number is a criminal offence. ie it will no longer be the case that a CE mark can simply be printed.

As a general rule, it is the manufacturer but technically anybody can put a product through the BPR. In most other regulations e.g. REACH it is the user that applies. However, the cost of doing this is so expensive and time-consuming ( with regard to how the BPR has been established) Manufacturers realised they had to take the primary responsibility for obtaining approval.

The BPR has 22 different categories. These are shown on the ECHA web site

https://echa.europa.eu/regulations/biocidal-products-regulation/in-situ-generated-active-substances

Only product types 2,4,5 and 11 have been supported under the BPR. When the BPR was introduced in 2013 a transition period was granted to allow manufacturers time to comply with the regulation. The first part of the transition period was for ozone to be put forward as an Active Substance. As part of that submission details of which product applications were to be covered needed to be submitted.

The consequence of only product groups 2,4 ,5 and 11 being submitted is that it is illegal to supply ozone as a biocide for all other application areas. For example PT1 : on human skin, PT3 for veterinary purposes, PT18 as an insecticide.

Unfortunately, the timeline for the implementation of the BPR (in the context) of ozone is unclear. The issues/complications of an in-situ generation when compared to a conventional liquid chemical evaluation create difficulties for conventional assessment by the authorities. When this is added to a complicated bureaucratic process it becomes difficult to predict the timeline. The dossiers being submitted in time to meet the September 2016 deadline shows how long the process has been to date!

The current scenario (at the time of writing FEB.21) is the Ozone Dossiers are being evaluated by the evaluating competent authorities and reviewed by ECHA. Once this is completed in Summer 2021 the Ozone Dossiers will be reviewed by all the member states of the EU. This process typically takes 1 year. We, therefore, expect the Ozone Dossiers to be approved in Summer 2022.

Once the Ozone dossiers are approved all companies wishing to continue manufacturing ozone generators will be given 18 months to submit their products for approval (end of 2023).

At this deadline date, all manufacturers who have not submitted a product application must stop supply.

This does not mean that those who have submitted a product application are approved. The products that have been submitted are allowed to continue supplying the market up and until a decision (approval or non-approval) is made. This may take a further 2-3 years.

The approval process can therefore be summarised in these steps

1. Ozone Dossier submission (deadline date September 2016)

2. Ozone Dossier assessment and approval (currently taking place)

3. Product application submission (18 months after the Ozone Dossier approval)

4. Product application approval (an unknown period of time after but typically 2 years)

It will become an illegal offence to supply ozone generators that have not been submitted for approval in the EU. There are heavy fines and custodial sentences available to the authorities.

Ozone generators can therefore be sold in the EU for Biocidal purposes provided they fall into categories 2, 4, 5 and 11. Applications outside of these areas are illegal today. Once the product application deadline is reached then those products being used for applications in product groups 2,4,5 and 11 that have not been submitted for approval must cease production.

One area that should not be overlooked is the National Law requirements. The BPR is an EU regulation and once it is fully enforced (at the product application submission deadline) takes precedence over national laws. However, in the meantime, National Laws apply. The circumstances of these National registration requirements vary throughout Europe. In some cases nothing is required in other cases a registration and approval may be required.

The OTF (Ozone Task Force) is a consortium of ozone generator manufacturers seeking to share the costs of complying to the BPR.

EuOTA is a trade association established to help Companies involved in the Ozone market understand the impact of the BPR might have on on their business.

The OTF is a consortium of Companies seeking compliance to the requirements of the BPR. It is a separate entity within EuOTA and an agreement to share costs is in place between those companies to share costs of compliance for the Ozone dossier submission.

A separate agreement covers those Companies who wish to continue working as a consortium for the Product application stage.

Eutoa aisbl was formed as a result of the UK leaving the EU. It is a requirement of the BPR that a representative company based within the EU manages the consortium and its activities relating to the ozone product approval. This need to be in place before the product application submission.

EuOTA aisbl is the EU based representative of the OTF.

To join EuOTA aisbl you need to be either a member of the OTF or have access via a Letter of Access (from the OTF).

There are two options available either Shared ownership (£50k) or a Letter of Access £10k per annum for 10 years)

The BPR does not allow Companies or consortiums to profit from making submissions. However, costs can be recovered. An example of those costs incurred between 2015-2016 can be seen (link to slide showing costs)

EuOTA offers two choices shared ownership or an LOA. Shared ownership provides a company with an intangible asset. In some countries, this provides tax advantages. It is also an asset that can be sold. It, therefore, adds value to a company.

The concept of the LOA £10k pa over 10 years was conceived to help smaller companies overcome the considerable costs of compliance.

An LOA holder is treated equally as a Shared ownership owner within the EuOTA consortium. (within certain boundaries).

As the Ozone Dossier is approved by all member states it covers all EU countries. The EuOTA shared ownership / LOA offer, therefore, covers all European countries.

The regulation states that products not submitted for approval need to be ‘removed from the market’.

Normally this would involve the production of the chemical and subsequent distribution to be phased out over a period of time 6-12 months. As this does not apply to in-situ generators it is unclear how and by who this process will be dealt with in regards to in-situ generation.

For the Ozone Dossier submission details of the properties of Ozone are submitted. There are some 50 end-points covering the effects of ozone on areas such as Human toxicity, environment considerations, effectiveness against target organisms, labelling etc. A representative product is submitted for each of the application areas 2,4 5 and 11. No product is approved at this stage. The ozone dossier is therefore the ‘instruction manual’ that allows the regulators to reference technical points that are specific to an application.

At the product application submission, the detail becomes much more specific. The regulators use those sections of the ozone dossier they deem relevant to an application. The hazards and efficacy data are completely different for an Ozone air application compared to an Ozone water application.

There are approx. 40 members of the OTF. It is this number of participants that makes the OTF membership ‘relatively’ so inexpensive. As the product application is more sensitive in its detail it was understood not all companies would want to share information and costs.

A break was therefore created in the BPR to allow companies to consider which was the best way forward for themselves.

The product consortium agreement currently has 30 participants (FEB21).

To join the product application Consortium you need to have access to an Ozone dossier via either shared ownership or a LOA.

This is not a straightforward answer as the rules are changing all the time. There are a number of different options available. Which is the most economic varies according to the business activity of each individual company.

You will need to demonstrate your products are safe to use and efficacious in the eyes of the regulators to obtain approval. This is not the same as what you might think is the case. The process of obtaining approval is not without risk!