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What is BPR ?

Biocidal Product Regulation; EU BPR 528/2012

The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product. This regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment.

Within BPR (528/2012), there are 22 product modes, consisted of 4 main groups: disinfectants, preservatives, pest control and other biocidal products.

The text was adopted on 22 May 2012 and applicable from 1 September 2013, with a transitional period for certain provisions. It will repeal the Biocidal Products Directive (Directive 98/8/EC).

All biocidal products require an authorisation before they can be placed on the market, and the active substances contained in that biocidal product must be previously approved.  Products containing new active substances that are still under assessment may also be allowed on the market where a provisional authorisation is granted.

More details please download the official BPR file (PDF)

Which countries are enfored BPR528/2012 ?

All countries of European Union



United Kingdom (Brexit)



California (pending)

Why ozone is regulated by BPR528/2012 ?

The Biocidal Product Regulations (EU) 528/2012 (BPR) containes a range of biocidal products, including disinfectants, pest control products and preservatives. All biocidal products require an authorisation before they enter into market, As an active substance, Ozone falls under the BPR as a disinfectant for human , animals, food and feed areas, as well as drinking water.

Ozone Generator is a DEVICE

The device produces a PRODUCT

The product contains an ACTIVE SUBSTANCE (Biocide) : Ozone

The two Stages of the BPR528/2012

Stage 1 : Ozone Dossier

Details of how it is produced

Physical and Chemical properties

Physical Hazards and Characteristics

Methods of detection and Identification

Effectiveness against target organisms

Intended uses and exposure

Toxicology on humans and animals

Eco toxicological Studies

Environmental fate behaviour

Measures adopted to protect humans animals and the environment

Data related to the chosen Product types 2,4,5,11…..representative products

Stage 2 : Product Dossier

The ozone Dossier Stage 1 is used as a reference document by the regulators to assess the application areas.

PT2 Disinfectants and Algaecides not intended for direct human contact.

PT4 Food and feed areas

PT5 Drinking water

PT11 Preservatives for Liquid cooling and processing systems

Who is doing the evaluation of the dossier?

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

How to get the dossier ?

EuOTA submitted an Ozone Dossier before September 2016

ozone generator manufacturers can only get this dossier through EuOTA before deadline of 2018.January

Does Aquapure get the dossier of BPR528/2012 now ?

Aquapure Europe GmBH as a full member of EuOTA and a co-owner of the European Ozone trade association limited Active substance dossiers for product Types 2,4 and 11 entitled. ozone generated from Oxygen (generated from ambient air, water or pure oxygen not supplied with the intention to generate ozone for a biocidal use)” that has been submitted to the Netherlands Competent Authority (Ctgb) (August2016)

EuOTA : the European Trade Association for ozone generator manufacturers supplying the European Market, and a co-owner of the EuTOA Ozone Dossier.

EuOTA was formed to work under the required regulations of the European Biocidal Products Regulations (BPR) EU 528/2012 BPR

EuOTA official website: www.euota.org/

What will happen if I import ozone products don’t apply and pass dossier of BRP528/2012 ?

If your market is in European Union ,UK, Switzerland, Norway, Australia, Taiwan, California (Pending)

It is illegal to import and sell ozone products without BPR528/2012 by 2019, otherwise will get punished by penalty (This is classified as a criminal offense)

There are so many ozone product manufacturers in China, How can I know if they are applying dossier of BPR528/2012  ?

According to EuOTA’s information,  only 1 Chinese manufacturer has applied for the Dossier from EuOTA . EuOTA has refused more companies to access the Dossier cause deadline was overdue. They have to wait till 2022.

The company who is applying for a Dossier of BPR528/2012 will get a membership certificate issued by EuOTA after payment of the appropriate fee

If you want to get a copy of our membership certificate, please contact info@aquapureasia.com.

For more information please contact us.

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