Pharmaceutical Water: Uncertainty caused by the New Biocidal Products Regulation

The new biocidal products regulation came into force on 1st September 2013 in the EU and has brought changes with serious consequences for all facilities operators with in-situ produced biocides. Indeed, in-situ produced biocides now also fall under the scope of this guideline. Particularly concerned are - within the pharmaceutical industry - water systems for which Ozone is used for sanitisation. According to the current wording of the Regulation, a product authorisation will be compulsory for in-situ produced ozone upon expiry of the transitional period (as of September 2017). Beside pharmaceutical systems, swimming pools and also some private households are also concerned since in-situ produced chlorine also falls under scope of the Regulation in addition to ozone. Approximately 1.7 Mio facilities in Europe should be affected. According to the Regulation, they will have to formally apply for a product authorisation as producer of a biocidal product, will undergo the registration procedure, and of course, will have to bear the costs for all of this. Even if one doesn't question the usefulness of those new provisions, why couldn't a authorisation on a facility scale - i.e. an authorisation for the manufacturer of the ozone generators - be considered? However, it also remains unclear how the competent authority - in that case the European Chemicals Agency - will be able to overcome such an avalanche of authorisation applications. A simplified authorisation would also be conceivable - as it is planned for substances named in Annex I of the Regulation. In that case, ozone should be added to the positive list which is currently only for "harmless substances".

To clarify all those uncertainties, stakeholders (like the Aqua Europe and the Ozone Registration Group) have come together to launch a clarification process with the EU Commission. We hope for a positive and meaningful outcome.

More information can be found on the REACH website as well as on the webpage of the European Chemicals Agency.

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