Tuesday 18 October 2016

More flexibility for authorisation of biocidal products

News on the regulation of biocides in Europe:


The regulation on the authorisation of same biocidal products has been updated to add new possibilities requested by industry. Companies are now able to get a national authorisation when a Union authorisation application exists for an identical product. The regulation will enter into force on 1 November.

Helsinki, 12 October 2016 – The Same Biocidal Products Regulation lays down a procedure for companies to get a secondary authorisation for a product based on either an existing authorisation or an on-going authorisation application for an identical product.
  • Following the update of the regulation, companies can now also use this authorisation procedure for:
  • a product when it is part of a product family for which an authorisation (or authorisation application) exists;
  • a product family when it is part of a larger product family for which an authorisation (or authorisation application) exists;
  • national authorisation when a corresponding Union authorisation (or authorisation application) exists.
The regulation was updated by the European Commission after a request from industry stating that the changes would help reduce the costs and administrative burden for companies.

The regulation was published in the Official Journal of the European Union on 12 October and will enter into force on 1 November 2016.

To allow for the new possibilities, ECHA will launch updated versions of the biocides IT tools – R4BP 3 and the SPC Editor – when the regulation enters into force.

Support will be available: a new web page, a practical guide and updated submission manuals will be published and a webinar on this topic will take place on 9 November 2016.

Source: ECHA

Posted by Dr. Tim Sandle

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