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Product Authorisation Explained

PRODUCT AUTHORISATION EXPLAINED

There are two regulatory steps to be taken before your biocidal products are fully compliant for marketing and use in the territory of the BPR.

1. Active Substance Approval

2. Product Authorisation

Although not strictly accurate (as the poison is actually characterised as a pesticide) it is possible to think of the difference between an active substance and a product by considering a can of fly spray.

The tiny drop of poison in the aerosol is the “active substance”.

The aerosol can, its labelling, the pressurised inert liquid in which the poison is mixed, and the valve that releases the spray into the atmosphere is the “Product”.

Under EU regulations it is necessary to first have the active substance approved. The Product itself, that uses the active substance, must then also be authorised for distribution and use.

To secure Product Authorisation it is necessary to prepare and submit a Dossier for review. The way that you choose to do this will depend on the markets in to which your organisation may wish to market its biocidal product(s). If you are only interested in your domestic market, you would be expected to apply to your Member State Competent Authority. In the UK this is the HSE.

If you wish to sell into a plurality of member states you may ask the HSE to notify the other States using a process called “Mutual Recognition”.

You may also apply directly to ECHA for Product Authorisation and ask that the ECHA authorisation be granted for all territories that adopt the BPR using a process called “Union Recognition”.

As the pursuit of these authorisations is entirely dependent upon the complexity of the active substance and your product, Tarn-Pure is unable to offer any thoughts as to the length of time that each application will take, or the cost. In order to understand better the details of this process we recommend that you either refer to your national regulator or to the ECHA web site pages that deal explicitly with Product Authorisation; and a good starting point will be the page that you can reach through this link:

http://echa.europa.eu/regulations/biocidal-products-regulation/authorisation-of-biocidal-products
The fee structure for biocides registrations is governed by another EU regulation (EU/564/2013) and full details may be found here

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