Parallel Trade

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There is a provision under Article 53 of the Biocidal Products Regulation that allows biocidal products to be made available and used within a Member State without the need for either a Union authorisation, or a National authorisation granted by that Member State.

This provision applies when the biocidal product in question has been authorised in another Member State, and there is an identical product already authorised in the Member State to which the authorisation holder wishes to introduce it. Where the Competent Authority of the Member State into which the biocidal product is to be introduced determines the products are identical, it can grant a parallel trade permit.

For the biocidal products to be considered as identical, the following conditions must be met:

(a) they have been manufactured by the same company, by an associated undertaking or under license in accordance with the same manufacturing process;

(b) they are identical in specification and content in respect of the active substances and the type of formulation;

(c) they are the same in respect of the non-active substances present; and

(d) they are either the same or equivalent in packaging size, material or form, in terms of the potential adverse impact on the safety of the product with regard to human health, animal health or the environment.

The permit for the biocidal product, if granted, will have the same conditions and duration as the authorisation of the reference biocidal product used to obtain the permit.