Authorisation of PPPs
A PPP may not be placed on the market or used unless it has been authorised in the Member State concerned in accordance with the Regulation. Exemptions apply, inter alia, with respect to products containing exclusively one or more basic substances, PPPs intended for research or development, and when a parallel trade permit has been granted.
A PPP may only be authorised in a Member State if its active substances, safen- ers, and synergists have been approved and its co-formulants are not among those listed in Annex III as not accepted for inclusion in PPPs. The PPP’s technical formulation must be such that user exposure or other risks are limited as much as possible without compromising the functioning of the product. The PPP must also be sufficiently effective and meet the requirements regarding effects on humans and the environment that PPPs containing a specific active substance must meet if that substance is to be authorised according to Article 4(3). (Arts 28 and 29.)
An authorisation must define plants or plant products and non-agricultural areas on which and the purposes for which the PPP may be used. It must also set out requirements relating to the placing on the market and use of the PPP Member States may review an authorisation at any time where there are indications that a requirement for authorisation is no longer satisfied. (Arts 31 and 44.)
The Commission has adopted uniform principles for evaluation and authorisation of PPPs.50
