Mutual recognition and candidates of substitution
The Regulation establishes a new system for mutual recognition of PPPs based on a division of the Member States into three zones—north, centre, and south51—in which relevant conditions are generally comparable. A PPP approved by one Member State shall normally be approved on the same conditions by another Member State in the same zone. However, specific environmental or agricultural circumstances can allow a Member State to amend an authorisation issued by another Member State, or refuse to authorise the PPP in its territory. The same applies where the level of protection of both human and animal health and the environment required by the Regulation cannot be achieved. An exemption from the general rule on mutual recognition can also be made, inter alia, when a PPP contains a so-called candidate of substitution. (Arts 40 and 41.)
A candidate of substitution is an active substance which meets any of the criteria laid down in point 4 of Annex II. These include meeting two of the criteria to be considered as a PBT or being classified as a carcinogen or toxic for reproduction in a certain category. Such substances may be approved or have a renewed approval for periods of no more than seven years. The Commission is required to establish a list of substances identified as candidates for substitution (CfS). At the time of writing, however, there was only a draft list containing seventy-seven CfS. Substances approved under the Regulation that meet the CfS criteria are to be listed in a separate Annex of Regulation 540/2011 (ie the list of approved active substances).
A Member State evaluating an application for authorisation for a PPP containing an active substance approved as a CfS must perform a so-called comparative assessment. Where the comparative assessment weighing up the risks and benefits demonstrates that, for the uses specified in the application, an authorised PPP, or a non-chemical control or prevention method, already exists which is significantly safer for human or animal health or the environment, the PPP shall either not be authorised or its use shall be restricted. However, this only applies if the substitution by plant protection products or non-chemical control or prevention methods does not present significant economic or practical disadvantages. The chemical diversity of the active substances or methods and practices of crop management and pest prevention must also be adequate to minimise the occurrence of resistance in the target organism. The result of the comparative assessment can differ from Member States and between uses. (Art 50.)
It is thus far from any automatic restriction of the use of PPPs containing a candidate for substitution.
In exceptional cases a Member State may also subject a PPP not containing a candidate for substitution to a comparative assessment and restrict its use accordingly if a non-chemical control or prevention method exists for the same use and it is in general use in that Member State (Art 50).
A PPP that is authorised in one Member State may be placed on the market or used in another Member State if the latter determines that the PPP is identical in composition to another PPP already authorised in its territory (a so-called ‘reference product’). The procedure for obtaining the required parallel trade permit is simpler than the approval procedure. (Art 52.)
The Regulation allows, under certain circumstances, for emergency measures to be taken either at the EU level or by individual Member States (Arts 69—71).
