How does the approval process work for plant protection products (PPPs)?
All active substances (active ingredient in a plant protection product) must be reviewed at EU level under Regulation (EC) 1107/2009/EC (formerly EU Directive 91/414). The EU approval process of an active substance starts with the submission of the results of the necessary tests and studies by the Company applying for an approval. The Member State (MS) to whom the application is made is referred to as the Rapporteur Member State (RMS) for that active substance. It is their responsibility to prepare a draft assessment report (DAR) of the submitted data and put forward an approval or non-approval proposal for the active substance based on the data provided by the Company.
Once completed, the DAR is subjected to detailed peer review by experts from other Member States and by the European Food Safety Authority (EFSA). Based on the outcome of the experts’ peer review, EFSA sends its conclusions to the Commission, which then proposes a decision on approval or non-approval based on these conclusions.
All draft Commission decisions regarding approval must be accepted by the European Commission’s Standing Committee on plants, animals, food and feed (SCoPAFF). The SCoPAFF is a Committee that helps the Commission in its role of implementing EU legislation. Its members are experts nominated by Member States. Based on the DAR and the EFSA conclusion, the SCoPAFF votes on full or conditional approval of the active substance, or may refuse its approval. In most cases, the first approval lasts for a maximum of 10 years, but substances may be reviewed at any time in light of new available information. If an active substance is approved, the plant protection product containing it must then be authorised in each Member State.
Following EU approval of the active substance, data to defend the plant protection product(s) containing the approved active substance must be fully examined. This process is conducted at zonal level with one MS within each of the 3 EU zones acting as zonal RMS. Each MS authorises or not the plant protection product taking into account the zonal RMS conclusion and specific local variations in climate, cropping patterns, etc. Both the data requirements for plant protection product (PPP) authorisation, and the criteria by which the EU and the MS evaluate PPPs (Uniform Principles) are harmonised at EU level.
The mutual recognition process
The EU framework legislation has always encouraged mutual recognition and Regulation (EC) No 1107/2009 requires greater cooperation among MS within three geographical zones in the EU: Northern, Central and Southern. Where a plant protection product is authorised in one MS, an applicant may seek mutual recognition of the authorisation in another MS within the same zone.
Reviews and controls
An EU review programme for all approved active substances is carried out periodically (usually every 10 years) or as deemed necessary based on new scientific evidence. Application for renewal of approval for each active substance must be made and peer reviewed. Following renewal of approval of an active substance, each plant protection product containing that active substance must also be reviewed and re-authorised or not.
Long-term health studies are undertaken to monitor possible links between health problems and exposure to PPPs. Older products must be routinely reviewed both by manufacturers and by the authorities to ensure that they meet the same safety standards as new products. Residues in food are monitored at EU level.