EU Readies for New Rules
Stricter criteria that jeopardizes re-authorization of key active substances begins in June.
March 3, 2011
A new regulatory system begins in June, and it could potentially eliminate some key active substances, depending on the European Commission’s definition of endocrine disruption.
Regulation 1107/2009 was adopted in late 2009 to replace the Directive 91-414, which currently rules the plant protection products market. The new regulation will introduce even stricter criteria and procedures for the authorization of crop protection products in the EU.
The major new provision — which all active substances contained in plant protection products will have to comply with before being sold in the EU — are the so-called “cut-off” criteria set in the regulation. The current EU authorization system focuses on the risk assessment of active substances. However, under the new system, substances that trigger these new hazard-based criteria could be directly banned, without going through a risk-assessment process. This new system will potentially lead to the loss of some active substances that have been risk assessed, according to latest scientific knowledge and have been approved and included in the EU’s safe list of active substances, as set out in Annex I of Directive 91-414.
Out of these new criteria, endocrine disruption appears notably problematic as there is no internationally agreed definition for it, and the interim definition introduced in the regulation raises some issues regarding its scientific validity. The regulation requires the presentation by the European Commission of scientific criteria to define endocrine disruption by end of 2013, and this should be based on sound science.
The implementation of these new criteria likely will translate into a situation where the number of tools available to EU farmers to protect their crops will decrease further even though the number of available active substances has already decreased by more than 70 percent following the review conducted under Directive 91-414. However, the potential impact of implementing these new criteria will not be immediate. The evaluation of individual substances will take place when their 10-year approval period comes up for review. For most substances, this review will take place between 2013 and 2016.
It is not possible to predict the impact that cut-off will have on the EU market. It should, however, be stressed that this impact can be mitigated by a derogation to the cut-off criteria that can allow approval when there is a serious danger to plant health and when no suitable alternative is available.
Comparative assessment is another new provision for the authorization process. Products containing active substances identified as candidates for substitution, according to criteria set in the regulation, should undergo a comparative assessment — that is to say that they will be compared with their competitors. If there is a significant difference in the risk profile of products assessed, products with an unfavorable profile could be removed from the market. This provision has the potential to be extremely complex, and there is a need to develop a clear process to ensure that the measure is implemented in a pragmatic manner to avoid unnecessary administrative burden and to minimize business unpredictability.
Regulation 1107/2009 also introduces a new system for the authorization of plant protection products. In the future, products will be assessed within three pre-determined zones by a rapporteur Member State. This aims to share the workload and avoid repetition of assessments for the same product within the EU. This new provision can bring substantial improvements for the placing of plant protection products on the market — but there are some major challenges. In particular, many Member States still have specific national requirements, and it is now essential to harmonize requirements of all EU Member States in order to allow this worksharing. Sufficient resources and coordination between national authorities will be fundamental, and flexibility is also needed between zones in sharing evaluations, particularly when cropping conditions are similar.
New rules on parallel trade have also been introduced in the Regulation and they are a welcome addition, particularly in the fight against illegal and counterfeit products. The trade in one Member State of a product approved in another Member State will only be possible through a parallel trade permit if the product is identical to a product already authorized in the Member State of introduction. This will include a requirement for the product to be from the same source, having identical specifications and the same or equivalent co-formulants and packaging. The implementation of this provision will introduce an important new filter, which will allow trade in legal products while introducing greater barriers for illegal products.
The implementation of the new legislative system does lead to many challenges, but the EU will remain an important market. The key challenge will be to maintain a pragmatic — and where possible, risk-based — system in order to keep sufficient tools available to EU farmers to protect their crops.
Euros Jones is director of regulatory affairs for the European Crop Protection Association. He is also an editorial advisor to FCI.