The EU Plant Protection Products Regulation: (EC) No 1107/2009 – Update
Cristina Benros-Ythier, EU Regulatory Manager
Some of the fog surrounding the new EU Regulatory regime, (effective from June 2011), is clearing, but plenty of issues and uncertainties still remain…
The EU Regulatory process in summary:
The process is two tiered; first, active ingredients which are evaluated at EU level for inclusion in the list of approved Active Substances (Annex to Implementing Regulation No 540/2011 – previously Annex I to Council Directive 91/414) and secondly, formulated products, which are evaluated at Member States level for authorization. The data requirements for active substances and for products are identified and listed in two regulations (Commission regulations (EU) No 544/2011 and No 545/2011 respectively – previously Annex II and Annex III of Directive 91/414/EEC).
Regarding the procedure leading to the approval of a new active substance, the Registrant first makes their data submission to their selected Rapporteur Member State, who prepares a Draft Assessment Report (DAR), which is Peer Reviewed by Member States, and a conclusion given by the European Food Safety Authority (EFSA). The EU Commission then presents a draft regulation on approval (or non-approval!) of the active substance. This is submitted to the vote of the Standing committee, and the decision is then published.
In line with the move to the controversial cut-off criteria, which are hazard rather than risk-based, the listing in the Annex to Implementing Regulation (EU) No 540/2011 will not be approved for Active Substances which are e.g. Persistent Organic Pollutants, Persistent Bio-accumulating Toxins, Carcinogens, Mutagens, Reprotoxins or Endocrine Disruptors.
In a second step, the Registrant can apply for authorization of formulated products containing approved active substances. The application is Zonal (North, Centre, and South), with submitted data evaluated by a Zonal Rapporteur Member State and then other Member States in that zone are asked to provide Mutual Recognition. Mutual recognition can also be asked in another zone – but in only 1 Member State.
The main outstanding issues and uncertainties:
- The use of cut-off criteria remains controversial and the definition of Endocrine Disruptors will not be clarified until 2014 – and could affect a number of key product classes, e.g. Triazole fungicides.
- There is a process for comparative assessment and substitution of “less safe” active substances, by (new) substances “significantly” safer to human health, or of lower risk to the environment. This will be done at Member State, not EU level, with the possibility of different standards being applied in each country. Furthermore, socio-economic factors (economic or practical usage considerations) can also be applied – which could also influence retention of key products at Member State level!
- The Zonal approach for authorization of Plant Protection Products is still to be tested. To what extent will Member States still ask for additional information e.g. on efficacy, residues because of “special conditions” in their own country?
- There will be a tendency for registrants to focus on using Zonal Rapporteurs from Member States that have a track record of efficiency and effectiveness – resulting in bottlenecks!
- Member states have only a short time to assess the equivalence of a different source of active substance (or following a change in the manufacturing process) to the one that has originally been approved for inclusion in the list of approved active substances.
- Data sharing and compensation with subsequent prospective registrants is also managed by Member States, with no agreed time limits for negotiations or EU process for intervention/arbitration! This contrasts strongly with the US system under FIFRA, where procedures (including binding arbitration) and timescales are well defined.
SynTech’s Regulatory Study services include product performance (GEP), environmental fate and ecotoxicology (GLP), and Operator Exposure Studies, using our network of 28 countries and our analytical laboratories.
SynTech’s Regulatory services include:
- Reporting in standard and customer-designed formats,
- Expert assembly of data and preparation of Biological Assessment Dossiers,
- Regulatory submissions to USA-EPA, PMRA, EU and Latin American authorities, by SynTech Research or with partner organizations.
For more information download SynTech’s Program Management and Regulatory Services brochure, or please contact our EU Regulatory Manager, Cristina Benros-Ythier, at email@example.com