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UK regulators strive for coherence amid EU rule confusion
2009-10-09 16:18:46   【Large middle Small】  Browse:4052Times   Source:www.pjbpubs.com 

The time for questioning the wisdom (or the lack of it) of the new EU rules governing the registration and use of pesticides is over; the emphasis now has to be on their accurate interpretation and effective implementation. This was the message that emanated from the one-day conference on the new regulations organised by the UK Chemicals Regulation Directorate (CRD - the former Pesticides Safety Directorate - PSD). Speakers from the CRD spoke on various aspects of the rules.

While it was made amply clear that the UK raised objections to the adoption of the rules by EU Ministers (see this issue), CRD regulators strove to chart a path that would help a seamless merger of the old and the new system. “My challenge is to convince you that we are on top as far as implementation is concerned,” CRD regulator Rob Mason told the audience. The CRD has formed ten individual projects and divided all elements of the new rules within them. The new rules are to enter into force on the 20th day after publication in the EU Official Journal later this month and are likely to be implemented in April 2011, 18 months after publication.

Quite a lot of the criticism about potential problems still holds true. Among Annex II criteria for active ingredient approval in the new rules, the three that generated most discussion and still present the most difficult challenges are those concerning the impact on human health, environmental fate and behaviour, and ecotoxicology. Under the new rules, any ai with mutagenic properties will straightaway be discarded. But there is a possibility of derogations for certain ais in case of “negligible exposure”. These include: carcinogenic category 1 and 2 (C1 and C2) ais; those ais displaying reproductive toxicity (R1 and R2); and endocrine disruptors. The “negligible exposure” has now been defined as “ais in closed systems having residues below 0.01 mg/kg”.

On the issue of endocrine disruptors, the Commission will come up with specific criteria within four years and the CRD hopes that they should be in place by mid-2013. But the interim definition leaves room for ambiguity. C3 and R3 ais will definitely be discarded, but if an ai has toxic effects on endocrine organs, it “may be” discarded. The regulators want more specifics on the exact connotation of “may be”. “Endocrine disruption criteria among hazard-based criteria are only indicative in nature, we cannot assess their impact and the Commission will not tell us,” lamented regulator Mark Hawkins.

One of the distinct advantages of the new rules when they were initially envisaged was that of compulsory mutual recognition, wherein a product authorisation granted by one member state in a regional zone would be adopted unchanged by other member states in that zone. During subsequent negotiations, some flexibility was introduced to apply additional restrictions, which will apply to all aspects ranging from the setting of additional risk mitigation measures to refusal of the authorisation. In sum, it will not be obligatory for a member state to accept a zonal authorisation.

Similarly, there are other loopholes likely to create confusion. For applications submitted to more than one zone, the rapporteur member states would have to agree on which one would evaluate the core dossier (non-zonal specific data). This is likely to generate disagreements among them. There will be a distinct benefit for certain uses, such as in greenhouses, post-harvest treatment, empty stores and seed treatments, in which only one rapporteur state can do an evaluation and it will be valid across all zones.

Steven Dobson sought to highlight the complexity of the task that lies in front of regulators. Starting with a striking analogy, he compared the rules to a pupa, which the regulators are expected to turn into a butterfly. Talking about the CRD’s current workload, he said that there were 72 ais in the resubmission programme and 80 ais that were new active substances (NAS). Apart from these, there is the workload of: peer review of green-track substances; ais awaiting confirmatory data; and hundreds of ais pending national re-registrations. A lot of this workload will spill over into the next few years, and in the midst of that, the new registration system will come into force in the middle of 2011.

Mr Dobson said that because of a huge workload on existing ais, the Directorate has effectively halted work on NASs. But when it finally manages to get on with reviewing them, it will be faced with a situation similar to that encountered with resubmission applications, where it found more data than anticipated. This was because companies were busy gathering data even when additional data were not required, just so as to be able to avoid any possible data gaps.

When the workload is seen in conjunction with the fact that, in general, the timelines for assessing the completeness of an application and the European Food Safety Authority peer review are shorter than before, the task becomes more daunting. Possibly to deal with the situation, the new rules have a facility allowing provisional authorisation, in the event of a member state not being able to arrive at a decision within 30 months. This provision is available for 78 months, or 6.5 years, after entry into force of the new rules.

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