EU amends 91/414 proposals

The European Commission has amended its proposed revision of the EU agrochemical registration Directive (91/414) in response to the large number of changes put forward by the European Parliament last year. The new proposal represents a mixed result for the crop protection industry. The Commission has rejected parliamentary calls to expand the range of hazard-based criteria used in pesticide assessments, a move welcomed by the European Crop Protection Association (ECPA). However, it also rejects a parliamentary amendment that would have maintained the provisional approval system for new active ingredients.

The introduction of certain hazard-based cut-off criteria in the assessment process was part of the Commission's original proposals, but the Parliament wanted this to be extended to include neurotoxic and immunotoxic properties. Last year, the ECPA warned that such a change would result in the banning of over 75% of ais. The Commission says that it has kept the original proposal to be in line with related EU legislation. However, it has agreed to amend the text to say that neurotoxic and immunotoxic ais should be approved as "candidates for substitution". This would make them subject to the proposed comparative assessment and product substitution system, where existing approved products could be removed from the market when suitable safer alternatives become available.

The ECPA remains concerned that the Commission has retained its original proposal on hazard criteria. "We remain strongly against the principle of all cut-offs, because they will ban many useful active substances based on hazard measurements instead of risk assessment. Separating the danger posed by a substance from how it is used makes absolutely no sense," says Friedhelm Schmider, the ECPA's director general. The existing proposal will still leave farmers with fewer solutions to protect their crops and "is a serious threat to the stability of European agriculture and food prices," he adds.

The industry is likely to be disappointed by the Commission's decision to reject the Parliament's bid to keep the existing provisional approval system. The Parliament suggested allowing EU member states to "pre-authorise" a new ai for a maximum of three years if there was evidence that deadlines for approval decisions would not be met. The Commission says that such a system would be "incompatible" with the proposed zonal authorisation system for products and the new EU pesticide maximum residue limit Regulation (396/2005). It stands by its argument that planned improvements to the registration system will remove the need for provisional approvals, although the ECPA doubts this claim.

In a similar fashion, the Commission has rejected the Parliament's call for the zonal authorisation concept to be abandoned. The parliamentary amendment would have "considerably undermined" the Commission's proposed revision of Directive 91/414 and would have "removed one of its key elements", it says.

Elsewhere, the Commission has accepted many parliamentary amendments that clarify the text. Its new proposal also incorporates the Parliament's provisions for EU-wide rules covering parallel imports of pesticides, a move that has long been called for by the industry.

The new rules would allow a product that is authorised in one member state to be used in a second member state if it was identical in specification and content of ais, safeners and synergists, type of formulation and composition to a product already approved in the second member state. Applications for parallel trade permits would be granted within 45 working days. Permits would be granted automatically if the member state had not reached a decision within the 45-day period. The permit would be valid for the duration of the approval of the original product. The proposed rules specify the determination of "identical" ais, safeners, synergists and products, an issue that has long caused problems for the industry due to the different interpretations applied by member states.

The Commission has also incorporated parliamentary amendments that should facilitate the extension of authorisation for minor uses, including the extension of data protection periods. However, it rejects a proposal to create a special fund for minor uses on the grounds that this does not fall within the aim of the Directive 91/414 revision.

Several parliamentary amendments to the proposed comparative assessment provisions are rejected by the Commission. The Parliament wanted to extend comparative assessment to all products and reduce the approval period for ais that are candidates for substitution from seven to five years. The Commission says that it cannot endorse these proposals because they are not risk-based, the additional administrative workload is not justified, and there would only be a minor effect on health and environmental protection.

The Commission rejects the Parliament's amendment that would require renewals of ai approvals in Annex I of Directive 91/414 to be reviewed every ten years. The Commission argues that its original proposal for renewed Annex I listings to be for an unlimited period would reduce administration and costs. Approvals could always be reviewed if "unfavourable" information became available, it points out.

Parliamentary efforts to introduce data protection for studies submitted for renewal or review of authorisations are rejected by the Commission as they would "undermine" the proposed data protection system. The amendments would weaken competition and reduce availability of pesticides to farmers, the Commission says. It argues that maintaining existing data protection provisions is better than having no data protection or imposing forced data sharing with financial compensation.

The Commission also rejects a call for a new category of "reduced-risk" pesticides with different data protection periods. The original proposal already provides for specific rules for "low-risk" ais, it says.

Some changes on record-keeping are incorporated into the new proposals, which already require producers, suppliers, distributors and professional users of pesticides to keep records of the products that they manufacture, store or use. The Commission has added in an amendment requiring pesticide producers to undertake post-registration monitoring and to notify the authorities of "any relevant information".

However, it has rejected changes to public access to farmer records and the introduction of a "pesticide passport". The original proposal provides that information should be made available to neighbours on request, the Commission points out. A pesticide passport for every lot of fruit and vegetables would be "unrealistic" because batches are mixed in trade, it says. It also rejects an amendment to make IPM principles obligatory from 2012 onwards.

The Commission has partly accepted amendments to the proposed review of safeners and synergists. It has agreed to define data requirements for safeners and synergists within five years of entry into force of the new agrochemical registration rules, pointing out that the Parliament's proposed review timetable was too short.

The revised proposal will go forward for consideration by EU Ministers. Earlier this year, EU Agriculture Ministers warned of delays to reaching an agreement on the original proposals because of the large number of amendments put forward by the Parliament.