This is an extract from the 2017/2018 Agrow Annual Review which you can download in full below.
The herbicide, glyphosate, occupied centre stage in the EU through most of 2017 as member state politics sought to subvert the regulatory process. The European Commission struggled to overcome some member states’ concerns over conflicting scientific opinions on the active ingredient’s carcinogenicity classification, despite the positive conclusions of EU evaluations. It had to cut the proposed approval period from the standard 15 years to ten and then five years. The Commission also met fierce resistance from some members of the European Parliament, who wanted a five- year phase-out of the ai.
The Commission declared its intention in July not to go ahead with the approval renewal without the support of a qualified majority of member states. That meant many months of indecision and inconclusive voting by member states when getting a qualified majority seemed impossible. After failing in late October to gain sufficient EU member-state support for a ten-year approval, the Commission cut its proposed renewal period to five years.
Finally, in almost a repeat of the scenario in 2016 when an 18-month extension to the ai’s authorisation was given merely days before it was to expire, the Commission managed to get a qualified majority of EU member states to back its proposal for a five-year renewal of the EU approval of the herbicide, two weeks before the extension was to expire on December 15th.
But the controversy was far from over as following the renewal, three political parties in the European Parliament called for a lawsuit against the renewal and the setting up of a special committee to examine the wider EU assessment process for pesticides. Following that, six EU member states, Belgium, France, Greece, Luxembourg, Malta and Slovenia, urged the Commission to go further than the five-year renewal and take steps towards ending the use of the ai.
Disagreements were the order of the day on the issue of criteria for identifying potential endocrine disruptors (EDs). In October, the European Parliament threw out proposed criteria for identifying potential EDs in agrochemicals, causing a further delay for the proposals, which were originally meant to be finalised by the end of 2013. The criteria were rejected because of an objection to the proposed exemption of insect growth regulators (IGRs) from the ED criteria.
Finally, in December, member states voted in favour of amended criteria for EDs in which an exemption for IGRs was removed. In the previous month, ED criteria for biocides were passed and published as Regulation 2017/2100. The IGR exemption was included in the biocide criteria, which did not receive any objection from the Parliament.
An EU member-states vote on a proposed ban on all outdoor uses of the neonicotinoid insecticides, clothianidin, imidacloprid and thiamethoxam, which was scheduled for December, was postponed to spring 2018. The move came as a result of a delay by the European Food Safety Authority (EFSA)
in its evaluation of data for a review of measures imposed in 2013 that suspended uses on certain crops. The completion of the review was delayed until February 2018. Member states will vote following the completion of the EFSA review.
The parity of the approval process of biologicals with conventional pesticides has been a cause for complaint in the biologicals sector of the crop protection industry, which has been asking for a more favourable registration procedure. In 2017, the Commission set about the task of extending the scope of ais that may be considered as “low-risk” substances, in a bid to boost approvals of biological and naturally occurring pesticides. It came about in August, when new criteria for identifying “low-risk” agrochemical ais came into force. Under the new criteria, micro-organisms, baculoviruses and semiochemicals will be considered as low- risk, unless specific concerns are identified, while naturally occurring substances will be exempted from certain hazard-based criteria.
Consultations for the Commission’s REFIT programme, which aims to made EU laws simpler and less costly, got under way in November when the Commission opened two consultations for the public and for stakeholders on its “fitness check” review of the implementation of the EU agrochemical registration Regulation (1107/2009) and the EU pesticide residues Regulation (396/2005). A roadmap was issued towards the end of 2016 outlining various concerns raised by industry and EU member states, including: mutual recognition of product approvals; the geographic zonal system for product approvals; implementation of comparative risk assessment of products containing ais that are candidates for substitution; data protection provisions; and the implementation of setting harmonised maximum residue limits. The deadlines for comments are February 12th 2018 for the public and December 31st 2018 for stakeholders.
In December, the Commission committed to allowing public access to industry studies submitted for agrochemical approvals. Legislative proposals will be issued in spring 2018. The commitment came as a response to a European Citizens Initiative petition that was demanding a ban on glyphosate as well as a reform of the pesticide approval procedure and setting of EU-wide mandatory reduction targets for pesticide use. The Commission rejected the demands for a ban and mandatory reduction targets.
The Commission acknowledged the concerns raised in the petition about transparency, and promised to act on its earlier pledge to examine ways to improve the rules. Those will include measures such as public access to raw data from study reports, but any changes will respect existing rules on the protection of legitimate confidential business information.
Another petition demand was for pesticide approvals to be based on published studies commissioned by public authorities, rather than industry. The Commission stressed the principle that public money should not be used for studies that would eventually help industry put a product onto the market, especially in view of the high cost.
Nevertheless, an option under consideration, already suggested at an earlier hearing on the petition, was to give the EFSA the power to commission ad hoc studies in case of serious doubts or conflicting results, for example, in case of widely used substances.
A long-awaited report by the Commission on the implementation of the EU sustainable use of pesticides Directive (2009/128) in EU member states was finally released in October. It found that implementation in member states had been insufficient and improvements made so far have not been enough to achieve the Directive’s aims of reducing the risks and impacts of pesticide use. But the report noted good progress in other areas, such as minimising aerial spraying and pesticide use in public places, and establishing training and certification programmes. The report was originally meant to be produced in 2014.
Although discussions between the EU and the UK are in the initial stages on Brexit, the
Commission began issuing specific advice in September for European agrochemical, biocide and biotechnology companies on the impact of the UK leaving the EU in 2019.
The advice for agrochemicals was in the form of a notice and “question and answer” document covering the implications for procedures for approving agrochemicals and setting maximum residue limits (MRLs). It warned firms that they may need to transfer some EU approval applications away from the UK. When and if the UK becomes a “third country”, it will no longer be able to act as a rapporteur for assessing applications for ais, zonal product approvals or MRLs. The Commission advised companies to carefully consider the time needed for EU procedures before they submit new applications and also be prepared to transfer existing applications out of the UK. It is working with EU member states and European Economic Area countries to establish a co-ordinated method for transferring files for new approvals and ais in the EU review programme.
Similar advice was issued to biocide and biotechnology companies.
Towards the end of December, member states voted through the reallocation of 21 ais going through the renewal process to a different rapporteur or co-rapporteur member state, because the UK will not complete its assigned duties before it leaves the EU in 2019. The vote came just in time for some of the ais that have a deadline of February 28th 2018 for companies to submit supplementary dossiers for evaluation.