New Pesticides Regulation enters into force in Europe
First published in AgroNews on 7 July 2011 and additionally and edited version featured in Specialty Chemicals online, August 2011.
Regulation 1107/2009 of the European Parliament and Council of 21 October 2009 concerning the placing of plant protection products on the market entered into force on 14th December 2009 and became effective on 14 June 2011. It replaces the current legislation on plant protection products (subject to some transitional measures), which is laid down in Council Directive 91/414/EEC and several implementing Regulations.
Broadly speaking, the harmonized authorization system for active substances used in plant protection products, as originally set out in Directive 91/414/EEC, is maintained. Indeed, the placing on the market of plant protection products is still subject to a two-steps process whereby active substances are approved at the EU-level (with the inclusion into a`positive list' - Annex I to the new Regulation) while formulated products are authorised at the national level based on `Uniform Principles' laid down in a new implementing Regulation 546/201111. However, the criteria underlying each of these two steps have changed remarkably.
From a procedural standpoint, in order to obtain an approval for the active substance, the applicant must first submit a comprehensive dossier on the substance, including full information on the nature and composition of the substance, details of tests carried out on crops and plants, safety data and means of detection, to a Rapporteur Member State (RMS). The RMS is then responsible for carrying out a full evaluation of the substance and submitting a draft assessment report to the Commission, the other member states and the European Food Safety Authority (EFSA). On the basis of this assessment report, EFSA will organize a peer review of the evaluation with the other member states and present its conclusion to the Commission within 120 days after the end of the commenting period. Based on the EFSA conclusions, the Commission will decide, through the regulatory `comitology' procedure, whether or not to include the substance in Annex I.
From a substantive standpoint, Regulation 1107/2009 introduces new hazard-based "cut-off criteria" for approval based on the intrinsic properties of the active substance, safener or synergist. In essence, the approval process should not proceed further if the substance is a carcinogen, mutagen or reproductive toxicant ("CMR"), a persistent organic pollutant ("POP"), a persistent¬bioaccumulative-toxic substance ("PBT") or a very persistent and very bio-accumulative substance ("vPvB"). Moreover, substances meeting the criteria for endocrine disruption will be under special scrutiny (however, the Commission is yet to adopt specific criteria). However, strictly legally speaking endocrine disruption is not a cut off criterion.
The new regulation also has a wider scope in that it provides for the approval of safeners and şynergists, a negative list of co-formulants and a future list of adjuvants to be adopted by the Commission, as well as new provisions for treated seeds and parallel imports.
Importantly, the new Regulation provides that active substances shall become candidates for substitution if certain conditions are met (e.g., where the ADI, ARfD or AOEL is significantly lower than another active substance or the substance meets two criteria for PBT), and plant protection products may be subject to a comparative assessment and substitution where there are other products presenting significantly lower risk for human health or the environment without entailing significant economic and practical disadvantages for the user.
The approval of an active substance may be subject to conditions and restrictions, such as restrictions on then means of application of plant protection products containing the active substance, crops to which they can be applied, limitation of use to professional users, monitoring after use and other risk-mitigation measures. Further measures are provided for in relation to the inspection and monitoring on production, storage, transport and use of plant protection products.
For active substances on the market when the regulation enters into force (and which have been or are being subject to the ongoing review programme under Article 8(2) of Directive 91/414/EEC), a review of the authorization will be carried out in the timelines foreseen under the old legislation, using the new criteria laid down in the new regulation.
The authorization of plant protection products will continue to be done by national authorities in line with harmonized EU rules and procedures. However, the new regulation introduces compulsory mutual recognition of authorizations only among Member States within the same defined zone, with a degree of flexibility to accommodate local conditions. Three zones have been defined on the basis of relevant factors, such as similar climatic, agricultural and ecological conditions:
- North zone - Denmark, Estonia, Latvia, Lithuania, Finland and Sweden.
- Central zone - Belgium, Czech Republic, Germany, Ireland, Luxembourg, Hungary, Netherlands, Austria, Poland, Romania, Slovenia, Slovakia and the U.K.
- South zone - Bulgaria, Spain, Greece, France, Italy, Cyprus, Malta and Portugal.
Lastly, Regulation 1107/2009 contains important new provisions on data confidentiality and data sharing to avoid the duplication of testing of plant protection products on vertebrate animals. In short, as regards confidentiality, the Regulation now contains a positive list of data which are in principle regarded as confidential (e.g., manufacturing process, impurities unless they are toxicologically relevant, see Article 63). As regards data sharing, data owners and prospective applicants must "make every effort" to ensure that they share tests and studies involving vertebrate animals against "fair share of the costs" incurred by the data owner. Broadly speaking this obligation applies to both vertebrate and non-vertebrate animal tests. However, in the case of vertebrate studies, should the parties concerned fail to reach an agreement, the Member State authorities are entitled to refer to the studies for the benefit of the prospective applicant, while the data owner has a claim before a national arbitration panel or Court for a "fair share" of the costs. Regulation 1107/2009 does not define in detail the procedure, timing or criteria for data sharing, nor does it specify what constitutes a "fair share". Accordingly, unless the Commission adopts a guidance document on data sharing these critical aspects may be further clarified by arbitration panels and Court decisions.
In conclusion, the new Regulation has tightened the rules and process for the placing on the market of plant protection products. Behind the stated intention of achieving a high level of protection for human health and the environment, the EU has increased significantly the standards that industry will have to meet in order to commercialise its products in the future. While benefitting from a new, comprehensive and fully harmonised regulatory platform the agrochemical industry will be faced with many new hurdles and variable parameters such as the `substitution principle' and comparative assessment, amongst others, requiring a close coordination of business, scientific and legal considerations.
1 Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products.