The new Pesticides Regulation
About the new Regulation
Regulation 1107/2009/EC concerning the placing of plant protection products on the market enters into force on 14 June 2011; it is referred to hereafter as the Pesticides Regulation. The Pesticides Regulation replaces Council Directive 91/414/EEC concerning the placing of plant protection products on the market, and Council Directive 79/117/EEC prohibiting the placing on the market and use of plant protection products containing certain active substances. A Regulation enters into force directly as Danish law without any transcription when it enters into force in the EU. The following is a brief introduction to the Pesticides Regulation.
Authorisation of active substances
Active substances shall, as previously, be evaluated and approved at EU level. Member States must, after conclusion of the evaluation, still vote on approval; however, approval no longer results in inclusion in Annex 1 of Directive 91/414, but in a separate approval Regulation. Active substances which have been assessed and are included in Annex 1 are transferred to the approval Regulation. The approval Regulation enters into force at the same time as the Pesticides Regulation on 14 June 2011.
(Zonal) authorisation and mutual recognition of plant protection products
Plant protection products shall, as previously, be authorised at national level, but a new aspect is the opportunity for authorisation based on a zonal assessment. A zonal assessment is prepared by one of the Member States in the zone - the Zonal Rapporteur Member State (ZRMS). The ZRMS prepares a core assessment in which the evaluation as far as possible covers the uses in the other countries in the zone for which authorisation has been requested. However, the authorities in each country must assess the national conditions, including risk mitigating measures, and grant the final authorisation for the placing of plant protection products on the market in their country. The applicant must also submit an application in each of the countries in which they wish to market the plant protection product. The applicant can propose the country they wish to act as ZRMS.
Denmark has been placed in the Northern zone together with Estonia, Latvia, Lithuania, Finland and Sweden. Moreover, Norway is participating in the Northern zone cooperation. In addition to the Northern zone, there is a Central zone and a Southern zone.
The EU is a single zone with regard to plant protection products for use in greenhouses, as post-harvest treatments, for treatment of empty storage rooms, and for seed treatments. This means that one Member State prepares a product assessment which covers all uses in all EU countries where authorisation has been applied for.
In addition to zonal authorisation, it is possible to apply for authorisation using mutual recognition. Mutual recognition can be granted if the plant protection product is authorised in one of the countries in the zone and if there is no unacceptable risk for humans or the environment in the country where the application has been submitted. It is possible for the national authorities to refuse authorisation or to introduce risk mitigating measures if this is deemed necessary to take account of the Member State's specific environmental or agronomic conditions.
Application for (zonal) authorisation
An application for authorisation shall include a complete dossier and summary dossier for the plant protection product, as well as for each active substance in the plant protection product . Moreover, an application for zonal authorisation shall contain a list of the intended uses in each zone and also in each of those Member States where authorisation has been applied for.
Until now, data requirements for applications for authorisation of active substances and plant protection products have been described in Annexes II and III, respectively, of Directive 91/414/EEC. These have been transferred to the Pesticides Regulation and continue to apply (until the amendments that are in progress have been adopted).
Evaluation of application for (zonal) authorisation
On receipt of an application for authorisation, the Member State that has been appointed as ZRMS must conduct a completeness check. This entails assessing whether all information has been included which is necessary to perform an evaluation covering the entire zone.
For the Northern zone, a Guidance document has been drawn up which describes how to apply for authorisation, and the evaluation process conducted by the ZRMS. The ZRMS produces a draft Registration Report which will be finalised after a round of comments in all Member States. The evaluation is conducted based on the Uniform Principles which have been transferred from Annex VI of the Plant Protection Products Directive to a separate Regulation.
The Danish Environmental Protection Agency is currently updating the Danish framework for assessment of PPPs which describes how the Danish Environmental Protection Agency assesses and evaluates applications for authorisation of plant protection products so that they are ready when the Pesticides Regulation enters into force.
Classification and labelling
A plant protection product can only be placed on the market after approval of the product label by the Danish Environmental Protection Agency. The requirements for labelling a plant protection product are listed in the Labelling Regulation which has just recently been passed The Danish Environmental Protection Agency is currently updating its Labelling Guidance for use by companies.
Plant protection products that have been labelled in accordance with Directive 91/414/EEC may stay on the market with the existing labelling until 14 June 2015. This date coincides with the date of transition to classification of mixtures, including plant protection products, in accordance with the CLP rules.
New rules for auxiliary substances, adjuvants, safeners, and synergists
A new aspect of the Regulation is the introduction of rules for certain auxiliary substances. Auxiliary substances must thereby not have any harmful effects on human or animal health, or on the groundwater and environment. Auxiliary substances that cannot be accepted will be included in Annex III of the Pesticides Regulation. After 14 June 2016 plant protection products containing auxiliary substances included in Annex III will not be authorised.
The Regulation also includes a provision according to which rules must be adopted concerning approval of adjuvants, safeners and synergists. The rules for safeners and synergists will be adopted no later than 14 December 2014, and will apply after 14 December 2019 for products that were already on the market when the Pesticides Regulation came into force. With regard to adjuvants, it is still uncertain which rules for approval will be adopted and when they will come into force.
In Denmark, the rules for auxiliary substances, adjuvants, safeners and synergists will not come into force until detailed rules have been adopted in the EU.