Last autumn, the EEA Joint Committee decided to incorporate the two main EU legal acts on plant protection into the Agreement on the European Economic Area (EEA Agreement). The first repeals a directive from 1991 and sets out the approval criteria for active substances to be used in PPPs and the approval process for PPPs. The second is a directive establishing a framework for Community action to achieve the sustainable use of pesticides. These two legal acts are part of the new EU framework in the field of plant protection.
Why do we need PPPs?
PPPs are used to protect crops against insects, pests or other organisms that may be harmful to plants. They are primarily used in the agricultural sector, but also in forestry, horticulture and amenity areas, as well as in home gardens. A PPP usually contains several components. The active component against plant diseases is called the active substance and can beany chemical, plant extract, pheromone or micro-organism that acts against “pests” on plants.
PPPs are important as they are used by farmers to protect crops from insect pests, weeds and fungal diseases whilst they are growing. However, as PPPs are used to kill unwanted pests, they can also be harmful to human health and to the environment. It is therefore important to strictly regulate the marketing and use of PPPs.
EEA EFTA exemption in 1992
The EU has taken several steps to harmonise the rules on the use of PPPs. The first legislation to regulate the marketing of PPPs in the EU was adopted in 1991 with the aim of fully protecting human health, animal health and the environment. It put forward a system for approving any active substances used in plant protection at EU level.
During the negotiations on the EEA Agreement, which was signed the following year, the EEA EFTA States obtained a derogation from this legislation. At the time, the EU rules were considered by the EEA EFTA States to be more lenient than their own. It was therefore in their interest to maintain stricter national legislation on PPPs, rather than to introduce the EU rules.
Improvements at EU level
Since the first EU legislation on plant protection was adopted in 1991, important developments have taken place at EU level to further secure human health and protection of the environment. In 2009, the EU adopted several legal acts on PPPs. This development meant that EU legislation in the field of PPPs improved significantly and the need for the EEA EFTA States to maintain a derogation was therefore reconsidered. Consequently, the EU legal acts from 2009 were incorporated into the EEA Agreement by a JCD in September 2014.
The Plant Protection Products Package introduces several changes. The legislation aims to harmonise, as far as possible, the overall arrangements for the authorisation of PPPs within the EEA.
A significant development introduced by the new package is the division of the EEA’s territory into three geographical zones. Member States within each zone have comparable conditions (agricultural, plant health, environmental and climatic) in order to facilitate mutual recognition. Zone A consist of northern Europe (including Iceland and Norway), Zone B consist of central Europe (including Liechtenstein) and Zone C consists of southern Europe.
The approval process
The process of approval occurs in three separate stages. The approval of the active substance, the approval of the PPP in each geographical zone and the approval of the PPP at national level.
First, an active substance will need to be approved by the European Commission before it can be used in a PPP within the EEA.
In the new approval process, the European Food Safety Authority (EFSA) is the key actor in risk assessment. Following a series of crises in the late 1990s, EFSA was set up in 2002 as an independent source of scientific advice and communication on risks associated with the food chain. In close cooperation with national authorities and in open consultation with stakeholders, EFSA provides independent scientific advice on existing and emerging risks. The European Commission, assisted by the Member States, make the decisions on regulatory issues including the approval of substances.
An application for approval of an active substance is sent to one of the Member States. This country is referred to as the Rapporteur Member State (RMS). All EEA States apart from Liechtenstein can be an RMS. The RMS assesses the admissibility of the application and reports to EFSA. EFSA then examines each substance and submits its conclusions to the Commission. After consulting the Standing Committee on the Food Chain and Animal Health, the Commission may adopt the approval of the active substance and publish a regulation in the Official Journal of the European Union.
Second, the applicant must specify in which Member State it intends to place the PPP (containing approved active substances) on the market. The application shall be examined at national level by the Member State in question, unless another Member State in the same zone agrees to examine it. Member States within the same zone may cooperate during this examination. The examining Member State then has 12 months to carry out a scientific assessment of the application and shall give all Member States in the same zone the opportunity to submit comments to be considered in the assessment. If this assessment is positive, the PPP can be authorised on the market in that State.
Finally, when a PPP has been authorised in one Member State, the holder of the authorisation may apply for authorisation of the same product, for the same use and under comparable agricultural practices, in another Member State under the mutual recognition procedure. When receiving such an application, a Member State has four months to examine it. It shall then authorise the PPP concerned under the same conditions as the Member State examining the first application. Some derogations are possible, but in principle mutual recognition applies between Member States, particularly when they are in the same zone.
The directive establishing a framework for Community action to achieve the sustainable use of pesticides contains measures to reduce the risks and impact of PPPs on health and the environment. It requires that national action plans be adopted, containing objectives, measures and timetables to reduce the risks of pesticides on human health and the environment. The plans should focus on integrated pest management and the use of non-chemical alternatives and techniques in order to reduce dependency on chemical PPPs. Members of the EEA are required to set up systems for the training of professional users, distributors and advisors.
For more information see the European Commission website.