A new proposal for a regulation concerning the placing of plant protection products on the market was issued by the European Commission on 12th July 2006. It aims to streamline and simplify mainly the national authorisation procedures for plant protection products and enshrines EFSA’s role in the assessments at EU-level. This proposal limits to three months the deadline for the peer review of each active substance (compared to 10 months in the current review programme). If adopted, this would replace Directive 91/414/EEC. It is expected that EFSA’s scientific work on the two remaining stages of the ongoing peer review process of existing substances will continue as originally foreseen and will not be directly affected by the adoption of the new Regulation. However, a future re-evaluation of all approved substances, to be launched in the coming years, is expected to be affected by any revision of the existing legislation.New proposal for a regulation concerning the placing of plant protection products on the market
The term “pesticides” is often used as a synonym for plant protection products, which are mainly used in agriculture to keep crops healthy and prevent them being destroyed as a consequence of disease and infestation. This is the most important group of pesticides dealt with by EFSA and has the longest history of legislation.
Plant growth regulators (which are used to influence particular growth processes in plants) and herbicides (which control unwanted plants) are also treated as plant protection products under EU legislation. However, biocides, which are intended for non-plant uses to control various pests and disease carriers such as insects, rats and mice, and which are sometimes referred to as pesticides, do not fall within the remit of EFSA.
The active substances used in plant protection products are the chemicals or micro-organisms including viruses that are the essential component enabling the product to do its job. For example, they may protect the plant against insects or fungi which destroy plants or, in the case of herbicides, destroy unwanted plants. Much of EFSA’s risk assessment work in the field of pesticides focuses specifically on these active substances
Pesticides in the European Union
In the EU, pesticides used to protect plants or plant products are principally regulated by Directive 91/414/EEC on the placing of plant protection products on the market. The Directive states that chemical substances or micro organisms (including viruses) in pesticides are only approved for use if they have undergone a peer-reviewed safety assessment. In 1993, the European Commission launched an extensive review programme (which includes the peer review of active substances used in plant protection products, managed by EFSA) to evaluate the safety of all active substances used in plant protection products in the EU. The deadline for this work is 2008. Once a substance is approved, Member States may authorise the use of plant protection products containing it.
EFSA's work with Pesticides
EFSA has the job of giving independent scientific advice on pesticides to the European Commission and EU Member States and is also responsible, in collaboration with the EU Member States, for the peer review of active substances used in plant protection products.
The risk assessment of pesticides aims to ensure that, when used correctly, these products have no harmful effect on human or domestic animal health directly or indirectly (e.g. through drinking water, food or feed) and do not adversely affect groundwater quality. In addition, the environmental risk assessment aims to characterise the potential impact on non target wild organisms when the products are used correctly.
It is important to note that the European Commission and EU Member States take management decisions on regulatory issues, including approval of active substances and setting Maximum Residue Levels (MRLs). EFSA does not take such decisions.
At EFSA, the Pesticide Risk Assessment Peer Review (PRAPeR) and the Panel on Plant Protection Products and their Residues (PPR) work in this area.
- Pesticide Risk Assessment Peer Review (PRAPeR)
Since mid-2003, EFSA has been responsible for Europe’s product peer review of active substances used in plant protection products. This task is carried out by EFSA’s Pesticide Risk Assessment Peer Review (PRAPeR) in line with legally agreed procedures and deadlines. The legislation requires the peer review of all active substances that were on the EU market in 1993 by 2008.
PRAPeR is also engaged in the risk assessment of Maximum Residue Levels (MRLs) in accordance with the provisions of Regulation (EC) No 396/2005. PRAPeR is involved in the process of assessing the safety of the proposed temporary European MRLs for a range of substances for which harmonised EU MRLs have not yet been agreed.
- Panel on Plant Protection Products and their Residues (PPR)
EFSA’s Panel on Plant Protection Products and their Residues (PPR) gives scientific advice on issues that cannot be resolved within the peer review of active substances used in plant protection products, or when further scientific guidance is needed on more generic issues, mostly in the field of toxicology, eco-toxicology, fate and behaviour of pesticides.
The European Commission also requests the PPR Panel for scientific opinions on residues of pesticides in fields outside the remit of the PRAPeR unit.For more information, see PPR Opinions.
The PPR Panel has the task of revising and updating existing guidance and developing new guidance documents for risk assessment. The first to be updated is the Guidance Document on Risk Assessment for Birds and Mammals under Council Directive 91/414/EEC, to be finalised by end of 2007 and followed by other issues in 2008.
What are the guidance documents?
The guidance documents provide guidance to notifying organisations and Member States on how to conduct a risk assessment for a particular area in the context of the peer review of active substances used in plant protection products.These documents do not produce legally binding effects and by their nature do not prejudice any measure taken by a Member State within the implementation prerogatives under Annexes II, III and VI of Directive 91/414/EEC, nor any case law developed with regard to these provisions. The documents also do not preclude the possibility that the European Court of Justice may give one or another provision direct effect in Member States.