Regulatory overview
Strictly regulated
Pesticides, like pharmaceuticals, are the most thoroughly tested chemicals in the world, and only those that pass strict government testing are authorised for use. Rigorous scientific assessments ensure that their use is safe both for human health and the environment. Accordingly, the European Directorate General for Health and Consumers (DG SANCO, European Commission) states: "In the European Union, no plant protection product can be used unless it has first been scientifically established that: they have no harmful effects on consumers, farmers and local residents and passers-by; they do not cause unacceptable effects on the environment; they are sufficiently effective against pests".
Pesticide approval
The core legislation regulating the approval of pesticides on the EU market is Regulation (EC) No. 1107/2009, directly applicable in Member States. Based on the predominance of health and environment protection over agricultural production, it sets EU-wide requirements for their registration.
Other legislations related to pesticides include:
- Directive 2009/128/EC establishing a framework for sustainable use of pesticides;
- Regulation (EC) No. 1185/2009 concerning statistics on plant protection products;
- Regulation (EC) No. 396/2005 on maximum residue levels of pesticides in or on food and feed;
- Regulation (EC) No. 1272/2008 on product classification, labelling and packaging;
- Directive 2000/60/EC establishing a framework for water policy;
- Directive 98/83/EC on quality of water intended for human consumption;
- Directive 2006/118/EC on the protection of groundwater;
- Directive 2004/35/CE on environmental liability.
EU legislation requires the comprehensive testing of active substances, which is increasingly extensive and continuously updated in line with scientific advances. Therefore the products used today are the safest ever made.
Residues
The majority of foodstuffs do not contain any measurable pesticide residues. Where residues remain following application, they are strictly regulated and assessed according to Regulation (EC) No 396/2005.
Maximum Residue Levels (MRLs) are set by EU scientific authorities for each pesticide used on each crop. These always include wide safety margins and are well below levels that could have any adverse effect on the health of consumers.
MRLs act as an indicator of the correct use of pesticides as specified on the label, and as trading standards for imported and exported food. They are based on two key safety benchmark values, the Acceptable Daily Intake (ADI) and the Acute Reference Dose (ARfD):
- An ARfD is the amount of pesticide in food that can be ingested in one day without harmful effects; and
- An ADI value is an estimate of the human daily intake of the product over a lifetime, which would have no harmful effects.
Registering plant protection products (pesticides) in the European Union
An overview of the regulatory framework for the registration of pesticide products in the European Union.
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