Regulation of pesticides in the European Union

A pesticide, also called Plant Protection Product (PPP), which is a term used in regulatory documents, consists of several different components.

The aims of these active substances are to specifically take action against organisms that are harmful to plants (Art.

These regulatory documents are set to ensure safe use of pesticides in the EU regarding human health and environmental sustainability.

Additionally, important stakeholders are the chemical producing companies, which develop PPPs and active substances that are to be evaluated by the regulatory authorities mentioned above.

They will also consider wider issues around the authorisation of pesticides.In the EU, there is a detailed procedure (Regulation (EC) No 1107/2009[1]) to evaluate whether an active substance is regarded as safe for human health and the environment.

If additional information is needed, the Rapporteur Member State will set a period of maximum 6 months for the submission of the revised application.

European Food Safety Authority’s Pesticides Unit[6] is responsible for the peer reviewing of the risk assessments on active substances.

After the conclusion of EFSA, the European Commission presents a review report to the Standing Committee for Food Chain and Animal Health.

The European Commission has subsequently the task of managing and updating the list of approved active substances, which is available online for the public.

If a PPP is given authorisation, it often has certain restrictions regarding the distribution and use, like mentioned in the “Requirements and content” above, in order to protect human health and the environment.

No matter what the Member State decides on, they have to justify the outcome of the evaluation in a document and provide it to both the applicant seeking authorisation, and the European Commission (Art.

A company or organization in possession of a valid authorisation for a PPP can apply for mutual recognition and obtain the approval for such products with the same use(s) under similar agricultural conditions.

The objectives of the system are: help harmonising the formal requirements for application among Member States, facilitate mutual recognition of authorisations between Member States in order to speed up time to market, improve the management of the evaluation of the authorisation process as wells as providing correct information to stakeholders on time.

The Member States also conduct this evaluation, but in the future this will be done through the Plant Protection Products Application Management Systems.

If there are acute concerns for human, animal and/or environmental health the PPPs should be immediately withdrawn from the market.

An authorisation will not be granted where the assessment of risks and benefits concludes that – among others – a substitution of the PPP is significantly safer for the environment, humans and animals, and not economically or practically disadvantageous (Art.

To ensure that PPPs are handled properly, a considerable amount of information is to be provided by the holder of an authorisation for such a product (Art.

New information on potential harmful effects on human or animal health concerning the PPP itself, its active substances, any associated metabolites, safeners or co-formulants have to be reported immediately to the Member State(s) that granted its authorisation.

In order to protect human health and the environment, monitoring of PPP residues in food is a crucial step.

In September 2008, the European Union issued new and revised Maximum Residue Limits (MRLs) in plants for the roughly 1,100 pesticides ever used in the world.

[15] The monitoring of the determined Maximum Residue Levels (MRLs) of pesticides in food is the duty of the responsible authorities of the Member States.

The chronic risk assessment is the estimated uptake and/or exposure levels of pesticide residues via food for a long-term period (predicted lifetime of a human).

There is not a high probability of health risk for consumers if the modelled values are equal or lower than the reference data.

The modelling starts with a conservative approach (e.g. consumers do not wash and/or cook the products) which may result in an overestimation of the actual toxicity of the respective pesticide.

The samples were taken from 11 different food products (aubergines, bananas, broccoli, virgin olive oil, orange juice, peas without pods, sweet peppers, table grapes, wheat, butter, and eggs).

The concentrations of pesticides alongside other chemical substances that pose a significant risk to the environment or to human health in surface waters in the European Union are limited to Environmental Quality Standards.

It is the responsibility of the Member States to establish monitoring programmes for Environmental Quality Standards and to incorporate these into river basin management plans.

Pesticides included in Directive on Environmental Quality Standards are to a large extent banned and not used in Europe.

Reported data are sparse due to the geographic extent and the large quantity of different chemical substances used as pesticides in agriculture.

[20] However, there is a variety of pesticide monitoring programmes within the European Union, independently of EU regulatory frameworks.