Tag Archives: Plant health legislation

Placing of plant protection products on the market

Placing of plant protection products on the market

Outline of the Community (European Union) legislation about Placing of plant protection products on the market


These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Plant health checks

Placing of plant protection products on the market

Document or Iniciative

Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC.


The Regulation confirms the importance that the European Commission places on a higher level of health and environmental protection, whilst seeking to harmonise the placing of plant protection products * on the market. Furthermore, it aims to improve agricultural production.

The scope of this Regulation covers plant protection products and their active substances *.

The Regulation lays down approval criteria for active substances. An active substance shall be approved if it fulfils the criteria detailed in points 2 and 3 of Annex II to the Regulation. These criteria relate to the efficacy of the substance, its composition, its characteristics, the methods of analysis available, the impact on human health and the environment, ecotoxicology and the relevance of metabolites and residues. As such, an active substance shall only be approved if it is not classified as category 1A or 1B mutagenic, carcinogenic or toxic for reproduction, and is not considered to have endocrine disrupting properties. Furthermore, an active substance which is considered to be a persistent organic pollutant, or as persistent, bioaccumulative and toxic, or even as a very persistent and very bioaccumulative substance, shall not be approved.

The first approval is valid for a limited period which cannot exceed ten years and may be subject to certain conditions or restrictions regarding, for example, the purity of the active substance, the intended crop and the category of user.

Authorisation to place plant protection products on the market remains the responsibility of Member States. Applications are submitted to the Member State where the product is intended to be placed on the market for the first time. Applications shall be accompanied by two dossiers containing all the information available to enable the potential effects of the plant protection product on human and animal health, and the possible impact on the environment, to be assessed. The information provided by the applicant or the producer may be protected by a confidentiality clause if it constitutes an industrial or trade secret.

The time required to examine the application for authorisation to place a plant protection product on the market is limited to a period of twelve months, commencing on the date that the Member State receives the application. During this period, the Member State shall check whether the product concerned satisfies the authorisation conditions. If further information is required, the Member State may extend the initial assessment period in order to allow the applicant time to provide it. This period may not exceed six months and shall expire when the Member State receives the additional information. Where at the end of that period, the applicant has not submitted the missing elements, the Member State shall inform the applicant that the application is inadmissible.

Authorisation for placing on the market is valid for 10 years and may be renewed. A Member State may review an authorisation at any time if it no longer complies with one of the pre-conditions for placing on the market. Should this be the case, a Member State may withdraw or amend the authorisation.

The principle of mutual recognition established in this Regulation enables the holder of an authorisation to place the product on the market in another Member State insofar as the agricultural, plant health and environmental conditions are comparable in the regions concerned. However, the Member State may provisionally limit or ban the movement of a product on its territory if the product in question presents a risk to human or animal health, or to the environment.

In order to ensure protection for certain crops, the Regulation enables the holder of an authorisation for a plant protection product which has already been authorised in the Member State concerned, to request that the authorisation be extended to minor uses not yet covered by that authorisation. These extensions of use are also covered by the principle of mutual recognition.

Member States shall update the information on authorised or withdrawn plant protection products at least once every three months. This information shall be accessible to the public.

A provisional authorisation may be granted for the placing on the market of plant protection products containing an active substance which has not yet been approved. The provisional authorisation shall be granted for a period not exceeding three years.

The classification, labelling and packaging of plant protection products is also subject to the requirements provided for by Directive 1999/45/EC regarding dangerous preparations. The packaging of the aforementioned products should prevent consumers from using the products incorrectly.

Member States shall carry out official controls in order to enforce compliance with this Regulation. They shall finalise and transmit to the Commission a report on the scope and the results of these controls within six months of the end of the year to which the report relates. The Commission shall call on experts to carry out general and specific audits in the Member States. The aim of these audits is to verify the official controls carried out by the Member States.

The Commission may adopt emergency measures in order to restrict or prohibit the use and/or sale of a plant protection product if it is likely to constitute a serious risk to human or animal health or the environment, and that such a risk cannot be contained by the Member State(s) concerned.


On 14 June 2011, this Regulation shall repeal and replace:

  • Directive 79/117/EEC concerning prohibited plant protection products; and
  • Directive 91/414/EEC concerning authorised plant protection products.
Key terms of the Act
  • Plant protection product: products consisting of or containing active substances, safeners or synergists, and intended for one of the following uses:
    1. protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for reasons of hygiene rather than for the protection of plants or plant products;
    2. influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient;
    3. preserving plant products, in so far as such substances or products are not subject to special Community provisions on preservatives;
    4. destroying undesired plants or parts of plants, except algae unless the products are applied on soil or water to protect plants;
    5. checking or preventing undesired growth of plants, except algae.
  • Active substances: substances or micro-organisms, including viruses, having general or specific action against harmful organisms or on plants, parts of plants or plant products.


Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1107/2009


OJ L 309 of 24.11.2009



Outline of the Community (European Union) legislation about Pesticides


These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Contamination and environmental factors


Document or Iniciative

Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides.


Pesticides are used in agriculture, to regulate the growth of plants on non-agricultural land, or for other purposes (for example, biocide products used to preserve wood, as disinfectants, and for some domestic uses). They are also used to kill or combat pests.


This Framework Directive covers only pesticides which are plant protection products. It does not apply to biocide products.

Member States may apply the precautionary principle to restrict or prohibit the use of pesticides in specific circumstances or areas.

National Action Plans

National Action Plans shall contain objectives, measures and timetables to reduce risks of pesticide use on human health and the environment. They should also foster the use of alternative ecological approaches or techniques.

National Action Plans shall also include indicators to monitor the use of plant protection products containing active substances of particular concern.

Training, sales of pesticides, and information

Member States shall set up systems of training for professional users, distributors and advisors. This training shall be sanctioned by the obtaining of a certificate. These certificates shall attest that professional users, distributors and advisors have acquired sufficient knowledge regarding: the legislation in force, the dangers and risks associated with pesticides, means of detection and monitoring, procedures for preparing equipment, emergency action in case of accident, etc.

Persons selling pesticides for professional use must hold the aforementioned certificate.

Member States shall inform the public and promote information and awareness-raising programmes regarding the risks for human health, non-target organisms and the environment arising from pesticide use.

Inspection of pesticide application equipment

Pesticide application equipment used by professionals must be inspected every five years by bodies designated by Member States. From 2020, the frequency of inspections will increase to once every three years. The purpose of these inspections is to check that equipment functions reliably and that it is used properly for its intended purpose, ensuring that pesticides can be accurately dosed and distributed.

These inspections concern the following equipment: power transmission parts, pumps, agitation devices, tanks, measuring systems, control and regulation systems, pipes and hoses, filters, etc.

Aerial spraying of pesticides

The aerial spraying of pesticides is prohibited. Derogations are nevertheless possible where there is no viable alternative, or where aerial spraying has advantages in terms of reduced impacts on human health and the environment as compared with land-based application. If a derogation is granted, measures must be taken as regards information and protection.

Protection of the aquatic environment and drinking water

Member States shall adopt specific measures to protect the aquatic environment and drinking water supplies. These measures give priority to the use of the least toxic products, the most effective techniques, equipment limiting drift of products, and the establishment of buffer zones along surface waters. These measures also aim at reducing or prohibiting spraying near roads or railways, or surfaces likely to be contaminated by the seepage or run-off of surface water or groundwater.

Protection of sensitive areas

In certain sensitive areas, the use of pesticides is prohibited or strictly limited. This measure aims at protecting areas covered by the “Birds” and “Habitats” Directives, and areas used by the general public or by sensitive groups of the population (parks, public gardens, sports grounds, recreation grounds, etc.).

Integrated pest management

Integrated pest management prioritises the least dangerous solutions for health and the environment. Professionals must therefore take into consideration all plant protection methods in order to eradicate pests. They must in particular give priority to those which cause the least disruption to agricultural ecosystems and encourage natural pest control mechanisms. These general principles for integrated pest management will become obligatory from 1 January 2014.

Risk indicators

The Commission establishes harmonised indicators according to statistics collected by the Member States. These indicators allow trends in risks from pesticide use to be estimated.

Member States may use their own national indicators in addition to the indicators harmonised at Community level.


The Framework Directive was originally one of two legislative proposals accompanying the 2006 Communication – A thematic strategy on the sustainable use of pesticides. The other legislative proposal led to the adoption of Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market.


Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 2009/128/EC



OJ L 309 of 24.11.2009

This summary is for information only. It is not designed to interpret or replace the reference document, which remains the only binding legal text.