Pesticide safety on the EU market

SUMMARY OF:

Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market

WHAT IS THE AIM OF THE REGULATION?

Regulation (EC) No 1107/2009 lays down rules for authorising the sale, use and control of plant protection products in the European Union (EU), and recognises the precautionary principle.
The regulation is complemented by the sustainable use directive (Directive 2009/128/EC), which sets out rules for the sustainable use of pesticides* (see summary).

KEY POINTS

The legislation applies to products used to protect or preserve plants, influence plants’ growth or destroy or stunt undesired plants.
An active substance (chemical, plant extract or microorganism) shall be approved if:
- plant protection products containing the active substance:
  - are effective,
  - have no immediate or delayed harmful effect on human health or animal health,
  - have no unacceptable effects on plants or the environment, and
  - do not cause unnecessary suffering or pain to vertebrates;
- residues of these products do not have any harmful effects on human health, including that of vulnerable groups, nor any unacceptable effect on the environment.
The European Commission or the relevant national authority in each EU Member State may set criteria or restrictions, such as a minimum degree of purity, type of preparation or manner and conditions of use, when approving an active substance or authorising a plant protection product for use.
The Commission gives its first approval for an active substance for a period not exceeding 10 years (or 15 years for low-risk active substances). A renewal of approval may be granted for no more than 15 years.
Applications for approval of an active substance, accompanied by the necessary scientific information, must be submitted to national authorities. They have a maximum of 12 months to examine the request, which is then peer-reviewed by Member States and the European Food Safety Authority.
Holders of an authorisation of a plant protection product for use in one Member State may use the mutual recognition procedure to request its use in another Member State.

The Commission has adopted the following legislation:

Implementing Regulation (EU) No 540/2011 as regards the list of approved active substances, which is amended regularly;
Regulation (EU) No 546/2011 implementing Regulation (EC) No 1107/2009 as regards uniform principles for evaluation and authorisation of plant protection products;
Regulation (EU) No 547/2011 implementing Regulation (EC) No 1107/2009 as regards labelling requirements for plant protection products (Annex I), the standard phrases for special risks to human or animal health and to the environment (Annex II) and standard phrases for safety precautions for the protection of human or animal health or of the environment (Annex III);
Regulation (EU) No 283/2013 setting out the data requirements for active substances, which has been amended several times to take into account current scientific and technical knowledge;
Regulation (EU) No 284/2013 setting out the data requirements for plant protection products, which has been amended several times to take into account current scientific and technical knowledge;
Implementing Regulation (EU) 2023/564 as regards the content and format of the records of plant protection products kept by professional users;
Implementing Regulation (EU) 2023/574 setting out detailed rules for the identification of unacceptable co-formulants in plant protection products; and
Regulation (EU) 2024/1487 defining data requirements for the approval of safeners* and synergists* and establishing a work programme for the gradual review of safeners and synergists on the market.

FROM WHEN DOES THE REGULATION APPLY?

It has applied since 14 June 2011.

BACKGROUND

The EU attaches great importance to protecting human and animal health and the environment. Standardising rules on placing plant protection products on the market helps to achieve this, ensures the smooth working of the single market and improves agricultural production.

For further information, see:

Pesticides (European Commission).

KEY TERMS

Pesticide. Something that prevents, destroys or controls a harmful organism (pest) or disease, or protects plants or plant products during production, storage and transport. Pesticide is a broader term than plant protection product since it covers non-plant/crop uses such as biocides.

Safener. A substance or preparation that is added to a plant protection product to eliminate or reduce the phytotoxic effects of the plant protection product on certain plants.

Synergist. A substance or preparation that can give enhanced activity to the active substance(s) in a plant protection product.

MAIN DOCUMENT

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 (OJ L 309, 24.11.2009, pp. 1–50).

Successive amendments to Regulation (EC) No 1107/2009 have been incorporated into the original text. This consolidated version is of documentary value only.