Help Print this page 
Title and reference
Placing of plant protection products on the market

Summaries of EU legislation: direct access to the main summaries page.
Languages and formats available
BG ES CS DA DE ET EL EN FR GA HR IT LV LT HU MT NL PL PT RO SK SL FI SV
HTML html ES html CS html DA html DE html EL html EN html FR html IT html HU html NL html PL html PT html RO html FI html SV
Multilingual display
Text

Placing of plant protection products on the market

This Regulation lays down rules for the authorisation of plant protection products in commercial form and for their placing on the market, use and control within the Union. This Regulation increases the level of health and environmental protection, contributes to better protection of agricultural production, enlarges and consolidates the internal market for plant protection products.

ACT

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.

SUMMARY

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.

Scope

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

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 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.

Issuing Marketing Authorisation

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 Marketing Authorisation 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.

Validity period for Marketing Authorisations

Marketing Authorisations are 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.

A provisional authorisation may be granted for placing pharmaceutical products on the market which contain an active substance which has not yet been approved. Provisional authorisation may be granted for a period not exceeding three years.

The principle of mutual recognition

This principle 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.

Information, classification, labelling and packaging

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.

The classification, labelling and packaging of plant protection products should meet 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.

Controls and emergency measures

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.

Context

This Regulation has repealed and replaced:

REFERENCES

Act

Entry into force

Deadline for transposition in the Member States

Official Journal

Regulation (EC) No 1107/2009

14.12.2009

-

OJ L 309 of 24.11.2009

RELATED ACTS

Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market [Official Journal L 93 of 3.4.2013].

This regulation, which repeals Regulation (EU) No 544/2011, alters the conditions which dossiers to be submitted should meet for the purpose of approving active substances, namely data requirements for active chemical substances, in order to take current scientific knowledge and techniques into consideration.

Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market [Official Journal L 93 of 3.4.2013].

This regulation, which repeals Regulation (EU) No 545/2011, alters the data requirements relating to chemical preparations for the authorisation of plant protection products, in order to take current scientific knowledge and techniques into consideration.

Proposal for a Council Regulation amending Regulation (EC) No 1107/2009 of the European Parliament and of the Council by reason of the accession of Croatia [ COM(2013) 073 final - Not published in the Official Journal].

This proposal should amend Appendix I of Regulation (EC) No 1107/2009, which defines the zones of authorisation for plant protection products. Croatia should therefore become part of zone C - South.

Proposal for a Regulation of the European Parliament and of the Council on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health, plant reproductive material, plant protection products and amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 1/2005, (EC) No 396/2005, (EC) No 834/2007, (EC) No 1099/2009, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No […]/2013, and Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC, 2008/120/EC and 2009/128/EC (Official controls Regulation) [ COM(2013) 265 final - Not published in the Official Journal].

The responsibility to respect EU legislation in the agri-food chain devolved to the Member States, in which the authorities ensure that the corresponding prescriptions are effectively applied, respected and executed throughout the EU. Regulation (EC No 882/2004 sets out rules on EU level which govern official control activities carried out by the Member States, in order to create an integrated and uniform approach for official controls throughout the food production chain. This proposal, which repeals and replaces Regulation No 882/2004 and various acts and sectorial provisions, reviews legislation on official controls in order to remedy the shortcomings which have been revealed following its application.

Proposal for a Regulation of the European Parliament and of the Council laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material, amending Council Directives 98/56/EC, 2000/29/EC and 2008/90/EC, Regulations (EC) No 178/2002, (EC) No 882/2004 and (EC) No 396/2005, Directive 2009/128/EC and Regulation (EC) No 1107/2009 and repealing Council Decisions 66/399/EEC, 76/894/EEC and 2009/470/EC of the Council [ COM(2013)0327 final - Not published in the Official Journal].

This Regulation proposal sets out the impact and objectives of spending relating to food production and to foodstuffs for animals for the period 2014-2020, with an upper limit of EUR 1,891,936 million at current prices. The pursued objectives are the following: i) an increased level of food production security and the production systems of these foodstuffs, ii) an improvement in sanitation levels and well-being of animals, iii) the detection and eradication of harmful organisms, iv)efficient execution of official controls. Each of these objectives is accompanied by guidelines.

Last updated: 10.04.2014

Top