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Plant protection products
What are the MRL (Maximum Residue Limits)?
September 2010
In the European Union, active substances of phytosanitary products can not be approved unless it has been scientifically proven before that:
- they do not have adverse effects on consumers, farmers or others, and
- they do not cause unacceptable effects on the environment, and
- they are sufficiently effective.
The use of pesticides on crops could result in residues, for example consequences of the use of phytosanitary products, including its metabolites and products resulting from its degradation or reaction.
Report on the presence of quaternary ammonium compounds in foods and feed. Resulting official control actions
Seen in the technical discussion forum meeting of the 4 October, 2012.
The Standing Committee on the Food Chain and Animal Health with representation of 27 EU Member States has recently adopted the risk management measures proposed by the European Commission concerning the presence of quaternary ammonium residue compounds above the MRL (maximum residue limit) in different food products, especially two chemical substances belonging to this group: didecyl dimethyl ammonium chloride (DDAC) and benzalkonium chloride (BAC).
Additionally, a strategic sampling plan has been devised for all EU Member States including a number of samples, which enables precise identification of the origin of quaternary ammonium residue compounds in food. Maximum limits (MRL) can then be set with more precision in accordance with Regulation (EC) No 396/2005 in such a way that ensures consumer health protection at all times
Límites Máximos de Residuos (LMRs) en productos alimenticios transformados
El marco legislativo en materia de residuos de plaguicidas se encuentra establecido en el Reglamento (CE) Nº 396/2005, del Parlamento Europeo y del Consejo relativo a los limites de residuos de plaguicidas (LMR) en alimentos y piensos de origen animal y vegetal y que modifica la Directiva 91/414/CEE del Consejo (Diario Oficial de la Unión Europea serie L70 del 16.03.05). En sus Anexos II y III se listan estos LMRs, los cuales, además se pueden consultar con facilidad en la base de datos disponible en la siguiente dirección de Internet: http://ec.europa.eu/sanco_pesticides/public/index.cfm
Sin embargo, y echando un vistazo a su Anexo I, se descubre que dichos límites se fijan sobre materias primas sin transformar, por ejemplo, uvas para vinificación en lugar de el vino, aceitunas para producción de aceite en lugar de aceite, uvas de mesa en lugar de pasas.
Es por ello que para conocer el LMR en productos transformados se hace necesario aplicar factores de transformación (concentración, dilución…etc.) sobre el LMR del producto inicial, según se establece en el artículo 20.1 del Reglamento anteriormente mencionado. A modo de ejemplo si el LMR para Trifloxystrobin es 0.3 mg/kg en aceitunas para la producción de aceite, y se considera un factor de, por ejemplo, 4 (es una sustancia activa soluble en grasa), la cantidad máxima de trifloxystrobin legalmente admitida en una muestra de aceite es de 1.2 mg/kg.
Dichos factores se recogerán próximamente en el anexo VI del Reglamento 396/2005 (aún no publicado), y es con este fin con el que la AESAN está trabajando actualmente en diversos foros como el Codex Alimentarius y la Comisión Europea.
Why MRLs are laid down in European legislation for active substances whose use is not permitted in the EU?
September 2010
In the first place it is worth dividing the scope of the two main rules, that, although closely interrelated, are independent;
- The Directive 91/414/EEC regulates the marketing and use of phytosanitary products. An active substance can be used in the EU to build a phytosanitary product if it is included in Annex I of the Directive (which will be replaced next year by Regulation (EU) No. 1107/2009). The authorization for the marketing and use of phytosanitary products in Spain is granted by the Directorate General of Agricultural and Livestock Resources of the Ministry of Environment and Rural and Marine.
- The Regulation (EU) No. 396/2005 is a rule of Public Health that establishes the MRLs of active substances in food as a result of the use of phytosanitary products.
Who is who in the establishment of an MRL? How are Maximum Residue Limits determined?
September 2010
While MRL applications are processed through a community procedure, authorization-registration of phytosanitary products remains the exclusive competence of the Member States in order to adequately take into account the particular characteristics of its climate-region ... etc.
- The competent national authorities of the Member States are responsible for the evaluation of risks on consumers related to such a measure (AESAN), as well as the registration of the use of the phytosanitary product (Ministry of Environment, Rural and Marine.). At the same time they are also in charge of the monitoring and the implementation of these MRLs (Autonomous Communities).
- The European Commission sets MRLs for all food and feed, based on the report on the consumer risk assessment of the EFSA (European Food Safety Authority), and with prior consultation with Member States through the Permanent Committee of the Food Chain and Animal Health.
Publication of a database for consultations on authorised pesticides and their MRL in food and animal feed
March 2009
The European Commission, in collaboration with EFSA (European Food Safety Authority) and the Member States, has completed a review of the approximately 1000 active substances that form part of pesticides existing in the EU before 1993. Only 250 of these have satisfactorily passed the risk assessment, which was based on three core principles:
- They must have no harmful effects on consumers, farmers or other people coming into contact with them.
- They must not harm the environment.
- They must be sufficiently effective as a pesticide.
In order that the information can be easily distributed and consulted, the European Commission has created an authorised pesticide database, so that the legal reference, toxicological information and Maximum Residue Limits (MRLs) permitted for each combination of pesticide-food can be consulted for each active substance (also in Spanish).
Maximum residue limits in pesticides: full implementation of the new legislative framework provided for in Regulation 396/2005
03/09/2008
The new legislative framework on pesticide residues laid down in Regulation (EC) No 396/2005 of 23 February 2005 of the European Parliament and of the Council has been fully implemented since Monday, 1 September. It concerns the maximum limits of pesticide residues in food and animal feed of plant and animal origin, and modifies Directive 91/141/EEC of the Council, as provisions in annexes II, III and IV, containing the maximum limit values for residues applying to each of the possible plant/pesticide combinations. The regulation was last updated on 30 August last through Commission Regulation (EC) No 839/2008 of 31 July 2008.
Report on authorisations for plant health products: Determining the risk of exposure to consumers
31/03/2006
The Spanish Agency for Food Safety is responsible for providing information on plant health products, as laid down in article 4.2.d) of royal Decree 709/2002, 19 July, approving the Statute of the Spanish Agency for Food Safety. The basis of this report is the determining the risk of exposure to consumers using the plant health products.
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