Plant protection products
What are the MRL (Maximum Residue Limits)?
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
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
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
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
Why MRLs are laid down in European legislation for active substances whose use is not permitted in the EU?
In the first place it is worth dividing the scope of the two main rules,
that, although closely interrelated, are independent;
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
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
Who is who in the establishment of an MRL? How are Maximum Residue Limits determined?
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
- 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
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).
authorised pesticides and their MRLs.
Maximum residue limits in pesticides: full implementation of the new legislative framework provided for in Regulation 396/2005
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
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.