Maximum Residue Levels for unprocessed products of vegetable and animal origin (food and feed)
Basis for the reassessment of all pesticides currently in use in the European Union
|Babyfood Directive 2006/141||
Annexes IX of this Directive list specific additional rules for pesticide residues in infant formulae and follow-on formulae
Maximum residue limits for specific organochlorine compounds in feed materials
Pesticides that can be sold and used have to first be authorised. Currently, active substances (the chemically active part of a manufactured product) is authorised at the European level. This authorisation has to take place before an active substance can be sold and then again at regular intervals for as long as it is on the market.
Once an active substance has been authorised it is then up to individual Member States to decide whether to authorise particular pesticide formulations (also known as pesticide products).
The rules concerning the placing of plant protection products on the market are laid down in Regulation 1107/2009 (consolidated version).
MRLs Maximum residue levels
Pesticides used in agriculture will often be detectable as residues in food or feed products. The EU sets what are known as ‘Maximum Residue Levels’ for each individual active substance that is authorised for use. The traces pesticides leave in treated products are called "residues".
A maximum residue level (MRL) is the highest level of a pesticide residue that is legally tolerated in or on food or feed when pesticides are applied correctly (Good Agricultural Practice). MRLs are set for unprocessed products of vegetable and animal origin intended for human consumption and for feed.
How are MRLs fixed?
To ensure that MRLs are as low as possible, applicants for an MRL have to submit scientific information about the minimum amounts of pesticide necessary to protect a crop and the residue level remaining on the crop after such treatment. This information have to come from supervised trials under specified use conditions (Good Agricultural Practice = GAP).
The European Food Safety Authority (EFSA) is responsible for the evaluation of intended new MRLs. To determine whether an MRL is acceptable, the intake of residues through all food that may be treated with that pesticide is calculated and compared with the ADI*) and the ARfD**), for long and short term intake and for all available models of European consumer groups. When there is a risk established for any consumer group, the MRL application will be rejected and the pesticide may not be used on that crop. Food safety thus has priority over plant protection.
In case that the MRL requested is not considered safe, the lowest limit of analytical determination (LOD) is set as the MRL. The LOD is also set for crops on which there are no uses of the pesticide and when uses do not leave any detectable residues. The default LOD in the EU legislation is 0.01 mg/kg.
*) ADI (Acceptable Daily Intake) reflects the chronic toxicity. It is the estimate of the amount of a substance in food, expressed on a body-weight basis that can be ingested daily over a lifetime without appreciable health risk to the consumer.
**) ARfD (Acute Reference Dose) reflects the acute toxicity. It is the estimate of the amount of a substance in food, expressed on a body-weight basis that can be ingested over a short period of time, usually during one meal or one day, without appreciable health risk to the consumer.
MRL EC Regulation No. 396/2005
From 1 September 2008, a 'new' legislative framework on pesticide residues is applicable. With these new set of rules, the harmonization and simplification of pesticide MRLs is completed, whilst ensuring better consumer protection throughout the EU.
The former MRL-regime was too complex as it combined harmonized EU and divergent national rules. This situation led to confusion about which MRL was applicable. It made the life of traders and importers difficult and gave rise to questions from consumers.
Regulation (EC) No. 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC is the result of a considerable joint effort by the Commission, the European Food Safety Authority (EFSA) and the Member States. The Annexes to Regulation (EC) No. 396/2005 specify the MRLs and the products to which they apply.
Annex I is the list of products to which the MRLs apply. It has been established by Commission Regulation (EC) No 178/2006. It contains 315 products, including oilseeds and oilfruits and animal products. Annex 1 has been changed to Regulation (EU) 2018/62.
If a pesticide is not included in any of the above mentioned Annexes, the default MRL of 0.01 mg/kg applies (Article 18(1b) of Regulation (EC) No. 396/2005).
EU MRL database
Since the MRLs are subject to changes, the European Commission has developed a database with all EU harmonised MRLs, which is always up-to-date.
This database is available since September 2008 following the enforcement of EU Regulation 396/2005. From that time all the European legislation on pesticides MRLs were harmonised.
The MRLs can be viewed by crop, by crop group, by crop code or by pesticides in all EU languages. A link is made to the legislation where the MRL is adopted and the history of changes to the MRLs can be follwed. Moreover, the information can be exported in excel format.
The database with EU harmonised MRLs can be found here.
MRL’s for feed products / GMP+ FSA
The maximum residue levels of pesticides (MRL) of the GMP+ FC scheme are based on EU Regulations, namely Regulation (EC) No. 396/2005 and Directive 2002/32/EG, Annex I, part IV regarding undesirable substances in feed.
The MRLs in 396/2005 are applicable to unprocessed products of vegetable and animal origin, with destination food or feed products. The structure/design of the Regulation No. 396/2005 is as such, that in many cases it is not immediately possible to indicate a MRL for a certain combination of feed / pesticide. Therefore chapter 4 in GMP+ BA1 provides guidance in finding the applicable MRL.
MRLs for babyfood
Annexes IX of Directive 2006/141/EC lists specific additional rules for pesticide residues in infant formulae and follow-on formulae.