Background
Pesticides are used to protect crops before and after harvest from infestation by pests and plant diseases. A possible consequence of their use may be the presence of pesticide residues in food.
Maximum Residue Levels (MRLs) are set to reflect the highest amount of pesticide residue expected in food when pesticides are applied correctly (in accordance with approved conditions of use). MRLs are primarily trading standards, but they also help ensure that residue levels do not pose unacceptable risks for consumers.
Farmers, importers, distributors and retailers are responsible for ensuring marketed food complies with all statutory MRLs set. National authorities are responsible for control and enforcement of the MRLs. Checks entail taking samples, analysing them and identifying the pesticides and respective pesticide levels present.
Details of the UK’s official residues monitoring programme can be viewed on the Committee on Pesticide Residues in Food (PRiF) home page.
Statutory arrangements governing MRLs
Until September 2008, the legislation for pesticide residues was a shared responsibility of the Commission and the Member States. Since 1976, more than 45,000 Community MRLs have been set for various commodities for 245 pesticides on fruit and vegetables, cereals, and foodstuff of animal origin. For the tens of thousands of pesticide/commodity combinations for which no Community MRLs existed, Member States could set MRLs at national level to facilitate trade and to protect the health of their consumers. Member States could also overwrite some EC MRLs with higher National MRLs to accommodate new uses in the Member State concerned.
Since September 2008 all statutory MRLs are set on an EC-wide basis, under EC Regulation 396/2005. This Regulation provides a harmonised system of MRLs setting, and applies to all foods treated with pesticides after 1 September 2008.
The Annexes to Regulation 396/2005 specify the MRLs and the food commodities to which they apply. All substances acting as pesticides are subject to these Regulations, whether or not they have authorised uses within the EC.
Annex I is the list of products to which the MRLs apply. Annex I has been established by Commission Regulation (EC) No 212/2013. It includes over 315 food commodities incorporating fruits, vegetables, spices, cereals, and animal products. MRLs are not yet set for fish and animal feeds, but these are expected to be added in the future.
Annex II is the list of EU definitive MRLs and it consolidates the existing EU legislation before 1 September 2008.
Annex III is the list of the so-called EU temporary MRLs. It is the result of the harmonisation process as it lists pesticides for which, before 1 September 2008, MRLs were only set at national level.
Annex IV lists pesticides for which no MRLs will be set because the residues resulting from pesticide use cannot be distinguished from levels arising naturally.
Annex V will contain the list of pesticides for which a default limit other than 0.01 mg/kg (see below) will apply. This Annex has not been developed yet.
Annex VI will contain the list of conversion factors of MRLs for processed commodities. This Annex has not been developed yet.
Annex VII contains a list of pesticides used as fumigants for which the Member States are allowed to apply special derogations before the products are placed on the market. The current listing for this Annex is published under Commission Regulation (EC) No 260/2008.
If a pesticide is not included in any of the above mentioned Annexes the default MRL of 0.01 mg/kg applies (Art 18(1b) of Reg. (EC) No 396/2005).
The current levels set under Annexes II and III, and the listing for Annex IV are published in two sets of Regulations – Commission Regulation (EC) No 149/2008, and Commission Regulation (EC) No 839/2008 and amending Regulations (see details on Published Commission Regulations under Regulation 396/2005).
Details of specific MRLs can be viewed by accessing CRD’s MRL database.
EC MRL setting procedures under Regulation 396/2005
Most statutory MRLs for pesticide residues are based on EC uses of pesticides authorised in accordance with EC Regulation 1107/2009.
MRL applications undergo a vigorous EU assessment to make sure that all classes of consumers, including the vulnerable ones, like babies and children, are sufficiently protected.
Applicants for an MRL have to submit data on the level of residues resulting from the specified agricultural use, and on the toxicology of the pesticide. Guidelines for making an application for a new or amended EC MRL can be found at the following link: The Applicant Guide: Maximum Residue Levels and Import Tolerances .
The level of the MRL is determined by 'supervised trials'. From the toxicological information an Acceptable Daily Intake (ADI) and an Acute Reference Dose (ARfD) are derived.
The acceptable daily intake (ADI) reflects the chronic toxicity of the pesticide. 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.
The acute reference dose (ARfD) reflects the acute toxicity of the pesticide. 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.
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.
Where an MRL requested is considered to be unsafe, and no alternative safe level is proposed, 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 MRL is 0.01 mg/kg.
The European Food Safety Authority (EFSA) is responsible for the risk assessment (employing supporting data and assessments from Member States) and evaluates each intended new MRL.
Based on EFSA's opinion, the EC Standing Committee on the Food Chain and Animal Health (SCFCAH - made up of representatives of the Commission and Member States) can propose a Regulation to establish a new MRL or to amend or remove an existing MRL. These proposals are subject to scrutiny by the European Parliament before a Regulation can be passed into law.
Applications for MRLs to cover uses of pesticides outside the EC
MRLs set under EC Regulation 396/2005 apply to all foods marketed within the EC, irrespective of whether they are produced within the EC or outside the EC. This means that in some cases, MRLs that have been based on EC uses of pesticides will not be sufficient to cover the residues resulting from uses in third countries.
In these circumstances importers or other interested parties must apply for appropriate MRLs (‘import tolerances’) before the products concerned are imported. Guidelines for making an application for an import tolerance can be found at the following link: The Applicant Guide: Maximum Residue Levels and Import Tolerances .
Non-statutory (Codex) MRLs
In addition to statutory EC MRLs, international non-statutory (Codex) levels are set for a wide variety of pesticide/commodity combinations. The Codex Alimentarius Commission (CAC) (responsible for setting Codex MRLs) is an international body that aims to protect the health of consumers, ensure fair trade practices in the food trade, and promote co-ordination of all food standards work undertaken by international governmental and non-governmental organisations.
Where produce is marketed within the EC and an EC MRL exists, it is the EC MRL that must be complied with (including, where appropriate, any default level that applies).
Contact information
Further clarification can be obtained from Russell Wedgbury; tel 01904 455780; fax 01904 455733; e-mail russell.wedgbury@hse.gsi.gov.uk
