Updated June 2011
A possible consequence of plant protection products (PPP) use may be the presence of residues in the treated products. In order to protect consumers from exposure to unacceptable levels of residues in food and feed, maximum residue levels (MRLs) are set by the European Commission. The pesticide residues found in food must be as low as possible and must be safe for consumers, corresponding to the lowest amount of pesticide that needs to be used on the crop in order to achieve the desired efficacy. A maximum residue level (MRL) is the highest possible level of a pesticide residue that is legally authorised in food and feed.
The EU legislation concerning pesticide MRLs covers food and feed produced in the EU, as well as imports from third countries (including ACP countries).
On 1 September 2008, Regulation (EC) No 396/2005 came into force. This set harmonised pesticide MRLs for all countries in the EU. The previous MRL regime was too complex as it included harmonised EU as well as divergent national (Member State) rules. This situation led to confusion about which MRL was applicable, and made the life of traders and importers difficult, particularly in cases where food exceeding the defined MRL in one Member State was acceptable in another.
The new harmonised provisions aim to facilitate trade and reduce potential technical barriers. However, it is important to note that there are differences between Codex and EU MRLs, as some EU MRLs are set lower or at the limit of determination. This could be critical because Codex MRLs are the ones used by the WTO in cases of dispute.
All decision-making in this area has to be science-based. To set an MRL, a consumer intake assessment has to be carried out by the rapporteur member state and EFSA. The assessments are based on the properties of the pesticide, on the maximum levels expected on food, and on the different diets of European consumers. These take into consideration the safety of all consumer groups, including, for example, babies, children and vegetarians.
Farmers, traders and importers are responsible for food safety, including compliance with MRLs. Member State authorities are responsible for the control and enforcement of the MRLs. The Commission carries out inspections in Member States to assess and audit their control activities.
A database on the European Commission's website specifies the MRL applicable to each crop and pesticide. This is freely accessible to guarantee transparent and up-to-date information on the EU pesticide residues legislation: http://ec.europa.eu/sanco_pesticides/public/index.cfm
The Annexes to Reg. (EC) No 396/2005 specify the MRLs and the products to which they apply:
- Annex I is the list of products (crops) to which the MRLs apply. Annex I has been established by Commission Regulation (EC) No 178/2006. It contains 315 products, including fruits, vegetables, spices, cereals, and animal products.
- Annex II is the list of EU definitive MRLs and it consolidates the existing EU legislation before 1 September 2008. It specifies MRLs for 245 pesticides.
- 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. It specifies MRLs for 471 pesticides.
- Annex IV is the list of pesticides (52) for which no MRLs are needed because of their low risk.
- Annex V will contain the list of pesticides for which a default limit other than 0,01 mg/kg will apply. This Annex has not been published yet.
- Annex VI will contain the list of conversion factors of MRLs for processed commodities. This Annex has not been published 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.
If a pesticide is not included in any of the above mentioned Annexes, the MRL is set at the default MRL of 0.01 mg/kg (Art 18(1b) of Reg. (EC) No 396/2005).
If substances are not included in these Annexes (and thus have no MRL), it is still possible to use these on crops being exported to the EU under the following circumstances:
• If the residue levels do not exceed the default MRL (LOQ) of 0.01 mg/kg
• Where there is an Import Tolerance (IT). In cases where there is no EU MRL for a pesticide that is used on a commodity imported into the EU, and where the residue exceeds the default LOQ, an application for an Import Tolerance can be submitted to the EU authorities. The dossier for an IT application must contain information on residues, toxicology, and risks to consumers, as well as an approval for use in the producing country, and a proposed MRL. An IT is a tolerance for a pesticide residue on an imported food or feed for which there is no EU MRL, but that meets EU safety standards.
• Where there is an approved Extrapolation from an existing MRL on a representative crop in the same crop group (e.g. from French beans to snow peas).
A problem facing the fruit and vegetable sector, in particular in ACP countries, is that many crops are classed as “minor crops” because they represent a small market for the plant protection product (PPP) industry. Generating the data needed to establish an MRL is expensive, and for many minor crops in ACP countries it is not an attractive investment for the PPP companies; the market is simply too small to cover the costs. Because of this, in a number of ACP fruit and vegetable crops, there are few or no MRLs for substances needed to control important pests or diseases.
PIP supports the ACP horticultural export sector in the most critical cases where there is no MRL for an affordable and available pesticide to control a serious and economically important pest. In these cases PIP becomes involved in the normally industry-led functions of generating data and establishing MRLs. This is conducted in partnership with plant protection product companies and ACP regulatory authorities. Between 2001 and 2009, PIP secured 39 new MRLs or ITs and 3 extrapolations.
Update on the Review process Under Article 12 Of Regulation 396/2005/EC (July 2011)
Article 12 of Regulation 396/2005 provides for a review of all MRLs:
- a) after the inclusion of an active substance in Annex 1 to Directive 91/414/EEC (Article 12(1));
- b) for those substances already in Annex I at the time of the adoption of 396/2005 in September 2008 (Article 12(2)).
The original timetable set out in Article 12 for these reviews was missed and so the exercise has been combined into a single review programme covering both substances included and not included in Annex I. The aim is to check that MRLs are set on the basis of a complete data package that conforms to modern standards. It is anticipated that some 300 active substances will be covered by the review, which is likely to take 3 – 4 years to complete.
The review is being conducted by the European Food Safety Authority (EFSA) on the basis of information supplied by Member States (MS). All MS were required to submit details of Good Agricultural Practices (GAPs) for their approved uses. These were submitted to the rapporteur MS who is responsible for identifying the critical GAP that determines the MRL. The GAPs and summary details of the supporting data were then submitted to EFSA.
These submissions to EFSA are now being reviewed and EFSA will notify the MS when a ‘draft Reasoned Opinion’ on the current MRLs for each active substance is adopted.
During 2010, four regulations were published amending EU MRLs for a certain number of active substances:
- COMMISSION REGULATION (EU) No 893/2010 of 8 October 2010 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards MRLs for acequinocyl, bentazone, carbendazim, cyfluthrin, fenamidone, fenazaquin, flonicamid, flutriafol, imidacloprid, ioxynil, metconazole, prothioconazole, tebufenozide and thiophanate-methyl in or on certain products
- COMMISSION REGULATION (EU) No 765/2010 of 25 August 2010 amending Annexes II and III as regards MRLs for chlorothalonil clothianidin, difenoconazole, fenhexamid, flubendiamide, nicotine, spirotetramat, thiacloprid and thiamethoxam in or on certain products
- COMMISSION REGULATION (EU) No 750/2010 of 7 July 2010 amending Annexes II and III as regards MRLs for: acibenzolar-S-methyl, amisulbrom, ametoctradin, azoxystrobin, bixafen, dimethomorph, dithiocarbamates (mancozeb), fipronil, fludioxonil, imazalil, prohexadione, pyraclostrobin, thiacloprid , pirimicarb, prosulfocarb, tebuconazole, triclopyr and valiphenal in or on certain product
- COMMISSION REGULATION (EU) No 459/2010 of 27 May 2010 amending Annexes II, III and IV as regards MRLs for: azoxystrobin, cypermethrin, ethephon, fenttrothion, indoxacarb, lamda-cyhalthrin, methomyl & thodicarb, profenofos, pyraclostrobin, thiachloprid, triadimefon & triadimenol, trifloxystrobin in or on certain products.
During 2011, five regulations have so far been published amending EU MRLs for a certain number of active substances:
- COMMISSION REGULATION (EU) No 508/2011 of 24 May 2011 concerning MRLs for abamectin, acetamiprid, cyprodinil, difenoconazole, dimethomorph, fenhexamid, proquinazid, prothioconazole, pyraclostrobin, spirotetramat, thiacloprid, thiamethoxam, trifloxystrobin in or on certain products
- COMMISSION REGULATION (EU) No 310/2011 of 28 March 2011 concerning MRLs for aldicarb, bromopropylate, chlorfenvinphos, endosulfan, EPTC, ethion, fenthion, fomesafen, methabenzthiazuron, methidathion, simazine, tetradifon, triforine in or on certain products
- COMMISSION REGULATION (EU) No 520/2011 of 25 May 2011 for benalaxil, boscalid, buprofezin, carbofuran, carbosulfan, cypermethrin, fluopicolide, hexythiazox, indoxacarb, metaflumizon, metoxyfenozide, paraquat, procloraz, spirodiclofen, protioconazolo and zoxamide in or on certain products
- COMMISSION REGULATION (EU) No 524/2011 of 26 May 2011 for biphenyl, deltamethrin, ethofumesate, isopyrazam, propiconazole, pymetrozine, pyrimethanil and tebuconazole in or on certain products
- COMMISSION REGULATION (EU) No 559/2011 of 7 June 2011 for captan, carbendazim, cyromazine, ethephon, fenamiphos, thiophanate-methyl, triasulfuron and triticonazole in or on certain products
MRL changes are regularly updated on the PIP website.