Contaminants [EU]

Contaminants in food

Contaminants are substances not intentionally added to food. These substances may be present in food as a result of production, packing, transport or storage, or as a result of environmental contamination. In order to limit the negative impact of contaminants in food and to prevent the risks to human health, the European Union (EU) is taking measures to reduce the level of contaminants in food.

Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food

Regulation (EEC) No 315/93 prohibits the marketing of foodstuffs containing an unacceptable amount of residual substances. These substances, called contaminants, are present in food as a result of treatment after production or through environmental contamination. They are likely to pose a hazard to public health. For this reason, the European Union regulates the toxicologically acceptable levels of contaminants and keeps them at the lowest possible levels.

This Regulation does not apply to contaminants which are the subject of more specific rules, or to extraneous matter, such as insect fragments, animal hair, etc.

A Member State may take restrictive measures by reference to the present Regulation if it suspects that the presence of a contaminant poses a hazard to public health. If so, it must inform the other Member States and the Commission immediately and give reasons for its decision. The Commission shall examine the reasons given by the Member State as soon as possible and take appropriate measures after having consulted the Standing Committee on the Food Chain and Animal Health. This Committee assists the Commission on all matters which concern contaminants, including the establishment of authorised maximum tolerances.

Member States may not prohibit trade in foods which comply with this Regulation.

EU regulation applies to contaminants in food.  These are substances not intentionally added.  They may become present as a result of production, packing, transport or storage or as a result of environmental contamination.

EU regulation prohibits marketing of foodstuffs containing an unacceptable amount of residual substance.  The EU regulates the toxicology acceptable level of contaminants and keeps them to the lowest level.

The regulation does not apply to contaminants which are the subject of more specific rules or to extraneous matter.

A state may take restrictive measures by reference to the regulation if it suspects the presence of a contaminant poses a hazard to public health.  If this occurs it must inform the states and the commission immediately and give reasons for its decision.

Maximum pesticide limits

All foodstuffs intended for human or animal consumption in the European Union (EU) are subject to a maximum residue level (MRL) of pesticides in their composition in order to protect animal and human health. The Regulation brings together and harmonises in one text the limits that apply to different human or animal food products and, in addition, it establishes a maximum limit applicable by default.

Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 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 [See amending acts].

The Regulation establishes the maximum quantities of pesticide residues permitted in products of animal or vegetable origin intended for human or animal consumption. These maximum residue levels * (MRLs) include, on the one hand, MRLs which are specific to particular foodstuffs intended for human or animal consumption and, on the other, a general limit which applies where no specific MRL has been set.

The objective is to ensure that pesticide residues in foodstuffs do not constitute an unacceptable risk for consumer and animal health.

Foodstuffs concerned

The Regulation covers all products intended for human or animal consumption listed in Annex I.

These products are not subject to the set limits if they are intended for sowing or planting, authorised tests on active substances, manufacture of non-food products, or export outside the European Union.

Default limit and specific limits

The maximum pesticide residue level in foodstuffs is 0.01 mg/kg. This general limit is applicable ‘by default’, i.e. in all cases where an MRL has not been specifically set for a product or product type.
Some of the specific MRLs listed in Annex II are higher than the default limit.

In some cases, provisional MRLs may be set and should then be listed in Annex III. Provisional MRLs should in particular be set in the following cases:

• for honey and herbal infusions;
• in certain exceptional circumstances of contamination by plant protection products;
• for national MRLs which have not yet been harmonised;
• where new products are listed in Annex I and a Member State requests it, in order to have enough time for a comprehensive scientific assessment and provided that no risk to the consumer has been detected.

Products which do not comply with the fixed limits may not be diluted except in the case of certain processed and/or composite products listed by the Commission (Annex VI).

Exceptions to the limits

Certain substances listed by the Commission (Annex VII) may be authorised even if they exceed their MRL, if they meet the following conditions:

• the products concerned are not intended for immediate consumption;
• controls are in place to ensure that these products are not made available to the consumer;
• the other Member States and the Commission are informed of the measures.

In exceptional cases, products which do not comply with the limits set in Annexes I and II may be authorised by a Member State if the products do not represent an unacceptable risk. The Member State must immediately inform the Commission, the other Member States and the European Food Safety Authority (EFSA) so that the appropriate measures may be taken as quickly as possible (provisional MRL, etc.).

Certain active substances are not subject to any residue limit. These are the active substances present in the plant protection products assessed pursuant to Directive 91/414/EEC (on the placing of plant protection products on the market) and for which no MRL was considered necessary. They are listed in Annex IV, which the Commission is to draw up within 12 months of the entry into force of this Regulation.

Setting, amending and removing MRLs

For a plant protection product to be placed on the market pursuant to Directive 91/414/EEC, the active substances which it contains should be assessed in order to determine the threshold above which their concentration in food products presents a risk for humans and animals.

This Regulation establishes the procedure for MRL applications. Such applications must be submitted to the Member State, which communicates them to the European Food Safety Authority (EFSA).

Risk assessment is the responsibility of the EFSA, which decides on each intended new MRL, amendment or removal (except in the case of removals resulting from an authorisation of a plant protection product being revoked). The EFSA issues an opinion including the anticipated limit of determination * for the pesticide/commodity combination, and a risk assessment for cases where the admissible daily intake is exceeded.

Based on the EFSA’s opinion, the Commission issues a Regulation to establish a new MRL or to amend or remove an existing MRL.

Checking of MRLs

Based on Community and national multi-annual programmes updated every year, the Member States carry out checks on pesticide residues to ensure compliance with the MRLs. These checks entail taking samples, analysing them and identifying the pesticides and respective pesticide levels present therein.

Context

Prior to this Regulation, each Member State applied its own maximum residue limits for pesticides. Previous European legislation set different limits for different kinds of product: fruit and vegetables (Directive 76/895/EEC), cereals (Directive 86/362/EEC), foodstuffs of animal origin (Directive 86/363/EEC) and plant products, including fruit and vegetables (Directive 90/642/EEC). This Regulation repeals all these Directives, proposing harmonised maximum limits for all foodstuffs instead. It includes the same level of protection for animal feedingstuffs. It is the first time that a common limit of this type is established at European level for all types of pesticide, without distinguishing between categories of food.

The use of active substances in plant protection products is one of the best methods of protecting vegetables from harmful organisms. This use can, however, cause residues to be present in treated products, in animals fed with those products and in honey produced by bees exposed to these substances. Care should therefore be taken to ensure that levels of these residues do not present unacceptable risks for human beings and, where appropriate, for animals.

The Standing Committee on the Food Chain and Animal Health helps the Commission to reach decisions on the maximum limits applicable to pesticide residues. In the Member States, the designated national authorities manage contacts with the Commission, the EFSA, the other Member States and all the stakeholders affected by this Regulation.

Maximum levels for certain contaminants

The European Union (EU) is setting maximum levels for certain contaminants with a view to reducing their presence in foodstuffs to the lowest levels reasonably achievable by means of good manufacturing or agricultural practices. The objective is to achieve a high level of public health protection, especially for sensitive population groups, such as children or people with allergies.

Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs [See amending act(s)].

This Regulation lays down the maximum quantities for certain contaminants: nitrates, mycotoxins * (aflatoxins, ochratoxin A, patulin and Fusarium toxins), heavy metals (lead, cadmium, mercury), monochloro-propane-1, 2- diol (3-MCPD), dioxins and dioxin-type PCBs, polycyclic aromatic hydrocarbons (PAH) and inorganic tin.

Food with levels of contaminants higher than those specified in the Annex to the Regulation may not be placed on the market.

These maximum limits cover the edible part of food and also apply to compound or processed, dried or diluted foods, whereby a concentration or dilution factor may be applied or by taking into account the relative proportions of the ingredients in the compound product.

The Regulation also lays down the lowest maximum levels for contaminants which are reasonably achievable with good manufacturing practices or good agricultural practices (ALARA, As Low As Reasonably Achievable).

Nitrates

They are mainly present in vegetables (spinach, lettuce).

Some Member States are temporarily authorised to place on their national markets spinach and lettuce with levels of nitrates higher than those laid down in the Annex to the Regulation as long as these quantities remain acceptable in terms of public health. This transitional period is intended to allow the Member States affected to take the necessary steps to be able to comply with Community standards as quickly as possible.

The maximum levels of nitrates in vegetables are laid down according to the season.

The acceptable daily intake (ADI) laid down by the Scientific Committee on Food (SCF) is 3.65 mg/kg body weight.

Aflatoxins

These are genotoxic carcinogenic substances which develop at high temperatures and levels of humidity.

Sorting methods or other physical treatments enable the level of aflatoxins to be reduced for certain products such as groundnuts, nuts, dried fruit, maize and rice.

This Regulation permits higher levels of aflatoxins in these products if they are not intended for direct human consumption or use as an ingredient in food.

Ochratoxin A (OTA)

Ochratoxin A (OTA) is a mycotoxin produced by several fungi (penicillium and aspergillus species) with carcinogenic, nephrotoxic, teratogenic, immunotoxic and possibly neurotoxic properties. It has also been associated with nephropathy in humans.

It is naturally present in many crop products throughout the world, such as cereals, coffee beans, cocoa and dried fruit.

This Regulation lays down the maximum levels of the said substance for cereals, cereal products, raisins, roasted coffee, wine, grape juice, spices, liquorice and food for children.

The tolerable weekly intake (TWI) of ochratoxin A is 120 ng/kg body weight.

Patulin

Patulin is a mycotoxin produced by several types of fungus. It may be found in fruit juice, especially apple juice.

The provisional maximum tolerable daily intake for this substance is 0.4 μg/kg body weight (bw).

Fusarium toxins

A variety of Fusarium fungi produces a number of mycotoxins * of the trichothecenes class, such as deoxynivalenol (DON), nivalenol (NIV), T-2 toxin, HT-2 toxin and some other toxins (zearalenone and fumonisins). Fusarium fungi are commonly found on cereals grown in the temperate regions of America, Europe and Asia. Several of the Fusarium fungi are capable, to a variable degree, of producing two or more of these toxins.

The SCF has adopted six opinions laying down a tolerable daily intake (TDI for these toxins. It established a TDI for deoxynivalenol of 1 μg/kg body weight, a provisional TDI of 0.2 μg/kg body weight for zearalenone, a TDI of 2 μg/kg body weight for fumonisins, a provisional TDI of 0.7 μg/kg body weight for nivalenol, a combined provisional TDI of 0.06 μg/kg body weight for T-2 and HT-2 toxins and an opinion on trichothecenes as a group.

On the basis of these scientific opinions and the assessment of the dietary intake, this Regulation lays down the maximum levels for deoxynivalenol, zearalenone and fumonisins.

The Regulation states that the presence of T-2 and TH-2 may also be a public health concern. The Commission will therefore develop a reliable and sensitive method for detecting these toxins and continue to study the causes of their appearance in cereals and in particular in oats.

Lead

Lead absorption may constitute a serious risk to public health, since it may slow cognitive development, impair intellectual performance in children and increase blood pressure and cardiovascular diseases in adults.

The maximum level of lead in fish has been changed to 0.30 mg/kg fresh weight by the EU, taking account of the discussions within the .

Cadmium

Cadmium absorption also constitutes a risk to humans, since it may induce kidney dysfunction, skeletal damage and reproductive disorders.

Mercury

This substance may induce alterations in the normal development of the brain of infants and at higher levels may induce neurological changes in adults. It mostly contaminates fish and fishery products.

Methylmercury is the chemical form of mercury which is the greatest source of concern.

3-monochloropropane-1,2-diol (3-MCPD)

This carcinogenic substance is formed under certain conditions during food processing. In particular, it may be produced during manufacture of the food ingredient “hydrolysed vegetable protein” by the acid hydrolysis method.

By adjusting the production processes, the amount of 3-MCPD in the above-mentioned product has been reduced significantly. The main sources of exposures through food are soya sauce and soya sauce-based products.

The TDI is 2 µg/kg body weight.

Dioxins and dioxin-type polychlorinated biphenyls (PCBs)

Dioxins are chemicals resulting from certain natural phenomena (volcanism, forest fires) or industrial processes (manufacturing of pesticides, metals or paint, paper bleaching, incineration, etc.).

PCBs are chemicals which are widespread and found in, inter alia, building materials, lubricants, waterproofing agents and paints. Both types of substance may cause serious health problems, including cancer, immune and nervous system disorders, liver damage and sterility.

The TWI is 14 pg World Health Organisation toxic equivalent (WHO-TEQ)/kg body weight.

Polycyclic aromatic hydrocarbons (PAHs)

Some of these are genotoxic carcinogens. Contamination by PAHs may occur during smoking, heating and drying of food or through environmental pollution, especially in fish.

In order to protect public health, maximum levels are necessary for benzo(a)pyrene in certain foods containing fats and oils and in foods where smoking or drying processes might cause high levels of contamination. Maximum levels are also necessary in foods where environmental pollution may cause high levels of contamination, in particular in fish and fishery products, resulting, for example, from oil spills caused by shipping.

Inorganic tin

This type of tin may be found in tinned food and canned drinks. It may provoke gastric irritation in certain susceptible groups of the population.

For tinned foods other than beverages, the maximum level was laid down at 200 mg/kg. For canned beverages, the maximum level was laid down at 100 mg/kg.

Mixing

Foods which comply with the maximum levels of contaminants may not be mixed with other foods which exceed these limits. By the same token, foods which must be sorted or subjected to other physical treatments to reduce the level of contamination may not be mixed with foods which comply with the maximum levels for human consumption.

Labelling

Labelling on groundnuts, other oilseeds, nuts, dried fruit, rice and maize put on the market as foods which have to be subjected to sorting or other physical treatment before human consumption must include the wording: “product must be subjected to sorting or other physical treatments to reduce aflatoxin contamination before human consumption or use as an ingredient in foodstuffs”.

In addition, labelling on groundnuts, other oilseeds, products derived from oilseeds and cereals must indicate the use and lot identification code. If it is not clearly specified that they are not intended for human consumption, the maximum levels laid down by this Regulation apply.

The maximum levels defined in the Annex for lettuces “grown in the open” apply.

Exceeding Limits

Aflatoxins

Groundnuts, other oilseeds, nuts, dried fruit, rice and maize which exceed the maximum limits specified in the Annex to the Regulation may be placed on the market as long as:

• they are not intended for human consumption;
• they do not exceed the maximum limits for these products which are to be sorted before human consumption..

Nitrates

Derogations may be granted to some countries for exceeding the maximum level of nitrates. They cover production and consumption in the territory of the country concerned of products such as fresh spinach (Belgium, Ireland and the United Kingdom) and lettuces (Ireland and the United Kingdom).

Dioxins and dioxin-like PCBs

This Regulation grants Finland and Sweden a derogation for exceeding the levels of dioxins and dioxin-type PCBs until 31 December 2011 for the following products, but only for production and consumption in the territory of salmon, herring, river lamprey, trout, char and vendace roe from the Baltic.

Control and Supervision

The Member States are responsible for supervising and controlling the level of nitrates in vegetables, especially green leaf vegetables.

They shall communicate the results to the Commission by 30 June every year.

Moreover, they shall communicate to the Commission the result of surveys carried out on the presence of contaminants in food every year

Disposal

This Regulation permits stocks of food which exceed the maximum levels of contaminants placed on the market before the date of entry into force of the respective limits for the contaminants to be disposed of.

Food for Children

This Regulation lays down maximum levels as low as possible for food for babies and for infants and young children in order to protect the health of this vulnerable population group. These maximum levels also apply to food for infants and young children covered by Directive 2006/125/EC and Directive 2006/141/EC.

The maximum levels for infants and young children according to this Regulation are:

• nitrates: 200 mg/kg;
• Aflatoxin B1: 0.10 µg/kg;
• Aflatoxin M1: 0.025 µg/kg;
• Ochratoxin A: 0.5 µg/kg and the same maximum level for dietary foods for specific medical purposes, specifically for infants;
• Patulin: 10 µg/kg;
• Deoxynivalenol: 200 µg/kg;
• Zearalenone: 20 µg/kg and the same level for maize-based formulae for infants and young children;
• Fumonisins: 200 µg/kg for maize-based formulae for infants and young children
• Lead: 0.020 mg/kg fresh weight;
• Inorganic tin: 50 mg/kg fresh weight and the same level for preparations for infant formulae and follow-on formulae and for canned dietary foods for special medical purposes specifically for infants (not including dried and powdered products);
• benzo(a)pyrene: 1 µg/kg fresh weight and the same maximum level for formulae for infants and follow-on formulae and for dietary foods for special medical purposes specifically for infants.

Residues of veterinary medicinal products

in foodstuffs of animal origin

This Regulation classifies pharmacologically active substances used in veterinary medicinal products with a view to ensuring food safety. It determines permissible content in foodstuffs of animal origin and lays down maximum limits for residues of veterinary medicinal products in these foodstuffs.

Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (Text with EEA relevance).

This Regulation aims at defining the rules and procedures to be applied when setting maximum residue limits for medicinal products in foodstuffs of animal origin in order to guarantee food safety.

Scope

This Regulation establishes on the one hand the maximum concentration of a residue of a pharmacologically active substance which may be permitted in foodstuffs of animal origin and on the other defines the level of residues of medicinal products for which a maximum limit has not yet been set.

Active principles of biological origin used in immunological veterinary medicinal products and substances covered by the Regulation on contaminants in foodstuffs for human consumption are excluded from its scope.

Maximum residue limits

Substances intended for use in veterinary medicinal products

The European Medicines Agency issues an opinion on any application relating to a pharmacologically active substance intended for use in veterinary medicinal products. This opinion consists of a scientific risk assessment and risk management recommendations. The Agency ensures that the final opinion of the Committee is given within 210 days.

Other substances requiring an opinion from the Agency

The European Commission or Member States may submit to the Agency a request for an opinion on maximum residue limits in the following cases:

• the use of the substance in question is authorised in a third country but has not been subject to an application for the establishment of a maximum residue limit by the Agency;
• the substance in question is contained in a medicinal product but has not been subject to an application for the establishment of a maximum residue limit by the Agency.

The Agency shall ensure that the opinion of the Committee concerning a relevant request from the European Commission or Member States is given within 210 days.

Once the opinions have been published, the Commission, in consultation with the Agency, Member States and interested parties, shall adopt the following measures:

• methodological principles to be applied following the risk assessment and recommendations described above;
• rules concerning the use of a maximum residue limit for medicinal products.

Classification

The Commission classifies the pharmacologically active substances which have already been subject to an opinion from the Agency. This classification includes a list of pharmacologically active substances and the therapeutic classes to which they belong, as well as the following:

• a maximum residue limit;
• a provisional maximum residue limit (for a period not exceeding five years);
• the absence of the need to establish a maximum residue limit;
• a prohibition on the administration of a substance.

A maximum residue limit may be provided if scientific data is incomplete, as long as the substance does not constitute a hazard to human health. It is presupposed that the residues do not constitute a hazard to the health of individuals.

It is possible to obtain an emergency authorisation for a veterinary medicinal product or biocide product by making an application to the Agency to carry out an accelerated procedure for the assessment of the maximum residue limit. The Agency shall ensure that the final opinion of the Committee is given within 120 days.

Reference points for action

The Commission can establish reference points for action for residues of pharmacologically active substances which are not classified.

Reference points for action are established in consultation with official control laboratories in accordance with a method corresponding to Community requirements.

A request for a risk assessment may be sent to the European Food Safety Authority (EFSA) in order to determine whether the reference points for action are adequate.

Various provisions

The Agency consults Community reference laboratories using analytical methods which are appropriate for analysing residues. The aim of this consultation is also to achieve harmonised controls in order to provide information on the methods used during the authorisation procedure for official control laboratories.

When placed on the market, foodstuffs of animal origin which contain residues of medicinal products at a level exceeding the limit established by this Regulation or containing an unclassified substance are not considered as complying with the legislation.

This Regulation repeals Regulation (EC) No 2377/90. The Commission includes pharmacologically active substances and their classification from Regulation (EC) No 2377/90 in Annexes I to IV.