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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.

ACT

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

SUMMARY

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).

CONTAMINANTS

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.

BAN ON 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.

SPECIFIC RULES ON 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 OF THE 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 OF STOCKS

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.

MAXIMUM LEVELS IN 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.
Key terms used in the act
  • Mycotoxins Certain types of moulds of fungoid origin produce powerful poisons, especially the family of mycotoxins. The term mycotoxin comes from the Greek (mycos), which means fungus, and the Latin (toxicum), which means poison. It designates toxic chemical substances produced by certain moulds which develop on certain foodstuffs, particularly cereals.

REFERENCES

ActEntry into force - Date of expiryDeadline for transposition in the Member StatesOfficial Journal

Regulation (EC) No 1881/2006

9.1.2007

Applicable as of 1.3.2007

OJ L 364 of 20.12. 2006

Amending act(s)Entry into force - Date of expiryDeadline for transposition in the Member StatesOfficial Journal

Regulation (EC) No 1126/2007

30.9.2007

-

OJ L 255 of 29.9.2007

Regulation (EC) No 629/2008

23.7.2008

-

OJ L 173 of 3.7.2008

Regulation (EC) No 165/2010

9.3.2010

-

OJ L 50 of 27.2.2010

The successive amendments and corrections to Regulation (EC) No 1881/2006 have been incorporated in the original text. This consolidated version is of documentary value only.

RELATED ACTS

METHODS OF SAMPLING AND METHODS OF ANALYSIS

Regulation (EC) No 333/2007 laying down methods of sampling and analysis for the official controls for the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs [Official Journal L 88 du 29.3.2007].

Commission Regulation (EC) No 1883/2006 of 19 December 2006 laying down methods of sampling and analysis for the official control of levels of dioxins and dioxin-type PCBs in certain foodstuffs [Official Journal L 364 of 20.12.2006].

Commission Regulation (EC) No 1882/2006 of 19 December 2006 laying down methods of sampling and analysis for the official control of the levels of nitrates in certain foodstuffs [Official Journal L 364 of 20.12.2006].

Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in food [Official Journal L 70 of 4.3.2006].
Amended by:
Regulation (EU) No 178/2010 [Official Journal L 52 of 3.3.2010].

IMPORTS

Commission Regulation (EC) No 1152/2009 of 27 November 2009 imposing special conditions governing the import of certain foodstuffs from certain third countries due to contamination risk by aflatoxins and repealing Decision 2006/504/EC [Official Journal L 313 of 28.11.2009].

Last updated: 25.06.2010
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