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Mycotoxins Legislation Worldwide (last updated February 2012)

Mariko Kubo Senior Regulatory Advisor
Leatherhead Food Research

 

A food contaminant is a substance not intentionally added to food but is present in such food as a result of manufacturing, processing, preparation, treatment, packing, packaging, transport or holding of such food, or as a result of environmental contamination.  Several types of mycotoxins, produced by fungi in foodstuffs such as nuts and dried fruits, are examples of a natural contaminant.

 

In general, the framework legislation of a country states that any food containing a contaminant in an amount that is unacceptable from a public health point of view, and in particular, at a toxicological level, cannot be marketed in that country.  Contaminant levels are required to be kept as low as can reasonably be achieved by good practice.

 

In most countries, regulations are established to control the contaminants in foodstuffs to protect human health; it may include specific maximum limits for several contaminants for different foods and a reference to the sampling methods and performance criteria of analysis to be used.

 

In terms of mycotoxins, legislation is established in several countries worldwide, specifying maximum limits for mycotoxins such as aflatoxins, ochratoxin A (OTA), patulin, fumonisins, zearalenone and deoxynivalenol for different foodstuffs.

 

 

Aflatoxins

 

Aflatoxin B1 and Total aflatoxins (B1 + B2 + G1 + G2)

 

The maximum limits for aflatoxins in foodstuffs are the single most commonly established mycotoxins limits worldwide. The limits for aflatoxins may be controlled as the total aflatoxins referring to the sum of aflatoxin B1, B2, G1, G2, and/or aflatoxin B1.

 

In the European Union (EU), maximum limits for total aflatoxins, aflatoxin B1 and/or limits for aflatoxin M1 for several foodstuffs are set in the Commission Regulation (EC) No 1881/2006 of 19 December 2006, as amended, on Setting Maximum Levels for Certain Contaminants in Foodstuffs.

 

For example, specific maximum limits for aflatoxin B1 and total aflatoxins are set for different types of nuts, dried fruits, cereals, products derived from cereals and processed cereal-based foods, certain type of spices, etc.  

 

In the EU, the lowest maximum limit for aflatoxin B1 other than for products for infants is set as 2.0 μg/kg for products such as groundnuts (peanuts), tree nuts, dried fruit and its processed products, cereals and products derived from cereals, including processed cereal products. The highest maximum limit for aflatoxin B1 is 12.0 μg/kg for foodstuffs such as almonds, pistachios and apricot kernels.

 

With regards to the total aflatoxins,  the lowest EU limit other than food for infants is 4.0 μg/kg for products such as groundnuts (peanuts) and tree nuts, dried fruit and its processed products, cereals and products derived from cereals, including processed cereal products. While the highest limit is set for groundnuts, almonds, pistachios, apricot kernel, hazelnuts and Brazil nuts at 15.0 μg/kg (these limits apply to the products to be subjected to sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs).

 

Provisions established in the Commission Regulation (EC) No 1881/2006 of 19 December 2006, as amended, are directly applicable in all 27 EU Member States. However, additional provisions may be laid down in national legislation in each Member State.

 

For instance, countries such as Austria, Germany, Denmark, Finland, Spain and Sweden have additional national limits set; these include maximum limits for aflatoxin B1 and/or the sum of total aflatoxins for all foodstuffs for which no specific limits are established in the Commission Regulation. These limits vary from 1 μg/kg in Austria to 5 μg/kg in Spain for aflatoxin B1 and 4 μg/kg in Denmark and Germany to 10 μg/kg in Spain for total aflatoxins.  

 

Other countries such as Turkey, Bosnia and Herzegovina and Switzerland seem to be influenced by the EU Regulation and tend to have comprehensive legislation controlling the level of aflatoxins.

 

As for international markets, China followed by Brazil and Mexico have the most comprehensive legislation on aflatoxins. Specific maximum limits are set for aflatoxin B1 and/or total aflatoxin in several foodstuffs in these countries. Other countries such as the United States of America (USA), Canada, Australia and New Zealand, Gulf Cooperation Council (GCC) and Nigeria lay down specific limits for total aflatoxins in mainly nuts as indicated Table 1.  

 

Table 1: Total aflatoxins limits in Australia / New Zealand, Canada, Codex, GCC, Nigeria, India, USA and South Africa

Country

Foodstuffs

Total aflatoxins

(µg/kg)

Australia / New Zealand

Peanuts

Tree nuts

15

Canada

Nut and nut products

15

Codex

GCC (a)

Nigeria 

Peanuts, almonds, shelled Brazil nuts, hazelnuts pistachios intended for further processing

15

Almonds, hazelnuts, pistachios, shelled Brazil nuts, “ready-to-eat”

10

India

Wheat, maize, jawar (sorghum) and bajra, rice, whole and split pulse (dal) masur (lentil), whole and split pulse urd (mung bean), whole and split pulse moong (green gram), whole and split pulse chana (gram), split pulse arhar (red gram), and other food grains

30

Groundnut kernels (shelled) (peanuts);

30

USA

Brazil nuts, peanuts and peanut products, pistachio products

20

South Africa

Peanuts

15

(a)       Members of GCC are Saudi Arabia, United Arab Emirates (UAE), Kuwait, Bahrain, Oman, Yemen and Qatar.

 

Similar to some EU Member States, countries such as India and USA establish a general maximum limit for total aflatoxins for foods for which no specific maximum limits are set: 30 µg/kg and 20 µg/kg, respectively. In South Africa, a general maximum limit for total aflatoxins is set at 10 µg/kg and additionally a general maximum limit for aflatoxin B1 is set at 5 µg/kg for all foodstuffs.

 

One of the strictest controls is in Japan where the total aflatoxins level in all foodstuffs must be blow 10 µg/kg.  

 

 

Aflatoxin M1

 

Limits for aflatoxin M1 are generally only laid down for milk and milk products and in some cases for infant and products for infants, worldwide, as illustrated in Table 2.

 

 


 

Table 2: Aflatoxin M1 limits

Country

Foodstuffs

Aflatoxin M1

(μg/kg)

EU

Bosnia and Herzegovina

Turkey

Raw milk, heat-treated milk and milk for the manufacture of milk-based products

0.050

Infant formulae and follow-on formulae, including infant milk and follow-on milk

0.025

(products ready to use)

Dietary foods for special medical purposes intended specifically for infants

0.025

(products ready to use)

China

Milk and milk products (for milk powder, calculated on a fresh milk basis)

0.5

Formulated foods for infants (milk or milk protein based)

0.5

(calculated on a dry powder basis)

Formulated foods for older infants and young children (milk or milk protein based)

0.5

(calculated on a dry powder basis)

Formulated foods for special medical purposes intended for infants

0.5

(calculated on a dry powder basis)

Codex, GCC, India, Kenya, USA

Milk

0.5

Argentina

 

Milk, liquid including milk used in the manufacture of milk and milk products and reconstituted milk

0.5 (1)

Milk, powder

5.0

Milk formula

ND

Mexico

Pasteurised, ultrapasteurised, sterilised and dehydrated milk, milk formula and combined milk products

0.5 (1)

South Africa

Milk

0.05

ND: Not Detectable

(1)       Given in µg/l.

 

All EU Member States other than Germany do not have any additional national limits laid down for aflatoxins M1.  The German national legislation specifies an additional maximum limit for aflatoxin M1 for dietetic foodstuffs for infants and young children at 0.01 µg/kg.

 

 

Ochratoxin A (OTA)

 

In the EU, the Commission Regulation (EC) No 1881/2006 of 19 December 2006, as amended lays down specific maximum limits for ochratoxin A (OTA) for foodstuffs such as unprocessed cereals and products derived from unprocessed cereals, dried vine fruit, coffee beans and soluble coffee, wine, grape juice, spices, liquorice and products for infants. The lowest maximum limit other than in products for infants is established for wine and grapejuice at 2.0 μg/kg, while the highest maximum limits is set at 80 μg/kg for liquorice extract for use in foods. Additional national maximum limits for OTA are established in EU Member States such as Denmark, Hungary, Italy and Germany in their national legislation.

 

Egypt and Bosnia and Herzegovina refer to the Commission Regulation for setting up their national maximum limits for OTA.  Although, the limits established are not identical to those in the EU, they are very similar.

 

In Russia, OTA limits are established for several cereals and cereal products, as well as various products for children. The limit in wheat, barley, rye, oat and rice cereals and cereal products is set at 0.005 mg/kg while the limit for specific products for children is set at 0.5 µg/kg. In China a limit of 5.0 μg/kg for OTA is set for cereals, milled products from cereals, legumes and pulses.

 

In the Codex Alimentarius Standard, an OTA limit of 5 μg/kg is set for raw wheat, barley and rye, only. These limits are adopted in GCC, Nigeria and Kenya. In India, a maximum limit for OTA is established for the same foodstuffs as in Codex; however the limit is set at 20 µg/kg.

 

No specific limits for OTA in foodstuffs are set in USA, Canada, Australia and New Zealand, Japan, Mexico and South Africa.  

 

 

Deoxynivalenol (DON)

 

Maximum limits for DON are commonly established for products such as unprocessed cereals and cereal products such as pasta and bread. In the EU, the maximum limits are set between 200 μg/kg for processed cereal-based foods and baby foods for infants and young children and 1750 μg/kg for unprocessed durum wheat and oats and unprocessed maize.

 

For other international countries, maximum limits are mainly set for cereals especially wheat. Table 3 summarises the maximum limits for DON in several international countries.

 

Table 3: Maximum limits for DON

Country

Foodstuffs

Deoxynivalenol

(μg/kg)

Canada

Uncleaned soft wheat for use in non-staple foods

2000

Uncleaned soft wheat for use in baby foods.

1000

China

Corn, cornmeal (coarse cornmeal, flakes)

1000

Wheat, barley, breakfast cereals, wheat flour

1000

India

Wheat

1000

Japan

Wheat

1100

(provisional limit)

Russia (a)

Wheat and wheat cereal, oatmeal and flakes; wheat flour; pasta products; bread; bakery products; wheat germ;  food protein from the seeds of wheat

700

Barley and barley cereal, oatmeal and flakes; barley flour; pasta products; bread; bakery products;  barley germ; food protein from the seeds of barley

1000

Flour confectionery

700

USA

Finished wheat products

1000

(advisory limit)

(a)       Additional limits are specified for several types of products for children and products for pregnant and nursing women.

 

No specific limits for DON for foodstuffs are established in Australia and New Zealand, Codex, GCC, Kenya and South Africa.

 

 

Patulin

 

In many markets such as China, GCC and USA a maximum limit for patulin is generally established for apple products such as apple juice. The maximum limit seems to be a universal limit of 50 μg/kg in all countries as provided in Table 4.

 

Table 4: Maximum limit for patulin

Country

Foodstuffs

Patulin

(μg/kg)

China

Fruit products containing apple or hawthorn (excluding Guo Dan Pi, a Chinese-style fruit snack)

50

Fruit or vegetable juice containing apple or hawthorn juice

50

Alcoholic beverages containing apple or hawthorn

50

Codex, GCC, Kenya, Nigeria,

Apple juice

50

India 

Apple juice and apple juice ingredients in other beverages

50

Japan

Apple juice and food made of only apple juice as raw material

50

South Africa

Apple juice, apple juice ingredients in other juices

50

USA

Apple juice, apple juice concentrates and apple juice products

50

 

In the EU, maximum limits for patulin are also mainly laid down for fruits and fruit products especially apple products; the universal limit of 50 μg/kg also applies to products such as fruit juices and nectars, spirit drinks, cider and other fermented drinks derived from apples or containing apple juice.  However, additional limits are laid down for products such as solid apple products, apple juice and baby foods. In Sweden, an additional limit of 50 μg/kg for patulin is established at national level for fruit and berry products not specified in the Commission Regulation (EC) No 1881/2006 of 19 December 2006, as amended.

 

In Russia the legislation for patulin is one of the most comprehensive in the world, laying down maximum limits for patulin in not only apple products like other countries, but also in tomato and sea-buckthorn based products such as juices and jams.  However, the limits seem to comply with the common limit of 50 μg/kg other than for products for infant/children and pregnant and nursing women.

 

No specific maximum limits for patulin for specific foodstuff are set in Australia and New Zealand, Canada and Mexico.

 

 

Fumonisins and Zearalenone

 

In the EU, maximum limits for fumonisins and zearalenone are established for certain foodstuffs mainly in cereal and cereal based foods products. Many countries, which take reference to the EU legislation, such as Turkey, Bosnia and Herzegovina, Norway and Switzerland, have established similar maximum limits for fumonisins and zearalenone.

 

In the international markets, however, no specific maximum limits for fumonisins are established in major markets including China, Japan, India, GCC, Russia, Canada and many Latin American countries. This may be due to the fact that the Codex Alimentarius has not yet established maximum limits of fumonisins. However, a code of practice for the prevention and reduction of mycotoxin contamination in cereals, including annexes on ochratoxin A, zearalenone, fumonisins and trichothecenes is published by the Codex Alimentarius.

 

In the USA, the Food and Drug Administration (FDA) issued an advisory to industry on certain substances, including fumonisins. The specific advisory maximum limits have been indicated in the Table 5 below.

 

In Brazil, new provisions have been established for mycotoxins by the Resolution RDC No. 7 of 18 February 2011. The Resolution lays down newly established Maximum Tolerable Levels (MTLs) for several types of mycotoxins including fumonisins. MTLs are laid down for fumonisins in certain maize-based products, including products such as popping corn, flour and starch, as well as foodstuffs for infants and young children.

 

Table 5: Advisory limits of fumonisins in USA

Foodstuffs

Fumonisin

(FB1 + FB2 + FB3)

(μg/kg)

Degermed dry milled corn products (e.g., flaking grits, corn grits, corn meal, corn flour with fat content of < 2.25%, dry weight basis)

2000

Whole or partially degermed dry milled corn products (e.g., flaking grits, corn grits, corn meal, corn flour with fat content of > 2.25 %, dry weight basis)

4000

Dry milled corn bran

4000

Cleaned corn intended for masa production

4000

Cleaned corn intended for popcorn

3000

 

Specific maximum limits for zearalenone are laid down in the Brazilian, Chinese and Russian national legislation. However, many other international countries including USA, Canada, Japan, Australian, New Zealand, GCC and African countries  do not establish specific maximum limits for zearalenone.

 

Interestingly, in Chile, a general maximum limit for zearalenone for all foodstuffs is set at 200 mg/kg.

 

 

Other mycotoxins

 

In Russia, specific maximum limits for T-2 toxin are established for several foodstuffs as shown in Table 6.

 

Table 6: T-2 toxin limits in Russia

Foodstuffs

T-2 Toxin

(μg/kg)

Food grain, including wheat, rye, triticale, oats, barley, millet, buckwheat, rice, corn, sorgo

100

Cereal, oatmeal, flakes

100

Wheat flour including for pasta; rye, triticale, corn, barley, millet, rice, buckwheat, sorgo flours

100

Cereal-based food products for children up to the age of 3 years

NP

50 (LOD)

Milk and cereal instant products for pregnant and nursing women

NP

50 (LOD)

Bakery, flour and groats products for children 3-14 years old

NP

50 (LOD)

Meat and vegetable canned foods that contain cereals for children up to 3 years old

NP

50 (LOD)

Fish and vegetable canned foods that contain cereals for children up to 3 years old

NP

50 (LOD)

Culinary products from fish containing flour and grains for children 3-14 years old

NP

 

Low protein products (starch, groats, pasta)

NP

50 (LOD)

LOD: Limit of Detection.

NP: Not Permitted.

 

No other country in the world currently regulates specific maximum limits for T-2 toxin, however, the European Commission asked the European Food Safety Authority (EFSA) for a scientific opinion on the risk to human and animal health related to the presence of T-2 and HT-2 toxin in food and feed which was published in December 2011.

 

In Australia and New Zealand limits for phomopsins and ergot alkaloids are established for cereal grains and lupin seeds; not many other countries establish specific limits for these mycotoxins.

 

In conclusion, in many countries, national legislation exists laying down specific maximum limits for several different types of mycotoxins in a variety of foodstuffs. The most commonly regulated mycotoxins are aflatoxins, ochratoxin A, patulin and deoxynivalenol however; other mycotoxins such as zearalenone, fumonisins, phomopsins and ergot alkaloids may also be regulated in some countries. In the absence of specific maximum limits for certain mycotoxins for some foodstuffs and/or countries, the framework legislation of the country, which generally stipulates that food must be safe and suitable for human consumption and free of harmful substances, always applies.

 

References

 

(1)       Argentina: Resolution No. 612 of 10 May 1988.

(2)       Argentina: Joint Resolution SPRyRS No. 66/02 and SAGPyA No. 344/02 of 16 December 2002 implementing MERCOSUR Resolution No. 25/02 on the maximum limits for aflatoxins in milk, peanut and maize. 

(3)       Australia New Zealand: Standard 1.4.1 on Contaminants and Natural Toxicants of the Australia New Zealand Food Standards Code, 2002, as amended

(4)       Austria: Order No. 251/1986 of the Federal Minister for Health and Environment Protection on maximum levels for mycotoxins, dated 14 May 1986, Bundesgestzblatt für die Republik Österreich, 1986 (100), 1873-4.

(5)       Brazil: Resolution RDC No. 7 of 18 February 2011.

(6)       Bosnia and Herzegovina: Rulebook on the maximum permitted levels of contaminants in foodstuff, Slu┼żbeni glasnik Bosne i Hercegovine, 37, 12/05/2009

(7)       Canada: Food and Drug Regulations of December 1954 with amendments

(8)       China: GB 2761-2011 Maximum Levels of Mycotoxins in Foods

(9)       Codex: Codex General Standard for Contaminants and Toxins in Food and Feed (CODEX STAN 193-1995), as amended

(10)     Denmark : Decree No. 148 of 19 February 2007 on certain contaminants in foodstuffs, as last amended by Decree No. 721 of 3 July 2008; Lovtidende

(11)     Egypt: Egyptian Standard 1875-1/1990 Maximum Limits for Mycotoxins in Foods – Aflatoxins

(12)     Egypt: Egyptian Standard 1875-2/2010 Maximum Limits for Mycotoxins in Foods – Ochratoxins

(13)     EU: Commission Regulation (EC) No 1881/2006 of 19 December 2006, as amended, on Setting Maximum Levels for Certain Contaminants in Foodstuffs

(14)     Finland: Trade and Industry Ministry Decree No. 237 of 22 March 2002 on maximum quantities of certain contaminants in foodstuffs, lays down additional national maximum levels for copper, aflatoxins, acrylonitrile, pentachloroanisol, vinyl chloride, erucic acid, glycoalkaloids, and indole in foodstuffs, as amended by Trade and Industry Ministry Decree No. 517 of 8 June 2005. 

(15)     Hungary: Decree No. 17/1999 of 16 June 1999 by EüM (Egészségügyi Minisztérium- Ministry of Health) on the control of hazardous chemical contamination, as amended.

(16)     India: Food Safety and Standard (Contaminants, Toxins and Residues) Regulation, 2011

(17)     Italy: Circular No. 10 of 9 June 1999, Official control of foodstuffs: maximum permitted levels for mycotoxins in those foods of natural, Community or third country origin, Gazzetta Ufficiale della Repubblica Italiana, 140 (135), 11/6/99, 52-7.

(18)     Japan: Notice No. 0131.5 of 31 March 2011 of Department of Food Safety of Pharmaceutical and Food Safety Bureau of Ministry of Health Labour and Welfare

(19)     Mexico: Mexican Official Standard NOM-243-SSA1-2010 of 25 June 2010 approves the sanitary specifications for milk, milk formula, combined milk products and milk derivatives. Analytical methods, as amended.

(20)     Norway, Regulation No. 1028 of 27 September 2002 on contaminants in foodstuffs as last amended by Regulation No. 400 3 January 2010

(21)     Resolution RDC No. 274 of 15 October 2002 establishing the Technical Regulation on “Maximum Limits of Aflatoxins in Milk, Peanut and Maize”, Diário Oficial da União, (I), 16/10/2002, 45.

(22)     Russia:  1. SanPin 2.3.2.1078-01 'Hygienic Requirements in respect of the Safety and Nutritional Value of Foodstuffs' of 14 November 2001, as amended; 2. Chapter 1 “Requirements for the safety and nutrition of foods” of the Unified Sanitary-Epidemiological and Hygiene Requirements of the Commission of the Customs Union of Russia, Belarus and Kazakhstan.

(23)   South Africa: 2004. Regulations Governing Tolerances for Fungus Produced Toxins in Foodstuffs, Government Notice (No. R.1145 of 8 October 2004), Government Gazette (26849).

(24)     Spain:  Royal Decree No. 475/1988 of 13 May establishes the maximum permitted limits for aflatoxin B1, B2, G1 and G2 in foodstuffs for human consumption; Boletín Oficial del Estado, 121, 20/05/1988, 15329.

(25)     Sweden: National Food Administration’s Ordinance on Certain Foreign Substances in Food (LIVSFS 1993:36) of 16 December 1993, last amended by Ordinance 2007:13

(26)     Switzerland: Ordinance No. 817.021.23 on Foreign Substances and Compounds in Foodstuffs of 26 June 1995, Recueil Officiel des Lois Fédérales, 1995 (26), 11/7/95, 2893-986, as last amended in April 2010.

(27)     Turkey: Turkish Food Codex Regulation on Contaminants, Official Gazette, No. 28157, 29 December 2011.

(28)     USA: Food and Drug Administration (FDA) Advisory for Deoxynivalenol (DON) in Finished Wheat Products Intended for Human Consumption and in Grain and Grain By-Products for Animal Feed, 16 September 1993

(29)     USA: US Food and Drug Administration Compliance Policy Guides, Chapter 5 - Foods, Colors and Cosmetics