1. INTRODUCTION AND LITERATURE REVIEW
1.6. International regulations and harmonisation activities
Knowing the adverse effects of mycotoxins on men and animals, many countries have established legislation that limits their presence in food and feed. Up to now more than 100 countries in the world are known to have specific limits for mycotoxins in foodstuffs and feedstuffs. Until the ‘90ies these regulations were depending on national authorities. But gradually several economic communities e.g. EU, Mercosur (Mercado Común del Sur), have taken precedence over the national regulations (55).
Organisations like the Joint Expert Committee on Food Additives act as scientific advisory body of the World Health Organization and the Food and Agriculture Organization. This Expert Committee provides assessment for the toxicity of additives, veterinary drug residues and contaminants. The hazard of mycotoxins has been evaluated in several sessions (56).
Table 5. Maximum levels of aflatoxin according to the Commission regulation (EC) No. 1881/2006 (57).
Maximum levels [μg/kg]
FOODSTUFFS
AfB1
Sum of AfB1, B2, G1 and G2
AfM1
1 Groundnuts to be subjected to sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs
8.0 15.0 - 2 Nuts to be subjected to sorting, or other physical treatment, before
human consumption or use as an ingredient in foodstuffs
5.0 10.0 -
3 Groundnuts and nuts and processed products thereof, intended for direct human consumption or use as an ingredient in foodstuffs
2.0 4.0 -
4 Dried fruit to be subjected to sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs
5.0 10.0 -
5 Dried fruit and processed products thereof, intended for direct human consumption or use as an ingredient in foodstuffs
2.0 4.0 -
6 All cereals and all products derived from cereals, including processed cereal products, with the exception of foodstuffs listed in 7, 10 and 12
2.0 4.0 -
7 Maize to be subjected to sorting or other physical treatment before human consumption or use as an ingredient in foodstuffs
5.0 10.0 -
8 Raw milk, heat-treated milk and milk for the manufacture of milk-based products
- - 0.050
9 Following species of spices: Capsicum spp. (dried fruits thereof, whole or ground, including chillies, chilli powder, cayenne and paprika) Piper spp. (fruits thereof, including white and black pepper) Myristica fragrans (nutmeg) Zingiber officinale (ginger) Curcuma longa (turmeric)
5.0 10.0 -
10 Processed cereal-based foods and baby foods for infants and young children
0.10 - -
11 Infant formulae and follow-on formulae, including infant milk and follow-on milk
- - 0.025
12 Dietary foods for special medicinal purposes intended for infant 0.10 - 0.025
Table 6. Maximum levels of ZON according to the Commission Regulation (EC) No. 1126/2007 (58).
Table 7. Maximum levels of PAT according to the Commission regulation (EC) No. 1881/2006 (57).
In Europe, there are several organisations that take part in the risk assessment of mycotoxins. For example, until 2002 the Scientific Committee on Food and the Scientific Committee on Animal Nutrition of the European Commission expressed regularly their opinions about risks associated with the occurrence of mycotoxins in food or animal feed, respectively. In 2002, the European Food Safety Authority was established with the idea to offer risk assessment regarding food and feed safety and among other issues mycotoxins are discussed (59).
FOODSTUFFS Maximum levels [μg/kg]
1 Unprocessed cereals other than maize. 100
2 Unprocessed maize with the exception of unprocessed maize intended to be processed by wet milling
350 3 Cereals intended for direct human consumption, cereal flour, bran as end
product marketed for direct human consumption and germ, with the exception of foodstuffs listed in 4, 7 and 8.
75
4 Maize intended for direct human consumption, maize flour, maize meal, maize grits, maize germ and refined maize oil.
100 5 Bread (including small bakery wares), pastries, biscuits, cereal snacks
and breakfast cereals, excluding maize snacks and maize based breakfast cereals.
50
6 Maize snacks and maize based breakfast cereals. 50 7 Processed cereal-based foods (excluding processed maize-based foods)
and baby foods for infants and young children.
20
8 Processed maize-based foods for infants and young children. 20
FOODSTUFFS Maximum levels [μg/kg]
1 Fruit juices, concentrated fruit juices as reconstituted and fruit nectars 50 2 Spirit drinks, ciders and other fermented drinks derived from apples or
containing apple juice
50
3 Solid apple products, including apple compote, apple puree intended for direct consumption with the exception of 4 and 5
25 4 Apple juice and solid apple products, including apple compote and
apple puree for infants and young children and labelled and sold as such
10
5 Baby foods other than processed cereal-based for infants and children 10
Actual maximum levels within the EU of aflatoxins, zearalenone and patulin are shown in Tab. 5 - 7.
An important activity within the EU is carried out by the Scientific Cooperation Task (SCOOP) on questions relating to food provided the scientific basis for the evaluation and management of risk to public health arising from dietary exposure to mycotoxins. In the 1990ies, these activities resulted in a report assessing exposure of Fusarium toxins, PAT and Ochratoxin A (35, 60, 61).
The International Life Sciences Institute (ILSI) is a non-profit-making, worldwide foundation established to advance the understanding of scientific issues relating to nutrition, food safety, toxicology, risk assessment and the environment, has a working group on natural toxins that organises international symposia on mycotoxins of European concern (62).
In order to assure a high level of protection of human life and health within the EU, a quick information-exchange called Rapid Alert System for Food and Feed (RASFF) was created (16). Further on, in 2002 with the introduction of the General Food Law Regulation (EC) No 178/2002 the system was further developed; the classification of the information started to be done under different headings - alert notifications, information notifications and news notification - depending on the extent of the risk and the need of direct action (63).
In July 2006, the Institute for Reference Materials and Measurements (IRMM) from the European Commission's Joint Research Centre was nominated as the community reference laboratory (CRL) for mycotoxins (64). This Community reference laboratory aims to facilitate the implementation of European legislation related to monitoring of mycotoxins in food of plant origin and animal feed and works together with appointed national reference laboratories of the EU Member States.
Additionally, certified reference materials are commercially available from IRMM. They can be classified as pure substances (standards), standard solutions (calibrators) or matrix materials (spiked or naturally contaminated) and include reference materials for i) aflatoxins in peanut, compound feed, and milk powder; ii) ochratoxin A in wheat; iii) deoxynivalenol in maize and wheat flour and iv) ZON in maize. IRMM also provides standard solutions for calibration purposes (calibrators) of AfB1, AfB2, AfG1, deoxynivalenol and nivalenol in
acetonitrile and AfM1 in chloroform. The certified reference materials are an important tool to assess about the quality of the measurement.
The availability of analytical methods is crucial for the establishment of regulatory limits for mycotoxins. In addition, analytical methods have to be validated at national and/or international level in which perfomance characteristics such as accuracy, precision, specificity, are checked. Afterwards they may be adopted as official methods (65).
Several international organisations are involved in the validation of the methods, including AOAC International, the International Union of Pure and Applied Chemistry (IUPAC) and the International Organization for Standardization at the global level, and the European Committee of Standardization (CEN) in Europe.
Methods of analysis accepted by these organisations must be validated by a collaborative study. Several protocols and guidelines for method validation and for the conduct of collaborative studies have been published (66, 67).
Some laboratories are accredited as part of their quality system. Accreditation demonstrates that the laboratories can produce accurate, high-quality results on a consistent basis, and an accreditation by a recognised body ensures that they are applying analytical quality assurance. Part of this analytical quality assurance needs the use of certified reference materials as well as the regular participation in interlaboratory comparison studies.
As part of a good analytical quality assurance system and complementary to the information about which analytical method has been used, it is recommended to provide the following information:
a) Surveillance data must be accompanied by a clear description of the analytical method used and an indication whether the method has been formally validated.
b) Limits of detection and quantification should be provided.
c) Recoveries determined by use of spiked samples or reference material should complement the analytical results and it should specify which spiking levels were applied and if the analytical data reported was corrected for recovery.
d) An estimate of the measurement uncertainty should be given.
e) The source of the calibrant should be provided and the method of preparation of the calibration solutions should be given.
f) An indication about the laboratory that reported the results should be given mentioning if it is accredited.
g) It should be indicated if the laboratory that reported the results takes part in inter-laboratory comparison studies and if so, for which analyte-matrix combinations.