PART III PROCESS SAFETY
5. Legislation and Regulation
Several studies have established that setting tolerance levels involves transparent tradeoffs between human health and economic opportunity (CAST, 2003). It has been estimated that deaths from a standard of 10 or 20 µg kg−1aflatoxin in the human diet would result in 39 cancer or 41 cancer deaths respectively per year per billion people for a European diet. In Asia a change from 20 to 10 µg kg−1 would result in 300 fewer deaths.
In terms of variations in legislation, the USA has a limit of 20 µg kg−1for total aflatoxins in all products, except milk, for human consumption, while those in the EU there are for various food commodities and range from 2 to 10 µg kg−1(see Table 5). The limits set by the US FDA and the EU for milk are of 0.5 and 0.05 µg L−1for aflatoxin M1, respectively.
The US FDA advisory limit for DON in wheat and wheat products for human consumption is 1000 µg kg−1; in the EU this limit varies from 200 µg kg−1, in cereal based food for infants, young children and babies, to 1750 µg kg−1in unprocessed cereal products (see Table 6). Russia has a limit of 1000 µg kg−1for hard wheat and Canada of 2000 µg kg−1for uncleaned soft wheat (EMAN, 2004).
Even within Europe there are differences between the EU and other countries.
The EU set limits for aflatoxins, Fusarium toxins, OTA, and patulin in several food commodities (Tables 5 to 8). Other countries in Europe have independent limits and in the EU each country may have other limits for other food commodities
TABLE 5. Aflatoxins regulations (Commission Regulation (EC) No 466/2001, and 683/2004)
Maximum Admissible Levels of
Commodities Aflatoxins (µg kg−1)
B1 B1+B2+G1+G2 M1
Groundnuts, nuts, dried fruit and processed 2 4
products thereof for direct human consumption or as a food ingredient
Groundnuts to be subjected to sorting, or other physical 8 15 treatment, before human consumption or as a food
ingredient
Nuts and dried fruit to be subjected to sorting, or other 5 10 physical treatment, before human consumption or as
a food ingredient
Cereals and processed products thereof for direct 2 4 human consumption or as a food ingredient
Chillies, chilli powder, cayenne pepper, paprika, white 5 10 and black pepper, nutmeg, ginger and turmeric
Milk (raw milk, milk for the manufacture of milk based 0.05 products and heat treated milk
Baby foods and processed cereal based foods for infants 0.1 and young children
Infant formulae and follow-on formulae, including 0.025
infant milk and follow-on milk
Dietary foods for special medical purposes intended 0.1 0.025 specifically for infants
and/or for other mycotoxins. Presumably this will become harmonised when more countries become members. However, there are almost certainly consider- able differences between EU member countries in their ability to implement the regulations, which relates to the relative economic status of each country. There is a clear requirement for the EU to further assist these countries.
TABLE6. Fusarium toxins regulations (Commission Regulation (EC) No 856/2005) Maximum Admissible Levels
Commodities (µg kg−1)
Deoxynivalenol
unprocessed cereals, other than durum wheat, oats and maize 1250
durum wheat and oats 1750
maize -*
cereal flour 750
bread, biscuits, cereal snacks and breakfast cereals 500
pasta (dried) 750
cereal based food for infants, young children, and baby food 200 Zearalenone
unprocessed cereals, other than maize 100
cereal flour except maize flour 75
bread, pastries, biscuits, (other than maize) cereal snacks and breakfast cereals
Maize, maize flour, and other maize based foods -*
Fumonisins -**
T-2 and HT-2 Toxin -*
*limits to be fixed before 1 July 2007
**limits to be fixed before 1 October 2007
TABLE 7. Ochratoxin A regulations (Commission Regulation (EC) No 472/2002, 683/2004, and 123/2005)
Maximum Admissible Levels
Commodities of Ochratoxin A (µg kg−1)
Cereals (including rice and buckwheat) and derived cereal
products. Raw cereal grains (including rice and buckwheat) 5 All products derived from cereal (including processed cereal
products and cereal grains intended for direct human
consumption) 3
Dried vine fruits (currents, raisins and sultanas) 10 Baby foods and processed cereal based foods for infants and
young children 0.5
Dietary foods for special medical purposes intended
specifically for infants 0.5
Roasted coffee beans and ground roasted coffee with the
exception of soluble coffee 5
Soluble Coffee (instant coffee) 10
Grape juice, grape must and wine 2
5.1. Process standards vs. product standards
It is particularly apparent that differences in tolerance levels are potential sources of conflict between countries. The use of good agricultural practices (GAPs) at preharvest and good manufacturing practices (GMPs) at processing and distribu- tion can be used to minimise risk, and provide procedures for reducing mycotox- ins levels acceptable to more countries (CAST, 2003). They compliment product standards and potentially reduce overall economic losses. The Codex recom- mended that GAPs and GMPs be used to establish HACCP safety systems throughout the food production chain (CAST, 2003). HACCP principles are likely to be among the most effective means of lowering risks and economic losses since prevention is more practical than decontamination (at least theoretically).
Mycotoxins are economically important although not publicly prominent.
Balancing economic cost and health benefits has become a source of friction especially for export-reliant developing countries. Trade disputes are likely to persist with respect to regulatory standards. Many factors that influence contam- ination are difficult or impossible to control. Tolerable health risks appear to depend on level of economic development and susceptibility of a nation’s crops.
Mycotoxins standards can be set without internationally accepted risk assess- ments because of the “precautionary principle”. To minimise risk, stakeholders should consider implementing GAPs, GMPs and HACCP principles, although developing countries will require assistance with implementation (CAST, 2003).