In 2002, an international inquiry on mycotoxins was initiated by the National Institute for Public Health and the Environment. As part of this inquiry, the Agricultural Services in Dutch Embassies around the world were requested to gather up-to-date information on the situation regarding mycotoxin regulations from local authorities in as many countries as possible. Where this procedure did not lead to the desired information, personal contacts were used.
The questions in the inquiry concerned in particular:
existence of mycotoxin regulations;
types of mycotoxins and products for which regulations are in force or proposed, together with maximum permissible levels;
authorities responsible for control of mycotoxins; and
use of official and published methods of sampling and analysis.
By the end of 2003, data were received from 89 countries. Together with information gathered in previous inquiries, detailed information became available about the existence or absence of specific mycotoxin limits and regulations in food and feed in 119 countries. All the information received was thoroughly examined and interpreted. Whenever it was necessary and feasible, questions for clarification were submitted to information providers. Corrections received by 31 December 2003 were taken into account in this document. Table 2 (in Annex 2) gives an overview of how up-to-date the information is per country, together with the country codes and population sizes. All data received were sorted by country and by economic community (Australia/New Zealand, EU, MERCOSUR). In addition, information was included about standards set by Codex Alimentarius. For each separate entry, the available data were classified into the categories food, dairy and feed and then tabulated in alphabetic order of the countries (see Table 3 in Annex 2).
On a worldwide basis, at least 99 countries had mycotoxin regulations1 for food and/or feed in 2003 (see Figure 1), an increase of approximately 30 percent compared to 1995. The total population in these countries represents approximately 87 percent of the worlds inhabitants. Figure 2 shows the share of the global population living in particular regions, where mycotoxin regulations were in force, in 1995 and in 2003. In 1995, 23 percent of the worlds inhabitants were living in a region where no known mycotoxin regulations were in force. This percentage had decreased to 13 percent in 2003, due to a slight increase in coverage in Latin America and Europe, and more significant increases in Africa and Asia/Oceania.
In fact, all countries with mycotoxin regulations in 2003 have at least regulatory limits for aflatoxin B1 or the sum of aflatoxins B1, B2, G1 and G2 in foods and/or feeds, a situation that was also observed in 1995. For several other mycotoxins, specific regulations exist as well (i.e. aflatoxin M1; the trichothecenes deoxynivalenol, diacetoxyscirpenol, T-2 toxin and HT-2 toxin; the fumonisins B1, B2, and B3; agaric acid; the ergot alkaloids; ochratoxin A; patulin; the phomopsins; sterigmatocystin and zearalenone). The number of countries regulating mycotoxins has significantly increased over the years. Comparing the situation in 1995 and 2003, it appears that in 2003 more mycotoxins are regulated in more commodities and products, whereas tolerance limits generally remain the same or tend to decrease. Regulations have become more diverse and detailed with newer requirements regarding official procedures for sampling and analytical methodology. At the same time, several regulations have been harmonized between countries belonging to economic communities (Australia/New Zealand, EU, MERCOSUR), or are in some stage of harmonization (see Section 3.5).
Figure 1: Countries with and without regulations for mycotoxins
Figures 3 and 4 illustrate the occurrences of the regulatory limits for various mycotoxins in Africa in food and feed respectively. Fifteen countries were known to have specific mycotoxin regulations. These countries cover approximately 59 percent of the inhabitants of the continent. For the majority of the African countries, specific mycotoxin regulations (probably) do not exist. The fact that countries have no specific regulatory limit for mycotoxins does not mean that the problem is ignored. Several of these countries recognize that they have problems due to mycotoxins and that regulations should be developed, and they indicated this in their responses to the inquiry.
The mycotoxin issue in Africa needs to be viewed, however, in the overall context of local food safety, health and agricultural issues (Shephard, 2004). The establishment of mycotoxin regulations will have limited effects in terms of health protection in those countries where many farmers grow agricultural produce for their own consumption (subsistence farming), which is the case in many African countries. Most of the existing mycotoxin regulations in Africa concern the aflatoxins. Morocco had the most detailed mycotoxin regulations.
Figure 2: Percentages of worlds inhabitants covered by mycotoxin regulations
Figure 3: Mycotoxins regulated in food in Africa
Figure 4: Mycotoxins regulated in feed in Africa
Asia and Oceania cover a very large part of the globe, with most countries in the tropics and subtropics, so it is expected that most mycotoxin problems be caused by fungi, which grow at higher temperatures (Pitt and Hocking, 2003). An exception is New Zealand, which has a temperate to cool climate and separate mycotoxin issues from Asia and northern Australia. Figures 5 and 6 show the occurrences of the regulatory limits in Asia/Oceania in food and feed respectively. Twenty-six countries in Asia/Oceania were known to have specific mycotoxin regulations (88 percent of the inhabitants of the region). Regulations for total aflatoxins dominate in food, whereas regulations for aflatoxin B1 dominate in feed. Australia and New Zealand have harmonized their mycotoxin regulations, which include limits for the "exotic" mycotoxins agaric acid and phomopsins (see also Section 3.5.1.) By far the most extensive and detailed regulations can be found in China and the Islamic Republic of Iran.
Figure 5: Mycotoxins regulated in food in Asia/Oceania
Figure 6: Mycotoxins regulated in feed in Asia/Oceania
In Europe, 39 countries, accounting for approximately 99 percent of the continents population, were known to have specific mycotoxin regulations in 2003. Figures 7 and 8 show the occurrences of regulatory limits for various mycotoxins in Europe in food and feed respectively.
Figure 7: Mycotoxins regulated in food in Europe
Figure 8: Mycotoxins regulated in feed in Europe
Compared to other regions of the world, Europe has the most extensive and detailed regulations for mycotoxins in food. In the EU, harmonized regulations exist for aflatoxins in various foodstuffs, aflatoxin M1 in milk, ochratoxin A in cereals and dried vine fruits, patulin in apple juice and apple products, and for aflatoxin B1 in various feedstuffs. Guideline limits have been established for deoxynivalenol in cereals and cereal products. It is of interest to note that many of the EU candidate member countries have mycotoxin regulations, which are often more detailed than those currently in force in the EU.
The major Latin American agricultural crops (maize, wheat, coffee, cotton, soybeans, barley, sunflower, groundnuts and tree nuts, cocoa and dairy products) are highly susceptible to fungal contamination and mycotoxin production (Pineiro, 2004). Figures 9 and 10 show the occurrences of regulatory limits for various mycotoxins in Latin America in food and feed respectively. Nineteen countries, accounting for 91 percent of the population of the region, were known to have specific mycotoxin regulations. Harmonized regulations for aflatoxins exist in MERCOSUR, a trading block consisting of Argentina, Brazil, Paraguay and Uruguay (see also Section 3.5.3). Incidentally other countries indicate that they follow MERCOSUR regulations. The aflatoxin regulations in food are often set for the sum of the aflatoxins B1, B2, G1 and G2. Uruguay has the most detailed regulations, including limits for ergot alkaloids in feeds, which is rather unique in the mycotoxin regulatory world.
Figure 9: Mycotoxins regulated in food in Latin America
Figure 10: Mycotoxins regulated in feed in Latin America
The United States and Canada have had mycotoxin regulations in place for many years, and implement advanced techniques for sampling and analysis. In both countries, limits for aflatoxins are set for the sum of the aflatoxins B1, B2, G1 and G2. Figures 11 and 12 show the occurrences of regulatory limits or guideline limits for various mycotoxins in North America in food and feed respectively.
Figure 11: Mycotoxins regulated in food in North America
In addition to limits for Fusarium toxins, Canada has also established tolerances for the percentage Fusarium-damaged kernels in wheat (both hard and soft wheat) and other grains. The Canadian Grain Commission (CGC) has issued an Official Grain Grading Guide, which contains Standard Procedures for Grain Inspection. In Canada, limits also exist for the percentage of ergot in various crops. In the United States detailed tolerance levels exist for the sum of the fumonisins B1, B2 and B3 in a wide variety of maize products. This is the only country known to have limits for the sum of these three fumonisins.
Figure 12: Mycotoxins regulated in feed in North America
The number of countries regulating aflatoxins has significantly increased over the years. The aflatoxin regulations are often detailed and specific for various foodstuffs, for dairy products and for feedstuffs. Table 4 (in Annex 2) attempts to compare medians, ranges and numbers of countries with legally established limits for aflatoxins in foodstuffs and animal feedstuffs (intended to be used for dairy cattle) in 1995 and 2003 in order to identify trends. Such a comparison is not easy to make, and subject to future adjustments, because not all data used may be fully correct. Another limitation is that some countries have many regulations specifying different tolerated levels for individual foods and feeds, while others have set only one tolerated level for instance for "all foods" or for "all feeds". Therefore simplifications were made.
For food, selections were made of limits established for aflatoxin B1 and total aflatoxins respectively for the category "all foods" or, if this category was not mentioned in the regulations, for those foodstuffs considered most close to this category. Similarly, for the comparison of limits for aflatoxin M1, a selection was made of regulatory levels set for milk (whereas many countries also had specific limits for milk products as milk powder, cheese and infant foods). Finally, as for aflatoxins in animal feedstuffs, some countries have many limits often dictated by the destination of the feedstuff. To compare the limits between countries for aflatoxin B1 and total aflatoxins respectively in animal feedstuffs, those were selected that were known or assumed to be relevant for feedstuffs for dairy cattle. These are often the most stringent from the point of view of human health, because of the carry-over of aflatoxin B1 into aflatoxin M1 in milk and dairy products.
For all five categories, for which some characteristics are summarized in Table 4, frequency distributions of the 2003 situation were prepared as illustrated in Figures 13, 14, 16, 17 and 18. An analysis of Table 4 and these figures leads to the following comments:
126.96.36.199 Aflatoxin B1 in food
Compared to the situation in 1995, the maximum tolerated levels for aflatoxin B1 in food have not changed dramatically in 2003, although the range of limits has narrowed a little (1-20 mg/kg), and 2 mg/kg is now a limit in force in at least 29 countries (see Figure 13). Most of these countries belong to the EU (where since 1998 harmonized limits for aflatoxin B1 and the sum of the aflatoxins B1, B2, G1 and G2 are in force for various products), the European Free Trade Association (EFTA) and candidate EU countries. By 2003, many of the candidate EU countries had harmonized their national regulations with the EU in anticipation of their membership (on 1 May 2004). Another major limit is visible at 5 mg/kg, followed by 21 countries, spread over Africa, Asia/Oceania, Latin America and Europe. The United States and Canada do not have a single limit for aflatoxin B1.
Figure 13: Worldwide limits for aflatoxin B1 in food
188.8.131.52 Total aflatoxins in food
As in 1995, in 2003 many countries regulated the aflatoxins with limits for the sum of the aflatoxins B1, B2, G1, and G2, sometimes in combination with a specific limit for aflatoxin B1. The range of limits (0-35 mg/kg) has narrowed a little compared to 1995, whereas the median limit (10 mg/kg) is slightly higher. The most frequently occurring limit (see Figure 14) is at 4 mg/kg (applied by 29 countries), again a limit found in the harmonized regulations in the EU, EFTA and candidate EU countries where dual limits for both aflatoxin B1 and total aflatoxins are enforced. Another major peak occurs at 20 mg/kg, applied by 17 countries, with half of them in Latin America (where it is also a MERCOSUR harmonized limit) and several in Africa. Also the United States, one of the first countries that established an aflatoxin action limit, follows the 20 mg/kg limit. Over the years, the "popularity" of a limit for total aflatoxins in foodstuffs has remained, resulting in 76 countries in 2003 applying this regulatory levels (as compared to 61 countries with a specific limit for aflatoxin B1).
Whether a regulatory level for the sum of the aflatoxins, which requires more analytical work than for aflatoxin B1 alone, contributes significantly to better protection of public health than a regulatory level for aflatoxin B1 alone is debatable. Aflatoxin B1 is the most important of the aflatoxins, considered from both the viewpoints of toxicology and occurrence. It is most unlikely that commodities will contain aflatoxins B2, G1 and G2 and not aflatoxin B1 (Yabe and Nakajima, 2004), and the concentration of the sum of the aflatoxins B2, G1 and G2 is generally less than the concentration of aflatoxin B1 alone.
Figure 14: Worldwide limits for total aflatoxins in food
Typical occurrence ratios for aflatoxins B1 and B2 (mainly produced by Aspergillus flavus) average approximately 4:1. Typical occurrence ratios for aflatoxin B1 and the sum of the aflatoxins B2, G1 and G2 (the G toxins are mainly produced by Aspergillus parasiticus) average approximately 1:0.8, although variations do occur for both ratios (Van Egmond et al., 1978). Regulatory authorities in those countries that apply a regulatory level for the sum of the aflatoxins should critically inspect the analytical data of monitoring agencies to see how frequently the availability of data on the sum of the aflatoxins (above that on aflatoxin B1) has been indispensable to adequately protect the consumer. Analysis of one target component (aflatoxin B1) seems to be efficient, sufficient and more practical.
In Figure 15, the ranges and medians of limits for total aflatoxins in food are depicted for the various world regions for 1995 and 2003. It appears that in Africa, Latin America and North America no observable changes have occurred, in contrast to Asia/Oceania and Europe, where a downward trend in the limits for total aflatoxins is visible.
Figure 15: Ranges and medians of limits for total aflatoxins in food per world region
184.108.40.206 Aflatoxin M1 in dairy products
Regulations for aflatoxin M1 existed in 60 countries at the end of 2003, a more than three-fold increase as compared to 1995. It is again the EU, EFTA and candidate EU countries that contribute in major part to the largest peak seen in Figure 16 at 0.05 mg/kg, but some other countries in Africa, Asia and Latin America also apply this limit. The other peaking limit is at 0.5 mg/kg. This higher regulatory level is applied in the United States, several Asian and European countries, and it occurs most frequently in Latin America, where it is also established as a harmonized MERCOSUR limit.
Figure 16: Worldwide limits for aflatoxin M1 in milk
The ten-fold difference between the two most prevailing limits for aflatoxin M1, which exist already for many years, has given rise to debates within Codex Alimentarius, leading to their request to JECFA to re-evaluate the human health risk of aflatoxin M1 (see section on hazard assessment). Apart from these sub-mg/kg regulatory limits, a few countries indicated in the 2002/2003 inquiry that they regulate aflatoxin M1 in milk at levels of 5 and 15 mg/kg. These levels do not seem realistic; however, it was impossible to determine whether mistakes occurred during the completion of the inquiry forms.
220.127.116.11 Aflatoxin B1 in feed
Many aflatoxin regulations exist for feedstuffs. Those that are applied for feed for dairy cattle are summarized in Figure 17. Whereas many more countries regulate aflatoxin B1 in feedstuffs for dairy cattle in 2003 than in 1995 (39 in 2003 versus 25 in 1995), the increase is only slightly visible for the countries that regulate the sum of the naturally occurring aflatoxins (21 in 2003 versus 17 in 1995). This is understandable and logical from the point of view that it is aflatoxin M1, the metabolite of aflatoxin B1, which causes health concern. Consequently limiting aflatoxin B1 in animal feeds is the most effective means of controlling aflatoxin M1 in milk. Figure 17 illustrates that a limit of 5 mg/kg dominates the distribution pattern of aflatoxin B1 regulations. This limit is applied by countries in the EU and EFTA, and is also followed in many of the candidate EU countries, and is only sporadically seen outside Europe. Strict application will normally be effective to prevent that aflatoxin M1 levels in milk remain below 0.05 mg/kg for dairy feed (where these countries have set their corresponding limit for aflatoxin M1 in milk).
Figure 17: Worldwide limits for aflatoxin B1 in feed for dairy cattle
18.104.22.168 Total aflatoxins in feed
The number of regulations for the sum of the aflatoxins in feedstuffs is considerably less than those existing for aflatoxin B1 only. The limits may vary, depending on the destination of the feedstuff. Figure 18 depicts the distribution of the limits for total aflatoxins in animal feeds that are (also) given to dairy cattle.
Figure 18: Worldwide limits for total aflatoxins in feed for dairy cattle
A relatively flat distribution is apparent with the most occurring limits set at 20 mg/kg. Further analysis reveals that regulatory levels for the sum of the aflatoxins B1, B2, G1 and G2 occur in feed regulations throughout the world but particularly in the Americas.
Limits for mycotoxins other than aflatoxins currently exist mostly for food and more incidentally for animal feed. It is to be expected that the number of regulations for mycotoxins other than aflatoxins will significantly increase in the near future, both for food and feed. The following discussions in Sections 22.214.171.124 to 126.96.36.199 are largely restricted to food.
Since 1995 many more countries have regulated patulin, mostly in fruit products such as apple juice. The vast majority of countries with regulations or guideline levels for patulin in food have set these at the same level (50 mg/kg) as illustrated in Figure 19. Harmonized EU limits for patulin have recently come into force for various products (European Commission, 2003a). This makes patulin one of the most regulated mycotoxins in the world.
Validated analytical methodology (AOAC, CEN) is readily available to determine patulin in fruit juice at a level of 50 mg/kg. However, the new EU limit of 10 mg/kg for baby food and infant formulae was put in a proviso that a suitable method of analysis would be timely available. It has caused additional research efforts by the EC Joint Research Centre/Institute for Reference Materials and Measurements in Geel, Belgium, and a collaborative study to prove that the newly developed methodology is fit for purpose has recently been completed successfully.
Figure 19: Worldwide limits for patulin in fruits and fruit juices
188.8.131.52 Ochratoxin A
At a first glance the developments in the area of regulations for ochratoxin A show strong similarities with those for patulin. A significant increase in the number of countries that apply limits in foods and good agreement about the desired limit for cereals and cereal products (see Figure 20). Cereals are considered the major source of human exposure to ochratoxin A. There is a restriction with the presentation of the data, however. Many countries have set a limit for ochratoxin A in cereals, many others for cereal products, and various have set separate (different) limits for both. For example, this latter situation occurs in the EU, where a limit of 5 mg/kg (the dominant peak in the figure) is in force for raw cereals and a limit of 3 mg/kg (not presented in Figure 20) for processed cereals. To present this all in one figure was difficult, and therefore the approach was followed to preferentially include a countrys limit for (raw) cereals in Figure 20 and, where this did not exist, to include the limit (if any) for cereal products. The current and proposed limits for ochratoxin A may need to be reviewed in the near future pending the outcome of an ongoing EC-supported project on "Mechanisms of ochratoxin A induced carcinogenicity as a basis for an improved risk assessment". This project is aimed at establishing whether or not the carcinogenicity of ochratoxin A is considered to arise through a threshold or non-threshold approach.
Figure 20: Worldwide limits for ochratoxin A in cereals and cereal products
As is the case with patulin and ochratoxin A, a few dozen countries have set regulatory or guideline limits for deoxynivalenol (DON) in food (see Figure 21). Whereas in 1995 this trichothecene was only sporadically regulated in food, it has become a toxin of high concern in monitoring programmes and among regulatory authorities since the late 1990s, when mg/kg concentrations were reported to occur in cereals and cereal products particularly in Europe. Similarly as with ochratoxin A, it was difficult to summarize the most occurring limits for DON in wheat and other cereals in one figure, and those interested in the full details of the many regulations that now exist for DON should consult Table 3. The peak at 750 mg/kg is dominated by the countries of the EU that currently apply this (unofficial) guideline limit for DON in flour used as raw materials since several years.
Figure 21: Worldwide limits for deoxynivalenol in wheat (flour) and other cereals
Recent information suggests that fungi that produce nivalenol, a trichothecene related to DON, frequently occurs in some Asian countries, sometimes more often than DON-producing species, for instance in Japan (Tanaka et al., 2004) and the Republic of Korea (Lee et al., 2004). However nivalenol-producing fungi have also recently been frequently identified in the south and west of England (Jennings et al., 2004). Regulations for nivalenol have not yet been established but given the relatively higher toxicity of nivalenol, as compared to DON (European Commission, 2002c), nivalenol might need to be given more attention from a regular point of perspective.
Zearalenone, an estrogenic mycotoxin, is now regulated in food in 16 countries (see Figure 22) compared to six countries in 1995. Zearalenone is structurally related to a-zearalanol (zeranol), an anabolic growth promoter banned in the EU in 1988. Zearalenone is metabolized in cattle to various compounds including zeranol. By regulating the zearalenone contents of animal feed, the problem of the occurrence of natural zeranol in edible tissues could be controlled. Limits for zearalenone in maize and other cereals currently vary from 50 to 1 000 mg/kg. Figure 22 betrays a tendency of setting limits at higher rather than at lower limits.
Figure 22: Worldwide limits for zearalenone in maize and other cereals
Fumonisins were discovered in the late 1980s. Whereas in 1995 fumonisins were only subject to regulations in one country, this number has now increased to six with limits for maize ranging from 1 000 to 3 000 mg/kg (see Figure 23). Although proportionally a very significant increase, the number of countries regulating fumonisins is too small to draw meaningful conclusions about generally agreed limits. Regulatory authorities currently considering the constitution of legal limits for fumonisins should carefully consider whether they wish to do so for fumonisin B1 only or for the sum of the naturally occurring fumonisins. A similar situation occurs here as with the aflatoxins, for which limits also exist for aflatoxin B1 and for total aflatoxins (see Section 3.4.1).
Figure 23: Worldwide limits for fumonisins in maize
184.108.40.206 Other mycotoxins
In addition to the mycotoxins mentioned in the previous sections, several other mycotoxins are subject to regulatory action. These are diacetoxyscirpenol, T-2 toxin and HT-2 toxin, agaric acid, the ergot alkaloids, phomopsins and sterigmatocystin. Since the number of countries that have established regulations for these mycotoxins is relatively low, they are not further discussed here.
Australia and New Zealand have recently harmonized their regulations for mycotoxins. Common limits are now applied for total aflatoxins in peanuts and tree nuts, and ergot (the sclerotium of Claviceps purpurea, not actually a mycotoxin but a dormant winter form of the fungus containing mycotoxins: the ergot alkaloids). In addition, the harmonized regulations include unique limits for phomopsins in lupin seeds and products thereof and for agaric acid in food, containing mushrooms and alcoholic beverages. Thus far, limits for these toxins are only known to exist in Australia and New Zealand.
As previously mentioned, the EU has harmonized EU regulations for aflatoxin B1 in various feeds since 1976 including official protocols for sampling and analysis. In 1998, the first EU-harmonized regulations for mycotoxins in food came into force (including sampling protocols and criteria for methods of analysis) and have gradually expanded to various mycotoxins in different foodstuffs.
In 2004 and subsequent years, a significant further expansion of EU-harmonized mycotoxin regulations may be expected for foods and feeds. For foods, this concerns patulin, aflatoxin B1, aflatoxin M1, ochratoxin A and DON in infant formulae and follow-up formulae; ochratoxin A in coffee, wine, beer, spices, grape juice, cocoa and cocoa products; several Fusarium-produced mycotoxins, i.e. trichothecenes (T-2 and HT-2 toxins, in addition to DON), fumonisins and zearalenone in cereal-based foodstuffs. In addition, new limits will probably be established for feeds in the years to come for several mycotoxins including ergot alkaloids, DON, zearalenone and ochratoxin A (European Commission, 2003b), and relevant scientific opinions of the EFSA panel on contaminants in the food chain are currently in preparation.
MERCOSUR consists of Argentina, Brazil, Paraguay and Uruguay. These countries apply common limits for total aflatoxins in peanuts, maize and products thereof, and for aflatoxin M1 in fluid and powdered milk. The MERCOSUR regulations for mycotoxins also include official methods of sampling and analysis. Brazil and Uruguay apply additional limits for certain mycotoxin/matrix combinations.
Current member countries of the Association of Southeast Asian Nations (ASEAN) comprise Brunei Darussalam, Cambodia, Indonesia, the Lao Peoples Democratic Republic, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Viet Nam. Most of these countries have specific regulations for mycotoxins (see Table 3). Whereas harmonized regulations are obviously not (yet) established by ASEAN, an ASEAN Task Force on Codex Alimentarius has taken a common position to support the 0.5 mg/kg level for aflatoxin M1 in milk.
The Codex Alimentarius Commission (CAC), supported by FAO and WHO, aims to facilitate world trade and protect the health of consumers through the development of international standards for foods and feeds. Currently 168 countries are members of Codex Alimentarius. Within the CAC, the Codex Committee on Food Additives and Contaminants (CCFAC) derives maximum limits (standards) for additives and contaminants in food, which are decisive in trade conflicts. The CCFAC develops standards based on a procedure that follows the principles of risk analysis as far as possible, according to rules and methods laid down in the Codex Procedural Manual as well as the Codex General Standard for Contaminants and Toxins in Food.
The procedure operates by requesting discussion papers about all relevant aspects of a food contaminant when there is reason to expect health concerns and trade problems, followed by developing proposals for maximum levels when all necessary requirements for standard setting are fulfilled. These requirements are that health concerns can be substantiated, preferably on the basis of a toxicological and exposure assessment by JECFA (see Section 2.1), and that sufficient reliable data about levels in foods are available (preferably worldwide distributed) to develop a maximum level on the basis of the ALARA principle (Kloet, 2002).
In the mycotoxin area, CCFAC established standards for total aflatoxins in unprocessed peanuts, aflatoxin M1 in milk and patulin in apple juice in 2003. A draft standard has been developed for ochratoxin A in wheat, barley, rice and derived products, and proposed standards for DON in cereals are currently under discussion.
The CCFAC has, apart from its goal to develop standards (Maximum Limits) where necessary, also decided to devote much attention to developing Codes of Practice in which principles and advice about practical measures to control mycotoxins during cultivation, storage and processing are assembled. Examples of these include the codes of practice developed for: i) the reduction of aflatoxin B1 in raw materials and supplemental feedstuffs for milk producing animals (Codex Alimentarius, 1997); ii) prevention and reduction of patulin contamination in apple juice and apple juice ingredients in other beverages (Codex Alimentarius, 2003a); and iii) the prevention and reduction of mycotoxin contamination in cereals including annexes on ochratoxin A, zearalenone, fumonisins and trichothecenes (Codex Alimentarius, 2003b).
 The word "regulations" used
in the text and the tables also includes other arrangements such as
 The figures in this document have been prepared using Corel® clipart (Corel Corporation Limited, Dublin, Ireland).
 See http://www.grainscanada.gc.ca/Pubs/fusarium/backgrounder/don-e.htm
 See http://www.uni-wuerzburg.de/toxikologie/EU-OTA/OchratoxinA.html