myco-UE-legisla

Since the discovery of aflatoxins in the early 1960s, regulations have been established in many countries to protect the consumer from the harmful effects of these mycotoxins. The recognition that aflatoxins and other mycotoxins can cause major illness in humans and animals has led to limits being set for aflatoxins and some other mycotoxins in different countries around the world, often however on an ad hoc basis. The European Union aims to harmonise legislation between the countries of the Union. Various factors play a role in the decision-making process required for setting these limits. These include scientific factors such as the availability of toxicological data, survey data, knowledge about the occurrence and distribution of mycotoxins in commodities, and analytical methodology. Economic and political factors such as commercial interests and sufficiency of food supply have their impact as well.

Aflatoxins are genotoxic substances that may be present in a large number of foods. For substances of this type there is no threshold below which no harmful effect is observed. No tolerable daily intake can therefore be set. Current scientific technical knowledge and improvements in production and storage techniques do not prevent the development of these moulds and consequently do not enable the presence of the aflatoxins in food to be eliminated entirely. It is, therefore, advisable to set limits as low as reasonably achievable for precautionary consumer protection. Because any toxicological evaluation has uncertainty, the setting of maximum levels has to be considered and include a sufficient safety margin even if the effect on health cannot be conclusively proved. Mycotoxins exhibit a wide range of toxicological effects and these include carcinogenicity, effects on the liver, kidneys and other organs, immunosuppresence, and many other problems.

Risk estimation is carried out by the assessment of toxicological data, e.g. identification of the toxic substances, the metabolic processes involved and both the acute and chronic toxicity. This must then be related to the occurrence of the toxins in foodstuffs and the amounts that are ingested by consumers. The uptake varies within different consumer groups and special attention must be paid to babies or infants, who may be susceptible to smaller amounts of contaminants.

The development and successful validation of analytical methods incorporating agreed general criteria with which methods of analysis have to comply are also important. It is vital to ensure that laboratories use methods with comparable levels of performance. Suitable sampling plans play a crucial part in the precision of the final analytical result because mycotoxins can be distributed very heterogeneously. Legislation must include compulsory statistically proven sampling methods and sampling plans so that these are standardised across all Member States on the basis of present knowledge. These should be flexible enough to incorporate advances in science and technology as they occur. Sampling for legislative purposes is demanding on time and labour and current legislation allows for alternative sampling plans for other purposes if they are shown to be appropriate.

For setting up a statutory maximum level, many aspects have to be considered and so different scientific organisations, authorities and other bodies are included in this process. A summary toxicological assessment of the substance with regard to its impact on human health and on the environment is reached by cooperation between the following organisations:

Within the EU, this assessment is the responsibility of the Scientific Committee on Food (SCF, http://europa.eu.int/comm/food/fs/sc/scf/index_en.html ). Furthermore, several working groups and expert committees with delegates from all Member States prepare the proposals. After detailed consultation, a proposal is given to the Scientific Committee on Food for a final assessment, after which the European Commission sets up a Steering Committee (e.g. the Steering Committee for Food) with representatives from all Member States and this ultimately leads to the adoption of the resulting Directive or Regulation. Throughout these discussions it has to be remembered that the EU is an important partner in international trade. So, when preparing maximum levels for mycotoxins, international standards or norms (e.g. Codex Alimentarius) have to be taken into account to ensure that international trade is not impeded without justification.

To meet new maximum levels, it may be necessary to develop new techniques for production, storage and transport or ensure that current recommendations are strictly carried out in order to reduce contamination levels in food. Additionally, measures for sampling and analysis as well as the training of staff have to be developed or adopted. Producers, traders and official authorities must take these additional factors that ensure acceptable quality assurance into account. Regulation can have major implications for the producing countries, which are often also developing countries, because they are forced to follow the increasing technical demands. Suitable provision must thus be taken to ensure that their economic existence is not threatened.

On the basis of Council Regulation (EEC) No. 315/93 * and the Council Directive 85/591/EC, maximum levels for aflatoxins in certain foodstuffs have been set by Commission Regulation (EC) No. 194/97 since amended by Commission Regulation (EC) No. 1525/98. Commission Directive 98/53/EC regulated the method of sampling. The Commission Regulation (EC) No. 466/2001 has been valid since April 2002, when Commission Regulation (EC) No. 194/97 was repealed. During this period, maximum levels for ochratoxin A have been set by Commission Regulation (EC) No. 472/2002 and the sampling method has been regulated by Commission Directives 2002/26/EC and 2002/27/EC. Furthermore, there are also national laws and regulations in the Member States covering either foodstuffs not regulated by European law or other mycotoxins.

Maximum levels for ochratoxin A in coffee beans, cocoa beans, dried fruit, wine, beer, spices and grape juice are likely to be set, probably by the end of 2003. In addition, there is a Scientific Cooperation (SCOOP) task collecting and collating information on the occurrence of and dietary exposure to Fusarium toxins. This is due to be completed in 2003. The European Commission has proposed maximum limits for patulin in apple juice, other apple products and other fruit juices, but the precise limits are still under discussion although decisions are expected during 2002. Discussions have begun regarding foods for small children and levels are likely to be set before April 2004.

The German authorities have notified the Commission of a draft order amending national orders laying down maximum levels for mycotoxins in different foods. This draft provides maximum levels for deoxynivalenol, zearalenone, fumonisins, and patulin besides levels for aflatoxins and ochratoxin A. Some of these levels are much lower than the existing levels and congruously the Commission asked Germany for supplementary information demonstrating the achievability of the proposed maximum levels. Setting up these maximum levels in Germany would lead to certain disparities between member states and the consequent risk of distortion of competition. EU measures are necessary in order to ensure market unity while abiding by the principle of proportionality. In general, maximum levels for contaminants must take into account consumer protection while minimising restrictions on trade.

* This and other regulations can be downloaded from the European Union Web pages:

Product	Maximum level (痢 / kg)
	B₁	_B1+B2+G1+G2	_M1
_{Groundnuts, nuts and dried fruit}
_{Groundnuts, nuts and dried fruit and processed products thereof, intended for direct human consumption or as an ingredient in foodstuffs}	₂	₄	_-
_{Groundnuts to be subjected to sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs}	₈	₁₅	_-
_{Nuts and dried fruit to be subjected to sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs}	₅	₁₀	_-

_{Cereals (including buckwheat, Fagopyrum sp.)}
_{Cereals (including buckwheat, Fagopyrum sp.) and processed products thereof intended for direct human consumption or as an ingredient in foodstuffs}	₂	₄	_-
_{Cereals (including buckwheat, Fagopyrum sp.), with the exception of maize, to be subjected to sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs}	₂	₄	_-
_{Maize to be subjected to sorting, or other physical treatment, before human consumption or use as an ingredient in foodstuffs}	_*	_*	_-

_{Milk (raw milk, milk for the manufacture of milk-based products and heat-treated milk as defined by Council Directive 92/46/EEC, as last amended by Council Directive 94/71/EC).}	_-	_-	_0,05

_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	₁₀

_Product	_{Maximum level (痢 / kg)}
_{Cereals (including rice and buckwheat) and derived cereal products}
_{Raw cereal grains (including raw rice and buckwheat)}	₅
_{All products derived from cereals (including processed cereal products and cereal grains intended for direct human consumption)}	₃
_{Dried vine fruit (currants, raisins and sultanas)}	₁₀
_{Green and roasted coffee and coffee products, wine, beer, grape juice, cocoa and cocoa products and spices}	_*