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M. PINEIRO, Head Mycotoxin Department, Technological Laboratory of Uruguay (LATU), Av. Italia 6201, CP 11500, Montevideo, Uruguay

Mycotoxins attract world-wide attention because of the significant losses associated with their impact on human health, animal productivity, and both international and domestic trade. In terms of their and economic implications, mycotoxins are one of the most important contaminants of the food chain. According to FAO estimates, world losses of foodstuffs due to mycotoxins are in the range of 1000 million tonnes a year. As a result, many countries have introduced stringent regulations (mandatory standards) and standards (voluntary) to control the levels of mycotoxins in both their national food supply and in international trade ( 13 Latin American countries have mycotoxin regulations, ranging from 0 to 50 ppb for aflatoxins). At the international level the Codex Alimentarius of the FAO/WHO has recently approved the first maximum limit for total aflatoxins in peanuts, sampling method, code of practice for reduction of aflatoxin B1 in dairy animal feed, as well as discussion papers for patulin, ochratoxin A , zearalenone and trichothecenes. The maximum limit for aflatoxin M1 has been setback due to heavy debate among member countries. Within regional trading blocks, the Common Market of the South (MERCOSUR), which includes Argentina, Brasil, Paraguay and Uruguay as full members and Bolivia and Chile as associates, has been the first group to set limits for mycotoxins . A strict and formal process of harmonization of national regulations took place resulting in common maximum limits for aflatoxins B1, B2, G1 and G2 for peanuts and corn and for aflatoxin M1 in dairy products, with their respective sampling plans and analytical methods. They have been in effect since 1994. In MERCOSUR the responsibility for establishment of common regulations resides with the Working Group 3 (SGT3), " Technical Regulations and Conformity Assessment", which meets four times a year since 1992. The general criteria and guidelines followed for harmonization of a common regional mycotoxin regulation have been: definition of priority products in view of trade and health relevance; comparison of national regulations with international standards or regulations; use of international risk assessment data as reference; application of equivalency principles and risk analysis. The specific steps taken in the process were: approval of a framework of general principles; definitions and food categorization; addition, amendments and re-evaluation crtiteria; technological need considerations; total diet studies including local foods; exposure assessment; analytical methodology feasibility; consultation with government, industry and consumers and final approval of common regulations for mycotoxin maximum limits.The approved regulations are then incorporated into the four memberīs legal bodies and become mandatory. The World Trade Organization (WTO) Agreements (SPS and TBT) have signaled a great advance in international food trade with the elimination of unfair and restrictive commercial practices establishing a transparent and scientifically based process for adoption of regulations and standards by member countries. As part of this process, mutual recognition of regulations and equivalence of conformity assessment structures among MERCOSUR countries has become an essential part of international negotiations. Certification and accreditation of laboratories responsible for control of compliance with these directives, are crucial aspects. Since 1998 the EU requires export certificates to be issued by laboratories accredited to ISO 17025 (former ISO 25) standard. Consequently for appropiate compliance and or enforcement of these regulations, governments and industries must have analytical capabilities with quality assurance systems in place, including validated methods and accredited laboratories.