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putrescine, cadaverine, spermidine, and spermine, although not exerting a direct toxic effect, can potentiate the toxic effects of tyramine and histamine by competing for the detoxifying enzymes (16), and act as precursors of carcinogenic nitrosoamines (243). Furthermore, some authors (13, 245) have reported that diets low in polyamines can have bene cial effects in reducing tumor growth. 3.2.8 RISK MANAGEMENT
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The primary goal of risk management associated with food is to protect public health by controlling all risks as effectively as possible through the selection and implementation of appropriate measures. Risk management decisions should take into account the whole food chain from primary production to consumption. In the food processing chain, managing risks should be based on scienti c knowledge of the microbiological hazards and an understanding of the primary production, processing and manufacturing technologies, handling during food preparation, storage, transport, retail, and catering. Hazard identi cation is the determination of whether or not a speci c constituent in food is causally linked to particular health effects. Hazard is usually determined experimentally in controlled toxicology studies with known doses or exposures to the toxic agent under study. Statistical considerations have resulted in the use of a maximum tolerated dose (MTD), the highest practical dose that can be administered, in most studies carried out in laboratory animals. In the speci c context of a food safety assessment, the World Health Organization (2000) has de ned hazard as a biological, chemical, or physical agent in, or condition of, food with the potential to cause an adverse health effect. The main European regulations, which include different aspects of the management of microbial risks as well as strategies for control and prevention of risks for consumer protection, are as follows (246): Regulation (EC) No. 852/2004 of the European Parliament (EUP) and of the Council on the hygiene of foodstuffs; Regulation (EC) No. 853/2004 of the EUP and of the Council laying down speci c hygiene rules for food of animal origin; Regulation (EC) No. 854/2004 laying down speci c rules for the organization of of cial controls on products of animal origin intended for human consumption; Regulation (EC) No. 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety; Regulation (EC) No. 882/2004 on of cial controls performed to ensure the veri cation of compliance with feeding and food law, animal health, and animal welfare;
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BIOGENIC AMINES
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Commission Regulation (EC) No. 2073/2005 on microbiological criteria for foodstuffs. Risk assessment on biogenic amines is dif cult because knowledge concerning the acute and especially long-term toxic effects of amines and dose response is incomplete. However, it is well known that some types of foods may pose a risk on sensitive persons and for patients using MAO- and DAOinhibiting drugs. Shalaby (240) reviewed the oral toxicity of histamine and other biogenic amines in foods for humans. He considered that histamine-induced poisoning is, in general, slight at 40 mg, moderate at >40 mg and severe at >100 mg. Based on an analysis of recent poisoning episodes, the following guidelines for histamine content of sh have been suggested: safe for consumption potentially toxic probably toxic toxic <5 mg/100 g 5 20 mg/100 g 20 100 mg/100 g >100 mg/100 g
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In the United Kingdom, guidelines for histamine content in sh are as follows (239): safe for consumption potentially toxic probably toxic toxic <10 mg/100 g 10 50 mg/100 g 50 100 mg/100 g >100 mg/100 g
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The US FDA guidelines established for tuna, mahimahi, and related sh, specify 50 mg/100 g as the toxicity concentration and 5 mg/100 g as the defect action concentration because histamine is not uniformly distributed in sh that has undergone temperature abuse. Therefore, if 5 mg/100 g is found in one section, there is a possibility that other units may exceed 50 mg/100 g (247). FDA requires the use of the AOAC uorometric method (248). In Australia and New Zealand, the concentration of histamine in a composite sample of sh or sh products, other than crustaceans and mollusks, must not exceed 20 mg/10 g. A composite sample is a sample taken from each lot, comprising ve portions of equal mass from ve representative samples. The European Union requires that nine samples are to be taken from each batch of sh species of the following families: Scombridae, Clupeidae, Engraulidae, and Coryphaenidae. These samples must ful ll the following requirements: mean value of all samples must not exceed <10 mg/100 g; two samples may be >10 mg/100 but <20 mg/100; and no sample may exceed 20 mg/100. Examinations must be carried out in accordance with reliable, scienti cally recognized methods such as HPLC (17).
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