| Food additives play an increasingly important role in food industry.Safety and function are two important aspects of food additives.To ensure that the use of food additive will not cause harm to the health of consumer,risk analysis has been used regularly in the management of food additives. Risk analysis is a process consisting of three components:risk assessment,risk management and risk communication.The systemic risk analysis has not been used very well in China,so it is very necessary to study on how to apply the systemic risk analysis in the management of food additives in China.Systemic risk assessment for two food additives containing aluminium and sulphites were conducted in this study and the risk management proposals for these food additives were proposed based on the results of risk assessment.The food intake data and body weight data of population were obtained from the national survey of the nutrition and health status of Chinese people in 2002.The content data of food additives in food from the national food contamination monitoring database which was collected from 2003-2007and the maximum level in Hygienic standards for uses of food additives(GB2760-2007).The hazard identification and hazard characterization for theses food additives in this study refere the results of JECFA.The method of exposure assessment of food additives in this study includes screen method by budget,point estimate and probabilistic assessment.The method of risk characterization of food additives is mainly in compare the results of exposure asseement with the ADI of sulphites or PTWI of aluminium,and then characterize of the possibility of adverse effect to health and the severity of the adverse effect which is likely to occurred.The application practice of risk analysis on the management of food additives in China were summarized in the study.The management of processing aids in China,CAC and other countries were compared and the proposals about how to improve the management of processing aids were proposed.The following factors were discussed in the study:the current method of hazard identification and exposure assessment,the data source used in the exposure assessment and the advantages and disadvantages of the data used in this study,the provisions and rules of the management of food additives in China,the factors which can restrict the risk assessment of food additives,the deficiency in the risk analysis of food additives in China.Following are main results and conclusions of this research.1.The conclusions of risk assessment and risk management proposals for food additives containing aluminium1.1The conclusions of risk assessment for food additives containing aluminium1.1.1The PTWI for aluminium prepared by JECFA in its 67th meeting is 1mg/kg·bw.The PTWI applied to aluminium in food from all source,including the aluminium from food additives containing aluminium. 1.1.2The results of monitor data for content of aluminium in foods show that the residues of aluminium in some fermented flour products(mainly steamed bread),deep-fried flour products(such as deep-fried flour cake and deep-fried flour stick),biscuit,bread,Puffed and extruded-type foods have exceed the maximum permitted residue level in GB2760-2007.The average aluminium residue content in the deep-fried flour products from monitor data have exceed the maximum permitted residue level in GB2760-2007.1.1.3 The screen results of two food additives containing aluminium including aluminium potassium sulfate and aluminium ammonium sulfate showed that precise exposure assessment was necessary for the two food additives.1.1.4 Point assessment was used to calculate the exposure of aluminium.Average,P50,P95,p97.5 of the food intake data and the aluminium residue data were calculated and the results were used to calculate the exposure with different combination.The contributions of each food to the taotal exposure of aluminium were also calculated.1.1.5 The results of point assessment of aluminium showed that the dietary exposure of aluminium in subgroup of female of 15-17 years old in city(0.9130mg/kg bw),male of more than18years old in city(0.9588mg/kg bw) and female of more than 18 years old in city(0.9157mg/kg bw) were lower than the PTWI when average level of the food intake combined with the maximum permitted residue level of aluminium.Except for above condtions,the exposures of aluminium in all subgroup have exceeded the PTWI when the maxiumum permitted residue level of aluminium combined with any food intake.It was concluded that the current maximum permitted residue level of 100mg/kg in food couldn't protect the health of consumer.1.1.6 The contributions of each food to the total exposure of almunimu of all subgroup under the condition that average food intake combined with average aluminium residue in foods were calculated.The results showed that deep-fried flour product,flour and fermented flour product were the main sources of aluminium exposure and the contribution were more than 90%.1.1.7The risk assessment software @RISK 4.5(Palisade Corporation) which based on Monte Carlo principles was used to calculate the probabilistic assessment of aluminium.The results showed that the average weekly exposure distribution of all subgroup have exceeded the PTWI of aluminium.The lowest average weekly exposure was 2.16 times of PTWI and the highest was 13.08 times of PTWI.The P95 of the weekly exposure of aluminium of different subgroup was different.The range was 8.28 to 61.18 times of PTWI.The percentage of people whose aluminium exposure lower than PTWI in different subgroup was different.The lowest was 4.36%and the highest was 55.81%.1.2 The risk management proposals for food additives containing aluminiumBased on the results of risk assessment and the results of comparation of provision of food additives containing aluminium in China,CAC and other countries,the following risk management measures were suggested:1)develop substitutes for food additives containing aluminium 2)reduce the maximum permitted residue level of aluminium in the standard based on the risk assessment 3)strengthen the supervision and management of the misuses of food additives containing aluminium 4) educate the users and consumer know the harm of excessive intake of aluminium.2.The conclusions of risk assessment and risk management suggestions for sulfites2.1 The results of risk assessment for sulfites2.1.1Sulfur dioxide,potassium metabisulphite,sodium metabifulphite,sodium sulfite,sodium hydrogen sulfite,sodium hyposulfite are Sulfities pemitted to use in China.A group ADI for these sulfites was 0-0.7 mg/kg·bw expressed as sulfur dioxide which were prepared by JECFA at its 17th meeting.2.1.2The results of monitoring data for sulfur dioxide showed that the residue of sulfur dioxide in some food category such as candied and preserved fruit,dried vegetables,vegetables in brine sauce,fresh edible fungi and seaweeds,canned or bottled(pasteurized) edible fungi and seaweeds, edible starch powder exceeded the maximum permitted level in which sulfites was permitted to added.Sulfites in some food category such as processed nuts and seeds,some starch products were misused in which sulfites were not permitted to be added.2.1.3Budget method was used to screen the intake of sulfites.The hypothesis which was used to calculate included that the maximum level of sulfur dioxide in solid foods was 400mg/kg,the maximum level of sulfur dioxide in liquid foods was 250mg/L,the percentage of solid food and liquid food were 25%.The results showed that precise exposure assessment was necessary.2.1.4 Point assessment was used to calculate the exposure of sulfur dioxide.Average,P50,P95, p97.5 of the food intake data and the residue data of sulfur dioxide were calculated and were used to calculate the exposure with different combination.The contributions of each food to the total exposure of sulfur dioxide were also calculated.2.1.5 The sulfur dioxide exposure of subgroup 1-3years old in all country,city and countryside and 4-6years old in all country and city exceed the ADI of sulfur dioxide under the conditions that P97.5 of the food intake combined with the maximum residue level of sulfur dioxide in GB2760-2007.So we could conclude that the maximum level of sulfites in hygienic standards for uses of food additives can protect the health of majority population but can't protect the health of sensitive subgroup population.2.1.6 Because the misuse of sulfites beyond the scope and maximum level permitted in GB2760, the dietary exposure of sulfur dioxide exceeded the ADI in all subgroup population when the food intake and the sulfur dioxide residue in food at high percentage.For example,the dietary exposure of sulfur dioxide exceeded the ADI in all subgroups other than female of 15-17years old in city when P97.5 of the food intake combined with P97.5 of residue of sulfur dioxide monitoring data. Effective measures should be applied to control the misuses of sulfites.2.1.7 Fresh edible fungi and seaweeds,dried edible fungi and seaweeds,nuts and seeds, vegetables in brine sauce and steamed bread were the main source of the dietary exposure of sulfur dioxide for most of the population.There were different between the population in city and in countryside.Dried edible fungi and seaweeds and nuts and seeds were main contributions to dietary exposure of sulfur dioxide to the population in city.Fresh edible fungi and seaweeds, vegetables in brine sauce and steamed bread were main contributions of dietary exposure of sulfur dioxide for the populations in countryside.The sulfur dioxide intake from theses foods should be emphasized when control the dietary exposure of fulfur dioxide.2.2 Risk management measures proposals for sulfitesBased on the results of risk assessment and the results of comparation of provision of sulfites in China,CAC and other countries,the following risk management measures were suggested: 1)Educate the producers and users of sulfites to abide by the provisions of sulfites in the GB2760-2007;2)Strengthen the monitor and inspection for the use of sulfites in foods,especially the food categories which are the main contributions of total dietary exposure of sulfur dioxide, such as edible fungus and seaweeds,nuts and seeds,vegetable in brine sauce,steamed bread.;3)Reduce the maximum permitted resiude level in candied and preserved fruit,biscuit, sugar and wine referring the provisions in GSFA.4) Improve the labeling of food which contain sulfur dioxide referring to the provisions in CAC and other countries.The sulfur dioxide and its content in foods must be labeled.3.Study on the management of processing aids and suggestions to strengthen the management of processing aids in ChinaThe management regulations on processing aids of CAC,Australia,Japan,Unites States of America and China were collected and compared in this study.The results showed that there were some deficiencies in the management of processing aids in China.The deficiency included that the definition of processing aids was not clear and idiographic,the technical purpose of each processing aid was not identified and the scope and maximum use level(or residue level) of each processing aid were not clear.The management measures to the above deficiency were suggested.1) Survey the actual use of processing aids in China and complete the list of processing aids which permitted 2) Prepare the principles and guidelines for use of processing aids and direct the use of them 3) Identify the technical effect,scope and maximum use level(or residue) in food for each processing aid based on risk assessment 4) Complete specifications and detect methods for processing aids to ensure the safety of processing aids.4.The deficiencies and suggestions in the risk analysis in ChinaThere were some deficiencies in the applying of risk analysis on management of food additives. There were no guidelines and principles about how to apply risk analysis on food additives.There were no ADI for food additives which were used only in China.No monitor data could be used to risk analysis for some food additives and systemic and complete risk assessment was impossible because of the lack of data.No any software based on probabilistic assessment can be used to assessment the dietary exposure of food additives.The following measures were suggested to above deficiencies.A risk analysis guideline on food additives should be prepared referring to the international risk anlaysis principles.The way of data collection should be broadened and the data necessary should be collectted systemically.A probabilistic assessment software which combined the food intake data and the content data of food additives in foods should be developed.All of these measures are important to systemic use of risk analysis.
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