食物过敏原发现与应对.pdf

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1、ALLERGENSWhy all the fuss?1CHIRAG BHATTDirector,Regulatory Affairs2AgendaWhat is?Why all the fuss?SolutionsAllergen ControlQ&AWhat is?MEDICAL CONDITION Exposure triggers harmful immune response Allergens are PROTEINS Mild to severe reaction(itchy to breathing)Anaphylaxis serious and sudden Wheezing,

2、shortness of breath,dizziness,paleness,tight throat,tongue/lips swelling,hives 30,000 ER visits,2,000 hospitalized,150 deaths 33 million Americans Children(18)5.6 million 40%children allergic to more than 1 Shellfish 24%,Dairy+Peanuts 36%4What is?FDA Risk Factor Study(2016 data)indicated that 70%PIC

3、 did NOT identify major allergens and related symptoms High number of food recalls Allergens Top food safety concern 2004:FALCPA act labeling requirements Food allergen awareness-training5TOP REASON FOR UNDECLARED ALLERGEN RECALLS AND PUBLIC HEALTH ALERTS:LOSS OF CONTROL DURING PACKAGING AND LABELIN

4、G Recalls due to undeclared allergenic foods.FDA issues firm press releases that list the most significant product action in the last 60 days,based on extent of distribution and the degree of health risk.Many food allergen recalls are included in these alerts and will eventually appear in an Enforce

5、ment Report.7What is?8 70%of the total public health alerts and recalls were due to loss of control during the packaging and labeling processes.15%of the mislabeling problems were from inadequate label approval.Remaining ones were from allergen cross contact during processing or from supplier failin

6、g to disclose specific allergen.Wrong packaging,wrong description(butter vs dairy),computer errors,or imported from other country 25%of these could have been avoided cGMPs,Preventive Controls,HACCP not effective or not in placeAllergen Control Plan9 Product Design(Research and Development)Segregatio