1、Food Allergens Management,食品过敏源,Contents内容,Definitions定义Principals of food allergy食品过敏症的原则Food allergens食品过敏源Allergen management programme过敏源管理计划Summary总结,Food allergy versus food intolerance食品过敏源与食品不耐性,Food allergy: the immune-mediated state of hypersensitivity resulting from exposure to a food-bor
2、ne allergen (usually a protein or glycoprotein). Normally developing serious reactions and even causing deaths.食品过敏症：高度敏感性的免疫调节状态，系由接触食品携带的过敏源（一般为蛋白质或糖原蛋白）而产生。通常发展为系列反应，甚至导致死亡。Food intolerance: are non-toxic, nonimmune-related mainly due to naturally occurring toxicants (e.g. gluten), microbial or c
3、hemical food contaminants (e.g. phenylanaline) and inherited metabolic disorders (e.g. lactose intolerance). Rarely life-threatening.食品不耐性：非毒性的、与免疫无关，主要由于自然生成的毒性物质（例如面筋），微生物或化学性食品污染（如苯胺）以及遗传新陈代谢失调（如乳糖不耐）。很少危及生命。,Principals of food allergy：Prevalence食品过敏症的原则:流行,The true prevalence is unknown. 真正流行不为人
4、知。It is estimated that 1% of adults and 5-6% of children have a true food allergy.据估算，1%成人、5-6%儿童有真正的食品过敏症。Approximately 950 severe reactions to foods requiring hospitalisation occur annually in the US. (According to the USDA 15% of the US population may be allergic to some food ingredients). 美国每年发生
5、大约950例对食品严重的反应,需要住院治疗。(根据USDA调查,15%的美国人口对一些食品原料过敏)In the UK it is estimated that there are a total of 15 million sufferers from allergies to various substances - not only foodstuffs- (1 in 4 of the population).英国估计有总数达1500万人对各种物质-不只是食品-过敏(人口总数的四分之一)Allergic individuals react to trace levels of the o
6、ffending allergen.过敏群体对所引发过敏源痕迹有反应。,Key players of allergenic response过敏源反应的关键因素,Three essential components三个关键部分:,Antigen抗原 (allergen过敏源),IgE Antibodies抗体,Effector cell 效应基因细胞(mast cell or basophil杆细胞或碱性细胞),IgE are produced by B cells (Lymphocytes) in response to exposure to the antigen.B细胞(淋巴细胞）遇到
7、抗体时产生IgE,Glycoproteins that are absorbed during digestion and distributed to the body via the blood stream在消化时吸收的糖原蛋白质通过血流分送到全身,Mast cells are found in the connective tissue杆细胞发现于结缔组织Basophils circulate in the blood stream碱性细胞在血流中循环Both have high-affinity IgE receptors on the surface它们都与表面的IgE受体有密切关
8、系,Clinical manifestations临床表现,Gastro-intestinal胃肠反应: Swelling of mouth parts, abdominal cramps, diarrhoea, nausea, vomiting. 嘴部肿胀、腹部痉挛、腹泻、恶心、呕吐。Respiratory呼吸反应: runny nose, difficulty breathing, constriction of throat.鼻子流涕、呼吸困难、喉咙堵塞。Cutaneous皮肤反应: swelling, hives and skin rash.肿胀、荨麻疹、皮疹。Systemic = A
9、naphylactic shock. 全身=过敏中风。 Death occurs due to cardiaorespiratory arrest and shock. Initial symptoms usually begin within 30 min after exposure.由于心脏和呼吸困难及中风导致死亡。通常在接触过敏源30分钟后出现初始症状。,食品过敏源,欧盟2003/89/EC指出的食品过敏原：花生大豆蛋奶鱼甲壳类树果（坚果）小麦其它一些会引起过敏的食品正在研究中，会及时在媒体公布在美国销售的食品如使用二氧化硫或亚硫酸盐作为防腐剂必须标注。,美国FDA指出的食品过敏原：谷
10、类包括麸皮及其制品（如小麦、黑麦、大麦、燕麦及其它们的杂交种）甲壳类及其制品蛋及蛋制品鱼及鱼制品花生及其制品大豆及豆制品奶和奶制品（包括含乳糖制品）坚果类及其制品，如板栗、榛子、腰果、杏仁、胡桃、山核桃等芹菜及其制品芥菜/芥末及其制品芝麻及其制品二氧化硫或亚硫酸盐含量在10ppm以上,比较明确的一些过敏原产品： 小麦制品、荞麦制品、蛋制品、奶制品、花生制品、鲍鱼、墨鱼/鱿鱼、三文鱼子/鱼子酱、虾类、橙桔类、蟹类、猕猴桃、牛肉制品、胡桃、三文鱼、大豆制品、鸡肉制品、猪肉制品、蘑菇/菌类制品、桃制品、芋制品、苹果制品、明胶制品等,Most common food allergens最常见的食品过敏
11、源,Major serious allergens include 主要严重的过敏源包括(IFST-1999):“Big eight八大样”: eggs, cows milk, peanut, soybean, wheat, tree nuts, fish and crustacean蛋品、牛奶、花生、黄豆、小麦、树木坚果、鱼类和甲壳类食品“Second eight八小样”: sesame seeds, sunflower seeds, cottonseed, poppy seed, fruits, beans other than green beans, peas and lentils.
12、芝麻籽、葵花子、棉籽、罂粟籽、水果、豆类（不包括绿豆）、豌豆和小扁豆Others其它: tartrazine, sulphites and latex.,KFI food allergen category list* KFI食品过敏源类别清单,Celery 芹菜Eggs蛋类Cows milk牛奶Peanut 花生Soybean 大豆Sulphites 亚硫酸盐Wheat 小麦Seeds 种子Seafood海鲜,Tree nuts树木坚果,Cottonseed棉籽poppy seeds罂粟子sesame seeds芝麻籽sunflower seeds葵花子,Crustacean甲壳类Fish鱼
13、类,almond 杏仁brazil nut巴西木坚果cashew 贾如树坚果chestnut 栗子hazelnut 榛子macadamia nut pine nuts 松子pistachio 阿月浑子的果实pecan美洲山核桃 walnut核桃,*Some exemptions are included in the list - Example一些例外在-实例表中列出,Food Allergens stability食品过敏源稳定性,Resistance to the digestive tract:抗消化系统能力Most food allergens are resistant to en
14、zymes, acids and bile salts present in the stomach. 大部分过敏源对胃中的酶、酸和胆汁盐具有抵抗力。Fresh fruits and vegetables are easily digested in the GI tract and do not cause systemic effects.新鲜水果和蔬菜很容易在GI系统中消化并不会影响系统。Resistance to proteolysis, hydrolysis and digestion:抗水解蛋白质、水解和消化Food allergens are resistant to prote
15、olysis and digestion (e.g. codfish, egg white).食品过敏源对水解蛋白质和消化有抵抗力（如鳕鱼、蛋白）。Extensive hydrolysis is necessary to eliminate allergenic properties of food allergens (e.g. casein, whey proteins, soybean).广泛的水解对于消除食品过敏源的过敏特性是必要的（例如酪蛋白、乳清蛋白质和大豆）。Allergen inactivation depends on the enzymatic or chemical tr
16、eatment used during hydrolysis and proteolysis.在水解或水解蛋白质时，可使用酶或者化学处理办法使过敏源失去作用。,Food Allergens stability食品过敏源稳定性,Resistance to heat: 抗热性Most food allergens are resistant to heat. Fruit and vegetables are heat-labile and can be eaten after heating or canning. 大部分食品过敏源抗热。水果和蔬菜遇热不稳定，可加热或制成罐头食品食用。Peanut
17、 and egg allergens remain stable when heated or boiled at 100 C. 当加热或煮沸到100度时，花生和蛋类过敏源仍保持稳定。Milk retains its allergenicity through condensation, evaporation, and drying.牛奶在经过凝聚、蒸发和烘干后仍保留过敏性。Acid stability: 酸稳定性Most allergens are stable to moderate acid treatments.大部分过敏源经过温和的酸处理仍保持稳定性。Peanut allergen
18、s are stable at pH 2.8 and egg ovalbumin at pH 3.0.花生过敏源在PH值2.8, 蛋类过敏源在PH值3.0的情况下仍保持稳定.,Management of food allergy食品过敏管理,The best therapy consist of strict elimination of the offending food from the diet最好的处理办法是将引发(过敏)的食品从食谱中去除.The application of due diligence by manufacturers制造商在以下几个方面应用时，应非常审慎：In
19、the use of allergens as ingredients.使用过敏源作为原料。In warning of the presence or potential presence of such allergens in foods.警告此过敏源在食品中出现或可能出现。In preventing cross-contamination of products with allergens present in other products or the environment.通过防止过敏源出现在其它产品或环境中而防止产品的交叉感染。ALLERGEN MANAGEMENT PROGR
20、AMME过敏源管理计划,That means意味着.,leading to.,Allergen management program过敏源管理计划,Based on a hierarchy of controls:基于控制等级：1.- Avoid the introduction of an allergen into a facility that did not already contain the allergen. 避免把过敏源引入到不含过敏源的设备中去。2.- Total dedication and segregation (of lines where possible) or
21、 equipment. 生产线（如可行）或设备完全专业化和隔离。3.-Extensive, well-documented cleaning and inspection procedures to prevent allergen cross-contact or carryover. 全面、详细记录清洁及检查程序，以防止过敏源交叉接触或产生遗留物4.- If the risk still present a precautionary label statement should be used. 如风险仍存在，应使用预先防范标签声明,避免引入-研发设计段,隔离-工厂生产段（物理、排产）,
22、GMP防交叉-生产及计划段,标识、提醒-合规性,1.- Avoidance of introduction避免引入,确认过敏源清单-表AIdentification of ingredients and other sources of allergens. 识别原料和其它过敏源的来源。Use Form B: Ingredient/packaging assessment -To identify sources of allergens. 使用表格B ：原料/包装评估-以识别过敏源的来源。,过敏源调查表,1.- Avoidance of introduction避免引入,Use Forms
23、C/D: Allergen Cross-Contact Assessment -To identify whether products can introduce undeclared allergens in other products run in the same line.使用表格C/D：过敏源交叉接触评估-以识别是否产品能传入同一生产线上其它产品所携带的未发现的过敏源。Effective tagging or coding procedures for allergen-containing ingredients, sub-ingredients and rework.为含过敏
24、源的原料、原料附件和重复产品制定有效的加注标签或编码程序。Formula/process revisions must be reviewed for introduction of new allergens. 修改配方/工序必须进行新过敏源引入审核。,FORM C: INGREDIENT/PACKAGING ASESSMENT 表格B：原料/包装评估,工厂：xxxx厂产品类别：米饼类产品,Form C allergen cross contamination Assessment表格C 过敏源交叉污染评估,工厂：XXXX厂生产线：三线,表格D 共用设备过敏源交叉污染评估,工厂：XXXX厂生
25、产线别：三线,1.- Avoidance of introduction避免引入,Allergens should be designed-out:应在设计时剔除过敏源Use non-allergenic substitutes to allergenic ingredients.使用无过敏源替代物代替过敏源原料。Avoid cross-contamination from other lines or other production areas.避免来自其它生产线或其它生产区域的交叉感染。Ensure a safe raw materials supply确保原材料供应安全:Audit s
26、uppliers allergen management program.审计供应商的过敏源管理计划。Contract/Specification review.合同/规格审核。Notification of any formulation change.通知任何配方更换。Training of personnel人员培训:An allergen awareness training session should be performed at least every year. 应至少每年举行过敏源意识培训会,2. Segregation隔离,Physical barriers:物理屏障Se
27、parate reception and storage areas for allergenic ingredients.为过敏源原料单独设立收货和储存区。Dedicate manufacturing areas within the factory在工厂内分离出生产区:Air extraction/filtration systems should remove any airborne allergen.空气抽取/过滤系统应去除任何空气传播过敏源。Control of personnel: change of overalls, hairnets and shoes.人员控制：更换衣服、
28、发网和鞋。Traffic patterns of people, ingredients and finished products.人们的交通模式、原料和成品。Identification of shared equipment and its ability to be dismantled识别共用设备及其拆卸能力:Use Form C/D使用表格C/D: Process step evaluation工序阶段评估To identify allergens that may be introduced from the process and/or processing environme
29、nt.识别有可能在加工或加工环境中进入的过敏源。Identify all shared equipment and product changeovers. 识别所有的共用设备和产品转换。,2. Segregation隔离,Production scheduling/Sequencing生产计划/排序:Avoid manufacturing carry-over.避免生产遗留物。Schedule allergen-containing products last in the production sequence. 将含有过敏源的产品排列在生产过程的最后程序。Schedule all pro
30、ducts containing the same allergen in the same run.将含有相同过敏源的所有产品排列在同一个队列中。Schedule long runs of allergen-containing products将含有过敏源的产品排列成长序列。Provide sufficient time to do a thorough allergen clean.提供充足时间，完全彻底清除过敏源。,2. Segregation隔离,Rework handling再加工处理:Rework/holdover containers must be clearly label
31、led (e.g. type and date) and segregated.再加工/盛装容器必须清晰标注标签（如，类型及时间）并加以隔离。Establish effective inventory controls.建立有效的库存货品检查机制。Rework usage will be clearly documented to assure traceability.再加工使用必须清晰记录在案，以便进行追踪工作。Develop rework/product matrix: like-into-like.建立再加工/产品基质：同类-归-同类。Monitoring: The origin of
32、 rework is recorded on the process sheet.追踪：加工表上注明再加工原因。Corrective action: If allergenic rework is added to product that is not in compliance with rework/product matrix place product in category I hold.更正措施：如过敏源再加工品加入了与再加工/产品基质不符合的产品，将产品放入留置类别I。Documentation: Rework records must be reviewed at least
33、 monthly is recommended. Rework/product matrix must be reviewed anytime that new ingredients are introduced.记录：建议至少每月检查一次再加工记录。无论何时加入新原料后，必须对再加工/产品基质进行检查。,2. Segregation隔离,Packaging handling包装:Use dedicated packaging lines whenever possible如可能，使用专用包装线。Make the packaging material visually distinctive
34、.包装材料应醒目、易识别。Label handling标签:Control of similar labels for different products不同产品使用相似标签的控制措施:Labels must be checked prior to start-up or changeover.在开始或更换前，必须检查标签。Monitoring: A label from each carton is visually checked prior to use. This check must be logged.追踪：使用前，必须目测检查每箱的标签，并记录在案。Corrective act
35、ion: If incorrect label is used place the affected product on Category I hold.更正措施：如使用了不正确的标签，将受到影响的产品放入留置类别I。Documentation: Rework records must be reviewed at least monthly is recommended. The label application procedure must be reviewed anytime that new ingredients/labels are used.记录：建议至少每月检查一次再加工
36、记录。任何时候如使用了新的原料/标签，必须核查标签应用程序。,3. Equipment Cleaning设备清洁,Define cleaning procedures for each shared equipment对每台共用设备制定清洁程序:Define a validated cleaning procedure to avoid carryover.制定有效的清洁程序，防止遗留物。Develop a product sequencing/cleaning matrix. 指定产品排序/清洁基质。Monitoring: Review the equipment inspection lo
37、g prior to start up.基质：开机前，核查设备检测记录。Corrective action: Repeat cleaning when product residues are visible.更正措施：如有产品残渣，再次进行清洁。Documentation: Records must be reviewed on a monthly basis. The sequencing/cleaning matrix must be reviewed anytime that a new product is introduced.记录：记录必须进行月检。无论何时加入了某种新产品，必须
38、检查排序/清洁基质。Avoid contamination of nearby lines防止污染临近工线: Use vacuum cleaning rather than air hoses.使用真空清洁法，而不要使用空气软管。Use dedicated cleaning equipment.使用专用清洁设备。,3. Equipment Cleaning设备清洁,Redesign or reconfigure equipment to make cleaning and inspection easier重新设计设备，便利清洁及检测工作:Easily opened and inspected
39、.开关方便，易于检测。All allergen contact surfaces must accessible for examination.所有接触过敏源表面必须易于检查。Quick release fasteners should be used for removable covers.可移盖必须使用快速开启装置。Avoid crossovers of conveyor belts or use shielding.防止输送线发生交叉，或使用遮护板。Develop an allergen spillage procedure制定过敏源溢出处理程序:Define isolation a
40、reas. 规定隔离区域。Place affected product on hold.留置受到影响的产品。Clean the cleaning equipment.对清洁设备进行清洁。All personnel affected must change overalls.所有受到影响的人员必须更换工装服。Inspect to verify that all allergen containing product has been removed.检查核实已清除所有含有过敏源的产品。,3. Equipment Cleaning设备清洁,Equipment flushing设备冲洗 (wet o
41、r dry e.g. Sugar湿洗或干洗，如糖类):Define a validated flushing procedure to avoid carryover. 制定有效的冲洗程序，防止遗留物。Specify time and/or amount of flushing material to be used.规定使用冲洗物的时间和/或数量。Develop a product sequencing/flushing matrix. 制定产品排序/冲洗基质。Monitoring: Review the equipment inspection log prior to start up.
42、 追踪：开始前，检查设备检测记录。Corrective action: Repeat flushing when product residues are visible.更正措施：如有产品残渣，再次进行冲洗程序。Documentation: Records must be reviewed on a monthly basis. The sequencing/flushing matrix must be reviewed anytime that a new product is introduced.记录：记录必须进行月检。无论何时加入某种新产品，必须核查排序/冲洗基质。The equi
43、pment cleaning/flushing procedure must be validated to demonstrate that it removes visible product residues from all product contact surfaces.设备清洁/冲洗程序必须十分有效，可以从所有接触产品表面清除可见的产品残渣。,4. Labelling加注标签,1.- If the allergen is included in the product formulation如产品配制中包含过敏源:It must be declared in the ingred
44、ient list.必须在原料表中标明。Allergens should be labelled so to avoid misinterpretation过敏源必须加注标签，防止产生曲解:Marketing ensures that the label communicates all allergens营销部分保证标签清楚传达了所有的过敏源Sources of ingredients should be declared必须标明原料来源:Lecithin can be labelled “soy lecithin”卵磷脂可标注为“大豆卵磷脂”Flavours can be labelled
45、 “natural flavour (contain milk)”调味品可标注为“天然调味品（含牛奶）”Processing aids must labelled if their presence in the finished product is enough to elicit allergenic reactions如加工辅料在制成品中的含量足以引起过敏反应，则必须加注标签:Declare processing aids that are likely to be present in the finish product.标明制成品中可能包含的加工辅料。Seek alternati
46、ve non-allergenic processing aids.寻求非过敏源加工辅料替代品。,Carryover of carryover shall not require labelling残留物的残留物无需加注标签。,4. Labelling加注标签,2.- If the allergen cannot be designed out or assessed as unavoidable如过敏源在设计过程中无法去除，或被鉴定为不可或缺的物质:The product will be appropriately labelled (in accordance with regulatio
47、ns and internal guidelines for labelling)该产品应加注适当的标签（遵照加注标签规则和内部原则）:R&D and manufacturing inform marketing of unavoidable allergens.研发和制造部门告知营销部门不可或缺的过敏源。Marketing is responsible for label modification when在下列情况下，营销部门负责更改标签:Unavoidable allergens in the formula (e.g. ingredients, supplier identified
48、carryover and rework containing allergens)配方中含有不可或缺的过敏源（如：原料、鉴别为供货商的残留物及再加工含有过敏源）Unavoidable cross-contamination.不可避免的交叉污染。Unavoidable carryover.不可避免的残留物。Avoid similar label mix up.防混淆相似标签。,5. Thresholds for Allergen Labelling 过敏源加注标签临界值,Allergen Thresholds caused by Cross Contact have been defined
49、for all Allergens on the PM WW HACCP Standard list Section 15, EXCEPT for在PM WW HACCP标准清单第15章中，已规定了交叉接触产生过敏源临界值，除了PM WW HACCP:Peanuts花生Tree nuts树木坚果Sulphites亚硫酸盐 - threshold already specified其临界值已规定 This does not apply to allergenic ingredient, only cross contact.本说明不适用于过敏源原料，仅适用于交叉接触。The threshold is该临界值为 10ppm = 10mg/100g,
