食品过敏原

食品过敏原 Research & Development Food Allergens 食品过敏源 Contents内容 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 项目进度计划表范例计划下载计划下载计划下载课程教学计划下载 ? Summary总结 2 Food allergy versus food intolerance食品过敏源与食品不耐 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-borne 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 chemical 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。 3 Principals of food allergy:Prevalence : 食品过敏症的原则:流行 食品过敏症的 原则 流行 ? ? ? The true prevalence is unknown. 真正流行不为人知。 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 offending allergen.过敏群 体对所引发过敏 源痕迹有反应。 4 Consumer complaints消费者投诉 (KFI database 2000数据库 数据库2000) 消费者投 诉 数据库 Responsibility 职责: Manufacturing 制造 Marketing 市场营销 Complaint type 投诉类 型: Confectionery 糖果 Food 食品 Total 总计: % vs total Wrong Wrong Mislabel Illness label complaints anaphylaxis packaging allergens 错 标签错 占投诉总数 包装错误 标出过敏源 过敏性疾病 误 比例 5 4 9 26 5 31 115 17 132 2 2 4 1.5% 0.3% Total number of complaints for confectionery: 5.996 对糖果投诉总数为:5.996 Total number of complaints for food: 11.077 对食品投诉总数为:11.077 5 Key players of allergenic response过敏源反应的关键因素 过敏源反应的关键因素 Three essential components三个关键部分: Effector cell Antigen 抗原 (allergen过 敏源) IgE Antibodies 抗体 效应基因细胞 (mast cell or basophil杆细胞或 碱性细胞) 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 IgE are produced by B cells (Lymphocytes) in response to exposure to the antigen.B 细胞(淋 巴细胞)遇到抗体 时产生IgE 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受体有密切关系 6 Clinical manifestations临床表现 临床表现 Gastro-intestinal胃肠反应 Swelling of mouth parts, abdominal 胃肠反应: 胃肠 反应 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 呼吸反应: 呼 吸反应 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 皮肤反应: 皮肤反应 疹。 Systemic = Anaphylactic 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。 ? ? 7 Most common food allergens最常见的食品过敏源 最常见的食品过敏源 Major serious allergens include 主要严重的过敏源包括(IFST1999): – “Big eight八大样”: eggs, cow′s milk, peanut, soybean, 八大样” 八大样 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, 八小样” 八小样 cottonseed, poppy seed, fruits, beans other than green beans, peas and lentils.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. 其它: 其它 8 KFI food allergen category list* KFI食品过敏源类别清单 食品过敏源类别清单 – – – – – – – Celery 芹菜 Eggs蛋类 Cow′s milk牛奶 Peanut 花生 Soybean 大豆 Sulphites 亚硫酸盐 Wheat 小麦 Cottonseed棉籽 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 9 – Seeds 种子 – Tree nuts poppy seeds罂粟子 sesame seeds芝麻籽 – 树木坚果 sunflower seeds葵花子 Crustacean甲壳类 Fish鱼类 – Seafood海鲜 *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 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 enzymes, 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 proteolysis 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 treatment 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。 10 Food Allergens stability食品过敏源稳定性 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 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 allergens 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. 11 Management of food allergy食品过敏管理 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„„ That means意味着 意味着„„ 意味着 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 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。 leading to„„ – 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。 12 Allergen management program过敏源管理计划 过敏源管理计划 : A cross-functional effort各职责部门共同努力 各职责部门共同努力 ? Purchasing:采购 – Wants ingredients that meet specifications at low cost.低成本采购满 足规格的原料。 Legal/regulatory:合法/满足规章 制度 关于办公室下班关闭电源制度矿山事故隐患举报和奖励制度制度下载人事管理制度doc盘点制度下载 – Wants to develop specifications with the minimum declared allergens possible.开发过敏源可能性最小的产品。 Manufacturing: 生产 – Wants efficient changeovers between products with minimum downtime.用最少 时间进行产品间转换。 Engineering: 工程 路基工程安全技术交底工程项目施工成本控制工程量增项单年度零星工程技术标正投影法基本原理 – Wants to design flexibility into the lines.把机动性 设计 领导形象设计圆作业设计ao工艺污水处理厂设计附属工程施工组织设计清扫机器人结构设计 加入到生产线中 。 Marketing:市场营销 – Wants the broadest market possible for new improved products.为新 开发产品提供尽可能广阔的市场。 13 Allergen management program过敏源管理计划 过敏源管理计划 : A cross-functional effort各职责部门共同努力 各职责部门共同努力 Auditors:审计师 – Want to obtain evidence of proper management of allergens at the processing facility.从加工设备中取得恰当管理过敏源的 证据。 ? Consumer relations:消费者联系 – Want to reduce the number of complaints regarding allergens. 减少关于过敏源的投诉数量。 ? Suppliers/Co-Manufacturers:供应商/合作生产商 – Want to comply with KFI expectations and additionally increase turnover.满足KFI期望， 并另外增加营业额。 ? Customers/Consumers:顾客/消费者 – Want to have sufficient and understandable information in the packaging to make a decision about whether or not to consume the product.详细理解包装上的说明，以决定是否消 费此产品。 14 Allergen management program过敏源管理计划 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 引入到不含过敏源 引入 的设备中去。 2.- Total dedication and segregation (of lines where possible) or equipment.生产线(如可行)或设备完全专业化和隔 equipment. 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 15 used.如风险仍存在，应使用预先防范标签 标签声明 标签 1.- Avoidance of introduction避免引入 避免引入 Identification of ingredients and other sources of allergens. 识别原料和其它 过 敏源的来源。 – Use Form C: Ingredient/packaging assessment -To identify sources of allergens.使用表格C :原料/包装评估-以识别过敏源的来源。 – Use Forms E: Allergen Cross-Contact Assessment -To identify whether products can introduce undeclared allergens in other products run in the same line.使用表格E: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。 16 FORM C: INGREDIENT/PACKAGING ASESSMENT 表格 :原料/包装评估 表格C:原料 包装评估 List the raw material (RM) number and name列出原材料(RM)号码和名称 List the storage condition列出储存条件: A=Ambient室温 , F=Frozen冷冻, R= Refrigerated冷藏 Describe the hazards描述危害 Determine the control mechanism CCP or PP 决定控制机制CCP或PP 17 Form E-1 Ingredient Allergen Assessment表格 表格E-1 配料过敏源评估 表格 List all ingredients containing allergens列出所有含过敏源的原料 - Example实例 List identified allergens列出已识别的过敏源 List all ingredients containing carryover列出所有含遗留过敏源的原料 List identified carry over allergens列出已识别的遗留过敏源 A List all ingredients containing allergens/sulfites per Food Allergen Category List (HACCP Standard). 按照食品过敏源类别 清单(HACCP 标准 excel标准偏差excel标准偏差函数exl标准差函数国标检验抽样标准表免费下载红头文件格式标准下载 )列出所有 含过敏源/亚硫酸盐的配料 B List identified allergens/sulfites of ingredients 列出配料中已识别 的过敏源/亚硫酸盐 C List identified ingredients containing carryover allergens/sulfites from supplier per allergen profile of Raw material Spec. 按照原材料规格 的过敏源档案，列出发自供应商 的已识别的含遗留过敏源/亚硫酸 盐的配料 D List identified carry over allergens/sulfites 列出已识别的 遗留过敏源/亚硫酸盐 18 Form E-2 Ingredient Allergen Assessment表格 表格E-2 配料过敏源评估 表格 List all products produced on the manufacturing line列出所有生产线出产的产品 - Example Are all identified allergens labelled是否所有已识别过敏源已作好标记? If “no” identify control mechanism(s) 如果“没有”，按识别控制机制 List all products produced on the manufacturing line 列出所有生产线出 产的产品 Are all identified allergens (per ingredient allergen assessment E-1, column B and D) labelled? 是否所有已识别过敏源已作好标记? (按照;原料过敏源评估 E-1，B 和 D 列) YES 是 NO 不是 (list allergens 列出过 敏源) If “No” identify control mechanism(s) 如果“没有”，按识别控制机制 (_ - CCP) (_ - PP ) 19 1.- Avoidance of introduction避免引入 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 suppliers’ 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 20 2. Segregation隔离 隔离 Physical barriers:物理屏障 – Separate 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、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 D使用表格D: Process step evaluation工序阶段评估 ? To identify allergens that may be introduced from the process and/or processing environment.识别有可能在加工或加 工环境中进入的过敏源。 识别有可能在加工或加工环境中进入的过敏源。 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。 21 FORM D: Processing step evaluation表格 :加工步骤评估 表格D: 表格 List all processing steps from raw materials to finished products e.g. addition of ingredients, rework, cooking, grinding, slicing, shredding, hydrating, mixing, etc. 列出从原材料到成品的所有加工步骤，例如原料增加、再加工、烹调、磨碾、 切片、 切成碎片、溶解、混合等。 Describe the hazards描述危害 PROCESSING STEP 加工步骤 BIOLOGICAL HAZARD 生物 危害 VP = Vegetative Pathogen 植 物病原体 SP = Sporeforming Pathogen 孢子产生病原体 BIOLOGICAL HAZARD CONTROL MECHANISMS 生物 危害控制机制 (___-CCP) (___- PP) CHEMICAL HAZARD (Allergens, Sulfites, Mycotoxins, Antibiotics, Pesticides)化 学危害( 过敏 化学危害( 化学危害 亚硫酸盐、真菌、 源 、 亚硫酸盐 、真菌 、 抗生 杀 虫剂) 素 、 杀虫剂) CHEMICAL HAZARD CONTROL MECHANISMS 化 学危害控制机制 (___-CCP) (___- PP) * PHYSICAL HAZARD Inherent to equipment or environment. (Metal, Glass, Hard Plastic) 物理危害 设备或环境固有的 金属、玻璃、硬塑料) (金属 、 玻璃、 硬塑料 ) PHYSICAL HAZARD CONTROL MECHANISMS 物理危害控制机制 (___-CCP) (___- PP) Determine the control mechanism CCP or PP 决定控制机制CCP或PP- Example举例 22 2. Segregation隔离 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 products 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。 23 2. Segregation隔离 隔离 Rework handling再加工处理: – Rework/holdover containers must be clearly labelled (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 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 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。 24 2. Segregation隔离 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.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 action: 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。 25 3. Equipment Cleaning设备清洁 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 log 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。 26 3. Equipment Cleaning设备清洁 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.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 areas. 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。 27 3. Equipment Cleaning设备清洁 设备清洁 Equipment flushing设备冲洗 (wet or 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. 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 equipment 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。 28 4. Labelling加注标签 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 ingredient 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 “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 alternative non-allergenic processing aids.寻求非过敏源加工辅料 替代品。 29 4. Labelling加注标签 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 regulations 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 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。 Carryover of carryover shall not require labelling残留物的残留物无需加注标签。 30 5. Thresholds for Allergen Labelling 过敏源加注标签临界值 – Allergen Thresholds caused by Cross Contact have been defined 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 31 5. Thresholds for Allergen Labelling过敏源临界值加注标签 过敏源临界值加注标 签 – This Threshold applies to Finished Products as sold to the consumer本临界 值适用于销售给消费者的制成品 Example例如: A level of 1mg/100g of wheat protein in a bar of chocolate, caused by cross contact with wheat crisps - would not need to be labelled ‘May contain traces of wheat’一块巧克力因与小麦脆片交叉接触，产生1 毫克/100克的小麦蛋白质 含量，则无需在标签中注明“可能含有少量小麦” Calculation example given in PM WW HACCP standard - Account for flushing and cleaning.PM WW HACCP 标准含有计算范例-适用于冲洗和清洁处理。 32 Summary总结 总结 OUR GOAL目标 目标 ? ? To formulate foods so to avoid the inclusion of allergens.配制食品，防 止含有过敏源。 To organise raw materials, production schedules and cleaning procedures to prevent allergen cross-contamination.组织原材料、生产 和清 洁程序，防止过敏源交叉污染。 To train personnel in allergen awareness.培训人员， 注意过敏源。 To clearly label allergens.清楚标注过敏源。 To have appropriate recall systems for products containing undeclared allergens.建立恰当体系，收回含有不明过 敏源的产品。 ? ? 33