作者

Anna Benevente

Director of Labeling, Ingredient and Product Review

作者

根据 FDA,椰子是否属于过敏原?

7 月 12, 2019

Approximately 33 million Americans suffer from food allergies. In response, Congress passed the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) which requires food labels to list all ingredients that may cause allergic reactions. 

该法律确定了九种主要的食物过敏原,其中一种是坚果。

美国食品药品监督管理局 (FDA) 将椰子视为一种树坚果,因此必须声明其过敏原。这对一些人来说可能令人困惑,因为椰子通常不被认为是坚果,很少有人对真正的树坚果和椰子过敏

尽管如此,椰子仍然在清单上,因此食品设施标记含有椰子的产品必须将其适当地列在成分中。

 

FALCPA Requirements for Declaring Allergens

FALCPA is applied to nine food groups that were chosen because they account for over 90% of all food allergies in the United States. They are:

  • 牛奶
  • 鸡蛋
  • 甲壳类贝类
  • 木本坚果
  • 花生
  • 小麦
  • 大豆
  • 芝麻

The Act requires food containing one or more of these nine major food allergens to label the product with either a ‘Contains’ statement, which lists the food source from which the allergen is derived, or to list the common or usual name of the food allergen in the standard list of ingredients. This is done to avoid consumer confusion over ingredients that are derived from food allergens (i.e. whey and milk).

“包含”语句必须与成分列表相邻,且大小和字体相同。对于含有树坚果、甲壳类贝类或鱼类的食品,特定类型的坚果,或鱼类或贝类的物种,必须用其常用名称声明。
 

同样重要的是,要确保您正在采取措施,通过食品安全现代化法案 (FSMA) 中规定的现行药品生产质量管理规范 (cGMP) 和预防性控制措施防止过敏原交叉接触

Is Coconut a Tree Nut Allergen?

While coconuts grow on trees and contain the word ‘nut’ in their title, Coconuts are botanically a drupe, a fruit with several hard layers. Despite this, they still fall under FDA’s designation of ‘tree nuts’ for the purpose of FALCPA. This can be confusing for labelers who may have not thought of coconut as being an actual nut or as a major food allergen.

While rare, there are a number of people who are allergic to coconut in the United States. FDA likely included coconut in the tree nut category to cover this known food allergen under the Act. FDA acknowledges that their tree nut- list is broad and may even contain species with no current food use.

事实上,根据该法案被确定为树坚果的许多坚果不是植物性树坚果,但FDA的职责是保护尽可能多的人免受食物过敏问题的影响,不一定是确定所有食物的正确分类。

Coconut and Allergen Labeling

With all this in mind, if you are a food facility labeling products containing coconut, you must declare the presence of coconut either in the ingredients statement or with an adjacent ‘Contains’ statement. Ingredients that are derived from coconut must use the common name ‘Coconut’ in the ingredients or say “contains coconut”.

如果不这样做,可能会导致 FDA 考虑产品品牌错误,从而可能导致监管行动,如警告信、进口警报或拘留。未能适当列出过敏原是最常见的食品安全违规行为之一,在创建产品标签时必须考虑这一点。

Registrar Corp is a private FDA compliance consultant that assists companies in complying with FDA regulation. Registrar Corp offers a Labeling and Ingredient Review service to help ensure your food label is FDA compliant, including that it contains appropriate allergen statements. For more information, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

 

作者


Anna Benevente

Director of Labeling, Ingredient and Product Review

Highly regarded as a top expert on FDA labeling regulations, Anna Benevente continues to educate companies on existing regulations and updates from U.S. FDA for food and beverage, cosmetic, drug, and medical device products. She has researched thousands of products to determine whether they meet the FDA requirements for compliance. In addition, Ms. Benevente has conducted multiple seminars for trade and customs broker associations.

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