投稿者

Anna Benevente

Director of Labeling, Ingredient and Product Review

FDAによると、ココナッツはアレルゲンですか?

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. 

この法律は、9つの主要な食物アレルゲンを識別し、そのうちの1つは木の実です。

米国食品医薬品局(FDA)は、ココナッツを木の実、したがって申告しなければならないアレルゲンとして認識しています。ココナッツは一般的にナッツとはみなされず、本物の木のナッツとココナッツの両方にアレルギーがある人は少ないため、これは混乱を招く可能性があります。

それにもかかわらず、ココナッツはリストに残っているので、ココナッツを含む食品をラベル付けする食品施設は、それを成分に適切にリストする必要があります。

 

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:

  • ミルク
  • 甲殻類
  • 木の実
  • ピーナッツ
  • 小麦
  • 大豆
  • ゴマ

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).

‘Contains’ ステートメントは、成分リストに隣接し、同じサイズとフォントでなければなりません。木の実、甲殻類、魚類を含む食品の場合、特定の種類のナッツ、魚類または甲殻類の種類は、その一般的または通常の名前で宣言する必要があります。
 

また、食品安全近代化法(FSMA)で定められているように、現行の適正製造基準(cGMP)と予防管理の両方を通じてアレルゲンとの交差接触から保護するための対策を講じることが重要です

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.

実際、この法律の下で木の実として識別されるナッツの多くは植物の木の実ではありませんが、FDAの仕事は、食品アレルギーの懸念からできるだけ多くの人々を保護することであり、必ずしもすべての食品の正しい分類を決定するものではありません。

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”.

これを怠ると、FDAが製品のブランドを誤認することを考慮することになり、警告書、輸入警告、拘留などの規制措置が取られる可能性があります。アレルゲンを適切にリストアップしないことは、食品の安全性に関する最も一般的な違反の1つであり、製品のラベルを作成する際に考慮することが重要です。

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.

 

投稿者


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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