9 replies to this topic

[QAKat]

Hello, 

 

I need some guidance from you all regarding ingredient statement. 

I looked at FDA regulations 21 CFR 101.4 Food; Designation of Ingredients but I need some clarification.

So, we add ingredients and sub ingredients to our statements but we do not add the sub ingredients in parentheses. Per the regulations there are two options:

 

(2) An ingredient which itself contains two or more ingredients and which has an established common or usual name, conforms to a standard established pursuant to the Meat Inspection or Poultry Products Inspection Acts by the U.S. Department of Agriculture, or conforms to a definition and standard of identity established pursuant to section 401 of the Federal Food, Drug, and Cosmetic Act, shall be designated in the statement of ingredients on the label of such food by either of the following alternatives: 

 

(i) By declaring the established common or usual name of the ingredient followed by a parenthetical listing of all ingredients contained therein in descending order of predominance except that, if the ingredient is a food subject to a definition and standard of identity established in subchapter B of this chapter that has specific labeling provisions for optional ingredients, optional ingredients may be declared within the parenthetical listing in accordance with those provisions. 

 

(ii) By incorporating into the statement of ingredients in descending order of predominance in the finished food, the common or usual name of every component of the ingredient without listing the ingredient itself.

 

As I understand the first option is to put sub ingredients in paranthesis. I do not completely understand the second option but I do believe that is the way we are doing it. 

 

Example Ingredient Statement we do: Wheat Flour, Malted Barley Flour, Niacin, Iron, Thiamin Mononitrate, Riboflavin, Folic Acid, Butter, Natural Flavor, Sugar, Egg, Water, Glycerin, Ethyl Alcohol, Acacia Gum, Xanthan Gum, Salt. Contains Wheat, Eggs and Milk.

 

The wheat flour is the ingredient and Malted Barley Flour, Niacin, Iron, Thiamin Mononitrate, Riboflavin, Folic Acid are the sub ingredients. Can we list them like I wrote it above or do we need the parentheses?

 

We also use Nat. Vanilla Flavor and on the spec sheet only the sub ingredients are listed (highlighted in blue) not sure if we need to include it as Natural Vanilla Flavor (sub ingredients).

 

Please help! 

 

Thank you all in advance!

 

[SHQuality]

You need the parentheses.

Right now, it looks like you use more riboflavin than eggs, because you haven't put the ingredients in descending order.

I'm also wondering if your product complies if you use more natural flavor than sugar or eggs.

Did your flavor supplier provide any documentation on how much the flavor should be dosed in recipes.

 

Your two options are:

 

A. Wheat Flour (Malted Barley Flour, Niacin, Iron, Thiamin Mononitrate, Riboflavin, Folic Acid), Butter, Natural Flavor, Sugar, Egg, Water, Glycerin, Ethyl Alcohol, Acacia Gum, Xanthan Gum, Salt. Contains Wheat, Eggs and Milk.

(Assuming the other ingredients are indeed in descending order)

 

B. All the ingredients (without listing the overall "Wheat Flour") name and putting those ingredients in descending order.

Malted Barley Flour, Niacin, Iron, Thiamin Mononitrate, Riboflavin, Folic Acid, Butter, Natural Flavor, Sugar, Egg, Water, Glycerin, Ethyl Alcohol, Acacia Gum, Xanthan Gum, Salt. Contains Wheat, Eggs and Milk. --> Don't forget to put these ingredients in descending order.

Edited by SHQuality, 10 February 2023 - 07:28 AM.

[Annnn]

Hi QAKat,

 

For the second option, my understanding is the same as yours. When doing food labels at my previous company, I usually went with the first option.

 

The wheat flour is the ingredient and Malted Barley Flour, Niacin, Iron, Thiamin Mononitrate, Riboflavin, Folic Acid are the sub ingredients. Can we list them like I wrote it above or do we need the parentheses?

 

4.2.1.3 Where an ingredient is itself the product of two or more ingredients, such a compound ingredient may be declared, as such, in the list of ingredients, provided that it is immediately accompanied by a list, in brackets, of its ingredients in descending order of proportion (m/m). Where a compound ingredient (for which a name has been established in a Codex standard or in national legislation) constitutes less than 5% of the food, the ingredients, other than food additives which serve a technological function in the finished product, need not be declared.

[From Codex Stan 1-1985]

 Codex Stan 1-1985.pdf   66.77KB   14 downloads

 

 

We also use Nat. Vanilla Flavor and on the spec sheet only the sub ingredients are listed (highlighted in blue) not sure if we need to include it as Natural Vanilla Flavor (sub ingredients).

 

In my opinion, it needs not to list out the sub ingredients of the natural vanilla flavor, label it as flavouring will do as according to the below:

 

4.2.3.4 The following class titles may be used for food additives falling in the respective classes and appearing in lists of food additives permitted generally for use in foods:

• Flavour(s) and Flavouring(s)

• Modified Starch(es)

The expression “flavours” may be qualified by “natural”, “nature identical”, “artificial” or a combination of these words as appropriate. 

[From Codex Stan 1-1985]

 Codex Stan 1-1985.pdf   66.77KB   14 downloads

 

24. The first sentence in Section 4.2.3.4 is understood more easily if it is compared to the labelling requirements for food additives in the list of ingredients for prepackaged food (see Section 4.2.3.3 of CODEX STAN 1-1985). Section 4.2.3.3 requires that the list of ingredients includes the name or recognized numerical identification (e.g., INS number) for each individual food additive and the technological functional (e.g., emulsifier) of the additive in the food. However, unlike the requirements for other types of food additives discussed in Section 4.2.3.3, Section 4.2.3.4 states that, and it is not required that, the individual flavouring substances be listed in the ingredient list for packaged foods; rather, flavourings may be labelled collectively by class name only (e.g., flavouring). 

[From Discussion Paper on The Inconsistent Terminology Related to Flavourings in Codex Texts]

 DISCUSSION PAPER ON THE INCONSISTENT TERMINOLOGY RELATED TO FLAVOURINGS IN CODEX.pdf   541.57KB   5 downloads

 

Hope this helps.

Edited by Annnn, 10 February 2023 - 07:52 AM.

[SHQuality]

You need the parentheses.

Right now, it looks like you use more riboflavin than eggs, because you haven't put the ingredients in descending order.

I'm also wondering if your product complies if you use more natural flavor than sugar or eggs.

Did your flavor supplier provide any documentation on how much the flavor should be dosed in recipes.

 

Your two options are:

 

A. Wheat Flour (Malted Barley Flour, Niacin, Iron, Thiamin Mononitrate, Riboflavin, Folic Acid), Butter, Natural Flavor, Sugar, Egg,  Salt. Contains Wheat, Eggs and Milk.

(Assuming the other ingredients are indeed in descending order)

 

B. All the ingredients (without listing the overall "Wheat Flour") name and putting those ingredients in descending order.

Malted Barley Flour, Niacin, Iron, Thiamin Mononitrate, Riboflavin, Folic Acid, Butter, Natural Flavor, Sugar, Egg, Salt. Contains Wheat, Eggs and Milk. --> Don't forget to put these ingredients in descending order.

 

EDIT: I removed the ingredients of the natural flavor as they are unlikely to require inclusion on the label (assuming you used it at a proper dosage).

 

To be clear, if you list both the ingredient name and the subingredients, you can only list the subingredients using brackets immediately after the main ingredient being specified.

Edited by SHQuality, 10 February 2023 - 07:56 AM.

[QAKat]

You need the parentheses.

Right now, it looks like you use more riboflavin than eggs, because you haven't put the ingredients in descending order.

I'm also wondering if your product complies if you use more natural flavor than sugar or eggs.

Did your flavor supplier provide any documentation on how much the flavor should be dosed in recipes.

 

Your two options are:

 

A. Wheat Flour (Malted Barley Flour, Niacin, Iron, Thiamin Mononitrate, Riboflavin, Folic Acid), Butter, Natural Flavor, Sugar, Egg, Water, Glycerin, Ethyl Alcohol, Acacia Gum, Xanthan Gum, Salt. Contains Wheat, Eggs and Milk.

(Assuming the other ingredients are indeed in descending order)

 

B. All the ingredients (without listing the overall "Wheat Flour") name and putting those ingredients in descending order.

Malted Barley Flour, Niacin, Iron, Thiamin Mononitrate, Riboflavin, Folic Acid, Butter, Natural Flavor, Sugar, Egg, Water, Glycerin, Ethyl Alcohol, Acacia Gum, Xanthan Gum, Salt. Contains Wheat, Eggs and Milk. --> Don't forget to put these ingredients in descending order.

Hello SHQuality!

 

We are not using more natural flavor than sugar or egg. In the statement I posted the natural flavor is a sub ingredient to the butter (Cream (Milk), Natural Flavor (Lactic Acid)) to what was explained to me they didn't add the cream (milk) as a sub ingredient because milk was going to be added to the allergen statement. 

 

The natural vanilla flavor is the ingredients starting after the egg. Also, I didn't know the allergens had to be in descending order either! >.<

 

Thank you so much for your input, appreciate you :) 

[QAKat]

 

Hi QAKat,

 

For the second option, my understanding is the same as yours. When doing food labels at my previous company, I usually went with the first option.

 

The wheat flour is the ingredient and Malted Barley Flour, Niacin, Iron, Thiamin Mononitrate, Riboflavin, Folic Acid are the sub ingredients. Can we list them like I wrote it above or do we need the parentheses?

 

4.2.1.3 Where an ingredient is itself the product of two or more ingredients, such a compound ingredient may be declared, as such, in the list of ingredients, provided that it is immediately accompanied by a list, in brackets, of its ingredients in descending order of proportion (m/m). Where a compound ingredient (for which a name has been established in a Codex standard or in national legislation) constitutes less than 5% of the food, the ingredients, other than food additives which serve a technological function in the finished product, need not be declared.

[From Codex Stan 1-1985]

Codex Stan 1-1985.pdf

 

 

We also use Nat. Vanilla Flavor and on the spec sheet only the sub ingredients are listed (highlighted in blue) not sure if we need to include it as Natural Vanilla Flavor (sub ingredients).

 

In my opinion, it needs not to list out the sub ingredients of the natural vanilla flavor, label it as flavouring will do as according to the below:

 

4.2.3.4 The following class titles may be used for food additives falling in the respective classes and appearing in lists of food additives permitted generally for use in foods:

• Flavour(s) and Flavouring(s)

• Modified Starch(es)

The expression “flavours” may be qualified by “natural”, “nature identical”, “artificial” or a combination of these words as appropriate. 

[From Codex Stan 1-1985]

Codex Stan 1-1985.pdf

 

24. The first sentence in Section 4.2.3.4 is understood more easily if it is compared to the labelling requirements for food additives in the list of ingredients for prepackaged food (see Section 4.2.3.3 of CODEX STAN 1-1985). Section 4.2.3.3 requires that the list of ingredients includes the name or recognized numerical identification (e.g., INS number) for each individual food additive and the technological functional (e.g., emulsifier) of the additive in the food. However, unlike the requirements for other types of food additives discussed in Section 4.2.3.3, Section 4.2.3.4 states that, and it is not required that, the individual flavouring substances be listed in the ingredient list for packaged foods; rather, flavourings may be labelled collectively by class name only (e.g., flavouring). 

[From Discussion Paper on The Inconsistent Terminology Related to Flavourings in Codex Texts]

DISCUSSION PAPER ON THE INCONSISTENT TERMINOLOGY RELATED TO FLAVOURINGS IN CODEX.pdf

 

Hope this helps.

 

Hello Annnn!

 

Yes, the first option is the one I am familiar with too. 

 

Thank you so much for your help and for the information provided. It helped clear a lot. 

[SHQuality]

Hi  @QAKat,

 

So what changes did you make to the declaration?

I'd like to see what you use after you've read the thread.

[QAKat]

Hi  @QAKat,

 

So what changes did you make to the declaration?

I'd like to see what you use after you've read the thread.

 

Hi SHQuality.

 

Before: Wheat Flour, Malted Barley Flour, Niacin, Iron, Thiamin Mononitrate, Riboflavin, Folic Acid, Butter, Natural Flavor, Sugar, Egg, Water, Glycerin, Ethyl Alcohol, Acacia Gum, Xanthan Gum, Salt. Contains Wheat, Eggs and Milk.

 

After: Wheat Flour (Malted Barley Flour, Niacin, Iron, Thiamin Mononitrate, Riboflavin, Folic Acid), Butter (Cream, Natural Flavor), Sugar, Egg, Natural Flavor, Salt. 

Contains: Wheat, Milk, Egg.

 

Also my boss sent me a link to a website called Foodlabels.com where they state that if unsalted butter is used then there is no need to add sub ingredients to the ingredient statement. It is ok to just add it as Butter or Unsalted Butter. I will link the website. By any chance do you know anything about this? I couldn't find anything on FDA Food Labeling Guide or CFR 21 Part 101.

 

Thank you!

[QAKat]

https://www.foodlabe...tml/2008_05.htm

[SHQuality]

 

Also my boss sent me a link to a website called Foodlabels.com where they state that if unsalted butter is used then there is no need to add sub ingredients to the ingredient statement. It is ok to just add it as Butter or Unsalted Butter. I will link the website. By any chance do you know anything about this? I couldn't find anything on FDA Food Labeling Guide or CFR 21 Part 101.

In my opinion, the link is correct: it's not wrong for butter to be considered a base ingredient. That said, I'm primarily familiar with EU legislation, so it is probably wise to get an American view on this as well.