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FDA Definition of Milk Product

FDA Milk product rice pudding

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#1 b.juarez

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Posted 27 July 2017 - 11:24 PM

We just had an SQF audit, and one of the questions that came up was regarding whether the rice pudding that we manufacture (around 72% milk content by weight) is considered a "milk product" by the FDA.  In FDA Title 21, Section 1240.3 (j), "milk product" is loosely defined, but it is unclear whether or not our rice pudding is considered a "milk product".

 

A couple of calls to the FDA were unsuccessful, with the people there not being able to answer the question.  Does anyone have any information on this, or any contacts at the FDA whom we can ask the question to?

 

Thanks in advance!


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#2 Ryan M.

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Posted 31 July 2017 - 08:08 PM

If your product has less than 65% by weight milk, or milk product combination, and/or less than 2.0% milk protein then it is not considered Grade A Milk, or Grade A Milk product.  See PMO definition below.

 

6. Products not included in Items 1-5 are Grade “A” milk products which have a minimum of 2.0% milk protein (Total Kjeldahl Nitrogen (TKN) X 6.38) and a minimum of sixty five percent (65%) by weight milk, milk product or a combination of milk products.

 

 

The 2015 Pasteurized Milk Ordinance defines GRADE A Milk as:

 

 

GG. MILK PRODUCTS: Grade “A” Milk and Milk Products include:

1. All milk and milk products with a standard of identity provided for in 21 CFR Part 131, excluding 21 CFR 131.120 Sweetened Condensed Milk.

2. Cottage cheese (21 CFR 133.128) and dry curd cottage cheese (21 CFR 131.129)2.

3. Whey and whey products as defined in 21 CFR 184.1979, 184.1979a, 184.1979b, 184.1979c, and Section 1., Whey Products of this Ordinance.

4. Modified versions of these foods listed above in Items 1 and 2, pursuant to 21 CFR 130.10- requirements for foods named by use of a nutrient content claim and a standardized term.

5. Milk and milk products as defined in Items 1, 2, 3 and 4 above, packaged in combination with food(s) not included in this definition that are appropriately labeled with a statement of identity to describe the food(s) in final packaged form, e.g., “cottage cheese with pineapple” and “fat free milk with plant sterols”.

6. Products not included in Items 1-5 are Grade “A” milk products which have a minimum of 2.0% milk protein (Total Kjeldahl Nitrogen (TKN) X 6.38) and a minimum of sixty five percent (65%) by weight milk, milk product or a combination of milk products.

Safe and suitable (as defined in 21 CFR 130.3(d)) non-grade “A” dairy ingredients, can be utilized in the products defined in Items 1-6 when added to a level needed for a functional or technical effect, and limited by Good Manufacturing Practices (GMPs) and are either:

a. Prior sanctioned or otherwise approved by FDA, or

b. GRAS (generally recognized as safe), or

c. An approved food additive listed in the CFR.

 

Except that with respect to those products which have a federal standard of identity, only ingredients provided for in the standard may be utilized.

NOTE: Non-grade “A” dairy ingredients may be used after the Regulatory Agency, in consultation with FDA, has reviewed and accepted information supporting that the use is to achieve a functional or technical effect in the finished milk or milk product(s). Supporting information shall be submitted by the milk plant and/or the ingredient manufacturer for review and approval by the Regulatory Agency and FDA prior to manufacturing and selling the finished milk or milk product(s). Once the Regulatory Agency, in consultation with FDA, has accepted the use of a non-grade “A” ingredient to achieve a functional or technical effect in the finished milk or milk product(s), any formulation or processing changes related to the non-grade “A” dairy ingredient shall be immediately communicated to the Regulatory Agency, and may result in the resubmission of supporting data, if it is determined by the Regulatory Agency, in consultation with FDA, that the change could potentially affect the functional or technical effect of the finished milk or milk product(s).

The supporting information shall include but is not limited to:

a. A statement of the proposed usage of a non-grade “A” dairy ingredient, including the expected functional and/or technical effect(s) in the finished milk or milk product(s) and justification of why this cannot be performed by a currently available Grade “A” dairy ingredient;

b. Non-grade “A” dairy ingredient description, composition and required usage level;

c. Finished milk or milk product(s) description including the current, if applicable, and proposed formula(s) including the current, if applicable, and proposed labeling information (e.g. statement of identity, ingredient declaration) and:

d. Applicable and recognized analytical measurements and/or organoleptic observations and evaluations that objectively demonstrate that the non-grade “A” dairy ingredient provides a specific functional and/or technical effect(s) that could not be achieved when using a currently available Grade “A” dairy ingredient(s) when used at similar concentrations and with similar proximates, i.e. protein, fat, ash, lactose, moisture, etc.

 

When a non-grade “A” dairy ingredient is used to increase weight or volume of the milk and/ or milk product, or displace Grade “A” dairy ingredients, this use is not a suitable functional or technical effect.


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#3 Ryan M.

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Posted 31 July 2017 - 08:09 PM

To add to the above...if your product falls under a "milk product" you will need to be monitored by the local dairy branch for your State.  I suggest you contact your local health department and ask for contact information on the milk and dairy branch.


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#4 b.juarez

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Posted 31 July 2017 - 08:40 PM

hi Ryan,

 

I appreciate your input, hopefully this helps answer some of our questions.

 

thanks again :spoton: 


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