Ingredient Substitution Keeps Production RollingBlog
By Irene Chau
Sr. Regulatory Compliance Specialist
With the Russia-Ukraine war aggregating the supply chain disruption from the COVID crisis, manufacturers are actively seeking for ingredients they can substitute in order to keep production rolling and prevent further damages from the cost increases.
While there is no enforcement discretion policy issued by CFIA from Canada for either of the occurrences, FDA from the U.S. has issued temporary policies specifically for the COVID-19, providing flexibility to manufacturers to make temporary and minor formulation changes without reflecting the changes on package label when it meets the following requirements:
- The ingredient substitute does not trigger adverse health effects (e.g. allergen, hypersensitivity)
- Ingredient is used at less than 2% by weight
- Ingredient that is being substituted is not highlighted on any marketing callouts
- Ingredient is not a characterizing ingredient listed in the name
- Ingredient would not affect any claims on label
- Ingredient does not have a significant impact on the finished product, including nutritional and functionality differences
Existing regulation provides labeling flexibilities
Notwithstanding the temporary policy, the existing food labeling regulations in both US and Canada already provide some labeling flexibilities that would not require a label change when a substitution is made.
The following classes of ingredients may be declared with the permitted class name and then list the specific ingredients in parentheses. When listing the specific ingredients, “and/or” or “contains one or more of the following” may be used, when the manufacturer is unable to adhere to a consistent pattern of ingredient in the product
- Vegetable/ animal/ marine oil or shortening blend
- —Permitted class name: “(source) shortening,” “(source) oil shortening,” “blend of (source) oil” with the source declared as “vegetables”, “animal”, “marine”
- —Example declaration: “animal fat (ghee and/or lard),” “vegetable oil (contains one or more of the following: soy oil, sunflower oil, cottonseed oil)”
- —Permitted class name: “leavening”
- —Example declaration: “leavening (contains one or more of the following: sodium acid pyrophosphate, baking soda, potassium bicarbonate, monocalcium phosphate)
- Yeast nutrients
- —Permitted class name: “yeast nutrients”
- —Example declaration: “yeast nutrients (calcium sulfate and/or ammonium phosphate)”
- Dough conditioners
- —Permitted class name: “dough conditioners”
- —Example declaration: “dough conditioners (L-cysteine and/or ammonium sulfate)”
- Firming agents
- —Permitted class name: “firming agents”
- —Example declaration: “Firming agents (calcium chloride, calcium lactate)”
- Food grade wax/ resin used on fresh produce in retail sale
- —Permitted class name: “(source)-based (wax/ resin)” with the source declare as vegetable-, petroleum-, beeswax-, and/or shellac
- —Example declaration: “Coated with food-grade vegetable-based wax, to maintain freshness”
- Fish protein ingredients consist primarily of myofibrillar protein faction from different fish species
- —Permitted class name: “fish protein”
- —Example declaration: “fish protein (contains one or more of the following: Pollock, cod, and/or pacific whiting)”.
Other than the use of the class name and “and/or” labeling, declaring ingredients using a permitted collective (generic) name will also allow flexibility. For example, “spices” means any whole/ broken/ ground spices not nutritional, but do not include garlic, onion, and celery. So manufacturer may declare “spices” on the label and substitute any spices actually used in the recipe, e.g. substituting black peppercorn with white peppercorn, substituting oregano with marjoram. Below is a complete list of permitted generic names permitted by regulation:
|Collective name||It means…|
|“Spices”||Whole/ broken/ ground spices not nutritional (See 21CFR101.22 and/or CPG Sec 525.750 for the full list of spices)|
|“Natural flavor or Natural flavoring”||Extractives, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis derived from a spice, fruit, vegetable, edible yeast, plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products|
|“Skim milk or nonfat milk”||Skim milk, concentrated skim milk, reconstituted skim milk, and nonfat dry milk|
|“Milk”||Milk, concentrated milk, reconstituted milk, and dry whole milk|
|“Buttermilk”||Sweetcream buttermilk, concentrated/ reconstituted/ dried sweetcream|
|“Whey”||Whey, concentrated/ reconstituted/ dried whey|
|“Cream”||Cream, concentrated/ reconstituted/ dried cream|
|“Butterfat”||Butteroil and dried butterfat|
|“Eggs”||Dried/ frozen/ liquid whole eggs|
|“Egg whites”||Dried/ frozen/ liquid egg whites|
|“Egg yolks”||Dried/ frozen/ liquid egg yolks|
Canada also has similar labeling regulations and provides labeling flexibilities that would not require a label change when a substitution is made.
The following collective name may be used in ingredient listing without the individual ingredients/components declared
|Collective name||It means…|
|“Vegetable oil” or “vegetable fat”||One or more vegetable fats or oils, except coconut oil, palm oil, palm kernel oil, peanut oil or cocoa butter|
|“Spices,” “seasonings” or “herbs”||One or more spices, seasonings (when used at <2%) or herbs except salt|
|“Milk ingredients”||Any of the following in liquid, concentrated, dry, frozen or reconstituted form, namely, butter, buttermilk, butter oil, milk fat, cream, milk, partly skimmed milk, skim milk and any other component of milk the chemical composition of which has not been altered|
|“Modified milk ingredients”||Any of the following in liquid, concentrated, dry, frozen or reconstituted form, namely, calcium-reduced skim milk (obtained by the ion-exchange process), casein, caseinates, cultured milk products, milk serum proteins, ultrafiltered milk, whey, whey butter, whey|
|“Sodium phosphate” or “sodium phosphates”||Any combination of disodium phosphate, monosodium phosphate, sodium hexametaphosphate, sodium tripolyphosphate, tetrasodium pyrophosphate and sodium acid pyrophosphate|
|“Toasted wheat crumbs”||Toasted wheat crumbs made by cooking a dough prepared with flour and water, which may be unleavened, or chemically or yeast-leavened, and which otherwise complies with the standard prescribed by Section B.13.021 or B.13.022|
|“Sugar”||Sugar, liquid sugar, invert sugar or liquid invert sugar, singly or in combination|
|“Sulfites,” “sulfiting agents,” “sulphites,” or “sulphiting agents”||One or more of the following food additives, namely, potassium bisulphite, potassium metabisulphite, sodium bisulphite, sodium dithionite, sodium metabisulphite, sodium sulphite, sulphur dioxide and sulphurous acid|
|“Vinegar”||Wine vinegar, spirit vinegar, alcohol vinegar, white vinegar, grain vinegar, malt vinegar, cider vinegar or apple vinegar, singly or in combination|
In addition, Canada has a long list of ingredients that are exempt from component declaration when used as an ingredient in another food. As a result, manufacturers may substitute any of these ingredients with different compositions. For example, substituting butter made with cream only, with butter made with cream and salt, and the label would still declare “butter”. Below are some examples that are exempt from the component declaration:
- “Butter” in Section B08.056
- “Margarine” in Section B09.016
- Breads subject to compositional standards in Sections B.13.021 to B.13.029
- “Flour” / “Enriched flour” in Section B13.001
- Baking powder in Section B03.002
- Milks subject to compositional standards in Sections B.08.003 to B.08.027
- Sweetening agents subject to compositional standards in Sections B.18.001 to B.18.018
- Vinegars subject to compositional standards in Sections B.19.003 to B.19.007
- Cheese for which a standard is prescribed in Division 8 of the FDR, if the total amount of cheese in a prepackaged product is less 10% of the packaged product
- Jams, marmalades and jellies subject to compositional standards in Sections B.11.201 to B.11.241 of the FDR when the total amount of those ingredients is less than 5% of a prepackaged product
- “Olives” in Section B.11.050, “pickles” / “relish” in Section B.11.051and horseradish when the total amount of those ingredients is less than 10% of the prepackaged product
- Prepared or preserved meat, fish, poultry meat, meat by-product or poultry by-product when the total amount of those ingredients is less than 10% of the prepackaged product that consists of an unstandardized food
- Pasta product (including pasta containing tomato or spinach powder) that does not contain egg in any form, any flour other than wheat flour,
- Toasted wheat crumbs used in or as a binder, filler or breading in or on a food product
Not specific for supply chain disruption due to COVID or Russia-Ukraine war, but per B.01.011, FDR and 284 SFCR, Canada does allow “and/or” labeling for ingredients that may be substitute, vary, or omit due to the variation in the supply for natural or economic reason.
- The substitution must not be misleading to consumer, e.g., replacing chocolate with imitation chocolate will be considered as misleading.
- All ingredients or components that may be used, substitute, vary, or omit, must be placed in ingredient list in descending order of predominance by weight.
- Recipe must be reviewed every 12-month and update with the appropriate ingredients or components that may be used in the product.
- Ingredient list must be shown in a way clearly identifying which ingredients or components may be substitute, vary, or omit. It could be identified in the body of the ingredient list, or an asterisk may appear next to the ingredient or components to indicate that an explanation regarding an omission, substitution or variation will appear at the end of the list of ingredients.
- Example of declaration:
–“Ingredients: Pork and/or Beef…”
–“Ingredients: Milk solids, Bacterial culture, Salt, *may contain Carotene.”
–“Ingredients: Baby romaine lettuce, Baby Swiss chard, Baby spinach, Baby kale, Arugula, Radicchio. The proportion of ingredients in each package may vary.”
In all other cases
For both U.S. and Canada, if none of the options apply, the manufacturer may over-sticker the labeling as a temporary solution, provided the manufacturer must ensure that the sticker is covering all incorrect information on the label, and the sticker must adhere to the label at all time while the product is available for sale.
If you are having trouble navigating your ingredients substitution, our experts can help. Contact us to get started.