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FOOD SAFETY

Certified colours and colours exempt from certification
Tuesday, 17 November, 2020, 15 : 00 PM [IST]
Sanjay Indani & Khushbu Shah
The Substances added to food inventory replaces what was previously known as ‘Everything Added to Foods in the United States' (EAFUS). The substances added to food inventory includes the following types of ingredients regulated by the U.S. Food and Drug Administration (FDA):
•    Food additives and colour additives that are listed in FDA regulations (21 CFR Parts 172, 173 and Parts 73, 74 respectively), and flavouring substances evaluated by FEMA* and JECFA*.
•    Generally Recognised as Safe ("GRAS") substances that are listed in FDA regulations (21 CFR Parts 182 and 184).
•    Substances approved for specific uses in foods prior to 6 September, 1958, known as prior-sanctioned substances (21 CFR Part 181).
•    Substances formerly used:
1.    Prohibited substances that are listed in FDA regulations (21 CFR Part 189) as prohibited from use in food (labeled as ‘Prohibited’ or ‘Prohibited with Exceptions’).
2.    Delisted colour additives in FDA regulations (21 CFR 81.10 and/or 81.30) (labelled as ‘'Delisted’).
3.    Some substances ‘no longer Fema Gras."
It is important to note that the inventory is only a partial list of food ingredients. Inclusion in this inventory of information from non-FDA entities does not indicate an FDA approval or evaluation of this use.

A colour additive is any substance that imparts colour to a food, drug, cosmetic or to the human body. Colour additives include both synthetic substances and substances derived from natural sources. Colour additives may be used in food to enhance natural colours, add colour to colourless and ‘fun’ foods such as cake decorations, and help identify flavours (such as purple for grape flavour or yellow for lemon). Colour additives are sometimes called food dyes.

Colour additives are safe when they are used in accordance with food regulations. When the regulation approves the use of a colour additive in food, it specify:
•    The types of foods in which it can be used,
•    Any maximum amounts allowed to be used, and
•    How the colour additive should be identified on the food label.

Federal Food, Drug, and Cosmetic Act requires all colour additives and new uses for listed colour additives must be approved by the FDA before they may be used in foods. When evaluating the safety of a new colour additive or a new use for a listed color additive, the FDA considers several factors. These include the short and long-term effects of consumption, composition and properties, manufacturing process, stability, likely amount of consumption and exposure, and the availability of analytical methods for determining its purity and the amount in food.

Synthetic colour additives, also known as certified colours, are required to undergo batch certification, a process in which the FDA analyses a representative sample of each batch of the colour additive to ensure it meets the required identity and specifications before it can be used. Prior to certifying a batch, the FDA analyses the chemical composition.

FDA-regulated products must comply with the colour additive regulations; otherwise they are adulterated and/or misbranded. Colour additive violations are common reasons for warning letters and import detentions.
 
Colour additives are required to be pre-approved by FDA and listed in the colour additive regulations before they may be used in food, drugs, cosmetics, and medical devices. Each colour additive is permitted only for the intended use stated in its listing regulation. Some are also subject to the FDA certification process.

Colour Additives Approved for Use in Human Food are included in the:
a.    Part 73, Subpart A: Colour additives exempt from batch certification
b.    Part 74, Subpart A: Colour additives subject to batch certification
There are nine certified colour additives approved by the FDA for use in food:
•    FD&C Blue No. 1 - Confections, beverages, cereals, frozen dairy desserts, popsicles, frostings and icings
•    FD&C Blue No. 2 - Baked goods, cereals, snack foods, ice cream, confections, and yogurt
•    FD&C Green No. 3 - Cereal, ice cream, sherbet, drink mixers, and baked goods
•    Orange B - Only approved for use in hot dog and sausage casings
•    Citrus Red No. 2 - Only approved for use to colour orange peels
•    FD&C Red No. 3 - Confections, beverages, cereals, ice cream cones, frozen dairy desserts, popsicles, frostings and icings
•    FD&C Red No. 40 - Cereal, beverages, gelatins, puddings, dairy products, and confections
•    FD&C Yellow No. 5 - Confections, cereals, snack foods, beverages, condiments, baked goods, and yogurt
•    FD&C Yellow No. 6 - Cereals, snack foods, baked goods, gelatins, beverages, dessert powders, crackers, and sauces

Certified colour additives are synthetic colourings that are used widely for intense, uniform colour, and because they blend easily to create a variety of hues. These additives are classified as certified because they are required to undergo certification every time a new batch is manufactured.
The FDA requires food manufacturers to list all ingredients on the label, with the ingredients used in the greatest amount first, followed in descending order by those in smaller amounts. The label must list the names of any FDA-certified color additive (e.g., FD&C Blue No. 1 or the abbreviated name, Blue 1). With the exception of carmine/cochineal extract, colour additives exempt from certification can be listed collectively as ‘artificial colours', ‘artificial colour added', ‘colour added', or equally informative terms, without naming each one. Due to potential allergic reactions in some people, carmine/cochineal extract are required to be identified by name on food labels.

Exempt colours include pigments from natural sources such as vegetables, minerals, or animals. Examples include annatto extract (yellow), dehydrated beets (bluish-red to brown), caramel (yellow to tan), beta-carotene (yellow to orange) and grape skin extract (red, green). Although exempt colour additives are not subject to batch certification requirements, they are still colour additives and FDA must approve them before they can be used in foods.

Following Code of Federal Regulations (CFR) addresses the various provisions for colour additives which are important for food businesses to understand and comply:

21 CFR Part 70 - Color Additives - These regulations address general provisions for colour additives, their packaging and labeling requirements, and the fees for filing a colour additive petition to list a new colour additive or a new use for a listed colour additive.

21 CFR Part 71 - Colour Additive Petitions - These regulations describe how to submit a colour additive petition to FDA as well as the information FDA requires in order to evaluate the petition.
21 CFR Part 73 - Listing of Colour Additives Exempt from Certification - These regulations list the FDA-approved colour additives that are exempt from FDA’s certification process. The regulations state the permitted uses, specifications, and restrictions that apply to each of these colour additives.
21 CFR Part 74 - Listing of Colour Additives Subject to Certification - These regulations list the FDA-approved colour additives that are subject to FDA’s certification process. The regulations state the permitted uses, specifications, and restrictions that apply to each of these colour additives.
21 CFR Part 80 - Colour Additive Certification - These regulations state the fees for colour additive certification and describe the certification procedures and requirements.
21 CFR Part 81 - General Specifications and General Restrictions for Provisional Colour Additives for Use in Foods, Drugs, and Cosmetics - These regulations include the provisional lists of colour additives and the colour additives whose provisional listings have been terminated.
21 CFR Part 82 - Listing of Certified Provisionally Listed Colours and Specifications - These regulations list the provisionally listed colour additive lakes, which are subject to FDA’s certification process. The regulations state the permitted uses, specifications, and restrictions that apply to each of these colour additives. (All colour additives were provisionally listed in response to the 1960 colour additive amendments to the Federal Food, Drug, and Cosmetic Act. Only lakes, which are insoluble pigments formed from color additives listed in 21 CFR part 74, remain provisionally listed.

Once a new colour additive is listed, FDA continually monitors its safe use, assuring the consideration of new data and safety information. Historically, this activity has resulted in regulatory changes for colour additives that were necessary to protect the public health.

(Indani is Head and Food Safety-Regulatory Advisor-Trainer and Shah is a Food safety Advisor-trainer at Safefoodz Solutions, Mumbai. They can be contacted at safefoodz@gmail.com )
 
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