For Industry

Draft Guidance for Industry: Fruit Juice and Vegetable Juice as Color Additives in Food

Resources

How to Comment

Comment period opens December 14, 2016

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 1, 2017.

Submit electronic comments on http://www.regulations.gov to docket number FDA-2016-D-4120.

Submit written comments to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852

All comments should be identified with the docket number FDA-2016-D-4120.

Questions?

For questions regarding this draft document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-1200.

Contains Nonbinding Recommendations

Draft-Not for Implementation

December 2016

Fruit juice and vegetable juice can be used under certain conditions as color additives in food under 21 CFR 73.250 (fruit juice) and 21 CFR 73.260 (vegetable juice). The color additive “fruit juice” is defined in § 73.250 as the juice expressed from mature varieties of fresh, edible fruits, or by the water infusion of the dried fruit. Similarly, the color additive “vegetable juice” is defined in § 73.260 as the juice expressed from mature varieties of fresh, edible vegetables, or by the water infusion of the dried vegetable.

The fact that plant material can be eaten does not necessarily mean that juice from such plant material meets the specifications of these regulations. This guidance is intended to help manufacturers determine whether a color additive derived from a plant material meets the specifications for fruit juice under § 73.250 or vegetable juice under § 73.260. This guidance, including our interpretation of the terms used in § 73.250 and § 73.260, is limited to these color additive regulations. This guidance does not address the use of fruit- or vegetable-derived color additives that are authorized under different color additive regulations or that are the subject of a color additive petition.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

Download Draft Guidance for Industry:
Fruit Juice and Vegetable Juice as Color Additives in Food
(PDF: 73KB)

This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance listed on the title page.

This guidance has been prepared by the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition at the Food and Drug Administration.


FDA Responses to Inquiries About Fruit Juice and Vegetable Juice as Color Additives in Foods

Available in PDF (69KB)

Fruit juice and vegetable juice can be used under certain conditions as color additives in foods under 21 CFR 73.250 (fruit juice) and 21 CFR 73.260 (vegetable juice).  These color additive regulations define “fruit juice” as a color additive prepared either by expressing the juice from mature varieties of fresh, edible fruits, or by the water infusion of the dried fruit.  Similarly, “vegetable juice” is defined as a color additive prepared either by expressing the juice from mature varieties of fresh, edible vegetables, or by the water infusion of the dried vegetable.  Both regulations specify that these color additives may be concentrated or dried and may contain diluents that are safe and suitable for use in color additive mixtures for coloring foods. 

We have issued a draft guidance, titled Fruit Juice and Vegetable Juice as Color Additives in Food:  Guidance for Industry, to help manufacturers determine whether a color additive derived from plant material meets the specifications for fruit juice under § 73.250 or vegetable juice under § 73.260.  You can find the draft guidance at:  [http://www.fda.gov/downloads/ForIndustry/ColorAdditives/GuidanceComplianceRegulatoryInformation/UCM529492.pdf]  Our draft guidance discusses both the process to be used in making the juice as well as the plant material from which the juice is made.

FDA has received inquiries from industry regarding whether certain color additives made from various plant materials would meet the specifications in the fruit juice or vegetable juice color additive regulations.  Below is a summary table of FDA responses to these inquiries. As applicable, our responses also addressed the process used to make the juice in addition to the plant material from which the juice was made. 

Material from Which Juice
Would be Made
Date of FDA Letter(s)FDA Responses on Whether Certain Juices Would be Covered Under § 73.250 or § 73.260
Flowers of hibiscus (Hibiscus spp.)5/11/1994No
Purple corn (Zea mays L. many varieties of the Kculli line, mature kernels)5/11/1994Yes
Blue green algae, Spirulina (Arthrospira platensis) [1]5/11/1994
3/6/1996
No
Safflower petals (Carthamus tinctorius L.)5/11/1994
6/10/1997
No
Nettle and spinach leaf extracts
(Urtica dioica and Spinacia oleracea, respectively)
7/26/1994No
Calyx of roselle (Hibiscus sabdariffa)3/24/1995
3/31/1995
Yes
Flower, fruit and/or seed  of cape jasmine (gardenia, Gardinia augusta)7/5/1996
7/24/2015
No
Chokeberry (Aronia spp., berries)8/14/1996Yes
Black carrots(Daucus carota variety atrorubens Alef., roots)5/5/1997Yes
Gardenia fruit – crocin extract(Gardenia augusta, L., currently named Gardenia jasminoides Ellis) 6/11/1998No
Grape extract (Vitis spp., fruit) [2]7/19/2002No
Red sugar beets (Beta vulgaris spp. vulgaris var. rubra, roots)11/20/2007Yes
Red cabbage(Brassica oleracea var. capitata f. rubra, leaves)11/20/2007Yes
Purple sweet potato(Ipomoea batatas L. tuber)11/20/2007Yes
Red radish(Raphanus sativus, root)11/20/2007Yes
North American and European black elderberry(Sambucus canadensis and Sambucus nigra L., respectively, berries)11/20/2007Yes
Watermelon (Citrullus lanatus, fruit)11/20/2007Yes
Acai11/20/2007No
Kokum11/20/2007No
Red perilla (Perilla frutescens variety crispa forma crispa (common name shiso), and Perilla frutescens variety crispa forma purpurea, leaves)2/29/2012
6/17/2015
Yes
Flowers of butterfly pea (Clitoria ternatea)3/13/2015
8/24/2015
No
Huito fruit (Genipa americana, Jagua)7/13/2015No
Seeds of Sorghum bicolor, (L.)Moench4/23/2015
9/11/2015
No
Red rhubarb petiole (Rheum rhubarbarum)9/4/2015Yes
 Prickly pear fruit (Opuntia ficus-indica )12/30/2015Yes
 Swiss chard stalk (Beta vulgaris L. ssp. vulgaris var. cicla)12/30/2015No
Wheatgrass (Triticum aesitivum, L.)4/19/2016No

[1] Spirulina extract was subsequently listed in a separate color additive regulation.  For conditions of safe use, see §§ 73.530 and 73.1530 Spirulina extract.
[2] Grape color extract and grape skin extract were subsequently listed in separate color additive regulations.  For conditions of safe use, see § 73.169 Grape color extract and § 73.170 Grape skin extract (enocianina).

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