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Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Rules and Regulations
lotter on DSK11XQN23PROD with RULES1

additive in: 1 Alcoholic beverages liquor, liqueurs, and flavored alcoholic beverages; 1 2 ready-to-drink nonalcoholic beverages; 3 liquid coffee creamers dairy and non-dairy; 4 ice cream and frozen dairy desserts; 5 fruit preparation in yogurt; 6 chewing gum;
7 coated nuts; 8 hard candy; and 9
soft candy, at levels consistent with good manufacturing practice GMP.
The petition describes butterfly pea flower extract as a dark blue watersoluble extract derived from the flower petals of Clitoria ternatea.
II. Background The color additive that is subject of this petition is the dark blue liquid produced through the water extraction of the dried flower petals of Clitoria ternatea, commonly known as the butterfly pea plant. Butterfly pea flower extract contains 42 to 62 percent water, 22 to 43 percent carbohydrates, and 8 to 12 percent proteins. The principal coloring components in butterfly pea flower extract are anthocyanins, mainly delphinidin derivatives. The extract also contains flavonols, mainly quercetin and kaempferol derivatives as minor components. These anthocyanins and flavonols are naturally present in various fruits and vegetables commonly consumed in the U.S. diet Ref. 1.
The color additive is manufactured by sourcing dried flowers of Clitoria ternatea. An infusion is prepared by adding demineralized water to the flower petals, which is separated from the plant mass via filtration. The butterfly pea flower extract is further processed by ultrafiltration to remove any residues of plant products greater than 2,500 daltons Da. The extract is then concentrated to a standardized liquid with an anthocyanin content of approximately 2 percent and pasteurized. Citric acid may be added to control the pH of the extract Ref. 2.
The petitioner proposed specifications for butterfly pea flower extract of less than 1 milligram per kilogram mg/kg 1 part per million ppm of arsenic, less than 1 mg/kg 1 ppm of cadmium, less than 1 mg/kg 1 ppm of lead, and less than 1 mg/kg 1 ppm of mercury, and pH 3.75 0.75
in the butterfly pea flower extract. Upon consideration of the data in the petition and other information available to FDA, we amended the proposed specification for pH to not less than 3.0 and not more than 4.5 at 25 C Ref. 2.
The petitioner manufactures the extract starting with butterfly pea flowers grown without the use of added 1 The proposed scope was subsequently amended to include all alcoholic beverages.

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pesticide substances. The petition provides data to support its assertion that no detectable levels of 340
substances commonly used as pesticide are found in the finished extract. The flowers were analyzed using the California Department of Food and Agriculture multi-residue pesticide analysis Ref. 3.
Currently, there are no residual pesticide tolerance levels for Clitoria ternatea codified by the U.S.
Environmental Protection Agency in 40
CFR part 180. In cases where no tolerance levels are set, the allowable residual pesticide levels that may remain on the raw agricultural commodity are zero 40 CFR 180.5.
Under section 402a2B of the Federal Food, Drug, and Cosmetic Act FD&C Act 21 U.S.C. 342a2B, food is adulterated if it bears or contains pesticide chemical residue that is unsafe within the meaning of section 408a of the FD&C Act 21 U.S.C. 346aa.
III. Safety Evaluation Under section 721b4 of the FD&C
Act 21 U.S.C. 379eb4, a color additive may not be listed for a proposed use unless the data and information available to FDA establish that the color additive is safe for that use. Our color additive regulations at 21
CFR 70.3i define safe to mean that there is convincing evidence establishing with reasonable certainty that no harm will result from the intended use of the color additive.
To determine whether a color additive is safe under the general safety clause, the FD&C Act requires FDA to conduct a fair evaluation of the available data and consider, among other relevant factors: 1 Probable consumption of, or other relevant exposure from, the additive and of any substance formed in or on food, drugs or devices, or cosmetics because of the use of the additive; 2 cumulative effect, if any, of such additive in the diet of man or animals, taking into account chemically or pharmacologically related substance or substances in such diet; and 3 safety factors recognized by experts as appropriate for the use of animal experimentation data see section 721b5A through C of the FD&C
Act.
As part of our safety evaluation to establish with reasonable certainty that a color additive is not harmful under its intended conditions of use, we consider the additives manufacturing and stability; the projected human dietary exposure to the additive and any impurities resulting from the petitioned use of the additive; the additives toxicological data; and other relevant
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information such as published literature available to us.
IV. Safety of Petitioned Use of the Color Additive A. Exposure Estimate The petitioner requested that butterfly pea flower extract be permitted at levels consistent with GMP and provided the maximum use levels for the color additive, representing GMP, for each proposed food use Ref. 4. The petitioner used food consumption data from the 20112014 National Health and Nutrition Examination Survey NHANES to estimate exposure to butterfly pea flower extract from the proposed uses. Upon further clarification of the proposed uses to include all alcoholic beverages Ref. 5, we amended the petitioners exposure estimate to include all alcoholic beverages Ref. 4.
Using food consumption data from the 20112014 NHANES, we estimated the eaters-only exposure to butterfly pea flower extract to be 198 milligrams per person per day 198 mg/p/d at the mean and 453 mg/p/d at the 90th percentile for the U.S. population aged 2 years and older and 56 mg/p/d at the mean and 118 mg/p/d at the 90th percentile for children 2 to 5 years of age Ref. 4.
The petition indicated that butterfly pea flower extract could contain up to 2 percent anthocyanins by weight.
Assuming a maximum of 2 percent, we estimated the dietary exposure to anthocyanins from the proposed uses to be 4 mg/p/d at the mean and 9 mg/p/
d at the 90th percentile for the U.S.
population 2 years of age and older Ref.
4. Because delphinidin was stated to be the principal anthocyanin in butterfly pea flower extract, the exposure to anthocyanins represents the exposure to delphinidin from the proposed uses of butterfly pea flower extract.
Similarly, we estimated the dietary exposure to quercetin resulting from the proposed uses of butterfly pea flower extract. The petition indicates that butterfly pea flower contains approximately 3 percent by weight of flavonols, which are comprised of various quercetin and kaempferol derivatives. We conservatively presumed that all the flavonols present in butterfly pea flower extract were present as quercetin see below and estimated quercetin exposure to be 6
mg/p/d at the mean and 14 mg/p/d at the 90th percentile for the U.S.
population 2 years of age and older Ref.
4.

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