ARCHIVED - Novel Food Information

Juice with Added FloraGLO^® Crystalline Lutein

Health Canada has notified A. Lassonde Inc., Rougemont, Québec, that it does not object to the sale of juice to which FloraGLO^® Crystalline Lutein (FCL) (manufactured by Kemin Foods L.C.), has been added, as requested, to a final concentration of 2 mg lutein (not including overage with label declarations of 2 mg lutein) per reference amount (Schedule M, Food and Drug Regulations) (250 mL) and per serving of stated size.

The Department has conducted a comprehensive safety assessment of the addition of lutein to the Canadian food supply, including fruit juice, according to its Guidelines for the Safety Assessment of Novel Foods Derived from Plants and Microorganisms, which are based on internationally accepted principles for establishing the safety of novel foods.

Background:

The following provides a summary of the notification from A. Lassonde Inc. and Health Canada's evaluation, but contains no confidential business information.

1. Introduction

Lutein is a carotenoid, specifically a xanthophyll, namely 4-[18-(4-hydroxy-2,6,6-trimethyl-1-cyclohexenyl)-3,7,12,16-tetramethyl-octadeca-1,3,5,7,9,11,13,15,17-nonaenyl]-3,5,5-trimethyl-cyclohex-2-en-1-ol. Dietary sources of lutein include various fruits and vegetables. Xanthophylls have a long history of safe use as colouring agents in food additive (technical) applications.

FloraGLO^® Crystalline Lutein (FCL) is produced through solvent extraction of marigold flowers (Tagetes erecta) to produce an oleoresin (approximately 70 % lutein). The oleoresin is further purified using another series of extractions, using either solvents (hexane, pentane, dichloromethane, ethanol, methanol), or, in the proponent's most recent patents, using propylene glycol and potassium hydrochloride. Both processes result in a final lutein product from which 99 to 99.9 % of organic solvents have been removed. The crystalline lutein is then suspended in corn oil to make the final FCL product.

2. Description of the Novel Process

The Food and Drug Regulations (FDR), Division 16 permit the use of xanthophylls, including lutein, for use as colouring agents in food and therefore, are considered to have a history of safe use. However, this proposed new application of lutein in juice is considered novel, based on the FDR Part B, Division 28, i.e., "a food that has been manufactured . . . by a process that has not been previously applied to that food, and causes the food to undergo a major change" because of the highly increased concentration.

3. Toxicological Assessment

Based on the metabolic profiles and lack of evidence of adverse effects after administration of high doses of lutein and zeaxanthin to both humans and animals the acceptable daily intake (ADI) established by JECFA for lutein from Tagetes erecta, 0-2 mg/kg bw, is considered an appropriate conservative guideline for the Canadian population.

4. Chemical Assessment

The compositional analysis reported that the purity of the lutein preparation is about 6 % lutein and carotenoids. The carotenoid composition of the preparation is 97.82 % lutein, with the remaining 2.18 % being various carotenoids including zeaxanthin. The preparation is sufficiently pure and unlikely to contain adventitious components that would pose any harm.

5. Nutrition

Although lutein is a carotenoid, it does not have any vitamin A activity. Lutein is found in high concentration in the macular region of the eye. There is some evidence to suggest that dietary consumption of lutein is beneficial to eye health; however, an assessment of health benefit was not conducted.

6. Dietary Exposure

Computer modelling was conducted by Health Canada to determine baseline lutein intakes (one day and usual) of Canadians and to determine the potential exposure of Canadians to lutein given various modelling scenarios and at different fortification levels of the food supply with lutein. Based on the results of the dietary modelling, Health Canada determined that to the addition of lutein, when added to a final concentration of not more than 2 mg (not including overage with label declarations of 2 mg lutein) per reference amount (Schedule M, Food and Drug Regulations) (250 mL) and per serving of stated size does not cause exposure to exceed the ADI.

7. Microbiology

Microbiological specifications were provided for FloraGLO^® Crystalline Lutein. It is unlikely that the addition of FloraGLO^® Crystalline Lutein at the proposed incorporation rate would affect the microbiological safety of the juices to which it is added. It is the continuing responsibility of the manufacturer to ensure that his products are in compliance with Part 1, Section 4, of the Food and Drugs Act.

8. Labelling

Health Canada and the Canadian Food Inspection Agency (CFIA) share responsibility in regard to labelling requirements for food. Health Canada is responsible for policy and standard setting under the FDR, whereas CFIA is responsible for enforcement. CFIA also administers and enforces those aspects of the Consumer Packaging and Labelling Act to ensure that labelling is understandable, truthful and not misleading.

Under nutrition labelling regulations, the amount of lutein may not be included in the Nutrition Facts table (NFT). However, the amount of lutein may be declared outside the NFT, in g per serving, rounded to the nearest multiple of 0.1 g and it is optional to declare the amount in mg, in brackets, next to the amount in g. In either case, the statement must not constitute a nutrient content claim.

Conclusion:

Health Canada has concluded that FloraGLO^® Crystalline Lutein is acceptable for addition to juice. Based on this assessment, lutein, when added to a final concentration of not more than 2 mg (not including overage with label declarations of 2 mg lutein) per reference amount (Schedule M, Food and Drug Regulations) (250 mL) and per serving of stated size is considered safe. The lutein content must be indicated on the label according to the correct format, as described above.

This Novel Food Information document has been prepared to summarize the opinion regarding the subject product provided by the Food Directorate, Health Products and Food Branch, Health Canada. This opinion is based on the comprehensive review of information submitted by the petitioner according to the Guidelines for the Safety Assessment of Novel Foods.

(Également disponible en français)

For further information, please contact:

Novel Foods Section
Food Directorate
Health Products and Food Branch
Health Canada
Tunney's Pasture
Ottawa, Ontario K1A 0K9
Telephone: (613) 941-5535
Facsimile: (613) 952-6400