Novel Food Information - FloraGLO® Crystalline Lutein

Health Canada has notified Kemin Foods, L.C. that it has no objection to the sale of FloraGLO^® Crystalline Lutein as a food ingredient to be added to a wide variety of foods at lutein levels of 0.3 to 10 mg/serving or reference amount to beverages, cereals, puddings and fillings, trail mix, plant based beverages, egg products, margarine-like spreads, salad dressings, frozen desserts, soups, candies, and at 20 mg/day level in food for special dietary use intended as the sole source of nutrition.

The Department has conducted a comprehensive safety assessment of the addition of lutein to the Canadian food supply, according to its Guidelines for the Safety Assessment of Novel Foods Derived from Plants and Microorganisms.

Background

The following provides a summary of the notification from Kemin Foods, L.C. and the evaluation by Health Canada and contains no confidential business information.

To date, the Food Directorate (FD) has issued letters of no objection (LONO) for the sale of several foods containing FloraGLO^® crystalline lutein manufactured by Kemin Foods L.C. These include fruit and vegetable juice blends at a level of 2 mg per 250 mL reference amount ( for orange juice; orange/carrot/mango juice; apple juice; vegetable cocktail; tropical blend; papaya exotic juice drink); lutein enhanced chicken eggs (lutein levels of up to 1 mg per 50 g serving egg and 1.1 mg lutein and 0.201 mg zeaxanthin per 50 g egg) up to 2 mg per 50 g reference amount of liquid eggs and egg products); and 0.250 mg per L infant formula as consumed.

1. Introduction

Lutein is a carotenoid, specifically a xanthophyll, having the chemical formula 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. Zeaxanthin, another xanthophyll, and lutein are stereoisomers but may be different functionally.

2. Description of the Novel Food

Food additives are regulated in Canada under the Food and Drug Regulations and associated Marketing Authorizations (MAs). Approved food additives and their permitted conditions of use are set out in the Lists of Permitted Food Additives that are incorporated by reference in the MAs. Item 1. of the List of Permitted Food Colouring Agents permits the use of xanthophylls, including lutein, for use as colouring agents in food at GMP (good manufacturing practice) levels. As well, the Food Directorate has issued LONOs for several lutein-containing novel foods, as noted above. The FD has been asked to now consider the request for addition to a wide variety of foods.

3. Product Development/Formulation

FloraGLO^® Lutein is produced through solvent (hexane, pentane, dichloromethane, ethanol, and/or methanol) extraction of marigold flowers (Tagetes erecta) to first produce an oleoresin (approximately 70 % lutein). The oleoresin is further purified using another series of extractions, using either the same solvents, or in the Petitioner's most recent patents, using propylene glycol. All of these solvents are permitted for use in the extraction of "natural extractives" or, in the case of the propylene glycol, for use as a vehicle (carrier) for flavours, colours or food additives generally. Both production processes result in a final lutein product from which 99 to 99.9 per cent of organic solvents have been removed. The crystalline lutein is then suspended in safflower oil or another oil to make the final FloraGLO^® Lutein product.

FloraGLO^® Crystalline Lutein has a chemical specification which requires a minimum of 80% by weight of total carotenoids comprising lutein, zeaxanthin and other carotenoids. The other 20% comprises C-29 to C35 waxes (about 15%), moisture (1%) and ash (1%).and small amounts of protein, metals (As, Cd, Pb, Hg), organic and inorganic materials including residual solvent. The formulation in this submission consists of approximately 83% by weight of the carotenoids with lutein and zeaxanthin (typically at 76% and 7% of the total weight respectively) and manufactured to meet the food-grade specification on file with the balance of 17% comprising waxes, moisture, ash and other organic/inorganic materials.

The FloraGLO^® Crystalline Lutein may be mixed with food-grade vegetable oils (corn oil, safflower oil) to produce lutein suspensions of various concentrations, such as Kemin's FloraGLO^® Lutein 5% and FloraGLO^® Lutein20% liquid products.

Lutein dry beadlets may also be manufactured from the crystalline lutein or from the lutein suspensions to be used in the manufacture of natural health products or added to conventional foods. Products in commerce in both Canada and United States include FloraGLO^® Lutein 5% VG Granules and FloraGLO^® Lutein 10% VG TabGrade products. Additionally, FloraGLO^® Lutein Crystalline Lutein is contained in FloraGLO Lutein 5% TG/P and FloraGLO Lutein 5% CWS/S-TG, which are manufactured by Kemin's commercial partner, DSM Nutritional Products.

FLoraGLO^® Crystalline Lutein complies with the specification of lutein extracted from T. erecta set forth by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), the USP32-NF27 SI monographs on Lutein and Lutein Preparation and also falls within the minimum specifications of the current Health Canada Natural Health Products Directorate (NHPD) Compendium of Monographs guidance document. All ingredients in the formulation, therefore, are contained in the Ingredient Master File for Lutein.

4. Dietary Exposure

The Petitioner provided results of modelling studies conducted in the United States, using USDA CSFII (1994-1996) and 1998 data [NHANES]. The petitioner concluded that with the proposed increased use-levels and addition of the proposed food uses, the total US population estimated mean and 90th percentile users lutein intakes increased by approximately 1.5 fold. The petitioner provided a rationale to support that Canadians' lutein intakes resulting from the proposed addition would be similar to those of the United States population.

Computer modelling was conducted by the FD 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 (lutein exposure from naturally-occurring lutein in foods, exposure from recently approved foods containing lutein and exposure from the expanded list of foods currently proposed by the petitioner).

Exposure distributions of lutein for each DRI age-sex group were estimated for the baseline plus all proposed uses, excluding infant and toddler foods and foods for special dietary use. Infant and toddler foods were excluded because the level of addition could not be determined from the information provided by the petitioner; foods for special dietary use were considered separately because they provide users a sole source of nutrition. The modelling results indicate that in the case of addition of lutein to all of the modelled foods at the requested levels, and 100% of food choices were the lutein-enriched versions, mean intakes of lutein in the Canadian population would increase from 3 mg to 16 mg/person per day, a 5-fold increase. In all cases, the mean intakes are lower than the Health Canada ADI.

The heavy consumers are identified as male teenagers (14-18) with a mean, 90 % ile and 95 %ile usual intakes of 22.9 [21.5, 24.3], 37.1 [34.0, 40.3] and 42.8 [38.6, 46.9] mg/person per day respectively]. On a body weight basis, children 1-3 years have the greatest mean, 90th %ile and 95th %ile values for usual intakes 0.85 [0.81, 0.88], 1.33 [1.26, 1.41] and 1.51 [1.41, 1.61] mg/kgbw per day. However, children 1-3 years old, may exceed the Health Canada ADI of 2 mg/kgbw per day when the confidence intervals are taken into consideration at the 99 %ile. Further evaluation of the 1-3 year group indicates that between 0% and 3% of that population is estimated to be above the ADI (further addition of lutein, in particular to infant and toddler foods, could increase beyond 3% the percentage above the ADI).

For foods for special dietary use, the exposure is stated to be 20 mg per person per day and the exposure is well below the ADI (taking into consideration 70 kg as an average body weight; this is approximately 0.3 mg/kg bw per day).

5. Chemical Assessment

The compositional specification for FloraGLO^® Crystalline Lutein specifies 76% lutein and 7% zeaxanthin of the total weight in the formulation. The manufacturer's specifications for chemical contaminants (arsenic, cadmium, lead, mercury and thiophenes) in FloraGLO^® crystalline lutein were assessed and not likely to pose an unacceptable risk to health for the general population (including heavy consumers), male teens or infants who consume the lutein used as an ingredient in foods as proposed by the petitioner.

6. Microbiological Assessment

Microbiological specifications were provided for food-grade FloraGLO^® Crystalline Lutein. It is unlikely that the addition of FloraGLO^® Crystalline Lutein at the levels proposed to be added to the foods would affect the mircobiological safety of the foods to which it is added. It is the continuing responsibility of the manufacturer and the producers of the final foods to ensure that their products are in compliance with Part I, section 4, of the Food and Drugs Act.

7. Nutrition

Lutein is found in high concentration in the macular region of the eye. Lutein and zeaxanthin are thought to be important for eye health. There is some evidence to suggest that lutein and zeaxanthin may reduce the risk of age-related macular degeneration (AMD) and cataracts. An assessment of health benefit was not conducted.

8. Toxicology

Based on the metabolic profiles and lack of evidence of adverse effects after the administration of high doses of lutein and zeaxanthin to both humans and animals a group acceptable daily intake (ADI) for the combined intake of lutein and zeaxanthin of up to 2 mg/kg bw/day is considered an appropriate conservative guideline for the general Canadian population. This ADI is consistent with that derived by JECFA (2006).

The dietary exposure from the proposed use of FloraGLO^® Crystalline lutein in conventional foods and in foods for special dietary use represented as the sole source of nutrition are within the allocated ADI and therefore not considered to pose any health concern for the general population above 3 years of age.

Additional information about the levels of addition to foods targeted for infants and toddlers (1-3 year olds) is required before a conclusion can be made regarding the safety of these food products.

Conclusion

Health Canada does not object to the addition of lutein to foods for children (greater than 3 years) or adults, or to its proposed use in foods for special dietary use represented as the sole source of nutrition. Foods intended for infants and toddlers (1 to 3 years old) will require more information and further assessment. No health claim assessment has been conducted. Petitioners wishing to expand the food list or level of inclusion or pursue a health claim for lutein should consult with the Food Directorate.

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 upon 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, PL2204A1
251 Frederick Banting Driveway
Ottawa, Ontario K1A 0K9
novelfoods-alimentsnouveaux@hc-sc.gc.ca