ARCHIVED - NOVEL FOOD INFORMATION

ARCHIVED - Admixture of NutractisTM to Butter, Cheese Spread and Whipped Cream

Health Canada has notified Technologie Biolactis Inc. that it has no objection to the limited food use of NutractisTM in for admixture in butter, cheese spread and whipped cream at specified levels. The Department conducted a comprehensive assessment of NutractisTM according to its Guidelines for the Safety Assessment of Novel Foods. These Guidelines are based upon internationally accepted principles for establishing the safety of novel foods.

BACKGROUND:

The following provides a summary of the notification from Technologie Biolactis Inc., and the evaluation by Heath Canada and contains no confidential business information.

1. Introduction

NutractisTM, referred to by the company as a malleable protein matrix (MPM), is a product derived from whey fermented with a strain of a bacterium of the species Lactobacillus kefiranofaciens. The current proposed use of NutractisTM is as a fat replacer for admixture in butter, cheese spreads and whipping cream.

The safety assessment performed by Food Directorate evaluators was conducted according to Health Canada's Guidelines for the Safety Assessment of Novel Foods. The assessment considered: how NutractisTM was developed; how the composition and nutritional quality of NutractisTM; and what the potential is for NutractisTM to be toxic or cause allergic reactions.

The Food Directorate has a legislated responsibility for pre-market assessment of novel foods and novel food ingredients as detailed in Division 28 of Part B of the Food and Drug Regulations (Novel Foods). NutractisTM is considered novel foods under the following part of the definition of novel foods:

  • "a) a substance, including a microorganism, that does not have a history of safe use as a food".

2. Development and Production of the NutractisTM

NutractisTM is the semisolid product derived from whey fermented with a bacterium of the species Lactobacillus kefiranofaciens. The whey is conditioned with calcium chloride, to help in the precipitation process, and the pH is adjusted with HCl. The conditioned whey is pasteurized, then inoculated with the L. kefiranofaciens culture and allowed to ferment. At the end of the fermentation, the pH is adjusted with NaOH and the fermentate is then pasteurized. The pasteurized fermented whey is then clarified by centrifugation to remove the aqueous portion of the coagulated product. The solid phase, or Malleable Proteinic Matrix (MPM) is used as the food ingredient.

During the fermentation process, the bacterium ferments sugars and other carbon sources contained in the whey. The bacterial culture may cause the coagulation of the whey proteins, in the presence of CaCl2, by secreting proteases to digest the whey proteins (much like rennet). While growing, the bacteria also produce an exopolysaccharide known as kefiran which encapsulates them. When calcium chloride is added, the proteins in the whey cross-link with one another and with the exopolysaccharides, entrapping the bacteria as a result. The MPM is thus composed of the cross-linked and precipitated whey solids, fermentable components of the whey, the kefiran and the heat-killed debris of L. kefiranofaciens, which are trapped in the MPM.

4. Dietary Exposure

Exposure to NutractisTM will be via the consumption of butter, cheese spreads and whipping cream. It is not expected that dietary exposure to butter, cheese spreads and whipping cream containing NutractisTM would be any different than their regular counterparts. In the population that will be consuming them, it is likely that these products will fully or partially replace their regular counterparts.

5. Chemistry

Data pertaining to chemical contaminants were reviewed, particularly for heavy metal contaminants and data was submitted for lead, copper and iron. For lead, the levels were all below 0.05 mg/kg, which is substantially lower than the Food Chemical Codex (FCC) limit for whey product (0.5 mg/kg).

For copper and iron, the levels were below the company's specification levels set at 5 mg/kg and 20 mg/kg, respectively. Based on a 25% incorporation level in butter-type spread, the estimated intake in the diet of these contaminants would be less than 1% of their respective Tolerable Daily Intakes.

Calcium chloride is used as a reactant, rather than a food additive, in the manufacture of NutractisTM, as it is used at a preliminary stage of production in order to condition the whey before pasteurization and fermentation and as there is no reported functional use for calcium chloride in the final product. The same is true for the use of hydrochloric acid and sodium hydroxide. No objection is given to these reactants, provided they conform to food-grade specifications such as those appearing in FCC.

6. Microbiology

L. kefiranofaciens strain R2C2, which is used in the fermentation stage of production, was isolated from kefir grains using Rogosa-Cheese Whey (RCW) agar. It is gram positive, nonmotile, catalase negative, and does not grow below 15∘C. There is no indication that this strain is pathogenic or linked to an adverse human health effect. Furthermore, the Guidelines for the Evaluation of Probiotics in Food published by the FAO/WHO in 2002 states that "...lactobacilli and bifidobacteria associated with food have been considered to be safe..." and that "...documented correlations between systemic infections and probiotic consumption are few and all occurred in patients with underlying medical conditions." No pathogenic or virulence properties have been found for lactobacilli, bifidobacteria or lactococci.

With regard to the potential for the production of antimicrobials by the strain, it is noted that lactic acid bacteria are known producers of bacteriocins. As bacteriocins are not chemically related to any clinically important antibiotics, their presence in the final product is not likely to result in the spread of antimicrobial resistance to antibiotics of clinical importance.

With regard to the potential antimicrobial resistance of the strain, the petitioner indicated that the product was pasteurized after the fermentation step, and that there was no detected viable R2C2 left in the final product. Certificates of analyses for total plate counts were provided, showing the final product's flora to be below detectable level, < 10 CFUs/g products.

The petitioner has provided a full description of the manufacturing process and information with regard to HACCP in the production line. A sampling plan was provided, showing eight critical control points at various steps. All samples are analysed for coliforms, E. coli, yeast & molds, and total aerobic plate count according to MAPAQ standard methods. The samples are also analysed by microscopic examination. Certificates of analysis for the product were provided on three lots of products showing that NutractisTM meet the set microbiological specifications.

The NutractisTM will be produced in a federally registered establishment, Fromagerie Boivin, in La Baie, QC, (Reg. No. 2702) and will be subject to CFIA oversight.

7. Nutrition

Analytical data on NutractisTM was provided for proximates, minerals (ten), amino acids (seventeen) and vitamins (six). Except for calcium, there are no concerns with the analysed constituents. NutractisTM contains 1211 mg calcium per 100 g product, which, on a dry matter basis represents 7.08% calcium, largely attributed from the calcium chloride used in the manufacture of the product. Ingredients with these concentrations of calcium can contribute substantial quantities of calcium to foods and raise potential safety concerns. Calcium is a nutrient with known adverse effects at high intakes and a narrow margin of safety.

In a previous policy decision by Nutrition Evaluation Division, modified milk ingredients designed to have more than 5% calcium on a dry matter basis have been designated as calcium fortificants, such that their use in foods must comply with the provisions of the Food and Drug Regulations pertaining to the addition of calcium to food. Section D.03.002 specifies the foods to which calcium can be added. Butter, cheese spreads and whipped cream are not included. Furthermore, the standards for butter (B.08.056 [s]), processed cheese spread (B.08.041.3 [s]) and cream (B.08.075 [s]) do not permit the addition of calcium.

New proposed regulations extending provisions for discretionary fortification would still exclude butter and cream. However, the butter being mixed with NutractisTM would not be allowed to be called butter and would be an unstandardized food. The same is true of whipping cream and cheese spread with NutractisTM

At the proposed level of NutractisTM addition, the calcium content of butter, cheese spread and whipping cream will be as follows:

  • A serving of butter (10g) provides 2 mg of calcium. A serving of butter with 25% NutractisTM will provide 32 mg of calcium. This is less than 10% of the Recommended Daily Intake (RDI for calcium is 1100 mg).

  • A serving of cheese spread (30g) provides 21 mg of calcium. A serving of cheese spread with 10% NutractisTM will provide 56 mg of calcium i.e., less than 10% of the RDI.

  • A serving of whipping cream (30g) provides 10 mg of calcium. A serving of whipping cream with 25% NutractisTM will provide 53 mg of calcium i.e., less than 10% of the RDI.

Since the amount of calcium added by the use of NutractisTM in the proposed products is below 10% of the RDI, the maximum that would be permitted for discretionary fortification with calcium, it is concluded that these products do not present a health hazard, and given that there is a legitimate technical use of the calcium chloride in this product, it was decided that these applications could be permitted outside of the current regulatory limits on fortification.

No concerns have been raised regarding the use of NutractisTM at the proposed levels in butter, cheese spread and whipping cream. Given that future proposed uses of NutractisTM are still unknown, it is unlikely that permission for use of this novel product beyond these three products will be granted without additional information.

8. Toxicology

No substances of a toxicological concern are found in NutractisTM. The bacterial strain used and the exopolysaccharide produced by the strain have a history of safe use as components of kefir. Whey by itself also has a history of safe use. As kefir grains are normally produced in milk, it is unlikely that the use of this bacterial strain isolated from kefir, and cultured in a dairy by-product, whey, would be harmful.

While the production of biogenic amines is a concern in the use of starter cultures for fermenting foods, levels of such amines are typically very low in yogurts and other dairy products, and the lactic acid bacteria used in the dairy industry have no potential to form biogenic amines.

The petitioner conducted some studies on rats and mice and submitted some of the data. Although the experiments were designed to study the impact of NutractisTM in reducing inflammation in a Crohn's disease rodent model (rodents in which intestinal inflammation was induced by the use of dextran sulfate sodium), some data were also generated on antibody production in the mice. Very little immune response was elicited by feeding NutractisTM to the animals, as there was little or no increase in antibody titers.

In regards to allergenicity considerations, milk and dairy derivatives are considered priority allergens. NutractisTM would also be considered a priority allergen in this regard, and labelling will eventually be required.

Because the fermentation organisms, the manufacturing process and the final product did not raise any toxicological concerns, no further information was required.

9. Labelling

The CFIA's Bureau of Food Safety and Consumer Protection and the Dairy Program have been consulted in regard to the naming of the novel food ingredient. The common name of NutractisTM, based on discussions with CFIA, is to be concentrated fermented whey (French: lactosérum fermenté concentré) or alternatively, concentrated cultured whey (French: lactosérum de culture concentré). The same common name shall be used on the list of ingredients of foods to which NutractisTM is added.

If a claim regarding the calcium content is made for any of these products, the product would be considered to be in violation of part D of the Food and Drug Regulations, since the source of the calcium is from the permitted "reactant" use and calcium may not be added as a nutrient to these foods under current regulations. This conclusion is based on a similar policy decision made for food additives that also happen to be sources of nutrients which was developed to discourage use of food additives as fortificants to by-pass the limitations on fortification. (See CFIA policy: http://www.inspection.gc.ca/english/fssa/labeti/inform/infole.shtml#add)

Regarding the Food Directorate's future regulatory proposal for the declaration of priority allergens, including milk and any dairy protein containing derivatives, which have been deliberately added to prepackaged foods, if this proposal is adopted in the future any foods containing NutractisTM would require the declaration of this major allergen by its common name followed by the name of the food.

CONCLUSION:

Health Canada's review of the information presented in support of the food use of NutractisTM in Butter, Cheese Spread and Whipped Cream, concluded that this use does not raise concerns related to safety. The safety assessment conducted by Food Directorate scientific evaluators has determined that there are no safety concerns associated with the admixture of NutractisTM in butter, cheese spread and whipped cream at a 25%, 10% and 25% incorporation rate, respectively. The butter, cheese spread and whipped cream should be permitted to enter the marketplace and be subjected to the same post-market standards applicable to all foods sold in Canada, provided that the ingredient NutractisTM is clearly identified on food labels by a proper common name and listing.

Health Canada's opinion deals only with the food use NutractisTM in Butter, Cheese Spread and Whipped Cream at the specified levels.


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.

For further information, please contact:

Novel Foods Section
Food Directorate
Health Products and Food Branch
Health Canada
Tunney's Pasture
Ottawa, Ontario K1A 0L2

Telephone: (613) 941-5535
Facsimile: (613) 952-6400

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