ARCHIVED - Novel Food Information: DHA-Enhanced Milk, and Dairy Products Made From This Milk

Health Canada notified Food Systems Innovation (FSI), Guelph, Ontario, in December 2003 that it has no objection to the sale of a milk, herein referred to as "DHA milk", and dairy products made from this milk, having a docosahexaenoic fatty acid (DHA) content resulting from the use of a specially formulated dairy cattle feed. The Department has conducted a comprehensive assessment of this milk 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 FSI and the evaluation by Health Canada and contains no confidential business information.

1. Introduction

DHA is a long-chain polyunsaturated fatty acid in the omega-3 family of fatty acids. While there is no recommended dietary allowance for DHA, it is an essential component of all cells in the body, especially brain and neural tissue. This DHA in the body can come either through bioconversion of dietary alpha-linolenic acid (ALA) or as preformed dietary DHA from sources such as fish and seafood.

The assessment conducted by Food Directorate evaluators considered: how the milk that is the subject of this notification is enhanced in DHA; how its composition and nutritional quality compare to traditional cows' milk; the nutritional impact and safety of the increased levels of DHA; and the potential for the presence of any toxicants, anti-nutrients, allergens or chemical contaminants introduced as a result of the novel process employed in producing the milk. Based on the data provided by FSI, no safety or nutritional concerns related to the consumption of DHA milk, and dairy products derived from this milk have been identified.

Under Division 28 of Part B of the Food and Drug Regulations, the Food Program has responsibility for pre-market assessment of novel foods and novel food ingredients. The product, DHA milk, was considered a novel food, as per B.28.001, as it is "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." This interpretation is based on the use of a patented cattle feed that succeeds in significantly increasing the DHA content of milk where other feeds fail to do so.

2. Description of the Novel Process

Milk is enhanced in DHA by the addition of a novel DHA-rich feed additive to dairy cattle feed rations. This feed additive contains a marine source of DHA and a by-pass ingredient which protects the DHA from degradation in the rumen. The combination of the 2 ingredients inhibits the degradation of DHA in the rumen. Some of the DHA is thus transferred to the cow's milk in significant amounts. The milks that are the subject of this submission are whole or partially skimmed (2%). The DHA content of the milk increases as the total fat content increases since DHA is contained in the milk fat. It should be noted that FSI licences this technology to dairy product producers and manufacturers (the licencees).

3. Microbiology

It is not expected the presence of DHA in milk would change the microbiological properties of the milk. It is the responsibility of milk and dairy product manufacturers to be in compliance with the regulatory standards set out for dairy products in the Food and Drug Regulations, Part B, Division 8 and to other standards applicable to these products.

4. Dietary Exposure

It is not expected that dietary exposure to this milk, or to any dairy products derived from it, would be different from that of commercially available dairy products. In the population who will be consuming them, these products would be expected to be used as a full or partial replacement for their regular counterparts.

5. Nutrition

The petitioner provided nutrient composition data pertaining to: proximate composition (protein, fat, moisture, carbohydrates, and ash); key micronutrient analysis (Ca, P, Mg, Zn, I, Vitamin E, tocopherols, Vitamin A); total lipids and fatty acid profile, including total omega-3 fatty acids, total omega-6 fatty acids, DHA and EPA (eicosahexaenoic acid) and total "trans" fatty acids. Data on appropriate comparators were also provided.

With the exception of total omega-3, total omega-6, DHA, EPA, and total "trans" fatty acids, the composition of DHA milk (in both the whole and 2% versions) is comparable to that of regular (whole and 2% ) milk. There were slight variations in the levels of total omega-3, total omega-6 and EPA, but these were not considered biologically significant for this product. DHA levels were several times higher in the DHA milk (0.18 % vs 0.06% of total fats) than in control milk. The DHA milk would contain 10 mg and 16 mg of DHA per 250 mL serving for 2% milk and whole milk, respectively. In a reasonable daily intake for milk of 30 fluid ounces (852 mL)^{Footnote 1}, a person could consume from 34 mg to 55 mg of DHA per day, depending on whether 2% milk or whole milk was consumed.

While there is no Recommended Dietary Allowance (RDA) or other recommended intake for DHA, the Directorate used information published in the US Institute of Medicine's Dietary Reference Intake report on macronutrients^{Footnote 2} to obtain guidance on appropriate lower and upper levels of intake. The chapter of that report on fats and fatty acids indicated that there are health benefits associated with consumption of DHA and that up to 10% of the Adequate Intake (AI) for n-3 fatty acids could be consumed as EPA (eicosapentaenoic acid) and/or DHA. The population-weighted AI for alpha-linolenic acid (ALA) for Canada was calculated to be 1267 mg. Ten percent of this represents127 mg of DHA and/or EPA for adults and 70 mg for children aged 1-3 years. Thus, consuming the reasonable daily intake of milk (2% or whole, respectively) as mentioned above, would provide approximately 24 to 40% of the 127 mg. In the case of a 1-3 year-old child who drinks two 250 ml servings of whole DHA milk (3.25% fat), the amount recommended in Canada's Food Guide to Healthy Eating:Focus on Preschoolers, the contribution of DHA from the DHA milk would be 32 mg, which represents 46% of the 70 mg, a substantial contribution.

No tolerable upper level of intake (UL)^{Footnote 3} has been established for DHA. At the same time, there have been some concerns raised that high intakes of omega-3 polyunsaturated fatty acids (n-3 PUFA), particularly EPA and DHA, may impair immune response and result in excessively prolonged bleeding times. The Dietary Reference Intakes (DRI) report on macronutrients provides guidance on the Acceptable Macronutrient Distribution Range (AMDR) for DHA and EPA combined. An AMDR is the range of intakes of a given macronutrient that is associated with reduced risk of chronic disease while ensuring sufficient intakes of essential dietary nutrients. While the upper end of the AMDR is not the same as a UL, in the absence of a UL or equivalent estimate of a tolerable upper intake, it can provide some guidance on a safe range of intake. The upper boundary of the AMDR for ALA is 1.2% of energy. Since the DRI committee considered that it would be appropriate to replace up to 10% of ALA intake with DHA and EPA, this means that, assuming energy intakes of 1500 to 3000 kcal per day, up to 200 to 400 mg/day of EPA and DHA combined could be safely consumed. Note that this does not mean that a higher intake could not also be safely consumed.

A computer modelling study was conducted to estimate the potential exposure of the Canadian population to DHA if all dairy products were manufactured from this DHA enhanced milk. The dairy products included in this modelling study were: whole milk, 2% milk, cheese (cheddar and mozzarella), yoghurt, whipping cream, butter and ice cream. The modelling study indicated that 90 % of people in all age groups would consume less than 90 mg DHA per day from these foods, with DHA present at a level of 0.20% of the milk fat. A single maximum intake of 270 mg based on a high intake of milk and dairy products by one individual in the database was considered an intake characteristic of a "very high consumer". Average dietary intakes in Canada, not including from DHA milk and products derived from it, were estimated to be 120 and 250 mg of DHA and EPA per day for Quebec and Nova Scotia, respectively, based on laboratory analysis of one collection of foods (Ratnayake, et al., Health Canada, unpublished data). The sum of the 90th percentile estimated intakes from DHA milk and estimated current average intakes of this fatty acid in the diet equals 210 and 340 mg per day, or equal to 10% of the AMDR noted above as being a safe level of intake. It was concluded that these intakes would not pose a threat to the health of Canadians.

As a further consideration, the amount of DHA that can be added to milk by this method, compared to direct addition to milk, is limited and therefore unlikely to result in unintended excessive exposure because of the biological processes that it must pass through to reach the milk from the cow's digestive system.

6. Chemistry/Toxicology

The nutritional assessment dealt with any potential toxicological issues associated with this product in regard to the DHA itself. However, as a marine source of DHA is used in the feed rations, the potential significance of PCB levels in the DHA milk was examined. It was determined that the highest total PCB intake resulting from the consumption of whole and 2% DHA milk would amount to less than 1.0% of the estimated provisional tolerable daily intake for PCBs for the Canadian population in general. Taking into account the contribution from other dairy products used in the exposure model described earlier, the highest total PCB intake resulting from the consumption of whole milk, 2% milk, cheese (cheddar and mozzarella), yoghurt, whipping cream, butter and ice cream would amount to less than 2.0% of the estimated provisional tolerable daily intake for PCBs, which is still negligible.

7. Labelling

Health Canada and the CFIA share responsibilities in regard to regulation and standard setting for food labelling and advertising. The Food Directorate is responsible for policy and standard setting related to the health and safety aspects of labelling and claims under the Food and Drugs Act and Regulations, whereas CFIA's Fair Labelling Practices Program applies these policies and enforces the regulations; this program also administers and enforces the non-health and safety food labelling provisions of the Food and Drug Regulations and the Consumer Packaging and Labelling Act, ensuring that labelling is understandable, truthful and not misleading. In regard to novel foods, the Food Directorate's role is to identify the information required to ensure safe use of a novel food that must be provided on the label(s) of that food. Labelling of a novel food is required if changes occurred in the food that the consumer needs to be informed of for health and safety reasons, such as allergenicity, or major compositional or nutritional changes. The Food Directorate would determine what type of information is needed on the label to inform Canadians about these changes in the food.

Due to the use of the feed described above, DHA content in this product is significant whereas regular milk may contain none or only trace amounts. This constitutes a significant compositional change in the food, and must clearly be indicated on the label of DHA milk and of products derived from this milk. However, the information pertaining to this change must also comply with other requirements set out in the Food and Drug Regulations, most notably the new Nutrition Labelling Regulations. The amount of DHA in the dairy products concerned must be indicated in an appropriate location on the label, but, must not be stated in such a way that it would constitute a source claim for DHA, as there is no provision for such a claim in the Nutrition Labelling Regulations. The closest allowable source claim would be for omega-3 fatty acids if there were more than 0.3 g of these in one serving of a food. This product does not reach this level.

Under the Nutrition Labelling Regulations, the amount of DHA, per se, cannot be indicated in the Nutrition Facts table but it can be indicated anywhere outside of this table, in grams per serving (e.g. "0.016 g DHA per 250 mL serving"), although it is not acceptable to add the word "contains" or other similar term that would constitute a source claim. If, however, any statements are made about any fatty acids on the label of or in advertisements for a food, a declaration of the amounts of omega-3 and omega-6 and monounsaturated fatty acids would be required in the Nutrition Facts table, in g per serving, where rounding is required to the nearest multiple of 0.1 g when the amount is less than 1 g per serving.

It is recommended that labels of these products carry a statement of the amount of DHA in a serving of the milk in a manner that conforms with the new Nutrition Labelling Regulations, as noted above.

If the petitioner or the licencee wishes to use any other wording to convey this information, it is recommended that they consult with the Nutrition Evaluation Division of Health Canada and the Fair Labelling Practices Program of CFIA to verify that the proposed statement does not constitute a source claim or is otherwise not in compliance with the Regulations. FSI and/or its licensees should consult with the Nutrition Evaluation Division of Health Canada and with the Fair Labelling Practices Program of CFIA with regard to the types and wording of other claims and statements concerning DHA that would be permitted on labels or in advertising, and with the Fair Labelling Practices Program of CFIA concerning all other aspects of the label and advertising.

Conclusion:

Health Canada's review of the information presented in support of the DHA-enhanced milk and dairy products made from this milk that are the subject of this notification, concluded that there are no human food safety concerns associated with their sale in Canada, provided that the DHA content is indicated on the label according to the correct format.

This opinion is solely with respect to the suitability of DHA-enhanced milk, and dairy products made from this milk, for sale as human food. It is the continuing responsibility of FSI and its licencees to ensure that their products are in compliance with all applicable statutory and regulatory requirements. Any new information obtained which has potential health and safety implications should be forwarded to Health Canada for our consideration in order to ensure the continued safety and integrity of all novel foods available in the Canadian marketplace. The sale of a food which poses a hazard to the health of consumers would contravene the provisions of the Food and Drugs Act.