ARCHIVED - Novel food information on: Omega-3 enhanced pork and products derived therefrom

Health Canada notified Les Petites Fermes du Centaure Inc., Saint Valérien de Milton, QC, in May of 2004 that it has no objection to the sale of pork, herein referred to as "Omega-3 enhanced pork", and products made from this pork, having a higher omega-3 content resulting from the use of a specially formulated swine feed. The Department has conducted a comprehensive assessment of this pork 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 Les Petites Fermes du Centaure Inc. and the evaluation by Heath Canada and contains no confidential business information.

1. Introduction

Alpha-linolenic acid (ALA) is an essential fatty acid of the omega-3 fatty acid family and is also the precursor of other long-chain polyunsaturated fatty acids in the omega-3 family. Long-chain omega-3 polyunsaturated fatty acids play an important role as structural membrane lipids, particularly in nerve tissue and the retina and are precursors to eicosanoids. ALA is not synthesized by humans and a lack of it results in adverse clinical symptoms, including scaly dermatitis, neurological abnormalities and poor growth.

The meat of the notified pork is enhanced in ALA by the intentional addition of ALA rich sources to pig feed rations.

The assessment conducted by Food Directorate evaluators considered: how the Omega-3 enhanced pork that is the subject of this notification is enhanced in omega 3 fatty acids; how its composition and nutritional quality compare to traditional pork meats; the nutritional impact and safety of the increased levels of ALA; 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 pork. Based on the data provided by Les Petites Fermes du Centaure Inc, no safety or nutritional concerns related to the consumption of Omega-3 enhanced pork, and products derived from this pork 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, Omega-3 enhanced pork, 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 intentional use of a swine feed for the purpose of significantly increasing the omega-3 content of pork.

2. Description of the Novel Process

The meat is enhanced in omega-3 fatty acids by the intentional addition of ALA rich sources to pig feed rations. In this case, flaxseed is added to the ration. Some of the ALA from flaxseed is incorporated into the lipids of the pig, especially in fatty tissues.

3. Microbiology

It is not expected the enhanced levels of ALA or other omega-3 fatty acids in pork meat would change the microbiological safety of the meat. It is the responsibility of pork meat producers/packers to be in compliance with the regulatory standards set out for meat products in the Food and Drug Regulations, Part B, Division 14 and to other standards applicable to these products.

4. Dietary Exposure

The use of Omega-3 enhanced pork would be expected to increase the omega-3 intake of those who choose this product. Possibly, more individuals will choose pork more often as meat of choice as a result of label claims. However, the servings size would not be expected to change.

5. Nutrition

The petitioner provided analytical data on the fatty acid profile of both pork meat from loin tissue back fat of control pigs fed a standard diet and test pigs fed the special diet containing the flaxseed (containing higher ALA content than the standard diet).

Data indicated that both control and test groups of pigs produced pork meat containing ALA, but the test group produced levels in the fat that were at least 2 times higher than that of controls. Increasing the flaxseed content of the pig diet resulted in decreased levels of total fats, including saturated fats, increased ALA in both the loin tissue and back fat and decreased levels of n-6 fats. Although there was significant variability in the levels of ALA in the meat of both test and control groups, it was determined that the test group produced meat containing higher ALA (an average of about 412 mg ALA per 100 g meat), while the control group produced meat with an average of 232 mg ALA per 100 g meat. Values in both groups ranged from as low as 200 to as high as 928 mg/100 g. Based on the evaluators calculation, ALA levels were twice as high in the test group as in the control group.

This pork meat is expected to provide a significant source of ALA in the diet of all segments of the population, when a reasonable daily intake amount is considered (100g). The Adequate Intake, or AI, for ALA is 1.6 g/day for adult males and 1.1 g/day for adult females; children aged 1 to 3 years is 700 mg; with 900 mg for children aged 4 to 8 years; boys 9-13: 1.2 g/day; 14-18 years: 1.6 g/day; girls 9-13 years: 1.0 g/day; and 14-18 years: 1.1 g/day. Consumption of 100 grams of the meat will introduce an average of 400 mg, which represents 25% of the AI value for adult males; 30% for teen boys; 36% for adult females; 40% for teen girls; 44% for children aged 4-8; and 57% for children aged 1 to 3 years.

6. Chemistry/Toxicology

No chemicals of concern have been linked with the use of flaxseed for animal feed. No chemical contaminants of known toxicity are introduced in this product through the feeding practice. No substances of unknown toxicity are introduced through the feed itself. The potential for transfer of potentially allergenic proteins from feed through to the animal products consumed by humans appears to be negligible based on the low absorption rate of intact proteins from the gastrointestinal tract, the likelyhood for hydrolysis of intact proteins during digestion and on extensive experience with more common feedstuffs containing human allergens such as soybean.

7. Labelling

Due to the feeding process described before, ALA levels in the Omega-3 enhanced pork are twice as high as in regular pork meat. This constitutes a significant compositional change in the food. However, there has been no health or safety concerns raised in regard to the levels of ALA in the Omega-3 enhanced pork. Based on this, it was not considered that mandatory labeling requirements, outside of those triggered by fatty acid claims, were required in this case.

According to the data provided, the level of ALA in the meat would be sufficient to permit a "source" claim (at least 0.3 g or 300 mg/100g serving for omega-3 fatty acids, as per the Food and Drugs Regulations). It should be noted that conventional pork meat may also possess higher levels of ALA from time to time, but the content may not be reliable enough to support a "source" claim.

If there are any statements 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 mono-unsaturated fatty acids would be required in the Nutrition Facts table, in g per serving, rounded to the nearest multiple of 0.1 g.

Conclusion:

Health Canada's review of the information presented in support of the Omega-3 enhanced pork and products derived therefrom, that are the subject of this notification, concluded that there are no human food safety concerns associated with their sale in Canada.

This opinion is solely with respect to the suitability of Omega-3 enhanced pork and products derived therefrom , for sale as human food. It is the continuing responsibility of Les Petites Fermes du Centaure Inc. to ensure that their products are in compliance with all applicable statutory and regulatory requirements. Any new information obtained in relation to these products 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 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.

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.

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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