ARCHIVED - Novel Food Information - Microencapsulated Fish Oil (MFO)
Health Canada notified Ocean Nutrition Canada (ONC), Dartmouth, Nova Scotia, in June, 2006, that it will take no objection to the addition of microencapsulated fish oil (MFO) when added in such a manner that the food as offered for sale contains not less than 8 mg and not more than 100 mg eicosapentaenoic fatty acid (EPA) and docosahexaenoic fatty acid (DHA) combined (not including overage for products declaring up to 100 mg on the label) per reference amount(Schedule M of the Food and Drug Regulations) and per serving of stated size to:
all foods except for flours, pasta, rice, butter, suet, lard, fresh fruits and vegetables, nuts, seeds, legumes, sugars and non-nutritive sweeteners, sugar syrups, maple syrup, honey and other sweetening agents, alcoholic beverages, seasonings, leaf tea, coffee beans, prepackaged water and ice, foods intended exclusively for children less than 2 years of age, herbs, spices and leavening agents (i.e. baking powder, yeast etc.).
It should be noted that microencapsulated fish oil is not permitted to be added to a food for which a standard exists in the Food and Drug Regulations unless provision is made in the standard for fish oil as an ingredient. For foods intended only for children less than 2 years, an appropriate level of addition has not been determined. With respect to infant formulas, this ingredient would not be considered a suitable source of DHA because of the high proportion of EPA.
The notification of June, 2006 supersedes the earlier letter of April 26, 2004 where ONC was informed that Health Canada has no objection to the addition of microencapsulated fish oil at a level resulting in no more than 50 mg per serving of total EPA and DHA content to selected categories of foods.
EPA and DHA are long-chain polyunsaturated fatty acids in the omega-3 (n-3) family of fatty acids, and are naturally present in some foods with fatty fish (salmon, herring, sardines, smelt, mackerel) being the main sources and other fish, and meat and eggs providing small amounts. Most n-3 fatty acids are consumed in the form of alpha-linolenic acid (ALA) from plant sources. A small portion of ALA (18:3 n-3), the essential n-3 fatty acid in the diet, is elongated to EPA and DHA in the body. EPA (20:5n-3) is a precursor of eicosanoids (i.e. prostaglandins, thromboxanes, etc.), a group of short-lived substances that mediate a wide variety of physiological responses such as vasoconstriction/dilation, platelet aggregation, inflammatory response and blood pressure regulation. DHA (22:6 n-3) is an essential component of phospholipids in human cell membrane, especially in brain and other neural tissues and retinal photoreceptors.
In general there is an interest from the food industry to add various fish oils and other sources of EPA and DHA to a wide variety of foods. Introduction of such foods is expected to increase significantly the exposure of the Canadian population to EPA and DHA. The Department has conducted a comprehensive assessment of the addition of fish oil 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.
Health Canada acknowledges that EPA and DHA have physiological functions, but there are human food safety concerns associated with excessive intake of these fatty acids. Therefore, it is necessary to restrict the amount of fish oil that can be added to foods. Based on available evidence, Health Canada has concluded that adequate intake of 500 mg/person/day and a reference safe intake of 1 g/person/day for all sources of EPA and DHA in the diet for Canadian population could be used as a guide for establishing acceptable population intake distributions. These levels were used to determine the acceptable level of MFO that would be permitted in the food categories requested by the petitioner.
In order to implement these limits, Health Canada is considering either amendments to the Food and Drug Regulations (FDR) or possible alternatives to regulation to limit the amounts of EPA and DHA that may be added to foods.
The following provides a summary of the notification from ONC and the evaluation by Health Canada and contains no confidential business information.
Microencapsulated fish oil is a refined fish oil called 18/12 TG encapsulated in a food grade antioxidant coating material. 18/12 TG contains approximately 18% EPA and 12% DHA, which are predominantly in the form of triglycerides. 18/12 TG is derived from crude fish oil extracted from anchovies (95-99%) and a small amount of other edible marine fish species (i.e. sardine, jack mackerel and mackerel) caught off the coast of Peru. It is blended with antioxidants and encapsulated in a gelatin-based material to mask the fishy odour and taste of the oil, and to convert the liquid oil to a dry powder for easy formulation and handling. One hundred grams of powder contains approximately 56 g fish oil with 16 g of EPA and DHA. Rest of the ingredients are permitted food ingredients or food additives.
2. Description of the Novel Process
Microencapsulated fish oil is considered a novel food ingredient, based on the microencapsulation process which has not been applied to this food before and which permits the addition of nonhydrogenated fish oil to foods on a scale that has hitherto not been possible.
The microencapsulation process changes the susceptibility to oxidation and the organoleptic properties of fish oil, thereby substantially resolving the problems associated with the addition of fish oils to foods. For this reason, microencapsulated fish oil powder is considered a novel food ingredient, as per 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".
The petitioner provided relevant nutrient composition data. The fatty acid profile of the microencapsulated fish oil indicate that the amounts of monounsaturated, saturated, and polyunsaturated fatty acids are comparable to other fish oils. The levels of trans-fatty acid (less than 0.2%) and cholesterol (below 6 mg/g oil) pose no nutritional concerns. The levels of fat-soluble vitamins are within safe limits.
Computer modelling was conducted by Health Canada to determine the potential exposure of the Canadian population to EPA and DHA intakes (both one day and usual intakes) for baseline and for a variety of scenarios including fortification at different levels of some or all of the foods requested for consideration. Based on the results of the dietary modelling, Health Canada determined that it will take no objection to the addition of MFO when added in such a manner that the food as offered for sale contains not less than 8 mg and not more than 100 mg EPA and DHA combined (not including overage for products declaring up to 100 mg on the label) per reference amount (Schedule M of the FDR) and per serving of stated size to:
all foods except for flours, pasta, rice, butter, suet, lard, fresh fruits and vegetables, nuts, seeds, legumes, sugars and non-nutritive sweeteners, sugar syrups, maple syrup, honey and other sweetening agents, alcoholic beverages, seasonings, leaf tea, coffee beans, prepackaged water and ice, foods intended exclusively for children less than 2 years of age, herbs, spices and leavening agents (i.e. baking powder, yeast etc.). For foods intended only for children less than 2 years, an appropriate level of addition has not been determined. With respect to infant formulas, this ingredient would not be considered a suitable source of DHA because of the high proportion of EPA.
4. Toxicological Assessment
Based on the available evidence, the toxicological evaluation concluded that intakes of EPA and DHA from the diet could safely rise to the point where 5% of people had intakes above 1 g/person/day. Currently, the 95th percentile of intake is 22 to 124 mg/day. This estimation attempts to take into consideration the clinical consequences of physiological effects associated with excess intakes of omega-3 fatty acids. This relatively conservative figure also takes into consideration sensitive sub-populations, such as those who take aspirin prophylactically or who are on warfarin or coumadin therapy, and children, given their lower body weights.
5. Chemical Assessment
Chemical data and data on potential contaminants provided by ONC were adequate to demonstrate that the final product is safe and raises no safety concerns.
The microbiological data pertaining to microencapsulated fish oil indicate that the final product undergoes and meets microbiological quality control requirements.
7. Health Risk/Benefit Assessment
While EPA and DHA intakes are associated with a number of potential beneficial effects, including an association with reduced risk of sudden cardiac death, there are risks to health associated with excessive intakes. The Institute of Medicine (IOM) identified immune function, bleeding and increased risk of hemorrhagic stroke and oxidative damage as adverse effects related to excessive intakes of EPA and DHA, but concluded that there were insufficient data to establish a Tolerable Upper Level of Intake (UL) for EPA and DHA.
The IOM also did not establish an Estimated Average Requirement or Adequate Intake (AI) for EPA and DHA but indicated that there are health benefits associated with consumption of EPA and DHA and that up to 10% of the AI for n-3 fatty acids could be consumed as EPA and/or DHA. In effect, this amounts to about 70 mg/day in young children to 160 mg/day in adult males.
A number of other scientific bodies have made recommendations with respect to EPA and DHA intakes because of the evidence supporting their beneficial effects in reduced risk of sudden cardiac death. These recommendations range from a 110 mg to 650 mg per person per day (adults).
Health Canada and the Canadian Food Inspection Agency (CFIA) share responsibilities in regard to labelling requirements for foods. Health Canada is responsible for policy and standard setting under the Food and Drugs Act and Regulations, whereas CFIA is responsible for enforcement. CFIA also administers and enforces those aspects of the Food and Drugs Act and the Consumer Packaging and Labelling Act that ensure labelling is understandable, truthful and not misleading.
It is assumed that manufacturers of foods containing microencapsulated fish oil will wish to signal the fact that their foods contain EPA and DHA. Under the new Nutrition Labelling Regulations, the amounts of EPA and DHA, per se, may not be included in the Nutrition Facts Table, although the total omega-3 content may be declared in g per serving, rounded to the nearest multiple of 0.1 g. The amounts of EPA and DHA may be declared outside the table, in g per serving with the option of putting the amount in milligrams in brackets next to the amount in grams, in a manner that does not constitute a nutrient content claim. If the petitioner or a 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.
Ocean Nutrition Canada and/or its licensees should also consult with Health Canada and CFIA with regard to the types and wording of other claims and statements concerning this product or foods containing this product.
Health Canada's review of the information presented in support of the proposal to add microencapsulated fish oil to foods concluded that there are human food safety concerns associated with the long chain fatty acids EPA and DHA such that restrictions must be placed on both the level of addition as well as the number of foods to which fish oils can be added. Ocean Nutrition's microencapsulated fish oil is an acceptable source of EPA and DHA for addition to foods. Based on the available scientific information, a level of 100 mg per reference amount (total EPA and DHA) is considered safe for addition to a restricted list of foods. The EPA and DHA content must be indicated on the label according to the correct format as described above. It is the continuing responsibility of ONC and its licensees to ensure that their products are in compliance with all applicable statutory and regulatory requirements. Health Canada's opinion deals solely with respect to the suitability for sale of ONC microencapsulated fish oil 18/12 TG.
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