A428 Draft Ass Exec Summary

 

12 December 2001

06/02

DRAFT ASSESSMENT - ( FULL ASSESSMENT - S.15)


 

Full Report [ pdf 307kb ]


 

EXECUTIVE SUMMARY

Background

The Australia New Zealand Food Authority (ANZFA) received an application (A428) on

13 March 2001, from Omega Tech Inc., to amend Standards A19 and 1.5.1 (the Novel Foods Standards) of the Food Standards Code to permit the use of dried marine micro-algae (Schizochytrium sp.) which is rich in the omega-3 long chain polyunsaturated fatty acid DHA (docosahexaenoic acid) as a novel food ingredient in a limited range of foods. The Applicant subsequently amended their application on 28 August 2001 to include DHA- rich oil derived from the same species for use as a novel food ingredient in a limited range of foods.

Under Standards A19 and 1.5.1 of the Food Standards code, novel food is defined as a sub-set of non-traditional food, as defined in the Standard. DHA-rich marine micro-algae (Schizochytriumsp.) and DHA-rich oil derived from Schizochytriumsp. are non-traditional foods because they do not have a history of significant human consumption by the broad community in Australia and New Zealand. They are considered to be novel foods for the purposes of the Standard because there is insufficient knowledge in the broad community to enable safe use of these foods in the form or context in which they are proposed to be presented.

Omega-3 long chain fatty acids, specifically, DHA have been identified as important dietary nutrients with specific roles in the developing foetus and pre-term infants. There are also recent reports that indicate that DHA, as one of the omega-3 fatty acids, may have an important role in cardiovascular health and beneficial effects on the immune system in the general population. DHA is also considered to be vital for the development and function of the brain and eyes.

ANZFA released a Preliminary Assessment Report in relation to this application on

8 May 2001, seeking public comment. The submission period ended on 20 June 2001. A total of 6 submissions were received.

Issues addressed

Proposed uses

The application proposes to use dried marine algae in the following foods (use levels ranging between 200-300mg per serving):

  • Bread and other baked goods such as crisp-spreads;
     
  • Breakfast foods;
     
  • Table spreads;
     
  • Dressings/mayonnaise;
     
  • Modified milk products; and
     
  • Special purpose foods such as Formulated Meal Replacements/Supplementary Foods but excluding infant foods.

The Application proposes to use DHA-rich oil derived from Schizochytrium sp. for use in the following foods (up to 150 mg per serving):

  • Liquid foods;
     
  • Beverages;
     
  • Fruit drinks;
     
  • Sports drinks;
     
  • Table spreads and dressings;
     
  • Dairy/non-dairy foods such as yoghurts, cheese products and ice creams;
     
  • Manufactured meat products and analogues; and
     
  • Infant food and infant formula.

Safety evaluation

Schizochytriummicro -algal species are widely distributed in marine habitats although there are no reports that they have been used for human consumption. There are no reports of toxins being found in this class of micro-algae. Detailed specifications for both the micro-algae and for the oil derived from the micro-algae have been provided.

The toxicological studies that support the safety of DHA-rich Schizochytriumsp.micro-algae indicate that the micro-algae has low toxicity, is not genotoxic or teratogenic and has no effect on reproductive parameters. The no-observable-effect level (NOEL) from a 13-week feeding study in rats was 8% in the diet (equivalent to 4000 mg/kg bw/day of micro-algae, which equates to approximately 430 mg/kg/day of DHA). This was the highest dose level tested in this study. There are no human toleration studies available on the micro-algae or on the oil derived from the micro-algae. However, the compositional analysis of DHA-rich micro-algae or DHA-rich oil derived from the micro-algae do not raise any particular concerns in relation to the safety of the components of these products. There are also numerous published studies available on the safety of DHA and other DHA-rich oils. None of the available studies indicate any toxicity associated with DHA, even at high levels of exposure.

The data from the available animal studies, taken together with the composition data and the data on known levels of exposure to DHA, do not indicate any potential for toxicity associated with dried micro-algae or the oil derived from this micro-algae.

Composition of DHA-rich oil extracted from Schizochytriumsp.

The compositional equivalence of this oil to other traditionally used DHA-rich oils available on the market has been examined. The results indicate that the fatty acid profile of DHA-rich oil is similar to those of other marine based oils. About 60% (w/w) of the micro-algae is made up of fatty acids of which DHA is the major component (35%) followed by palmitic acid (24%), DPA (13.6%) and myristic acid (10.1%).

Sterols make up about 3% of the total mass of the DHA-rich oil, all of which are present in the human food supply. Exposure to these sterols from the consumption of foods containing these DHA-rich products at the proposed levels would not exceed the current consumption of sterols in the general population from other food sources.

Estimated dietary exposure

The principal dietary sources of DHA are oily fish species such as salmon, tuna, sardines, and herrings which feed on the micro algae. Game meat is also a source of DHA. However, the consumption of fish/game meats in Australia and New Zealand is relatively low and therefore the normal exposure to DHA is low.

Using Australian nutrient composition data, ANZFA has estimated that mean exposure to DHA, from existing food sources, to be 100 mg per day for all respondents aged 2-100 years, with high consumers (95th percentile) exposed to 480 mg per day. Estimates of diet-derived DHA exposure were not able to be determined for New Zealanders, as information on the levels of DHA in New Zealand foods was not available.

Dietary modelling has been conducted on the proposed uses of the DHA-rich micro-algae and its oil in various foods to determine the dietary intakes for the mean consumer and the 95th percentile consumer. The mean total dietary exposure based on exposure to DHA solely from the use of micro-algae was determined to be 260 mg per day in Australia and 280 mg per day in New Zealand. The 95th percentile total dietary exposure based on the same exposure data was determined to be 600 mg per day in Australia and 690 mg per day in New Zealand. Thus, exposure to DHA from all sources, even for the 95th percentile consumer, would be under 1000 mg per day. Human breast milk contains low but significant levels of DHA and this source provides a daily intake of approximately 1.5 g of DHA for breast-milk fed infants.

Risk Analysis

The assessment of the safety of DHA-rich micro-algae (Schizochytriumsp.) and DHA-rich oil derived from Schizochytriumsp. is based on: (i) consideration of the safety of the source organism; (ii) the composition of the dried micro-algae and the oil derived from the micro-algae; (iii) toxicology studies conducted on the micro-algae; (iv) safety studies on DHA and DHA-rich oils; and (v) a history of human exposure to DHA in foods. Considered together, this data demonstrates that the DHA-rich micro-algae and the oil derived from it are safe. There is no evidence of toxicity associated with exposure to the micro-algae or to other sources of DHA at the anticipated levels of exposure. The compositional analysis of the micro-algae and the oil derived from the micro-algae indicates that the oil is comparable to other traditional sources of DHA and does not raise any safety concerns regarding other minor ingredients.

The dietary exposure assessment indicates the potential exposure to DHA from the micro-algae or the oil derived from the micro-algae is well within the levels shown to be safe from the animal studies conducted on the micro-algae, and from the animal and human studies conducted on DHA derived from other sources.

On the basis of the available data, it is proposed that there be no restriction on the level of use of DHA-rich micro-algae or DHA-rich oil derived from micro-algae as novel food ingredients. Both products are required to comply with the specifications proposed in the draft variations to Volumes 1 and 2 of the Food Standards Code.

T he use of novel foods in Australia and New Zealand should be monitored in future in order to confirm their low risk nature and to review whether any additional regulatory action may be warranted in order to protect public health and safety.

Conclusions
  1. The available data on DHA-rich micro-algae (Schizochytriumsp.) and on DHA-rich oil derived fromSchizochytriumsp. does not raise any safety concerns at the anticipated levels of exposure. 
     
  2. The fatty acid composition of the Schizochytriumsp. micro-algae and the oil derived from Schizochytriumsp. are comparable to other traditional sources of DHA.
     
  3. Schizochytriumsp. micro-algae and oil derived from the micro-algae will provide an alternative source of omega-3 fatty acids in foods. 
     
  4. The proposed changes to Volume 1 and Volume 2 of the Food Standards Code are consistent with the section 10 objectives of the ANZFA Act and the regulatory impact assessment.

Full Report [ pdf 307kb ]