A1247 D-allulose as a novel food

Samyang Corporation (Samyang) is a food ingredient manufacturer based in Korea and is

seeking to amend Schedule 25 of the #Australia New Zealand Food Standards Code (the Code)to permit the sale of D-allulose as a #novel food in Australia and New Zealand. D-allulose, also known as D-psicose, is a monosaccharide sugar that is an epimer of D-fructose and occurs naturally at very low levels in foods such as cakes, brown sugar, fruits and maple syrup (1.5 -130 milligrams per 100 grams). D-allulose provides only a fraction of the metabolisable energy of conventional sugars such as sucrose, meaning that D-allulose is well suited as a low-energy sugar substitute ingredient.

Samyang is seeking approval to add D-allulose to foods such as bakery products, cereals,

chewing gum, yoghurt, jams, non-alcoholic beverages and as a table sugar substitute at levels

ranging from 2 – 100%. These intended use levels of D-allulose will result in significantly higher dietary intake compared to intake from natural D-allulose levels in foods, meaning that Samyang’s D-allulose meets the definition of novel food in the Code. Novel foods require

assessment and approval by FSANZ before they can be sold as food or added to food.

Samyang is requesting exclusive permission for its ‘Allulosa’ brand of D-allulose in the classes of food listed in Table A.1 of the application.

D-allulose is approximately 70% as sweet as sucrose. In order to provide a similar sweetness

profile to sucrose, D-allulose may need to be added at to foods at slightly greater amounts than the sucrose it replaces or can be added at lower levels when combined with other non-sugar sweeteners (such as intense sweeteners or sugar alcohols). Despite the lower metabolisable energy content of D-allulose, the ingredient fulfils or exceeds properties that make conventional sugars and intense sweeteners popular ingredients in food, including bulking and sensory properties, browning, foaming properties in aerated foods, and antioxidant and gelling qualities.

These properties of D-allulose, combined with the low-energy content, make D-allulose an

attractive ingredient for food manufacturers to incorporate into a variety food matrices.

Samyang’s D-allulose is produced by conversion of fructose by the enzyme D-allulose-3-

epimerase (also known as D-psicose-3-epimerase), which is naturally present in a nongenetically modified organism, Microbacterium foliorum (SYG27B-MF). The enzyme is not currently permitted to be used as a #processing aid in Australia and New Zealand. Samyang is therefore also seeking to amend Schedule 18 of the Code to permit the use of D-allulose-3-epimerase, harboured in M. foliorum (SYG27B-MF), as a processing aid. The safety of the enzyme and M. foliorum for use food production is demonstrated in this application. The enzyme and M. foliorum is totally removed from commercially available D-allulose and will not be present in food.

D-allulose is not metabolised in the body like sugars such as sucrose, meaning it has a lower

available energy content compared to sucrose and other conventional sugars typically used to sweeten foods. Most ingested D-allulose is absorbed in the small intestine but is not broken down and is subsequently excreted in urine. The small amount of D-allulose that passes to the large intestine is poorly fermented by intestinal microflora and is mostly excreted in faeces.

D-allulose provides only 1 kJ/g of metabolisable energy compared to 17 kJ/g for traditional

simple carbohydrates. Samyang is requesting an energy factor of 1 kJ/g for D-allulose be

included in Schedule 11 of the Code for nutrition information labelling purposes. Inclusion of this energy factor for D-allulose in Schedule 11 will ensure that the appropriate energy value for Dallulose can be reflected on the labels of foods containing D-allulose as an ingredient.

Samyang D-allulose novel food application.

Given the unique low-energy properties of D-allulose, this application also requests that

D-allulose be treated differently to conventional sugars in the context of making sugar nutrition content claims, including claims relating to ‘low’, ‘reduced’ and ‘no added’ sugars. Unlike conventional sugar ingredients, D-allulose provides negligible metabolisable energy and Samyang considers this unique property distinguishes D-allulose from the types of sugars that are subject to the conditions for sugar nutrition content claims in section S4—3 of the Code.

This application therefore requests that FSANZ investigate an appropriate mechanism to

exclude D-allulose from the conditions for sugar nutrition content claims.

D-allulose has been extensively studied in animal and human trials and has been demonstrated to be very well tolerated at doses above the intended use levels included in this application.

Very high doses of D-allulose can produce similar intestinal reactions to other commonly

consumed non-digestible carbohydrates, including bloating and diarrhea. A tolerable intake level in humans of up to 0.55 grams per kilogram of body weight per day is considered protective of these adverse effects, with some people being able to consume much higher amounts without experiencing adverse effects. The intended uses of D-allulose will result in dietary exposures well below this tolerable intake level. Estimated dietary intakes using United States food consumption data suggest that all consumers of D-allulose containing foods have an estimated dietary intake below the tolerable level (including 90th percentile consumers). Actual dietary intakes are expected to be much lower because of the conservative assumptions made in calculating the estimated dietary intakes.

In summary, D-allulose is demonstrated to be safe at the intended levels of use outlined in this application and provides an attractive very low energy alternative to conventional sugar

ingredients that are commonly used in foods.

Whereas:

1. Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.
2. Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) establishing a Union list of authorised novel foods was adopted.
3. On 25 March 2019, the company VDF FutureCeuticals, Inc. (‘the applicant’) submitted an application to the Commission pursuant to Article 10(1) of Regulation (EU) 2015/2283 to place calcium fructoborate on the Union market as a novel food. The applicant requested calcium fructoborate to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3), for the adult population, excluding pregnant and lactating women.
4. The applicant also submitted a request to the Commission for the protection of proprietary data for a number of data submitted in support of the application, namely, detailed description of the production process (4); methods of analysis (5); certificates of analysis (6); stability report (7); dietary boron intake assessment (8); toxicokinetic study (9); bacterial reverse mutation test (10); in vitro mammalian micronucleus assay (11); 90-day toxicity study in rats (12); particle size analysis (13); particle size method of analysis (14); fructose analysis (15); amino acid analysis (16); microorganisms analysis (17); physiochemical stability (18); stability of fructose in the novel food (19); background dietary boron intakes (20); boron dissociation under varying pH (21).
5. In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted #the European Food Safety Authority (‘the Authority’) on 10 July 2019, requesting it to provide a scientific opinion by carrying out a #safety assessment of calcium fructoborate as a #novel food.
6. On 25 May 2021, the Authority adopted its scientific opinion on the ‘Safety of calcium fructoborate as a novel food pursuant to Regulation (EU) 2015/2283’ (22). This opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.
7. In that opinion, the Authority concluded that the novel food, calcium fructoborate, is safe for the adult population, excluding pregnant and lactating women, at intake levels up to 220 mg/day (3,14 mg/kg bw per day). Therefore, the opinion of the Authority gives sufficient grounds to establish that calcium fructoborate under the specific conditions of use complies with Article 12(1) of Regulation (EU) 2015/2283.
8. Since few data are available regarding the safety of calcium fructoborate in the population under 18 years of age and by pregnant and lactating women, a labelling should be provided in order to properly inform the consumers that the food supplements containing calcium fructoborate should not be consumed by those population groups.
9. In its opinion, the Authority considered that all the data for which the applicant requested data protection, except for the dietary boron intake assessment and background dietary boron intakes, served as a basis to establish the safety of the novel food. On this basis, the Commission considers that the conclusions on the safety of calcium fructoborate could not have been reached without the data from the reports of those studies.
10. The Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over those data and to clarify their claim to an exclusive right of reference to those data, as required under Article 26(2)(b) of Regulation (EU) 2015/2283.
11. The applicant declared that, at the time of the submission of the application, they held proprietary and exclusive rights of reference to those data under national law, and that therefore third parties cannot lawfully access or use those data or refer to those data.
12. The Commission assessed all the information provided by the applicant and considered that the applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, detailed description of the production process; methods of analysis; certificates of analysis; stability report; toxicokinetic study; bacterial reverse mutation test; in vitro mammalian micronucleus assay; 90-day toxicity study in rats; particle size analysis; particle size method of analysis; fructose analysis; amino acid analysis; microorganisms analysis; physiochemical stability; stability of fructose in the novel food; boron dissociation under varying pH contained in the applicant’s file, on which the Authority based its conclusion on the safety of the novel food and without which it could not have assessed the novel food, should not be used by the Authority for the benefit of any subsequent applicant for a period of 5 years from the date of entry into force of this Regulation. Accordingly, only the applicant should be authorised to place calcium fructoborate on the market within the Union during that period.
13. However, restricting the authorisation of calcium fructoborate and of the reference to the data contained in the applicant’s file for the sole use of the applicant, does not prevent other applicants from applying for an authorisation to place on the market the same novel food, provided that their application is based on legally obtained information supporting such authorisation under Regulation (EU) 2015/2283.
14. Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.
15. The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

The original link:

https://www.foodstandards.gov.au/code/applications/Documents/A1247%20Executive%20Summary.pdf

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Keywords: #novel food #FSANZ #OCI #food regulation #food compliance #safety assessment #novel food regulation #processing aid