cx/fa 15/47/16 add.1 joint fao/who food … · used in food processing ... processing aids on the...

Agenda Item 7a CX/FA 15/47/16 Add.1 March 2015

Original Language Only

JOINT FAO/WHO FOOD STANDARDS PROGRAMME

CODEX COMMITTEE ON FOOD ADDITIVES

Forty-Seventh Session

Xi’an, China, 23-27 March 2015

PROPOSALS FOR ADDITIONS AND CHANGES TO THE PRIORITY LIST OF SUBSTANCES PROPOSED FOR EVALUATION BY JECFA

(Replies to CL 2014/13-FA)

Replies of Australia, European Union, Malaysia, Sudan, African Union, ELC and ISDI

AUSTRALIA

Australia would like to offer the following clarification to the reply to CL2014-13/FA.

Tannins (Tannic acid) (INS 181) - Safety assessment and establishment of specifications

Australia would like to clarify that the listing on the Priority list should refer only to ‘tannins’ as evaluation is requested for the oenological tannins that do not have a JECFA specification. Tannic acid is a subset of the tannins used as additives to wine and foods.

Potassium bisulfite (INS 228) - Safety assessment and establishment of specifications

7. Food products and food categories within the GSFA in which the substance is used as a food additive or as an ingredient, including use level(s).

Australia’s original submission proposed addition at GMP in food category 14.2.3 “Grape wines” and its subcategories. Potassium bisulfite has not been individually evaluated by JECFA though is treated as part of the sulfite group within the GSFA, we therefore revoke the proposal for GMP. The limit for potassium bisulfite should reflect the group ADI for sulfites and the outcome of the JECFA assessment.

EUROPEAN UNION

The European Union and its Member States are proposing to add the following substances to the priority list of substances proposed for evaluation by JECFA:

1) Alpha-amylase in Aspergillus niger

2) Alpha-amylase in Bacillus licheniformis

3) Asparaginase in Bacillus subtilis

4) Xylanase in Bacillus licheniformis

EUROPEAN UNION

Enclosure 1

INFORMATION ON THE SUBSTANCE TO BE EVALUATED BY JECFA

1. Proposal for inclusion submitted by:

Danish Veterinary and Food Administration

2. Name of substance; trade name(s); chemical name(s):

Substance: Alpha-amylase from Rhizomucor pusillus expressed in Aspergillus niger

Chemical name: 1,4-alpha D-glucan glucanohydrolase; CAS 9000-90-2, EC 3.2.1.1

CX/FA 15/47/16 Add.1 2

3. Names and addresses of basic producers:

Novozymes A/S

Krogshøjvej 36

DK-2880 Bagsværd, Denmark

4. Has the manufacturer made a commitment to provide data?

Novozymes A/S commits to provide data to support the proposal for inclusion of the alpha-amylase in the list of substances to be evaluated by JECFA.

5. Identification of the manufacturer that will be providing data (Please indicate contact person):

Novozymes A/S

Krogshøjvej 36


Attn: Tine Vitved Jensen, email: [email protected],

Telephone: +45 4446 0804

6. Justification for use:

The alpha-amylase enzyme preparation is used as a processing aid during food manufacture for hydrolysis of starch during processing of starch containing foods. The alpha-amylase is typically used in the following food processes:

- Starch processing

- Beverage alcohol (distilling) processes

- Baking and other cereal based processes

7. Food products and food categories within the GSFA in which the compound is used as a food additive or as an ingredient, including use level(s):

The enzymes preparation is not added to final foodstuffs but used as a processing aid during food manufacturing. The typical food processes in which the alpha-amylase is used are listed in above section.

The alpha-amylase is used at the minimum dosage necessary to achieve the desired enzymatic reaction.

The ranges of dosage recommended for the alpha-amylase are as follows (expressed in enzyme activity units).

Starch processing: Up to 200 FAU(F) per kilogram of starch dry matter.

Beverage alcohol (distilling) processes: Up to 200 FAU(F) per kilogram of starch dry matter.

Baking and other cereal based processes: Up to 200 FAU(F) per kilogram of starch dry matter.

8. Is the compound currently used in food that is legally traded in more than one country?

The enzyme was approved under the trade name Novozym 27470 in Denmark in 2014 and was positively evaluated by the regulatory authorities in Mexico and included in the positive list. Novozymes has also applied for approval of the enzyme in France and Brazil. The approvals are expected in 2015.

9. List of data available (please check, if available)

Toxicological data i.e. (i) Metabolic and pharmacokinetic studies; (ii) Short-term toxicity, long-term toxicity/carcinogenicity, reproductive toxicity, and developmental toxicity studies in animals and genotoxicity studies; (iii) Epidemiological and/or clinical studies and special considerations; (iv) Other data

Studies conducted

- The following food toxicity program according to the EFSA Guidelinei has been performed:

i. Test for mutagenic activity (Ames Test)

ii. In vitro micronucleus

iii. 13 weeks oral toxicity study in rats

mailto:[email protected]

CX/FA 15/47/16 Add.1 3

The main conclusions of the safety studies can be summarized as follows:

- The alpha-amylase preparation is considered non-cytotoxic and showed no mutagenic activity by testing in a bacterial reverse mutation assay (Ames Test) and by showing no induction of micronuclei in cultured human peripheral blood lymphocytes in vitro.

- The alpha-amylase preparation was well tolerated at all dose levels when administered to rats for 13 weeks, and the overall No Observed Adverse Effect Level (NOAEL) is considered to be the highest administered dose, corresponding to 1400 mg TOS/kg body weight (bw)/day or 687.6 FAU(F)/kg bw/day.

- The safety studies described above were all performed on liquid alpha-amylase enzyme concentrate produced in accordance with ordinary production procedure, omitting stabilization and standardization.

- Aspergillus niger is generally considered to be a safe production organism with a long history of safe use for food ingredients. Furthermore, the production strain lacks the ability to produce relevant mycotoxins.

Technological data (i.e. (i) Specifications for the identity and purity of the listed compounds (specifications applied during development and toxicological studies; proposed specifications for commerce) and (ii) Technological and nutritional considerations relating to the manufacture and use of the listed compound

- The alpha-amylase enzyme preparation complies with the purity criteria recommended for enzyme preparations by Food Chemicals Codex (VIII online edition, 2012). In addition to this, the enzyme preparation also conforms to the General Specifications and Considerations for Enzyme Preparations Used in Food Processing (2006) as proposed by the Joint FAO/WHO Expert Committee on Food Additives in Combined Compendium of Food Additive Specifications.

Intake assessment data

(i) Levels of the listed substance used in food or expected to be used in food based on technological function and the range of foods in which they are used; and (ii) Estimation of dietary intakes based on food consumption data for foods in which the substance may be used.

- The exposure assessment is performed according to the Budget Method (ILSI, 1997). - Overall, the human exposure to the alpha-amylase will be negligible because the enzyme preparation is

used as a processing aid and in low dosages. - The Budget Method assumptions represent a "maximum worst case" situation of human consumption, in

which the enzyme would be used at its maximum recommended dosages in all processed food and all processed beverages and not only in those food and drink processes described above.

- It is also supposed that the totality of the food enzyme will end up in the final food. This assumption is exaggerated since the enzyme protein and the other substances resulting from the fermentation are diluted or removed in certain processing steps.

- Therefore the safety margin calculation derived from this method is highly conservative.

Assumptions in the Budget Method

Solid food The maximum energy intake over the course of a lifetime is 50 kcal/kg bw/day.

50 kcal corresponds to 25 g foods.

Therefore, adults ingest 25 g foods per kg bw per day.

Assuming that 50% of the food is processed food, the daily consumption will be 12.5 g processed foods per kg bw.

It is further assumed that, in average, all processed food contains 25% starch (or starch-derived) dry matter = 3.12 g starch derived dry matter per kg bw per day.

Liquids The maximum intake of liquids (other than milk) is 100 ml/kg bw/day.

Assuming that 25% of the non-milk beverages is processed, the daily consumption will be 25 ml processed beverages per kg bw.

It is further assumed that all processed beverages contain 10% starch hydrolysates = 2.50 g starch derived dry matter per kg bw per day.

It is assumed that the densities of the beverages are ~ 1.

CX/FA 15/47/16 Add.1 4

Theoretical Maximum Daily Intake (TMDI) calculation

Solid Food:

The highest dosage for solid food is 200 FAU(F) per kg starch based raw material. 200 FAU(F) correspond to 407 mg TOS. Based on this, 3.12 gram starch-derived dry matter in solid food will maximally contain 1.27 mg TOS.

Liquid Food:

The highest dosage for liquid food (excluding distilled beverage spirits vide supra) is 200 FAU(F) per kg starch based raw material. 200 FAU(F) corresponds to 407 mg TOS. Based on this, 2.50 gram starch-derived dry matter in liquids will maximally contain 1.02 mg TOS.

The theoretical maximum daily intake (TMDI) of consumers of the enzyme is:

1.27 + 1.02 = 2.29 mg TOS/kg bw/day.

Other information as necessary

10. Date on which data could be submitted to JECFA:

November 2015

i Guidance of EFSA prepared by the Scientific Panel of Food Contact Material, Enzymes, Flavourings and Processing Aids on the Submission of a Dossier on Food Enzymes. The EFSA Journal (2009) 1305, 1-26

Enclosure 2



Danish Veterinary and Food Administration.


Substance: Alpha-amylase from Bacillus stearothermophilus expressed in Bacillus licheniformis.

Chemical name: 1,4-alpha D-glucan glucanohydrolase; CAS 9000-90-2, EC 3.2.1.1


Novozymes A/S

Krogshøjvej 36



Novozymes A/S commits to provide data to support the proposal for inclusion of the alpha-amylase in the list of substances to be evaluated by JECFA.


Novozymes A/S

Krogshøjvej 36


Attn.: Tine Vitved Jensen email: [email protected]

Telephone: +45 4446 0804


The alpha-amylase enzyme preparation is used as a processing aid during food manufacture for hydrolysis of starch during processing of starch containing foods. The alpha-amylase is typically used in the following food processes:

- Starch processing - Beverage alcohol (distilling) processes - Brewing processes and other cereal based beverage processes - Cereal based processes - Removal of starch in sugar processing - Fruit and vegetable processing


CX/FA 15/47/16 Add.1 5


The enzymes preparation is not added to final foodstuffs but used as a processing aid during food manufacturing. The typical food processes in which the alpha-amylase is used are listed in above section.

The alpha-amylase is used at the minimum dosage necessary to achieve the desired enzymatic reaction.

The ranges of dosage recommended for the alpha-amylase are as follows (expressed in enzyme activity units).

Starch processing:

Up to 80 KNU(S) per kilogram of starch dry matter.

Beverage alcohol (distilling) processes:


Brewing processes and other cereal based beverage processes:


Cereal based processes:


Removal of starch in sugar processing:

Up to 2 KNU(S) per kilogram of sugar dry matter.

Fruit and vegetable processing:

Up to 4 KNU(S) per litre of juice. This corresponds to approximately 400 KNU(S) per kilogram of starch dry matter.


The enzyme was approved under the trade name Termamyl®SC in Denmark in 2006. The enzyme has

been positively evaluated by a number of regulatory authorities and included in relevant positive lists in various countries, e.g. Australia, Brazil, France and Mexico.


Toxicological data

(i) Metabolic and pharmacokinetic studies; (ii) Short-term toxicity, long-term toxicity/carcinogenicity, reproductive toxicity, and developmental toxicity studies in animals and genotoxicity studies; (iii) Epidemiological and/or clinical studies and special considerations; (iv) Other data

- The production organism is from a safe strain lineage as described in the decision tree in Pariza and Johnson, 2001

i. The safety of the enzyme product is covered by safety studies according to the

EFSA Guidelineii conducted on the actual production strain or a previous production strain in the

same strain lineage.

The following studies were performed:

- Test for mutagenic activity (Ames Test) - In vitro micronucleus - 13 weeks oral toxicity study in rats.


- The alpha-amylase preparation is considered non-cytotoxic and showed no mutagenic activity by testing in a bacterial reverse mutation assay (Ames Test) and by showing no induction of micronuclei in cultured human peripheral blood lymphocytes in vitro.

- Oral administration to rats of up to 10 ml/kg body weight/day (16689 KNU(S)/kg bw/day or 660 mg Total Organic Solids (TOS) /kg bw/day) for 13 weeks did not reveal any significant toxic effects attributable to the test substance and is considered the No Ob-served Adverse Effect Level (NOAEL).

- The safety studies described above were all performed on liquid alpha-amylase enzyme concentrate produced in accordance with ordinary production procedure, omitting stabilization and standardization.

CX/FA 15/47/16 Add.1 6

Technological data

(i) Specifications for the identity and purity of the listed compounds (specifications applied during development and toxicological studies; proposed specifications for commerce); (ii) Technological and nutritional considerations relating to the manufacture and use of the listed compound

- The alpha-amylase enzyme preparation complies with the purity criteria recommended for enzyme preparations by Food Chemicals Codex (VIII online edition, 2012). In addition to this, the enzyme preparation also conforms to the General Specifications and Considerations for Enzyme Preparations Used in Food Processing (2006) as proposed by the Joint FAO/WHO Expert Committee on Food Additives in Combined Compendium of Food Additive Specifications.


(i) Levels of the listed substance used in food or expected to be used in food based on technological function and the range of foods in which they are used; (ii) Estimation of dietary intakes based on food consumption data for foods in which the substance may be used.

- The alpha-amylase enzyme preparation is to be used for starch hydrolysis during food processing. - The exposure assessment is performed according to the Budget Method (ILSI, 1997). - Overall, the human exposure to the alpha-amylase will be negligible because the enzyme

preparation is used as a processing aid and in very low dosages. - In order to demonstrate a worst case calculation, an exaggerated human intake is estimated using

the following assumptions.

a) The food enzyme would be used at its maximum recommended dosage in all processed food and all processed beverages.

b) According to the Budget method, a conservative estimate for the food intake is 25 g per kg body weight (bw) per day of which processed food is 50% of the food intake or 12.5 g per kg bw per day. It is further assumed that in average all processed food contains 25% starch (or starch derived) dry matter = 3.12 g starch derived dry matter per kg bw per day.

c) Also according to the Budget method, a conservative estimate for the beverage (non-milk) intake is 100 ml per kg bw per day of which processed beverages (soft drink) is 25% of the non-milk beverage intake or 25 ml per kg bw per day. It is further assumed that all processed beverages contain 10% starch hydrolysates = 2.50 g starch derived dry matter per kg/bw/day. It is assumed that the densities of the beverages are ~ 1.

d) The calculation is made assuming that all TOS remains in the final product. This assumption is exaggerated since the enzyme protein and the other substances resulting from the fermentation are diluted or removed in certain processing steps.

- The highest dosage recommended in above applications is 240 KNU(S) per kg starch based raw material.

- 240 KNU(S) correspond to 9.48 mg TOS. Based on this, 3.12 gram starch-derived dry matter in solid food will maximally contain 0.0296 mg TOS. Furthermore, 2.50 gram starch-derived dry matter in liquids will maximally contain 0.0237 mg TOS.

- The theoretical maximum daily intake (TMDI) of consumers of the food enzyme is therefore 0.0533 mg TOS/kg bw/day.

- However, this does not include the special applications ‘Removal of starch in sugar processing and ‘Fruit and vegetable processing’ where the aim is to remove small amounts of starch.

- For sugar processing, the worst case intake was calculated to be 0.001 TOS /kg bw/day. Since this amount is less than the 0.0296 mg TOS /kg bw/day as estimated by the Budget Method for solid foods, use of the alpha-amylase for starch removal in sugar processing is covered by the Budget Method calculation above.

- For fruit and vegetable processing, the worst case intake was calculated to be 0.0040 TOS /kg bw/day. Since this amount is less than the 0.0237 mg TOS /kg bw/day as estimated by the Budget Method for liquids, use of the alpha-amylase in production of fruit and vegetable juices for starch removal is covered by the Budget Method calculation above.



November 2015

i Pariza, M.W. and Johnson, E.A.. Evaluating the Safety of Microbial Enzyme Preparations Used in Food Processing: Update for a New Century. Reg. Tox and Pharm 33: 173-186, 2001.

CX/FA 15/47/16 Add.1 7

ii Guidance of EFSA prepared by the Scientific Panel of Food Contact Material, Enzymes, Flavourings and

Processing Aids on the Submission of a Dossier on Food Enzymes. The EFSA Journal (2009) 1305, 1-26

Enclosure 3





Substance: Pyrococcus furiosus asparaginase expressed in Bacillus subtilis

Chemical name: L-asparagine amidohydrolase, CAS 9015-68-3, EC 3.5.1.1


Novozymes A/S

Krogshøjvej 36



Novozymes A/S commits to provide data to support the proposal for inclusion of the asparaginase in the list of substances to be evaluated by JECFA.


Novozymes A/S

Krogshøjvej 36


Attn.:Tine Vitved Jensen email: [email protected]

Telephone: +45 4446 0804


The asparaginase enzyme preparation is used as a processing aid during food manufacture to convert asparagine to aspartic acid in order to reduce the risk for acrylamide formation. The enzyme is thermotolerant and therefore well suited for use in high temperature processing like production of breakfast cereals.

The asparaginase is typically used in the following food processes:

- Baking processes

- Other cereal based processes

- Fruit and vegetable processing

- Coffee and cocoa processing


The asparaginase enzyme preparation is intended to be used to convert asparagine to aspartic acid in order to reduce the risk of formation of acrylamide during food production of products such as breakfast cereals, fabricated potato chips and french fries, and wheat dough based products such as cookies and crackers.

The asparaginase is used at the minimum dosage necessary to achieve the desired enzymatic reaction.

Below table lists the typical food processes in which the asparaginase is used and ranges of dosage recommended (expressed in enzyme activity units).


A US GRAS (Generally Recognized As Safe) notification was submitted to FDA and the agency did not question Novozymes’ conclusion that the asparaginase enzyme preparation is GRAS under the intended conditions of use. The enzyme was approved under the trade name Acrylaway

® HighT in Denmark in


CX/FA 15/47/16 Add.1 8

2013. Furthermore, the enzyme has been positively evaluated and included in the positive lists in Brazil and Mexico.


Toxicological data


The asparaginase enzyme preparation has been subjected to a standard package of toxicological tests according to the EFSA Guideline

i. The following studies were performed:

- Test for mutagenic activity (Ames Test)

- In vitro micronucleus

- 13 weeks oral toxicity study in rats


- The asparaginase preparation is considered non-cytotoxic and showed no mutagenic activity by testing in a bacterial reverse mutation assay (Ames Test) and by showing no induction of micronuclei in cultured human peripheral blood lymphocytes in vitro.

- The asparaginase preparation was well tolerated at all dose levels when administered to rats for 13 weeks, and the overall No Observed Adverse Effect Level (NOAEL) is considered to be the highest administered dose, corresponding to 1.207 g TOS/kg/day or 584568 TASU/kg body weight/day.

- The safety studies described above were all performed on liquid asparaginase enzyme concentrate, produced in accordance with ordinary production procedure, omitting stabilization and standardization.

Technological data

(i) Specifications for the identity and purity of the listed compounds (specifications applied during development and toxicological studies; proposed specifications for commerce); (ii) Technological and nutritional considerations relating to the manufacture and use of the listed compound

- The asparaginase enzyme preparation complies with the purity criteria recommended for enzyme preparations by Food Chemicals Codex (VIII online edition, 2012). In addition to this, the enzyme preparation also conforms to the General Specifications and Considerations for Enzyme Preparations Used in Food Processing (2006) as proposed by the Joint FAO/WHO Expert Committee on Food Additives in Combined Compendium of Food Additive Specifications.



- The asparaginase is used in the manufacture of a wide variety of foods, food ingredients, and beverages. Due to this wide variety of applications the most appropriate way to estimate the human consumption is using the Budget Method (ILSI, 1997). This method enables to calculate the theoretical maximum daily intake (TMDI) based on conservative assumptions regarding physiological requirements for energy from food and the energy density of food rather than on food consumption survey data.

- Overall, the human exposure to the food enzyme will be negligible because the enzyme preparation is used as a processing aid and in very low dosages. In order to demonstrate a worst case calculation, an exaggerated human intake is estimated using the following assumptions.

- It is assumed that the totality of the food enzyme will end up in the final food. This assumption is highly exaggerated since the enzyme protein and the other substances resulting from the fermentation are diluted or removed in certain processing steps. Furthermore, far from all processed food and beverages are produced with the enzyme, and those that are, are not always produced with the maximum recommended dosage.

CX/FA 15/47/16 Add.1 9

Solid food The maximum energy intake over the course of a lifetime is 50 kcal/kg body weight (bw)/day.

50 kcal corresponds to 25 g foods.

Therefore, adults ingest 25 g foods per kg bw per day.

Assuming that 50% of the food is processed food the daily consumption will be 12.5 g processed foods per kg bw.

Liquid food The maximum intake of liquid food (other than milk) is 100 ml/kg bw/day.

Assuming that 25% of the non-milk beverages is processed the daily consumption will be 25 ml processed beverages per kg bw.

It is assumed that the densities of the beverages are 1 g/ml.

Processed food

The processed food applications are “Baking and other cereal based processes” and “Fruit and vegetable processing”. The highest dosage is 15000 TASU/kg final food corresponding to 27.8 mg TOS.

Based on this 12.5 gram final solid food will maximally contain 0.348 mg TOS.

Processed beverages

The highest dosage given above is 12500 TASU per kg final roasted coffee or cocoa beans. It is assumed that:

- 1000 ml coffee or cocoa is made from 60 gram roasted (and milled) beans

- 60 gram roasted beans is dosed with 12500 x 60/1000 = 750 TASU corresponding to 1.39 mg TOS

Based on this, 25 ml coffee will contain 1.39 mg TOS x 25 ml/1000 ml = 0.035 mg TOS.

The theoretical maximum daily intake (TMDI)

The TMDI of consumers of the xylanase is 0.348 + 0.035 = 0.383 mg TOS/kg bw/day.


November 2015


Enclosure 4





Substance: Bacillus licheniformis Xylanase expressed in Bacillus licheniformis

Chemical name: Endo-1,4-beta-xylanase; CAS 9025-57-4, EC 3.2.1.8


Novozymes A/S

Krogshøjvej 36



Novozymes A/S commits to provide data to support the proposal for inclusion of the xylanase in the list of substances to be evaluated by JECFA.


Novozymes A/S

CX/FA 15/47/16 Add.1 10

Krogshøjvej 36

DK-2880 Bagsværd

Denmark

Attn.:Tine Vitved Jensen Email: [email protected]

Telephone: +45 4446 0804


The xylanase enzyme preparation is used as a processing aid during food manufacture. The enzyme catalyzes the endo-hydrolysis of 1,4-beta-D-xylosidic linkages in xylans, including arabinoxylans (also called pentosans) in various plant materials including the cell walls and endosperm of cereals, such as wheat, barley, oats and malt. The xylanase is typically used in baking processes and other cereal based processes where it improves handling of the dough, the dough structure and behavior during the baking step in addition to characteristics of the final bread.


The enzyme preparation is not added to final foodstuffs but used as a processing aid during food manufacturing. The xylanase is used at the minimum dosage necessary to achieve the desired enzymatic reaction. The recommended dosage for the xylanase in baking and other cereal based processes is up to 60 NXU per kg of flour.


A US GRAS (Generally Recognized As Safe) notification was submitted to FDA and the agency did not question Novozymes’ conclusion that the xylanase enzyme preparation is GRAS under the intended conditions of use. The enzyme was approved under the trade name Panzea

® in Denmark in 2013.

Furthermore, the enzyme has been positively evaluated and included in the positive lists in Brazil and Mexico.


Toxicological data


- The following food toxicity program according to the EFSA Guidelinei has been performed:

i. Test for mutagenic activity (Ames Test)

ii. In vitro micronucleus

iii. 13 weeks oral toxicity study in rats


- The xylanase preparation is considered non-cytotoxic and showed no mutagenic activity by testing in a bacterial reverse mutation assay (Ames Test) and by showing no induction of micronuclei in cultured human peripheral blood lymphocytes in vitro.

- The xylanase preparation was well tolerated at all dose levels when administered to rats for 13 weeks, and the overall No Observed Adverse Effect Level (NOAEL) is considered to be the highest administered dose, corresponding to 1.02 g TOS/kg body weight (bw)/day or 38608 NXU/kg bw/day.

- The safety studies described above were all performed on liquid xylanase enzyme concentrate produced in accordance with ordinary production procedure, omitting stabilization and standardization.

Technological data

(i) Specifications for the identity and purity of the listed compounds (specifications applied during development and toxicological studies; proposed specifications for commerce) (ii) Technological and nutritional considerations relating to the manufacture and use of the listed compound

- The xylanase enzyme preparation complies with the purity criteria recommended for enzyme preparations by Food Chemicals Codex (VIII online edition, 2012). In addition to this, the xylanase enzyme preparation also conforms to the General Specifications and Considerations for Enzyme Preparations Used in Food Processing (2006) as proposed by the Joint FAO/WHO Expert Committee on Food Additives in Combined Compendium of Food Additive Specifications.


CX/FA 15/47/16 Add.1 11



- In order to demonstrate a worst case calculation, an exaggerated human intake is estimated using the following method and assumptions.

- The xylanase is used at its maximum recommended dosage in baking and other cereal based processes combined with the human intake of the foods produced with the enzyme as given in The EFSA Comprehensive European Food Consumption Database

ii. According to this database the

summarized intake of relevant food products, taken as the maximum average intake over 17 countries and all age groups, is 10.7 g “Grains and grain-based products”/kg bw/day.

- It is supposed that the totality of the enzyme will end up in the final food. This assumption is exaggerated since the enzyme protein and the other substances resulting from the fermentation are diluted or removed in certain processing steps.

- It is also assumed that all grains and grain-based products are produced with the enzyme, which is not the case.

- The baking processes (mixing flour and water and other relevant ingredients followed by a heating step) on average results in 140 g of final baked product from 100 g of flour. Therefore, an intake per kg bw per day of 10.7 g of baked “Grains and grain-based products” corresponds to 10.7 x 100 / 140 = 7.64 g flour/kg bw/day.

- The dosage for the enzyme in baking and other cereal based processes is up to 60 NXU per kg flour corresponding to 1.00 mg TOS.

- Based on this, 7.64 g flour/kg bw/day will result in an exposure of 0.0076 mg TOS/kg bw/day. - Thereby, the Theoretical Maximum Daily Intake (TMDI) of the enzyme by consumers is 0.0076 mg

TOS/kg bw/day.



November 2015


ii http://www.efsa.europa.eu/en/datexfoodcdb/datexfooddb.htm. Used information: Chronic food

consumption statistics - reported in g/kg bw/day (Published 2 March 2011) - Excel sheet L1 ‘Consumers Only’ for “Grains and grain-based products” (Other children, Bulgaria).

MALAYSIA

In Response to Paraguay Comments

Proposal from Malaysia regarding the review for JECFA specification on steviol glycosides to include rebaudioside M and rebaudioside E and to delete the requirement for stevioside and/or rebaudioside A as the primary steviol glycosides in stevia preparations.

During the upcoming Codex Committee on Food Additives (CCFA) meeting in China in March 2015, several food additives will be considered for inclusion in the priority list to be evaluated by JECFA. Steviol glycosides are one of the additives that will be for discussion during the meeting, on the basis of a petition submitted to JECFA for the revision of steviol glycosides.

The requested revision encompasses two aspects:

1) Amend the JECFA specifications in order to add two steviol glycosides - Rebaudioside M and Rebaudioside E - to the current list of 9 already authorized steviol glycosides; and

2) Increase the opportunity for other steviol glycosides to be the predominant glycoside in the finished ingredient by removing the requirement for Stevoiside and Rebaudioside A as the only major steviol glycosides .

Malaysia has been informed that Paraguay has expressed some concerns in relation to the nature of the petition and its impact on consumers and on the socio-economic landscape. Malaysia would like to thank Paraguay for bringing this matter to its attention and would like to provide more information on the key aspects of the petition to CCFA to help regulators to better understand and evaluate the situation.

We would like to highlight the following points:

http://www.efsa.europa.eu/en/datexfoodcdb/datexfooddb.htm

CX/FA 15/47/16 Add.1 12

Steviol glycosides referenced in the petition are extracted from stevia leaves with traditional methods without employing any novel technology.

Manufacturing method covered in Malaysia’s proposal involves the same manufacturing used in the last JECFA evaluation

Both Rebaudioside M and Rebaudioside E are minor steviol glycoside constituents which occur naturally in the Stevia rebaudiana plant. Both glycosides share the same backbone structure as all the other already authorized steviol glycosides, and differ only with respect to the number of glycosyl units attached to steviol. Commercially available preparations of stevia extracts already contain measurable levels of Rebaudioside M and Rebaudioside E. Due to their presence at very low level; these molecules were previously not considered pivotal for inclusion in the JECFA specifications.

New varieties of stevia plants with higher than normal content of Reb M or Reb E have been identified that can be used as the source to produce stevia extract where Reb M content may vary from 50-95%.

During the purification steps, stevia extract with high concentration of Reb M or Reb E can be obtained through multiple steps of purification (crystallization). After isolating Reb M or Reb E rich-extract, the remaining extract with high concentration of Reb A and Stevioside can be used also as sweeteners by purification/ crystallization steps.

Both Rebaudioside M and Rebaudioside E can be detected in commercial preparations using the same procedures described in the current JECFA specifications.

Stevia farmers and growers remain vital to the stevia supply chain. It is important to note that the petition in no way threatens the growth of stevia farming. The stevia product resulting from the revised specifications will still be entirely derived from the stevia leaf.

Rebaudioside M preparations are sweeter (approximately 350 times as sweet as sucrose at 5% sucrose equivalency) than currently available steviol glycoside preparations (which are 200 to 300 time as sweet as sucrose). These stevia-based preparations have an improved sweetness quality that more closely resembles to sucrose. Thus, the proposed changes to the specifications will result in an increased number of great tasting, naturally sweetened stevia based-products.

As more steviol glycosides with unique taste properties are discovered and added to the JECFA specifications, one can expect to see an increase in the number of stevia products on the market. For the leaf growers, this translates into an increased demand for stevia leaf products.

In conclusion, the stevia extract referenced in the petition is extracted directly from the stevia leaf using methods as described within JECFA specifications. Additional Steviol Glycosides, Rebaudiosides M &E, can be detected in commercial preparations using the same methodology outlined in JECFA specifications. No novel technologies were used to produce this stevia extract.Stevia farmers and growers remain vital to the stevia supply chain. It is important to note that the petition in no way threatens the growth of stevia farming. The stevia product resulting from the revised specifications will still be entirely derived from the stevia leaf.

SUDAN

Background

1. Codex Alimentarius Commission at the 23rd session , Rome1999, defined Gum Arabic as :” Gum Arabic is a dried exudation obtained from the stems and branches ofAcacia senegal (L) or A. seyal (fam. Leguminosae)”,this definition puts two types of gum obtained from two botanically different trees with

Completely different structural and physiological properties under one name "Gum Arabic".

2. The new JECFA common monograph for A.senegal and A.seyal gums gives different specifications of identity and purity, different processing quality and usage patterns, affirms that they are not technologically interchangeable. Further, the two gums are traded as separate commodities with different specifications and prices.

3. JECFA ’ established practice of assigning a unique INS and separate monograph for each gum used as food additive (e. g Guar INS E 412, Gellan INS E 418, Karaya INS E 416, Xanthan INS E 415) has not been adhered to in the case of Gum Arabic (senegal) and Gum Talha(seyal)

4. The criteria of inclusion of topics in JECFA priority list include: the diversity of the national legislations and any apparent impediments to the international trade, in additional to the needs and concerns of the developing countries, as well as the prevention of the unfair trade practices.

CX/FA 15/47/16 Add.1 13

5. Considering the Proposals for Changes and /or Additions to the INS list (CL2014/12 FA) section 2 (New sub-classes of INS Numbers), Sudan’s request for a revision is based on Annex 2, (justification for requested INS Change in section 3, new or additional technological purpose).

6. JECFA demanded from Sudan, since the late 90s, to provide new evidence of differences between the two

gums, in order to revise the decision regarding the amalgamation of Gum Arabic and Gum Talha in one monograph.

The Taxonomical Differences:

7. Reports, regarding the taxonomy of A. senegal and A. seyal,indicated that they are not closely related species, though they belong to the family Leguminosae. They had been extensively described in the literature and the differences between them had been established beyonddoubt (Elamin,1972).Further A.senegal was subdivided to sub-species such as A. senegal var. senegal, and A.senegal var. kernsis etc.( Ross,1979).The significant botanical differencesare strongly reflected in the differences between the gums derived from the two different trees.

Structural and Physicochemical Differences:

8. Gum Arabic and Gum Talha are very complex biopolymers made up of polysaccharides and proteins. They are hetero-poly-disperse molecules of great variation in the proportions of building mono-saccharides and the mode of linkage. This complexity is reflected in the physicochemical properties and functional characteristics as shown in the following table:

Parameters Gum Arabic Gum Talha

------------------------------------------------------------------------------

Loss on drying (%) 10 12.6

Specific optical rotation (deg) -29 +45

Intrinsic viscosity (ml/g) 16 14

Nitrogen (%) 0.3 0.15

Protein (%) 2.4 1

Rhamnose (%) 14 3

Arabinose (%) 27 44

Galactose (%) 35 36

Uronic Acid (%) 21 16

Molecular weight Mw (Dalton) ~105 ~106

Source: Siddig et al 2005

The above data indicate the quantitative differences in the values of the parameters that include: loss on drying, specific optical rotation, intrinsic viscosity, nitrogen, protein, rhaminose, arabinose, galactose, urinic acid and average molecular weight. The proportion of the monosaccharaidescontent is also different. These differences agree with the taxonomic separation of the two species and, consequently the two gums, into two distinct series (Vulgares and Gummiferae). Recent spectroscopic analysis of the molecular structure of Gum Arabic and Gum Talha (Shoa-Pin Nie et al 2013) identified the mode of linkage and proposed a motif of molecularsegment for the two gums. Annexes 1 and 2 shows the proposed models for the molecular structure for the two gums and figure 3 and 4 show the nmr spectra.

Environmental and Socioeconomic Impacts:

9. A.senegal tree is found naturally in a belt covering an area of about 520,000 km known as Gum belt of the Sudan between latitude 10 and 14 degree north. The tree is perceived as the most important tree /crop of Sudan producing Gum Arabic that contributes to the livelihood of six millions traditional farmers. The product of the tree- Gum Arabic- is produced in agro forestry system that combine, a part from the tree, other equally important stable food and cash crops namely, pear millet, sorghum, ground nut, sesame, watermelon and live stock

CX/FA 15/47/16 Add.1 14

10. A.senegal management is well integrated with the plant and animal crops. The management of the natural stands of the tree by, experienced farmers plays the major role in maintaining the sustainability of production. Knowledge and understanding of the surrounding have led to the development of risk strategies

11. Other merits of A.senegal is the regeneration of the soil fertility and combat of the desertification, acting as a buffer zone against the southwards moving sands in the north towards the high rainfall fertile zone in the south.

12. A.seyal is natural untended tree that exudes gum naturally. The Gum is collected by nomadic people without tapping the tree, resulting in a wild product not owned by farmers .The tree is subjected to natural and man –made fires and it is not integrated in a farming system. However, tapping has started recently.

13. The profit-oriented de-evaluation of Gum Arabic in favor of Gum Talha without giving due considerations for the impact on the environment and the livelihood of indigenous poor resource farmers has lead and will further lead to poverty and scarcity of food which will lead to the consumption of the discarded food and the unpredictable wild food and migration to the urban areas.

Conclusion

14. Sudan requests the revision of the decision taken by JECFA and endorsed by Codex Alimentarius Commission at the23 meeting, Rome1999 regarding the amalgamation of Gum Arabic from A.senegal with Gum Talha from A.seyal

Sudan suggests to reevaluate specification of Gum Arabic INS E414 so as to assign these gums in to two different monographs one for A. senegal (Gum Arabic} and that derived from A. seyal (Gum Talha) .

References

El Amin, H.M.(1972).Sudan Acacias.Forest Research Bullitin No. 1 The Publishing Section, Information Department,Forest Research Institurem Khartoum.

El Amin, H.M. (1990 ),Trees and Shrubs of Sudan. Etheca Press, Richmond Road, Exeter ,

Ross,J. H.(1972 ),Mom. Bot. Surv. S.Africa, No.44.

Shao-Ping Nie,Cathy Wang,Steve,w.Cui,Qi Wang,Ming-yong Xie,Phillips,G.O.(2013)A further amendment to the classical core structure of gum arabic (Accacia senegal ).Food Hydrocolloids.31:42-48.

Shao-Ping Nie,Cathy Wang,Steve, W. Cui,Qi Wang, Ming-Yong Xie,Glyn O.Phillips(2013).The core carbohydrate structure of Acacia seyal var.seyal (Gum Arabic ).Food Hydrocolloids, 32;221-227.

Siddig, N.E.,Osman,M.E,Phillips,P.A.,Williams,P.A.(2005).Studies acacia exudates gums,Part IV: Distribution of molecular componants in Acacia seyal in relation to Acacia senegal.Food Hydrocooloids.19:679-686.

Annex 1 : Proposed model for molecular structure of GumArabic ( Shoa-Ping Nie etal 2013)

CX/FA 15/47/16 Add.1 15

Annex2: Proposed model for the molecular structure of Gum Talha(Shoa-Ping Nie et al 2013).

Fig 3: H1 and C13 nmr of Gum Arabic (Shoa –Ping Nie 201

Fig. 4: H1 and C13 nmr of Gum Talha (Shoa-Ping Nie 2013)

CX/FA 15/47/16 Add.1 16

Form on Which Information on the Substance To Be

Evaluated By JECFA Is Provided

Name of Substance Gum Arabic

QUESTION(S)to be answered by JECFA

JECFA included in one monograph and under one INS Number (i.e.) both Gum Arabic “Acacia Senegal “and Gum Talha “Acacia seyal “, in spite of the difference between the two gums. These differences originate from the botanical sources of the two gums, Their physicochemical characteristic and even in their detailed molecular structures, In addition to their market prices.

Gum Arabic (Acacia Senegal) has been subjected to extensive toxicological evaluation and granted ADI not specified status.

The inclusion of A. seyal with A. Senegal is not justified as the former gum and has not been subjected to the normal procedure of screening.

Sudan request hence re evaluation of the specification for Gum Arabic so as to separate the specification of Gum Arabic Acacia senegal from that of A. seyal

1. Proposal for inclusion submitted by: Sudanese Standard &Meteorology Organization

2. Name of Substance; trade name(s); chemical name(s): Gum Arabic “Acacia senegal” Trade Name: KordufanGum, Hashab Gum

INS No. E414

CAS No.9000-01-5

3. Names and addresses of basic producers: Sudan

4. Has the manufacturer made a commitment to provide data: Yes

5. Identification of the manufacturer that will be providing data: Sudanese Standard & Metrology Organization

CX/FA 15/47/16 Add.1 17

Researchers and Scientist of SSMO Technical Committee of Natural Gums

1. Dr. Kamal Alhadi Mohamed Head of Standard and Specification Department Sudanese Standard &Metrology Organization /Head Quarter Khartoum /Sudan , Algamaa St. Email: [email protected]

2. Mrs. Mayada Awad Elkareem

Sudanese Standard &Metrology Organization Email: [email protected]

3. Codex Contact point /Sudan

Email: [email protected] Ministry of Agriculture & irrigation, Quality Control & Export development Unit Agr.Engineer / Ms. Ula Abdelaziz Makkawi Codex Contact Person Email: ulaabdelaziz @gmail.com

6. Justification for use: well established emulsifier, encapsulator, thickener, viscosity& bulking agent, stabilizer, carrier, glazing& suspending agent and pre biotic.

7. Food products and food categories within the GSFA in which the substance is used as a food additive or as an ingredient, including use level(s):

Listed with limits 1000 mg/kg.

0.1.1.2Dairy-based drinks, flavoured and/or fermented (e.g., chocolate milk, cocoa, eggnog, drinking yoghurt, whey-based drinks)

01.3 Condensed milk and analogues (plain)

01.4.3 Clotted cream (plain)

01.4.4 Cream analogues

01.5 Milk powder and cream powder and powder analogues (plain)

01.6.1 Unripened cheese

01.6.2 Ripened cheese

01.6.4 Processed cheese

01.6.5 Cheese analogues

01.7 Dairy-based desserts (e.g., pudding, fruit or flavoured yoghurt)

01.8.1 Liquid whey and whey products, excluding whey cheeses

02.2.2 Fat spreads, dairy fat spreads and blended spreads

02.3 Fat emulsions mainly of type oil-in-water, including mixed and/or flavoured products based on fat emulsions

02.4 Fat-based desserts excluding dairy-based dessert products of food category 01.7

03.0 Edible ices, including sherbet and sorbet

04.1.2 Processed fruit

04.2.2.2 Dried vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), seaweeds, and nuts and seeds

04.2.2.3 Vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), and seaweeds in vinegar, oil, brine, or soybean sauce

04.2.2.4 Canned or bottled (pasteurized) or retort pouch vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), and seaweeds

04.2.2.5 Vegetable (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), seaweed, and nut and seed purees and spreads (e.g., peanut butter)



CX/FA 15/47/16 Add.1 18

04.2.2.6 Vegetable (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), seaweed, and nut and seed pulps and preparations (e.g., vegetable desserts and sauces, candied vegetables) other than food category 04.2.2.5

04.2.2.8 Cooked or fried vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), and seaweeds

05.0 Confectionery

06.3 Breakfast cereals, including rolled oats

06.4.3 Pre-cooked pastas and noodles and like products

06.5 Cereal and starch based desserts (e.g., rice pudding, tapioca pudding)

06.6 Batters (e.g., for breading or batters for fish or poultry)

06.7 Pre-cooked or processed rice products, including rice cakes (Oriental type only)

06.8 Soybean products (excluding soybean-based seasonings and condiments of food category 12.9)

07.0 Bakery wares

08.2 Processed meat, poultry, and game products in whole pieces or cuts

08.3 Processed comminuted meat, poultry, and game products

08.4 Edible casings (e.g., sausage casings)

09.3 Semi-preserved fish and fish products, including mollusks, crustaceans, and echinoderms

09.4 Fully preserved, including canned or fermented fish and fish products, including mollusks, crustaceans, and echinoderms

10.2.3 Dried and/or heat coagulated egg products

10.3 Preserved eggs, including alkaline, salted, and canned eggs

10.4 Egg-based desserts (e.g., custard)

11.6 Table-top sweeteners, including those containing high-intensity sweeteners

12.2.2 Seasonings and condiments

12.3 Vinegars

12.4 Mustards

12.5 Soups and broths

12.6 Sauces and like products

12.7 Salads (e.g., macaroni salad, potato salad) and sandwich spreads excluding cocoa- and nut-based spreads of food categories 04.2.2.5 and 05.1.3

12.8 Yeast and like products

12.9 Soybean-based seasonings and condiments

12.10 Protein products other than from soybeans

13.3 Dietetic foods intended for special medical purposes (excluding products of food category 13.1)

13.4 Dietetic formulae for slimming purposes and weight reduction

13.5 Dietetic foods (e.g., supplementary foods for dietary use) excluding products of food categories 13.1 - 13.4 and 13.6

13.6 Food supplements

14.1.4 Water-based flavoured drinks, including "sport," "energy," or "electrolyte" drinks and particulated? drinks

14.2.1 Beer and malt beverages

14.2.2 Cider and Perry

CX/FA 15/47/16 Add.1 19

14.2.4 Wines (other than grape)

14.2.5 Mead

14.2.6 Distilled spirituous beverages containing more than 15% alcohol

14.2.7 Aromatized alcoholic beverages (e.g., beer, wine and spirituous cooler-type beverages, low alcoholic refreshers)

15.0 Ready-to-eat savories

16.0 Prepared foods

8. Is the Substance currently used in food that is legally traded in more than one country? (Please identify the country) or has the substance been approved for use in food in one or more country?

YES, it is used in many countries including Europe, Japan and United State of America


Toxicological data:

1. Data for “Acacia Senegal “ Gum Arabic

A. Senegal has been evaluated extensively and assigned. ADI not specified.

2. Data for "Acacia seyal" Gum Talha:

Should be submitted when requested.

Technological data:

I. Specifications for the identity and purity of the listed substances (specifications applied during development and toxicological studies; proposed specifications for competence). Specification for purity available

II. Technological and nutritional considerations relating to the manufacture and use of the listed substance.

Intake Assessment data:

I. Levels of the listed substance used in food or expected to be used in food based on technological function and the range of foods in which they are used. ADI not specified

II. Estimation of dietary intakes based on food consumption data for foods in which the substance may be used.

Data Available


10. Date on which data could be submitted to JECFA.

December 2015

AFRICAN UNION

AU supports the lists of substances submitted by member countries for evaluation by JECFA.

FEDERATION OF EUROPEAN SPECIALITY FOOD INGREDIENTS INDUSTRIES (ELC)

FORM ON WHICH INFORMATION ON THE COMPOUND TO BE EVALUATED BY JECFA IS PROVIDED

Name of Compound(s): Carotenes from Dunaliella salina

Question(s) to be answered by JECFA

Safety assessment including establishment of an ADI and revision of specification

1. Proposal for inclusion submitted by: Germany

2. Name of compound; trade name(s); chemical name(s): Carotenes from Dunaliella salina; Natural beta-carotene; Carotenes-natural; Algal carotenes; CI Food Orange 5; INS No. 160a(iv);

3. Names and addresses of basic producers: BASF SE, D-68623 Lampertheim, Germany

4. Has the manufacturer made a commitment to provide data? Yes

CX/FA 15/47/16 Add.1 20

5. Identification of the manufacturer that will be providing data (Please indicate contact person): Dr. Bernd Haber Director Regulatory Affairs / Human Nutrition, BASF SE Phone: +49 621 60-28787 Fax: +49 621 60-6628787 E-Mail: [email protected]

6. Justification for use: Alternative source of carotenoids for colouring purposes and as nutrient source.

7. Food products and food categories within the GSFA in which the compound is used as a food additive or as an ingredient, including use level(s): Same categories as carotenoids INS 160a (i)-(iii)

8. Is the compound currently used in food that is legally traded in more than one country?; or, has the compound been approved for use in food in one or more country?

Permitted as food colour and natural carotene source in the EU and other countries

9. List of data available

Toxicological data

(i) Metabolic and pharmacokinetic studies Available; (ii) Short-term toxicity, long-term toxicity/carcinogenicity, reproductive toxicity, and developmental toxicity studies in animals and genotoxicity studies Available; (iii) Epidemiological and/or clinical studies and special considerations Available; (iv) Other data

Technological data

(i) Specifications for the identity and purity of the listed compounds (specifications applied during development and toxicological studies; proposed specifications for commerce) Available

(ii) Technological and nutritional considerations relating to the manufacture and use of the listed compound Available


(i) Levels of the listed compound used in food or expected to be used in food based on technological function and the range of foods in which they are used Comparable to INS 160a (i)-(iii)

(ii) Estimation of dietary intakes based on food consumption data for foods in which the compound may be used. Comparable to INS 160a (i)-(iii)



December 2015

FORM ON WHICH INFORMATION ON THE COMPOUND TO BE EVALUATED BY JECFA IS PROVIDED

Name of Compound(s): Riboflavin from Ashbya gossypii

Question(s) to be answered by JECFA

Safety assessment including establishment of an ADI and a specification

1. Proposal for inclusion submitted by: Germany

2. Name of compound; trade name(s); chemical name(s): Riboflavin; Lactoflavin; Vitamin B2; 3,10-dihydro-7,8-dimethyl-10-[(2S,3S,4R)-2,3,4,5-tetrahydroxypentyl]benzo-[g]pteridine-2,4-dione; 7,8-dimethyl-10-(1'-Dribityl)isoalloxazine

3. Names and addresses of basic producers: BASF SE, D-68623 Lampertheim, Germany

4. Has the manufacturer made a commitment to provide data? Yes

5. Identification of the manufacturer that will be providing data (Please indicate contact person): Dr. Bernd Haber Director Regulatory Affairs / Human Nutrition, BASF SE Phone: +49 621 60-28787 Fax: +49 621 60-6628787 E-Mail: [email protected]

6. Justification for use: Alternative source of riboflavin for colouring purposes and as nutrient source.

7. Food products and food categories within the GSFA in which the compound is used as a food additive or as an ingredient, including use level(s): Same categories as riboflavins INS 101(i)-(iii)

8. Is the compound currently used in food that is legally traded in more than one country? (please identify the countries); or, has the compound been approved for use in food in one or more country? (please identify the country(ies)) Permitted as food colour and vitamin B2 source in the EU, USA and other countries

CX/FA 15/47/16 Add.1 21


Toxicological data

(i) Metabolic and pharmacokinetic studies Available ; (ii) Short-term toxicity, long-term toxicity/carcinogenicity, reproductive toxicity, and developmental toxicity studies in animals and genotoxicity studies Available; (iii) Epidemiological and/or clinical studies and special considerations Available; (iv) Other data

Technological data

(i) Specifications for the identity and purity of the listed compounds (specifications applied during development and toxicological studies; proposed specifications for commerce) Available

(ii) Technological and nutritional considerations relating to the manufacture and use of the listed compound Available


(i) Levels of the listed compound used in food or expected to be used in food based on technological function and the range of foods in which they are used Comparable to: INS 101 (i)-(iii)

(ii) Estimation of dietary intakes based on food consumption data for foods in which the compound may be used. Comparable to INS 101 (i)-(iii)



December 2015

INTERNATIONAL SPECIAL DIETARY FOODS INDUSTRIES (ISDI)

In January 2015, ISDI provided the information to CCFA on a number of dossiers, including Gellan gum. Unfortunately, the document (see attachment – page 37 – number 2), contains a typo: the IUPAC name is listed as “Gelatin” instead of Gellan Gum.

INFORMATION ON GELLAN GUM (INS 418) REQUESTED FOR JECFA EVALUATION FOR USE IN INFANT FORMULA AND FORMULAE FOR SPECIAL MEDICAL PURPOSES INTENDED FOR INFANTS


International Special Dietary Foods Industries (ISDI)


Gellan Gum; trade name is Keltrol ®,Kelcogel®; IUPAC Name is Gellan Gum, INS No. 418; CAS#: 71010-52-1; E275-117-5


Abbott Nutrition 625 Cleveland Avenue Columbus OH 43215, USA


Yes.


Brinda Mahadevan, Ph.D Manager, Regulatory Affairs Abbott Nutrition 3300 Stelzer Road Columbus OH 43219, USA Phone: 614-624-3089, Fax: 614-727-6245 E-mail: [email protected]


Gellan gum acts as a stabilizer in ready-to-feed infant formula, or concentrated liquid products to improve physical stability through mechanisms such as maintaining homogeneity or minimizing

CX/FA 15/47/16 Add.1 22

ingredient sedimentation. Gellan gum helps to keep minerals such as calcium and phosphorus in suspension and prevents physical separation of the product.

7. Food products and food categories within the GSFA in which the substance is used as a food additive or as an ingredient, including use level(s):

Proposed for use as a stabilizer up to 100 mg/kg, as consumed, in food category 13.1 infant formulae, follow-on formulae and formulae for special medical purposes for infants

8. Is the substance currently used in food that is legally traded in more than one country?

Gellan gum is an approved food additive in the US. It’s an approved additive for specific categories in Canada and is recognized by EU and Codex in other categories.


Toxicological data

√ (i) Metabolic and pharmacokinetic studies

√ (ii) Short-term toxicity

√ (iii) Epidemiological and/or clinical studies and special considerations

√ (iv) Other data

Technological data

√ (i) Specifications for the identity and purity of the listed compounds (specifications applied during development and toxicological studies; proposed specifications for commerce)

√ (ii) Technological and nutritional considerations relating to the manufacture and use of the listed compound


√ (i) Levels of the listed compound used in food or expected to be used in food based on technological function and the range of foods in which they are used

√ (ii) Estimation of dietary intakes based on food consumption data for foods in which the compound may be used


11. Date on which data could be submitted to JECFA.

December 20, 2016

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