Codex Alimentarius Commission

FOOD AND AGRICULTURE WORLD ORGANISATION HEALTH OF THE UNITED NATIONS ORGANISATION

JOINT OFFICE: Viale delle Terme di Caracalla 00153 ROME Tel: (+39) 06 57051 Fax: (+39) 06 5705 4593 Email: codex@fao.org - www.codexalimentarius.net

43rd SESSION OF THE CODEX COMMITTEE ON

FOOD ADDITIVES,

14-18 MARCH 2011, XIAMEN, CHINA

INDIA’S COMMENTS

AGENDA ITEMS 4(a), 4 (b), 5(a), 5(b), 5(c), 5(d), 5(e), 5(g), 5(h), 6,

7, 9(b) AND 10

1. AGENDA ITEM 4(a) : ENDORSEMENT AND/OR REVISION OF MAXIMUM

LEVELS FOR FOOD ADDITIVES AND PROCESSING AIDS IN CODEX STANDARDS (CX/FA 11/43/4) i. Proposed draft Codex Standard for Desiccated Coconut (revision of CODEX

STAN 177-1991) : Comment: Under item 4.2, we support Option 1.

Rationale: The additives provision shall be enlisted under General Standards for Food Additives (GSFA).

2. AGENDA ITEM 4 (b): DISCUSSION PAPER ON FOOD ADDITIVE PROVISIONS IN

THE STANDARD FOR INFANT FORMULAS AND FORMULA FOR SPECIAL

MEDICAL PURPOSES (CODEX STAN 72-1981) (CX/FA 11/43/5)

i. We support the Recommendations in Paragraphs 26 – 28. ii. Annex II: Request for additional food additives for use in formula for

specific medical purposes (Section B) (from TABLE 2: ALINORM 07/30/26-Rev., APPENDIX III) Comment: We support the additive provisions for sodium alginate, carob bean gum, guar gum, xanthan gum, pectins, gum arabic, sodium carboxy methyl cellulose – as thickeners that helps retain homogeneity. Rationale: FSMP formulations may lack the natural emulsification properties of whole protein, which provides stability and integrity to the reconstituted formula. Emulsifiers, stabilizers etc. are therefore a technological requirement for these formulas to ensure both palatability and prevention of separation of the formula after reconstitution. E.g. Guar gum is known to minimise and delay physical separation of the

product, fat separation and fat globule coalescence. Guar gum is an excellent water binder, it does not form gel, which is an advantage in liquid products and it is cold water soluble. E.g. Carob bean gum is added to help babies that are suffering from uncomplicated regurgitation, reflux or vomiting. Carob bean gum is an ingredient that helps this group of infants by nutritional management. It thickens the formula (in the stomach) so that it is more difficult to flow back.

3. AGENDA ITEM 5 (a): DRAFT AND PROPOSED DRAFT FOOD ADDITIVE PROVISIONS OF THE GSFA (CX/FA 11/43/7)

PART I – Colour Additives

Paragraph 11 – Caramel IV Recommendation 2

i. Comment: Under Cat 1.1.2 Dairy-based drinks, flavoured and/or

fermented (e.g., chocolate milk, cocoa, eggnog, drinking yoghurt, whey-based drinks) - we propose deletion of Note 52 from column on comments. Rationale: Ideally, due to the presence of cocoa ingredients in chocolate milk like cocoa powder or chocolate, addition of colour is normally should not be required. However colour variations in cocoa powder is a common and normal phenomenon. Such a caramel addition is minimal and self limiting in this case. In India usage of caramel colours in such products is permitted. We also highlight precedence of allowance: viz. Category 1.7 is a similar dairy based desserts category which covers products such as chocolate yoghurts, chocolate puddings. This category does not exempt caramel usage in chocolate products. We recommend that Category 1.1.2 should also allow the usage of caramel in chocolate based dairy products hence propose deletion of Note 52.

ii. Comment: Under Cat 6.3 Breakfast Cereals, including rolled oats - we propose deletion of Note AA from column on comments. Rationale: Usage of the term rolled oats under the breakfast cereals does not connote commodity but a value added product from oats,

that may be flavoured, contain inclusions such as syrups and coloured for better consumer appeal and colour consistency. We recommend that colour usage should be allowed in this category, hence propose deletion of Note AA.

iii. Comment: We support the caramel levels suggested by the eWG under categories 14.1.2.2, 14.1.2.4, 14.1.3.2 and 14.1.3.4 Rationale: Usage of caramel is permitted under local regulations in India at GMP level. Any level lesser than 5% of usage of caramel will not serve the purpose of addition as colorant.

PART II – Miscellaneous

Paragraph 26 – Sorbates Recommendation 1:

i. Comment: Under Cat 1.1.2 Dairy-based drinks, flavoured and/or fermented (e.g., chocolate milk, cocoa, eggnog, drinking yoghurt, whey-based drinks) - we propose max level of 500 ppm based on the

technological need. Rationale: While the antimycotic property of sorbates is wellknown, it is now known to also inhibit bacteria. Since most of the products under dairy based drinks category have less acidic value (>pH 6.0), it would require higher level than normally used in acidic products (pH <4.5) for desired efficacy. The proposed concentrations do not alter the taste or odour of the products.

Recommendation 3: ii. Co

mment: Food categories 01.6.1 (Unripened cheese), 01.6.2 (Ripened cheese) and 01.6.4 (Processed cheese): We support the proposal to allow use of sorbates at 3000 mg/kg in these products Rationale: It is required for preventing spoilage of these products due to mold growth.

iii. Co

mment: Food category 01.7 (Dairy – based desserts (e.g. pudding, fruit or flavoured yoghurt)) As per the CODEX STAN 243 on Fermented Milks, preservatives are permitted for use only in

flavoured fermented milks heat treated after fermentation. This should be appropriately indicated in the provision.

iv. Comment: We support the levels proposed under food categories 04.1.2.8 / 04.1.2.9 / 5.2 / 14.1.4.1 /14.1.4.2 / 14.1.4.3 and 14.1.4.5 as preservative. Rationale: The proposed levels are required to achieve effective preservation of these product categories

Hydroxybenzoates, para (Preservative) Recommendation 1: Proposed adoption of draft food additive provisions at Step 6

v. Co

mment: Food category 01.7 (Dairy – based desserts (e.g. pudding,

fruit or flavoured yoghurt)) As per the CODEX STAN 243 on Fermented Milks, preservatives are permitted for use only in flavoured fermented milks heat treated after fermentation. This should be appropriately indicated in the provision

Nisin ( Preservative) Recommendation 3: Proposed further discussion on draft food additive provisions at Step 6

vi. Co

mment: Food category 01.6.4 (Processed cheese): We support the proposal to allow use of nisin but the proposed level (250 mg/kg) is too high. A level of 12.5 ppm would be adequate for the desired preservative effect.

Phosphates (Acidity regulator, sequesterant, emulsifier, texturizing agent, stabilizer and moisture retention agent) Recommendation 3: Proposed further discussion on draft food additive provisions at Step 6

vii. Comment: Food category 01.1.1 (Milk and buttermilk (plain)): We propose that phosphates should be allowed for use only in sterilized and UHT-treated milks, where these would be useful in improving the heat stability of milk to be sterilized and UHT treated, and in heat treated buttermilk to safeguard against precipitation of milk protein. This should be appropriately indicated in the provision.

4. AGENDA ITEM 5 (b): PROPOSED DRAFT FOOD ADDITIVE PROVISIONS (NEW AND REVISED) OF THE GSFA (CX/FA 11/43/8)

Appendix 1: Circulated for comments at Step 3 i. Comments: We propose to discontinue the provision of addition of steviol

glycosides under categories 01.1 / 01.2 / 01.2.1 Rationale: There is no technological necessity for usage of sweeteners in any form in these categories. Some of these in category 01.1, and all in 01.2 and 01.2.1, are plain and under the relevant commodity standards, sweeteners are not permitted for these categories.

ii. Comments: We support the provision for addition of steviol glycosides under categories 01.1.2 / 1.7 / 14.1.4/ 14.1.5 and 15.0 Rationale: Usage of other sweeteners is permitted under these categories.

Appendix 2: Discussion at 43rd CCFA iii. Comments: We propose to discontinue the provision of addition of steviol

glycosides under food category 01.2.2 Renneted milk (plain) Rationale: There is no technological justification for use of sweeteners in

plain renneted milks. We propose to discontinue further consideration of the proposal.

iv. Comments: We support the provision for addition of steviol glycosides under food category 14.1.2

Rationale: Usage of other sweeteners is required and permitted under this category. Appendix 3: eWG recommends discontinue work Sulfites v. Comments: We propose that committee continues work and finalizes the

provisions of sulphites especially under food categories 04.1.2.6 - Fruit-based spreads (e.g., chutney) excluding products of food category 04.1.2.5 and 04.1.2.8 - Fruit preparations, including pulp, purees, fruit toppings and coconut milk – We propose level of 1000 ppm under category 04.1.2.8. Rationale: Sulphur dioxide is used in India by small scale manufacturers involved for producing chemically preserved fruit pulp or industry

intermediate fruit extracts. These are small scale manufacturers and do not have highly capital intensive heat processing and packaging facilities. Most of the industry intermediates are subjected to desulphitation process; hence the level of sulphite in the final product is at trace levels.

Erythrosine

vi. Comments: It has been proposed to discontinue the proposal to allow use of erythrosine at a level of 300 mg/kg in food categories 01.1.2 (Dairy-based drinks, flavoured and/or fermented, e.g. chocolate milk, cocoa, eggnog, drinking yoghurt, whey-based drinks) and 01.7 (Dairy-based desserts, e.g. pudding, fruit or flavoured yoghurt) as the ADI is being exceeded. We propose that committee continues the work and finalise the provisions of erythrosine for food categories 01.1.2 / 01.7 / 4.2.2.3 / 6.8.1 / 12.2. It may be appropriate to consider the provision to allow its use in these food categories with a reduced maximum use level, such as 100 mg/kg in 01.1.2 and 01.7. Rationale: Erythrosine is a commonly used colour, is allowed for use in India at this level in categories 01.1.2 and 01.7, and is adequate for the desired technological need.

5. AGENDA ITEM 5(C): COMMENTS AND INFORMATION ON SEVERAL FOOD

ADDITIVES (CX/FA 11/43/9; CL 2010/7-FA AND CL 2010/39-FA) Comments on CL 2010/7-FA (Part B: Request for Comments and Information) are reproduced below: i. Point 11. Comments at Step 3 for provisions for lycopenes (INS

160d(i)(ii)(iii)) and sodium hydrogen sulfate (INS 514) in Table 3 of the

GSFA (ALINORM 10/33/12, paras 36 and 39)

It has been proposed to include lycopene and sodium hydrogen sulfate in the Table 3 of the GSFA as the JECFA has indicated the ADI as „Not Specified’ for these food additives. The proposal is acceptable.

ii. Point 12. Proposals on uses and use levels for lycopenes (INS 160d(i)(ii)(iii)) and sodium hydrogen sulfate (INS 514) for food categories listed in the Annex to Table 3 (ALINORM 10/33/12, paras 36 and 39)

We do not have any proposal on use and use levels for lycopenes and sodium hydrogen sulfate for food categories listed in Annex to Table 3.

iii. Point 13. Use and use levels of sucrose oligoesters (SOE) type I and type II

(INS 473a) (ALINORM 10/33/12, para. 40)

We do not have any proposal on use and use levels for sucrose oligoesters.

iv. Point 14. Specific additional information on several food additives

(ALINORM 10/33/12, paras 58, 60, 63 and Appendix VI).

Our comments on the dairy related draft provisions are as follows

Caramel III – Ammonia Process (INS 150c): The draft proposal at step 3 is

to allow its use in food categories 01.6.1 Unripened cheese, 01.6.2 Ripened

cheese and 01.6.4 Processed cheese at a maximum level of 50,000 mg/kg

each, for which information on their use including the cheeses which employ

the additive and use levels has been sought.

Use of Caramel III – Ammonia Process (INS 150c) is not permitted in Indian food laws in the above products.

Nisin: The draft proposal at Step 3 is to allow its use in food category 01.6.1

Unripened cheese at a maximum level of 500 mg/kg, for which information

on their use including the cheeses which employ the additive and use levels

has been sought.

Use of nisin is allowed in cheeses, processed cheese, processed cheese spread and paneer at maximum 12.5 mg/kg each in the Indian food laws.

6. AGENDA ITEM 5 (d): PROVISIONS FOR ALUMINIUM CONTAINING FOOD

ADDITIVES (CX/FA 11/43/10; CL 2009/10-FA) It has been indicated in the compilation that calcium aluminium silicate (INS 556) is allowed for use in India in food categories 01.6.1 (Unripened cheese) and 01.6.2.1 (Ripened cheese, includes rind), which is not correct. In relation to the dairy products, the only aluminium containing food additive, from amongst those listed in the Circular Letter CL 2009/10-FA, allowed under the Indian food law is aluminium silicate in cheese/sliced/cut/shredded cheese, which includes both above food categories (ripened and unripened cheese), at a level of 10,000 mg/kg on whole aluminium silicate basis. i. Comment: This needs to be corrected in the compilation. Sodium aluminium silicate ii. Comment: We propose that level of 5000 ppm under food category 14.1.4.3,

and would urge committee to finalize this level. Rationale: This level is required for technological purpose. This is the only anticaking agent permitted in India under this category.

7. AGENDA ITEM 5 (e): Proposed draft revision of the food category system

(food categories 5.1, 5.2 and 5.4) (N07-2010) (CX/FA 11/43/11)

Comment: Under the category 5.2, after the text ending with “Includes all types of products that primarily contain sugar and their dietetic counterparts manufactured with nutritive or non-nutritive high-intensity sweeteners.……..........….. hard candy (05.2.1), soft candy (05.2.2), and nougats

and marzipans (05.2.3)”, we propose to add “ include cereal or nut based bar, Nutribar , chikki and ghazak” Rationale: Such products are commonly made in Northern and Western parts of India. Chikki and ghazak are very famous and popular products made from sugar and/or jaggery with puffed cereals, nuts, honey and other nutritive sweeteners. E.g. groundnut chikki, puffed rice chikki, jaggery ghazak. The more commercial versions are also available in markets now as Cereal bars, Nutribars with cereals, sugars, nuts and other healthy ingredients.

8. AGENDA ITEM 5 (g): DISCUSSION PAPER ON USE OF NOTE 161 (CX/FA

11/43/13) It has been indicated that the eWG did not reach consensus on the proposal „criteria and conditions on use of Note 161‟. We reiterate our previous stand that Note 161 should be used sparingly and only in

such cases when there are differences in the views of the members with respect to the suitability of specific food additive(s), of a technologically approved food additive class, in a particular food. However, once the proposed use of specific food additive(s) is accepted in principle and the differences in views only pertain to the use levels, the highest level proposed should be allowed for use, provided the same would not result in the ADI being exceeded, without resorting to the use of the note 161. If a proposal is not consistent with the guidance in the Section 3.2 of the Preamble, the food additive provision should not be considered.

9. AGENDA ITEM 5 (h): DISCUSSION PAPER ON THE REVISION OF SECTION 4 “CARRY-OVER PRINCIPLE OF FOOD ADDITIVES INTO FOOD” OF THE

PREAMBLE OF THE GSFA (CX/FA 11/43/14) Paragraph 25 includes 4 recommendations made by the EWG. Our comments on the same are provided below: i. Recommendation I: in the Annex I, third Column provides the

recommendations of the eWG to amend the Section 4. The recommendations are generally acceptable with following proposals:

Section 4.1: First, the proposed text in the square brackets in the title is acceptable and it is proposed to remove the square brackets. Second, in respect of the proposed text in square brackets in Points a. – c., the following text would be more appropriate and clear: “and/or applicable Commodity Standard”.

Section 4.2: The proposed amendments indicated through square bracketed text are acceptable in principle. However, the phrase “is not exceeded” may be deleted from the text in square brackets in the penultimate sentence. We support the existing text with the proposed amendments in preference to the alternative proposed text.

ii. Recommendations II-IV: These recommendations are acceptable.

10. AGENDA ITEM 6: Proposed draft revision of the Codex Standard for

Food Grade Salt (CODEX STAN 150-1985) (N08-2010) (CX/FA 11/43/15)

Comment: We support the proposal for Codex Standard for Food Grade Salt with respect to proposed level of contaminants.

11. AGENDA ITEM 7: PROPOSALS FOR CHANGES AND/OR ADDITIONS TO

THE INTERNATIONAL NUMBERING SYSTEM FOR FOOD ADDITIVES (CX/FA 11/43/16) APPENDIX I The proposals for changes and/or additions to the CAC/GL 36-1989 are generally acceptable with the following comments: i. Section 2: Table of functional classes, definitions and technological

purposes The proposed amendments are acceptable. However, for the purpose of consistency, these amendments would require following consequential changes in the definitions for the corresponding food additive classes: “5. Bleaching agent: A food additive (non-flour use) used to decolourize food. Bleaching agents do not include pigments.” “15. Flour treatment agent: A food additive, which is added to flour or dough to improve its baking quality or colour.”

ii. Section 3: International Numbering System for food additives, list in numerical order

On the comments in the first bullet, we agree that the names of the additives corresponding to INS 150c and 150d in Table 1 should also be modified for

consistency.

iii. Table 1: New INS numbers and changes in INS numbers In respect of the magnesium stearate, we support use of the number 470 (iii) as 470 (i) and 470 (ii) are already in use. Use of the alternate proposed number 470 (b) would be confusing in absence of 470 (a).

iv. Table 3: Proposals for additional technological purposes taking into account Food Chemical Codex

In respect of the proposals for additional technological purposes for silicon dioxide, amorphous (INS 551) and chlorine (INS 925), we do not support

inclusion of the functions conditioning agent and antimicrobial agent, respectively. Inclusion of these technological purposes, that are not as per the adopted INS, would create confusion and is, therefore, not acceptable.

12. AGENDA ITEM 9(b): DISCUSSION PAPER ON MECHANISMS FOR RE-

EVALUATION OF SUBTANCES BY JECFA (CX/FA 11/43/19) The discussion paper is generally acceptable. However, in Paragraph 25 that provides criteria for prioritization of food additives for JECFA evaluation, the following two criteria are too general and may need to be worked upon to make them reasonably specific, during the course of further development of the

document:

Overall indication that previous evaluation may be changed

Time since last evaluation

13. AGENDA ITEM 10: DISCUSSION PAPER ON DEVELOPMENT OF A DATABASE

ON PROCESSING AIDS (CX/FA 11/43/20) The discussion paper is generally acceptable with the following specific comments: i. Section 2.5 Option 2: It has been proposed to include „Processing aids used in

packaged water and in water used as an ingredient in other foods‟ as a new technological function categories of substances used as processing aids.

Different substances may be used in water for a variety of technological functions. Therefore, inclusion of a commodity based category in the list of technological functions would be erroneous and confusing. The proposal is, therefore, not acceptable. In case there are substances used in water for technological functions not already covered in the list of IPA technological function categories, the same may be considered for inclusion.

ii. Section 3.2 Option 1 (Codex uses): The criteria provided in the last bullet should be amended as follows for clarity:

„Meet any applicable microbiological criteria elaborated as per under CAC/GL 21 1997’

iii. Paragraphs 21 and 22: We agree that Options 3 is the preferred option (Paragraph 21), and that Option 4 need not be recommended at this time, (Paragraph 22) for developing a database of processing aids.

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