# L_2013230EN.01000701.xml

| 29.8.2013 | EN | Official Journal of the European Union | L 230/7 |
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29.8.2013

EN

Official Journal of the European Union

L 230/7

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COMMISSION REGULATION (EU) No 817/2013

of 28 August 2013

amending Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards Octenyl succinic acid modified gum arabic

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Article 10(3), Article 14 and Article 30(5) thereof,

Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (2), and in particular Article 7(5) thereof,

Whereas:

| (1) | Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use. |
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(1)

Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use.

| (2) | Annex III to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food additives, food enzymes, flavourings, nutrients and their conditions of use. |
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(2)

Annex III to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food additives, food enzymes, flavourings, nutrients and their conditions of use.

| (3) | Commission Regulation (EU) No 231/2012 (3) lays down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008. |
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(3)

Commission Regulation (EU) No 231/2012 (3) lays down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008.

| (4) | Those lists and the specifications may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 either on the initiative of the Commission or following an application. |
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(4)

Those lists and the specifications may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 either on the initiative of the Commission or following an application.

| (5) | An application for authorisation of the use of Octenyl succinic acid modified gum arabic as an emulsifier in certain food categories and in flavourings was submitted on 12 November 2007 and has been made available to the Member States. |
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(5)

An application for authorisation of the use of Octenyl succinic acid modified gum arabic as an emulsifier in certain food categories and in flavourings was submitted on 12 November 2007 and has been made available to the Member States.

| (6) | The European Food Safety Authority evaluated the safety of octenyl succinic acid modified gum arabic, as emulsifier to be added to flavourings and certain other foodstuffs and expressed its opinion on 11 March 2010 (4). The Authority concluded that, based on the results of the available studies, the information on gum acacia itself and on other Octenyl succinic acid modified starches, the use of octenyl succinic acid modified gum arabic as an emulsifier in foods at the proposed uses and use levels is not of a safety concern. |
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(6)

The European Food Safety Authority evaluated the safety of octenyl succinic acid modified gum arabic, as emulsifier to be added to flavourings and certain other foodstuffs and expressed its opinion on 11 March 2010 (4). The Authority concluded that, based on the results of the available studies, the information on gum acacia itself and on other Octenyl succinic acid modified starches, the use of octenyl succinic acid modified gum arabic as an emulsifier in foods at the proposed uses and use levels is not of a safety concern.

| (7) | There is a technological need to use Octenyl succinic acid modified gum arabic as an emulsifier in certain foodstuffs as well as an emulsifier in flavouring-oil emulsions which are added to a variety of foodstuffs as it has improved properties compared to existing emulsifiers. It is therefore appropriate to authorise the use of octenyl succinic acid modified gum arabic in the food categories applied for and to assign number E 423 to that food additive. |
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(7)

There is a technological need to use Octenyl succinic acid modified gum arabic as an emulsifier in certain foodstuffs as well as an emulsifier in flavouring-oil emulsions which are added to a variety of foodstuffs as it has improved properties compared to existing emulsifiers. It is therefore appropriate to authorise the use of octenyl succinic acid modified gum arabic in the food categories applied for and to assign number E 423 to that food additive.

| (8) | The specifications for Octenyl succinic acid modified gum arabic should be included in Regulation (EU) No 231/2012 when it is included in the Union lists of food additives laid down in Annexes II and III to Regulation (EC) No 1333/2008 for the first time. |
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(8)

The specifications for Octenyl succinic acid modified gum arabic should be included in Regulation (EU) No 231/2012 when it is included in the Union lists of food additives laid down in Annexes II and III to Regulation (EC) No 1333/2008 for the first time.

| (9) | Regulation (EC) No 1333/2008 and Regulation (EU) No 231/2012 should therefore be amended accordingly. |
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(9)

Regulation (EC) No 1333/2008 and Regulation (EU) No 231/2012 should therefore be amended accordingly.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them, |
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(10)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes II and III to Regulation (EC) No 1333/2008 are amended in accordance with Annex I to this Regulation.

Article 2

The Annex to Regulation (EU) No 231/2012 is amended in accordance with Annex II to this Regulation.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 28 August 2013.

For the Commission

The President

José Manuel BARROSO

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(1)  
  OJ L 354, 31.12.2008, p. 16.

1

(2)  
  OJ L 354, 31.12.2008, p. 1.

2

(3)  
  OJ L 83, 22.3.2012, p. 1.

3

(4)  
  EFSA Journal 2010; 8(3):1539.

4

EFSA Journal 2010

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ANNEX I

A.

| (1) | In Part B, in Table 3 ‘Additives other than colours and sweeteners’ the following entry is inserted after the entry for food additive E 422:






  ‘E 423 | Octenyl succinic acid modified gum arabic’ |
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(1)

In Part B, in Table 3 ‘Additives other than colours and sweeteners’ the following entry is inserted after the entry for food additive E 422:

‘E 423

Octenyl succinic acid modified gum arabic’

| (2) | Part E is amended as follows:






  (a) | in category 05.4 ‘Decorations, coatings and fillings, except fruit based fillings covered by category 4.2.4’, the following entry is inserted after the entry for food additive E 416: | ‘E 423 | Octenyl succinic acid modified gum arabic | 10 000 | Only icings’ | |
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(2)

Part E is amended as follows:

(a)

in category 05.4 ‘Decorations, coatings and fillings, except fruit based fillings covered by category 4.2.4’, the following entry is inserted after the entry for food additive E 416:

‘E 423

Octenyl succinic acid modified gum arabic

10 000

Only icings’

| (b) | in category 12.6 ‘Sauces’, the following entry is inserted after the entry for food additive E 416: | ‘E 423 | Octenyl succinic acid modified gum arabic | 10 000 ’ | | |
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(b)

in category 12.6 ‘Sauces’, the following entry is inserted after the entry for food additive E 416:

‘E 423

Octenyl succinic acid modified gum arabic

10 000 ’

| (c) | in category 14.1.4 ‘Flavoured drinks’ the following entry is inserted after the entry for food additive E 405: | ‘E 423 | Octenyl succinic acid modified gum arabic | 1 000 | only in energy drinks and in drinks containing fruit juice’ | |
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(c)

in category 14.1.4 ‘Flavoured drinks’ the following entry is inserted after the entry for food additive E 405:

‘E 423

Octenyl succinic acid modified gum arabic

1 000

only in energy drinks and in drinks containing fruit juice’

B.

In Part 4 ‘Food additives including carriers in food flavourings’, the following entry is inserted after the entry for food additive E 416:

| ‘E 423 | Octenyl succinic acid modified gum arabic | Flavouring-oil emulsions used in categories 03: edible ices; 07.2: Fine bakery wares; 08.2: Processed meat, only processed poultry; 09.2: Processed fish and fishery products including mollusks and crustaceans and in category 16: Desserts excluding products covered in category 1, 3 and 4. | 500 mg/kg in the flavouring emulsion |
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| Flavouring-oil emulsions used in category 14.1.4: Flavoured drinks, only flavoured drinks not containing fruit juices and in carbonated flavoured drinks containing fruit juices and in category 14.2: Alcoholic beverages, including alcohol-free and low-alcohol counterparts | 220 mg/kg in the flavouring emulsion |
| Flavouring-oil emulsions used in categories 05.1: Cocoa and Chocolate products as covered by Directive 2000/36/EC, 05.2: Other confectionery including breath refreshening microsweets, 05.4: Decorations, coatings and fillings, except fruit based fillings covered by category 4.2.4 and in category 06.3: Breakfast cereals. | 300 mg/kg in the flavouring emulsion |
| Flavouring-oil emulsions used in category 01.7.5: Processed cheese. | 120 mg/kg in the flavouring emulsion |
| Flavouring-oil emulsions used in category 05.3: Chewing gum. | 60 mg/kg in the flavouring emulsion |
| Flavouring-oil emulsions used in category 01.8: Dairy analogues, including beverage whiteners; 04.2.5: Jam, jellies and marmalades and similar products; 04.2.5.4: Nut butters and nut spreads; 08.2: Processed meat; 12.5: Soups and broths, 14.1.5.2: Other, only instant coffee and tea and in cereal based ready-to-eat-dishes. | 240 mg/kg in the flavouring emulsion |
| Flavouring-oil emulsions used in category 10.2: Processed eggs and egg products. | 140 mg/kg in the flavouring emulsion |
| Flavouring-oil emulsions used in category 14.1.4: Flavoured drinks, only non carbonated flavoured drinks containing fruit juices; 14.1.2: Fruit juices as defined by Directive 2001/112/EC and vegetable juices, only vegetable juices and in category 12.6: Sauces, only gravies and sweet sauces. | 400 mg/kg in the flavouring emulsion |
| Flavouring-oil emulsions used in category 15: Ready-to-eat savouries and snacks. | 440 mg/kg in the flavouring emulsion’ |

‘E 423

Octenyl succinic acid modified gum arabic

Flavouring-oil emulsions used in categories 03: edible ices; 07.2: Fine bakery wares; 08.2: Processed meat, only processed poultry; 09.2: Processed fish and fishery products including mollusks and crustaceans and in category 16: Desserts excluding products covered in category 1, 3 and 4.

500 mg/kg in the flavouring emulsion

Flavouring-oil emulsions used in category 14.1.4: Flavoured drinks, only flavoured drinks not containing fruit juices and in carbonated flavoured drinks containing fruit juices and in category 14.2: Alcoholic beverages, including alcohol-free and low-alcohol counterparts

220 mg/kg in the flavouring emulsion

Flavouring-oil emulsions used in categories 05.1: Cocoa and Chocolate products as covered by Directive 2000/36/EC, 05.2: Other confectionery including breath refreshening microsweets, 05.4: Decorations, coatings and fillings, except fruit based fillings covered by category 4.2.4 and in category 06.3: Breakfast cereals.

300 mg/kg in the flavouring emulsion

Flavouring-oil emulsions used in category 01.7.5: Processed cheese.

120 mg/kg in the flavouring emulsion

Flavouring-oil emulsions used in category 05.3: Chewing gum.

60 mg/kg in the flavouring emulsion

Flavouring-oil emulsions used in category 01.8: Dairy analogues, including beverage whiteners; 04.2.5: Jam, jellies and marmalades and similar products; 04.2.5.4: Nut butters and nut spreads; 08.2: Processed meat; 12.5: Soups and broths, 14.1.5.2: Other, only instant coffee and tea and in cereal based ready-to-eat-dishes.

240 mg/kg in the flavouring emulsion

Flavouring-oil emulsions used in category 10.2: Processed eggs and egg products.

140 mg/kg in the flavouring emulsion

Flavouring-oil emulsions used in category 14.1.4: Flavoured drinks, only non carbonated flavoured drinks containing fruit juices; 14.1.2: Fruit juices as defined by Directive 2001/112/EC and vegetable juices, only vegetable juices and in category 12.6: Sauces, only gravies and sweet sauces.

400 mg/kg in the flavouring emulsion

Flavouring-oil emulsions used in category 15: Ready-to-eat savouries and snacks.

440 mg/kg in the flavouring emulsion’

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ANNEX II

In the Annex to Regulation (EU) No 231/2012, the following entry is inserted after the specifications for food additive E 422:

‘
  E 423 OCTENYL SUCCINIC ACID MODIFIED GUM ARABIC

| Synonyms | Gum arabic hydrogen octenylbutandioate; Gum arabic hydrogen octenylsuccinate; OSA modified gum arabic; OSA modified gum acacia |
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| Definition | Octenyl succinic acid modified gum arabic is produced by esterifying gum arabic (Acacia seyal), or gum arabic (Acacia senegal) in aqueous solution with not more than 3 % of octenyl succinic acid anhydride. It is subsequently spray dried. |
| Einecs | |
| Chemical name | |
| Chemical formula | |
| Weight Average Molecular Weight | Fraction (i): 3,105 g/mol
  Fraction (ii) 1,106 g/mol |
| Assay | |
| Description | Off-white to light tan, free flowing powder |
| Identification |
| Viscosity of a 5 % solution at 25 °C | Not more than 30 mPa.s. |
| Precipitation reaction | Forms flocculent precipitate in lead sub-acetate solution (TS) |
| Solubility | Freely soluble in water; insoluble in ethanol |
| pH for a 5 % aqueous solution | 3,5 to 6,5 |
| Purity |
| Loss on drying | Not more than 15 % (105 °C, 5 h) |
| Degree of esterification | Not more than 0,6 % |
| Total ash | Not more than 10 % (530 °C) |
| Acid-insoluble ash | Not more than 0,5 % |
| Water insoluble matter | Not more than 1,0 % |
| Test for starch or dextrine | Boil a 1 in 50 aqueous solution of the sample, add about 0,1 ml iodine TS. No bluish or reddish colour should be produced. |
| Test for tannin-bearing gums | To 10 ml of a 1 in 50 aqueous solution of the sample add about 0,1 ml ferric chloride TS. No blackish coloration or blackish precipitate should be formed. |
| Residual octenyl succinic acid | Not more than 0,3 % |
| Lead | Not more than 2 mg/kg |
| Microbiological criteria |
| Salmonella sp. | Absent in 25 g |
| Escherichia coli | Absent in 1 g’ |

Synonyms

Gum arabic hydrogen octenylbutandioate; Gum arabic hydrogen octenylsuccinate; OSA modified gum arabic; OSA modified gum acacia

Definition

Octenyl succinic acid modified gum arabic is produced by esterifying gum arabic (Acacia seyal), or gum arabic (Acacia senegal) in aqueous solution with not more than 3 % of octenyl succinic acid anhydride. It is subsequently spray dried.

Einecs

Chemical name

Chemical formula

Weight Average Molecular Weight

Fraction (i): 3,105 g/mol

Fraction (ii) 1,106 g/mol

Assay

Description

Off-white to light tan, free flowing powder

Identification

Viscosity of a 5 % solution at 25 °C

Not more than 30 mPa.s.

Precipitation reaction

Forms flocculent precipitate in lead sub-acetate solution (TS)

Solubility

Freely soluble in water; insoluble in ethanol

pH for a 5 % aqueous solution

3,5 to 6,5

Purity

Loss on drying

Not more than 15 % (105 °C, 5 h)

Degree of esterification

Not more than 0,6 %

Total ash

Not more than 10 % (530 °C)

Acid-insoluble ash

Not more than 0,5 %

Water insoluble matter

Not more than 1,0 %

Test for starch or dextrine

Boil a 1 in 50 aqueous solution of the sample, add about 0,1 ml iodine TS. No bluish or reddish colour should be produced.

Test for tannin-bearing gums

To 10 ml of a 1 in 50 aqueous solution of the sample add about 0,1 ml ferric chloride TS. No blackish coloration or blackish precipitate should be formed.

Residual octenyl succinic acid

Not more than 0,3 %

Lead

Not more than 2 mg/kg

Microbiological criteria

Salmonella sp.

Absent in 25 g

Escherichia coli

Absent in 1 g’

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