# L_2020059EN.01000601.xml

| 28.2.2020 | EN | Official Journal of the European Union | L 59/6 |
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28.2.2020

EN

Official Journal of the European Union

L 59/6

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COMMISSION REGULATION (EU) 2020/279

of 27 February 2020

amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of soybean hemicellulose (E 426)

(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) thereof,

Whereas:

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

| (2) | That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council (2), either on the initiative of the Commission or following an application. |
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(2)

That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council (2), either on the initiative of the Commission or following an application.

| (3) | Pursuant to Annex II to Regulation (EC) No 1333/2008, soybean hemicellulose (E 426) is currently authorised for use as a food additive in a wide variety of foods at maximum levels ranging between 1 500 and 30 000 mg/kg. |
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(3)

Pursuant to Annex II to Regulation (EC) No 1333/2008, soybean hemicellulose (E 426) is currently authorised for use as a food additive in a wide variety of foods at maximum levels ranging between 1 500 and 30 000 mg/kg.

| (4) | On 16 August 2017, an application was submitted for the extension of use of soybean hemicellulose (E 426) as a stabiliser in flavoured fermented milk products and flavoured drinks. The application was subsequently made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. |
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(4)

On 16 August 2017, an application was submitted for the extension of use of soybean hemicellulose (E 426) as a stabiliser in flavoured fermented milk products and flavoured drinks. The application was subsequently made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.

| (5) | Soybean hemicellulose (E 426), when used as a stabiliser in flavoured fermented milk products and flavoured drinks, prevents an agglomeration and precipitation of proteins and phase separation under acidic conditions. |
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(5)

Soybean hemicellulose (E 426), when used as a stabiliser in flavoured fermented milk products and flavoured drinks, prevents an agglomeration and precipitation of proteins and phase separation under acidic conditions.

| (6) | Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission has to seek the opinion of the European Food Safety Authority (‘the Authority’) in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where the update in question is not liable to have an effect on human health. |
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(6)

Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission has to seek the opinion of the European Food Safety Authority (‘the Authority’) in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where the update in question is not liable to have an effect on human health.

| (7) | On 14 March 2017, the Authority published a scientific opinion re-evaluating the safety of soybean hemicellulose (E 426) as a food additive (3). The Authority concluded that it is very unlikely that there is a safety concern from the current use of soybean hemicellulose (E 426) as a food additive, and that there is no need for a numerical acceptable daily intake (ADI). Such conclusion is used for substances of a very low safety concern and only if there is reliable information for both exposure and toxicity and there is a low probability of adverse health effects in humans at doses that do not induce nutritional imbalance in animals (4). |
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(7)

On 14 March 2017, the Authority published a scientific opinion re-evaluating the safety of soybean hemicellulose (E 426) as a food additive (3). The Authority concluded that it is very unlikely that there is a safety concern from the current use of soybean hemicellulose (E 426) as a food additive, and that there is no need for a numerical acceptable daily intake (ADI). Such conclusion is used for substances of a very low safety concern and only if there is reliable information for both exposure and toxicity and there is a low probability of adverse health effects in humans at doses that do not induce nutritional imbalance in animals (4).

| (8) | Part C of Annex II to Regulation (EC) No 1333/2008 defines all groups of additives. In general, Group I of Part C lists food additives, except for colours and sweeteners, for which there is no need for a numerical acceptable daily intake and which are authorised for use in many foods in accordance with quantum satis principle as defined in Article 3(2)(h) of that Regulation. |
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(8)

Part C of Annex II to Regulation (EC) No 1333/2008 defines all groups of additives. In general, Group I of Part C lists food additives, except for colours and sweeteners, for which there is no need for a numerical acceptable daily intake and which are authorised for use in many foods in accordance with quantum satis principle as defined in Article 3(2)(h) of that Regulation.

| (9) | The outcome of the safety assessment of soybean hemicellulose (E 426) allows its inclusion in Group I of Part C of Annex II to Regulation (EC) No 1333/2008. Since in accordance with Part E of Annex II to Regulation (EC) No 1333/2008 the use of Group I additives is already permitted in flavoured fermented milk products and flavoured drinks, the inclusion of soybean hemicellulose (E 426) in Group I would address the requested extension of use. The inclusion of soybean hemicellulose (E 426) in Group I would also make redundant the existing entries for soybean hemicellulose (E 426) in Part E of Annex II to Regulation (EC) No 1333/2008 since the use of Group I additives is permitted in all the concerned food categories, and they should be therefore deleted. Similarly, the existing reference to the maximum level of soybean hemicellulose (E 426) in the introduction part for food category 17 (Food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (5)) in Part E of Annex II to Regulation (EC) No 1333/2008 should be deleted, since within Group I soybean hemicellulose (E 426) is to be authorised in accordance with the quantum satis principle. |
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(9)

The outcome of the safety assessment of soybean hemicellulose (E 426) allows its inclusion in Group I of Part C of Annex II to Regulation (EC) No 1333/2008. Since in accordance with Part E of Annex II to Regulation (EC) No 1333/2008 the use of Group I additives is already permitted in flavoured fermented milk products and flavoured drinks, the inclusion of soybean hemicellulose (E 426) in Group I would address the requested extension of use. The inclusion of soybean hemicellulose (E 426) in Group I would also make redundant the existing entries for soybean hemicellulose (E 426) in Part E of Annex II to Regulation (EC) No 1333/2008 since the use of Group I additives is permitted in all the concerned food categories, and they should be therefore deleted. Similarly, the existing reference to the maximum level of soybean hemicellulose (E 426) in the introduction part for food category 17 (Food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (5)) in Part E of Annex II to Regulation (EC) No 1333/2008 should be deleted, since within Group I soybean hemicellulose (E 426) is to be authorised in accordance with the quantum satis principle.

| (10) | Annex II to Regulation (EC) No 1333/2008 should therefore be amended accordingly. |
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(10)

Annex II to Regulation (EC) No 1333/2008 should therefore be amended accordingly.

| (11) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(11)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation.

Article 2

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, 27 February 2020.

For the Commission

The President

Ursula VON DER LEYEN

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

1

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

2

(3)  
  EFSA Journal 2017;15(3):4721.

3

EFSA Journal

(4)  
  EFSA Journal 2014;12(6):3697, Statement on a conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EU) No 257/2010.

4

EFSA Journal

(5)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).

5

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ANNEX

Annex II to Regulation (EC) No 1333/2008 is amended as follows:

| (1) | in Part C, Group I, the entry for E 426 is inserted after the entry for E 425:







  ‘E 426 | Soybean hemicellulose | quantum satis’ |
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(1)

in Part C, Group I, the entry for E 426 is inserted after the entry for E 425:

‘E 426

Soybean hemicellulose

quantum satis’

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






  (a) | The entries for E 426 (Soybean hemicellulose) in categories 04.2.6 (Processed potato products), 05.2 (Other confectionery including breath freshening microsweets), 05.4 (Decorations, coatings and fillings, except fruit-based fillings covered by category 4.2.4), 06.5 (Noodles), 06.7 (Pre-cooked or processed cereals), 07.2 (Fine bakery wares), 10.2 (Processed eggs and egg products), 12.6 (Sauces), 14.1.4 (Flavoured drinks), 17.1 (Food supplements supplied in a solid form, excluding food supplements for infants and young children) and 17.2 (Food supplements supplied in a liquid form, excluding food supplements for infants and young children) are deleted. |
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(2)

part E is amended as follows:

(a)

The entries for E 426 (Soybean hemicellulose) in categories 04.2.6 (Processed potato products), 05.2 (Other confectionery including breath freshening microsweets), 05.4 (Decorations, coatings and fillings, except fruit-based fillings covered by category 4.2.4), 06.5 (Noodles), 06.7 (Pre-cooked or processed cereals), 07.2 (Fine bakery wares), 10.2 (Processed eggs and egg products), 12.6 (Sauces), 14.1.4 (Flavoured drinks), 17.1 (Food supplements supplied in a solid form, excluding food supplements for infants and young children) and 17.2 (Food supplements supplied in a liquid form, excluding food supplements for infants and young children) are deleted.

| (b) | The introductory part of entry for food category 17. ‘Food supplements as defined in Directive 2002/46/EC’ is replaced as follows:






  ‘17. | Food supplements as defined in Directive 2002/46/EC |
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| | INTRODUCTION PART, APPLIES TO ALL SUBCATEGORIES |
| | The maximum levels of use indicated for colours, polyols, sweeteners, and E 200-213, E 338-452, E 405, E 416, E 432-436, E 459, E 468, E 473-475, E 491-495, E 551-553, E 901-904, E 961, E 1201-1204, E 1505 and E 1521 refer to the food supplements ready for consumption prepared following the instructions of use provided by the manufacturer.
  The dilution factor for those food supplements that have to be diluted or dissolved has to be communicated together with the instructions of use.’ |

(b)

The introductory part of entry for food category 17. ‘Food supplements as defined in Directive 2002/46/EC’ is replaced as follows:

‘17.

Food supplements as defined in Directive 2002/46/EC

INTRODUCTION PART, APPLIES TO ALL SUBCATEGORIES

The maximum levels of use indicated for colours, polyols, sweeteners, and E 200-213, E 338-452, E 405, E 416, E 432-436, E 459, E 468, E 473-475, E 491-495, E 551-553, E 901-904, E 961, E 1201-1204, E 1505 and E 1521 refer to the food supplements ready for consumption prepared following the instructions of use provided by the manufacturer.

The dilution factor for those food supplements that have to be diluted or dissolved has to be communicated together with the instructions of use.’

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