# L_2015213EN.01000101.xml

| 12.8.2015 | EN | Official Journal of the European Union | L 213/1 |
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12.8.2015

EN

Official Journal of the European Union

L 213/1

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COMMISSION REGULATION (EU) 2015/1378

of 11 August 2015

amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of riboflavins (E 101) and carotenes (E 160a) in dried potato granules and flakes

(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),

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) | The Union list of food additives 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)

The Union list of food additives 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) | An application for authorisation of the use of certain colours in dried potato granules and flakes was submitted on 23 June 2014 and was made available to the Member States. |
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(3)

An application for authorisation of the use of certain colours in dried potato granules and flakes was submitted on 23 June 2014 and was made available to the Member States.

| (4) | Colour of dehydrated potato powder is affected in particular by a range of different colour shades of raw potatoes and oxidative reactions that occur during processing. Currently only curcumin (E 100) is authorised for use in dried potato granules and flakes to restore a visually acceptable appearance of the final product intended for consumption. Riboflavins (E 101) and carotenes (E 160a) are suitable alternatives to curcumin capable of fulfilling the same technological effect. |
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(4)

Colour of dehydrated potato powder is affected in particular by a range of different colour shades of raw potatoes and oxidative reactions that occur during processing. Currently only curcumin (E 100) is authorised for use in dried potato granules and flakes to restore a visually acceptable appearance of the final product intended for consumption. Riboflavins (E 101) and carotenes (E 160a) are suitable alternatives to curcumin capable of fulfilling the same technological effect.

| (5) | On 12 September 2013 the European Food Safety Authority (‘the Authority’) issued an opinion (3) re-evaluating the safety of riboflavins as food additives. The Authority concluded that riboflavin (E 101(i)) and riboflavin-5′-phosphate sodium (E 101(ii)) are unlikely to be of a safety concern at the currently authorised uses and use levels as food additives. In the opinion category 04.2 ‘Processed fruit and vegetables’ covering the category 04.2.6 ‘Processed potato products’ was included in the exposure assessment. Therefore, the extension of use of riboflavins (E 101) to dried potato granules and flakes should not have an impact on the estimated exposure and on the conclusions of the safety re-evaluation. |
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(5)

On 12 September 2013 the European Food Safety Authority (‘the Authority’) issued an opinion (3) re-evaluating the safety of riboflavins as food additives. The Authority concluded that riboflavin (E 101(i)) and riboflavin-5′-phosphate sodium (E 101(ii)) are unlikely to be of a safety concern at the currently authorised uses and use levels as food additives. In the opinion category 04.2 ‘Processed fruit and vegetables’ covering the category 04.2.6 ‘Processed potato products’ was included in the exposure assessment. Therefore, the extension of use of riboflavins (E 101) to dried potato granules and flakes should not have an impact on the estimated exposure and on the conclusions of the safety re-evaluation.

| (6) | On 16 February 2012, the Authority issued an opinion (4) re-evaluating the safety of carotenes as food additives and concluded that the use of (synthetic) beta-carotene and mixed beta-carotenes obtained from palm fruit oil, carrots and algae as a food colour is not of a safety concern, provided the intake from this use as a food additive and as a food supplement is not more than the amount likely to be ingested from the regular consumption of the foods in which they occur naturally (5-10 mg/day). According to the opinion the conservative exposure estimates for food additive uses were below 5-10 mg/day and processed potato products were taken into account. Therefore, the extension of use of carotenes (E 160a) to dried potato granules and flakes should not have an impact on the estimated exposure and on the conclusions of the safety re-evaluation. |
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(6)

On 16 February 2012, the Authority issued an opinion (4) re-evaluating the safety of carotenes as food additives and concluded that the use of (synthetic) beta-carotene and mixed beta-carotenes obtained from palm fruit oil, carrots and algae as a food colour is not of a safety concern, provided the intake from this use as a food additive and as a food supplement is not more than the amount likely to be ingested from the regular consumption of the foods in which they occur naturally (5-10 mg/day). According to the opinion the conservative exposure estimates for food additive uses were below 5-10 mg/day and processed potato products were taken into account. Therefore, the extension of use of carotenes (E 160a) to dried potato granules and flakes should not have an impact on the estimated exposure and on the conclusions of the safety re-evaluation.

| (7) | Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of 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 such update is not liable to have an effect on human health. Since the authorisation of the use of riboflavins and carotenes in dried potato granules and flakes constitute an update of that list which is not liable to have an effect on human health, it is not necessary to seek the opinion of the Authority. |
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(7)

Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of 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 such update is not liable to have an effect on human health. Since the authorisation of the use of riboflavins and carotenes in dried potato granules and flakes constitute an update of that list which is not liable to have an effect on human health, it is not necessary to seek the opinion of the Authority.

| (8) | Therefore, Annex II to Regulation (EC) No 1333/2008 should be amended accordingly. |
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(8)

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

| (9) | 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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(9)

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, 11 August 2015.

For the Commission

The President

Jean-Claude JUNCKER

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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 Panel on Food Additives and Nutrient Sources Added to Food, 2013. Scientific opinion on the re-evaluation of riboflavin (E 101(i)) and riboflavin-5 -phosphate sodium (E 101(ii)) as food additives, (The EFSA Journal 2013;11(10):3357).

3

The EFSA Journal 2013;11(10):3357

(4)  EFSA Panel on Food Additives and Nutrient Sources added to Food, 2012. Scientific Opinion on the re-evaluation of Mixed Carotenes (E 160a (i)) and beta-Carotene (E 160a (ii)) as a food additive, (The EFSA Journal 2012;10(3):2593).

4

The EFSA Journal 2012;10(3):2593

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ANNEX

In Part E of Annex II to Regulation (EC) No 1333/2008, in food subcategory 04.2.6 ‘Processed potato products’, the following entries are inserted after the entry for food additive E 100:

| | ‘E 101 | Riboflavins | quantum satis | | only dried potato granules and flakes |
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| | E 160a | Carotenes | quantum satis | | only dried potato granules and flakes’ |

‘E 101

Riboflavins

quantum satis

only dried potato granules and flakes

E 160a

Carotenes

quantum satis

only dried potato granules and flakes’

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