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