(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)

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

(3)

The Union lists in Annexes II and III to Regulation (EC) No 1333/2008 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.

(4)

An application for authorisation of the use of trimagnesium dicitrate anhydrous as a stabiliser and anti-caking agent in food supplements in solid and chewable forms was submitted on 24 June 2015 and was made available to the Member States.

(5)

Trimagnesium dicitrate anhydrous is intended for use in food supplements in solid and chewable forms for binding small amounts of residual water during processing and inside the packaging.

(6)

The European Food Safety Authority (‘the Authority’) evaluated the safety of trimagnesium dicitrate anhydrous (4) when used as an additive in food supplements in solid and chewable forms and concluded that its use in solid food supplements at the proposed typical use level of 50 000 mg/kg is of no safety concern, whereas at the proposed maximum use level of 120 000 mg/kg, the resulting dietary exposure estimate of magnesium for adults and the elderly for high percentiles would be above the tolerable upper intake level (‘UL’) of 250 mg/day for supplemental magnesium set by the Scientific Committee on Food, based on a mild, transient laxative effect which is easily reversible and to which the body can easily adapt within days. Provided that dietary exposure estimates of magnesium from the use of the food additive trimagnesium dicitrate anhydrous in the food supplement were below the UL, the Authority considered that there would not be a safety concern from the proposed typical use levels of trimagnesium dicitrate anhydrous as a stabiliser and anticaking agent in food supplements.

(7)

Following the Authority’s opinion, the applicant lowered the requested maximum use levels to 100 000 mg/kg so that the resulting exposure to magnesium in adults and the elderly at the high-level under the instructions of use provided by the manufacturer for the normal use of the food supplement would not be above the UL authorised as nutrient in food supplements.

(8)

It is, therefore, appropriate to authorise the use of trimagnesium dicitrate anhydrous as a stabiliser and anti-caking agent in solid food supplements and to assign E 345(i) as E-number to that additive.

(9)

The specifications for trimagnesium dicitrate (E 345(i)) should be included in Regulation (EU) No 231/2012 as it is included in the Union list of food additives laid down in Annex II to Regulation (EC) No 1333/2008 for the first time.

(10)

Regulations (EC) No 1333/2008 and (EU) No 231/2012 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,