(Utkast) Kommisjonens gjennomføringsforordning om endring av Kommisjonens gjennomføringsforordning (EU) 2017/2470 når det gjelder bruk av lacitol som ny mat
(Draft) Commission Implementing Regulation amending Commission Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food lactitol
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 13.6.2018
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(1) Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.
(2) Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 was adopted, which establishes a Union list of authorised novel foods.
(3) Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on the updating of the Union list.
(4) Commission Implementing Decision (EU) 2017/450 authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council , the placing on the market of lactitol as a novel food to be used in capsule or tablet in food supplements intended for the adult population.
(5) On 22 March 2018, the company DuPont Nutrition Biosciences ApS made a request to the Commission to change the conditions of use of the novel food lactitol within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requested to include powder as an allowed form of lactitol to be used in food supplements.
(6) The Commission did not request an opinion from the European Food Safety Authority in accordance with Article 10(3) as the amendment of the conditions of use of the novel food lactitol by including powder, as an allowed form of lactitol to be used in food supplements is not liable to have an effect on human health.
(7) The maximum level of lactitol authorised by Implementing Decision (EU) 2017/450 as a novel food to be used in capsule or tablet in food supplements is 20 g/day. The proposed use level of the novel food lactitol in powder form in the same food category corresponds to the maximum level that is currently authorized. Therefore, it is appropriate to amend the conditions of use of lactitol to authorise its use in powder form at the existing maximum authorised level.
(8) The information provided in the application gives sufficient grounds to establish that the application for changing of the conditions of use of the novel food lactitol by including powder, as an allowed form of lactitol to be used in food supplements, comply with Article 12(2) of Regulation (EU) 2015/2283.
(9) Directive 2002/46/EC of the European Parliament and of the Council lays down requirements on food supplements. The additional form of lactitol to be used in food supplements should be authorised without prejudice to that Directive.
(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed
Helse- og omsorgsdepartementet