(Utkast) Kommisjonens gjennomføringsforordning om godkjenning av endring av spesifikasjonene til olje fra Coriandrum sativum som en nytt næringsmiddel i henhold til europaparlaments- og rådsforordning (EU) 2015/2283, og om endring av gjennomføringsforordning (EU) 2017/2470
(Draft) Commission Implementing Regulation authorising the change of the specifications of the novel food coriander seed oil from Coriandrum sativum under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 12.2.2019
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 establishing a Union list of authorised novel foods was adopted.
(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 2014/155/EU of 19 March 2014 authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council , the placing on the market of coriander seed oil from Coriandrum sativum as a novel food ingredient to be used in food supplements.
(5) On 17 May 2018, the company Ovalie Innovation (‘the Applicant’) made a request to the Commission to change the specifications of coriander seed oil from Coriandrum sativum within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The applicant requested to decrease the lower range of the saponification value from the current 186 mg KOH/g to 179 mg KOH/g.
(6) The applicant justifies the request by indicating that the change is necessary in order to take account the variation in the saponification values in the course of the production process of the coriander oil during its refinement processing for use in food supplements.
(7) The Commission considers that a safety evaluation of the current application by the European Food Safety Authority in accordance with Article 10(3) is not necessary as the proposed decrease in saponification values of the coriander oil is limited, while the concomitant increase in unsaponifiable matter, which could be considered of relevance to the safety of the novel food, remains within the authorised limit values.
(8) The proposed change in the saponification values of coriander seed oil from Coriandrum sativum do not alter the safety considerations that supported its authorisation. Therefore, it is appropriate to amend the specifications of the novel food 'coriander seed oil from Coriandrum sativum’ at the proposed level for saponifiable value.
(9) The information provided in the application gives sufficient grounds to establish that the proposed changes to the specifications of the novel food coriander seed oil from Coriandrum sativum comply with Article 12 of Regulation (EU) 2015/2283.
(10) The Annex to Implementing Regulation (EU) 2017/2470 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
Helse- og omsorgsdepartementet