Commission Implementing Regulation (EU) 2019/456 of 20 March 2019 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 (Text with EEA relevance.)
Date: 2019-03-20
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: food inspection, food safety, food supplement, human nutrition, market approval, novel food, seed, vegetable oil








L_2019079EN.01001301.xml










21.3.2019   


EN


Official Journal of the European Union


L 79/13








            COMMISSION IMPLEMENTING REGULATION (EU) 2019/456
of 20 March 2019
         
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
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,

Whereas:







(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 (2) 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 (3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (4), 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 figure 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 of the variation in the saponification values in the course of the production process of the coriander seed 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) of Regulation (EU) 2015/2283 is not necessary as the proposed decrease in saponification values of the coriander seed 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,





HAS ADOPTED THIS REGULATION:



Article 1
The entry in the Union list of authorised novel foods, as provided for in Article 6 of Regulation (EU) 2015/2283 and included in Implementing Regulation (EU) 2017/2470, referring to the novel food coriander seed oil from Coriandrum sativum, is amended as specified in 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, 20 March 2019.


For the Commission


The President

Jean-Claude JUNCKER
            





(1)  
            OJ L 327, 11.12.2015, p. 1.

(2)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

(3)  Commission Implementing Decision 2014/155/EU of 19 March 2014 authorising the placing on the market of coriander seed oil as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 85, 21.3.2014, p. 13).

(4)  Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1).




ANNEX
The entry for ‘Coriander seed oil from Coriandrum sativum
         ’ in Table 2 (Specifications) of the Annex to Implementing Regulation (EU) 2017/2470 is replaced by the following:







Authorised Novel Food


Specifications




‘Coriander seed oil from

Coriandrum sativum





Description/Definition:

Coriander seed oil is an oil containing glycerides of fatty acids that is produced from the seeds of the coriander plant Coriandrum sativum L.
Slight yellow colour, bland taste
CAS No: 8008-52-4
Composition of fatty acids:






 


Palmitic acid (C16:0): 2-5 %










 


Stearic acid (C18:0): < 1,5 %










 


Petroselinic acid (cis-C18:1(n-12)): 60-75 %










 


Oleic acid (cis-C18:1 (n-9)): 8-15 %










 


Linoleic acid (C18:2): 12-19 %










 


α-Linolenic acid (C18:3): < 1,0 %










 


Trans fatty acids: ≤ 1,0 %





Purity:

Refractive index (20 °C): 1,466-1,474
Acid value: ≤ 2,5 mg KOH/g
Peroxide value (PV): ≤ 5,0 meq/kg
Iodine value: 88-110 units
Saponification value: 179-200 mg KOH/g
Unsaponifiable matter: ≤ 15 g/kg’