COMMI SSION IMPLEMENTING REGUL ATION (EU) 2018/1132 
of 13 August 2018 
author ising the change of the designation and specif ic labelling requirement of the novel food 
synthetic zeaxa nthin 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 EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d 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 provi des that only novel foods author ised 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) 
was adopt ed, which establishes a Union list of author ised novel foods. 
(3)  Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to submit a draf t implementing act 
author ising the placing on the Union market of a novel food and updating the Union list. 
(4)  Natural zeaxanthin is a component of the normal human diet as it is found in many fruits and green veget ables 
as well as in egg yolk. It is also currently used in food supplements as defined in Directive 2002/46/EC of the 
European Parliament and of the Council (3). 
(5)  Commission Imple menting Decision 2013/49/EU (4) author ised, in accordance with Regulation (EC) No 258/97 
of the European Parliament and of the Council (5), the placing on the market of synthetic zeaxanthin as a novel 
food ingredient in food supplements at the maximum intake of up to 2 mg per day. The designation of synthetic 
zeaxanthin author ised by Implementing Decision 2013/49/EU on the labelling of the foodstuffs containing it is 
‘synthetic zeaxanthin’. 
(6)  On 23 Febr uary 2018, the compan y DSM Nutr itional Products Europe (‘the Applicant’ ) made a request to the 
Commission to author ise the amendment of the designation and of the specifi c labelling requirements for 
synthetic zeaxanthin within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requests 
the deletion of the term ‘synthetic’ from the designation of the novel food as liste d in the Union list and from the 
labelling of foodstuffs containing it. 
(7)  The Applicant considers that the change of the designation and the labelling requirements of zeaxanthin is 
necessar y to alleviate any poten tial negative economic impact that the use of the term ‘synthetic’ on the labelling 
of food supplements containing synthetic zeaxanthin may cause due to the negat ive connotation of the term 
‘synthetic’ . The Applicant also claims that such poten tial negative economic impact is most probably not 
exper ienced by economic operat ors placing on the mark et food supplements containing author ised synthetic 
novel foods whic h do not carry the term ‘synthetic’ on their labelling. 14.8.2018 L 205/15 Official Jour nal of the European Union EN     
(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)Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the appro ximation of the laws of the Member 
States relating to food supplements (OJ L 183, 12.7.2002, p. 51). 
(4)Commission Implementing Decision 2013/49/EU of 22 Januar y 2013 author ising the placing on the market of synthetic zeaxanthin as 
a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 21, 24.1.2013, p. 32). 
(5)Regulation (EC) No 258/97 of the European Parliament and of the Council concer ning novel food and novel food ingredients (OJ L 43, 
14.2.1997, p. 1). (8)  There are a number of synthetic substances currently author ised and listed in the Union list of novel foods, of 
whic h the counte rparts from natural origin exist, and both forms are used in food supplements. However those 
synthetic substances are not designat ed as synthetic in the Union list and are not labelled as such. The change in 
the designation and labelling of synthetic zeaxanthin will ensure consiste ncy with the designation and labelling of 
those synthetic substances. 
(9)  There are no changes in the proposed uses and use levels of zeaxanthin when used as an ingredient in food 
supplements, the safety considerations that suppor ted the author isation of synthetic zeaxanthin by Implementing 
Decision 2013/49/EU remain valid and theref ore this change does not pose any safet y concer ns. Taking into 
account these legitimate factors, the proposed change s compl y with Article 12(1) of Regulation (EU) 2015/2283. 
(10)  The imp lementation of the new labelling requirement in accordance with this Implementing Regulation might 
involve chang es for the business operators who currently place synthetic zeaxanthin on the mark et. Theref ore, it 
is appropr iate to provide for a transitional period. 
(11)  Directive 2002/46/EC lays down requirements on food supplements. The change of designation and of specifi c 
labelling requirement for zeaxanthin should be author ised without prejudice to that Directive. 
(12)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
1. The entr y in the Union list of author ised novel foods as provided for in Article 8 of Regulation (EU) 2015/2283 
referring to the substance zeaxanthin shall be amended as specified in the Annex to this Regulation. 
2. The entr y in the Union list referred to in the first paragraph shall include conditions of use and the labelling 
requirements laid down in the Annex to this Regulation. 
3. The author isation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC. 
Article 2 
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation. 
Article 3 
Food supplements containing synthetic zeaxanthin and compl ying with Regulation (EU) 2015/2283 as applicable before 
the entr y into force of this Regulation may be placed on the mark et until 3 Sept ember 2019 and may remain on the 
mark et until exhaustion of stoc ks. 
Article 4 
This Regulation shall enter into force on the twentieth day followi ng 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 State s. 
Done at Brussels, 13 August 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  14.8.2018 L 205/16 Official Jour nal of the European Union EN     ANNEX 
In Table 1 (Author ised novel foods) of the Annex to Imp lementing Regulation (EU) 2017/2470 the entr y for ‘Zeaxanthin’ is replaced by the followi ng: 
Autho rised novel food Conditions under whic h the novel food may be used Additional specific labelling requirements 
‘Zeaxant hin Specified food categor y Maximum levels The designation of the novel food on the labelling of the 
foodstuffs containing it shall be “Zeaxanthin”.’ 
Food Supplements as defined in Directive 2002/46/EC 2 mg/da y   14.8.2018 L 205/17 Official Jour nal of the European Union EN