Commission Implementing Regulation (EU) 2018/1132 of 13 August 2018 authorising the change of the designation and specific labelling requirement of the novel food synthetic zeaxanthin 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.)

• CELEX: Implementing Regulation (EU) 2018/1132
• Articles: 5

Article 1

1.   The entry in the Union list of authorised 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 entry 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 authorisation 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 complying with Regulation (EU) 2015/2283 as applicable before the entry into force of this Regulation may be placed on the market until 3 September 2019 and may remain on the market until exhaustion of stocks.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

In Table 1 (Authorised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470 the entry for ‘Zeaxanthin’ is replaced by the following:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

‘ Zeaxanthin

Specified food category

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/day