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Commission Implementing Regulation (EU) 2018/1123 of 10 August 2018 authorising the placing on the market of 1-methylnicotinamide chloride as a novel food 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)
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There are currently no known outstanding effects for the Commission Implementing Regulation (EU) 2018/1123, ANNEX.
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The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
the following last column is added in Table 1 (Authorised novel foods):
‘Data Protection’
The following entry is inserted in Table 1 (Authorised novel foods) in alphabetical order:
Authorised novel food | Conditions under which the novel food may be used | Additional specific labelling requirements | Other requirements | Data Protection | |
---|---|---|---|---|---|
‘1-Methylnicotinamide chloride | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be “1- Methylnicotinamide chloride”. Food supplements containing 1-Methylnicotinamide shall bear the following statement: This food supplement should be consumed by adults only excluding pregnant and lactating women | Authorised on 2 September 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Pharmena SA, Wolczanska 178, 90 530 Lodz, Poland. During the period of data protection the novel food 1-methylnicotinamide chloride is authorised for placing on the market within the Union only by Pharmena S.A. unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Pharmena S.A. End date of the data protection: 2 September 2023’. | |
Food Supplements as defined in Directive 2002/46/EC for the adult population excluding pregnant and lactating women | 58 mg/day |
The following entry is inserted in Table 2 (Specifications) in alphabetical order:
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