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Commission Implementing Decision of 19 March 2014 authorising the placing on the market of (6S)-5-methyltetrahydrofolic acid, glucosamine salt as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2014) 1683) (Only the Italian text is authentic) (2014/154/EU)
Consolidated text: Commission Implementing Decision of 19 March 2014 authorising the placing on the market of (6S)-5-methyltetrahydrofolic acid, glucosamine salt as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2014) 1683) (Only the Italian text is authentic) (2014/154/EU)
Commission Implementing Decision of 19 March 2014 authorising the placing on the market of (6S)-5-methyltetrahydrofolic acid, glucosamine salt as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2014) 1683) (Only the Italian text is authentic) (2014/154/EU)
Date of entry into force unknown (pending notification) or not yet in force.
17/12/2014
02014D0154 — EN — 17.12.2014 — 001.002
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
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COMMISSION IMPLEMENTING DECISION of 19 March 2014 authorising the placing on the market of (6S)-5-methyltetrahydrofolic acid, glucosamine salt as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2014) 1683) (Only the Italian text is authentic) (OJ L 085 21.3.2014, p. 10) |
Amended by:
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Official Journal |
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No |
page |
date |
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COMMISSION IMPLEMENTING DECISION 2014/916/EU of 15 December 2014 |
L 360 |
58 |
17.12.2014 |
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COMMISSION IMPLEMENTING DECISION
of 19 March 2014
authorising the placing on the market of (6S)-5-methyltetrahydrofolic acid, glucosamine salt as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
(notified under document C(2014) 1683)
(Only the Italian text is authentic)
(2014/154/EU)
Article 1
(6S)-5-methyltetrahydrofolic acid, glucosamine salt as a source of folate as specified in the Annex may be placed on the market in the Union as a novel food ingredient to be used in food supplements without prejudice to the specific provisions of Directive 2002/46/EC.
Article 2
The designation of (6S)-5-methyltetrahydrofolic acid, glucosamine salt, authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘(6S)-5-methyltetrahydrofolic acid, glucosamine salt’ or ‘5MTHF-glucosamine’.
Article 3
This Decision is addressed to Gnosis SpA, Via Lavoratori Autobianchi 1, 20832 Desio (MB), Italy.
ANNEX
SPECIFICATION OF (6S)-5-METHYLTETRAHYDROFOLIC ACID, GLUCOSAMINE SALT
Definition:
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Chemical name |
N-[4-[[[(6S)-2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl]methyl]amino]benzoyl]-L-glutamic acid, glucosamine salt |
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Chemical formula |
C32H51N9O16 |
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Molecular weight |
817,80 g/mol (anhydrous) |
Description: Creamy to light-brown powder.
Identification:
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CAS No. |
1181972-37-1 |
Purity:
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Diastereoisomeric purity |
At least 99 % of (6S)-5-methyltetrahydrofolic acid |
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Glucosamine assay |
34-46 % in dry basis |
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5-Methyltetrahydrofolic acid assay |
54-59 % in dry basis |
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Water content |
Not more than 8,0 % |
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Lead |
Not more than 2,0 ppm |
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Cadmium |
Not more than 1,0 ppm |
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Mercury |
Not more than 0,1 ppm |
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Arsenic |
Not more than 2,0 ppm |
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Boron |
Not more than 10 ppm |
Microbiological criteria:
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Total aerobic microbial count |
Not more than 100 cfu/g |
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Total combined yeast and moulds |
Not more than 100 cfu/g |
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Escherichia coli |
Absent in 10 g |