Decree No. 319 / 2010 Coll.
Decree amending Decree No. 235 / 2010 Coll., on the establishment of purity requirements and identification of additives
Valid
Order
Effective from 01.04.2011
319
DECLARATION
of 11 November 2010
amending Decree No. 235 / 2010 Coll., laying down the requirements for purity and identification of additives
According to Article 19 (1) (a) of Act No. 110 / 1997 Coll., on Food and Tobacco Products and amending and supplementing certain related laws, as amended by Act No. 306 / 2000 Coll., Act No. 146 / 2002 Coll., Act No. 316 / 2004 Coll. and Act No. 120 / 2008 Coll.:
Decree No 235 / 2010 Coll., on the determination of purity requirements and the identification of additives, is amended as follows:
1. footnote 1 shall read:
"(1) Commission Directive 2008 / 60 / EC of 17 June 2008 laying down specific purity criteria for sweeteners for use in foodstuffs. Commission Directive 2008 / 84 / EC of 27 August 2008 laying down specific purity criteria for food additives other than colours and sweeteners. Commission Directive 2008 / 128 / EC of 22 December 2008 laying down specific purity criteria concerning colours for use in foodstuffs. Commission Directive 2009 / 10 / EC of 13 February 2009 amending Commission Directive 2008 / 84 / EC laying down specific purity criteria for food additives other than colours and sweeteners. Commission Directive 2010 / 37 / EU of 17 June 2010 amending Commission Directive 2008 / 60 / EC laying down specific purity criteria for sweeteners for use in foodstuffs. '
2. In Annex 2, the following entry E 961 NEOTAM is inserted after entry E 959 NEOHESPERIDINDIHYDROCHALKON:
| „E 961 NEOTAM | |
| Synonyma | N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-fenylalanin-1-methylester 1-methyl-N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-fenylalaninát |
| Definice | Neotam se vyrábí tlakovou reakcí aspartamu, 3,3-dimethylbutanalu a vodíku v methanolu za přítomnosti katalyzátoru – palladia na uhlíku. Produkt se izoluje a čistí filtrací, při níž se může použít infuzoriová hlinka (křemelina). Po odstranění rozpouštědla destilací se neotam promyje vodou, izoluje odstředěním a nakonec suší ve vakuu. |
| CAS | 165450-17-9 |
| Chemický název | N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-fenylalanin, 1-methylester |
| Chemický vzorec | C20H30N2O5 |
| Relativní molekulová hmotnost | 378,47 |
| Obsah | nejméně 97 % vztaženo na sušinu |
| Popis | bílý až téměř bílý prášek |
| Identifikace | |
| Rozpustnost | 4,75% hmot. při 60°C ve vodě, rozpustný v ethanolu a ethylacetátu |
| Čistota | |
| Obsah vody | nejvýše 5% stanoveno metodou Karl-Fischera u vzorku o hmotnosti 25 ± 5mg |
| pH 0,5%ního vodného roztoku | 5,0 – 7,0 |
| Rozmezí bodu tání | 81 – 84°C |
| N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-fenylalanin | nejvýše 1,5% |
| Olovo | nejvýše 1 mg/kg“. |
Efficacy
This Decree shall take effect on 1 April 2011.
Minister:
Doc. MUDr. Heger, CSc., v. r.
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Regulation Information
| Citation | Decree No. 319 / 2010 Coll., amending Decree No. 235 / 2010 Coll., on the determination of purity and identification requirements for additives |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 29.11.2010 |
|---|---|
| Effective from | 01.04.2011 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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