My bookmarksSign up free
Source

Commission Implementing Regulation (EU) 2023/1583 of 1 August 2023 amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food Lacto-N-neotetraose (microbial source) (Text with EEA relevance)

Commission Implementing Regulation (EU) 2023/1583 of 1 August 2023 amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food Lacto-N-neotetraose (microbial source) (Text with EEA relevance)

Implementing Regulation (EU) 2023/1583 · Regulation · 3 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

Open ↗

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2

Open ↗

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

Supplementary provisions

ANNEXSupplementary provisions

Open ↗

ANNEX In the Annex to Implementing Regulation (EU) 2017/2470, in Table 2 (Specifications), the entry for Lacto- N -neotetraose (microbial source) is replaced by the following: ‘ Lacto- N -neotetraose (microbial source) Definition Chemical name: β-D-Galactopyranosyl-(1→4)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyranose Chemical formula: C 26 H 45 NO 21 CAS No: 13007-32-4 Molecular weight: 707,63 g/mol Description/Source Lacto- N -neotetraose is a white to off-white powder that is produced by a microbiological process using genetically modified strain of Escherichia coli K-12, and/or of Escherichia coli BL21(DE3). An additional optional genetically modified degradation strain of Escherichia coli BL21(DE3) may be used in the production process to degrade intermediate carbohydrate by-products and remaining starting carbohydrate substrates. Purity Assay (water free): ≥ 80 % D-Lactose: ≤ 10,0 % Lacto- N -triose II: ≤ 3,0 % para -Lacto- N -neohexaose: ≤ 5,0 % Lacto- N -neotetraose fructose isomer: ≤ 1,0 % Sum of saccharides (Lacto- N -neotetraose, D-Lactose, Lacto- N -triose II, para -Lacto- N -neohexaose, Lacto- N -neotetraose fructose isomer): ≥ 92 % (% w/w dry matter) pH (20 °C, 5 % solution): 4,0-7,0 Water: ≤ 9,0 % Ash, sulphated: ≤ 1,0 % Residual solvents (methanol): ≤ 100 mg/kg Residual proteins: ≤ 0,01 % Microbiological criteria Aerobic mesophilic bacteria total count: ≤ 500 CFU/g Yeasts and moulds: ≤ 50 CFU/g Residual endotoxins: ≤ 10 EU/mg CFU: Colony Forming Units; EU: Endotoxin Units’

Other acts of the same type
Commission Implementing Regulation (EU) 2015/2295 of 9 December 2015 amending Regulation (EC) No 2074/2005 as regards lists of approved food establishments (Text with EEA relevance)Commission Regulation (EU) 2015/2285 of 8 December 2015 amending Annex II to Regulation (EC) No 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption as regards certain requirements for live bivalve molluscs, echinoderms, tunicates and marine gastropods and Annex I to Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs (Text with EEA relevance)Commission Implementing Regulation (EU) 2015/2286 of 8 December 2015 Approving non-minor amendments to the specification for a name entered in the register of traditional specialities guaranteed [Belokranjska pogača (TSG)]Commission Implementing Regulation (EU) 2015/2315 of 8 December 2015 concerning the classification of certain goods in the Combined NomenclatureCommission Implementing Regulation (EU) 2015/2316 of 8 December 2015 concerning the classification of certain goods in the Combined NomenclatureCommission Implementing Regulation (EU) 2015/2317 of 8 December 2015 concerning the classification of certain goods in the Combined NomenclatureCommission Implementing Regulation (EU) 2015/2318 of 8 December 2015 concerning the classification of certain goods in the Combined NomenclatureCommission Implementing Regulation (EU) 2015/2319 of 8 December 2015 concerning the classification of certain goods in the Combined NomenclatureCommission Implementing Regulation (EU) 2015/2320 of 8 December 2015 concerning the classification of certain goods in the Combined NomenclatureCommission Implementing Regulation (EU) 2015/2321 of 8 December 2015 concerning the classification of certain goods in the Combined NomenclatureCommission Regulation (EU) 2015/2314 of 7 December 2015 authorising a health claim made on foods, other than those referring to the reduction of disease risk and to children's development and health and amending Regulation (EU) No 432/2012 (Text with EEA relevance)Commission Regulation (EU) 2016/266 of 7 December 2015 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance)

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

Contents

What to look at next