Lacto-N-tetraose is an oligosacharide naturally present in human breast milk. The new food, lacto-N-tetraose (LNT), is obtained by microbial fermentation with the genetically modified strain of Escherichia coli K12 DH1. Microbial source LMT is authorized in a large number of food categories (see the Regulations).
The authorization is based on exclusive data provided by the applicant, the essentiality of which the Authority (EFSA) has recognized to demonstrate security. This provides the applicant with data protection for a period of five years from the date of entry into force of this Regulation. In addition, the placing on the market in the LNT Union should therefore be reserved for the sole applicant during this period for lacto-N-tetraose as characterized in the application.
For the use of lacto-N-tetraose in food supplements, the labeling of food supplements containing lacto-N-tetraose should mention that the supplements should not be used if other foodstuffs with the addition of lacto-N -tetraose are consumed the same day.
For more information, you can consult the COMMISSION IMPLEMENTING REGULATION (EU) 2020/484 of 2 April 2020 on this subject.
Orchidali can help you in the preparation and writing of regulatory files.
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Authorization of placing lacto-n-tetraose as a novel food on the European market
Lacto-N-tetraose is an oligosacharide naturally present in human breast milk. The new food, lacto-N-tetraose (LNT), is obtained by microbial fermentation with the genetically modified strain of Escherichia coli K12 DH1. Microbial source LMT is authorized in a large number of food categories (see the Regulations).
The authorization is based on exclusive data provided by the applicant, the essentiality of which the Authority (EFSA) has recognized to demonstrate security. This provides the applicant with data protection for a period of five years from the date of entry into force of this Regulation. In addition, the placing on the market in the LNT Union should therefore be reserved for the sole applicant during this period for lacto-N-tetraose as characterized in the application.
For the use of lacto-N-tetraose in food supplements, the labeling of food supplements containing lacto-N-tetraose should mention that the supplements should not be used if other foodstuffs with the addition of lacto-N -tetraose are consumed the same day.
For more information, you can consult the COMMISSION IMPLEMENTING REGULATION (EU) 2020/484 of 2 April 2020 on this subject.
Orchidali can help you in the preparation and writing of regulatory files.
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