Qualifications and approvals

INTERNATIONAL DEPOSIT


Our strain: Kluyveromyces marxianus fragilis B0399 dated April 1999 c/o BCCM/MUCL (Belgium Federal Office for Scientific technical and cultural affairs) deposit reference number obtained . Validity: worldwide.

USA

  • Food and Drug Administration (FDA) Approval of the feed supplement containing the strain Kluyveromyces B0399 and the label: obtained : dated Sept. 6, 2005 - Ref. DAF 02131
  • AAFCO pubblication (April 2010)
  • Handbook of Probiotics and Prebiotics, Second Edition Edited by Yuan Kun Lee and Seppo Salminen, Copyright 2009 John Wiley & Sons, Inc. (pages 129 and 591)

CANADA

Canadian Food Inspection Agency (CFIA) Approval of the viable microbial strain Kluyveromyces B0399 (Turval B0399): obtained (Apr. 19, 2004)

EUROPEAN COMMUNITY

Community approval of the additive TURVAL B0399:

  • the Italian Ministry of Health approved the additive Turval B0399 (Jun. 22, 2001
  • QPS Qualified presumption of safety - European approval (EFSA Panel on Biological Hazards (BIOHAZ, 2013 update)
  • the French Ministry of Economy gave preliminary approval (Aug. 29, 2001)
  • European Food Safety Authority (EFSA ) Brussels: Authorisation of the use of the micro-organism preparation with Kluyveromyces B0399 (Turval B0399) in the piglets : obtained - May 22, 2006 (Commission regulation)

ITALY

  • KLUYVEROMYCES B0399 (TURVAL B0399) approved as a "probiotic " by  the Italian Ministry of Health (Dec. 9, 2009)
  • Laboratori and production licence (renewal) obtained by A.S.S. n. 4 (Ministry of Health) “Medio Friuli” on Feb. 21, 2002
  • Laboratory approved by the Ministry of Research N.52796FCP
  • Production of additive  Kluyveromyces B0399: biotechnological process and quality control approved by the Ministry of Health on Jun. 20, 2001 (Executive Order 123/99) number: IT M 0001 UD
  • Approval of the probiotic with Kluyveromyces B0399 for military use (human and animal) by the Italian Ministry of Defence obtained in 1998
  • Production of premix for animal: biotechnological process and quality control approved by the Ministry of Health on Jun. 20, 2001 (Executive Order 123/99) number: IT 000137 UD
  • EUFYR (COOP Italia) supplement for humans (with ingredient Kluveromyces B0399): notification as a Probiotic Lacti Yeast at the Ministry of Health July 13, 2013
  • BIOVAL PLUS (Lab. Turval) supplement for humans (with ingredient  Kluyveromyces  B0399): first notification at the Ministry of Health on Jan. 29, 1999 and Aug. 24, 2001 (Executive Order 111/92)
  • BIOVAL COMPLEX (Parapharma) supplement for humans (with ingredient  Kluyveromyces B0399): notification at the Ministry of Health on Jan. 22, 2001 (Order 111/92)
  • BIOSYMPA (Csm) (with ingredient Kluveromyces B0399) approved as a "probiotic " by  the Italian Ministry of Health ( Dec. 9, 2009)
  • LACTIFAST (Marco Viti) supplement for humans (with ingredient Kluyveromyces B0399): notification at the Ministry of Health on Sept. 25, 2003
  • LIEVILACTIS (Parapharma) supplement for humans (with ingredient Kluyveromyces B0399): notification at the Ministry of Health on Mar. 12, 2001

GERMANY

Approval from the Chamber Authorities of Bavaria for the insertion of Kluyveromyces B0399 among the probiotics for human use on October 2000.

GB

The Veterinary Medicines Directorate approved the labelling of Turval Horse feed supplement (with Kluyveromyces B0399) on Nov. 17, 1995 and stated that no ulterior authorization was needed.

IRELAND

The MInistery of Health Directorate in Dec. 2004 approved the labelling of BIOVAL PLUS probiotic for humans (with ingredient Kluyveromyces B0399 and stated that no ulterior authorization was needed.

ARGENTINA

Approval by the Ministry of Economy for Turval Horse feed supplement ( with Kluyveromyces B0399) Buenos Aires number: 98416/A and number: 98415/A.

URUGUAY

Approval by the Ministerio de Ganaderia Agricolura for Turval Horse feed supplement (with Kluyveromyces B0399) Montevideo: number: 5335 and number: 5336.

EGYPT

Approval of Turval Horse line obtained by the Ministry of Healt number 4175/6

Kluyveromyces:

- Turval B0399 in zootechnical field

- KLUYVER B0399 in human field

THAILAND

Approval of Kluyveromyces fragilis B0399 of Ministry of Thailand number 2551 for fish (shrimps) on Jul. 23, 2008

ROMANIA

  • BETAGAL (Galsor) supplement for humans (with ingredient Kuyveromyces B0399) notification at the Ministerul Agriculturii - Institutul De Bioresurse Alimentare of Bucaresti: certificate number AA/3694 on Mar. 29, 2010

 

BRAZIL

ANVISA (Brazilian Health Regulatory Agency: Approval of the yeast Kluyveromyces marxianus fragilis B0399 that comprises three independent aspects: 1) strain identity - approved, 2) Safety - approved, 3) proof of effectivness as a probiotic - ongoing

MAPA (Brazilian Ministry of Agriculture, Livestock and Food Supply): Approval of Kluyveromyces marxianus fragilis B0399 (MUCL 55798) as a probiotic for pigs, obtained on Dic, 31, 2021

 

INDIA

 FSSAI (Food Safety and Standard Authority of India): Approval of Non Specified Food under 13.6 Category (Health Supplement) of Microbial Strain of the viable microbial strain Kluyveromyces marxianus fragilis B0399 (Turval B0399) - approved in March, 2022.