Qualifications and approvals

 

 

INTERNATIONAL deposit


Our strain: Kluyveomyces Marxianus fragilis B0399 dated April 1999 c/o MUCL BCCM ( 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 6th 2005 Ref. DAF 02131

CANADA


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

EUROPEAN COMMUNITY


Community approval of the additive TURVAL B0399:

  • the Italian Ministry of Health approved the additive Turval B0300 on June 22, 2001.
  • the French Ministry of Economy gave preliminary approval on August 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 on May 22th, 2006 (Commission regulation).

ITALY

  • Laboratori and production licence (renewal) obtained by A.S.S. n 4 (Ministry of Health) “Medio Friuli” on 21.02.2002.
  • 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 June 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 June 20, 2001 (Executive Order 123/99) number: IT 000137 UD.
  • BIOVAL PLUS supplement for humans (with ingredient  Kluyveromyces  B0399): first notification at the Ministry of Health on January 29, 1999 and August 24, 2001 (Executive Order 111/92).
  • BIOVAL COMPLEX supplement for humans (with ingredient  Kluyveromyces B0399): notification at the Ministry of Health on January 22, 2001 (Order 111/92). 
  • BIOSYMPA (CSM Omeopatici) supplement for humans (with ingredient Kluveromyces B0399): notification at the Ministry of Health 2003
  • LACTIFAST (Marco Viti) supplement for humans (with ingredient Kluyveromyces B0399): notification at the Ministry of Health on september 25, 2003
  • LIEVILACTIS (Parapharma) supplement for humans (with ingredient Kluyveromyces B0399): notification at the Ministry of Health on Marc 12, 2001

GERMANY


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

GB


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

IRELAND


The MInistery of Health Directorate in Dec 2004 approved the labeling 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 theMinisterio de Ganaderia Agricolura for Turval Horse feed supplement (with Kluyveromyces B0399) Montevideo: number: 5336 and number: 5335.

EGYPT


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

 

                                                                                                      

   

Kluyveromyces:

- Turval B0399 in zootecnical field

- KLUYVER B0399 in human field