Quality

  • BioXtract is FSSC22000 certified : since 2014 and after two cycles of ISO 22000 : 2005 (from 2008 to 2013), BioXtract decided to move to a more complete food safety system certification : FSSC 22000, which is a certification scheme for food safety systems including ISO 22000, ISO 9001, ISO/TS 22003, and technical specifications for sector-specific Pre-Requisite Programs (PRPs), such as ISO/TS 22002-1. Besides these standards, the Scheme contains so-called FSSC Additional Requirements, which can be found in the FSSC 22000 Scheme documents. BioXtract has initiated in 2020 his third cycle of certification with the FSSC 22000 version 5.1 (November 2020) including ISO 22000 : 2018 and ISO/TS 22002-1 : 2009. This certification includes an annual re-audit control plan with at least one unannounced audit during the cycle.
     

Certificate N°: INS162/01/0192 valid until 21th of October 2023

 

  • BioXtract is GMP certified according to NSF/ANSI Standard 173, Section 8 dedicated to dietary supplements for both our laboratory and logistic/manufacture premises since September 2016, . This certification includes FSMA and cGMP (21 CFR 111), (21 CFR 117), and implies an annual three-days audit and a one-day follow-up audit 6 months later for the checking of the implementation of the corrective actions issued from the general audit. The certification can be checked on-line on the website of NSF.
     

Certificate N°: C0306287-DS-2 valid until 12th of January 2022 for the logistic/manufacture facility

Certificate N°: C0316008-DS-2 valid until 12th of January 2022 for the analytical laboratory

 

 

  • The logistic/manufacture facility of BioXtract is registered and approved by the AFSCA (Federal Agency for the Food Chain Safety) for food supplement production under the Registration Number AER/NAM/004889 since 2006 (this approval can be checked directly through the link and is only available in French or Dutch),

 

 

  • BioXtract was the first Belgian company in the food supplement sector to implement in 2008 a self-inspection system (SIS) validated according to AFSCA requirements and to the sectorial guide SAC G-011 by an external inspection body approved by the competent authorities. Since 2008, this inspection in renewed annually and recorded by the AFSCA. As for the production authorization, the self-inspection status is available through the same Internet link.

 

Certificate N°: INS200/01/0661 valid until 24th of September 2021