Quality and certificates
Certified food supplement manufacturing in Slovenia, EU
Our production is certified by Bureau Veritas to FSSC 22000 and ISO 22000, confirmed for Good Manufacturing Practice and HACCP, and our facility is registered with the U.S. FDA. Every certificate is shown below.
Our certificates
Select a certificate to enlarge it. Full-size copies are available on request.
Certificate details
- Certified company
- BIO PAK Nutraceuticals Ltd, Savska loka 22, 4000 Kranj, Slovenia (registered with the FDA as BIO PAK, D.O.O.)
- FSSC 22000 (version 6)
- Certificate no. SI013190-1 · Bureau Veritas Certification Holding SAS, UK Branch · issued 7 January 2026 · valid until 22 February 2029
- ISO 22000:2018
- Certificate no. SI013192 · Bureau Veritas Certification Holding SAS, UK Branch · issued 12 January 2026 · valid until 28 February 2029
- Good Manufacturing Practice (GMP)
- Letter of confirmation no. SI013199 · Bureau Veritas, d.o.o. · dated 7 January 2026 · expires 22 February 2027 · based on FSSC 22000 certificate SI013190-1
- HACCP
- Letter of confirmation no. SI013200 · Bureau Veritas, d.o.o. · dated 7 January 2026 · expires 22 February 2027 · Codex Alimentarius CXC 1-1969, Rev. 2022
- U.S. FDA food facility registration
- Registered under Section 415(a) of the U.S. Federal Food, Drug, and Cosmetic Act · registration number 18563226286 · U.S. agent: United Safety Agents · valid until 1 January 2027
Scope of certification
The FSSC 22000, ISO 22000, GMP and HACCP certificates cover the same scope: production (homogenization, encapsulation, blistering, packing) of dietary food supplements powdered or oil medium in hard shell capsules, packed in blisters, PET packers and powder jars. Packing of soft gels, tablets and powder premixes of dietary food supplements in PET packers, powder jars, plastic stand-up pouches and sticks.
FSSC food chain category: CIV, processing of ambient stable products.
Certificates FAQ
Which certificates does BIO PAK hold?
Our production is certified by Bureau Veritas to FSSC 22000 (version 6) and ISO 22000:2018. Bureau Veritas has also issued letters of confirmation for Good Manufacturing Practice (GMP) and for HACCP (Codex Alimentarius CXC 1-1969, Rev. 2022). Our facility is registered with the U.S. FDA, and we are EU Organic certified with Bureau Veritas Slovenia (SI-EKO-003).
Who issues the certificates?
FSSC 22000 and ISO 22000 are certified by Bureau Veritas Certification Holding SAS, UK Branch. The GMP and HACCP letters of confirmation are issued by Bureau Veritas, d.o.o. in Ljubljana, Slovenia, based on our FSSC 22000 certificate.
What does the certification cover?
The scope is the production (homogenization, encapsulation, blistering and packing) of dietary food supplements, powdered or in oil medium, in hard shell capsules, as well as the packing of soft gels, tablets and powder premixes. The full wording is under Scope of certification above.
Is BIO PAK FDA approved?
BIO PAK is registered with the U.S. Food and Drug Administration as a food facility, which is required for facilities that manufacture food for the U.S. market. Registration is not an approval or certification by the FDA. It is handled through our U.S. agent, United Safety Agents.
How can I verify the certificates?
The FSSC 22000 certificate can be verified in the public FSSC 22000 database at www.fssc.com. To check the validity of the ISO 22000 certificate or a letter of confirmation, call Bureau Veritas in Ljubljana on +386 1 47 57 670.
Can I get copies for a supplier audit?
Yes. Send us a message through the quote form or email info@biopak.si and we will send full copies of any certificate.
Need our certificates for a supplier audit?
Ask for full copies of any certificate. We reply by email.