ISO 22000:2018
Certified by Bureau Veritas in 2020, covering the manufacture of food supplements (capsules, tablets, powders, liquids) and their packaging (blisters, pill boxes, sachets, bottles, softgels).
Compliance proven by analysis, not by promise
Two internal laboratories, six COFRAC-certified partner laboratories and a certification set that covers Europe, the United States and export markets.
The regulatory context
Europe sets the strictest bar in the world
EU regulations, overseen by the EFSA (European Food Safety Authority), are among the strictest in the world: they require rigorous scientific validation of every health claim and full traceability.
In France, ANSES's nutrivigilance system ensures a unique post-market safety monitoring programme, making 'Made in France' a guarantee of reliability rather than a marketing line. For a brand exporting outside Europe, that regulatory rigour becomes a competitive argument: a product built to EU standards clears most other jurisdictions with far less friction.
Our quality team — one quality manager and two quality assistants — is responsible for controls from goods-in through to dispatch. Regulatory watch is carried out in partnership with Pharmanager Development, a scientific and regulatory consultancy.
Certifications
Our certifications
Audited, renewed and verifiable — each one covers a specific market requirement.
GMP — Good Manufacturing Practices
Attestation obtained in June 2020, covering the whole manufacturing process.
Organic — Certipaq
Certified organic since April 2017, for supplements compliant with the EU organic regulation.
HACCP
Hazard study carried out and kept continuously up to date, backed by Good Hygiene Practices across manufacturing.
FDA Registered
Facility registration allowing supply to the United States market.
NF EN 17444 — anti-doping
Conformity with the anti-doping standard, for supplements aimed at competitive athletes.
Halal
Halal certification for export to markets where it is required.
How it actually works
Systems and protocols behind the certificates
HACCP and Good Hygiene Practices
A hazard analysis maintained continuously, not revisited at audit time, and Good Hygiene Practices applied throughout manufacturing.
Stability studies under ICH conditions
Shelf life is established under internationally recognised conditions, so the date on the pack holds in real distribution.
Food Defense
A security plan protecting products against malicious acts, from goods-in to dispatch.
Regulation 1935/2004
Conformity required of primary packaging articles and of the machines in contact with the product.
NF EN ISO/IEC 17025:2017
The standard our partner analytical laboratories are certified against.
A dedicated quality team
One quality manager and two quality assistants, responsible for controls from reception through to shipment.
Testing
Ask for our certificates
Two internal laboratories, six external
Critical analyses are never outsourced. Our two internal laboratories control the quality of the raw materials used and ensure product quality throughout the process; six external COFRAC-certified laboratories carry out final analyses and stability studies.
In-house testing
- Microbiology
- FTIR identification
- Disintegration
- Hardness
- Particle size
- Density (densimeter)
- Loss on drying
- Thickness
- Friability
Frequently asked questions
Which certifications does Bewell Nutraceutique hold?
ISO 22000:2018 (certified by Bureau Veritas in 2020), a GMP attestation obtained in June 2020, organic certification by Certipaq since April 2017, HACCP, FDA registration, NF EN 17444 anti-doping conformity and Halal certification.
Are analyses carried out internally or outsourced?
Both, deliberately. Two internal laboratories control raw materials on reception and product quality throughout the process — these analyses are never outsourced. Six external laboratories, certified COFRAC to NF EN ISO/IEC 17025:2017, carry out final analyses and stability studies, which require independent accreditation.
What does the ISO 22000 certification cover?
It covers the manufacture of food supplements in all galenic forms — capsules, tablets, powders and liquids — and their packaging in blisters, pill boxes, sachets, bottles and softgels.
How do you keep up with regulatory changes?
Regulatory watch is carried out in partnership with Pharmanager Development, a scientific and regulatory consultancy. This covers health claims, permitted ingredients and dosages, and labelling requirements in the markets our clients supply.
Let's talk about your project
Tell us your idea, your target market and your volumes. Our R&D and regulatory teams come back to you with a feasibility answer and a costed proposal.