The European supplement market is one of the most strictly regulated in the world. Consumers expect safe, high-quality products, and regulators demand compliance with Good Manufacturing Practice (GMP) and international quality standards such as ISO. For any entrepreneur or company launching a supplement line in Europe, these certifications are not optional—they are essential for market access and brand credibility.
This guide explains how to successfully launch a supplement brand in Europe while ensuring full compliance with GMP and ISO.
Why GMP and ISO certifications matter in the supplement industry
GMP (Good Manufacturing Practice)
- Ensures supplements are consistently produced to the highest quality standards.
- Covers everything from ingredient sourcing to hygiene, machinery, staff training and documentation.
- In the EU, GMP compliance is legally required for dietary supplements and nutraceuticals.
ISO standards
- ISO 22000: focuses on food safety management.
- ISO 9001: covers quality management systems.
- ISO 13485: applicable if supplements are positioned closer to medical devices.
- ISO certification provides international recognition and demonstrates operational excellence.
Step-by-step guide to launching a compliant supplement brand in Europe
1. Define your business model
- Private label: fastest route, using pre-formulated GMP-certified products.
- Custom formulation: more investment, but greater differentiation.
2. Select a certified manufacturer
- Verify GMP and ISO certificates.
- Request site audits or documentation.
- Ask for stability and microbiological testing records.
3. Product development and compliance
- Ensure all ingredients comply with EU Novel Foods regulation.
- Avoid unapproved health claims under EFSA (European Food Safety Authority).
- Prepare labels in multiple EU languages if distributing cross-border.
4. Documentation and traceability
- Keep batch records and certificates of analysis (CoA).
- Ensure your manufacturer maintains a robust HACCP plan.
5. Packaging and labelling
- Include mandatory information: ingredients, nutrition table, allergen warnings, recommended daily dose, storage instructions.
- Claims must align with EU regulations (Regulation (EC) 1924/2006).
6. Certifications and audits
- ISO audits are carried out by accredited certification bodies.
- GMP audits may be requested by authorities or distributors.
- Passing audits boosts credibility with retailers, pharmacies and B2B buyers.
Checklist for launching a GMP- and ISO-compliant supplement line
- Select a GMP- and ISO-certified manufacturer.
- Verify documentation: HACCP, CoA, stability testing.
- Check ingredient compliance with EU Novel Foods list.
- Prepare compliant labels and translations.
- Undergo third-party testing where necessary.
- Plan regular audits and renew certifications.
Common mistakes to avoid
- Assuming GMP or ISO are optional for supplements (they are mandatory for credibility and distribution).
- Using health claims that are not authorised by EFSA.
- Partnering with manufacturers without verified certification.
- Overlooking language and labelling requirements for EU-wide sales.
FAQs
Is GMP mandatory for supplement brands in Europe?
Yes, GMP compliance is required by EU law to ensure product safety and quality.
What ISO certification is most relevant for supplements?
ISO 22000 (food safety) and ISO 9001 (quality management) are the most widely used.
Can a startup achieve GMP and ISO compliance without its own factory?
Yes. By partnering with a contract manufacturer already certified, startups can launch without building facilities.
Conclusion
Launching a supplement line in Europe requires more than just a good formula. Success depends on full compliance with GMP and ISO standards, which guarantee quality, safety and consumer trust.
At Techlabs Europe, we help entrepreneurs and established brands launch supplements that meet all regulatory requirements, from formulation to certification.
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