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EU GMP Contract Filling for Cosmetics and Food Supplements: What “GMP Certified” Actually Means

There is no single “EU GMP” certification covering both cosmetics and food supplements. Cosmetics manufactured in the EU follow ISO 22716, the cosmetics GMP standard referenced by Regulation (EC) 1223/2009. Food supplements have no unified EU GMP, requirements are set at member-state level around HACCP and ISO 22000. EU GMP (EudraLex Volume 4) applies to medicinal products.

 

In this guide

 

What does “EU GMP” actually mean?

EU GMP (EudraLex Volume 4) applies to medicinal products, not cosmetics or supplements

EudraLex Volume 4 is the EU’s Good Manufacturing Practice framework for medicinal products, governed by Directive 2003/94/EC. It’s the strictest GMP tier in the EU, and it’s specific to pharmaceuticals. If a contract filler tells you they’re “EU GMP certified” for a cosmetic or supplement, ask them to clarify exactly what that means, because the term doesn’t map cleanly onto either category.

Cosmetics: ISO 22716 is the GMP standard 

For cosmetics sold in the EU, ISO 22716 is the recognized Good Manufacturing Practice standard, explicitly referenced by Regulation (EC) No 1223/2009, Article 8. This is what a cosmetics brand should actually be asking for, not “EU GMP.”

Food supplements: there is no single EU GMP

Food supplements don’t have one unified EU-wide GMP standard the way medicinal products do. Requirements are implemented at the member-state level, generally built around HACCP and ISO 22000 food safety management, under the general hygiene framework of Regulation (EC) No 852/2004.

For the fuller regulatory picture, see our overview of food supplement legislation in the EU.

How this differs from US 21 CFR 111 and 21 CFR 210/211

In the US, dietary supplements are governed by 21 CFR Part 111, a single federal cGMP standard. Pharmaceuticals fall under the stricter 21 CFR Parts 210/211. The EU simply doesn’t have a direct equivalent to 21 CFR 111 for supplements, which is exactly why “EU GMP for supplements” as a single, requestable certification doesn’t exist.

A note on terminology: “GMP contract” in construction means something else entirely

Worth flagging directly: search “GMP contract” and you’ll find results about construction, where GMP means Guaranteed Maximum Price, a pricing structure, not a manufacturing standard. If you’re researching manufacturing, search “GMP certified manufacturing” or a specific standard (ISO 22716, 21 CFR 111) rather than “GMP contract” alone.

 

Product category Applicable standard Legal basis Who audits it
Cosmetics (EU) ISO 22716 Regulation (EC) 1223/2009, Art. 8 Accredited certification body
Food supplements (EU) HACCP + ISO 22000 + member-state GMP Regulation (EC) 852/2004 Certification body / national authority
Cosmetics (US) ISO 22716 alignment + MoCRA MoCRA (2022) FDA / certification body
Supplements (US) 21 CFR Part 111 FDA FDA
Medicinal products (EU) EU GMP / EudraLex Vol. 4 Directive 2003/94/EC National competent authority

 

What to require instead of “EU GMP”

The table above is the short answer: match your request to your actual product category rather than asking for “EU GMP” as if it were one thing. If a manufacturer handles both cosmetics and supplements, confirm each category is separately certified under its own applicable standard, ISO 22716 for the cosmetic line, HACCP/ISO 22000 for the supplement line. A single blanket “GMP certified” claim covering both isn’t meaningful without knowing which standard applies to which product.

How to verify a contract filler’s GMP certification

This is the part almost nobody covers, certification bodies issue certificates, they don’t publish guides on how a buyer should check someone else’s.

Ask for the certificate number, not the logo

A logo on a website proves nothing on its own. Ask for the actual certificate, which includes a unique certificate number you can reference.

Check the scope

A certificate covers specific processes and a specific site. Confirm the scope actually includes the product type and the facility you’d be working with, not a different site under the same parent company.

Check the expiry date and the certification body

Certificates have renewal cycles. Confirm the certificate is currently valid and note which accredited body issued it.

Accredited vs. non-accredited ISO 22716 certification

This distinction is rarely explained, and it matters. Accredited certification means the certifying body itself is overseen by a national accreditation authority, adding a layer of independent oversight. Non-accredited certification can still be legitimate and is common in the cosmetics GMP space, but it’s worth knowing which type you’re looking at rather than assuming.

Verify with the certification body directly

Reputable certification bodies (SGS, Intertek, LRQA, Bureau Veritas, NSF, and others) can typically confirm whether a certificate number is valid and current if you contact them directly.

Six red flags 

One facility, two categories: what changes

Separate areas, separate documentation

A facility filling both cosmetics and food supplements under one roof needs separated production areas and separate documentation trails for each category, not just separate equipment.

Cross-contamination and allergen control

Ask specifically how a shared facility manages cross-contamination risk and allergen control between product lines, this is a common gap that’s easy to overlook until it becomes a problem.

Why a cosmetics-only filler may not be able to fill an ingestible product

A facility certified only under ISO 22716 for cosmetics isn’t automatically equipped, or certified, to fill something intended for ingestion. Confirm both certifications exist independently if you need both categories from the same partner.

What to ask if you need both under one roof

Request evidence of separated production zones, category-specific batch records, and confirmation that both ISO 22716 and the relevant food supplement framework (HACCP/ISO 22000) are independently certified for that facility.

 

If your product also requires sourcing raw cannabinoid material rather than a finished formulation, our raw and bulk materials page covers isolate, distillate, and crude extract sourced under the same certified facility.

Documentation you should receive with every batch

At minimum: a Certificate of Analysis (COA), a batch production record, a retained sample kept on file, a Material Safety Data Sheet (MSDS) where applicable, packaging compatibility and stability data for cosmetics, and, for cosmetics specifically, input supporting your Product Information File (PIF).

For broader lab testing and regulatory support beyond individual batch documentation, see our laboratory services and regulatory support page.

Regulatory responsibility: who does what

Cosmetics: PIF, Responsible Person, CPNP notification

Selling cosmetics in the EU requires a Product Information File (PIF), a designated Responsible Person, and notification through the Cosmetic Products Notification Portal (CPNP) before the product goes to market.

Food supplements: Novel Food status

A supplement containing an ingredient not established as safe for human consumption in the EU before May 1997 may fall under Novel Food assessment requirements under Regulation (EU) 2015/2283, a process that can add significant time to market entry if not planned for early.

For a deeper walkthrough of the Novel Food process itself, see our guide on understanding Novel Food status.

What a filler will, and won’t, do for you

Most contract fillers can supply documentation related to their own facility and process. Very few handle your product’s market-specific regulatory filing (a PIF, CPNP notification, or Novel Food dossier) as part of a standard filling agreement, confirm this scope explicitly rather than assuming it’s included.

Why choose a skincare or cosmetics manufacturer in Europe

A manufacturer already based in the EU and familiar with EU cosmetic and food supplement regulation can meaningfully shorten market entry timelines for brands sourcing private label cosmetics in Europe or supplements, compared to retrofitting a non-EU-made product for EU compliance after the fact.

Brands searching for a cosmetics manufacturer in Europe, or a contract manufacturer in Europe more broadly, generally find that regulatory familiarity outweighs a marginally lower unit cost from a non-EU facility.

 

For a deeper walkthrough of how hemp-derived cosmetics and supplements move from raw material to finished, compliant product, see our CBD contract manufacturing guide.

MOQs and lead times for GMP contract filling

Nobody in this space publishes real numbers, which is exactly why concrete figures matter here.

Format Industry average MOQ PharmaHemp MOQ How we compare
Simple liquids / dropper bottles 100-500 units From 100 units At or below industry average
Creams and emulsions 300-1,000 units From 100 units Below industry average
Serums / actives-heavy formulas 500-2,000 units From 100 units Well below industry average
Airless / specialty packaging 1,000+ units From 100 units Well below industry average

Across every format we produce, our minimum stays at 100 units, while the wider industry typically requires anywhere from 100 to 2,000+ depending on complexity. That makes us a realistic option for brands testing a new product or launching for the first time. 

Get in touch with our team for a quote specific to your format and volume.

Questions to ask before you sign

  1. Which specific standard applies to my product category, ISO 22716, HACCP/ISO 22000, or something else?
  2. Can you provide the certificate number and scope in writing?
  3. Is the certification accredited or non-accredited, and does that matter for my target market?
  4. If you handle multiple product categories, is each one separately certified?
  5. Can we conduct a facility audit before committing?
  6. Do you provide a COA for every batch, or only on request?
  7. Who handles PIF, CPNP, or Novel Food support, you or us?
  8. What’s your MOQ and lead time in writing, not a verbal estimate?
  9. How do you manage cross-contamination if you handle multiple categories?
  10. What happens if a batch fails quality control?
  11. Do you supply your own packaging, or do we need to source it?
  12. What happens to unused packaging or materials if the project is cancelled?
  13. Can you share references from brands in a similar product category?

Frequently asked questions

Is there an EU GMP certification for cosmetics?

No single “EU GMP” certification exists for cosmetics. The applicable standard is ISO 22716, referenced by EU Regulation 1223/2009.

Is there an EU GMP certification for food supplements?

No. Food supplements have no unified EU GMP standard, requirements are set at member-state level, generally built around HACCP and ISO 22000.

What is ISO 22716 certification?

ISO 22716 is the international standard for Good Manufacturing Practice specific to cosmetic products, covering production, control, storage, and shipment.

What is the difference between ISO 9001 and ISO 22716?

ISO 9001 is a general quality management standard applicable across industries. ISO 22716 is specific to cosmetics GMP. A cosmetics manufacturer should hold ISO 22716 specifically, ISO 9001 alone doesn’t cover cosmetics GMP requirements.

Is ISO 22716 mandatory?

EU Regulation 1223/2009 references ISO 22716 as the standard cosmetic manufacturers should follow to demonstrate GMP compliance, making it the de facto requirement for serious cosmetic manufacturing in the EU market.

How do you get ISO 22716 certification?

A facility undergoes an audit by an accredited (or non-accredited) certification body against the ISO 22716 standard, covering production, quality control, storage, and documentation practices.

What does GMP certified mean?

It means a facility has been independently audited and certified against a specific Good Manufacturing Practice standard. The specific standard varies by product category, always ask which one.

What is a GMP certified facility?

A facility that holds current, valid certification against the applicable GMP standard for its product category, verifiable by certificate number and scope.

Is “GMP compliant” the same as “GMP certified”?

No. “GMP compliant” can mean a facility follows GMP principles without having been independently certified. “GMP certified” means an accredited or recognized body has formally audited and certified the facility. Always ask which claim applies.

What is the difference between EU GMP and 21 CFR 111?

EU GMP (EudraLex Volume 4) applies to medicinal products in the EU. 21 CFR 111 is the US federal standard specifically for dietary supplements. Neither directly maps onto the other’s scope.

Can one facility fill both cosmetics and food supplements?

Yes, provided it holds separate, valid certification for each category (ISO 22716 for cosmetics, HACCP/ISO 22000 for supplements) and maintains separated production areas and documentation.

What is a GMP contract?

In manufacturing, it informally refers to an agreement with a GMP-certified producer. In construction, “GMP contract” means something entirely different, a Guaranteed Maximum Price contract structure. Make sure you’re both talking about the same thing.

How do I verify a contract filler’s GMP certificate?

Request the certificate number and scope, confirm it covers the specific site and product category you need, check the expiry date, and, if in doubt, contact the issuing certification body directly.

What MOQ should I expect from a GMP contract filler?

It varies significantly by manufacturer and format. PharmaHemp’s MOQ starts from 100 units, with production typically scheduled 2-3 weeks from a confirmed order.

Do I need an EU-based filler to sell cosmetics in the EU?

Not strictly required, but an EU-based manufacturer familiar with PIF, Responsible Person, and CPNP requirements typically simplifies EU market entry compared to a non-EU facility.

Where PharmaHemp fits, and where it doesn’t

PharmaHemp holds ISO 22716 certification for cosmetics and GMP certification for food supplements, alongside ISO 9001, ISO 22000, and HACCP, with MOQs starting from 100 units and production typically scheduled within 2-3 weeks of a confirmed order. As a skincare manufacturer in Europe based in Ljubljana, Slovenia, PharmaHemp is positioned specifically for brands entering the EU market or sourcing hemp-derived ingredients. It’s not the right fit for every brand, if you need a US-based facility for domestic FDA compliance and logistics, or your product has no connection to hemp-derived formulations, a different manufacturer may be the better starting point. 

You can explore our certifications and contract manufacturing services directly, or get in touch to discuss your product category and target market.

If you’re weighing whether to build a fully custom formulation or launch faster with an existing one, our Private Label vs. White Label guide breaks down that decision independently of the certification question covered here.

 

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