An operator at the coating pan at our EU plant
Quality

Certifications

The certificates of our EU plant, where your product is manufactured and packed. Your contract is with PharmaEurope, PHARMA EUROPE SOLUTIONS 2023 SL, CIF B56533847.

The plant is certified to ISO 22000:2018, GMP and HACCP by BM Certification and registered with the US FDA as a food facility. The scans are below; copies of the certificates with their numbers are sent to clients on request.

Operator at a coating pan in the production area of the plant

The ISO 22000, GMP and HACCP certificates are issued by BM Certification. The FDA document is not a certificate and is not issued by the FDA: it is a written confirmation of the facility registration, issued by the facility’s US agent. Copies of the certificates with their numbers are sent to clients on request.

CertificationIssued byValid to
ISO 22000:2018BM Certification7 January 2029
HACCP, Regulation (EC) 852/2004BM Certification17 May 2027
GMP, Food Supplements Europe guideBM Certification17 May 2027
US FDA facility registrationFDA register · confirmed by Easy Impex LLC, Sacramento31 December 2026
Certificate by certificate

What each one covers

What each certificate covers, in the words printed on it.

  • ISO 22000:2018

    Issued by BM Certification on 8 January 2026, valid to 7 January 2029. Covered by the IAF multilateral recognition arrangement.

    The scope printed on the certificate is: Manufacturing and packaging of food supplements (tablets, capsules, powders).

    Two things follow from that wording. Packaging is inside the certified scope, not a separate uncertified step. And the scope names the formats — so tablets, capsules and powders are covered by the words on the document rather than by our description of it.

    Verification: ask us for a copy of the certificate with its number, and BM Certification (info@bmcertification.com) confirms it to anyone who asks.

  • HACCP

    The plant operates a food safety management system built on HACCP principles as required by Regulation (EC) No 852/2004 on the hygiene of foodstuffs, audited by BM Certification.

  • GMP for food supplements

    Production control and internal processes are audited against the Food Supplements Europe Guide to Good Manufacturing Practice for Manufacturers of Food Supplements, by BM Certification.

    This is the GMP standard that applies to food supplements in Europe. It is not pharmaceutical GMP, and a supplement plant that claims pharmaceutical GMP without a medicines-manufacturing authorisation is describing something it does not have.

  • US FDA facility registration

    The facility is registered with the United States Food and Drug Administration as a food facility, valid to 31 December 2026, under the Federal Food, Drug and Cosmetic Act and the Food Safety Modernization Act.

    A registration is not an approval and not a certification. The FDA does not certify or approve supplement manufacturers, and it does not issue certificates of registration — confirmations of registration are issued by private agents. Any company telling you it is “FDA certified” or “FDA approved” is describing something that does not exist.

    What the registration does mean: the facility is on the FDA's register and may ship food products to the United States. The registration is held with Easy Impex LLC of Sacramento, California as the facility's US agent, and the scan above is that agent's written confirmation.

“A batch does not leave the warehouse without a clean test report and a Certificate of Analysis. At the final stage we check the physical parameters — average weight, uniformity of mass and disintegration time; microbiological purity — yeasts and moulds within limits, no E. coli and no Salmonella — and heavy metals; the assay, meaning the real content of each active ingredient against what your label declares; and the seal — the induction membrane and the closure — so the product does not oxidise or take on moisture in transit.”

Chief Technologist, PharmaEurope plant
With every batch

Documents you receive

  • Certificate of Analysis
  • Product specification
  • Raw material documentation
  • Allergen statement
  • Shelf-life statement

Additional documents are available depending on the product and the destination market.

Honesty

What is not on this list

Halal is certified per product rather than per plant, so it is arranged for the specific product you are making and quoted with the project. We do not hold kosher or organic certification, and we do not claim them.

A vegan or vegetarian claim on a finished product is not a plant certificate — it depends on every ingredient in that specific formula, and we confirm it in writing per product before it is printed on a label.

Common questions

About our certification

What certification does your manufacturing hold?

An ISO 22000:2018 certificate issued by BM Certification and valid to 7 January 2029, with a scope covering manufacturing and packaging of food supplements. The plant also works to HACCP under Regulation (EC) 852/2004 and to the Food Supplements Europe GMP guide, and is registered with the US FDA. Copies of the certificates with their numbers are sent to clients on request.

Who are the certificates issued to?

To our plant, where production takes place. Your contract is with PharmaEurope, registered in Spain.

Can I verify the certificate myself?

Yes. Ask us for a copy of the certificate with its number, then contact BM Certification at info@bmcertification.com to confirm it.

Are you GMP certified?

The plant is audited against the Food Supplements Europe GMP guide — the GMP standard that applies to food supplements in Europe. It is not pharmaceutical GMP, which requires a medicines manufacturing authorisation and is a different thing entirely.

Are you FDA approved?

No, and neither is any supplement manufacturer. The FDA registers food facilities rather than approving or certifying them. A copy of the registration is sent to clients on request.

Is the packing certified too?

Yes. The ISO 22000 scope reads manufacturing and packaging of food supplements, so packing is inside the same certified scope and is done at the same site.

Do you have halal certification?

Halal is certified per product, not per factory — which is how halal certification actually works for food supplements. We arrange it for the specific product you are making, so ask for it with your enquiry and it is quoted as part of the project.

Does certification mean my product is approved for sale?

No. Certification covers how the product is made. Placing it on the market is a separate step. Food supplements in the EU are not pre-approved at EU level: most Member States require a notification before sale, filed by the company named on the label — in Spain with AESAN. We supply the documentation the notification needs.

Read more

EU supplement manufacturing quality systems — GMP, HACCP and ISO 22000· Quality control for supplement manufacturing in Europe· Supplement batch release — what happens before products leave the factory· Raw material documentation for food supplements

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