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A2LA vs UKAS vs COFRAC: Which Accreditation Body Is Right for You?

Comparing A2LA, UKAS, and COFRAC — the three most important laboratory accreditation bodies for manufacturers targeting US, UK, and EU markets. Which one do you need?

Nour Abochama Quality & Regulatory Advisor, Care Europe | VP Operations, Qalitex

Key Takeaway

Comparing A2LA, UKAS, and COFRAC — the three most important laboratory accreditation bodies for manufacturers targeting US, UK, and EU markets. Which one do you need?

A supplement brand entering both the US and EU markets asked us a straightforward question last year: “Which accreditation body should our contract laboratory have?” The answer wasn’t straightforward — it depended on which regulatory submissions they were targeting, which markets they were entering first, and what their long-term expansion plans looked like.

If you’re selecting a contract laboratory, building a laboratory quality system, or advising a manufacturer on regulatory strategy, understanding the differences between A2LA, UKAS, and COFRAC — and when each one matters — is essential knowledge.

What Are Accreditation Bodies and Why Do They Matter?

Accreditation bodies are national organisations that formally assess and confirm that testing and calibration laboratories meet the requirements of ISO/IEC 17025. They operate under the oversight of national governments and are signatories to international mutual recognition arrangements that make their accreditations recognised globally.

The key principle: an accreditation body’s stamp on a laboratory’s scope of accreditation tells you that an independent, competent authority has verified that the laboratory produces technically valid results for the specific test methods listed. Without that verification, you’re relying on the laboratory’s own claims about its competence.

All three bodies discussed here — A2LA, UKAS, and COFRAC — are signatories to:

  • ILAC MRA (International Laboratory Accreditation Cooperation Mutual Recognition Arrangement) — global recognition
  • IAF MLA (International Accreditation Forum Multilateral Agreement) — for certification body accreditation

This means their accreditations are mutually recognised internationally. A test report from a COFRAC-accredited laboratory is accepted in the USA, and vice versa.

A2LA: American Association for Laboratory Accreditation

Founded: 1978
Country: USA
Laboratories accredited: 5,000+ across 100+ countries
Primary regulatory markets: FDA, USDA, EPA, DoD, OSHA, US Customs

A2LA is the largest and most internationally active of the three bodies. It accredits laboratories in over 100 countries, making it the most commonly encountered accreditation body for US regulatory submissions.

When You Need A2LA Accreditation

  • FDA submissions: FDA 21 CFR Part 111 (dietary supplements), 21 CFR Part 117 (food safety), cosmetic testing under MoCRA — FDA auditors recognise A2LA accreditation as evidence of laboratory competence
  • USDA organic and food safety programmes: Many USDA programmes require or prefer A2LA accredited laboratories
  • US military and government contracts: DoD and federal agency contracts frequently specify A2LA accreditation
  • Amazon third-party testing: Amazon’s Compliance Programme for supplements and cosmetics accepts A2LA accredited test reports

A2LA Accreditation Process

A2LA uses a peer-assessment model — assessors are typically active laboratory professionals from the relevant technical field. The process follows the standard ISO 17025 pathway: application, document review, on-site assessment, corrective action, accreditation.

A2LA’s scope system is granular — accreditation covers specific test methods (e.g., AOAC 2007.01 for pesticide residues in food) and specific matrices (e.g., dietary supplements, cosmetics, drinking water). A laboratory accredited for heavy metals in food is not automatically accredited for heavy metals in cosmetics — the scope must specifically list the matrix.

Typical timeline: 6 to 18 months for initial accreditation
Annual surveillance: Required; typically remote with periodic on-site reassessment
Cost range: $3,000 to $20,000+ for initial assessment depending on scope size

UKAS: United Kingdom Accreditation Service

Founded: 1995 (successor to NAMAS and NACCB)
Country: United Kingdom
Laboratories accredited: 2,500+ in the UK and internationally
Primary regulatory markets: UK regulators (MHRA, FSA, EA), EU (legacy recognition), international

UKAS is the UK’s sole national accreditation body, operating under the authority of the UK government. Post-Brexit, UKAS is no longer part of the European Accreditation (EA) network, which has implications for EU regulatory recognition.

When You Need UKAS Accreditation

  • UK regulatory submissions: MHRA (medicines), FSA (food safety), Environment Agency — all UK regulatory bodies recognise UKAS accreditation
  • UK market access: Brands selling in the UK post-Brexit need UK-specific regulatory compliance, and UKAS accredited laboratories provide the test data foundation
  • International recognition: UKAS remains an ILAC MRA signatory, so UKAS accreditation is internationally recognised — including in the EU, though it no longer carries the EA MLA presumption of equivalence

The Post-Brexit Complication

Before Brexit, UKAS was a full member of the European Accreditation (EA) network, and UKAS accreditation was automatically recognised across all EU member states under Regulation (EC) No 765/2008. Post-Brexit, this automatic recognition no longer applies.

In practice, most EU regulatory authorities continue to accept UKAS accredited test reports under ILAC MRA recognition. But for submissions where EU regulatory authorities are applying strict interpretations of Regulation (EC) No 765/2008 — particularly in France (ANSM, DGCCRF) and Germany (BfArM) — a COFRAC or DAkkS accredited laboratory may be preferred.

For brands targeting both UK and EU markets, the safest approach is a laboratory with both UKAS and an EA-member accreditation (COFRAC, DAkkS, etc.), or separate laboratories for UK and EU submissions.

Typical timeline: 6 to 18 months for initial accreditation
Annual surveillance: Required
Cost range: £3,000 to £15,000+ for initial assessment

COFRAC: Comité Français d’Accréditation

Founded: 1994
Country: France
Laboratories accredited: 1,200+ in France and internationally
Primary regulatory markets: French regulators (ANSM, DGCCRF, INRS), EU regulators, international

COFRAC is France’s sole national accreditation body, operating under the authority of the French government and designated under EU Regulation (EC) No 765/2008. It is a full member of the European Accreditation (EA) network.

When You Need COFRAC Accreditation

  • French regulatory submissions: ANSM (cosmetics, medicines), DGCCRF (food safety, consumer products), INRS (occupational health) — French authorities have a strong preference for COFRAC accredited laboratories
  • EU regulatory submissions: As an EA MLA signatory, COFRAC accreditation is recognised across all EU member states without additional verification
  • EU cosmetics regulation: For CPSR (Cosmetic Product Safety Report) testing, COFRAC accredited laboratories provide the strongest evidence of competence for EU market surveillance authorities
  • French public procurement: Many French government contracts and public health programmes specify COFRAC accreditation

COFRAC’s Scope Structure

COFRAC organises its accreditation activities into sections:

  • Section Laboratoires (LAB): Testing and calibration laboratories (ISO/IEC 17025)
  • Section Inspection (INSP): Inspection bodies (ISO/IEC 17020)
  • Section Certification (CERT): Certification bodies (ISO/IEC 17021, 17065)
  • Section Santé (SAN): Medical laboratories (ISO 15189)

For cosmetic and supplement testing, COFRAC LAB accreditation is the relevant category.

Typical timeline: 12 to 24 months for initial accreditation (COFRAC tends to be more rigorous and slower than A2LA)
Annual surveillance: Required; COFRAC conducts thorough surveillance assessments
Cost range: €4,000 to €20,000+ for initial assessment

Comparison Table: A2LA vs UKAS vs COFRAC

FactorA2LAUKASCOFRAC
CountryUSAUKFrance
EA memberNoNo (post-Brexit)Yes
ILAC MRAYesYesYes
EU recognitionILAC MRAILAC MRA (not EA MLA)Full EA MLA
FDA recognitionStrongAcceptedAccepted
UK recognitionAcceptedStrongAccepted
French/EU recognitionAcceptedAccepted (with caveats)Strong
Assessment rigourHighHighVery high
Timeline6-18 months6-18 months12-24 months
Cost$3K-$20K+£3K-£15K+€4K-€20K+
Best forUS market, FDA submissionsUK marketEU/French market

Which Accreditation Body Do You Actually Need?

The answer depends on your regulatory targets:

US market only: A2LA is the standard choice. FDA recognises it, Amazon accepts it, and it covers the widest range of US regulatory programmes.

UK market only: UKAS is the appropriate choice for UK regulatory submissions.

EU market only: COFRAC (France), DAkkS (Germany), or another EA-member body is the right choice. COFRAC is particularly relevant for brands entering France first or working with French contract manufacturers.

US + EU markets: The most practical approach is a laboratory with A2LA accreditation for US submissions and COFRAC or DAkkS accreditation for EU submissions. Some larger European contract laboratories hold both. Alternatively, use separate laboratories for US and EU testing — not ideal for cost, but sometimes necessary for scope coverage.

UK + EU markets: A laboratory with both UKAS and an EA-member accreditation (COFRAC, DAkkS) is ideal. Alternatively, COFRAC accreditation alone covers both EU and UK submissions in most practical situations under ILAC MRA.

At Care Europe, we help brands navigate laboratory selection for multi-market regulatory strategies. The accreditation body question is always the starting point — but scope coverage (which specific test methods and matrices are accredited) is equally important and often where the practical gaps are found.

Contact us at [email protected] to discuss your laboratory selection strategy.

Nour Abochama

Written by

Nour Abochama

Quality & Regulatory Advisor, Care Europe | VP Operations, Qalitex

Chemical engineer with 17+ years of experience in laboratory operations, quality assurance, and regulatory compliance across Europe and North America. VP of Operations at Qalitex (ISO/IEC 17025 accredited laboratory). Expert in GMP compliance, ISO 17025 quality systems, EU cosmetics regulation, and export requirements for the USA and Canadian markets. Based in Europe with deep knowledge of French and EU regulatory frameworks.

Chemical Engineering17+ Years Lab OperationsISO 17025 ExpertGMP & EU Compliance Specialist
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