"GMPC US/EU/China" Certification Differences: How Cross-Border Brands Should Choose OEM Manufacturers?

When you ask a Chinese OEM factory, "Do you have GMPC certification?" and get a "Yes," the question isn't actually finished—because GMPC in the US, EU, and China represents three different regulatory logics, different audit standards, and inevitably, different levels of legal enforcement.

For cross-border brands planning to sell products in multiple markets, understanding the differences among these three is the first crucial hurdle in selecting an OEM, and the most important homework to avoid falling into a compliance "black hole" after entering a market.

Basic Cognition: What Is the Relationship Between GMPC and ISO 22716?

Before diving into the three-way comparison, a key premise needs to be clarified.

GMPC (Good Manufacturing Practice for Cosmetics) aims to ensure that cosmetic quality standards meet operational guidelines for continuous production and control. Its core focus remains the same: minimizing production process risks that cannot be eliminated through final finished product testing. ISO 22716 is the comprehensive international GMP standard specifically developed by the International Organization for Standardization (ISO) for the cosmetics industry, covering the entire process of production, control, storage, and shipment.

What we usually refer to as a "GMPC certificate" actually refers to the US GMPC standard; whereas the ISO 22716 certificate is the mandatory requirement for cosmetics entering the EU and the globally recognized certificate. If a company needs to obtain both certificates simultaneously, passing the ISO 22716 certification audit allows the GMPC certificate to be issued alongside it without repeating the on-site audit—because the two are largely identical, covering five major modules: quality management system, procurement, production, subcontracted production, and quality management.

The EU: ISO 22716 — Mandatory and Irreplaceable

Among the three regions, the EU's GMP requirements are the most explicit and legally binding.

EU Cosmetics Regulation (EC) No 1223/2009 explicitly stipulates: All cosmetics produced and sold in the EU market must comply with the GMP requirements of the ISO 22716 standard. In the EU, GMP compliance is mandatory. All cosmetics must be produced under GMP conditions compliant with ISO 22716, and all product claims must be supported by appropriate scientific or technical evidence before marketing. Furthermore, entering the EU market also requires a Responsible Person within the EU, a complete Product Information File (PIF), and a Cosmetic Product Safety Report (CPSR).

Key point at the operational level: On April 21, 2011, the Official Journal of the European Union officially published the "EN ISO 22716:2007 Cosmetics - Good Manufacturing Practices (GMP) - Guidelines on Good Manufacturing Practices," announcing it as the harmonized standard for GMP under EU Cosmetics Regulation (EC) No 1223/2009. This means that since July 11, 2013, cosmetic manufacturing enterprises entering the EU market must execute and pass ISO 22716:2007 certification.

For cross-border brands targeting the European market, ISO 22716 certification is a hard prerequisite when choosing an OEM; lacking this document means the product cannot legally enter the EU market.

The US: MoCRA Market Landscape — GMP Regulations in Limbo

The US market's GMP requirements are in a historic transition period. Brands need to understand both "what it is now" and "what it will be in the future."

For a long time, the GMP standard implemented in the US was not mandatory but strongly encouraged by the FDA. However, since 2024, this situation is changing. US legislation requires that cosmetics sold in the US must be produced according to GMP standards determined and enforced by the FDA.

The game-changing law is the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)—the most significant overhaul of US cosmetic regulation in 80 years. MoCRA officially took effect on December 29, 2023, with facility registration and product listing execution officially launching in July 2024, marking the shift from the preparation phase to the subsequent compliance phase.

However, the formulation of specific GMP regulations has been delayed: MoCRA required the FDA to issue a GMP draft regulation by December 29, 2024, and finalize it by December 29, 2025. However, the latest unified display shows the FDA's rulemaking is classified as a "long-term action" with no clear timeline. The most optimistic expectation is that the GMP final draft might not be seen until October 2026 at the earliest.

Regulations not yet landing does not mean they can be ignored—the FDA has already begun releasing signals by issuing warning letters to facilities that produce both drugs and cosmetics, indicating that once GMP requirements are finalized, they will be strictly enforced. Additionally, a large amount of public comment supports adopting ISO 22716 as the US GMP standard, aligning with EU requirements.

For brands targeting the US market: Choosing an OEM holding ISO 22716 certification currently complies with US GMPC expectations and prepares a compliance warehouse in advance for the future formal landing of MoCRA GMP.

China: "Cosmetic Production Quality Management Specification" — Mandatory and Strict

China's GMP system has entered the formal regulatory mandatory enforcement stage since 2022 and has unique localization characteristics.

On January 7, 2022, the "Cosmetic Production Quality Management Specification" (hereinafter referred to as the "Specification") was officially released and implemented on July 1, 2022. The "Specification" consists of 9 chapters and 67 articles, clarifying the requirements for institutional setup, responsibilities, quality control, factories and equipment, material and product management, production process management, commissioned production management, and product sales management. It is the basic requirement that cosmetic registrants and filing entities must abide by.

The relevant inspection standards are also very clear: The "Key Points and Scoring Principles for Inspection of Cosmetic Production Quality Management Specifications" has a total of 82 inspection items for the actual production version, including 29 key items and 53 general items; the commissioned production version has 24 inspection items, including 9 key items. It is worth noting that currently 80% of the Chinese cosmetic market consists of commissioned production products, but inspections have found that some commissioning parties do not possess the corresponding commissioned production qualifications.

The most practical intersection between China's GMP and ISO 22716 is reflected in animal testing exemptions: Holding a GMP certificate issued by a government agency is one of the important prerequisites for applying for an exemption from animal testing for ordinary cosmetics. This has direct commercial significance for brands hoping to introduce internationally compliant Chinese OEM products into the European market.

Three-Way Certification Comparison Quick Table

Dimension	US (MoCRA/GMPC)	EU (ISO 22716)	China (Cosmetic GMP Specification)
Legal Enforcement	In transition, GMP final draft expected in 2026	Mandatory, since 2013	Mandatory, since July 2022
Applicable Standard	ISO 22716 (Expected) / FDA GMPC Guidelines	ISO 22716 / EN ISO 22716:2007	NMPA "Cosmetic Production Quality Management Specification"
Certification Body	Third-party (SGS, Intertek, etc.)	Third-party (EU-recognized bodies)	Government regulatory inspection + Third-party certification
Certificate Validity	3 years (Third-party audit)	3 years (Surveillance audit + Recertification)	3 years
Market Entry Barriers	Facility Registration (Mandatory) + GMP Regulation (Pending)	ISO 22716 + Responsible Person + CPSR + PIF	GMP Compliance Inspection + Product Registration/Filing

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Three Practical Suggestions for Cross-Border Brands Choosing OEMs

1. Use ISO 22716 as the Baseline

Do not accept OEMs that only hold domestic GMP certificates. ISO 22716 is a mandatory requirement for the EU, the most likely standard to be adopted by US MoCRA, and is also recognized by institutions like China's CQC for domestic GMP assessment. The most reliable high-quality OEM/ODM factories usually hold both ISO 22716 and GMPC certificates simultaneously. This is the minimum certificate combination that can best meet the compliance needs of the three major markets.

2. Confirm the OEM's MoCRA Facility Registration Status

MoCRA officially took effect on December 29, 2023, and registration and product listing execution started in July 2024. If the products manufactured by the OEM will enter the US market, the factory itself (or the US importer/brand owner) must complete the corresponding registration in the FDA's Cosmetics Direct system. OEMs that have not completed this step represent a compliance blind spot for exports to the US.

3. Focus on Commissioned Production Qualifications, Not Just the "Certificate Wall"

In the Chinese market, 80% of cosmetics are commissioned production, but regulatory inspections have found that some commissioning parties lack the corresponding qualifications. This means there may be an obvious gap between the certificates hanging in the OEM's showroom and their actual ability to pass official GMP inspections. Requesting the OEM to provide their most recent official GMP inspection record is a more effective due diligence method than just looking at certificates.

Choose OEM Manufacturers Summary

GMP certification is not a "pass" to cross borders, but the intersection of three regulatory systems with different logics, enforcement levels, and update speeds. GMPC/ISO 22716 certification applies to production facilities and operational processes, not the product itself—but producing in a certified facility is a necessary prerequisite for product registration and market access. When choosing an OEM, asking "What certifications do you have?" is just the starting point. The real question is: "Which markets do your certifications cover, when do they expire, and what were the results of your last official inspection?"