On April 25, 2026, China’s National Medical Products Administration (NMPA) released a draft standardization plan proposing the formulation or revision of 27 new cosmetic-related standards — including mandatory technical requirements for hair dye ingredients (e.g., 2-methoxymethyl-p-phenylenediamine), cosmetic raw materials, and general technical specifications for toothpaste. This development directly affects exporters, OEM/ODM suppliers, and international buyers sourcing from China — particularly those targeting markets with strict ingredient traceability and safety dossier requirements, such as the EU, Middle East, and Southeast Asia.

Event Overview

On April 25, 2026, the NMPA published its draft cosmetics standard立项 plan, listing 27 proposed new or revised standards. Confirmed scope includes: (1) specifications for hair dye raw materials; (2) general technical requirements for toothpaste; (3) testing methods and safety assessment criteria for cosmetic ingredients; and (4) a requirement that all newly used cosmetic raw materials must complete registration or filing with the NMPA before export or domestic use. The plan is currently in the public consultation phase; no final effective date has been announced.

Industries Affected by Segment

Direct Exporters & Trading Enterprises

These entities face immediate compliance pressure when shipping finished products containing newly regulated ingredients — especially to regions enforcing the EU Cosmetics Regulation (EC No 1223/2009), Saudi FDA requirements, or ASEAN Cosmetic Directive Annexes. Under the draft, export declarations may soon require validated NMPA registration numbers for listed dye substances or toothpaste base components, affecting customs clearance and buyer acceptance.

Raw Material Procurement & Sourcing Firms

Suppliers managing global ingredient portfolios must verify whether their current inventory or contracted raw materials fall under the 27 proposed standards — particularly those related to amine-based hair dyes and fluoride/non-fluoride toothpaste actives. The draft mandates full documentation alignment with NMPA’s upcoming safety data submission templates (e.g., VCRP/FDA/SAFETY DATA packages), increasing due diligence burden on procurement audits and vendor qualification.

OEM/ODM Manufacturing Service Providers

Contract manufacturers serving international brands will need to update internal compliance files, including raw material safety dossiers, batch traceability records, and formulation disclosure packages. Since the draft requires all new cosmetic ingredients to be registered or filed prior to use, production planning for new SKUs — especially colorants and oral care formulations — may face delays pending NMPA review timelines.

Supply Chain & Regulatory Support Services

Third-party labs, regulatory consultants, and dossier preparation firms will see increased demand for NMPA-aligned technical documentation — particularly for ingredient-specific toxicological summaries, impurity profiling (e.g., for 2-methoxymethyl-p-phenylenediamine), and cross-referenced submissions supporting both NMPA and overseas filings (e.g., EU CPNP, US FDA VCRP). However, service scope remains contingent on final standard texts and implementation guidance.

What Relevant Enterprises or Practitioners Should Focus On Now

Monitor Official Updates and Consultation Feedback Periods

The NMPA draft is open for public comment. Enterprises should track official announcements via the NMPA website and national standardization platforms to identify which specific substances or clauses draw regulatory emphasis — especially any revisions to transition timelines or grandfathering provisions for existing formulations.

Prioritize Ingredient-Level Review for High-Risk Categories

Focus initial internal assessment on hair dye intermediates (e.g., substituted p-phenylenediamines) and toothpaste functional ingredients (e.g., abrasives, fluorides, antimicrobials). Cross-check current supplier SDS, INCI names, and CAS numbers against the draft list — noting that ‘2-methoxymethyl-p-phenylenediamine’ is explicitly cited as a targeted substance.

Distinguish Between Policy Signal and Operational Requirement

This is a draft standardization plan — not an enforceable regulation. While it signals tightening oversight, actual compliance obligations will only arise upon formal publication and stipulated effective dates. Companies should avoid premature reformulation or costly dossier overhauls until final texts and enforcement schedules are confirmed.

Prepare Documentation Frameworks Ahead of Finalization

Begin aligning internal raw material master files with anticipated NMPA dossier structures — including safety data summaries, impurity profiles, and usage concentration limits. Pre-build templates compatible with both NMPA requirements and parallel submissions (e.g., FDA VCRP, EU CPNP) to streamline future dual-market compliance workflows.

Editorial Perspective / Industry Observation

From an industry perspective, this draft plan is best understood as a regulatory signal — not yet an operational mandate. It reflects the NMPA’s strategic shift toward upstream control of high-risk cosmetic ingredients and harmonization with international safety expectations, especially for categories with documented sensitization or systemic exposure potential (e.g., oxidative hair dyes, oral care products). Analysis来看, the inclusion of toothpaste under cosmetic standards marks a formal consolidation of regulatory oversight previously split between NMPA and the former State Drug Administration — suggesting long-term convergence of safety frameworks across personal care subcategories. Observation来看, the explicit naming of 2-methoxymethyl-p-phenylenediamine indicates heightened scrutiny of amine-based dye derivatives, likely driven by emerging toxicological data. Current more appropriate interpretation is that this represents a staged alignment effort — where standard-setting precedes enforcement, allowing industry time to adapt without abrupt disruption.

Conclusion

This draft standardization initiative does not introduce immediate legal obligations but establishes a clear trajectory for tighter ingredient-level governance in China’s cosmetic and oral care supply chain. Its significance lies not in present-day enforcement, but in its role as a forward-looking framework shaping procurement, manufacturing, and regulatory strategy over the next 12–24 months. A rational, evidence-based reading treats it as an early-stage policy signal — one requiring structured monitoring and preparatory alignment, rather than urgent operational overhaul.

Source Attribution

Main source: National Medical Products Administration (NMPA) of the People’s Republic of China — Draft Cosmetic Standardization Plan Announcement (April 25, 2026).
Items requiring ongoing observation: Final standard texts, effective dates, transitional arrangements, and official interpretation of ‘new raw material’ definitions (e.g., grandfathering criteria for currently marketed substances).