Regulatory compliance (EU / US FDA) Registered regulatory filing 5 major reforms, emerging brands market share 57.37% higher, OEM embraces dual strategic advantage

On 3 April 2026, the industry received two heavy-pound signals at the same time: regulatory compliance (EU / US FDA), which issued a bulletin on 31 March on matters related to the registration of cosmetics and regulatory filing (a consultation draft), introduced five key changes involving China's initial release of exempt materials and the relief of animal trials, and was open to industry-wide consultations until 30 April; at the same time, the Southern Metropolitan News Day reported that the market share of emerging brands make-up brands in 2025 had reached 57.37 per cent, and the first line emerging brands brand was accelerating globalization with Hong Kong shares. Two major signal superimposed, for the OEM contract manufacturing industry, meant that a rare strategic window was opening.

I. regulatory compliance (EU / US FDA) Heavy pounds reform: registration regulatory filing 5 Key Change Depth Interpretation

Regulatory compliance (EU / US FDA) published the Opinion on Deepening Cosmetic Regulatory Reform for Quality Development in Industry in November 2025. The main post-No. 18 initiative, which ended on 30 April 2026, is expected to take place in the second half of 2026.

Change 1: Encourage the new cosmetics "China Launch" - to open up the world's premiere.

Core content: regulatory filing, when registered, is required to provide a description of product formulation and process innovation for new products of international cosmetics listed in China, or simultaneously in China and other countries (regions). formulation + China has initiated a statement of commitment exempting it from submitting the normally required "sales of documents listed in producing countries".

Industry implications: This change directly breaks one of the biggest barriers to international brand registration in China. In the past, overseas brands had to be listed in their home countries before submitting "listed certificates". If the new rule is implementation, China is expected to become the world’s first market for new make-up products, directly attracting an accelerated international branding.

Impact on OEM: The international brand selection in China necessarily requires OEM/ODM factory from mainland China as a production compliance partner. The contract manufacturing plant with GMP certification capacity to complete the regulatory filing service will be a priority.

Change 2: Reduced cosmetic animal testing requirements - a much shorter research and development cycle is expected

Scope of application (two conditions are met simultaneously):

  • (a) The category type is: hot hair in special cosmetics, non-oxidized hair, brightening products with only physical cover; or common cosmetics using new materials from the safety monitoring period;
  • Production enterprises have obtained certification of the production quality management system qualification issued by the government of the country (region) in which they are located, and safety is fully recognized in the product safety risk assessment.

Comparison of data: The current toxicological animal trials usually take 3 to 6 months and, if exempted, the registration/regulatory filing cycle for the products concerned is expected to be reduced from 18 to 24 months to 9 to 15 months, increasing the direct listing rate of new products by 40 to 50 per cent.

Change 3: efficacy claims that the evaluation methodology has been significantly expanded - the self-building approach of the enterprise is acceptable

With the exception of brightening, sun protection, and the three special types of disempowerment protection efficacy, the remaining efficacy declared (e.g. moisturizing, soothing, firming, anti-wrinkle, brightening skin, etc.) to allow enterprises to independently choose national standards, industry standards, international standards, technical guidelines, or conduct efficacy evaluation in a fully validated manner.

This means that the contract manufacturing plant, which has its own laboratory and efficacy evaluation system, has internal test data that can be used as a direct basis for efficacy to claim that it no longer relies on third-party testing agencies to effectively reduce research and development costs and cycles.

Change 4: formulation system approximation products share safety and efficacy data - multiplication of product series propulsion efficiency Increase

The same brand of "formulation system approximation product" (e.g., series of products with the same bottom formulation, different aroma/chromosomal variants) allows the sharing of safety assessment reports and efficacy evaluation data for representative products when registered with regulatory filing, without the need to duplicate information for each product.

For OEM contract manufacturing, this change is important for advancing "sequence product development" (e.g., a fine base + multi-skin/colour version) by significantly reducing the cost of registering regulatory filing for brand customers and increasing the value of partnerships with platforms such as QuickOEM.

Change 5: Simplify change of information on responsible persons in the country - barrier to entry

The information on applications for changes required by duty-bearers in China will be simplified, and the reduction in the number of barrier to entry of foreign brands replacing China ' s compliance agents will help attract more offshore brands to key beauty markets through agency cooperation modalities.

II. emerging brands market share 57.37%: structural changes behind five years of boom

The Southern Metropolis report of 3 April 2026, citing Ewiy International data, shows that the market share of the emerging brands make-up brands reached 57.37 per cent in 2025, behind which there has been a sustained increase over the past five years:

The continued growth of market shares stems from three main structural underpinnings:

Support 1: A logical shift in consumption decision-making. The report states that 58.8 per cent of consumers use " ingredient " as the core purchasing decision indicator, while 41.4 per cent view " efficacy " at the core. emerging brands brands break the "brand premium" barrier for international brands through ingredient Kopp+ efficacy (EWG/CIR/Clinical literature endorsement).

Support 2: R & D inputs added continuously. The industry average R & D cost rate rose from 2.36 per cent in 2020 to 3.24 per cent reported in 2025; the head brands of Perais, Hua Hee-Bian and Upper United States shares have established a large stand-alone AI formulation model and developed a substantial evolution of capacity.

Support 3: A systematic retreat of international brands releases market space. In 2024-2025, more than 23 international brands, including Filorga, Hince, Iti House and others, withdrew or significantly contracted out of key beauty markets or contracted distribution channel. The released shelf space is being systematically taken over by emerging brands emerging brands, such as Nature Hall, Valley Rain and HBN.

Emerging brands make-up global expansion into "capital acceleration"

Emerging brands make-up not only establishes a leading position in the local market, but also uses port shares as a key springboard for global expansion. As of April 2026, many brands had entered the Hong Kong stock listing process:

  • Pelea (August 2025): launch of the "A+H" dual listing for overseas distribution channel construction and brand localization
  • Natural Hall (September 2025): submission of a copy of the register of places of residence to strengthen DTC distribution channel and offshore operations
  • Maru Mei (November 2025): Apparel Port Unit, Target Internationalization Strategy
  • Half acre of flower fields (January 2026): Sprinting Port Unit, which received $1.895 billion for the first nine months

China Gold has analysed the "A+H" model as helping the emerging brands brand to match global capital in a context of geo-uncertainty, and as more effective in raising the awareness of offshore investors of the R & D power and business model of emerging brands.

A triple strategic opportunity for the OEM contract manufacturing sector

In the face of regulatory compliance (EU / US FDA) reform + emerging brands rising + global expansion accelerating the triple signal superheavy, the OEM contract manufacturing industry is facing systemic opportunities:

Opportunity 1: Take over the production compliance services of China ' s initial international brand

Regulatory compliance (EU / US FDA), the new rule of implementation, will accelerate the choice of an international brand in China. For contract manufacturing plants with international GMP certification (ISO 22716, FDA registered, EU cosmetics factory qualification), it is a new market of high value and high barriers. QuickOEM is systematically combing the list of co-operatives eligible for "first production".

Opportunity 2: Assist brand customers in using the formulation logical development series

The new regulations allow for the sharing of safety data for similar products in the formulation system, and theoretically a "formulation + N variant" serialized development model will be mainstreamed. OEM factory can proactively provide a one-stop service to clients for "the bottom formulation + serialization program" to reduce the cost of individual regulatory filing for clients and to increase the depth and viscosity of cooperation.

Opportunity 3: Layout "global expansion compliance contract manufacturing " capability to follow brands to the global level

The international compliance capacity of the emerging brands brand with large-scale global expansion, contract manufacturing plant (EU CPNP regulatory filing, United States FDA OTC registration, Japan ' s Ministry of Health, Labour and Welfare regulatory filing, ASEAN Cosmetic Directive for Southeast Asian countries) will become core competitiveness. It is recommended that the contract manufacturing plant focus in 2026 on the construction of the global expansion compliance system and participate with QuickOEM in the emerging brands brand of global expansion supply chain.

V. Proposals for action

Yes, brand owner.

  • Regulatory compliance (EU / US FDA) consultation draft by 30 April: To keep abreast of the details of the reforms, in particular the animal test relief and sharing of formulation provisions, and to plan ahead for the development of new products.
  • Formulation "Strategy " formulation: Develop the "formulation + series variant" programme in consultation with contract manufacturing plant to reduce the registration regulatory filing cost by 30-50%.
  • Improvement of OEM compliance files prior to the roll-out: contract manufacturing GMP certificates, quality system audit reports, environmental compliance documents need to be filed in advance if there is a Hong Kong stock listing plan.

For OEM contract manufacturing plant

  • Application for access to international GMP qualification: seek ISO 22716 international certification in preparation for taking over international brand production from China.
  • Establishment of efficacy evaluation self-building method: efficacy evaluation laboratory within the investment to form an intra-firm methodological theory and reduce third-party testing reliance on customer brands.
  • Global expansion/ompliance capacity-building: Cooperation with professional compliance services to systematically streamline the process of registering cosmetics in the European Union, Japan and South-East Asia, in preparation for following emerging brands brand global expansion/.

Contract manufacturing service

Data sources

  • Regulatory compliance (EU / US FDA) Integrated Division Bulletin on Cosmetics Registration regulatory filing Related Matters (Approval Draft) (published on 31 March 2026, call-up deadline 30 April)
  • The Southern Metropolitan newspaper, emerging brands, has a market share of nearly 58 per cent, and the Hong Kong stock has become an important springboard for internationalization.
  • Europe-Wise International, China Cosmetics Market Share Tracking 2025
  • China Gold Company, Double Listing Study of emerging brands Makeup Port Stock
  • Regulatory compliance (EU / US FDA) Observations on Deepening Regulation of Cosmetics Reforms for Quality Industrial Development (2025) Number 18)
  • What's worth buying / Tiger Sniff?

Other Organiser

This article is published by the QuickOEM Make-up OEM Smart Matching Platform. More makeup OEM knowledge, cosmetics contract manufacturing, skin protection private label, make-up customizationontent are available at the Knowledge Centre. If you need advice on OEM contract manufacturing, please contact 1814805760 or submit your request through an online request for quotation.

Keywords: Precision, OEM, contract manufacturing, sun protection, contract manufacturing, HBN, Hong Kong Cosmetics IPO, DTC, emerging brands market share, Animal Test Relief, ODM, regulatory compliance (EU / US FDA) Cosmetic Registration regulatory filing Reform, U.S., U.S.S., OEM contract manufacturing Opportunities, Cosmetic Information, Trends in the Cosmetic Industry, Cosmetics Market Dynamics, Cosmetic Policy Regulations

QuickOEM is a QuickOEM platform for vertical digitization of cosmetics services (known as QuickOEM) focusing on OEM, cosmetics contract manufacturing, skins private label, cosmetics z, brand-wide, ODM contract manufacturing services. AI smart matches the 500+ certification contract manufacturing plant, providing a one-stop package from formulation R&D to regulatory compliance (EU / US FDA) covering skin, makeup, sheet mask, serum, eye patch, category, category, etc.

Core functions

  • Makeup OEM needs to be published to match factory AI intelligence
  • Cosmetics contract manufacturing / skin protection private label customization ODM service
  • Formulation R&D management and multi-version tracking
  • Ingredient Compliance testing (regulatory compliance (EU / US FDA)/EU 1223/2009/FDA)
  • Regulatory compliance (EU / US FDA) Cosmetics regulatory filing fully tracked
  • Supply chain
  • Advertising Law Compliance Testing
  • Z / eye patch / serum / z all category

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