Since the start of 2026, the hottest term in the cosmetics industry hasn't been "efficacy"—it's "compliance."
The National Medical Products Administration has been issuing a密集 wave of new regulations since the beginning of the year—the revised Cosmetics Registration and Filing Administration Measures, the Cosmetics Efficacy Claim Evaluation Specifications, the Cosmetics Complete Version Safety Assessment Guidelines, the Cosmetics Labeling Administration Measures... A series of documents have rewritten the rules of the entire contract manufacturing industry chain.
Many brand owners have recently come to us, and the first question they ask is: "Can the products I made before still be sold?"
My usual answer is: Yes, but it depends on how your cooperation agreement with the contract manufacturer is written, and whether the factory can cooperate with you to make changes. The new regulations mainly constrain newly filed products; already filed products are given a transition period (generally until the end of 2027). However, brand owners are advised to gradually complete the documentation for old products in accordance with the new regulations during the transition period to avoid being targeted by professional anti-counterfeiting claimants. If not completed during the transition period, after the end of 2027, old products may also face delisting risks.
Today, let's break down the most direct impacts of the 2026 new regulations on contract manufacturing cooperation, focusing on 4 things brand owners must confirm with factories in advance. After reading this, you should have a clear idea of how to negotiate with contract manufacturers.
1. Ingredient Submission Code: Every Ingredient Needs an "ID Card"
Original text of the new regulation: Starting January 1, 2026, all cosmetics filing products must fill in the ingredient submission code (ingredient safety information code); those not filled in will not be filed.
Impact on contract manufacturing cooperation: The ingredient submission code is applied for by the ingredient manufacturer in the National Medical Products Administration system, and each ingredient corresponds to an independent submission code. If a certain ingredient used by the contract manufacturer does not have a submission code, the entire product filing cannot be done.
One point worth noting: The ingredient submission code is applied for by the ingredient manufacturer; neither the brand owner nor the contract manufacturer is eligible to apply. However, if the contract manufacturer has self-developed ingredients (proprietary formula, proprietary production process), the contract manufacturer can apply as the ingredient manufacturer. Therefore, when selecting a factory, ask clearly whether their ingredients are externally sourced or self-developed, and who is the applicant for the submission code.
The first thing brand owners must confirm with the factory: What is the coverage rate of ingredient submission codes in your commonly used ingredient library?
The industry status quo is that, according to data as of July 1, 2026, the coverage rate of domestic cosmetics ingredient submission codes is about 65% (data source: public notice by the National Medical Products Administration). There are still 35% of commonly used ingredients without submission codes, mainly concentrated in the following categories:
Compound efficacy ingredients (such as ambiguously named ones like "whitening complex" and "anti-acne essence")
Plant extracts (many plant extracts have complex compositions, making it difficult to apply for a single submission code)
Fermented ingredients (the application cycle for submission codes for fermented ingredients is long)
Weitai's ingredient submission code coverage: As of July 2026, of the 2,600+ ingredients in the commonly used ingredient library, 2,480 have applied for submission codes, with a coverage rate of 95.4%. The remaining 4.6% are fermented ingredients and some niche plant extracts, which are already in the process of supplementary application.
If your contract manufacturer's ingredient submission code coverage rate is below 90%, it is recommended to immediately ask the factory to provide a rectification timetable. Either change ingredients, wait for the factory to complete supplementary applications, or change factories.
2. Complete Version Safety Assessment: Formulas Cannot "Go Out Barefoot"
Original text of the new regulation: Starting May 1, 2026, cosmetics filing must submit a complete version safety assessment report; simplified version assessments will no longer be accepted (except for some cleaning cosmetics with the lowest risk assessment level).
Impact on contract manufacturing cooperation: The complete version safety assessment report is a highly professional technical document that requires evaluating the toxicological data of each ingredient, exposure dose, interactions between formula components, and the margin of safety (MoS) of the final product. This report cannot be produced casually by a factory; it must be jointly signed by qualified toxicologists and formulators.
The second thing brand owners must confirm with the factory: Can you provide me with a complete version safety assessment? Who will sign the report?
Compliance requirements for the complete version safety assessment report:
Assessors must have a bachelor's degree or above in toxicology, pharmacy, or cosmetics-related fields
Assessors must have undergone complete version safety assessment training recognized by the National Medical Products Administration
The assessment report must be signed by the assessor personally; proxy signatures are not allowed
All data in the report must be traceable (ingredient COA, toxicological literature, formula table)
Many brand owners are concerned about costs. The price of a complete version safety assessment report is directly linked to formula complexity: simple formulas (within 10 ingredients) cost about 30,000-50,000 RMB; complex formulas (20-30 ingredients) cost about 80,000-150,000 RMB; efficacy formulas (containing efficacy ingredients) cost about 150,000-300,000 RMB. Brand owners should include this cost in their budgeting.
Weitai's safety assessment capability: In-house complete version safety assessment team of 5 people (all with master's degrees or above in toxicology from key universities, all trained by the National Medical Products Administration and holding qualification certificates). In 2025, completed 1,200+ complete version safety assessment reports, covering five major categories: creams, essences, masks, cleansers, and wash-care products.
If your contract manufacturer claims they "can produce complete version safety assessments" but cannot specify the assessors' qualifications, training certificates, or the number of assessment cases in the past year, then the report is likely template-based, and the review center will take notice.
3. Efficacy Claim Basis: If You Dare to Claim, You Must Have Evidence
Original text of the new regulation: Starting June 1, 2026, cosmetics efficacy claims must be supported by at least one of three types of evidence: human efficacy tests, consumer use tests, or laboratory data. Efficacy claims without efficacy basis will be directly rejected during filing.
Impact on contract manufacturing cooperation: Many brand owners previously used to write efficacy claims like "7-day whitening," "28-day acne removal," "deep hydration." But after June 1, 2026, such claims must be supported by human efficacy test data (or consumer use tests, laboratory data), otherwise they cannot be written.
The third thing brand owners must confirm with the factory: Can you cooperate with me to conduct human efficacy tests? How long is the test cycle? How are costs calculated?
First, a key question: Do all products need human efficacy tests? Not necessarily. It depends on the type of efficacy claim. Moisturizing, cleansing, aromatic, hair dyeing, perming, bodybuilding, and deodorizing efficacy can follow a simplified path and do not necessarily require human efficacy tests. However, efficacy claims such as whitening, spot removal, sunscreen, anti-hair loss, acne removal, anti-wrinkle, firming, and repairing must undergo human efficacy tests or consumer use tests. Therefore, when planning product lines, brand owners can reasonably choose the types of efficacy claims to reduce unnecessary testing costs.
General process of human efficacy tests:
Test protocol design: 2-4 weeks
Ethics committee approval: 1-2 weeks
Subject recruitment + screening: 2-4 weeks
Test execution: 4-12 weeks (depending on efficacy type)
Data statistical analysis + report: 2-4 weeks
Total cycle: 3-6 months.
Cost: The efficacy test cost for a single product ranges from 80,000 to 300,000 RMB (depending on efficacy type, sample size, and test cycle). Whitening and spot removal are the most expensive (≥200,000 RMB), while moisturizing is relatively cheaper (80,000-150,000 RMB).
Weitai's efficacy claim capability: Long-term cooperation with 3 tertiary hospitals' efficacy evaluation centers, including Southern Medical University and Xiangya Hospital. In 2025, completed 80+ human efficacy tests, covering seven major efficacy types: whitening, spot removal, acne removal, anti-wrinkle, soothing, repairing, and moisturizing.
If your contract manufacturer says "write efficacy claims as you like," they are basically fooling you. Either the factory has its own human efficacy testing capability (such factories are rare), or the factory has connected with a third-party efficacy evaluation center (this kind of cooperation can save brand owners 30% of time and cost), or the factory tells you "we can't do it, advise you not to write it" (this kind of factory is more honest).
If the contract manufacturer really does not cooperate with efficacy tests, brand owners also have several options: First, change factories; second, brand owners find a third-party efficacy evaluation center themselves—the advantage is neutrality and authoritative reports, the disadvantage is high price and long cycle; third, reduce efficacy claims and only write categories that do not require human tests (moisturizing, cleansing, etc.). Brand owners who have been in cosmetics for the long term are advised to connect with at least 2-3 third-party efficacy evaluation centers to leave enough backup options.
4. Registrant's Primary Responsibility: If Something Goes Wrong, Brand Owner and Factory Bear It Together
Original text of the new regulation: Starting January 1, 2026, the cosmetics registrant/filer bears full legal responsibility for the product's quality safety and efficacy claims. The entrusted production enterprise (contract manufacturer) bears corresponding responsibility for the quality safety of the production process.
Impact on contract manufacturing cooperation: This clause is the most critical in the 2026 new regulations.
In many previous contract manufacturing cooperations, the rights and responsibilities of brand owners and factories were vague. Brand owners provided ideas and designs, factories provided production. When something went wrong, the brand owner said "it was produced by the factory," and the factory said "the brand owner told us to do it this way," shifting blame back and forth.
After 2026, this blame-shifting no longer works.
The new regulation clearly states: The registrant/filer is the first responsible person for product quality safety. The registrant can be the brand owner itself, or a legal entity entrusted by the brand owner (such as a contract manufacturer). But no matter who serves as the registrant, if something goes wrong, the registrant cannot escape, and the entrusted production enterprise must also bear corresponding responsibility.
The fourth thing brand owners must confirm with the factory: In our cooperation agreement, who is written as the registrant entity? How are responsibilities shared if something goes wrong?
There are 3 models here:
Model 1: Brand owner as registrant, contract manufacturer as entrusted production enterprise. The brand owner bears all quality safety responsibility, and the factory is only responsible for production process quality. The advantage is that the brand owner has complete control over the product; the disadvantage is that the brand owner faces the greatest legal risk.
Model 2: Factory as registrant, brand owner as distributor. The factory bears quality safety responsibility, and the brand owner is only responsible for sales. The advantage is that the brand owner has low legal risk; the disadvantage is that the brand owner has weak control over the product, and the product registration certificate belongs to the factory.
Model 3: Brand owner + factory joint registrant. Both parties jointly serve as registrants and are jointly responsible for the product. The advantage is that the rights and responsibilities of both parties are clear; the disadvantage is that the cooperation agreement must be written in great detail, otherwise "gray areas" are likely to appear.
Weitai's compliance model: All three models can be done, but in 2026 we recommend that brand owners adopt Model 1 (brand owner as registrant, Weitai as entrusted production enterprise). There are three reasons: First, the brand owner has complete control over the product; second, the registration certificate belongs to the brand owner, and long-term assets are in the brand owner's hands; third, the factory only bears production responsibility, avoiding the hidden danger of "the contract manufacturer using my registration certificate to take orders from others."
Several points that must be clarified in the cooperation agreement:
Who is written as the registrant entity, and who owns the registration certificate
Who owns the formula intellectual property
Who is responsible for ingredient procurement
Who is responsible for packaging design, and who checks copy compliance
How to share responsibility and determine compensation ratios in case of quality accidents
How to handle the registration certificate, formula, and packaging after cooperation termination
Weitai's Recommended Contract Manufacturing Cooperation Process
Based on the requirements of the 2026 new regulations, Weitai recommends that brand owners negotiate with contract manufacturers according to the following process:
Step 1: Factory qualification review. Check the factory's business license, production license, cosmetics production license, medical device production license (if doing medical device products). Check the factory's ingredient submission code coverage rate, complete version safety assessment team, and efficacy claim cooperation resources.
Step 2: Registrant entity confirmation. Clearly specify the registrant entity and the rights and responsibilities of both parties in the cooperation agreement.
Step 3: Ingredient submission code verification. List all ingredients, verify submission codes one by one; for missing ones, either replace or wait.
Step 4: Complete version safety assessment connection. The factory produces the complete version safety assessment report, and the brand owner confirms the report content and signatory qualifications.
Step 5: Efficacy claim planning. Based on product positioning, determine which efficacy claims need to be written, and the factory cooperates with human efficacy tests or connects with third parties.
Step 6: Packaging copy compliance review. The brand owner produces the initial copy draft, the factory provides compliance review opinions, and both parties confirm before finalizing.
Step 7: Filing submission. The factory assists the brand owner in submitting the filing; after filing approval, mass production begins.
Step 8: Post-market regulatory cooperation. After the product is launched, if subject to regulatory sampling or complaints, the brand owner and factory must cooperate in providing ingredient COA, production records, inspection reports, etc.
