Regulations

Behind a 1.2 Million Yuan Fine: A Cosmetics OEM Factory Fell for 'Unauthorized Formula Changes'—What Brands Should Understand

Behind a 1.2 Million Yuan Fine: A Cosmetics OEM Factory Fell for 'Unauthorized Formula Changes'—What Brands Should Understand

Having been in the OEM business for over a decade, I've seen many storms, but this fine from September 2026 is still worth every brand owner and product maker's repeated review.

According to administrative penalty information from the Dongguan Municipal Market Supervision Administration (penalty decision date September 16, 2026, publicly reported by media including Nandu · Wan Cai She starting October 12, 2026), Dongguan Yongfei Cosmetics Co., Ltd. was fined 1.2 million yuan for three violations: producing cosmetics that do not meet technical specifications, failing to produce according to the technical requirements stated in the filing materials, and failing to label all ingredients on the label.

The product involved is the familiar "colorkey珂拉琪 Soft Focus Long-Lasting Loose Powder Transparent," with ordinary cosmetics filing number 粤G妆网备字2024405285, the entrusting party is Meishang (Guangzhou) Cosmetics Co., Ltd., and the entrusted manufacturer is Yongfei.

To be honest, this is not a case of a "product safety incident," but a typical case of serial violations—one set of filing materials, another set of actual ingredients, and yet another set of label claims. The problem occurred in the production phase, but beyond the penalty, every brand owner who outsources production should be sweating.

I. Event Review: 130,000 Boxes of Loose Powder, Three Violations Uncovered

According to public administrative penalty information, the sequence of events is clear.

The Dongguan Institute for Drug Control conducted sampling inspections on two batches of retained samples, detecting methyl 4-hydroxybenzoate (methylparaben) at 0.2% and propyl 4-hydroxybenzoate (propylparaben) at 0.15% in both batches.

The two batches had batch numbers YI36451 and YI33951, totaling 130,000 boxes produced, with YI36451 batch at 30,000 boxes and YI33951 batch at 100,000 boxes, at a uniform ex-factory unit price of 6 yuan/box, with a total value of 780,000 yuan, all sold to the entrusting party Meishang (Guangzhou).

On April 22, 2026, the company formulated a recall plan; as of May 15, 61,448 boxes were recalled and sealed and seized according to law; on July 21, 368,688 yuan in recalled goods payments were refunded. 68,552 boxes still actually entered the market, and illegal gains of 172,065.74 yuan were confirmed.

After the incident was exposed, Yongfei responded that rectification had been completed, the involved batches had been cleared, and the product would no longer be produced in the future, but some products could not be recalled; Meishang stated that it had quickly removed the products from shelves, locked inventory, and returned all to the OEM factory for unified disposal by the local regulatory authorities.

The numbers all come from the penalty information itself. Today we are not evaluating the companies, but clarifying one thing: how did these three violations occur one after another?

II. Breaking Down the Three Violations: The Problem Lies in 'Formula Consistency'

Violation 1: Producing Cosmetics That Do Not Meet Technical Specifications

There is a detail in the sampling results that many overlook: methylparaben was detected at 0.2%, which is compliant—the "Cosmetics Safety Technical Specifications" (2015 edition) sets the limit for this ingredient at no more than 0.4%.

The real violation is propylparaben. Both batches measured 0.15%, while the specification sets a mandatory safety limit for "propyl esters and their salts, total" at no more than 0.14%.

Don't underestimate this 0.01% difference. The limit values in the safety technical specifications are mandatory safety bottom lines, and the inspection conclusion is "non-compliant with technical specifications," with no room for negotiation. It's not that the ingredient cannot be added, but if added, it must stay within the limit.

Violation 2: Failing to Produce According to the Technical Requirements Stated in the Filing Materials

This point is actually more noteworthy than the exceedance itself.

The filed formula for this product only lists: mica, silica, dimethicone, aluminum starch octenylsuccinate, octanediol, tocopheryl acetate—from start to finish, these two preservatives were not included.

That is, when producing batches YI36451 and YI33951, the party added two preservative raw materials outside the filed formula without undergoing the change filing procedure, altering the already filed formula system, and this change was not reflected in the production records.

According to the requirements of the "Cosmetics Supervision and Administration Regulations," the entrusted manufacturer shall produce cosmetics according to the technical requirements stated in the registration or filing materials; if the formula truly needs adjustment, a change filing shall be handled according to law, rather than acting first and filing later, or not filing at all.

Violation 3: Labels Failing to Truthfully and Completely List All Ingredients

Ingredients were added to the formula, but the outer packaging label of the smallest sales unit did not list the names of these two ingredients.

The "Cosmetics Labeling Management Measures" clearly require that cosmetic labels shall truthfully, completely, and accurately list all ingredients of the product. If actual ingredients do not match the label claims, the ingredient list is incomplete, which harms consumers' right to know and also deprives regulators of a basis for traceability.

Looking at the three together: unauthorized addition of ingredients → addition amount exceeding the limit → not disclosed on the label—the consistency between filing, production, and labeling was completely broken in this case.

Cosmetics laboratory testing and formula record verification

III. Why Did a 'Small Action' Lead to a 1.2 Million Yuan Fine?

Some peers might think: just adding two preservatives, is a 1.2 million yuan fine justified?

Let's break down the numbers.

First, this is not an isolated mistake but three violations stacked. Non-compliance with technical specifications, failure to produce according to filed technical requirements, and non-compliant labeling—each falls under the regulatory scope of Articles 60 and 61 of the "Cosmetics Supervision and Administration Regulations," and can be separately characterized and considered together according to law.

Second, the base is not low. The two batches totaled 130,000 boxes, with a value of 780,000 yuan. Cosmetic penalty discretion is usually linked to the value of goods, illegal gains, recall situation, harmful consequences, and rectification attitude; the larger the value, the higher the corresponding penalty range.

Third, the products actually entered the market. Although 61,448 boxes were recalled, 68,552 boxes still flowed to consumers, and illegal gains of 172,065.74 yuan were confirmed. The risk has spilled over, which is completely different in discretion from the situation where all are sealed and not shipped.

In other words, the 1.2 million yuan is not the price of "adding an extra scoop of ingredient," but the total price of the entire chain of behavior: "unauthorized alteration of the filed formula system + exceeding mandatory limits + label concealment + tens of thousands of boxes entering the market." The regulatory signal is clear: there is no "good enough" in cosmetics production; filing, ingredients, testing, records, and labeling—any link that deviates from technical requirements will be held accountable.

IV. Lessons Brands Must Learn: Outsourcing Production Does Not Outsource Responsibility

Many brand owners doing production for the first time easily have an illusion: I am the entrusting party, the factory is a licensed manufacturer, production matters should naturally be the factory's responsibility, and I just sell the goods.

This idea is dangerous.

In the responsibility framework established by the "Cosmetics Supervision and Administration Regulations," the registrant and filer of cosmetics are responsible for the quality, safety, and efficacy claims of the cosmetics. Entrusted production does not equal transfer of responsibility; as the filer, even if the brand owner does not enter the workshop, it is one of the responsible entities for product quality and safety. If the factory is chosen carelessly and the process is loosely managed, when problems arise, delisting, recalls, and reputational damage directly pressure the brand side.

Based on this case, brand owners should at least keep an eye on five things:

1. The filed formula and actual ingredients must be consistent. The formula table used for bulk production must be checked word by word against the formula in the filing system. Any "process optimization" or "adding a little extra" is not allowed outside the filing.

2. Changes must be filed before production. If the formula, raw material suppliers, or production process truly need adjustment, go through the change filing procedure, and only arrange production scheduling after obtaining the result; the order cannot be reversed.

3. Raw material limits must be included in the factory's ingredient control. For permitted components such as preservatives, sunscreens, and colorants, the addition amount must not only consider whether to use them but also what the limit is, how to weigh, and how to double-check. The difference between 0.14% and 0.15% relies on the workshop's weighing verification and finished product testing.

4. Production batch records and retained samples must be checked. Whether each batch's production records, inspection records, and retained samples are complete, and whether ingredient addition, weighing, filling, and inspection are traceable. In this case, the change "was not reflected in production records," which is a hard flaw in itself. When inspecting goods, brand owners should not only look at the finished product feel but also develop the habit of checking batch records.

5. The label ingredient list must match the filing and actual ingredients. Conduct a label compliance review before packaging goes to print, checking the ingredient list, net content, filing number, domestic responsible person information, etc., item by item, so that outer packaging does not become the overlooked link.

V. Compliance Checklist for Choosing an OEM Factory: Clarify These Before Starting Work

Cosmetics packaging label ingredient list compliance review

Choosing a factory is not just about workshop decoration and quotation sheets. It is recommended that brand owners go through the following checklist item by item before sampling and ordering:

  • Are qualifications within the validity period? Business license, cosmetics production license, and whether the permitted scope covers the category you want to produce (e.g., loose powder corresponds to the relevant production unit).
  • Is the system operating, not just on the wall? Look at ISO22716 and GMPC-related system documents, and more importantly, whether the system is truly implemented in batch records and inspection records.
  • Does it insist on producing according to filed technical requirements? Ask clearly about the factory's control method for "filed formula is production formula," and whether there is a change evaluation and filing linkage mechanism.
  • How are weighing and ingredient addition double-checked? How are limited components weighed, who double-checks, and where are records kept? This is the first gate to prevent exceedances.
  • Does it have testing capability and a retained sample system? Is it self-testing or sent for testing, are ex-factory inspection items complete, and do retained sample quantity and duration meet traceability and re-inspection needs?
  • Is there a dedicated person for label review? Are packaging design drafts cross-checked with regulatory requirements and filing information, and can the ingredient list be consistent with actual ingredients?
  • Do recall and emergency mechanisms truly exist? Is there a recall plan, a ledger traceable to batch numbers and customers, and can batches and flow be quickly locked down if problems arise?
  • Is communication transparent? A qualified OEM factory will proactively tell you "this change needs filing first" or "this ingredient at this amount is risky," rather than saying everything is "negotiable."

We, Weitai, have been providing cosmetics OEM services for over ten years, with 4 major production bases, organizing production according to filed technical requirements, implementing ISO22716 and US GMPC quality management systems, and have provided OEM services for over 800 cooperative brands, with more than 100 products completing filing and market launch, accumulating over 70 technical achievements, and participating in the formulation of 3 industry standards. Here, formula changes are evaluated and filed first, batch records and retained samples are kept by batch, and packaging labels undergo compliance review before going online—these actions do not directly generate sales, but they determine whether a brand can go far. Brand owners with compliance OEM needs can contact customer service or leave a message online.

VI. Frequently Asked Questions

Q1: If the OEM factory changes the formula without authorization, is the brand owner responsible?

Yes. As the cosmetics filer, the brand owner bears primary responsibility for product quality and safety, and entrusted production does not transfer this responsibility. The brand owner needs to fulfill its quality obligations through factory selection evaluation, contract agreements, batch record verification, and incoming inspection; if the factory changes the formula without authorization, the factory bears legal responsibility in the production phase, and the brand owner also faces product disposal, recall, and its own responsibility determination issues.

Q2: What should be done if the formula needs adjustment after product filing?

Handle the change filing first, then arrange production. If the formula involves changes such as adding or removing raw materials or adjusting amounts, the filing change should be completed according to regulations before production; for special circumstances, handle according to the specific requirements of the regulatory authorities. Never produce first and complete procedures later, and certainly not produce while waiting for results.

Q3: Does this mean preservatives cannot be used at all?

No. Preservatives are used legally within the permitted component list of the "Cosmetics Safety Technical Specifications" (2015 edition), and the key is "permitted use, limited amount, limited scope." In this case, methylparaben detected at 0.2% is within the limit; the problem is propylparaben at 0.15% exceeding the mandatory limit of 0.14%, and it was not in the filed formula at all. Compliant use and illegal excess or unauthorized addition are two different things in nature.

Q4: Must all ingredients on the product label be listed?

Yes. The "Cosmetics Labeling Management Measures" require labels to truthfully, completely, and accurately list all ingredients; all actually added ingredients should be reflected in the ingredient list, arranged according to relevant rules. Omitting or concealing actually added ingredients is a labeling violation.

Q5: For a first-time private label, how to verify whether a factory is compliant?

At the initial stage, do four steps: first check licenses (business license, cosmetics production license and permitted scope), then inspect on-site or via video (workshop, weighing, testing, retained samples, warehousing), then review systems (production according to filed formula, change filing, batch records, label review, recall plan), and then monitor the first bulk order (check batch production records, inspection reports, retained samples, and label ingredient list). If uncertain, rather go slower than bet the brand on a factory that "agrees to everything."

Conclusion

This 1.2 million yuan fine is a lesson for the penalized company and a public textbook for the entire industry: the bottom line of cosmetics production lies in the boring details of filed formulas, weighing and ingredient addition, inspection records, and packaging labels.

When brand owners choose an OEM factory, they are never just choosing capacity and price, but a set of capabilities to implement "filing is the criterion" in every batch. Only by holding the compliance line can a brand be qualified to talk about growth.

Some content in this article was generated with the assistance of AI tools and has been manually verified and revised by editors.

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