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KONGDY
The Safety Gate 2025 Report Read as a Rhythm: What 4,671 Alerts and 5,794 Actions Mean for a Slimming Patch OEM in 2026
The Safety Gate 2025 Report Read as a Rhythm: What 4,671 Alerts and 5,794 Actions Mean for a Slimming Patch OEM in 2026
The European Commission published its Safety Gate annual report for 2025 on 5 March 2026, and the two numbers at the top of it are 4,671 alerts and 5,794 follow-up actions.
Almost every reader of that report will take the first number and ignore the second, and for a manufacturer the second is the more useful of the two.
The first number is a count of what was found. The second is a count of what was done about it, and it is larger because one finding can produce a withdrawal in one country, a hold at a border in another, a listing removal from a platform in a third and a recall in a fourth. The 4,671 is how many incidents there were. The 5,794 is how many times somebody had to act.
But the annual figure is also a retrospective, and this is where the panel of weekly data matters. The report describes 2025. The Safety Gate itself publishes a rolling weekly panel, and by the end of the first 38 weeks of 2026 it had already recorded 2,663 notifications, of which 1,528 or 57.4 percent were China-origin, against 40.1 percent in the same period of 2025.
A slimming patch OEM reading only the annual report is reading a system as it looked twelve months ago, and a system that publishes close to a hundred notifications a week does not stand still for twelve months.
Read together, the two datasets say something that neither says alone. The annual report tells you the scale and the shape of the system. The weekly panel tells you that the system is running continuously, at close to 100 notifications a week, and that the composition of what it finds changed sharply within a single year.
For a slimming patch OEM the question those two datasets actually answer is narrower than the numbers and much more actionable. If a cosmetic patch is being assessed for a European launch in 2026, the relevant question is not how many alerts there were. It is how the alerts arrive, what they consist of, and where the file that prevents them sits.
1. The weekly panel is not a quarterly report
The Safety Gate publishes validated alerts continuously and issues a weekly report every Friday, and in 2025 that worked out at almost 100 notifications a week.
| The figure | What it is | What it does not mean |
|---|---|---|
| 4,671 alerts in 2025 | The annual total of validated notifications | It is not a sample, and it is not a figure for any one product line |
| Almost 100 notifications a week | The average rate at which findings are validated and published | It is not evenly distributed across the year, and it is not a schedule you can plan around |
| 5,794 follow-up actions | The annual total of decisions taken by national authorities | It is not one action per alert, and it is not a count of products pulled |
| 2,663 notifications in weeks 1 to 38 of 2026 | The year-to-date panel, published from 1 January to 25 September | It is not a full-year figure and it must not be compared with a full-year total |
The third row of that grid is the one that catches people who read two years of data side by side. The 2,663 for the first 38 weeks of 2026 and the 4,671 for the whole of 2025 are not comparable, because one is 38 weeks and the other is 52.
Scale the 38 weeks up and 2026 is running at a materially higher rate than 2025 for the same period. That is the useful comparison, and it is not the one that appears in most summaries of the data.
A slimming patch OEM that quotes the 2,663 against the 4,671 as though they were two points on one curve is making the most common mistake with this dataset, and the mistake flatters the trend by understating it.
A slimming patch OEM that treats this as a once-a-year question has the wrong cadence. At close to 100 notifications a week, and with cosmetics as the single largest category three years running, the relevant question for a launch is whether the file holds against the current weekly panel rather than whether it held against last year.
The distinction matters because the two figures answer different questions. An annual total tells a company how big the system is, and a weekly panel tells it how fast the system is moving. A slimming patch OEM needs the second number to schedule anything, because the first number does not change what happens this week.
2. The composition, and the one number that dominates everything
Cosmetics accounted for 36 percent of all 2025 notifications, which is the third consecutive year the category has come first, and chemical risk accounted for 53 percent of all notifications, more than half of the whole system.
| Category or risk | Share of 2025 notifications | What it tells a cosmetic patch programme |
|---|---|---|
| Cosmetics | 36 percent, first for the third consecutive year | The category a patch sits in is the category most closely watched, which means a cosmetic finding is not an unusual event |
| Toys | 16 percent | A distant second, and a category with its own separate regulation |
| Electrical appliances and equipment | 11 percent | A third, and a category whose failures are electrical rather than chemical |
| Chemical risk | 53 percent of all notifications | The dominant failure mode in the entire system is a substance in the product |
| Injuries | 14 percent | The second risk type, and the one driven by mechanics rather than chemistry |
| Choking | 9 percent | The third, and a category with almost no relevance to a topical product |
Almost eight in ten of the cosmetics alerts in 2025 related to the presence of BMHCA, a banned synthetic fragrance that can harm the reproductive system and irritate skin. That single substance is the reason a 36 percent share exists, and it is worth pausing on what that means.
A cosmetic patch programme reading 36 percent and concluding that a third of their risk is fragrances is reading a statistic about one substance and calling it a statistic about a category. The share is real. The generalisation from it is not, because the 36 percent is not a measure of how often cosmetic patches are the subject of an alert.
For a slimming patch OEM the useful reading of the 36 percent is narrower and more useful. It says the cosmetics enforcement machinery is fully staffed, fully reported and has been for three consecutive years, so the time to prepare a file is now and not at the point of launch.
A slimming patch OEM that reads the 36 percent as a probability is reading it wrong. It is a share of a category that is being watched closely, and the two statements do not mean the same thing.
3. The shift inside a single year
Within the 2026 panel for weeks 1 to 38, China-origin products accounted for 1,528 of 2,663 notifications, which is 57.4 percent, against 40.1 percent in the same period of 2025. That is a rise of 17.3 percentage points in one year.
| The 2026 weeks 1 to 38 panel | China-origin notifications | What it means |
|---|---|---|
| Toys | 456 | The largest category by volume in the panel, and the one least like a patch |
| Electrical appliances and equipment | 405 | Second by volume, and a category with different failure modes |
| Childcare articles and children's equipment | 77 | Third, and a category with its own dedicated regulation |
| Cosmetics | 76 | Fourth by count, and first by relevance to a cosmetic patch programme |
| Lighting chains | 61 | Fifth |
| Machinery | 58 | Sixth |
| Chemical products | 45 | The row a patch programme should read most carefully, because a chemical product failure and a cosmetic failure are the same kind of failure |
| Clothing, textiles and fashion items | 44 | The eighth largest row |
The cosmetics row is fourth by volume with 76 notifications, and it is the row that matters most to a patch programme. The two rows above it are a toy and an electrical appliance, and a reader who takes the ranking as a risk table ends up watching the wrong line.
The chemical products row at 45 is the more interesting one, because a chemical product failure and a cosmetic failure are structurally the same failure. A restricted substance in a formulation, found by a sampling authority, and the product is withdrawn. That row is the closest neighbour to a patch line in the whole panel.
A slimming patch OEM that reads this panel should take two numbers from it rather than the ranking: 76 for cosmetics, because that is how many notifications in the panel involved the category this product sits in, and 45 for chemical products, because that is how many involved the same kind of failure.
Those two numbers are the whole of what a slimming patch OEM can act on this quarter, and they are a better use of attention than the four rows above them.
4. Where the substance failures actually come from
The 2025 annual report names two substances, and the January 2026 weekly cases name three more, and the pattern across them is more useful to a manufacturer than any count.
| Substance or class | What the record says | What it asks of a manufacturer |
|---|---|---|
| BMHCA | Almost eight in ten cosmetics alerts in 2025; in the January 2026 weekly cases, Slovakia had several wash and care products containing BMHCA withdrawn and recalled from end users | A fragrance claim in the marketing copy is a regulatory exposure, and a recall is a consumer remedy obligation |
| TPO | Banned in 2025; Czechia had several nail polishes containing TPO destroyed or banned from sale in the January 2026 weekly cases | A substance that was legal until a recent date can still be inside a formulation written against an older annex |
| HICC | Bulgaria had two perfumes containing BMHCA and HICC withdrawn in the January 2026 weekly cases | One product can carry two restricted substances at once, so a single test against one substance proves very little |
| Formaldehyde | Slovakia had two haircare products containing formaldehyde, which is prohibited in cosmetics, with sales ceased | A preservative or a cross-linker can be prohibited without appearing on the label |
| delta-9-THC and delta-9-THCA | Lithuania had a skin care oil containing both withdrawn in the January 2026 weekly cases | A botanical that is lawful to sell as a substance can be prohibited in a cosmetic formulation |
Two things run through that grid. The first is that the cases which were acted on hardest were the ones where a prohibited substance was present, not the ones where a document was missing.
The second is that the list contains substances nobody would think of as active or hazardous: a preservative, a cross-linker, a botanical. HICC is not an active ingredient. Formaldehyde is not usually marketed as one. That is the practical reason a marketing claim and a formulation screen have to be treated as one exercise rather than two.
For a slimming patch OEM on the cosmetic route, the screen that matters runs against Regulation (EC) No 1223/2009, where Article 10 names the responsible person, Article 11 the product information file, Article 19 the labelling and Article 22 and its annex the restricted substances. A product that satisfies all four on the same date is a product whose file matches the product.
A slimming patch OEM that can state the date on which that screen was done has closed the largest single category of finding in the 2025 report, and it has done so with one line rather than with a laboratory programme.
5. The channel that turned a backlog into a live exposure
The report describes a development with no counterpart in earlier years, and it is the reason an annual total cannot be the end of the analysis.
| The 2025 development | The figure | What it changes |
|---|---|---|
| The eSurveillance Webcrawler | Scanned more than 1.6 million websites in 2025 and found more than 20,800 products already listed in Safety Gate still being offered online | A notification is not a historical record while the listing is live, so the exposure in a category is larger than the flow of new notifications suggests |
| Safety Gate Portal registration | More than 1,200 online marketplaces had registered by the end of 2025 | Every major platform now has a single point of contact, which makes a removal instruction fast to execute and hard to ignore |
| The Consumer Safety Gateway | Consumers can report safety issues directly | A complaint can now open an alert without any inspection having taken place |
| Recall remedies under the GPSR | Businesses must offer remedies to consumers for recalled products | A recall is a service obligation, not only a withdrawal |
The 20,800 figure is the one that changes how the annual total should be read. Those are products that had already been notified and were still being offered, which means the backlog of live listings is larger than the flow of new notifications that produced the 4,671.
For a slimming patch OEM the version of the product that matters commercially is the version a buyer can find online, because that is the version the crawler reaches. A formulation that is sound but a listing that claims something the file does not support is a product in the enforcement system and not in the quality system, which is the worst of both positions.
A slimming patch OEM that has an approved claim block and checks the listing against it before publication has closed the one gap that the crawler is actually built to find.
6. The two growth rates, read together
Alerts grew 13 percent in 2025 and follow-up actions grew 35 percent, and the difference between those two rates is the most actionable number in the report.
| Measure | 2025 figure | Change | What the change means |
|---|---|---|---|
| Alerts validated | 4,671 | Up 13 percent on 2024, more than double 2022 | More non-conforming products are being found |
| Follow-up actions | 5,794 | Up 35 percent on the previous year, the highest on record | When something is found, more is done about it |
| Notifications per week | Almost 100 | The implied rate from 4,671 across 52 weeks | The system runs continuously rather than in campaigns |
| Online marketplaces registered | More than 1,200 by the end of 2025 | A new obligation under the GPSR | The removal instruction now has a channel that answers quickly |
| Products already notified but still online | More than 20,800 | Found in one year of crawling 1.6 million sites | The live backlog exceeds one year of new notifications |
The third row of that grid is the one that turns the report into a working cadence. At almost 100 notifications a week, a cosmetic patch programme is not facing an inspection regime that runs in the background. It is facing one that publishes continuously, and the window in which a supplier can put a file together after a problem is found is short.
The Commissioner for Democracy, Justice, Rule of Law and Consumer Protection, Michael McGrath, described the direction of travel as authorities identifying dangerous products more quickly and withdrawing them faster. For a slimming patch OEM that sentence is a scheduling problem rather than a legal one, and the answer to a scheduling problem is a file that is already complete when the week starts.
A slimming patch OEM that has a dated file does not need to respond quickly, because the work was done before the question was asked. That is the entire difference between a manufacturer and a supplier.
7. What 2026 is adding to the picture
Three things were already in preparation when the report was published, and each of them changes the timing of a finding rather than the nature of it.
| What is coming | What it is | The consequence for a manufacturer |
|---|---|---|
| The 2026 product safety sweep | The Commission is preparing it with national market surveillance authorities, a set of online checks carried out simultaneously in one sector | A single sector can be checked across the whole market at once, so a single-file gap does not stay unexamined |
| Coordinated Actions for the Safety of Products | National authorities test the same products together and exchange best practice | Test methods converge, so the method a supplier used has to be the method the authorities now use |
| The Product Safety Act | The Commission will update market surveillance and compliance rules later in 2026, under the Single Market Strategy 2025 and the 2030 Consumer Agenda | The rules are still moving, which favours a file that can be updated over one built around a fixed reading |
The middle row is the one with commercial consequences that a supplier feels before it feels a finding. Coordinated testing means the method that one authority accepts becomes the reference method for the others, and a file built on a method that later diverges is a file that has to be redone.
The third row is why the article does not end with a fixed list of things to do. A 2026 rule change will arrive, the sweep will run, and a company that has chosen its file structure on the basis of the current text will have to redo it. What does not change is the shape: a responsible person under Article 10, a product information file under Article 11, labelling under Article 19, and a substance list under Article 22 that was checked on a date.
8. What this dataset settles, and what it does not
Two datasets read together settle a good deal, and they also leave a few questions open that are worth naming.
| These two datasets settle | These two datasets do not settle |
|---|---|
| The scale and the shape of the EU enforcement system for consumer products | The likelihood that any particular product of yours is named |
| That enforcement is continuous at close to 100 notifications a week | Which of the six measures would be taken in your case, which is often not stated |
| That the category you sell into is the most closely watched one | The chemical profile of the cosmetics category, which the annual report does not break down |
| That the response is deepening faster than the violation rate | The official China-origin split for the full year 2025, which the annual report does not publish |
| That the live backlog of listings is larger than one year of new notifications | Whether your own listings are among the ones still being found |
The third row of the second column is the one that needs the most care, and it is a question of measurement rather than of fact. The 2026 weekly panel puts China-origin products at 57.4 percent of notifications for weeks 1 to 38, and the 2025 annual report does not publish a China-origin breakdown at all. A third-party reading of that report puts the 2025 figure at around 2,000 of the 4,671, which is a different number from anything in the official text.
Those two figures are not in conflict, because they are measured over different populations and on different definitions. One is a share of a year-to-date panel filtered to one origin category, and the other is an estimate produced outside the report. A slimming patch OEM that quotes either of them should say which one it is and where it came from, because a buyer who checks will find both and will not forgive a supplier who presented one as the other.
This is worth stating plainly for a slimming patch OEM because the temptation to quote the larger and more alarming number without its definition is exactly the kind of shortcut the rest of this dataset is arguing against.
What the dataset does settle is the working rhythm. Close to 100 notifications a week, a category that is the most closely watched in the system, and a live backlog that the crawler can find at any time. That is a description of a system running continuously, and the only sensible response to it is a file that is complete before the week starts.
About KONGDY Medical
Henan Kongdy Medical Devices Co., LTD. (KONGDY) was founded in 1989 and has 37 years of production experience as of 2026 across pain relief patches, slimming patches, capsicum plasters, heat patches, cooling gel patches, detox foot patches, steam eye masks, mosquito repellent patches and nose strips. Headquartered in Henan, China, KONGDY operates a 100,000-class GMP workshop built in 2008 and obtained ISO 13485 medical device Quality Management System European Standard Certification in 2014. The company runs OEM and ODM services for international brands across multiple regulatory pathways.
For a 2026 procurement evaluation the qualification team can supply the ISO 13485 certificate, GMP workshop audit reports, stability programme documentation, and reference customer case studies upon request via our contact page.
Frequently asked questions
What was the total number of Safety Gate alerts in 2025?
National authorities validated 4,671, the highest since the system launched in 2003, a 13 percent increase on 2024 and more than double the figure for 2022. That is close to 100 notifications a week.
Why are there 5,794 follow-up actions against 4,671 alerts?
Because one alert can trigger several actions in several countries. The system covers the 27 member states plus Norway, Iceland and Liechtenstein, and an authority may withdraw a product and separately order a marketplace to remove the listing. Actions grew 35 percent while alerts grew 13 percent, which says the response is deepening faster than the violation rate.
Which substances appear most often in cosmetics alerts?
BMHCA, a banned synthetic fragrance, appears in almost eight in ten of the cosmetics alerts in 2025. It can harm the reproductive system and irritate skin. TPO was banned in 2025 and nail polish alerts containing it were notified for the first time that year.
Can I compare the 2026 year-to-date figure with the 2025 annual total?
Not directly, and this is the most common mistake made with this data. The 2,663 notifications cover weeks 1 to 38 of 2026, published from 1 January to 25 September, while the 4,671 covers all 52 weeks of 2025. The comparable question is what the first 38 weeks of 2025 looked like, and on that basis 2026 is running at a materially higher rate.
What does the panel say about China-origin products?
For weeks 1 to 38 of 2026, 1,528 of 2,663 notifications were China-origin, which is 57.4 percent against 40.1 percent in the same period of 2025, a rise of 17.3 percentage points. The 2025 annual report does not publish an official China-origin breakdown, so any full-year figure for 2025 comes from outside the report and should be labelled as such.
Why does the crawler finding matter if it is only about listings?
Because a listing is where a product is found and sold. The eSurveillance Webcrawler scanned more than 1.6 million websites in 2025 and found more than 20,800 products already listed in Safety Gate still being offered. That is the live exposure, and it is larger than one year of new notifications.
What should a slimming patch manufacturer do differently in 2026?
Three things. Re-screen raw materials against the current annex rather than the version in force when the formula was written. Bring the marketing claim set under the same review as the formulation, because that is where a product is found. And keep the file dated, because the rules are moving and a file built around a fixed reading of the current text will need rebuilding.
Does a slimming patch fall inside the Safety Gate system?
A cosmetic patch sold into the EU is a consumer product and is covered by the General Product Safety Regulation, Regulation (EU) 2023/988. Products that are medicines or medical devices sit outside this system and are regulated under their own frameworks, which is why the regulatory route a product takes determines which alert system it can appear in at all.
Related Guides
Five further references from the KONGDY knowledge base:
- Detox Foot Patch OEM: the EU Safety Gate enforcement matrix
- Cooling Gel Patch OEM: regulatory categories and stability evidence
- Frequently asked compliance questions
- KONGDY OEM and ODM manufacturing services
- Pain Relief Patch OEM: contract and documentation overview
