What is the signal?
On 8 July 2026 the European Commission notified the WTO of a draft amendment to the Cosmetics Regulation. The industry refers to these as Omnibus Act IX, covering CMRs, and Omnibus Act 3, covering ingredients. Together they bring into the Cosmetics Regulation the substances classified as CMRs under Delegated Regulation (EU) 2025/1222, along with the most recent opinions of the Scientific Committee on Consumer Safety (SCCS) published between 2025 and 2026.
The core of it is an expanded prohibition list. The draft adds 16 substances or substance groups to Annex II: ozone and dinitrogen oxide, Benzophenone-1 and Benzophenone-2, Basic Brown 16 and Basic Blue 99, tetrahydrofurfuryl methacrylate, trimethyl phosphate, alpha-methylstyrene, several fluorinated monomers, and prostaglandins and their analogues used in eyelash-growth products.
Restricted entries change as well. Cannabidiol (CBD) would be allowed in leave-on, rinse-off and oral care products up to a maximum of 0.19%, with the impurity THC not exceeding 0.00025% (2.5 ppm). Butylated hydroxyanisole (BHA) would be limited to a maximum of 0.07% in leave-on and rinse-off products and would not be permitted in oral care products or in products that could result in exposure of the lungs through inhalation. For mercury, the remaining carve-outs disappear, deleting the entries that still allowed thiomersal and phenylmercuric salts as preservatives.
That said, this is not yet a finalized text in the Official Journal. What can be confirmed at this point is the draft notified to the WTO and the analyses summarizing it from regulatory consultancies, with the committee vote on Omnibus IX and 3 reported as scheduled for 16 September 2026. If approved, the regulation would enter into force 20 days after publication in the Official Journal, which is expected to fall in December 2026 or January 2027. The list of substances and the limits may be adjusted in the final text, so at this stage it is more accurate to read this as which ingredients have come under review rather than what has been decided.
1. Note that there are two separate dates
This amendment does not have a single application date. The first group of prohibitions following the CMR classification, together with the new entry concerning butylparaben, is given as applying from 1 February 2027, a date aligned with the timetable of Delegated Regulation (EU) 2025/1222.
The remaining prohibitions and restrictions carry their own transitional periods. Twelve months after the regulation enters into force, non-compliant products may no longer be placed on the EU market; twenty-four months after, products already in distribution may no longer be made available on the market. In other words, the deadline for what you newly ship and the deadline for stock already out there are different.
In practice it is better to record these two dates separately for each product. Managing them as a single deadline makes stock planning go wrong. Volumes held by European distributors in particular are hard for a brand to control directly, so the dates should be shared with the contracting party.
2. This list is less about high-use ingredients than about ones quietly left in
Looking at the 16 additions, few are ingredients that go into finished formulas in large amounts. Benzophenone-1 is a substance the SCCS concluded is not safe for use as a light stabilizer, and for Benzophenone-2 the assessment was that genotoxic potential cannot be excluded. Both are more often used in a supporting role such as stabilization or color retention than for the product's main function.
These are exactly the ingredients a brand tends to miss. They are often not ingredients the brand selected in formula design, but ones that arrive inside a compound raw material or a colorant supplied by an ingredient house. They appear on the full ingredient list even though they are not on the planner's mental list.
So the check has to go below the single finished-product ingredient list, down to the composition data for each raw material. Getting written confirmation from the supplier on whether a substance is present also gives you documentation you can use as evidence later.
- Have you gathered the full ingredient lists of EU export products currently on sale into one file?
- Have you obtained the constituent composition of compound raw materials and colorants?
- Have you confirmed in writing with the supplier whether the substances are present?
- Have you recorded the placing-on-the-market date and the making-available date separately for each product?
3. Check lash and nail products separately
The prostaglandins and their analogues included in the draft are a substance group referenced in products claiming eyelash growth. Methacrylate-type substances and fluorinated monomers sit closer to the raw material families used in artificial nails and cured products. For a brand that has managed formulas with skincare at the center, these are categories that fell outside the scope of review.
In Korea these categories also fall under different product type classifications, so they are often managed by different parties. If skincare formulas are managed in-house while lash or nail items sit with a separate partner, there is a high chance they will be left out of this review.
It is worth laying out the list of items currently shipping to the EU by category. A product whose name is not on the list does not get checked.
4. CBD and BHA are conditions, not bans, which makes them harder
A prohibited ingredient is simple to handle: take it out. A substance that gains a limit, on the other hand, has to be brought within a number, and you have to be able to show on paper that you did. For CBD there is not only the 0.19% use limit but also the 0.00025% THC impurity criterion attached, which makes lot-by-lot analytical data necessary.
For BHA, whether it is allowed depends on product type. It may be used up to 0.07% in leave-on and rinse-off products, but not in oral care products, and not in product forms that could expose the lungs through inhalation. If you were planning to extend the same formula into a spray or powder format, this is the point to check first.
That means it is better to handle format extension plans and regulatory checks in the same meeting. Fix the formula first and change the format later, and the order becomes one where you discover an ingredient that cannot be used in the new format.
5. EU standards do not stop at the EU
The EU prohibition list is used as a reference in regulatory discussions in a number of countries. Even if you do not export to the EU now, a formula that keeps using a substance added to this list may come under review in other markets as time passes.
Applying EU standards across every product is not the best answer either. Because standards differ by country, unifying around the single strictest standard means narrowing options that were available in other markets. The judgment depends on export mix and product lifespan.
A realistic middle path is to reflect EU standards in new formulas while managing deadlines by export region for existing products. The cost of avoiding a contested ingredient in a formula you are newly opening is low; the cost of changing a product already on sale is high.
The first question for the brief
Write this on the first line of the brief: does a substance from this list enter our formula, directly or through a compound raw material, and if it does, what do we have to change and by when? Omnibus Act IX is still a draft, but the time needed for ingredient substitution, stability confirmation, label revision and stock depletion does not wait for a regulation to be finalized. Finishing the check before the list is confirmed turns out to be the fastest route.
Sources
- Notification G/TBT/N/EU/1219: Draft Commission Regulation amending the Cosmetics Regulation — European Commission, 2026-07-08
- SCCS Scientific Advice on Cannabidiol (CBD) used in cosmetic products — European Commission Scientific Committee on Consumer Safety, 2026-04-24
- SCCS Scientific Advice on Butylated Hydroxyanisole (BHA) — European Commission Scientific Committee on Consumer Safety, 2026-04-16
- Omnibus Act IX: new ingredients banned in the EU from 1 February 2027 — COSlaw.eu
- EU Proposes Updates to Cosmetics Regulation: Involving Annexes II, III and V — CIRS Group
- EU: Omnibus Act IX Draft Bans Cosmetics Ingredients From February 2027 — Obsidian Regulatory Intelligence
- EU Omnibus Act IX: New Cosmetic Ingredient Bans and Restrictions Expected from 2027 — Certified Cosmetics
- EU Cosmetics Regulation 1223/2009 Updates: Testing for CBD, BHA & Ingredient Bans — Contract Laboratory
- Omnibus Act IX: New EU Cosmetic Ingredient Restrictions and Bans Expected from 2027 — BeLab Services
For more context, see the product development guide and MOQ 1,000 guide.