Banned, or Just De-listed? How to Read a Photoinitiator's Regulatory Status Across the EU, Switzerland, Germany and the USA
September 18, 2026 · Technical
Last reviewed: 18 September 2026. Regulatory lists change. Every figure below is attributed to a named instrument so you can check it rather than trust it.
Twice this year a customer has told us that a photoinitiator we supply is banned. Both times the substance was legal. What had happened was that it had been dropped from a voluntary industry list, and somewhere along the chain that had been converted into a legal prohibition. The distinction matters commercially, because the two events call for completely different responses, and getting it wrong in front of a customer's consultant is expensive.
Three different things get called "restricted"
When someone says a photoinitiator is restricted, they may mean any of three things that operate independently.
The first is law. A substance is in the Candidate List, or restricted under Annex XVII, or harmonised-classified under CLP, or proposed for the Authorisation List. These are legal instruments. They are published, they have dates, and you can read them.
The second is a positive list. For food-contact applications a jurisdiction may publish a list of substances permitted in a given material, each with a specific migration limit. Absence from a positive list is not the same as prohibition either. It usually means the substance must travel a different route, such as a non-listed-substance assessment with a very low migration threshold.
The third is a voluntary industry list. The EuPIA suitability list is the one that matters most in printing inks. It is not law. No regulator enforces it. But for a converter supplying a branded food manufacturer, it is frequently the binding constraint, because the brand owner's specification references it.
Most of the confusion in this market comes from collapsing these three into the word "banned".
TPO: a case that shows why the collapse is costly
TPO is a good worked example because it is genuinely awkward, and because the awkwardness is usually misreported in one of two directions.
It is an SVHC, on the Candidate List since 2023, and it carries a harmonised Repr. 1B classification applying from 1 September 2025. Under Commission Regulation (EU) 2025/1731 it was brought into Annex XVII by way of Appendix 6 to Entry 30, which restricts supply to the general public. Industrial use is not general public supply.
In Switzerland it remains positively listed in Annex 10 of SR 817.023.21, at a specific migration limit of 0.05 mg/kg, in the edition in force from 1 August 2026.
In Germany the position is different, and the difference is not about TPO's legal status in the abstract. Germany's Anlage 14 to the Bedarfsgegenständeverordnung operates a positive list for printing inks, and separately excludes CMR substances from the non-listed-substance route. A CMR 1B substance that is not on the German positive list can therefore use neither route, which makes it effectively unusable there rather than formally prohibited.
And in January 2026 EuPIA dropped TPO from its suitability list. That is voluntary. It is also, for many buyers, decisive.
So the accurate sentence is longer than a headline but it is the one that survives scrutiny:
TPO is an SVHC with a harmonised Repr. 1B classification. It remains Swiss-positive-listed at 0.05 mg/kg. It has been removed from the EuPIA suitability list, and it is excluded from the German CMR and 10 ppb non-listed routes.
Four facts, three instruments, one substance. None of them is "banned".
A counterintuitive point that trips people up
There is a widespread assumption that a CMR substance cannot appear on a positive list. It is not true.
Swiss Annex 10 contains vinyl chloride, a Carc. 1A substance, along with ethylene oxide, acrylamide and formaldehyde, all Carc. 1B or equivalent. The CMR exclusion operates only in two specific places: it bars CMR substances from the non-listed-substance route, and from the functional-barrier exemption. It does not bar them from being listed.
That is precisely why 369 and 379 can be positively listed in Switzerland at 0.15 and 0.05 mg/kg respectively while both carry harmonised Repr. 1B classifications. A formulator who assumes "CMR means it cannot be listed" will misread the list and may reformulate for no reason.
The four jurisdictions, side by side
This is the summary we give customers who ask which of our photoinitiators they may use where. It is not legal advice and it is not a substitute for reading the instruments, but it tells you where to look.
| Grade | CAS | EU 10/2011 Annex I | Swiss Annex 10 (v3.5) | German Anlage 14 | USA 21 CFR |
|---|---|---|---|---|---|
| Benzophenone | 119-61-9 | Listed, FCM 38240, SML 0.6 mg/kg | Listed, 0.6 mg/kg as sum with methylbenzophenones | In the sum limit only | Not listed |
| ITX | 5495-84-1 | Not listed | Listed, 0.05 mg/kg | Listed, entry 204 (limit not confirmed here) | Not listed |
| 4-MBP | 134-84-9 | Not listed | Listed, 0.05 mg/kg | Listed, entry 233 (limit not confirmed here) | Not listed |
| TPO | 75980-60-8 | Not listed | Listed, 0.05 mg/kg | Not listed | Not listed |
| 369 | 119313-12-1 | Not listed | Listed, 0.15 mg/kg | Not listed | Not listed |
| 379 | 119344-86-4 | Not listed | Listed, 0.05 mg/kg | Not listed | Not listed |
| 907 | 71868-10-5 | Not listed | Not listed | Not listed | Not listed |
| 1173, 184, 651, CBP, DETX, MBF, TPO-L, OBM, 4-PBZ | various | Not listed | Not listed | Not confirmed | Not listed |
Three things to read carefully in that table.
The first is 907. It is not Swiss-listed and it carries a harmonised Repr. 1B classification. In Switzerland that combination closes both routes at once, which is a harder position than TPO's. It is worth knowing before you specify it into a food-contact direction.
The second is Germany, and it is the sharpest commercial fact in this article. The category V photoinitiator list in Anlage 14 contains two substances: ITX and 4-MBP. TPO, 907, 369 and 379 are not on it, and all four carry harmonised Repr. 1B classifications. Because the German framework excludes CMR substances from the non-listed-substance route, those four cannot use the positive-list route or the non-listed route. They are not prohibited in Germany. They are effectively unusable there, which for a formulator amounts to the same practical outcome, and it is the reason "market-by-market loss of use, Germany first" is a more accurate framing than "banned".
The third is honesty about limits. We have confirmed which substances appear in the category V list but not the numeric group limit that attaches to entry 32 in the German table. We are not going to print a number we have not read. If you need that figure, get it from Anlage 14 directly, or from your importer, and do not take it from a supplier summary, including ours.
The 10/2011 point that gets misused in sales conversations
Competitors sometimes tell buyers that a photoinitiator "does not comply with EU 10/2011". That framing is usually wrong, and it is worth understanding why.
Regulation (EU) No 10/2011 governs plastic materials and articles. Article 2(3) states that it applies without prejudice to Union or national provisions applicable to substances in adhesives, coatings and printing inks. Article 6(1) and (2) leave colorants, solvents and polymer production aids to national law.
Printing inks are therefore a national-law matter in the EU, not a 10/2011 matter. A photoinitiator absent from the 10/2011 Annex I positive list is not in breach of 10/2011. It is outside its scope. The instrument you actually need is the national one, which is exactly why the German and Swiss lists above are the ones that decide the question.
This distinction is not pedantry. It changes which question you ask your supplier, and it changes which document you need from them.
How to check a substance before you specify it
Ask three questions in this order, and ask for a date with each answer.
Which legal instruments cover it? Check the Candidate List, Annex XVII including its appendices, Annex VI of CLP, and Annex XIV including pending recommendations.
Which positive lists cover it, for the material and the market you are selling into? For printing inks that means the national list, not 10/2011.
Which voluntary lists does your customer's specification reference? This is often the question that decides the outcome, and it is the one suppliers most often skip.
If your supplier answers only the first question, you have half an answer.
What we do and do not claim
We supply the grades in the table above, and we also supply low-migration chemistry: polymeric and bifunctional photoinitiators intended for food-contact and direct-contact applications. Those are the products that tend to satisfy both the legal lists and the voluntary ones, which as a practical matter is what buyers need.
Specifically: TPO, TPO-L, 369, 379, 907, benzophenone, ITX, 4-MBP and MBF, alongside the polymeric and bifunctional low-migration grades.
We will not tell you a product is banned when it has merely been de-listed, and we will not tell you it is compliant when we have not read the list. If your market is Germany and the answer depends on a list we have not finished reading, we will say so and we will tell you when we expect to know.
Ask us for the SDS and the current regulatory summary for the grade you are considering, and check them yourself. A supplier who is uncomfortable with that request is telling you something.