Octocrylene limits and safety status in the EU, UK and US
Octocrylene is a sunscreen UV filter allowed at up to 10% in the EU, GB and US. The EU caps propellant sprays at 9%. A REACH restriction is proposed.
Octocrylene (CAS 6197-30-4) is an organic UV filter used in sunscreens and other cosmetics. It is still allowed at up to 10% in the EU, Great Britain and the US, but propellant sprays are capped at 9% in the EU and Northern Ireland (EU rules, GB rules, US monograph).
What is octocrylene?
Octocrylene (EC 228-250-8) is entry 10 of Annex VI to the EU Cosmetics Regulation, the list of permitted UV filters (CosIng entry). ECHA uses the spelling "octocrilene" (substance record).
Octocrylene sunscreen limits by market
| Market | Maximum concentration | Basis |
|---|---|---|
| EU and Northern Ireland | 9% in propellant sprays, 10% in other products | Regulation (EU) 2022/1176 |
| Great Britain | 10% (as acid) in all products | GB Annex VI |
| US | 10% | FDA OTC Monograph M020 |
The EU act requires benzophenone, an impurity and degradation product, to stay at trace level. That entry has no extra warning on the label. The 18 May 2026 consolidated regulation retains these limits.
Northern Ireland follows EU cosmetics rules (Article 5A). A propellant spray at 9% or less meets the octocrylene limit in both GB and Northern Ireland. Check the current GB Annex VI before relying on its 10% limit.
Is octocrylene safe?
The EU Scientific Committee on Consumer Safety (SCCS) found 10% safe when octocrylene is used on its own. It was also safe at 10% in combined use of sunscreen cream or lotion, sunscreen pump spray, face cream, hand cream and lipstick. A propellant spray at 10% was not safe in combined use. Up to 9% was safe alongside 10% face cream, hand cream and lipstick. The endocrine data were "not conclusive enough" to set an endocrine-related point of departure (SCCS/1627/21).
GB's Scientific Advisory Group on Chemical Safety (SAG-CS) accepted 10% individually and in combination, including sprays. It used a 70 kg adult rather than the SCCS's 60 kg. That produced a combined-use margin of safety of 106, above 100 (Opinion 15).
SAG-CS also reported that 27-80% of people photoallergic to ketoprofen react to octocrylene. That figure concerns this specific group, not all sunscreen users. It called for a full assessment for children and adolescents once adequate data exist (Opinion 15).
US sunscreens are over-the-counter drugs. The FDA's 2021 proposed order treated octocrylene, among 12 filters, as not generally recognised as safe and effective because data were insufficient. FDA said this was not a conclusion that the ingredients are unsafe. The current monograph, effective 9 August 2026, still lists octocrylene at up to 10%. The 11 September 2026 final order removes only PABA and trolamine salicylate, from 11 September 2027, and leaves the octocrylene decision to a future order. FDA's sunscreen Q&A, current as of 10 September 2026, also names it among ingredients that need more data.
Octocrylene and cancer
Octocrylene has no harmonised EU CLP classification (ECHA risk assessment opinion). None of the regulators cited here (SCCS, SAG-CS, FDA, ECHA RAC) classifies octocrylene as a carcinogen. The benzophenone point concerns an impurity: benzophenone can form as octocrylene degrades, and the SCCS says it should stay at trace level (SCCS opinion). The EU added benzophenone itself to the prohibited list in Regulation (EU) 2023/1490.
Proposed octocrylene REACH restriction
As of 21 October 2026, France's REACH restriction on octocrylene is a proposal, not a ban in force. It would stop finished cosmetic products at 0.001% w/w or more from being placed on the market, 24 months after entry into force (ECHA process record). The proposal rests on environmental concerns, mainly aquatic and sediment toxicity and persistence, not on a human-health finding. It is a separate track from the SCCS and SAG-CS consumer-safety opinions.
ECHA's Risk Assessment Committee backed that restriction on 4 June 2026. It agreed that 0.001% would end octocrylene's use in cosmetics (RAC opinion). The Commission's restrictions page lists the case under committee review, with aquatic toxicity as the hazard and no draft regulation yet. Final committee opinions and a Commission decision are the next steps. There is no adopted compliance deadline.
Homosalate, oxybenzone and 4-MBC
EU homosalate is limited to 7.34% in face products, excluding propellant sprays (2022/2195). GB's limit remains 10%, and SAG-CS found up to 10% in sunscreen acceptable (Opinion 17).
In the EU, oxybenzone (benzophenone-3) is limited to 6% in face, hand and lip products other than propellant and pump sprays, 2.2% in body products including sprays, and 0.5% in other products (2022/1176). EU products need a "Contains Benzophenone-3" warning, except at 0.5% or less when it only protects the product. GB, from 21 January 2026, allows 6% in face, hand and lip products, 2.2% in body products and 0.5% as a stabiliser (SI 2025/901).
4-MBC is prohibited in the EU (2024/996). GB's ban took effect on 15 July 2026, and old stock may stay on sale until 14 January 2027 (SI 2026/23).
See the source documents in RegAffairs AI's answer on octocrylene.