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Since 1 December 2023, a neem extract has been listed in Annex II of the EU Cosmetics Regulation, the list of prohibited substances. Several ingredient databases have since flagged neem oil itself as “prohibited”, which worries the brands and laboratories that use it. What the text actually covers, where the confusion comes from, and how to secure a purchase of organic neem oil.
What Regulation (EU) 2023/1490 says
Regulation (EU) 2023/1490 adapts Regulation (EC) No 1223/2009 to substances newly classified as carcinogenic, mutagenic or toxic for reproduction (CMR) under the CLP Regulation. Applicable since 1 December 2023, it adds to Annex II an entry worded as follows:
“Margosa, ext. [from the kernels of Azadirachta indica extracted with water and further processed with organic solvents]” — CAS 84696-25-3, EC 283-644-7.
The ban therefore targets an extract defined by its process: neem kernels extracted with water, then processed with organic solvents. The harmonised classification proposal submitted to the European Chemicals Agency identified it as toxic for reproduction, category 2, a skin sensitiser and toxic to aquatic life.
Where the confusion comes from
- The same CAS number: CAS 84696-25-3 is used generically for Azadirachta indica extracts. It appears on many data sheets for cold-pressed neem oil.
- Two INCI names: the Commission’s CosIng database lists both Azadirachta Indica Seed Oil and Melia Azadirachta Seed Oil. Some tools link the first to the Annex II entry and display it as prohibited.
An oil obtained by simple mechanical pressing of the seeds, without solvent, does not match the description in the entry. But it is the safety assessor, under the responsibility of the responsible person, who reaches a conclusion for a given ingredient. That conclusion rests on documentation of the process, and this is what you need to obtain from the supplier.
Documents to ask for
- Process statement: cold mechanical pressing of the seeds, no aqueous extraction and no organic solvent, no chemical refining.
- Identity: INCI name used, CAS and EC numbers shown on the documents, country of origin.
- Batch certificate of analysis: acid value, peroxide value, fatty acid profile; azadirachtin content if your assessor asks for it.
- Contaminants: aflatoxins, pesticide residues, heavy metals.
- Organic certificate, valid, for an oil sold as organic.
- Up-to-date safety data sheet, consistent with the declared classification.
Cosmetic, biocide or medical device: the claims boundary
A product’s status also depends on what it promises. A product claiming to repel insects falls under Regulation (EU) No 528/2012 on biocidal products, not the Cosmetics Regulation. A product presented as a head lice treatment generally falls under medical device or medicinal product rules. With neem oil the temptation to make such claims is strong: they must be excluded from any product placed on the market as a cosmetic.
Formulation constraints
- Strong odour, sulphurous and garlicky: it limits the dosage in fragranced products and points towards hair care, soaps and balms.
- Partial solidification in cool weather: plan gentle warming before sampling.
- Cosmetic or technical use only: neem oil is not a food ingredient.
Proforma Tropical organic neem oil
Our organic neem oil is a virgin oil obtained by cold mechanical pressing of the seeds, then filtration, with no solvent and no refining; grown and pressed in India. Its data sheet identifies it by the INCI name Melia Azadirachta Seed Oil, with CAS numbers 8002-65-1 and 90063-92-6, not by the CAS number of the prohibited extract. It is COSMOS certified 100% organic and NATRUE conform. Main specifications: acid value below 15 mg KOH/g, peroxide value below 10 meq O₂/kg, azadirachtin above 1,700 mg/kg (natural content). It solidifies at about 10 °C. The process statement, batch certificate of analysis and safety data sheet come with the quotation.
Frequently asked questions from buyers
Is neem oil banned in cosmetics in Europe?
Since 1 December 2023, Annex II of Regulation (EC) No 1223/2009 has prohibited a specific extract: neem kernels extracted with water and then processed with organic solvents. A cold-pressed oil made without solvent does not match that description, but the conclusion for a given ingredient lies with the safety assessor, based on documentation of the process.
Why do some tools display neem oil as prohibited?
Because CAS 84696-25-3, used in the prohibited entry, is also used generically on neem oil data sheets, and some tools link the INCI name Azadirachta Indica Seed Oil to that entry.
Can a neem oil cosmetic claim to repel mosquitoes?
No. A repellent claim makes the product fall under Regulation (EU) No 528/2012 on biocidal products, with its own authorisation requirements.
Which documents come with your organic neem oil?
A cold-pressing process statement, the batch certificate of analysis, a valid organic certificate and the safety data sheet.
Sourcing organic neem oil for a formulation or a listing? Tell us the grade, volume and packaging you need: we reply within 48 hours with a quotation, the technical data sheet, the certificate of analysis and, for organic references, a valid organic certificate. Samples are available, with a flat contribution to shipping costs.
Sources
- Commission Regulation (EU) 2023/1490 of 19 July 2023 amending Regulation (EC) No 1223/2009 as regards the use in cosmetic products of certain substances classified as CMR, EUR-Lex.
- Regulation (EC) No 1223/2009 on cosmetic products, Annex II.
- European Chemicals Agency (ECHA), proposal and opinion on the harmonised classification of Margosa, ext. (EC 283-644-7).
- European Commission CosIng database: Azadirachta Indica Seed Oil, Melia Azadirachta Seed Oil.
- Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, EUR-Lex.