On 30 June 2023, International Fragrance Association (IFRA) announced the notification of the 51st Amendment to the Standards.
Relevant changes to the guidance
- Clarification about paper products
- Clarification about the categorization of fabric softener sheets, dryer sheets and dry-cleaning kits
- Categorization of Pillow Spray
- Categorization of Reed Diffusers
- Handling of traces
- Phototoxicity considerations for products in Category 6
- Elimination of “sunblock” terminology in the guidance
- Clarification that make-up remover for the face and eyes also includes potential exposure to lips
- Clarification about “aftershaves of all types” in Category 4
List of New Standards
- 1 new IFRA Restriction Specification Standard:
- "Allyl-3-cyclohexylpropionate"/INCI name Allyl cyclohexylpropionate (CAS no 2705-87-5)
- 32 new IFRA Restriction Standards based on dermal sensitization and systemic toxicity:
- 4-tert-Butylcyclohexanone (CAS no 98-53-3)
- 1-(2-tert.-Butyl cyclohexyloxy)-2-butanol (CAS no 139504-68-0)
- Carvomenthone (CAS no 499-70-7/ 59471-80-6)
- Citronellyl acetate (CAS no 150-84-5/ 67601-05-2/ 141-11-7)
- Cyclohexadecanone (CAS no 2550-52-9)
- Cyclohexadecenone (CAS no 88642-03-9/ 5365-06-0/ 2550-59-6/ 3100-36-5/ 5120-20-7/ 854373-71-0/ 854373-70-9
- alpha-Cyclohexylidene benzeneacetonitrile (CAS no 10461-98-0)
- 2-Cyclohexylidene-2-ortho-tolylacetonitrile (CAS no 916887-53-1)
- Dimethyl octenone (CAS no 2550-11-0)
- (Ethoxymethoxy)-cyclododecane (CAS no 58567-11-6)
- Ethyl and Methyl furaneo (CAS no 27538-09-6/ 27538-10-9)
- Ethyl isopropyl bicycloheptene-2-carboxylate (CAS no 116044-44-1/ 116126-82-0)
- cis-3-Heptenyl acetate (CAS no 1576-78-9)
- cis-3-Hexenyl isovalerate (CAS no 35154-45-1)
- cis-3-Hexenyl methyl carbonate (CAS no 67633-96-9)
- 6-Hydroxy-2,6-dimethylheptanal (CAS no 62439-42-3)
- Isobutyl cinnamate (CAS no 122-67-8)
- Isoeugenyl acetate (CAS no 93-29-8)
- Isopentylcyclohexanone (CAS no 16587-71-6)
- 2-Methyl-2-pentenal (CAS no 623-36-9)
- 3-Methyl-5-phenylpent-2-enenitrile (CAS no 93893-89-1/ 53243-59-7/ 53243-60-0)
- 4-Methyl-1-propan-2-ylbicyclo[2.2.2]oct-2-ene-8-carboxylate (CAS no 68966-86-9)
- Methyl vanillyl ether (CAS no 5533-03-9)
- cis-3-Nonenyl acetate (CAS no 13049-88-2)
- 3,4,5,6,6-Pentamethylhept-3-en-2-one (CAS no 81786-75-6/ 81786-73-4/ 86115-11-9/ 81786-74-5)
- Phenoxyacetaldehyde (CAS no 2120-70-9)
- Tetramethyl bicyclo-2-heptene-2-propionaldehyde (CAS no 33885-52-8)
- 2,4,4,7-Tetramethyl-6-octen-3-one (CAS no 74338-72-0)
- 1-(2,2,6-Trimethylcyclohexyl)-3-hexanol (CAS no 70788-30-6)
- 1-(2,2,6-Trimethylcyclohexyl)-3-pentanol (CAS no 60241-52-3/ 60241-53-4)
- 3,6,7-Trimethyl-2,6-octadienal (CAS no 1891-67-4)
- Woody furan (CAS no 338735-71-0, 351343-77-6)
- 11 new IFRA Restriction Standards to control potential dermal sensitization effects solely based on QRA2:
- alpha-Amylcinnamicaldehyde diethyl acetal (CAS no 60763-41-9)
- alpha-Amylcinnamicaldehyde dimethyl acetal (CAS no 91-87-2)
- Carvyl acetate (CAS no 97-42-7/ 1205-42-1/ 1134-95-8)
- 5-Hexen-1-yl 2-methylbutanoate (CAS no 155514-23-1)
- 2-Hexylidenecyclohexan-1-one (CAS no 16429-07-5)
- Methyl lavender ketone (CAS no 67801-33-6/ 67633-95-8)
- Myraldyl acetate (CAS no 72403-67-9)
- 2-Octen-4-one (CAS no 4643-27-0)
- 3-Octen-2-one (CAS no 1669-44-9)
- Octahydro-dimethylnaphthalene-2-carbaldehyde (mixed isomers) (CAS no 68738-94-3/ 68738-96-5/ 68991-96-8/ 68991-97-9)
- 2,5-Octadien-4-one, 5,6,7-trimethyl-, (2E)- (CAS no 358331-95-0/ 357650-26-1/ 847144-75-6)
- 2 new IFRA Restriction Standards for which risk management is based on Systemic Toxicity (TTC):
- Methoxycyclododecane (CAS no 2986-54-1) and
- 7-Methoxy-3,7-dimethyloct-1-ene (CAS no 53767-86-5)
- 1 new IFRA Restriction Standard due to potential of depigmentation:
- p-Cresol (CAS no 1319-77-3, 106-44-5)
- 1 new IFRA Prohibition Standard due to potential genotoxicity effects:
- 3-Acetyl-2,5-dimethylfuran (CAS no 10599-70-9)
List of Revised Standards
- 7 Revised IFRA Restriction Standards to control potential dermal sensitization effects for which the systemic toxicity endpoints have now also been evaluated:
- Dihydrocoumarin (CAS no 119-84-6),
- Eugenol (CAS no 97-53-0),
- Geraniol (CAS no 106-24-1),
- 2-Hexenal ( CAS no 6728-26-3/ 505-57-7/16635-54-4),
- Hydroxycitronellal (CAS no 107-75-5),
- p-Methoxybenzaldehyde (CAS no 123-11-5),
- 4-Methoxy-alpha-mehtylbenzenepropanal (CAS no 5462-06-6)
- 1 Revised IFRA Restriction Standard based on new dermal sensitization data:
- 3-Propylidenephthalide (CAS no 17369-59-4)
- 1 Revised IFRA Restriction Standard based on phototoxicity and systemic toxicity (and 1 Updated Standard with regard to Maximum Acceptable Concentration (MAC) in Category 6):
- Methyl-N-methylanthranilate (CAS no 85-91-6, revised Standard), and
- Tagetes oil and absolute (CAS no 91722-29-1/ 8016-84-0/ 91770-75-1, updated Standard)
- 2 Revised IFRA Restriction Standards based on systemic toxicity:
- Estragole (CAS no 140-67-0/ 1407-27-8/ 77525-18-9) and
- Methyl eugenol (CAS no 93-15-2)
Minor updates to existing Standards and format changes
- Revised Restriction Standard: Farnesol. More CAS numbers: 106-28-5 (2E, 6E) and 3790-71-4 (2Z, 6E) are added to the Standard for clarification.
- Revised Prohibition Standard: Mintlactone. One more CAS number: 38049-04-6 is added to the Standard for clarification.
Timeline
The timelines provided in the Standards refer to mixtures of fragrance ingredients (formulas) and not
to finished consumer product(s). The date for compliance with the IFRA Amendments corresponds to the date of placement of fragrance mixtures on the market, meaning for them to leave a fragrance house. From a documentation point of view, this should be considered to be the earliest of the following dates: the date of dispatch/ or the date of invoice.
“New creations” are defined as any fragrance mixture for which the brief (client's request) has been issued after the completion of the information exchange across the supply chain period (i.e., update of IT systems, bilateral information exchange between fragrance houses, and information exchange between fragrance houses and customers). In practice, this means that briefs received after the Notification can only be verified for compliance with the requirements of the new Amendment once companies are fully operational.
“Existing creations” are those fragrance mixtures that have already been placed on the market in a consumer product(s) or are already in the development phase at the time the completion of the information exchange comes to its end. This includes:
- fragrance mixtures for which a brief has been received prior to the date of the Notification of
the Amendment; - fragrance mixtures for which the brief has been received during the period of information
exchange across the supply chain; - fragrance mixtures that are already in development by the fragrance manufacturer or even
in the hands of the consumer product manufacturer.
Table 1: Compliance timeline applicable for the 51st Amendment.
| IFRA Standards | Date for Standards entering into force for new creations | Date for Standards entering into force for existing creations |
| Standard prohibiting the use of ingredients | 2 months after the date of the letter of Notification (i.e. 30 August 2023) | 13 months after the date of the letter of Notification (i.e. 30 July 2024) |
| Standards restricting the use of ingredients or setting specifications | 9 months after the date of the letter of Notification (i.e. 30 March 2024) | 28 months after the date of the letter of Notification (i.e. 30 October 2025) |
Next Step
With this amendment, the cosmetic industry should particularly pay attention to the new requirement of IFRA certification. Cosmetic manufacturers are advised to obtain declarations from fragrance suppliers for the existing fragrance and check the content of the fragrance.