On August 15, 2023, amendments to the European Union’s Cosmetic Regulation (EC) No. 1223/2009 will take effect. Among these amendments is an update to fragrance allergens listed in Annex III, which adds 56 new substances.

Although these amendments are specific to an EU regulation, products sold into the state of California may be impacted. California’s Cleaning Product Right to Know Act (CPRTKA) requires disclosure of specific information on websites and labels for designated products. Specific to fragrance allergens, the CPRTKA requires disclosure of fragrance allergens included on Annex III of the EU Cosmetics Regulation No. 1223/2009 (as required to be labeled by the EU Detergents Regulation No. 648/2004) as follows:

Website disclosure:

  • Disclose each fragrance allergen present in the designated product at a concentration equal to or greater than 0.01% (100ppm).

Label disclosure:

  • Option 1: disclose each fragrance allergen present in the designated product at a concentration equal to or greater than 0.01% (100 ppm).
  • Option 2: a statement that reads “Contains fragrance allergen(s)” when a fragrance allergen is present in the designated product at a concentration equal to or greater than 0.01% (100 ppm).

When a change to a designated list or Annex III would result in a revised disclosure of a designated product, the CPRTKA requires manufacturers to revise the website and label disclosures as outlined below:

  • Website disclosure: revisions to the disclosure must be made no later than six months¥ after the adoption of the revised list by its respective authoritative body.
  • Label disclosure: revisions to the label disclosure must be made no later than 18 months¥ after the adoption of the revised list by its respective authoritative body.

Because designated lists and Annex III are not static, it is strongly recommended to conduct a review at least every 6 months to ensure product disclosures are up to date. SRC offers services from formulation reviews to full assessments and preparation of CPRTKA-compliant disclosures. Contact SRC for more details!

Fragrance allergens listed in Annex III, as amended:

  • Benzyl Alcohol
  • 2- Benzylidenehe ptanal (Amyl Cinnamal)
  • Cinnamyl alcohol
  • 6-Methylcoumarin
  • 3,7-Dimethyl-2,6-octadienal (Citral)
  • (E)-3,7-dimethylocta-2,6-dienal (Geranial)
  • (Z)-3,7-dimethylocta-2,6-dienal (Neral)
  • Phenol, 2- methoxy-4-(2- propenyl) (Eugenol)
  • 7- Hydroxycitronellal (Hydroxycitronellal)
  • Isoeugenol
    • Phenol, 2-methoxy4-(1-propenyl)
    • (E)-2-methoxy4-(prop-1-enyl) phenol; (trans-Isoeugenol)
    • (Z)-2-methoxy4-(prop-1-enyl) phenol; (cis-Isoeugenol)
  • 2-Pentyl-3- phenylprop-2- en-1-ol (Amylcinnamyl Alcohol)
  • Benzyl salicylate
  • 2-Propenal, 3- phenyl (Cinnamal)
  • 2H-1- Benzopyran-2- one (Coumarin)
  • 2,6-Octadien1-ol, 3,7- dimethyl,(2E)- (Geraniol)
  • 4- Methoxybenzy l alcohol (Anise Alcohol)
  • 2-Propenoic acid, 3-phenyl- , phenylmethyl ester (Benzyl Cinnamate)
  • 2,6,10-Dodecatrien-1- ol, 3,7,11- trimethyl (Farnesol)
  • 2-(4-tertButylbenzyl) propionaldehyde (Butylphenyl Methylpropional)
  • 1,6-Octadien3-ol, 3,7- dimethyl (Linalool)
  • Benzyl benzoate
  • Citronellol
    • (±) 3,7-Dimethyl6-octen-1-ol
    • (3 R)-3,7-dimethyloct-6-en-1-ol
    • (3S)-3,7-dimethyloct-6-en-1-ol
  • 2-Benzylideneoctana (Hexyl cinnamal)
  • Limonene
    • 1-methyl-4-prop1-en-2-ylcyclohexene; dl-limonene (racemic); Dipentene
    • (R)-p- mentha-1,8-diene; (d-limonene),
    • (S)-pmentha-1,8-diene; (l-limonene)
  • Methyl heptin carbonate (Methyl 2-octynoate)
  • 3-Methyl-4-(2,6,6- trimethyl-2- cyclohexen-1-yl)-3- buten-2-one (alpha-Isomethyl ionone),
  • Oak moss extract (Evernia prunastri extract),
  • Treemoss extract (Evernia furfuracea extract),
  • Pinus mugo leaf and twig oil and extract (Pinus Mugo Leaf Oil / Pinus Mugo Twig Leaf Extract / Pinus Mugo Twig Oil)
  • Pinus pumila leaf and twig oil and extract (Pinus Pumila Needle Extract / Pinus Pumila Twig Leaf Extract / Pinus Pumila Twig Leaf Oi),
  • Cedrus atlantica oil and extract (Cedrus Atlantica Bark Extract / Cedrus Atlantica Bark Oil / Cedrus Atlantica Bark Water / Cedrus Atlantica Leaf Extract / Cedrus Atlantica Wood Extract / Cedrus Atlantica Wood Oil)
  • Turpentine gum (Pinus spp.); Turpentine oil and rectified oil; Turpentine, steam distilled (Pinus spp.) (Turpentine)
  • p-Mentha-1,3-diene (Alpha-Terpinene)
  • p-Mentha-1,4(8)- diene (Terpinolene)
  • Myroxylon balsamum var. pereirae; extracts and distillates; Balsam Peru oil, absolute and anhydrol (Balsam Oil Peru) (Myroxylon Balsamum Pereirae Balsam Extract / Myroxylon Balsamum Pereirae Balsam Oil / Myroxylon Pereirae Oil / Myroxylon Pereirae Resin Extract / Myroxylon Pereirae Resin)
  • 1-(2,6,6-trimethyl2-cyclohexen-1-yl)- 2-buten-1-one
    • Alpha-Damascone; cis-Rose ketone 1
    • trans-Rose ketone 1
    • 1-(2,6,6-Trimethylcyclohexa-1,3-dien1-yl)-2-buten1-one (Rose ketone 4 (Damascone))
    • 1-(2,6,6- Trimethyl3-cyclohexen-1-yl)- 2-buten-1-one (Rose ketone 3 (delta-Damascone))
    • (Z)- 1-(2,6,6-trimethyl1-cyclohexen-1-yl)- 2-buten-1-one (cis-Rose ketone 2 (cis-beta Damascone))
    • (E)- 1-(2,6,6- Trimethyl1-cyclohexen-1-yl)- 2-buten-1-one (trans-Rose ketone 2 (trans-betaDamascone))
  • 3-Propylidene-1(3H)- isobenzofuranone; 3-Propylidenephthalide
  • Verbena absolute (Lippia citriodora absolute)
  • Methyl 2-hydroxybenzoate (Methyl Salicylate)
  • [3R-(3α,3aβ,7β,8aα)]- 1-(2,3,4,7,8,8ahexahydro-3,6,8,8-tetramethyl1H-3a,7-methanoazulen-5-yl)ethan1-one (Acetyl Cedrene)
  • Pentyl-2-hydroxybenzoate (Amyl Salicylate)
  • 1-Methoxy-4-(1E)- 1-propen-1-ylbenzene (transAnethole) (Anethole)
  • Benzaldehyde
  • Bornan-2-one; 1,7,7-Trimethylbicyclo[2.2.1]- 2-heptanone (Camphor)
  • (1R,4E,9S)-4,11,11-Trimethyl8-methylenebicyclo [7.2.0]undec4-ene (Beta Caryophyllene)
  • 2-methyl-5-(prop1-en-2-yl)cyclohex2-en-1-one;(5R)- 2-Methyl-5-prop1-en-2-ylcyclohex2-en-1-one;(5S)- 2-Methyl-5-prop1-en-2-ylcyclohex2-en-1-one (Carvone)
  • 2-Methyl-1-phenyl2-propyl acetate (Dimethyl Phenethyl Acetate)
  • Oxacycloheptadecan-2-one (Hexadecanolac­tone)
  • 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta-γ2-benzopyran (Hexamethylinda­nopyran)
  • 3,7-Dimethyl octa-1,6-diene-3-yl acetate (Linalyl Acetate)
  • Menthol; dl-menthol; l-menthol; d-menthol (Menthol)
  • 3-Methyl5-(2,2,3- Trimethyl3-Cyclopentenyl) pent-4-en-2-ol (Trimethylcyclopentenyl Methylisopentenol)
  • o-Hydroxybenzaldehyde (Salicylaldehyde)
  • 5-(2,3-Dimethyltricyclo[2.2.1.02,6]- hept-3-yl)- 2-methylpent-2-en1-ol (alpha-Santalol); (1S-(1a,2a(Z),4a))- 2-Methyl5-(2-methyl3-methylenebicyclo [2.2.1]hept-2-yl)- 2-penten-1-ol (beta-Santalol) (Santalol)
  • [1R-(1alpha)]-alphaEthenyldecahydro2-hydroxy-a,2,5,5,8apentamethyl1-naphthalenepropanol (Sclareol)
  • 2-(4-methylcyclohex3-en-1-yl)propan2-ol; p-Menth-1-en8-ol (alphaTerpineol); 1-methyl4-(1-methylvinyl) cyclohexan-1-ol (beta-Terpineol); 1-methyl4-(1-methylethylidene)cyclohexan-1-ol (gammaTerpineol) (Terpineol)
  • 1-(1,2,3,4,5,6,7,8-octahydro-2,3,8,8-tetramethyl2-naphthyl)ethan1-one; 1-(1,2,3,4,5,6,7,8-octahydro-2,3,5,5-tetramethyl2-naphthyl)ethan1-one; 1-(1,2,3,5,6,7,8,8aoctahydro-2,3,8,8-tetramethyl2-naphthyl)ethan1-one; 1-(1,2,3,4,6,7,8,8aoctahydro-2,3,8,8-tetramethyl2-naphthyl)ethan1-one (Tetramethyl acetyloctahydronaphthalenes)
  • 3-(2,2-Dimethyl3-hydroxypropyl) toluene (Trimethylbenzenepropanol)
  • 4-Hydroxy3-methoxybenzaldehyde (Vanillin)
  • Cananga odorata flower oil and extract; Ylang Ylang flower oil and extract (Cananga Odorata Flower Extract / Cananga Odorata Flower Oil)
  • Cinnamomum cassia leaf Oil
  • Cinnamomum zeylanicum bark oil
  • Citrus aurantium amara and dulcis flower oil
    • Citrus Aurantium Amara Flower Oil
    • Citrus Aurantium Dulcis Flower Oil
  • Citrus aurantium amara and dulcis peel oil
    • Citrus Aurantium Amara Peel Oil
    • Citrus Aurantium Dulcis Peel Oil / Citrus Sinensis Peel Oil
  • Citrus aurantium bergamia oil (Bergamot oil)
  • Citrus limon oil / Citrus limon peel oil
  • Cymbopogon citratus / schoenanthus/ flexuous oils
    • Cymbopogon Schoenanthus Oil
    • Cymbopogon Flexuosus Oil
    • Cymbopogon Citratus Leaf Oil
  • Eucalyptus globulus oil
    • Eucalyptus Globulus Leaf Oil
    • Eucalyptus Globulus Leaf / Twig Oil
  • Eugenia caryophyllus oil
    • Eugenia Caryophyllus Leaf Oil
    • Eugenia Caryophyllus Flower Oil
    • Eugenia Caryophyllus Stem oil
    • Eugenia Caryophyllus Bud oil
  • Jasminum grandiflorum / officinale oil and extract (Jasminum Grandiflorum Flower Extract / Jasminum Officinale Oil / Jasminum Officinale Flower Extract)
  • Juniperus virginiana oil / Juniperus Virginiana Wood Oil
  • Laurus nobilis oil / Laurus Nobilis Leaf Oil
  • Lavandula hybrida oil/extract (Lavandula Hybrida Oil / Lavandula Hybrida Extract / Lavandula Hybrida Flower Extract)
  • Lavandula intermedia oil/extract (Lavandula Intermedia Flower/Leaf/Stem Extract / Lavandula Intermedia Flower/Leaf/Stem Oil / Lavandula Intermedia Oil)
  • Lavandula angustifolia oil/extract (Lavandula Angustifolia Oil / Lavandula Angustifolia Flower/Leaf/Stem Extract)
  • Mentha piperita oil
  • Mentha spicata oil (spearmint oil) / Mentha Viridis Leaf Oil
  • Narcissus poeticus/ pseudonarcissus/ jonquilla/tazetta extract
    • Narcissus Poeticus Extract
    • Narcissus Pseudonarcissus Flower Extract
    • Narcissus Jonquilla Extract Narcissus Tazetta Extract
  • Pelargonium graveolens oil / Pelargonium Graveolens Flower Oil
  • Pogostemon cablin oil
  • Rosa damascena flower oil/extract (Rosa Damascena Flower Oil / Rosa Damascena Flower Extract)
  • Rosa alba flower oil/extract (Rosa Alba Flower Oil / Rosa Alba Flower Extract)
  • Rosa canina flower oil
  • Rosa centifolia oil/extract
  • Rosa gallica flower oil
  • Rosa moschata flower oil
  • Rosa rugosa flower oil
  • Santalum album oil
  • Phenol, 2-methoxy4-(2-propenyl)-, acetate (Eugenyl Acetate)
  • 2,6-Octadien-1-ol, 3,7-dimethyl- ,1-acetate, (2E)- (Geranyl Acetate)
  • 2-Methoxy-4-prop1-enylphenyl acetate (Isoeugenyl Acetate)
  • 2,6,6-Trimethylbicyclo[3.1.1]hept2-ene (alpha-Pinene); 6,6-Dimethyl2-methylenebicyclo [3.1.1]heptane (betaPinene) (Pinene)

 

*As set forth in Ch. 13 Part 3 of Div. 104 of the California Health and Safety Code, a “Designated product” means a finished product that is an air care product, automotive product, general cleaning product, or a polish or floor maintenance product used primarily for janitorial, domestic, or institutional cleaning purposes. “Designated product” shall not mean any of the following:

(1) Foods, drugs, and cosmetics, including personal care items such as toothpaste, shampoo, and hand soap.

(2) Industrial products specifically manufactured for, and exclusively used in the following:

Oil and gas production, Steel production, Heavy industry manufacturing, Industrial water treatment,  Industrial textile maintenance and processing other than industrial laundering, Food and beverage processing and packaging, Other industrial manufacturing processes.

(3) A trial sample of a designated product that is not packaged for individual sale, resale, or retail and includes a statement indicating that the product is not for sale or resale.

“Air care product” means a chemically formulated consumer product labeled to indicate that the purpose of the product is to enhance or condition the indoor environment by eliminating unpleasant odors or freshening the air.

“Automotive product” means a chemically formulated consumer product labeled to indicate that the purpose of the product is to maintain the appearance of a motor vehicle, as defined in Section 670 of the Vehicle Code, including products for washing, waxing, polishing, cleaning, or treating the exterior or interior surfaces of motor vehicles. “Automotive product” does not include automotive paint or paint repair products.

“General cleaning product” means a soap, detergent, or other chemically formulated consumer product labeled to indicate that the purpose of the product is to clean, disinfect, or otherwise care for fabric, dishes, or other wares; surfaces including, but not limited to, floors, furniture, countertops, showers, and baths; or other hard surfaces, such as stovetops, microwaves, and other appliances.

¥Unless a later date of effect is established by the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) or Annex III of the EU Cosmetics Regulation No. 1223/2009 (as required to be labeled by the EU Detergents Regulation No. 648/2004.

 

Jamie Venable

Senior Consultant

Published August 8,2023