Regulation (EC) No. 1223/2009 amendments to Annex III (List of Substances which Cosmetic Products must not Contain Except Subject to the Restrictions Laid Down):
1. entries 45, 46, 70, 73, 86, 88, 109, 114, 122, 124, 131, 133, 154, 157, 175, 196 and 324 are replaced by establishing appropriate restrictions on the indication of substances in the list of ingredients when their concentration exceeds: 0.001% in leave-on products and 0.01% in rinse-off products; clarifying the common names of chemical substances; supplementing and amending the relevant CAS and EC numbers. The amendment specifies the transitional periods and relevant notes for the relevant entries (see point 1 of the annex to the regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R1545);
2. entries 125, 126, 158, 160-163, 165, 167 and 168 are deleted;
3. new fragrances are included, which must be mentioned in the list of ingredients when their concentration exceeds: 0.001% in leave-on products and 0.01% in rinse-off products. The new allergens that must be listed on labels are:
- Acetyl Cedrene (CAS Nr. 32388-55-9);
- Amyl Salicylate (CAS Nr. 2050-08-0);
- Anethole (CAS Nr. 104-46-1/ 4180-23-8);
- Benzaldehyde (CAS Nr. 100-52-7);
- Camphor (CAS Nr. 76-22-2/ 21368-68-3/ 464-49-3/ 464-48-2);
- Beta-Caryophyllene (CAS Nr. 87-44-5);
- Carvone (CAS Nr. 99-49-0 / 6485-40-1/ 2244-16-8);
- Dimethyl Phenethyl Acetate (CAS Nr. 151-05-3);
- Hexadecanolac-tone (CAS Nr. 109-29-5);
- Hexamethylinda-nopyran (CAS Nr. 1222-05-5);
- Linalyl Acetate (CAS Nr. 115-95-7);
- Menthol (CAS Nr. 89-78-1 / 1490-04-6 / 2216-51-5 / 15356-60-2);
- Trimethylcyclo- pentenyl Methylisopentenol (CAS Nr. 67801-20-1);
- Salicylaldehyde (CAS Nr. 90-02-8);
- Santalol (CAS Nr. 11031-45-1/ 115-71-9/ 77-42-9);
- Sclareol (CAS Nr. 515-03-7);
- Terpineol (CAS Nr. 8000-41-7/ 98-55-5/ 138-87-4/ 586-81-2);
- Tetramethyl acetyloctahydro-naphthalenes (CAS Nr. 54464-57-2/ 54464-59-4/ 68155-66-8/ 68155-67-9/);
- Trimethylbenzene-propanol (CAS Nr. 103694-68—4);
- Vanillin (CAS Nr. 121-33-5);
- Cananga Odorata Flower Extract; Cananga Odorata Flower Oil (CAS Nr. 83863-30-3/ 8006-81-3/ 68606-83-7/ 93686-30-7);
- Cinnamomum Cassia Leaf Oil (CAS Nr. 8007-80-5/ 84961-46-6);
- Cinnamomum Zeylanicum Bark Oil (CAS Nr. 8015-91-6/ 84649-98-9);
- Citrus Aurantium Amara Flower Oil (CAS Nr. 72968-50-4), Citrus Aurantium Dulcis Flower Oil (CAS Nr. 8028-48-6/ 8016-38-4);
- Citrus Aurantium Amara Peel Oil (CAS Nr. 68916-04-1/ 72968-50-4), Citrus Aurantium Dulcis Peel Oil; Citrus Sinensis Peel Oil (CAS Nr. 97766-30-8/ 8028-48-6/ 8008-57-9);
- Citrus Aurantium Bergamia Peel Oil (CAS Nr. 8007-75-8/ 89957-91-5/ 68648-33-9/ 8007-75-8/ 85049-52-1);
- Citrus Limon Peel Oil (CAS Nr. 84929-31-7/ 8008-56-8);
- Cymbopogon Schoenanthus Oil (CAS Nr. 8007-02-1/ 89998-16-3), Cymbopogon Flexuosus Oil (CAS Nr. 91844-92-7), Cymbopogon Citratus Leaf Oil (CAS Nr. 8007-02-1/ 91844-92-7);
- Eucalyptus Globulus Leaf Oil (CAS Nr. 97926-40-4/ 8000-48-4/), Eucalyptus Globulus Leaf/Twig Oil (CAS Nr. 8000-48-4);
- Eugenia Caryophyllus Leaf Oil (CAS Nr. 8000-34-8 / 8015-97-2/ 84961-50-2), Eugenia Caryophyllus Flower Oil (CAS Nr. 84961-50-2), Eugenia Caryophyllus Stem oil (CAS Nr. 84961-50-2), Eugenia Caryophyllus Bud oil (CAS Nr. 84961-50-2);
- Jasminum Grandiflorum Flower Extract; Jasminum Officinale Oil; Jasminum Officinale Flower Extract (CAS Nr. 84776-64-7/ 90045-94-6/ 8022-96-6/ 8024-43-9/ 90045-94-6);
- Juniperus Virginiana Oil; Juniperus Virginiana Wood Oil (CAS Nr. 8000-27-9 / 85085-41-2);
- Laurus Nobilis Leaf Oil (CAS Nr. 8002-41-3/ 8007-48-5/ 84603-73-6);
- Lavandula Hybrida Oil; Lavandula Hybrida Extract; Lavandula Hybrida Flower Extract (CAS Nr. 91722-69-9/ 8022-15-9/ 93455-96-0/ 93455-97-1/ 92623-76-2), Lavandula Intermedia Flower/Leaf/Stem Extract; Lavandula Intermedia Flower/Leaf/Stem Oil; Lavandula Intermedia Oil (CAS Nr. 84776-65-8/ 8000-28-0/ 90063-37-9), Lavandula Angustifolia Oil; Lavandula Angustifolia Flower/Leaf/Stem Extract (CAS Nr. 84776-65-8/ 8000-28-0/ 90063-37-9);
- Mentha Piperita Oil (CAS Nr. 8006-90-4/ 84082-70-2);
- Mentha Viridis Leaf Oil (CAS Nr. 8008-79-5/ 84696-51-5);
- Narcissus Poeticus Extract (CAS Nr. 90064-26-9/ 68917-12-4), Narcissus Pseudonarcissus Flower Extract (CAS Nr. 90064-27-0), Narcissus Jonquilla Extract Narcissus Tazetta Extract (CAS Nr. 90064-25-8);
- Pelargonium Graveolens Flower Oil (CAS Nr. 90082-51-2/ 8000-46-2);
- Pogostemon Cablin Oil (CAS Nr. 8014-09-3/ 84238-39-1);
- Rosa Damascena Flower Oil; Rosa Damascena Flower Extract (CAS Nr. 8007-01-0/ 90106-38-0/), Rosa Alba Flower Oil; Rosa Alba Flower Extract (CAS Nr. 93334-48-6), Rosa Canina Flower Oil (CAS Nr. 84696-47-9), Rosa Centifolia Flower Oil; Rosa Centifolia Flower Extract (CAS Nr. 84604-12-6), Rosa Gallica Flower Oil (CAS Nr. 84604-13-7), Rosa Moschata Flower Oil (CAS Nr. - ), Rosa Rugosa Flower Oil (CAS Nr. 92347-25-6);
- Santalum Album Oil (CAS Nr. 8006-87-9/ 84787-70-2);
- Eugenyl Acetate (CAS Nr. 93-28-7);
- Geranyl Acetate (CAS Nr. 105-87-3);
- Isoeugenyl Acetate (CAS Nr. 93-29-8);
- Pinene (CAS Nr. 80-56-8/ 7785-70-8/ 127-91-3/ 18172-67-3).
The amendment specifies transitional periods and relevant notes for the relevant entries (see point 3 of the annex to the regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R1545).
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Regulation (EC) No. 1223/2009 amendments to Annex II (List of Substances Prohibited in Cosmetic Products):
1. Entry 1024 is amended to include salts of 2-ethylhexanoic acid (CAS No. 149-57-5) and is set out as follows: “2-ethylhexanoic acid and its salts with the exception of those specified elsewhere in Annex VI to Regulation (EC) No 1272/2008 (CAS No. 149-57-5/-)“;
2. It is prohibited to use substances classified as CMR category 1A, 1B or 2 substances in cosmetic products, therefore to Regulation (EC) No. 1223/2009 Annex II includes 30 chemicals listed below:
- Ammonium bromide (CAS No. 12124-97-9);
- Dibutyltin bis(2-ethylhexanoate) (CAS No. 2781-10-4);
- Dibutyltin di(acetate) (CAS No. 1067-33-0);
- Tellurium dioxide (CAS No. 7446-07-3);
- Barium diboron tetraoxide (CAS No. 13701-59-2);
- 2,2-dimethylpropan-1-ol,tribromo derivative, 3-bromo-2,2-bis(bromomethyl)propan-1-ol (CAS No. 36483-57-5/ 1522-92-5);
- 2,4,6-tri-tert-butylphenol (CAS No. 732-26-3);
- 4,4'-sulfonyl diphenol, bisphenol S (CAS No. 80-09-1);
- Benzophenone (CAS No. 119-61-9);
- Quinoclamine (ISO); 2-amino-3-chloro-1,4-naphthoquinone (CAS No 2797-51-5);
- Perfluoroheptanoic acid; tridecafluoroheptanoic acid (CAS No 375-85-9);
- methyl N-(isopropoxycarbonyl)-L-valyl-(3RS)-3-(4-chlorophenyl)-β-alaninate, Valifenalate (CAS No. 283159-90-0);
- 6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid, sodium and tris(2-hydroxyethyl)ammonium salts (CAS No. - );
- 6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid (CAS No. 2156592-54-8);
- 6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid (CAS No. - );
- Theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione (CAS No 58-55-9);
- 1,3,5-triazine-2,4,6-triamine; melamine (CAS No. 108-78-1);
- Fluopicolide (ISO); 2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide (CAS No 607-285-6);
- N-(2-nitrophenyl) phosphoric triamide (CAS No. 874819-71-3);
- N-(5-chloro-2-isopropylbenzyl)-N-cyclopropyl-3-(difluoromethyl)-5-fluoro-1-methyl-1H-pyrazole-4-carboxamide; isoflucypram (CAS No. 1255734-28-1);
- Reaction mass of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide and 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide [≥ 78 % syn isomers ≤ 15 % anti isomers relative content]; isopyrazam (CAS No. 881685-58-1);
- Margosa, ext. [from the kernels of Azadirachta indica extracted with water and further processed with organic solvents] (CAS No. 84696-25-3);
- Cumene (CAS No. 98-82-8);
- 2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate; 2,2-bis(acryloyloxymethyl)butyl acrylate; trimethylolpropane triacrylate; (CAS No 15625-89-5);
- Pentapotassium 2,2’,2’’,2’’’,2’’’’-(ethane-1,2-diylnitrilo) pentaacetate (CAS No. 7216-95-7);
- N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid); Pentetic Acid (INCI) (CAS No. 67-43-6);
- Pentasodium (carboxylatomethyl)iminobis (ethylenenitrilo)tetraacetate; Pentasodium Pentetate (INCI) (CAS No 140-01-2);
- Acetamiprid (ISO); (1E)-N-[(6-chloropyridin-3-yl)methyl]-N’-cyano-N-methylethanimidamide; (E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine (CAS No. 135410-20-7/ 160430-64-8);
- Pendimethalin (ISO); N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene (CAS No. 40487-42-1);
- Bentazone (ISO); 3-isopropyl-2,1,3-benzothiadiazine-4-one-2,2-dioxide (CAS No. 25057-89-0).
IMPORTANT!
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 December 2023.
