On 15 December 2020, the European Commission has published Directives (EU) 2020/2088 and 2020/2089 to amend Annex II to Toy Safety Directive 2009/48/EC, regarding allergenic fragrances in toys. Member States shall apply the amendments from 5 July 2022. Here is the summary of the new requirements:
Amendments to the list of allergenic fragrances which require labelling
According to the current requirement in Part III, Annex II to the Directive, the name of allergenic fragrance listed in Paragraph 3 of Point 11 shall be stated on a toy, on an affixed label, on the packaging or in an accompanying leaflet, if the fragrance is added to the toy or component at a concentration exceeding 100 mg/kg.
The Commission has approved to amend the list by:
| No | Name of the allergenic fragrance | CAS number |
| (12) | Acetylcedrene | 32388-55-9 |
| (13) | Amyl salicylate | 2050-08-0 |
| (14) | trans-Anethole | 4180-23-8 |
| (15) | Benzaldehyde | 100-52-7 |
| (16) | Camphor | 76-22-2; 464-49-3 |
| (17) | Carvone | 99-49-0; 6485-40-1; 2244-16-8 |
| (18) | beta-Caryophyllene (ox.) | 87-44-5 |
| (19) | Rose ketone-4 (Damascenone) | 23696-85-7 |
| (20) | alpha-Damascone (TMCHB) | 43052-87-5; 23726-94-5 |
| (21) | cis-beta-Damascone | 23726-92-3 |
| (22) | delta-Damascone | 57378-68-4 |
| (23) | Dimethylbenzyl carbinyl acetate (DMBCA) | 151-05-3 |
| (24) | Hexadecanolactone | 109-29-5 |
| (25) | Hexamethylindanopyran | 1222-05-5 |
| (26) | (DL)-Limonene | 138-86-3 |
| (27) | Linalyl acetate | 115-95-7 |
| (28) | Menthol | 1490-04-6; 89-78-1; 2216-51-5 |
| (29) | Methyl salicylate | 119-36-8 |
| (30) | 3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-4-en-2-ol | 67801-20-1 |
| (31) | alpha-Pinene | 80-56-8 |
| (32) | beta-Pinene | 127-91-3 |
| (33) | Propylidene phthalide | 17369-59-4 |
| (34) | Salicylaldehyde | 90-02-8 |
| (35) | alpha-Santalol | 115-71-9 |
| (36) | beta-Santalol | 77-42-9 |
| (37) | Sclareol | 515-03-7 |
| (38) | alpha-Terpineol | 10482-56-1; 98-55-5 |
| (39) | Terpineol (mixture of isomers) | 8000-41-7 |
| (40) | Terpinolene | 586-62-9 |
| (41) | Tetramethyl acetyloctahydro naphthalenes | 54464-57-2; 54464-59-4; 68155-66-8; 68155-67-9 |
| (42) | Trimethyl benzenepropanol (Majantol) | 103694-68-4 |
| (43) | Vanillin | 121-33-5 |
| (44) | Cananga odorata and Ylang-ylang oil | 83863-30-3; 8006-81-3 |
| (45) | Cedrus atlantica bark oil | 92201-55-3; 8000-27-9 |
| (46) | Cinnamomum cassia leaf oil | 8007-80-5 |
| (47) | Cinnamomum zeylanicum bark oil | 84649-98-9 |
| (48) | Citrus aurantium amara flower oil | 8016-38-4 |
| (49) | Citrus aurantium amara peel oil | 72968-50-4 |
| (50) | Citrus bergamia peel oil expressed | 89957-91-5 |
| (51) | Citrus limonum peel oil expressed | 84929-31-7 |
| (52) | Citrus sinensis (syn.: Aurantium dulcis) peel oil expressed | 97766-30-8; 8028-48-6 |
| (53) | Cymbopogon citratus/schoenanthus oils | 89998-14-1; 8007-02-01; 89998-16-3 |
| (54) | Eucalyptus spp. leaf oil | 92502-70-0; 8000-48-4 |
| (55) | Eugenia caryophyllus leaf/flower oil | 8000-34-8 |
| (56) | Jasminum grandiflorum/officinale | 84776-64-7; 90045-94-6; 8022-96-6 |
| (57) | Juniperus virginiana | 8000-27-9; 85085-41-2 |
| (58) | Laurus nobilis fruit oil | 8007-48-5 |
| (59) | Laurus nobilis leaf oil | 8002-41-3 |
| (60) | Laurus nobilis seed oil | 84603-73-6 |
| (61) | Lavandula hybrida | 91722-69-9 |
| (62) | Lavandula officinalis | 84776-65-8 |
| (63) | Mentha piperita | 8006-90-4; 84082-70-2 |
| (64) | Mentha spicata | 84696-51-5 |
| (65) | Narcissus spp. | Diverse, including 90064-25-8 |
| (66) | Pelargonium graveolens | 90082-51-2; 8000-46-2 |
| (67) | Pinus mugo | 90082-72-7 |
| (68) | Pinus pumila | 97676-05-6 |
| (69) | Pogostemon cablin | 8014-09-3; 84238-39-1 |
| (70) | Rose flower oil (Rosa spp.) | Diverse, including 8007-01-0, 93334-48-6, 84696-47-9, 84604-12-6, 90106-38-0, 84604-13-7, 92347-25-6 |
| (71) | Santalum album | 84787-70-2; 8006-87-9 |
| (72) | Turpentine (oil) | 8006-64-2; 9005-90-7; 8052-14-0 |
Prohibition of 3 allergenic fragrances
The following 3 allergenic fragrances shall be banned:
| No | Name of the allergenic fragrance | CAS number |
| (56) | Atranol (2,6-Dihydroxy-4-methyl-benzaldehyde) | 526-37-4 |
| (57) | Chloroatranol (3-Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde) | 57074-21-2 |
| (58) | Methyl heptine carbonate | 111-12-6 |
The above ban shall not apply to traces of the fragrances in which the presence is technically unavoidable under good manufacturing practice and does not exceed 100 mg/kg.
As methyl heptine carbonate has become a prohibited fragrance, it shall be removed from the list of allergenic fragrances which require labelling.
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