ALLERGEN, COSMETIC REGULATION / 23-09-25
香料过敏原清单：关于新法规的一切
新的化妆品香料过敏原清单于2023年8月生效。以下是您需要了解的法规内容以及如何确保合规。
香料过敏原清单：关于新法规的一切
2023年8月，修订后的香料过敏原清单生效，当这些成分用于化妆品配方时，需进行适当标识。新法规在原有的26种过敏原清单中增加了56种成分。以下是化妆品制造商需要了解的内容。
关于新的化妆品香料过敏原清单和标签的规定是什么？
欧洲委员会负责化妆品法规的部门于2022年9月15日宣布，他们正在修订《欧盟法规（EC）第1223/2009号》。该法规涉及化妆品中香料过敏原的标签标识，正在更新以反映需要单独标识的香料过敏原清单的不断增加。尽管原来的26种过敏原清单仍然有效，但已经新增了56种由欧盟消费者安全科学委员会（SCCS）确认对人体过敏的成分。什么是香料过敏原？这一法规更新对化妆品制造商有何影响？以下是您需要了解的内容。什么是香料过敏原？
那么，香料过敏原究竟是什么呢？香水和有香味的化妆品中含有香料。这些香料以不同的比例组合，可以创造出无限多的香味，化妆品制造商将它们添加到产品中，使产品更具特色和使用感更佳。目前有超过2,500种香料成分被认为在适当的浓度下可安全用于化妆品配方中。然而，即使在低于这个阈值的情况下，某些香料仍可能引发某些人的皮肤刺激或过敏反应。这些被称为"香料过敏原"的成分包括合成香料以及天然植物提取物和精油。
消费者安全科学委员会估计，16%的湿疹患者对这些化合物产生了敏感，且多达3%的欧洲人对这些成分表现出过敏反应。因此，香料过敏原需要在成分列表中清楚标明。《欧盟法规（EC）第1223/2009号》附录III规定，如果这些过敏原的使用浓度超过一定阈值，目前已列出的26种过敏原必须强制标示在标签上。
- 对于免洗产品（如化妆品或身体乳液），当总浓度超过0.001%时，需要标示。
- 对于冲洗型产品（如洗发水或沐浴露），当总浓度超过0.01%时，需要标示。
过敏原清单做了哪些更改？
标签要求的性质保持不变。香料过敏原必须在成分列表中标明，并在容器或包装上通过"parfum"或"aroma"这些术语清楚标识。更新后的过敏原清单在《附录III》中新增了约58种物质，纳入法规范围。
| Pinus Mugo leaf and twig oil and extract | Pinus Mugo Leaf oil |
| Pinus Pumila leaf and twig oil and extract | Pinus Pumila Needle Extract |
| 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 |
| 2,6,6-Trimethylbi-cyclo[3.1.1]hept-2-ene; (alpha-Pinene) 6,6-Dimethyl- 2-methylenebicyclo[3.1.1]heptane (beta-Pinene) | Pinene |
| p- Mentha-1,3-diene | alpha-Terpinene |
| p-Mentha-1,4(8)-diene; Terpinolene | 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 |
| 1-(2,6,6-trimethyl-2-cyclohexen-1-yl)-2-buten-1-one 1- (2,6,6-Trimethylcyclohexa-1,3-dien-1- yl)-2-buten-1-one 1- (2,6,6-Trimethyl-3- cyclohexen-1-yl)-2- buten-1-one (Z)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one (E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one | Rose ketone 1 (alpha-Damascone) cis-Rose ketone 1 trans-Rose ketone 1 Rose ketone 4 (Damascenone) Rose ketone 3 (delta-Damascone) trans-Rose ketone 3 cis Rose ketone 2 (cis-beta-Damascone) trans-Rose ketone 2 (trans-beta-Damascone) |
| 3-Propylidene-phthalide | Propylidene phthalide |
| Verbena absolute (Lippia citriodora Kunth.) | Lippia citriodora absolute |
| [3R-(3α,3aβ,7β,8aα)]-1-(2,3,4,7,8,8a-hexahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl)ethan-1-one | Acetylcedrene |
| Pentyl-2-hydroxy-benzoate | Amyl salicylate |
| 1-Methoxy-4-(1E)-1-propen-1-yl-benzene (trans-Anethole) | Anethole |
| Benzaldehyde | Benzaldehyde |
| Bornan-2-one; 1,7,7-Trimethylbi-cyclo[2.2.1]-2-heptanone | Camphor |
| (1R,4E,9S)-4,11,11-Trimethyl-8-methylenebicyclo[ 7.2.0]undec-4-ene; | beta-Caryophyllene |
| 2-methyl-5-(prop-1-en-2-yl)cyclohex-2-en-1-one; (5R)-2-Methyl-5-prop-1-en-2-ylcyclohex-2-en-1-one; 2-Methyl-5-(1-methylethenyl)-2-cyclohexenone | Carvone |
| 2-Methyl-1-phenyl-2-propyl acetate | Dimethylbenzyl Carbinyl Acetate |
| Oxacyclohepta-decan-2-one | Hexadecanolactone |
| 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta- γ-2-benzopyran | Hexamethylindanopyran |
| 3,7-Dimethyl octa-1,6-diene-3-yl acetate | Linalyl acetate |
| Menthol; dl-menthol; l-menthol; d-menthol | Menthol |
| Methyl 2- hydroxy benzoate; Methyl salicylate | Methyl salicylate |
| 3-Methyl-5-(2,2,3-Trimethyl-3-Cyclopentenyl)pent-4-en-2-ol | 3-Methyl-5-(2,2,3-Trimethyl-3-Cyclopentenyl)pent-4-en-2-ol |
| o-Hydroxy-benzaldehyde | Salicylaldehyde |
| 5-(2,3-Dimethyl-tricyclo[2.2.1.02,6]-hept-3-yl)-2-methylpent-2-en-1-ol (alpha-Santalol); (1S-(1a,2a(Z),4a))-2-Methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)-2-penten-1-ol (beta-Santalol) | alpha-Santalol beta-Santanol |
| [1R-(1alpha)]-alpha-Ethenyldecahydro-2-hydroxy-a,2,5,5,8a-pentamethyl-1-naphthalenepropanol | Sclareol |
| Terpineol; p-Menth-1-en-8-ol (alpha-Terpineol); 1-methyl-4-(1-methylvinyl)cyclohexan-1-ol (beta-Terpineol); 1-methyl-4-(1-methylethylidene)cyclohexan-1-ol (gamma-Terpineol) | Terpineol |
| 1-(1,2,3,4,5,6,7,8-Octahydro-2,3,8,8-tetramethyl- 2-naphthalenyl)-ethanone ; 1-(1,2,3,4,5,6,7,8-Octahydro-2,3,5,5-tetramethyl- 2-naphthalenyl)-ethanone ; 1-(1,2,3,5,6,7,8,8a-Octahydro-2,3,8,8-tetramethyl- 2-naphthalenyl)-ethanone; 1-(1,2,3,4,6,7,8,8a-Octahydro-2,3,8,8-tetramethyl- 2-naphthalenyl)-ethanone | Tetramethyl acetyloctahydro-naphthalenes |
| 3-(2,2-Dimethyl-3-hydroxypropyl)toluene | Trimethyl-benzenepropanol |
| 4-Hydroxy-3-methoxybenz-aldehyde | Vanillin |
| Cananga Odorata flower oil; Cananga Odorata Flower Extract; Ylang Ylang Flower oil and Extract | Cananga Odorata Flower Extract; Cananga Odorata Flower Oil; Cananga Odorata Flower Wax; Cananga Odorata Leaf Oil |
| Cinnamomum Cassia Leaf Oil | Cinnamomum Cassia Leaf Oil |
| Cinnamomum Zeylanicum Bark Oil | Cinnamomum Zeylanicum Bark Oil |
| Citrus Aurantium Flower oil | Citrus Aurantium Amara Flower Oil; Citrus Aurantium Dulcis Flower Oil; |
| Citrus Aurantium Peel Oil | Citrus Aurantium Amara Peel Oil; Citrus Aurantium Dulcis Peel Oil; Citrus Sinensis Peel Oil |
| Bergamot oil | Citrus Aurantium Bergamia Peel Oil; Citrus Aurantium Bergamia Fruit Extract; Citrus Aurantium Bergamia Fruit Oil |
| Citrus Limon oil | Citrus Limon Peel Oil |
| Cymbopogon Citratus / Schoenanthus/Flexuosus Oils | Cymbopogon Schoenanthus Oil; Cymbopogon Flexuosus Oil; Cymbopogon Citratus Leaf Oil; Cymbopogon Citratus Extract |
| Eucalyptus Globulus Oil | Eucalyptus Globulus Leaf Oil; Eucalyptus Globulus Leaf/Twig Oil |
| Eugenia Caryophyllus Leaf 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 Oil; Juniperus Virginiana Wood Oil |
| Laurus Nobilis oil (with the exception of the substance in Annex II, reference number 359) | Laurus Nobilis Leaf Oil |
| Lavandula Hybrida oil; Lavandula intermedia oil; Lavandula Angustifolia Oil | Lavandula Hybrida Oil; Lavandula Hybrida Extract; Lavandula Hybrida Flower Extract; Lavandula Hybrida Flower Water Lavandula Intermedia Flower/Leaf/Stem Extract; Lavandula Intermedia Flower/Leaf/Stem Oil; Lavandula Intermedia Flower/Leaf/Stem Water; Lavandula Intermedia Oil Lavandula Angustifolia Oil; Lavandula Angustifolia Flower/Leaf/Stem Extract |
| Mentha Piperita oil | Mentha Piperita Oil |
| Spearmint oil/Spearmint ext. | Mentha Viridis Leaf Oil Mentha Spicata Oil |
| Narcissus extract | Narcissus Poeticus Extract Narcissus Pseudonarcissus Flower Extract Narcissus Jonquilla Extract Narcissus Tazetta Extract |
| Pelargonium Graveolens oil | Pelargonium Graveolens Flower Oil |
| Pogostemon Cablin oil | Pogostemon Cablin Oil |
| Rosa Damascena Flower Oil/Extract; Rosa Alba Flower Oil/Extract Rosa Canina Flower Oil; Rosa Centifolia Flower Oil/Extract; Rosa Gallica Flower Oil; Rosa Moschata Flower Oil; Rosa Rugosa Flower Oil | Rosa Damascena Flower Oil; Rosa Damascena Flower Extract; Rosa Alba Flower Oil; Rosa Alba Flower Extract; Rosa Canina Flower Oil; Rosa Centifolia Flower Oil; Rosa Centifolia Flower Extract; Rosa Gallica Flower Oil; Rosa Moschata Flower Oil; Rosa Rugosa Flower Oil |
| Santalum Album oil | Rosa Damascena Flower Oil; Rosa Damascena Flower Extract; Rosa Alba Flower Oil; Rosa Alba Flower Extract; Rosa Canina Flower Oil; Rosa Centifolia Flower Oil; Rosa Centifolia Flower Extract; Rosa Gallica Flower Oil; Rosa Moschata Flower Oil; Rosa Rugosa Flower Oil |
| Santalum Album oil | Santalum Album Oil; Santalum Album Wood Oil |
| Phenol, 2-methoxy-4-(2-propenyl)-, acetate | Eugenyl acetate |
| 2,6-Octadien-1-ol, 3,7-dimethyl-,1-acetate, (2E)- | Geranyl acetate |
| 2-Methoxy-4-prop-1-enylphenyl acetate | Isoeugenyl acetate |
| 6-Methylcoumarin | 6-Methylcoumarin |
此次更新涵盖了82种香料过敏原，旨在为消费者提供益处和保护。它让消费者能够获取更好、更有用的信息，帮助他们了解涂抹在皮肤上的成分。增加的透明度也将有助于增强消费者对产品安全性的信任。
这一扩展的通过原定于2020年进行。然而，多个因素——其中之一是新冠疫情——推迟了其实施。随着扩展现已启动，制造商需要更新其流程，确保其包装符合相关要求。
香料过敏原清单的时间表是什么？
该修正案于2023年8月17日全面生效。从此时起，制造商有三年的时间来调整其产品配方和包装，以确保在将化妆品投放到欧盟市场之前符合法规要求。对于在新标签规定生效前已投放市场的产品，企业将获得额外的时间进行调整。法规生效五年后，所有不符合要求的产品将逐步淘汰，制造商将被要求从市场上撤回任何不合规的产品。
