Fragrance Allergen Requirements in the EU Updated
Annex III of EU Cosmetic Regulation 1223/2009 currently lists 26 allergens, all of which must be listed in the ingredients list on the label or packaging of a product if they are present in concentrations greater than 0.001% in leave-on products and 0.01% in rinse-off products.
In 2011, the Scientific Committee on Consumer Safety (SCCS) published an opinion on fragrance allergens in cosmetic products (SCCS/1459/11). In response to the SCCS opinion, the European Commission published a public consultation on fragrance allergens. The deadline for comments was 14 May 2014.
In the consultation they indicated that three allergens: Hydroxyl- Isohexylcyclohexene Carboxaldehyde (HICC) (annex III, entry 79), Atranol and Chloroatranol should not be used in cosmetics. A transition period of two years for removing from the market products containing Atranol and Chloratranol is proposed. For HICC, the proposed transitional period is two years for placing on the market products containing HICC, and five years for their withdrawal. The transition period would start from the date when the proposed amendment to regulation 1223/2009 comes into force. The European Commission also plans to amend annex III for the following entries, to include the requirement that these substances are included in the ingredient list if they are present in concentrations greater than 0.001% (leave-on products) and 0.01% (rinse-off products).
It is proposed that entries 167 and 168 in annex III, for 1-Limonene; (S)-p-Mentha- 1,8-diene and dl-Limonene (racemic); 1,8(9)-p-Menthadiene; p-Mentha-1,8-diene (Dipentene) respectively, are deleted. Entry 88 in annex III, for d-Limonene(4R)-1-Methyl-4-(1-methylethenyl)cyclohexene, will remain.
In addition to these changes, the European Commission proposes to add the substances in Table 2 to Annex III and require that they are included in the ingredient list when their concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products.
EU Cosmetic Regulation Compliance
SGS is experienced in enabling organisations to demonstrate their compliance with the EU cosmetics regulation. We conduct tests and safety assessments, as well as monitor regulatory changes, to ensure that cosmetic products are safe to be placed on the market and comply with all relevant national and international regulations. With a network of experts and testing facilities across the EU, America and Asia, SGS is the partner to trust.
Table 1: Proposed annex iii Amendments
Ref. No | CHEMICAL NAME | NAME OF COMMON INGREDIENTS GLOSSARY |
---|---|---|
109 | Pinus Mugo oil and extract | Pinus Mugo Leaf Oil; Pinus Mugo Twig Leaf Extract; Pinus Mugo Twig Oil |
114 | Pinus pumila oil and extract | Pinus Pumila Twig Leaf Extract; Pinus Pumila Twig Leaf Oil |
122 | Cedrus atlantica oil and extract | Cedrus Atlantica Bark Extract; Cedrus Atlantica Bark Water; Cedrus Atlantica Leaf Extract; Cedrus Atlantica Wood Extract; Cedrus Atlantica Wood Oil |
122 bis | Cedrus Atlantica oil | Cedrus Atlantica Bark Oil |
124 | Turpentine gum (Pinus spp.) | Turpentine |
125 | Turpentine oil and rectified oil | Turpentine |
126 | Turpentine, steam distilled (Pinus spp.) | Turpentine |
130 bis | 2,6,6-Trimethylbicyclo[3.1.1]hept-2-ene; 6,6-Dimethyl-2-methylenebicyclo[3.1.1] heptane |
alpha-Pinene and beta-Pinene |
131 | p- Mentha-1,3-diene | alpha-Terpinene |
133 | p-Mentha-1,4(8)-diene | |
154 | 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 |
157 | (Z)-1-(2,6,6-trimethyl-2-cyclohexen-1-yl)-2- buten-1-one (TMCHB) |
alpha-Damascone |
160 | Rose ketone-4; 1- (2,6,6- Trimethylcyclohexa-1,3-dien-1- yl)-2- buten-1-one (Damascenone) |
Rose Ketone-4 |
161 | Rose ketone-3; 1- (2,6,6-Trimethyl-3-cyclohexen- 1-yl)-2- buten-1-one (Delta- Damascone) |
delta-Damascone |
162 | (2Z)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)- 2-buten-1-one (cis-beta-Damascone) |
cis-Rose Ketone-2 |
175 |
3-Propylidenephthalide | Propylidene Phthalide |
196 | Verbena absolute (Lippia citriodora Kunth) |
Table 2: Proposed Annex III Amendments
Acetylcedrene | Cinnamomum Zeylanicum Bark Oil |
---|---|
Amyl Salicylate | Citrus Aurantium Amara Flower Oil, Citrus Aurantium Amara Peel Oil |
Anethole | Citrus Bergamia Peel Oil Expressed |
Benzaldehyde | Citrus Limon Peel Oil |
Camphor | Citrus Sinensis Peel Oil Expressed, Citrus Aurantium Dulcis Peel Oil Expressed, Citrus Aurantium Dulcis Peel Oil |
beta-Caryophyllene | Cymbopogon Citratus Leaf Oil, Cymbopogon Schoenantus Oil |
Carvone | Eucalyptus Species Leaf Oil, Eucalyptus Globulus Leaf Oil |
Dimethylbenzyl Carbinyl Acetate (DMBCA) |
Eugenia Caryophyllus Leaf Oil, Eugenia Caryophyllus Flower Oil |
Hexadecanolactone | Jasminum Grandiflorum Flower Extract, Jasminum Officinale Flower Oil, Jasminum Officinale Oil |
Hexamethylindanopyran | Juniperus Virginiana Oil, Juniperus Virginiana Wood Oil |
Linalyl Acetate | Laurus Nobilis Oil, Laurus Nobilis Leaf Oil (oil from the seeds of Laurus nobilis L. is prohibited (annex II entry 359) |
Menthol | Lavandula Hydrida Herb Oil |
Methyl Salicylate | Lavandula Officinalis Flower Oil, Lavandula Angustifolia Oil |
3-Methyl-5-(2,2,3-Trimethyl-3-Cyclopentenyl) pent-4-en-2-ol |
Mentha Piperita Oil |
Salicylaldehyde | Mentha Spicata Herb Oil, Mentha Viridis Extract |
alpha-Santalol and beta-Santalol | Narcissus Poeticus Extract, Narcissus Poeticus Flower Extract |
Sclareol | Pelargonium Graveolens Flower Oil |
Terpineol | Pogostemon Cablin Oil |
alpha-Terpineol | Rosa Alba Flower Extract, Rosa Canina Flower Oil, Rosa Centifolia Flower Oil, Rosa Damascena Flower Oil, Rosa Gallica Flower Oil, Rosa Moschata Oil, Rosa Rugosa Flower Oil |
Tetramethyl |
Santalum Album Wood Oil, Santalum Album Oil |
Trimethyl-Benzenepropanol | Geranial |
Vanillin | Eugenyl Acetate |
Cananga Odorata Flower Extract, Cananga Odorata Flower Oi |
Geranyl Acetate |
Cinnamomum Cassia Leaf Oil | Isoeugenyl Acetate |
For more information, please visit SGS Cosmetics website:
Martin Perry
Cosmetic Safety Assessor
SGS United Kingdom Limited
t: +44 1274 303080