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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
Acetyloctahydronaphthalenes

 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