“Fragrance substances are organic compounds with characteristic, usually pleasant, odours. They are widely used in perfumes and other perfumed cosmetic products, but also in many other products such as detergents, fabric softeners and other household products.
Contact allergy is a life-long, altered specific reactivity in the human immune system. Upon re-exposure to a sufficient amount of an allergen, eczema (allergic contact dermatitis) may develop. When a person has already been sensitised to an allergen, a much lower concentration of it is sufficient to trigger symptoms of an allergy.
For the purposes of primary prevention, a restriction of fragrance allergens may be sufficient. However, sensitised persons may develop symptoms when they are exposed to lower concentrations of an allergen than the maximum permitted levels. Therefore, as a measure of secondary prevention, it is important to provide information on the presence of individual fragrance allergens in cosmetic products so that sensitised persons can avoid contact with the substance to which they are allergic”.
Perfumes and deodorants are the most frequent sources of sensitisation to fragrance ingredients in women, while aftershave products and deodorants are most often responsible in men. Thereafter, eczema may appear or be worsened by contact with other fragranced products such as cosmetics, toiletries, household products, industrial contacts and flavourings. Between 10 and 25% of patients routinely tested for suspected allergic contact dermatitis react to a standard indicator of fragrance allergy and they report it in the medical interview.
Allergens already have their legislative history. In 2003 list of 26 allergens has been introduced into the Cosmetics Directive 2003/15/EC of the European Parliament and of the Council (26 initially, but two were banned: Lilial, Lyral).
In December 2011, the European Scientific Committee on Consumer Safety (SCCS) adopted SCCS/1459/11 – “Opinion on fragrance allergens in cosmetic products” , which concluded that humans were sensitive to more substances than the 26 already listed in Regulation 1223/2009. Plans were made to add around 56 more substances to the regulation’s scope and in 2023, the new regulation enters into force: Commission Regulation (EU) 2023/1545 of 26 July 2023 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards labelling of fragrance allergens in cosmetic products.
The additional substances included in Annex III are:
- 29 pure substances: Alpha-Terpinene, Terpinolene, Rose Ketones, 3-Propylidenephthalide, Methyl Salicylate, Acetyl Cedrene, Amyl Salicylate, Anethole, Benzaldehyde, Camphor, Beta-Caryophyllene, Carvone, Dimethyl Phenethyl Acetate, Hexadecanolactone, Hexamethylindanopyran, Linalyl Acetate, Menthol, Trimethylcyclopentenyl Methylisopentenol, Salicylaldehyd, Santalol, Sclareol, Terpineol, Tetramethyl acetyloctahydronaphthalenes, Trimethylbenzenepropanol, Vanillin, Eugenyl Acetate, Geranyl Acetate, Isoeugenyl Acetate, Pinene.
- 27 natural extracts and oils: Pinus Mugo, Pinus Pumila, Cedrus Atlantica Oil/Extract, Turpentine, Myroxylon Pereirae Oil/Extract, Lippia Citriodora Absolute, Cananga Odorata Oil/Extract, Cinnamomum Cassia Leaf Oil, Cinnamomum Zeylanicum Bark Oil, Citrus Aurantium Flower Oil, Citrus Aurantium Peel Oil, Citrus Aurantium Bergamia Peel Oil, Citrus Limon Peel Oil, Lemongrass Oil, Eucalyptus Globulus Oil, Eugenia Caryophyllus Oil, Jasmine Oil/Extract, Juniperus Virginiana Oil, Laurus Nobilis Leaf Oil, Lavandula Oil/Extract, Mentha Piperita Oil, Mentha Viridis Leaf Oil, Narcissus Extract, Pelargonium Graveolens Flower Oil, Pogostemon Cablin Oil, Rose Flower Oil/Extract, Santalum Album Oil.
These substances must be additional listed on the container or packaging of cosmetic, according to already existing rules, when present at the following or greater levels:
- 0,01% in a rinse-off cosmetic (e.g., soap, shower gel, shampoo),
- 0,001% in a leave-on cosmetic (e.g., cream, lotion, tonic).
Labelling is mandatory if the substance is present in the cosmetic product above mentioned specific threshold concentrations, which are different for leave-on and rinse-off products. So the new regulation expands this list to 80+ allergens. Note that the purpose of this additional labelling is to inform those sensitised individuals who have been tested and know which ingredients to avoid. It will tell them whether the substance to which they are sensitised is present in the product. The formula has not changed. There is no requirement to remove these substances and no need to consider reformulating out of these ingredients. The overwhelming majority of cosmetic users will not experience any undesirable effects associated with the presence of these substances.
What is important the expansion of the list of allergens introduced new regulatory and implementation challenges, such as:
- many complex names to be memorised by allergic consumers for the same type of allergen (56 new allergens correspond to > 100 INCI names),
- issue of space on labels due to very long list of ingredients.
To address these issues, a new annex III regulatory approach had to be developed in the new regulation, allowing substances with the same cross-sensitising properties to be listed under a common group name rather than the individual substance name.
In the regulation there are two regulatory approaches for the naming of allergens in annex III, which are referred to in the document as ‘Standalone’ and ‘Grouped’. The ‘Standalone’ allergen entry approach is the usual regulatory approach used in the past for the 24 allergens. The ‘Grouped’ allergen entry approach is a new regulatory approach, which was developed to solve the issue of the length of ingredient lists, which would have made the label too long and complicated, and therefore not consumer friendly (especially for allergic people). Instead of forcing the allergic person to memorise the whole list of substances belonging to the same cross-sensitisation group, only one name for each group is to be memorised by the concerned allergic consumers. That is the so called ‘Group Names’ (GN) – ‘grouping names’ for different substances containing the same (type of) allergen.
What can be the sources of allergens in cosmetics?
An allergen can be present in a cosmetic product due to:
- its presence in the fragrance or aroma mixture either added directly or as part of a natural complex substance (e.g., essential oil, botanical extract),
- its presence as constituent of a natural complex substance (NCS) (e.g., essential oil, botanical extract),
- its presence as an impurity or contaminant (very rarely or not at all),
- a combination of two or more of the above (no contribution as cosmetic ingredient),
- its intentional addition as a cosmetic ingredient (i.e., not a fragrance or aroma mixture),
- combination of one or more of the above.
Regulation 2023/1545 confirms the transition period mentioned in the draft Regulation that we already know, and beauty brands will have to adapt the labels to the new requirements according to the following timelines:
- In 3 years for new cosmetic products to enter the EU market; until 31 July 2026,
- In 5 years for cosmetic products that are already on the EU market, until 31 July 2028.
There are numerous changes and adaptations that the cosmetics industry must face continuously to adjust to the standards and regulations set in Europe and around the world.
The introduced regulation will certainly be reflected in the declarations of ‘hypoallergenic product’, ‘free from’ and products for children.
An important challenge linked to the expansion of the list of allergens is the impact at international level, and the need to secure globally compatible labels for cosmetics. Indeed, regulatory discrepancies in labelling requirements fragment the market and create supply chain complexities and unnecessary additional cost.
Mindful of the potential challenges ahead, the EU cosmetic industry is preparing an explanatory document to be shared with international regulators to help clarify the new regulatory requirements in the EU and introduce the allergen guideline.
This document is aiming to ensure global authorities understand:
- that these additionally labelled substances/group of substances were already present in the product under the ingredient ‘PARFUM’ or ‘FRAGRANCE’ or as a substance/constituent of the existing ingredient and have not been newly added,
- thus, that the extension of the allergens list of the product is made to comply with new EU labelling requirements and does not reflect a change of formula,
- that all these substances and groups of substances are labelled with a recognized INCI name. – that there are implementation timelines (‘placing on the market’ and ‘making available’) which are important for the industry because they need to conduct the assessment for each product and adapt the labelling in compliance with the new regulation,
- that allergens are labelled to inform sensitized consumers about their presence in the product above the safety thresholds (asking the exact percentage of each allergen present in the formula is not appropriate since it does not accurately predict the risk of an allergic reaction and can thus be misleading).
In the light of changing cosmetic legislation we need to keep in mind the main purpose of the changes is the information to allergic consumers, who are aware of their specific allergies, about the present of the specific allergens in an easy recognizable format and do not forget that the cosmetic industry should to be support to implement the new changes.
(References: GUIDELINES ON THE ‘FRAGRANCE ALLERGENS’ REQUIREMENTS, 7 November 2023)
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