Survey and health assessment of chemical substances in massage oils
9 Summary and conclusions
Massage, baby and body oils as well as essential oils are in a grey area as to which legislation applies to the products. To determine the existing legislation it is necessary to carry out an overall assessment of several factors for each type of product such as target group, claims, objective, labelling, packaging and the general appearance.
An assessment of all the factors has been made for each of the purchased products., This assessment was made according to EU’s guidance on borderline products. The assessment show that 15 products are covered by the cosmetic legislation. The remaining 13 are covered by the legislation on chemicals substances and products and due to this covered by the rules of classification and labelling. Among other things this means that there are specific rules regarding labelling of sensitising substances.
An evaluation of the purchased 28 products illustrates that the producers of massage- baby- and body oils in most cases follow the cosmetics regulations governing the INCI list of ingredients.
The tested essential oils were also assessed not to comply with the regulations on labelling of chemical substances and products. The test results illustrated that the essential oils marketed in concentrated form contained more than 0.1% of one or more fragrance allergens. Because of insufficient allergy warning on the label, the labelling regulations had not been observed.
According to the products' list of ingredients, massage, baby and body oils on the Danish market are primarily composed of non-volatile and volatile oils. Other substances are found in very limited amounts. Only a few products are based solely on mineral oils and other additives such as pigments and preservatives.
The result of the chemical analysis of 16 massage, baby and body oils and essential oils (7 massage oils, 2 baby oils, 3 body oils and 4 essential oils) showed that 15 of the products contain one or more of the fragrance allergens. One of the 4 products analysed for methyleugenole contained a concentration of the substance 8 times the legal maximum limit for methyleugenole in a cosmetic leave-on product. One product was analysed for content of Peru balsam and several of the subcomponents of Peru balsam were detected. This indicates presence of the substance which is unwanted in cosmetic products. safrol and methylsalicylate were not found in the analysed products.
The limit of declaration for the 26 fragrance allergens in leave on products assessed by the EU is 0.001 weight percentage. In 94% of the analysed products, 1 or more of the 26 fragrance allergens are contained in concentrations of 0.001 weight percentage and are to be stated on the label.
For chemical products the regulation among other things states that if the product contains more than 0,1 % of a sensitizer the product must be labelled: ”Contains (chemical name). May cause allergy”.
Safety/toxicological profiles were prepared for the substances benzyl cinnamate, cinnamal, citral, citronellol and Peru balsam, which were all present in one or more of the analysed products. In addition, safety/toxicological profiles from previous surveys have been used for assessment of user exposure.
Exposure scenarios were drawn up for two average models (adult, baby) of the found fragrance allergens (a total of 19) and the user exposure was assessed. The result showed that the largest concentrations of fragrance allergens are found in products for adults. For the fragrance linalool a margin of safety (MoS) below 100 was found which indicates a health risk. In addition, the safety assessment showed that perfumed massage and body oils as well as basic oils mixed with essential oils for adults should not be used on babies.
Two baby oils were tested. In one of the products the content of d-limonene was so high that the safety margin of the product was determined to be below 100. Based on this the product is assessed to present a health risk to babies. However, as only two baby oils have been analysed the number is too small to conclude that the concentration of fragrance allergens in baby oils is a general health concern.
SCCNFP has assessed the 26 fragrance substances to be allergenic by skin contact. As this effect has no “zero effect level”, it is important to emphasize that for persons with sensitive skin or perfume allergy skin, contact with these substances should be avoided. Likewise these persons should avoid using the massage, baby and body oils and basic oils mixed with essential oils containing the 26 fragrance substances as they are in fact applied to a large area of the skin. These allergenic substances must be stated on the product label of cosmetics products, in order for the consumer to have the possibility not to choose products containing unwanted fragrance substances.