Survey and health assessment of chemical substances in massage oils
Summary and conclusions
In the spring of 2005, DTC has assessed 49 typical massage, baby and body oils as well as essential oils for self-mixing. 28 of the products were purchased. The majority of the products is marketed to adults and only baby oils are regarded as meant for children.
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 point of sale, target group, claims, labelling, packaging and the general appearance. If the product is assessed neither to be a cosmetic nor a medicine, if for instance it is assessed to be used mainly for well-being, it is assumed that the legislation on chemical substances and products applies and this determines the guideline directives for classification and labelling of the product. Irrespective of the existing legislation, all products are applied to the skin and must not be hazardous to human health when used.
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.
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 sensitizing fragrances. 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 balm and several of the subcomponents of Peru balm 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 EU limit for labelling of 26 fragrances allergens in leave-on cosmetics is 0.001 percentage by weight. A large part of the analysed products (94%) contains one or more of the 26 fragrance allergens in a concentration higher than 0.001 percentage by weight and should therefore be declared on the product.
For chemical products the regulation 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 benzylcinnamate, cinnamal, citral, citronellol and Peru balm, 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 concentration of fragrance allergens is to be found in products for adults. For the fragrance linalool a safety margin (Mos) below 100 was found which indicates a health risk. In addition, the safety assessment showed that perfumed massage oils for adults should not be used on babies.
Two baby oils were tested. In one of the products the content of d-limonen was so high that the product received a safety margin below 100. Based on this the product is assessed as presenting 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.
There is no lower concentration limit concerning the sensitizing effects of the substances. Consequently, several of the products in the survey might present a risk of developing allergy in consumers who are especially sensitive. Likewise there a risk that consumers with perfume allergies might experience irritation, eczema or the likes when using the products.