Survey and health assessment of chemical substances in massage oils
6.1 Labelling and legislation
Massage oils are in a grey area with respect to legislation. To determine which legislation is prevailing for the product group, it is necessary to make a total evaluation of more factors for the individual products, e.g. where they are sold, target group, objective, claims and labelling as well as type of packaging and appearance.
All massage, baby and body oils are applied to a greater or smaller area of the skin and are not intended to be washed off. Generally, the cosmetics legislation is relevant for all products for the skin. When marketed, the products must be specifically labelled in accordance with the cosmetics legislation, among others with an INCI declaration. If the product has a healing or relieving effect, the regulations for pharmaceuticals must be observed. If the product is assessed to be neither a cosmetics or a pharmaceutical, for instance if it is mainly intended for procuring the feeling of well-being, the legislation on chemical substances and product is prevailing and provides among others guideline directions for classification and labelling of the product.
Definition of cosmetics and chemical substances are given below.
184.108.40.206 Definition of cosmetics and chemical substances
I accordance with the “kosmetikbekendtgørelsen”, the Danish cosmetics statutory order (1), cosmetic products are defined as any substance or preparation intended for contact with different kinds of the surface of the human body. This may be skin, hair of the head or other areas with hair, nails, lips, and exterior sexual organs, or if the product is intended for contact with the teeth and the mucosa of the mouth. The preparation must be applied solely or mainly for the purpose of cleaning and perfuming, changing appearance, correcting body odour, protecting or keeping in good condition the area of application. The enclosure of the Danish cosmetics statutory order contains an indicative list of products that are regarded as cosmetics, e.g. cream, emulsion, lotion, gel and oil for the skin.
The cosmetics statutory order does not comprise preparations that prevent, recognize, relieve, treat and heal illnesses, illness symptoms, pain or changes of the body functions. These products fall within the legislation for pharmaceuticals.
By chemical products are understood both solvents such as solid, liquid and gaseous mixtures of two or more chemical substances. Medicine, food stuffs etc., cosmetics and pesticides constitute an exception due to their different legislation Before being sold, chemical products must be classified to identify the physical-chemical, toxicological and ecotoxicological properties that may cause hazards by normal handling or use. The classification comprises placing in hazard classes, allocation of risk sentences (R-sentences) specifying the hazard of the products. To protect the user, chemical products classified as dangerous must be labelled with hazard symbols and risk sentences as well as security sentences (S-sentences) providing directions of necessary precautions to be taken in account (5).
The majority of the purchased product has a label with directions for use. On the label is often also described the effect of the oil when applied to the skin. This description is part of the marketing of the product and is in many in the nature of a claim. Emotional expressions are often used, often adjectives, and the consumers are not left in doubt that the product is good for the skin and may also have a relaxing effect and prevents stretch marks in the skin. Among the words on the label of the products, could be for instance: caring, vitalizing, preventing, relaxing, bracing, moisting, stimulating, warming, protects, rejuvenates dry and pale skin, stimulates the blood circulation in the skin, prevents muscular tensions, prevents stretch marks. Table 6-1 exemplifies text of the product labelling. It should be emphasized that not only the labelling of the product decides, whether it is a cosmetics but also a total consideration of several factors on the individual products, for instance where it is sold, target group, claims and labelling as well as type of packaging and other appearance.
In some cases, you may doubt, whether the claimed effect is caused by the massage or the massage oil.
Table 6-1 Examples of labelling of purchased massage, body and baby oils.
Table 6-1 illustrates that the products are labelled very differently with respect to claims/effect. As part of the products is marked as ‘ good for the skin’ and as it is applied just like cosmetics products, the safety effects will be assessed based on the Danish cosmetics statutory order and the chemicals legislation.
Claims for essential oils often emphasise that application of the oil has special physic and psychical advantages. The properties of the essential oils are well defined, but it is difficult to find scientific investigations confirming the claimed effects. Examples of claims on the effects of essential oils are given below in table 6-2.
Table 6-2 Examples of the effect of pure essential oils when applied
Besides the positive claims indicated in table 6-2 ,marketing folders have warned seriously against wrong application of essential oils, e.g. intake or application of undiluted essential oil.
6.2 Assessment of massage oils
Compliance with the legislation and particularly the labelling of the different product types is described in the following.
6.2.1 Massage and body oils
Only a limited number of the selected products claim to be for massage purposes without also mentioning effects such as softeners, moisteners or other caring effect which massage oils can add to the skin. Of 18 purchased massage and body oils, 4 products did not have any indication of caring effect on the label, but only describes application for massage. However, 3 of these 4 products followed the determinations in the Danish statutory order on cosmetics, as they were labelled with the INCI declaration of ingredients. 2 of the products had indications of one or more of the 26 fragrance allergens. Judged from its presentation (logo and packaging), the last product could be a cosmetics product.
Of the purchased 18 massage- and body oils, 14 products were indicated to have a caring effect to the skin. The product packagings were coloured or uncoloured bottles of plastic or glass, one single product in the form of an ointment. Most bottles had no special eye catcher as for instance gold or silver shining print and gave the impression of being a neutral, almost medicine like drug. All products had the INCI declaration of ingredients.
Of the purchased massage- and body oils, 10 products, all with INCI declarations were tested for content of the 26 fragrance allergens. In its INCI declaration, one of the products indicated content of limonene. However this could not be demonstrated by the test. The results of the remaining 9 tested products showed content of more of the 26 fragrance allergens, however only one was declared on the label.
6.2.2 Baby oils
Of 28 purchased massage oils, 6 products were for baby massage. The products were all composed of a number of fragrance substances . One of these products did not indicate caring effect to the skin and consequently it was not labelled in accordance with the cosmetics regulations. The product contained essential oil and its presentation (logo and packaging) might give the impression of being a cosmetics product. The remaining 5 products, all indicating caring effect can be regarded as cosmetics and was labelled with the INCI declaration of ingredients. One of these product did not contain perfume, the other five did.
Later on, two of the baby oils were tested for content of the 26 fragrance allergens. The test results showed that one of the tested products had not indicated the detected fragrance allergens in its INCI declaration of ingredients, whereas the other product had indicated the current fragrance allergens correctly.
6.2.3 Essential oils
The selected and purchased essential oils were all in small bottles of brown glass with a volume of 5 and 10 ml, some containing an information sheet indicating the application. The packaging, labelling or indications on the labels or on the information sheet did not give the impression that the products were for cosmetic use or should be applied as a pharmaceutical. The selected essential oils were labelled in accordance with the chemicals legislation.
In the survey, 4 essential oils were tested for content of the 26 fragrance allergens. The test results revealed however that the essential oils marketed in concentrated form contained more than 0.1% of one or more fragrance allergens and that the labelling regulations on allergy warning had not been observed, as this was not indicated on the label. If the product contains a sensitizing substance in a concentration > 0.1%, the following must be indicated “contain (name of the sensitizing substance). may cause allergic reaction”, unless other limits have been specified for the substance in question (5).
An assessment of all the factors like where they are sold, target group, objective, claims and labelling as well as type of packaging and appearance
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 of the 28 purchased products are covered by the cosmetic legislation (1). The remaining 13 are covered by the legislation on chemicals substances and products and due to this also covered by the rules of classification and labelling (5). As stated above this means among other things that there are specific rules regarding labelling of sensitising substances.