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Survey and health assessment of chemical substances in massage oils
6 Legislation
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.
6.1.1.1 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).
6.1.2 Claims
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.
| Product ID |
Comments |
| 4 |
…stimulates the blood circulation in the skin, strengthen its natural functions and keep it smooth and lithe. Massage using the massage oil warms, loosens and prevents muscle tightenings. It also prevents pregnancy stretch marks in the skin. |
| 16 |
...an effective skin care product to be applied to almost any kind of skin problems, e.g. dry skin, skin abrations, flushing and sun burning. The oil also effects lithe and softening of the skin, which fx reducing the risk of stretch marks during pregnancy'. |
| 17 |
Especially recommended for cleaning of the diper area, for baby massage and generally for skin care. |
| 18 |
Recommende for relaxation, cure of swollenness and colic. |
| 19 |
Ante-natal oil is a purely natural, particularly developmed care product to be applied before delivery. Almond oil and wheat germ oil rich of vitamin E – loosen and increase the elastidity in the perineal tissue. Massage imporves the blood circulation, which again increases the litheness in the perineum. |
| 23 |
The material of the producer says:…. ‘a soft and nourishing film is creasted on the skin of your baby during and after bathing’….and ‘ the lavender in these mixtures is very calming and may contribute to making the babies relax at the end of the day.’ |
| 24 |
The material of the producer says: ‘ Massaging the child’s stomach clockwise may contribute to cure painful, troublesome colic. Apply more oil if demanded and continue the massage, until the child calms down and relaxes. This massage oil is also good for stressed mothers.’ |
| 25 |
This mild oil is particularly applicable to thighs and buttocks, where the skin is uneven with small dimples and needs extra care. |
| 30 |
Prevents stress marks in pregnancy. Regular massage with the oil on abdomen, thights, seats and breast prevents stretch marks and protects the skin from drying. |
| 31 |
Gives freshness and is a good cure against cellulitis. |
| 32 |
Birch extract strengthen the body after hard training, where arnika coddles the skin with strenght and warmth. |
| 33 |
The warming qualities of the lavender restitute the peace of the body and the mind, qualities that makes this body- and massage oil ideal for the modern life. |
| 34 |
For sensitive skin care for sensitive people. Softens and reduces flushing and irritated skin. Applicable in old people’s care |
| 35 |
Caring oil for protection and softening of the skin. The beautiful fragrance has an relaxing effect and increases the well being. Particularly well fitted for sensitive skin and skin sensitive to weather changes. |
| 36 |
This exclusive body oil is good in stressing/exhausting periods. Rose oil has a nourishing effect on even the most sensitive skin and is particularly suited for babycare and for children and women. |
| 37 |
Stimulates lactation. Massage with the oil increases circulation and warms through the breast. |
| 38 |
A fantastixwarming and protecting allround body oil. |
| 39 |
Effective against cellulitis. Massage the oil into thights, hips and buttocks with rotating movements. The oil penetrates the skin gently, gives the skin a silky gloss and permits the valuable active substances to go deep into the skin. |
| 40 |
…with a refreshing fragrance of lemon the skin functions harmonize and and keep the skin fresh and elastics and protects from drying. For every-day application after bath. To be massaged into the warm and humid skin. Calendula has a cleansing effect.. |
| 41 |
Cares and protects dry skin. Softens and lithes the skin. Stimulates circulation and harmonizes the functions of the skin. Contain almond oil that protects the skin from drying. Easily absorbed by the skin. Gives a fresh natural lemon fragrance. Relieving effect on children’s eczema. |
| 42 |
A mild massage with lavender massage oil cares for the skin and gives relaxation to both body and mind. The sun saturated essential oils of the lavender flower spreads a mild fragrance, which loosens up inner tensions and gives balance. Also good for children with difficulty in falling asleep at night.. |
| 43 |
...Cares and has a nice fragrance. It Den appeals to the body and the mind and maintain the skin elastic and lithe. The oil from Rosa mosqueta, jojoba oil and almond oil coddles og refreshes the skin. The mild fragrance of roses has a calming and harmonizing effect . Is easily absorbed by the skin. |
| 44 |
A lovely composition of sesame oil, hawthorn oil and naturally essential oils has an intensely caring and protecting effect to the skin also at environemental strains and after sun bathing. The skin gets vital force and feels lithe and nice. Can be applied to cure athlete's foot. |
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
| Essential oil |
Application |
| Eucalyptus and rosemary |
Winter cold and constipation. Enables breathing through the nose. |
| Lavender and Ylang ylang |
Nervousness and sleeping problems. Calms down the mind and gives a good night’s sleep. |
| Rosmarin og pebermynte |
Lack of concentration. To clear the mind. |
| Appelsin og Ylang ylang |
Busyness. Relaxing effect. |
| Jasmin |
Warming effect |
| Citron |
Stimulating effect |
| Rose |
Creates inner balance |
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).
6.2.4 Evaluation
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.
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Version 1.0 October 2006, © Danish Environmental Protection Agency
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