| Front page | | Contents | | Previous | | Next |

Survey and health assessment of chemical substances in essential oils and fragrance oils

2 Survey

• 2.1 Delimitation of the survey
• 2.2 The market for essential oils and fragrance oils
  • 2.2.1 Product types
  • 2.2.2 Actors on the market and turnover
  • 2.2.3 Consumer groups
  • 2.2.4 Found products
• 2.3 Use pattern for the products
• 2.4 Constituents
  • 2.4.1 Essential oils
  • 2.4.2 Fragrance oils
• 2.5 Labelling, legislation and recommendations
  • 2.5.1 Classification and labelling according to chemical legislation
  • 2.5.2 Labelled in accordance with the cosmetics legislation
  • 2.5.3 Labelling of products and recommendations
• 2.6 Summary of previous investigations on chemical substances in traditional air fresheners

2.1 Delimitation of the survey

A long series of products are used for spreading fragrances at home and in the car. The products may be divided roughly in three groups:

• Traditional aroma fresheners: aroma balls, "Wunderbaums", electric air fresheners, etc.
• Joss sticks and scented incense tops;
• Essential oils and aroma oils used for aromatherapy.

This survey covers the third of the groups as the two other groups have been included in previous investigations.

Traditional air fresheners

A number of air fresheners have previously been examined for several known sensitizing fragrances in the project "Mapping of chemical substances in air fresheners and other fragrance liberating products", carried out by Eurofins for the Danish Environmental Protection Agency (DEPA) (Survey of chemical substances in consumer products no. 30, 2003, Danish only). In this project was included a survey of the market for air fresheners and 19 products were tested for the content of 24 specific fragrances, known for having a sensitizing effect when contact with the skin. In the project it was not investigated to which extent the substances are emitted to the room and whether the substances could have any impact by exposure to humans by inhalation.

Joss sticks and tops

The emission of chemical substances from burning incense was investigated in the project "Survey and emission of chemical substances from incense " (Survey of chemical substances in consumer products no. 39, 2003). In this project a screening of 12 types of incense products was made and afterwards a quantitative analysis of the emission of chemical substances from 6 selected incense sticks. The survey showed that it cannot be excluded that there can be health problems connected with use of scented incense products and especially the burn off products could cause health risks.

What is aromatherapy?

Aromatherapy is use of therapeutic oils. Primarily oils extracted from natural plant material are used, but on the market are also so-called "nature-identical" synthetic oils.

Where the traditional air fresheners primarily should add a scent of clean and freshness to the air, the use of aromatherapy oils has - as the name suggests - a broader perspective as it is assumed that exposure to the oils have a positive health effect on the user.

The oils are particularly said to have an influence on the mental condition of the user and different oils may for example be marketed as giving a sense of calm, a soporific effect, be relaxing, enforcing, refreshing, exhilarating or sexually stimulating. Where the oils are used directly on the skin (e.g. in baths or by massage) the different essential oils are marketed as being stimulating for the skin, with a cleansing effect, stimulating for the blood circulation or as relaxation for the muscles.

Aromatherapy includes different uses of essential and other low-viscosity oils. At most uses the primary exposure to chemical substances in the oils is via inhalation and this project is directed specifically to these uses.

Essential oils are also used for dilution in massage oils and by this use the primary exposure will probably be through the skin. This usage of essential oil has been covered by a previous survey. In the project "Survey and health assessment of chemical substances in massage oils" (Survey of chemical substances in consumer products, no. 78, 2006) there was included an identification of essential oils being part of the massage oils.

This project is mainly directed towards the use of oils at home and the exposure of professional aroma therapists is not covered by the elaborated exposure assessments.

The term aromatherapy will be used widely and partly covers use of fragrances where the use is described as being part of an actual therapeutic process where, through a more systematic use of fragrances, the aim is a specific effect, partly "self-therapy" where the person uses the fragrance from a knowledge of their effect, for example from books - or just uses the oils because he/she finds it comfortable and pleasant.

2.2 The market for essential oils and fragrance oils

2.2.1 Product types

Oils that are used for aromatherapy can be divided into two groups:

• Pure essential oils extracted from natural plant material;
• Fragrance oils that are either a mixture of essential oils and synthetic "nature-identical" fragrances or pure mixtures of synthetic fragrances.

2.2.2 Actors on the market and turnover

Sale from shops

Store visits in the second largest town in Denmark (Aarhus) showed that essential oils were sold in the visited department stores (2 ), materialists (3 shops) and health food shops (2). All the stores also sold fragrance lamps, but not other aggregates for diffusion of the fragrances. The shops have from 5 to 50 fragrance variants on the shelf, but could typically obtain more. Two hardware dealers also sold fragrance lamps, but not the oils. One visited hobby shop sold essential oils, but the intended use was for making soaps and candies. One visited super market and one alternative life style shop sold neither oil nor lamps. If it is roughly assumed that all department stores, warehouses, materialists and health food shops sell essential oils, the total number of suppliers in these sectors are approximately 1400 (search on companies with this sector a primary category in Krak Markedsdata). To this should be added that the products will probably be distributed from some pharmacies and lifestyle shops.

The Internet

There are several internet shops selling products for aromatherapy. The shops typically sell products for the alternative therapy market and apart from essential oils and fragrance mixtures they also sell for example other types of oils, stones and crystals, tea and aromatic plants, pendulums and books on alternative therapy and life style.

Producers and importers

Based on store checks, internet search and other contact with actors on the market, the following companies have been identified marketing a wide range of oils:

• Natur-drogeriet A/S, Denmark
• Urtegaarden aps, Denmark
• RO-CO, Denmark
• Weibel Naturprodukter, Denmark
• The Body Shop, UK (Danish distributor: The Body Shop)
• Primavera Life GmbH, Germany (Danish supplier: Ulla Kvintel )
• Jurlique, Australia (Danish agent: Anne Frølund).

The Greek producer Apivita that has a broad range of essential oils has a Danish agent saying that essential oils or fragrance oils are not imported from Apivita.

Turnover

Production and import of essential oils and fragrance oils are not part of the statistic from Danish Statistics where these oils are listed with a number of other vegetable oils.

According to information from an important supplier there has been a considerable increase in the use of essential oils and fragrance oils with a 100% increase of sales during the last 2 years, but the consumption is still far below what is seen in e.g. Great Britain.

The total sale in Denmark has been estimated based on figures for one of the largest suppliers to the market. Based on this information it is estimated that total sales in 2006 seems to be approx. 300,000 to 700,000 bottles of essential oils and 100,000-300,000 bottles of fragrance oils. The bottles may be 1½, 5, 10 and 100 ml with 10 ml being the most frequent.

2.2.3 Consumer groups

There seem to be a tendency that more women than men are interested in aromatherapy and the use of essential oils. There also seems to be a tendency that more persons above 40 years of age than below use aroma oils. Many users of the products get to know these products through an aroma therapeutic session, but there are probably also many users of the lamps using the oils to spread a good atmosphere without being familiar with the effect of each of the oils. In aroma therapeutic sessions the use of fragrance oils are often combined with massage and healing. At some sessions the client must - after advise from the therapist - over a period use certain essential oils daily, but in view of achieving a desired effect.

There was found no information showing that children to a larger extent use aromatic oils at home, but children can also participate in aroma therapeutic sessions.

2.2.4 Found products

Essential oils

A long series of essential oils are marketed in Denmark. In table 2.1 is a list of oils found on the market, but the list probably does not include all essential oils marketed in Denmark. Apart from aromatherapy the oils are used as fragrances for other purposes, for example massage oils and production of candles, softeners, candies and perfumes. On the shop shelves and at homepages on the Intranet it is often not specifically mentioned whether the oils should be used for aromatherapy only and in principle all the oils could be used by the ordinary consumer in e.g. fragrance lamps. In the table there are oils specifically recommended (in books or at Danish internet pages) for use in aroma lamps or other uses where inhalation is the most important way of exposure. This applies for approximately 50 products.

Table 2.1 Essential oils on the Danish marked - either pure or in mixtures

*1 (bot) The botanical name is listed because the product is not on the INCI list.

The essential oils are often used in mixtures that is said to have various effects on the user. You can either buy ready-to-use oils or mix them yourself from recipes that can be found in books on aromatherapy. Examples of recipes for mixture of essential oils for fragrance lamps can be seen in table 2.2.

Table 2.2 Examples of mixtures of essential oils and their stated effect (Source: Unique Products 2007)

There is no statistic information on sales of each oil.

According to one supplier the most popular oils for candle diffusers are lavender, eucalyptus, bergamot and orange, whereas another suppler says that the most used are lavender, eucalyptus, peppermint, citronella, lemon grass, citrus oils (lemon, orange, bergamot, grape, etc.) rosemary, ylang ylang, patchouli and litsea.

Fragrance oils

A number of fragrance oils are marketed mainly consisting of mixtures of synthetic aroma substances and essential oils. Some, however, only consist of synthetic parts. The fragrance oils are often labelled "nature-identical", meaning that they consist of synthetic substances, identical with substances to be found in natural oils. In many cases there can be minor differences in for example the steric structure between the synthetic and natural substances. The reason for using the fragrance oils is partly that they elicit flower scents better than essential oils, partly that the oils are cheaper.

The composition of fragrance oils are generally considered to be confidential. Information on classified ingredients for a number of oils is based on information from safety data sheets listed in Appendix 3. The names of the fragrance oils are removed as the products can be linked to specific producers.

The oils are treated especially for use in aroma lamps and other uses related to aromatherapy. Examples of 40 fragrance oils sold in Denmark are shown in table 2.4 with information on the content of 26 potentially sensitizing substances (will be discussed later).

2.3 Use pattern for the products

Uses of essential oils and fragrance oils, where the primary way of exposure is inhalation cover (Lotus 1985, Mojay 1996, Web Which 2006 and consulted aroma therapists):

• Diffusion of the substances to the air in the room by use of candle diffusers, scented stones, electrical fragrance diffusers, etc.
   
• Aroma cushions. At certain cushions, drops are placed on a heated cushion which is then placed on for example your shoulders. The heat and the effect of the essential oils last, according to the supplier, approx. 45 minutes. At other cushions a few drops are dripped on a cushion used as a sleeping pillow in bed.
   
• Aroma baths. Some drops of oil are added to the bath water.
   
• Inhalation: A small bowl is filled with boiling water. A few drops of essential oils are added. The user takes a towel over the head and inhales the vapour.
   
• Water basin method: A few drops of essential oils are added every morning to a water basin filled with hot water. The user moistens a washing cloth in the scented water, presses it against the face and breathes deeply. This is done a couple of times.
   
• Aroma sauna: 3-5 drops of oil in sufficient hot water are poured on the hot stones in the sauna.
   
• Aroma jewellery: The jewellery is filled with a few drops of essential oils with a pipette. The scent is emitted slowly over 2-3 weeks.

Aggregates to diffuse the fragrances

There is a long series of aggregates for diffusing the fragrances to the room. In all cases 2 to 10 drops are used and diffused to the room over a period of up to some hours. By contact to suppliers and searching the Danish homepages the following aggregates have been found, illustrated in the following:

• Candle diffusers: A few drops of essential oils are added to a small bowl with little water. Under the bowl is a tea light heating up the bowl, the water evaporates and diffuses the fragrances in the room. One or several oils can be used in combination depending on which scent or effect is desired. Lamps seem to be the most extended use and candle diffusers are sold from many stores and from several internet shops. There are a large number of different designs, all functioning according to the same principles. Some suppliers suggest adding 2-5 drops, others 5-10.
   
• Aroma figures and stones: Drops of oil are added which slowly evaporates. Works without heating.
   
• Ceramic lamp ring. A few drops of oil are added to the ring placed on an electric bulb. When the bulb is lit, the heat will diffuse the scent of the oil out in the room.
   
• Fragrance spray. Works by vaporizing the oil and thus diffusing it out in the room.
   
• Electric fragrance diffusers (Aroma Stream or aroma mouse): Consists of a cotton-wool-like material and a fan. 1-10 drops of essential oil are dripped on the material and the air flow from the fan diffuses the fragrance in the room. The oil is not heated. On the Internet a lot of American web sites have these products, but there is only found one Danish web site selling these products.

Apart from the above a Danish supplier has given information about the following aggregates that are not possible to find by contacting suppliers of oil for aromatherapy or on the Internet.

• Electric bowl: a few drops of essential oils are dripped into a small bowl that is heated electrically and thus diffusing the scent to the room. It is a bit the same principle as with candle diffusers, but no water is used. There is no use of a fan.
   
• Wool-cotton roundel: A few drops of essential oil are dripped on the wool-cotton roundel (a porous slice that is placed on a warm radiator.

Examples of products for diffusing the scents are shown below.

	Candle diffusers Source: Urtegården at http://www.urtegaarden.dk/Default.aspx?ID=42 "Candle diffusers are used to spread the scent from the fragrance oils and the essential oils slowly and agreably. Fill the bowl of the lamp with water, add 5-10 drops of oil and lit the candle"
	Aroma figure, Angel Source: Urtegården at http://www.urtegaarden.dk/Default.aspx?ID=527
	Aroma stone - lotus Source: Den Naturlige Butik http://www.dennaturligebutik.dk/product.asp? product=4683&sub=0&page=1 "Add a few drops of your favorite oil to create exactly the atmosphere you want"
	Ceramic lamp ring Source: No. 29atrade http://www.No.29trade.dk/ "Add oil and place on an electric bulb - normal large size. When the bulb is lit, the heat diffuses the scent of the oil into the room".
	Fragrance spray Source: PrimaVera http://www.primavera-life.de/de/produkte/sairsprays.php
	Aroma pillow Source: Duft og Natur http://shop.duftnatur.dk/aroma_terapi/ aroma_puder_og_kirsebaerpuder/ aroma_hvedepude_roed_cirkulationsfremmende.html "With each pillow comes 5 ml of essential oils that you can drop on the inner pillow after heating (in micro oven or ordinary oven). The heat and the effect of the essential oil last approx. 45 minutes".
	Aroma diffuser Source: BodyMind Company http://bodymindcompany.zafi.netimage.dk/ index.php?pid=3&item_id=274 "Aroma Stream offers a clean, safe and efficient method to spread an aroma in a room without use of fire. A stream of air simply evaporates the essential oil and keeps its scent in its pure form. In this way heating of the oil is avoided, which can burn it, change its scent and qualities." "With most essential oils one drop is enough on a part of the filter insertion. When you want a new fragrance Aroma Stream should just be on until the scent of the existing oil is evaporated where after a new oil can be added to the same filter insertion"
	Aroma mouse Source: BodyMind Company http://bodymindcompany.zafi.netimage.dk/ index.php?pid=3&item_id=273 "The Aroma mouse is a portable fragrance diffuser. You can use it everywhere in your home and clinic as it uses batteries and has an ordinary plug outlet" "There are 5 refill pads in the package and you can easily order more pads for the Aroma mouse. The pads can be used over a longer period with one aroma per pad. Drip approx. 10 drops per pad depending on the sixe of the room and how strong you would like the aroma to be"
	Aroma jewellery "In the jewellery is added scent after your own choice - we recommend 2 drops of essential oil - a pipette is enclosed for filling the oil. The fragrance lasts 2-3 weeks where after you must fill up again" Source: Description in a shop selling the jewellery. Own photo.

Apart from these usages, we searched on electrical fragrance diffusers and air fresheners and found 2 product groups beyond the limits of this project.

• Electric fragrance diffusers, sold to dog and cat owners to diffuse calming pheromones (behavioural fragrances);
• Electric air fresheners for the professional market (ex. Pure for Sure and Dan Dryer Fresh-air).

2.4 Constituents

2.4.1 Essential oils

The essential oils typically contain more than 100 different chemical substances. As it is a question of natural oils there can be differences between extracts from the same plant depending on which sort, growth place, weather conditions when growing and the method of how to extract the oils. The main parts are however often the same, but in different concentrations.

Examples of chemical content of selected essential oils are shown in Appendix 2. The statements are based on scientific investigations of the content of each oil and there will be deviations between the mixture of the analysed oils and the concrete oils on the Danish market.

The most important classes of substances found in essential oils are listed below (Tisserand and Balacs 1995) with examples of substances mentioned in this report:

• Hydrocarbons:
  • Terpenes (camphene, pinene, limonene, Myrcene, Caryophyllene);
• Oxidized compounds:
  • Alcohols (citronellol, geraniol, farnesol, linalool, nerolidol, menthol, terpineol);
  • Aldehydes (cinnamal);
  • Ketones (pulegone);
  • Esters (benzylbenzoate, methylsalicylate, methylbenzoate, methoxyphenylacetate);
  • Phenols (eugenol, iso-eugenil, cresol);
  • Ethers and oxides;
  • Peroxides;
  • Furanes (dimethylbenzofurane);
  • Lactones (coumarin);
  • Acids;
• Other compounds:
  • Sulphur compounds;
  • Nitrogen compounds.

Information about the constituents of essential oils has been collected from companies marketing the products in Denmark.

The essential oils typically have their own CAS number and in many cases the only information on the products' safety data sheets is that the product contains this CAS number in a 100% concentration. The datasheet may be supplemented by a datasheet showing the content of 26 sensitizing substances. In other cases the companies list which chemical substances classified dangerous are contained in the oils. The classification is primarily based on the companies' self-classification of dangerous substances.

26 fragrances allergens

Many of the 26 fragrance allergens that must be declared according to Appendix 3 in the Statutory Order on Cosmetics (BEK no. 422) are found in essential oils and fragrance oils. As the essential oils in many cases are used in cosmetics, the suppliers have elaborated datasheets showing the oils' content of the 26 substances. The presence of the substance in cosmetic products must be stated when the concentration exceeds 0.001% in products that are not cleansed off and 0.01% in products that are cleansed off.

The list with all 26 substances can be seen in Appendix 1. The fragrance allergens are assessed as such based on their effect at skin contact.

26 fragrance allergens in essential oils

Table 2.3 shows the content of 26 substances in a number of essential oils listed to be used for aroma therapy. For some of the essential oils constituents are listed in oils from two different suppliers. Out of 26 substances, 14 of the substances are present in one or several of the essential soils. The substances d-limonene and linalool are the most frequent and are present in the major part of the products.

In some of the oils the fragrance allergens constitute more than 50% of the products. D-limonene constitute thus more than 50% of orange oil, lemon oil, mandarin oil and grapefruit oil (max. in orange oil 94%), linalool constitute more than 50% of coriander oil and rose tree oil (max. in rose tree oil of 94%) whereas citral, cinnamal and eugenol constitute more than 50% of lemongrass oil, cassia tree oil and cove bud oil (max. 75% in lemongrass oil).

From one of the producers it has been stated that the products contain limonene (CAS no. 138-86-3) whereas for similar products from other producers it has been listed as d-limonene (CAS no. 5989-27-5). Limonene (CAS no. 138-86-3) is a mixture of (R) and (S) enantiomeren of limonene. In literature it is mentioned that for example oils from citrus fruits contain limonene in the form of (R) antimeren d-limonene which has a characteristic citrus scent, whereas S (enantiomeren l-limonene has a terpentine smell. Limonene and d-limonene have the same classification according to the list of dangerous substances, but limonene (CAS no. 138-86-3) is not on the list of the 26 substances.

Citral and d-limonene that are both on the list of dangerous substances are classified with R38 and R43 and present with more than 1% in most of the oils.

26 fragrance allergens in fragrance oils

In table 2.4 information is given on the constituents of the 26 substances in a number of fragrance oils stated to be used for aromatherapy. 18 of the 26 substances are part of the fragrance oils. For confidentiality reasons the fragrance oils are listed with a number. In appendix 3 is information about some of the oils and their constituents based on safety data sheets. The numbers refer to, for products listed in appendix 2, the sequential numbering in this appendix. The fragrance oils are typically named after aromatic flowers or fruits or have exotic names as Satsuma, Erotica, Africa Spa and Flower Meadow.

Apart from the mentioned fragrance oils there are also fragrance oils on the market being a mixture of some of these fragrance oils and some of the mentioned essential oils. Apart from this there is to a certain extent also pure mixtures of essential oils called "aroma oils".

As for the essential oils d-limonene and linalool are part of most of the oils, but also citronellol is a constituent in the main part of the fragrance oils. In a very large part of the products, substances from the 26-list constitutes more than half of the product. In one of the products none of the substances are present.

Table 2.3 Content of fragrances from EU's 26-substances-list in essential oils from Danish suppliers. The concentration is shown in %. Only substances that constitutes more than 0.1% are listed. If the substance constitutes more than 10%, it has been marked in bold.

Click here to see Table 2.3

Table 2.4 Content of fragrances from EU's 26-substances-list in fragrance oils from Danish suppliers. The concentration is shown in %. Only substances that constitute more than 0.1% is listed. If the substance constitutes more than 10%, it has been marked in bold.

Click here to see Table 2.4

Constituents classified hazardous

As previously mentioned the safety datasheets from some suppliers contain information about constituents included in the list of dangerous substances, the 26-substances-list or which are classified dangerous by the company's self- classification.

Table 2.5 below shows a list of all the substances on the safety datasheets with the classification according to the list of dangerous substances.

In view of selecting substances for laboratory analysis and health assessments it is listed in the table whether the substances previously have been examined in the consumer projects by the Danish Environmental Protection Agency, the AT limit values (set by the Danish Working Environment Authority), LCI values and German NIK values.

The limit values of the Danish Working Authority have been made for content in the air in the working climate (AT 2007) whereas the LCI values (Lowest Concentration of interest) have been made especially for indoor climate.

The LCI values have been defined as the lowest concentration of a given substance, which, based on present knowledge, don't cause any risk for hazardous effects on humans by exposure in indoor climate. LCI values were introduced in Denmark in a survey on degassing of wood and wooden materials (Larsen et al. 1999). LCI is not considered an actual limit value for indoor climate, but an estimate for when there can be expected to be irritations, typically of mucous membranes and skin irritations in a particular indoor climate. The listed LCI values mainly derive from Jensen et al. (2001) which is a scientific article based on the above investigation. For substances not being part of Jensen et al. (2001), but part of a previous report from European Collaborative Action on Indoor Air Quality and its Impact on Man (ECA-IAQ 1999), values from this report is stated. The listed LCI values in the ECA-IAQ (1999) derive from a Finnish study referred to in the report.

The German NIK values (AgBB 2005) equal the LCI values and have been calculated according to the same principles. The values are used in Germany for assessment of degassing from building materials to the indoor climate.

The same data set is shown in table 2.6 where the concentration of the substances in each of the essential oils is listed. There is information on the substances from two producers and one of them generally classifies more of the constituents so that it is not possible to make an unambiguous comparison between the products.

In the table the producers' own classification of the products with R-phrases is listed related to health effects. The most frequent R-phrases are R38 (Irritating to skin), R43 (May cause sensitization by skin contact) and R65 (Harmful: may cause lung damage if swallowed). As it can be seen the own classification is not identical where there is information from several producers.

Tea tree oil and wintergreen oil have been assigned the sentence R22 (Harmful if swallowed). One oil (nutmeg oil) has been assigned the sentence R45 (May cause cancer) due to the presence of 5-allyl-1,3-benzodioxol, whereas. Products labeled R45 are forbidden to sell to the general public in Denmark. The Chemical Inspection Service has dealt with the infringement of the regulation and the product is no longer at the Danish Market

It is worth mentioning that none of the oils are classified with the sentences R23 (Toxic by inhalation) or R42 (May cause sensitization by inhalation).

Apart from this, several of the oils are classified as being hazardous (to a varying extent) for organisms living in water and may cause undesired long term effects in the water environment.

In table 25 it can also be seen which of the substances that has been health assessed in previous consumer project. Apart from these substances, the following, only being part of fragrance oils, have been subject to a health assessment (see table 2.7):

Table 2.5 Detected substances in essential oils that are on the list of dangerous substances, either being danger classified by the producers own classification. AT limit values and whether the substances have previously been assessed in a consumer project by DEPA.

Click here to see Table 2.5

Table 2.6 Content of dangerous substances in essential oils from two suppliers and R-phrases* related to health. Classification of product as stated on safety data sheets.

Click here to see Table 2.6

2.4.2 Fragrance oils

All constituents listed on the safety data sheet, that have been supplied by producers of fragrance oils, are listed in table 2.7.

For each of the 80 substances their classification is given according to the List of Dangerous Substances and material safety data sheet, which fragrance oils they are part of and the content in weight percentage in each fragrance oil.

As it can be seen for some of the essential oils being part of the fragrance oils, only the oil's CAS number is listed and not the constituents of the oil. As a consequence there might be a large number of classified constituents that are not on the list.

It is again worth mentioning that none of the constituents are classified with R42 (May cause sensitization by inhalation).

None of the substances are on the Danish Working Environment Authority's list of limit values (AT 2007).

Table 2.7 Constituents of fragrance oils, their classification according to list of dangerous substances and safety data sheet, and which products they are part of with which percentage.

Click here to see Table 2.7

2.5 Labelling, legislation and recommendations

Definition

Essential oils and fragrance oils are in a grey area concerning which legislation applies to the products. Some use of the oils will be under the cosmetics legislation whereas products for other usage will fall under the chemical legislation. In order to decide which legislation the products are covered by it is necessary to make an assessment of where the products are sold, at what purpose, appraisals and labelling.

Cosmetic products are denotes in the Statutory Order on Cosmetic Products as "any substance or preparation intended to come into contact with various parts of the surface of the human body (skin, hair of the head and other hair, nails, lips and external genital organs) or with the teeth and the mucous membranes in the oral cavity, with the exclusive of main purpose of cleaning and perfuming them, changing their appearance and/or correcting body odours and/or protecting or keeping them in good condition". When essential oils are used for example as additives to the bath tub they will be in contact with the human body and can be regarded as "bath and shower preparations" which are on the recommended list of products that can be considered to be cosmetic products.

The question is, however, whether the products are designated for this purpose or whether it is just a use of the product. The products are generally marketed as used for aromatherapy where the major part of the usages are beyond the limits of the cosmetic legislation as they are not intended to be in contact with the listed parts of the surface of the human body. It also seems to be the general opinion among companies marketing the products that the products are covered by the legislation for chemical substances and products.

2.5.1 Classification and labelling according to chemical legislation

According to Act on Chemical Substances and Products (LBK nr 1755 of 22/12/2006) any producer or importer of a chemical substance or product before sale or import hereof get information on the qualities and effects of the substance or product in order that he/she can classify, pack and label it according to the law.

Classification of constituents and products and the subsequent labelling for chemical products must be made according to the Statutory Order on classification, packing, labelling, sale and storage of chemical substances and products (BEK nr. 329 of 16/05/2002).

For a long series of chemical substances, the classification can be seen in Statutory Order on the list of dangerous substances (BEK no. 923 of 28/09/2005), but for substances not on the list, producers and importers must make their own self-classification based on the principles in the legislative order.

As is can be seen from table 2.5 and 2.7 a long series of essential oils and fragrance oils contain substances that are either on the list of dangerous substances or are classified as harmful to your health by one or several producers.

The rules for classification and labelling of the products based on classification of constituents can be seen in Statutory Order on classification, packing, labelling, sale and storage of chemical substances and products and depend on classification and concentration of each of the substances. Chemical products must be classified for fire and explosion hazards according to the same criteria as single substances only with specific rules for gas mixtures. As a main rule, the classification of products is based on the classification of each substance and their concentration. Test data on product level may, if they are available, be used for classification for most health and environmental impacts with the exception of CMR (carcinogenic, mutagenic or toxic for reproduction) effects, aspiration hazard, bioaccumulation and biodegradation and danger for the ozone layer.

For the examined substances and products it is especially the content of substances with local irritating effects and/or sensitizing impacts that has a consequence for labelling of the products. For each of the substances there may be other effects that have not been considered here.

Irritant effects

For products containing one substance classified as irritant(Xi) with R36, R37 and/or R38 the product must also be classified as irritant with R36, R37 and/or R38 if the substance is present in concentrations above 20% unless any individual limits are given in the list of dangerous substances. This for example applies for products containing more than 20% d-limonene and citral.

For products containing several substances with this classification, a summation formula with a concentration limit for the products' classification in the actual danger category for each substance in the product is used. This means that the product, where the total concentration of substances classified with R38 (e.g. d-limonene and citral) is above 20%, should be classified as irritant with R38.

Sensitizing effects

Products containing a substance classified as sensitized must be classified as sensitizing with R43 and assigned the danger symbol and designation Xi, if the concentration of the substance with R43 is higher or equals 1%. This for example applies to products containing more than 1% d-limonene or citral.

For products containing several substances with this classification, the classification is determined based on each of the constituents whose concentration equals or exceeds the general concentration limits listed in the Statutory Order or any individual limits given in the list of dangerous substances.

Labelling

Products containing hazardous chemical substances must be marked with a label showing:

a) danger category and danger symbols,

b) R-phrases and

c) S-phrases.

This means that packing for essential oils or fragrance oils, classified according to above-mentioned rules must be labelled with danger category and danger symbols, R-phrases and S-phrases.

However, if the content of the pack is 125 ml or less (which is typical for essential oils and fragrance oils) labelling with R-phrases and S-phrases is not required:

• In the case of highly flammable, flammable, oxidizing and irritant substances or products. This also applies in the case of the same volume of harmful substances not retailed to the general public;
   
• In the case of a chemical product classified as dangerous for the environment with the danger symbol N, highly flammable, oxidising or irritant with R36, R37 and/or R38.

In a similar way, labelling with S-phrases is not required if the content of the package/bottle is 125 ml or less:

• In the case of a chemical product classified as flammable or dangerous for the environment without the danger symbol N.

Constituents should be listed in accordance with current rules.

On the label of chemical products, classified as sensitising, it should for example be listed which substances cause the classification of the product. For products containing more than 1% d-limonene there should be danger symbol, danger designation Xi and R-phrases for the product and it should be stated that it contains d-limonene.

Chemical products not classified sensitizing but containing at least one substance classified sensitizing in a concentration of more than 0.1%, unless a lower limit is specified in the list of dangerous substances , must bear the inscription on the label:“Indeholder (navnet på det sensibiliserende stof). Kan udløse allergisk reaktion” [Contains (name of sensitizing substance). May produce an allergic reaction].

Based on the gathered information on the content of sensitizing substances in the products it may be concluded that on the packaging of the main part of the products, classification and names of the sensitizing substances they contain must be stated.

2.5.2 Labelled in accordance with the cosmetics legislation

If the products are mainly marketed for uses covered by the cosmetics legislation products should be labelled with an INCI declaration. One of the things to be stated is the presence of 26 fragrances with particularly labelling requirements when the concentration is above 0.001% in products that are not cleansed off and 0.01% in products that are cleansed off.

If the essential oils are marketed as cosmetic products, what they normally are not, a very large part of the products should be marked with one or several of the 26 sensitizing substances.

2.5.3 Labelling of products and recommendations

Recommendations on the packaging of 10 purchased products are shown in table 2.8.

Table 2.8 Recommendations on the packaging of purchased products.

*1 Text - including missing words- is identical with the text on the packaging

Based on analyses of constituents of the products, all the products except no. 27 and no. 38 should be classified with R43 as they contain either d-limonene or citral, both classified R43 in concentrations above 1%. They should also be marked with danger symbol and danger designation Xi and with R43 on the packaging and it must be stated which ingredients have caused the classification. As no. 38 contains >>0.1% d-limonene this oil it should also be labelled "Contains (name of the sensitizing substance). May cause an allergic reaction."

None of the purchased products was labelled with information that they contained sensitizing substances and they were not labelled correctly. Most distributors' catalogues and homepages have general recommendations with precautionary rules.

An example is on the homepage for Unique Products where the Danish agent has the following rules of precaution [translated into English]: (http://www.danishbusiness.com/tekst/foraroma.htm):

"Rules of precaution":

The oils are very concentrated and should only be used in small quantities.

If you suffer from too high blood pressure, epilepsy of progressive nerve diseases, you should not use essential oils as they in some cases may worsen the situation. If you're pregnant it is also recommended that you do not use essential oils.

The oils are for external use only. They should not be in contact with eyes or mucous membranes.

They should be stored out of children's reach. Do not use undiluted essential oils directly on the skin.

If you have a tendency to allergy you should make an allergy test before using the oil for the first time.

Orange oil, bergamot oil, lemon oil, grapefruit, mandarin oil should not be used 12 hours before sunbathing and for perfuming of clothes."

2.6 Summary of previous investigations on chemical substances in traditional air fresheners

The Danish Environmental Protection Agency has previously carried out a survey of chemical substances air fresheners and other fragrance liberating products (Pors & Fuhlendorff 2003). The survey did not include products for aromatherapy.

Through contact to suppliers of these products a number of different types of air fresheners were found. The results of the survey could be concluded as follows:

• Suspending – few manufactures (3-4), several fragrances (10-15);
• Electrical – several manufactures (5-8), several fragrances (5-10);
• Spray – few manufactures (2-3), several fragrances (5-10);
• Balls – few manufactures (2-3), several fragrances (10-15);
• Gel plates/pressure cans - several producers (5-8), several fragrances (10-15).

From the manufacturers it was informed that 5% of the population in Denmark uses air fresheners in their cars or home and out of the total sale of air fresheners it was assumed that the households using air fresheners approximately uses 26 air fresheners on average a year.

In the investigation 19 air fresheners and fragrance balls, covering the market in various groups, were analyzed. The products were selected to represent the various areas of application and origin, and a certain sales volume..

The tests were analyzed for the presence of 24 ingredients that EU’s scientific committee has identified as allergens (same list as the 26 ingredients mentioned in the present study exclusive of oak moss extract and three moss extract).

At least one of the 24 constituents were detected in all samples. Single ingredients were detected from 3.5 mg/kg to 62,000 mg/kg (6.2 weight %). For the total content of the constituents the concentrations varied from 10 mg/kg to 162,000 mg/kg (16%weight %). Five of the products had a total content of the 24 constituents = 10%.

There were also made qualitative analyses for a number of solvents: ethylacetate, isopropanol, ethanol, isoamylacetate, isoamylbutyrate and hexane acid ethylester.

Solvents were present in six of the products. Two of these products were fragrance products from vacuum cleaners and the other products were all liquids for various purposes.

The survey did not include measurement of the release of fragrances from the products or a health assessment of the possible exposure of the users.

| Front page | | Contents | | Previous | | Next | | Top |

Version 1.0 April 2008, © Danish Environmental Protection Agency