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Caution to essential oils
- hazardous substances -

 

The rules reach

The reach regulation, applied since June 1, 2007, confirms the obligation for the producer of any chemical listed in the einecs inventory to produce a safety data sheet (fds) either when the substance is classified as hazardous or when, as preparation, it contains more than 1% by weight, at least one substance that poses a health or environmental hazard.
Since the introduction of this regulation, many products that had no information on their labels are now forced to display regulatory information. and this is true for many products, essential oils included.

 

Essential oils and regulations

In fact, essential oils, known to the Egyptians, have always been used for various and varied uses: therapeutic, food, perfumery, cosmetics, detergents, industry.
O,r regulation does not provide for the existence of essential oils as such. a each type of use refers to a specific regulation that should be respected according to the use recommended for the product.
Essential oils can therefore be classified as medical devices, dietary supplements, cosmetics, insecticides or chemicals in any other case.
Information given to consumers will be different since each case is governed by different legislation whereas it's the same product that comes from the same can.

 

7 gold rules for safe use

1 - Scrupulously respect dosages, job precautions, duration of treatment and route of administration. these are active extracts, whose use must be rigorous. For this, always keep your essential oil in its original packaging, with its instructions, to which you can refer at any time.

2 - Do not replace without knowing another essential oil, even if their name is close. example, true lavender and aspic lavender have different indications, like thymol thyme and linalol thyme, ravensare and ravintsara ...

3 - Always wash your hands carefully after using an essential oil.

4 - Do not heat essential oils (e.g. by putting a cup on a candle). Use a diffuser by cold nebulization or soft ceramic heat, or a mistizer.

5 - Respect the precautions of employment. Many essential oils are prohibited during pregnancy (especially 1 trimester) and during breastfeeding. In children, some are generally not recommended for 7 years. in the event of kidney and liver problems, convulsive disorders, cardiovascular pathologies or in persons subject to epilepsy, asthma and, in general, in the case of long-term medical treatment or illness, always ask your doctor's advice.

6 - If you are undergoing medical treatment, attention to interactions with essential oils! ask your doctor or pharmacist for advice.

7 - An allergy is always possible, especially in fragile or sensitized subjects. It is best to perform a skin test (up to 1 to 2 drops of essential oil in the elbow, wait 48 hours then start again and wait 1 hour to check the absence of reaction).

 

Essential oils, food supplements

We find in the trade of essential oils sold under the name "food supplements." this name allows manufacturers to escape the regulation on "chemical products" but also to sell these products with a tva to 5.5% instead of 20. %.

According to the European Directive 2002/46/EC, food supplements are foods that have a nutritional or physiological effect, marketed in the form of capsules, pastilles, tablets, bulbs, capsules, tisanes or drinkable solutions, the aim of which is to complement our usual diet." in france, it is Decree No.2006-352 of 20 March 2006 which supervises the marketing of food supplements.

As the current regulation does not require manufacturers to prove the efficacy and safety of their product, so it is very easy to transform an essential oil considered to be "safe substance" into a "food product. ".
The only constraint is the label that will be different, since on top you will have to find the indication "food supplement," with possibly the information "advised to exceed the indicated daily dose" and "held out of the reach of young children. ".

Article 3 of Chapter ii of this Order states: "the ingredients mentioned in Article 2 may only be used in the manufacture of food supplements if they lead to the manufacture of safe products, not harmful to the health of consumers, as established by scientific data generally accepted"
Concretely, this means that all essential oils cannot be marketed as food supplements. only those who are consumable will be allowed, which already represents an important list (about 40).

Take, for example, the fds of essential mountain sarriette oil (EINECS/CAS: 90106-57-3) edited by a manufacturer on 11/03/2011 to sgh standards. Section 15 lists the regulatory information that will be required to appear on the label of all commercialized bottles:

  • H226 liquid and flammable vapours
  • H302 nocif in case of ingestion
  • H304 can be fatal in case of ingestion and penetration in the respiratory tract
  • H314 causes skin burns and severe eye damage
  • H318 causes severe eye damage
  • H317 can cause skin allergy
  • P301+P310 in case of ingestion: immediately call a poison centre or a doctor
  • P405 keep under key

So, is the essential mountain savory oil a "safe substance" ?
Yes, if we read the manufacturer's fds. No, if we consider that it is authorized and marketed under the name "food supplement" !

 

Essential oils in diffusion

If we take the case of essential oils intended for diffusion, as they can not be classified as aroma or as cosmetics they can only be classified as chemicals or hazardous substances.
If the legislation is there to warn the consumer of the dangers of the use of certain products, the manufacturer does not want to scare consumers by a set of information that might discourage the buyer from consuming its product !
So many manufacturers, following the interpretation of the various articles on labelling dangerous substances (flacon no one wants to be the first to put on his label a "death head" or a "dead fish." and that can be understood !

 

Essential oils can be n, c, xi, t, xn, ...

logo huiles essentielles


A product label must be identical to the safety data sheet (fds) that is provided with the product.
When you start reading the fds of the most common essential oils, it is true that it can scare.
Most are considered harmful (xn) and often hazardous to the environment (n). But that's not all. when they are not indicated "irritating to the skin," they are specified "avoid contact with the skin." that say thyme which causes burns (corrosive symbol). for products that can be classified as cosmetics, we do not understand logic.

On the 285 essential oils contained in the table edited by the effa, only 4 do not contain a symbol of danger. which means that most essential oils of trade should contain a danger symbol on the label. as it is rarely the case, we will look at what these symbols correspond to:

  • N-Dangerous for the environment
    For aquatic toxicity (fish, seaweed, daphnia) its classification will depend on the amount of mg/litre of water for which it will be considered to be:
    1. R53 if 100mg/l
    2. R52/53 if ≥10 mg/l and
    3. R51/53 if 1mg/ and
    4. R50/53 if 1mg/l = very toxic
    According to this classification it means that essential oils of rosemary, orange or lemon are considered as toxic as cypermethrin (insecticide R50/53 toxic with only 3×10-4 mg/l) and essential oil of chamomile, with its R51/53, is identical to glyphosate (well known desherbant).

    This is certainly true in theory, but in practice, given that essential oils are considered insoluble in water and that the field of application is not the same, the products are hardly comparable.
    Given the high price of essential oils, it is unlikely that a person, voluntarily or accidentally, will pour his essential oil bottle into a river. iil is, however, very easy to pollute a stream of water by weeding its land just before a rain.
    A study of the ifen (August 2006) showed that glyphosate and ampha (derived from glyphosate) were the most found substances in the waters in france, while glyphosate is classified as less toxic than orange essential oil.

  • C-Corrosif
    Corrosive definition (inrs): Which, in contact with living tissues, can exert destructive action on these latter, there are more than 200 corrosive substances. There are mainly acids and bases such as caustic soda but also thymol, phenol contained in thyme oil. Even if the essential thyme oil is much less corrosive than sulphuric acid, it should be used carefully. Avoid, like some people, taking a bath by adding essential oil of pure thyme, otherwise you take the risk of coming out as a shrimp.

  • Xi-irritant
    Irritating definition (inrs): Not corrosive but may, by immediate, prolonged or repeated contact with the skin or mucous membranes, cause inflammatory reaction. practically all essential oils are classified irritating but this does not mean that if you put a drop of essential lavender oil on the hand you will have a redness. This means that there are rules for the use of essential oils and that they must be respected. the first of these rules is to avoid using them pure on the skin but only after dilution in a vegetable oil, which is indicated in all aromatherapy books.

  • T-Toxique
    Toxic definition (inrs): Causing death by inhalation, ingestion or skin penetration in small quantities, or harming health in an acute or chronic manner.
    The logo t should be present on a bottle when at least one phrase "toxic risk" will be present in the fds. This can be toxic by inhalation, contact with the skin or ingestion.
    These are essential oils that are particularly dangerous to use but there are less than fifteen that are actually classified as toxic (death head). This includes sassafras, mustard, nutmeg, etc. these essential oils are not normally sold free or then banned in, frank as sassafras.

  • Xn-Nocif
    Definition nocif (inrs): May, by inhalation, ingestion or skin penetration, lead to death or damage to health acutely or chronically
    The xn logo must be present on a bottle when at least one phrase "nocif risk" will be present in the fds. This can be harmful by inhalation, by contact with the skin, in case of ingestion or can cause damage to the lungs in case of ingestion !
    So few essential oils are classified t, many essential oils are classified xn.
    If we follow the definition, it means that more than 60% of the essential oils found in the trade can lead to death in their uses. It is therefore important to clarify this point.

    Definition of LD50-LC50 = this indicator measures the dose of substance causing the death of 50% of a given animal population (often mice or rats) under specific conditions of experimentation.
    It will be estimated that 1gr of essential oil = 20 drops
    The data below shows that the range is wide since there is a ratio of 10 between the minimum and the maximum, in order to verify the danger, the calculations will be carried out on the minimums.

    • Nocif by ingestion (r22): 200mg/kg ≥ ld50 for a person of 50kg = 10grs, which makes about 200 drops of essential oils to be absorbed before reaching the nocivity threshold. it is technically very difficult to inert a bottle of essential oil from officinal sage or thuya.

    • Nocif by contact with the skin (r21): 400mg/kg ✱ ld50 starting on the same calculation as above we arrive at 20 ml. technically, it is possible to massage the whole body with 2 bottles of pure essential oil, but it is the total ignorance of the products. oils classified in r21 are rare. For example, the oregano or the cinnamon of china. these two oils are indicated in all aromatherapy books as to " never use pure on the skin but always diluted"

    • Nocif by inhalation r20: 2mg/L of air ≥ lc50 ≥20mg/L of air
      A small room makes about 20m3, the nocivity threshold will be reached with 40grs of essential oils in the ambient air, with a powerful diffuser vaporise in air 2g/h or 20 hours of diffusion without aerating before reaching the critical threshold. essential oils classified as r20 are rare, such as raifort and mustard, so the nocif by inhalation seems unlikely except on purpose!

The xn symbol that can appear on a bottle rarely comes from r20 or r21 or r22 but most often from R65 (nocif: may cause lung damage in case of ingestion) that is present on most fds of essential oils.

R65 is applicable to all substances containing aliphatic, alicyclic and aromatic hydrocarbons with low cinematic viscosity (the main source of production of aromatic hydrocarbons is crude oil refinement. but aromatic compounds are also found in fragrant plants such as pine, eucalyptus, thyme, mint.

As the essential oils are classified as "dangerous substances," the same calculation is applied to them that applied to the white spirit, the essence of terebenthine and other oil solvents.
This method of calculation leads to all substances that have a viscosity of up to 7 times that of water (viscosity of water at 20°C = 1 and 40°c = 0.661 mm2/s) and that contain at least 10% of an aromatic organic compound. they must have on the bottle the xn symbol and the R65 sentence. Most essential oils such as lavender, cypress, rosemary, pine, eucalyptus, but also all that contain lemonene such as orange, lemon or tangerine.

We understand why manufacturers are not in a hurry to put the xn symbol next to the ab logo on an orange essential oil bottle while it is often used in food to scent a cake.

 

Essential oil safety data sheet

It is necessary to know that the safety data sheet (often called fds on our site) is made by the manufacturer of the product.
If for synthetic products it can be simple since the products are always identical, for natural products it can be much more complex.
The molecular composition of essential oils can change from one production to another, from one lot to another, but normally, the composition meets the minimum and maximum percentages of components, in accordance with the standard.
Essential oils are classified on the basis of direct tests on their physical, chemical, toxicological and ecotoxicological properties. but many test results are not available or too old or unclear to be valid.
In that case, classification is based on the application of the rules applicable to hazardous preparations, from the hazard properties of the basic chemical compounds of the gasoline and the percentage of presence in it.

Pending testing on essential oils, the manufacturer must rely on tables edited by the effa (european flavour and fragrance association)
-table 1 classification, danger symbols, r and s phrases of pure essential oils
-table 2 classification of components entering the preparation of essential oils
The simplest is to use table 1 and apply the information: example for absolute lavender (N°CE:294-470-6): Xi-R38-R43-R52/53 (effa)
Or then you can use Table 2 and make the calculation for each component of your essential oil. example for absolute lavender (N°CE:294-470-6): R66 R52/53 (interprofessional committee for French essential oils)
I can see that for the even product (even number,) the information is not identical. but it is true that it depends on the origin of the lavender.

 

Are essential oils dangerous ?

Essential oils have, in some cases, caused adverse reactions: the convulsive effect of essential oils of camphor and eucalyptus in young children has been known for a long time. analyze the three possible cases of human toxicity:

  1. Ingestion toxicity
    In the United States, in 2006, the monitoring system (aapcp) identified 7377 cases of ingestion exposures to essential oils. 74% is primarily concerned with children under 6 years of age and 1.2 percent of cases followed by normal use.
    These results should be handled with caution as the ingested quantity is absent for a majority of exposures and there is no difference in classification errors of substances and diagnostic errors.
    It should be noted that no deaths have been reported following the ingestion of these different oils and that, in general, no deaths are reported in the literature.

    Almost all toxicological data are obtained after experimental tests on laboratory animals and thus lack precision. Moreover, they are obtained by testing active compounds alone and not complete oil.
    These data are therefore difficult to use to assess the risks of essential oils that are mixtures of several compounds.
    Human toxicity data were most often obtained as a result of accidental ingestion (most often at very high doses and mainly on children).
    Scientific studies show that essential oils may have some toxicity, but they appear to be toxic by ingestion only if it is made in large quantities and outside the conventional framework of use.

  2. Contact toxicity
    Little toxicological data are available on the toxicity of essential oils by contact but some studies exist on essential oil of tea tree and lavender.
    Patient sensitivity is tested through patches of a variable concentration of essential oil (1 to 100%). .
    • Irritation:
      These results do not allow for a possible link between concentration in tea tree and increase of irritation reactions (in view of the wide dispersion of results and the absence of medical history of patients).
    • Allergies by contact:
      The results seem to indicate a possible link between the increase in the concentration in tea tree and that of the number of allergies. allergic reaction percentages, although relatively low, indicate that certain oils have an allergic power and can thus be counter-indicated.
    Oils will only be toxic by contact if significant concentrations are applied.

  3. Inhalation toxicity
    If the toxicity of the major inland air pollutants begins to be better known and to be subject to risk management measures, few studies have so far been initiated on the formation of volatile compounds that may be inhaled following the evaporation of essential oils.
    The specific effects of essential oils by inhalation remain largely unknown to date. However, in general, essential oils are suspected of being at least awareness agents.

Source of this paragraph: potential risks and benefits of essential oils (March 2008-ecole ehesp)