EEC regulations -
the dangers of trade interests and civil servants
making the rules.

The article below written 2002-3 by Martin Watt.
See earlier articles below.

I have heard with great alarm that a couple of essential oil trade organisations in the UK have accepted that the sale of essential oils is to fall under the European cosmetic regulations. In that case they will, by default, have to carry the new 'sensitisers' warning labels.

I consider that the respective committees' policy to accept this classification is incorrect. The consequences for the vast areas of business that these organisations do not represent seem to have been ignored. Even potential adverse effects on the businesses of their own members are open to question. I believe any such decisions should be challenged, for the following reasons:

1. The EEC cosmetics directives are supposed to be targeted at products classified as "cosmetics". I believe that essential oils sold bulk or retail should have no such classification; they are simply 'raw materials' no different in principle to a barrel of crude oil. I would maintain therefore that the cosmetics regulations labelling requirements are not applicable to the wholesale or retail sale of essential oils.

Essential oils - whether in barrels or in 10 ml. bottles - may be used to create many products, for example: in candles; room fragrances; non skin contact perfumes; as pest repellents; as starting materials in the manufacture of a variety of chemicals; as home medication remedies; in cough sweets; as food flavourings, etc. Home use may or may not be the same as commercial use. Therefore, a member of the public purchasing a bottle of an essential oil may not ever intend using it for a "cosmetic purpose". Conversely, if a supplier sells an essential oil and states on the product or in associated literature that it can be used in the bath or on the skin, then it is correctly classified as a cosmetic.

2. Any substance sold as a raw material has to comply with the UK CHIP regulations and any known hazards should be declared. Under EEC laws it is left to each company to declare any known hazards. Trade organisations may give guidance to their members but that is not law. A Material Safety Data Sheet only has to be supplied if someone asks for one, and in any case is not legally required for those
materials which have no scientifically valid risks. It does not have to be automatically attached to the product. It is for the customer to decide on the end use of raw materials not the supplier.

3. It has been said that essential oils must be classified as something and that if we do not accept the classification as being "cosmetic" that the bureaucrats might class them as "medicinal products". I would point out that numerous essential oils have never been used as medicines and therefore could not fall under that classification. On the other hand, some essential oils (e.g. garlic and asafoetida) have never been used in cosmetics and probably never will be. It follows that it is wrong to classify any raw material under a category that defines the end use of that material in a consumer product.

What we seem to have here - once again - is trade committee members agreeing to interpretations of laws. Such classifications may be biased, or incorrect and have nothing to do with protecting the interests of the public, yet they will be viewed as law by various enforcement authorities. Nothing is law unless it is in writing, approved by the respective Parliaments or has been the subject of a court decision. I have not seen any official documents stating that: pure essential oils sold as raw materials to the public are "cosmetic products".

The implications of having to label essential oils under the illogical European guidelines for cosmetic products are horrendous. Implications for small companies getting continued insurance cover do not bear thinking about. For therapists practising complementary medicine, you can put money on it that your premiums will go through the roof because you will be using products labelled as containing "sensitisers".

A huge problem for small essential oil suppliers is that the levels of so called 'sensitisers' are so low that only sophisticated and expensive analysis will detect the 0.001% criteria for leave-on products see article below. Any essential oils coming from small distillers direct to aromatherapy suppliers will not have that kind of analysis routinely done. The only way a supplier will know exactly what is in this oil is to pay for analysis far in excess of what would normally be considered sufficient. That kind of cost can only be recovered by increasing the price of the oil to the end user.

Just a few more tweaks upwards to unemployment caused by the tunnel vision of the idiot bureaucrats in the European Commission, their numerous advisory hangers-on, and now it seems endorsed by a small clique of trade associations.



European regulations.
Article written around 2001

A huge threat to essential oil supplies worldwide.

A massive threat to natural plant extracts in cosmetic products.

This article is primarily for European readers but the implications are International and I know there are great concerns in America over these proposals.

For those that are not aware of what is happening with EEC legislation, below are some details:

To put the following proposals into perspective, the reason for them is that an EEC committee of dermatologists are reporting a steady increase in cases of skin sensitisation in the European population. However, getting verification of the accuracy of these figures seems impossible. In addition, they seem to be completely ignoring the fact that spicy foods in particular can trigger skin sensitisation, the regular consumption of which has increased dramatically over the last 30-40 years. Instead, their first line of attack is to blame the fragrance trade without considering other possibilities.

My concern is that the next trade in line will be the food flavouring industry. But perhaps the Eurocrats will worry about taking on the big American fast food outlets! You could end up with warnings on your chilli sauce, mustard, cinnamon sticks, black peppercorns, etc. "might cause an allergic reaction" and peppermint and orange liqueurs would probably have to be banned.

Under Amendment 38 Article 1, Point 6 A (new), Annex III - Part I (Directive 76/768/EEC) it is proposed that 26 chemicals are listed as "sensitisers" among the following: Benzyl Alcohol - Benzyl Salicylate - Cinnamyl Alcohol - Cinnamal - Citral - Coumarin - Eugenol - Geraniol - Isoeugenol - Anise Alcohol - Benzyl Benzoate - Benzyl Cinnamate - Citronellol - Farnesol - Limonene and Linalool.

If any of those chemicals are used in any cosmetic product then the product must bear a warning label. The proposed maximum levels of use below which labelling is not required are:
0.001 % in leave on the skin products like colognes, creams and antiperspirants.
0.010 % in wash off products like soap and shampoo.

Many essential oils contain one - or often more - of the listed chemicals at significantly higher levels than the above. For example Rose oil contains geraniol at around 20%, as well as linalool and citronellol. Therefore, any cosmetic containing rose oil must be labelled "may cause an allergic reaction" or similar. Even if a whole essential oil has been scientifically proven as an anti inflammatory, the above based on the individual chemicals that it contains still applies - crazy or what?.

Another chemical on the list is d-limonene which occurs in all the citrus peel oils as well as many others. Indeed in orange oil it can be 90% or more.

Another chemical on the list is linalool is a major constituent of lavender oil - widely used as an anti inflammatory and skin healing oil.

Non of the above limits are based on sound science. It is just based on the opinions of so called "expert" dermatologists - advised by chemists - who do not have the first clue about natural essential oils. Yet despite this unbelievably inept science these proposals are about to become European law.

So how does all this affect essential oils supply?

The bulk of essential oils are still used in the fragrance and flavour trades. Raw materials suppliers to the International fragrance and flavour trade deal in oils by the Tonne. Aromatherapy use is a drop in the ocean by comparison.

The danger with this new EEC legislation are that the big fragrance users will:
a) Steer away from using natural oils. Instead they will increase their use of those synthetic chemicals not needing to be labelled as "sensitisers". Note: 5 years after this was written this has already occurred, and some of the old essential oil dealers are up for sale!
b) They will process essential oils to remove any chemicals in the EEC list, but that will inevitably increase their costs. Also these processed oils will inevitably find their way into the aromatherapy market.

The net result has to be that farmers who produce aromatic crops will be forced to:
a) reduce production; this will increase the price of oils - less sales for farmers equals out of business.
b) produce a surplus; this will initially reduce the costs but equals farmers still go out of business.

I expect many of you will think: "So what, most aromatherapy suppliers get their oils from small farmers and by wild harvesting"? Sorry but that is just the marketing hype endemic in our trade. Yes there are a few small producers around who will be relatively unaffected, but the fact is that the majority of essential oils on sale via aromatherapy outlets are from mass-produced agricultural crops.

You might be delighted by a reduction in the price of your oils, but what you should consider is the effect that will have on the overall production. What will happen is more producers will stop growing aromatic crops, which will then push the price up even higher than previously.

The utter madness of the Eurocrats is that they always fail to realise what the wider implications of their crazy laws are, in this case on their own countries farmers. On third world country farmers the results could be catastrophic. Farming world wide is in a perilous financial state and this kind of unjustified regulatory nonsense based on poor science does not help one bit.

To make the whole thing even crazier, if more European farmers are put out of business, the more you taxpayers have to pay in social support for them. In particular, the EEC budget has to pay considerable sums of our money to support farms, yet in the case of aromatic crops - if left alone - those farms could be perfectly viable.

This latest round of Euro madness is in my opinion the biggest threat the aromatherapy trade has ever seen. In the past we had to worry about such things as "could practitioners continue" but that seems to have been put on temporary hold. However, if you restrict the producers of the materials that practitioners use, what a clever way of achieving the objectives of the pharmaceutical/medical establishment. I am not suggesting this is a deliberate attempt to hammer complementary medicine, but boy will certain people just rub their hands in glee.

Another problem related to these proposals is that I have heard one insurance company has already significantly increased their premiums to bulk essential oil suppliers. The reason was they are aware of these new proposals on the limits of supposed "sensitising chemicals". Therefore, they are worried that essential oil suppliers staff are suddenly going to start suing their employers for any kind of skin problems that might crop up. That will surely work its way through to insurance for therapists - another nail in the coffin of complementary therapies.

Perhaps the biggest problem with all these European regulations - as well as many in the UK- is that our laws are increasingly being set by committees of vested trade interests, not by our elected politicians. This is far from being democracy in action and may be one reason the European population are starting to reject the whole merry-go-round of the EEC and the politicians in the countries that support it. Talks on the above regulations have been going on for around two years in the secretive cloistered world of advisory committees, yet what have you the electors been told about it? Answer nothing! No advice has been sought from people outside of the trades concerned, no advice or input from the general public or from the numerous other trades that might be affected. It is a typical case of the way democratic procedures are being increasingly sidelined.

In theory the final decision rests with the politicians, in practice many such regulations will be read as amendments to existing laws at times when only a couple of MPs or MEPs are in their seats. Where the rest are I will leave to your own imagination! The Civil servants are well versed in such devious practices and know exactly how to get new legislation enacted with little if any political debate on their wider implications.

Only a public reaction can stop these stupid and illogical regulations. We did it once in the UK a few years back over draconian Traditional Medicines regulations, we can do it again. This time though maybe on an International scale.

So only you the reader can do much about this by making representations to your politicians or letting the media know how big the threat to natural products in cosmetics is.


Below is a much older article but many points are still related to the above,

Controls on Natural Remedies

In the UK, it part of our common law rights to utilise whatever health care regime an individual wishes. This is contrary to most European countries where an individuals access to health care of their choice, and practised by anyone other than registered medical practitioners is uncommon.

If the EEC place severe restrictions on the AVAILABILITY TO THE GENERAL PUBLIC of so called natural medicines, this will result in one of our fundamental freedoms being eroded. It is against The Treaty of Rome to enforce new laws that can interfere with the cultural traditions of a given state.

Here is a clause from The Treaty of Rome:

2. The Union shall respect fundamental rights, as guaranteed by the European Convention for the Protection of Human Rights and Fundamental Freedoms signed in Rome on 4 November 1950 and as they result from the CONSTITUTIONAL TRADITIONS common to the Member States, as general principles of Community law.


Currently various UK government departments are working on the implementation into UK law of a number of EEC directives. The cumulative effect of these regulations is a potential severe impact on the publics availability to traditional remedies.

We have a biocides directive; this is aimed at producing a positive list of substances that may have anti microbial effects or insecticidal or insect repellent activity. If a substance does not appear on this positive list then in future it may not be sold in the EC.  The UK Health and Safety executive have asked essential oil suppliers to provide them with a list of essential oils that they consider have the above properties, so they may be added to this positive list.

Now just to complicate matters further, the UK Medicines Control Agency are formulating a set of proposals that if fully implemented, would classify those products mentioned in the biocidal directive as medicinal substances thus requiring full medicines licenses in the same way as drugs. End result; the trade gives the HSE the information that another department (the MCA) can hang us with!

It does at least now look promising, that the MCA may decide on a method of assessing herbal remedies differently to drugs. However, this has only been after they ran into a lot of opposition to their plans from the natural medicines lobby.

The UK Medicines Control Agency is now going to appoint a committee to assess the status of 'medicinal products'.  They say it will be independent, and yet they appoint the members.  Very strange use of the word 'independent'!

No one in the Common market or in the UK Government, seems to have enough BRAINS to look at the wider picture of the consequences of producing a plethora of uncoordinated bits of legislation. In the EEC in particular, there is a continual process of churning out mountains of ill thought out legislation, I could not believe my eyes when I looked at just some of it. Remember the fiasco on the size of bananas!

Some examples of idiotic regulations are as follows:

The INCI list. This is a list of botanical names, that a producer of cosmetic products must use if they include botanical extracts in their products. The concept was fine; that anyone in a European country should know what was in their product. However what we have now is a huge list of INCORRECT botanical names produced by a trade committee whose members obviously had not the first clue about plants. The killer is that this inaccurate list is now UK law.

The proposed UK evaluation committee to asses the status of so called 'borderline products'. If this is allowed to pass unchallenged it will still, despite much lobbying, set up our MCA as judge, jury and executioner as to the status of all traditional remedies that the public perceived to have any medicinal value.

The above provisions are contrary to the following:

Common provisions among the European Union.

Article F

1. The Union shall respect the national identities of its Member States, whose systems of government are founded on the principles of democracy.


Treaty of Rome Rome, 25 March, 1957

Preamble:

"Affirming as the essential objective of their efforts the constant improvement of the living and working conditions of their peoples".

Anything that can put people out of work, is an infringement of this fundamental principle. The restriction of traditional remedies to pharmacies only would have resulted in massive unemployment and bankruptcies in the UK natural remedies trades.,

"Recognising that the removal of existing obstacles calls for concerted action in order to guarantee steady expansion, balanced trade and fair competition"

By requiring license fees for natural medicines this promotes unfair trading practises because then only large companies can afford the licensing procedures.


Article 6.

3. This Article shall not prevent any Member State from maintaining or adopting measures providing for specific advantages in order to make it easier for WOMEN to pursue a vocational activity or to prevent or compensate for disadvantages in their professional careers.

Well, if aromatherapists will be unable to obtain their essential oils because their suppliers are forced out of business, then the aromatherapists will be out of work. 90 percent or more of aromatherapists are women. Therefore attempts to suppress the availability of their working materials are contrary to the treaty of Rome!!!


Article 3.

(o) a contribution to the attainment of a high level of health protection;

(p) a contribution to education and training of quality and to the FLOWERING OF THE CULTURES of the Member States;

In the UK, freedom of health care provision is part of our cultural identity. Therefore any activity that threatens that is suppressing not supporting the flowering of the cultures.


Article 39. 1. The objectives of the common agricultural policy shall be:

(b) thus to ensure a fair standard of living for the agricultural community, in particular by increasing the individual earnings of persons engaged in agriculture.

Since many small organic growers supply goods to the herbals suppliers and essential oils markets, if the medicines control restrictions damage that market, then the objectives of the above clause are not met and the opposite will occur.

Another major objective of the treaty is the improvement of agriculture and the standards of living and health in underdeveloped area of the community as well as in third world countries. The plants that are used as herbal medicines and for essential oil production frequently originate in deprived rural locations in France, Italy, Spain and Greece. Therefore any laws that can damage the traditional markets for these products will be contrary to the stated objects in the Treaty Of Rome. In addition, it will require extra funds from the community to support the people whose livelihoods these new laws are damaging.

(e) to ensure that supplies reach consumers at reasonable prices.

If natural medicines are forced from the open market and into the hands of pharmaceutical interests, then prices will inevitably INCREASE.

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