Legislation Affecting Aromatherapists and Product Designers
When you make and sell any consumer product in the UK or EU that product will have to comply with one or more of the various product or industry specific consumer product safety regulations. Below lists the various regulations that are likely to apply to a range of products commonly marketed under the banner of aromatherapy and should help you to identify which regulations are likely to apply to the products you intend to supply.
There is a widely held view that clinical aromatherapists rely on the provisions of Section 12(1) of the Medicines Act 1968 as the legal basis of their practice. Section 12(1) is commonly referred to as the 'herbalist exemption' and permits unlicensed remedies to be made up and supplied by a practitioner to meet the needs of an individual subject to specific conditions.
Following the implementation of the Traditional Herbal Medicinal Products Directive (THMPD) known in the UK as The Medicines Regulations 2005 (for human use), which came into full force on 30 April 2011, practitioners who supply unlicensed herbal remedies have been granted Statutory Regulation. This means that products containing essential oils (accepted as herbal ingredients) and other botanical extracts with medicinal properties can be supplied to clients as unlicensed herbal remedies for minor conditions like local pain relief, treatment of inflammation, minor non-clinical stress/depression, symptoms of psoriasis, eczema etc. This exemption applies only to typical herbal medicinal products supplied to clients under the terms of the exemption and not the general public, as you cannot make medicinal claims for unlicensed products supplied to the general public. However, if you supply non-medicinal products like cosmetics and general products to your clients then they have to comply with the Cosmetic Regulations in the same way as when you supply them to the public. In this respect there is no difference between a consumer you know (client) and a consumer you don’t know (the general public).
The Healthcare Professions Council have been appointed to set up the statutory register of herbal practitioners and when this is in place it will pave the way for Section 12(1) to be reformed and then only practitioners who are on the register will be allowed in law to supply unlicensed herbal remedies.
Medicines and Healthcare products Regulatory Agency (MHRA)
Department of Health
Healthcare Professions Council
Regulations that Apply to Specific Products Supplied to Clients and/or the General Public
There is no single piece of legislation for aromatherapy products and they are controlled by a variety of regulations depending on their composition, presentation and intended use. When sold to clients and/or the general public aromatherapy products typically fall under the following main headings:
Essential oil(s) packaged as single oil or as a blend of 2 or more essential oils with no other type of ingredient added are typically subject to the General Products Safety Regulation 2005 (GPSR). There are specific labelling requirements contained in the regulations, which can be downloaded here.
Essential oils blended with any other ingredient for example vegetable oils (described as massage oils) and/or bases like creams, lotions, gels, detergents etc. that meet the definition of a cosmetic product are likely to be subject to the Cosmetic Regulations. These regulations are much more severe than the General Products Safety Regulations and is largely based on the products intended use and how they are made available on the market as defined in the regulations.
If a product meets this definition, then the cosmetic regulations will apply and you will have to make sure that your ingredients comply with the various restrictions given in the various annexes. This includes establishing a product information file that contains the Cosmetic Product Safety Report which in turn contains a safety assessment made by a safety assessor with the qualifications and experience specified in the regulation. A list of the common criteria to be applied to product claims for cosmetic products, as per Commission Regulation (EU) No. 655/2013 is available to download here.
You will also need to establish a shelf life for your products, this is usually done by conducting stability tests on the product in its packaging and may include a preservative efficacy test. This is explained on the Oxford Biosciences website - click on ‘safety’ in the menu bar, you will find stability testing there as well as a lot of other useful information. This company also does the safety assessments. Depending on how much work needs to be done the costs of stability testing and safety assessment are likely to be in the region of £600 per product. This is a competitive market and there are a lot of safety assessors who do this kind of work so it is a good idea to shop around on price. You can get this work done much cheaper from a company called Naturally Thinking.
There is also a requirement in the cosmetic regulation to notify cosmetic products to the EU cosmetic product safety database using the on-line Cosmetic Products Notification Portal before placing them on the market. This is free of charge but will require planning to assemble the information required which can be found here which includes a very useful guide to the entire process.
In summary, you should read through all parts of the regulation carefully and pay particular attention to:
Article 4 page L342/65 the Responsible Person - that will be you.
Article 10 and 11 on page L342/67 on the safety assessment and the product Information file that includes the Cosmetic Product Safety Report that in turn includes the Cosmetic Product Safety Assessment as described in Annex 1 on page L342/79
Article 13 on page L342/68 on notification. There is a link above to the CTPA page with links to the guidance that covers how to go about setting up an account in EU the system and then making the notification.
Annex 19 on page L342/72 on labelling. There is a need to identify and include in the list of ingredients the skin allergens listed in annex III that are in your product, if any, they start at number 67 on page L342/152, there are 26 altogether 16 of which are found in essential oils and run sequentially identified by a note of the labelling requirement subject to a labelling threshold. Your fragrance compound supplier or essential oil supplier will be able to tell you which fragrance allergens if any and their concentration in the products you buy from them.
Annex II and III starting on page L342/83 and L342/128 contain a list of the ingredients that are prohibited or restricted and you should check to see if any of your ingredients are listed. Your fragrance/ingredient supplier will be able to certify that the products you have purchased comply with the requirements of the cosmetic regulations and provide a certificate of compliance to the International Fragrance Association (IFRA) code of practice and the maximum concentration that can be used in various types of product. This concentration is not necessarily the one that a cosmetic product safety assessor will allow but they will take it into consideration in making their assessment.
Generally cosmetic product safety assessors will only approve cosmetic products intended to be left on the skin with a maximum level (total) of essential oils of 1%. Rinse off products may be higher up to 2% depending on the essential oils used. Once a formula has been developed it is a good idea to contact the safety assessor of your choice and check to see if there are any problems with your formula before committing to stability testing and safety assessment. It is much easier, and cheaper, to reformulate at the beginning of the process than the end.
However if your product does not meet the definition of a cosmetic product and many aromatherapy products don’t, then your product will simply be regulated by the General Products Safety Regulation (GPSR). This is a default regulation intended to apply to consumer products that do not meet the definition of one of the industry or product specific regulations like cosmetics, food, medicines etc. You will notice that neither massage or typical aromatherapy claims for example relaxation, promoting the quality of sleep, relieving everyday aches and pains in muscles and joints, everyday stresses and strains etc. are mentioned in the definition of a cosmetic and if your products intended use is as a massage oil with the oils intended for aromatherapy use then it is likely that your product will be regulated by the GPSR.
The GPSR is much easier to comply with as it does not specify the standard of safety in the way that the Cosmetic Regulation does. The product still has to be safe for the consumer to use and as a trained aromatherapist you can make the required risk assessments yourself in the same way that you do for your clients but adapted for the general public. You will need to take into consideration the provisions and restrictions in the Cosmetic Regulations if your products are to be used on the skin for example as massage oils as the ingredients and conditions of use are similar and so the risks to the user will be similar. Useful sources of information on safety assessment can be obtained from the International Fragrance Association (IFRA) Code of Practice and Standards and the EU guide lines on product safety assessment.
General products are subject to classification under the Classification, Labelling and Packaging of Chemicals Regulation (CLP).There is guidance available on the regulation here. The regulation and guidance describes the process of making a classification for a mixture based on the classification of its component ingredients. When you buy your essential oils (and any other ingredient), as a professional or industrial user you are entitled by law to receive a safety data sheet (SDS) for all hazardous ingredients that will have (or should have) the hazard classification listed on it, and you can use this to determine whether the mixture is hazardous and if so how to label it as specified in the CLP regulation. How to classify a mixture based on the hazards of its components is described in the CLP regulation and guidance. In addition there are specific packaging requirements like the use of child resistant closures and hazard warning triangles for some types of hazard that have to be considered. All essential oils are classified as hazardous under the CLP regulation, although whether this will make the mixture hazardous will depend on what other ingredients you have used and their concentration in the product. For more general safety information visit the General Product Safety Directive.
You will notice that in the UK single species essential oils and blends supplied in small quantities are not typically labelled with their CLP hazards. This is an historical position and although it is no longer valid Trading Standards have not yet challenged it. This is not the case in all EU member states and some like Germany require all hazardous essential oils to be labelled with their hazards irrespective of quantity in the bottle.
To add, the General Product regulations are in the process of being upgraded and will require a formal written risk assessment together with the compilation of a product information file similar to that now required by the cosmetic regulation although it is not expected that the new regulation will actually specify who should make the risk assessment in the way that the cosmetic regulation does. In recent discussions with a local Trading Standards Officer in relation to risk assessments for general products containing essential oils for use on the skin it is their opinion that it would be best practice to have them assessed by a qualified cosmetic products assessor rather than by a trained aromatherapist.
Essential oils blended with other ingredients in the form of a spray/diffuser not intended to be applied to the skin e.g. a room spray, wardrobe care etc. is generally classed as a household product subject to the GPSR and/or the CHIP4 regulations now replaced by the Classification, Labelling and Packaging Regulation (CLP). There is also a code of practice operated by AISE for this class of product, which can be found here.
Like any household product and although products like aura sprays are not typically labelled with their hazards Trading Standards have started to challenge this and I am aware of one company supplying these types of sprays that have been caught by trading Standards. Supplying hazardous products to the public without the required labelling can be a serious offence so this aspect of classification and labelling for general products needs to be taken seriously.
Products containing essential oils that meet the definition of a medicine by function or by description are controlled by the Medicines Act/Traditional Herbal Medicinal Products Directive (THMPD) and if they meet the definition of a veterinary product then the Veterinary Medicines Regulations apply.
Candles containing essential oils are likely to be subject to the GPSR, the candle safety labelling code of practice and the European Standard BS EN 15494-2007. A guide to candle safety labelling can be downloaded here. The trade association for this product area is the British Candle Makers Federation.
Essential oils presented on their own or in combination with other ingredients that contain biocidal ingredients or are described as being biocidal, i.e. to kill or repel bacteria, fungi, yeasts, viruses and insects are likely to be considered to be biocides controlled by the Biocides Regulations unless their primary function is as a cosmetic and the biocidal activity/claim is a secondary function in which case they are likely to be subject to the cosmetics regulations.
Whichever regulations your product meets you will also have to comply with the Weights and Measures Regulations.
You will also have to make the product somewhere, if you do this at home, and I don’t recommend this, then you need to be careful that you do not invalidate the terms of your domestic insurance and terms of mortgage (most policies exclude conducting a business on domestic premises) and that you check that the local authority plan does not prevent you from conducting a business in a residential area.
In addition you will need product liability insurance in case anything goes wrong and your products cause an injury to a consumer. It is becoming increasingly difficult to get product liability insurance unless you can demonstrate competency to make the products you intend to supply. This is not a problem for qualified aromatherapists as product liability insurance tends to be included in professional liability policies. For unqualified people it is much easier to get product liability insurance for cosmetic products as they as are assessed for safety by a qualified typically independent safety assessor. Although it is not a legal requirement to hold product liability insurance if something goes wrong and someone is injured by a product supplied by you, your assets may be at risk if they take legal action and win damages against you. In practice this is a must have item when making and supplying product to the public. An internet search for ‘product liability insurance for cosmetic products’ will find specialist insurers who also insure general products as well.
Medicinal Claims Prohibited
When supplying products to the general public you cannot make medicinal claims (unless the product is licensed under the Medicines Act/THMPD see Guidance note 8 ‘What is a medicine’ published by the MHRA where you can find the sorts of words and phrases MHRA consider to be medicinal and are therefore to be avoided when advertising products for sale to the public without a medicines licence. You can also download a document on how MHRA suggest you construct websites (to avoid making medicinal claims) on the same page.
It is very easy to make medicinal claims for the properties of essential oils and products containing them as this is the way that essential oils are often promoted to the general public by suppliers and people who write aromatherapy blogs as well as those who write books and articles on aromatherapy. This is fine for your personal use but you cannot make the same claims to promote or advertise products for sale to the general public. There are any number of products containing essential oils available on-line that make quite blatant medicinal claims for products containing essential oils, this is actually illegal and contravenes the medicines regulations. The only reason they are still doing it is because they have not been caught yet.
However should you want to consider product licensing under the medicines regulations this is the way to go about it . You can also find products already granted Traditional Herbal Registration (THR) here and for products granted a full product license based on proof of efficacy here. This database is searchable simply enter an essential oil or other active ingredient of interest in the search box.
It is easier to get a license for a product that has already been licensed than it is to do everything from scratch.
Essential oils are multi-functional ingredients with properties and benefits that can meet the definitions of a variety of different types of product, as mentioned above. One of the biggest problems for aromatherapists to get to grips with is that they typically make medicinal claims for the products supplied to clients quite legally, as described above. However, when suppling products to the general public one has to avoid making medicinal claims and this can be a challenge when supplying aromatherapy type products as it is very easy to make claims that MHRA consider to be medicinal.
Pain relief is a problem because it is very difficult to describe this type of use without making a medicinal claim and one is restricted to claims like soothing and comforting to mind and body. The same applies to anti-inflammatory claims.
Sleep is a little easier as you can talk about supporting the conditions that ensure or support the quality of sleep. You cannot claim to help people to get to sleep, this is sedation, but describing the quality of sleep in terms of restful, peaceful etc. is acceptable.
Stress is another issue as is anti-depressant. Calming the mind is likely to be seen as a claim to treat mental stress, so you have to qualify stress as supporting the everyday stresses and strains associated with everyday activities like a hectic lifestyle, and stress at work and exam times, in bereavement and so on. The same applies to muscle and joint pain, this has to be associated with overdoing everyday activities like gardening, walking, sports etc. and not medical conditions like arthritis, muscle tension etc.
Congestion is another issue, there are licensed products for it like Olbas Oil and any number of vapour rubs. So you can talk about supporting cool and clear breathing and normal or healthy respiratory systems. MHRA consider that medicines are used to bring someone back to normal health and complementary products are there to support well people, and essential oils are used to support well-being of course, so that needs to be the focus of aromatherapy type products.
There are no specific regulations that apply to aromatherapy type products intended for men, women or children, other than cosmetic products that have a specific safety assessment for products intended to be supplied exclusively for children, especially those under 3 years. All consumer products have to be safe for the consumer to use so special cases like use in pregnancy, use by children and vulnerable adults, interactions with medicines and use by people taking medication will have to be taken into consideration when supplying products to the general public. Making safety assessments for clients is easy as they are in front of you but the general public are not so your safety assessment has to reflect this degree of uncertainty.
This information was provided by the Aromatherapy Trade Council (ATC). The ATC wishes to make it clear that the information contained in this advice is provided in good faith, it is based on the information that is available to it at the time and every effort has been made to ensure its accuracy. It is not necessarily comprehensive and is subject to revision in the light of further information. The ATC cannot accept any liability for reliance on the information provided and it remains the responsibility of the marketer to ensure they comply with the legal requirements in force at any time.
ATC is the trade association for the specialist aromatherapy essential oil trade representing the interests of manufacturers and suppliers of essential oils and aromatherapy products. For more information please visit: www.a-t-c.org.uk or call Ray Gransby on 01673 844 672 during office hours 10am to 4pm Monday to Friday or email firstname.lastname@example.org