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Regulations that are likely to apply to aromatherapy products supplied to professional and industrial users and to the general public in the UK/EU

Posted by Lauren at 10:16 on 12 Aug 2019

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‘Herbalists exemption’ supplying herbal remedies to clients
Under some circumstances the regulations that apply to products supplied to clients is different to those that apply to products supplied to the general public, so I will deal with the regulations that apply to products supplied to the general public first and then comment on supplying clients and the types of typical product claims that aromatherapists tend to make for clients that cannot be made when supplying products to the general public.

Regulations that apply to aromatherapy products supplied to the general public in the UK When you make and sell any consumer product in the UK/EU that product will have to comply with one or more of the various product or industry specific consumer product safety regulations, which ones will apply to your products will depend on their composition, presentation (packaging and labelling) and especially their intended use. I have attached a copy of our information sheet with links to the various regulations that are likely to apply to a range of products commonly marketed under the banner of aromatherapy that should help you to identify which regulations are likely to apply to the products you intend to supply.

As you cannot make medicinal claims (* see below) for unlicensed products, in practice aromatherapy type products are likely to be regulated by the Cosmetic Regulations or the General Products Regulations. The way to approach it is to look at the definition of a cosmetic product on page L342/64 of the cosmetic regulation EC 1223/2009 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF which is based on the intended use of the product as follows:

Article 2

Definitions

1.  For the purposes of this Regulation, the following definitions shall apply:

 (a) ‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;

If it 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 and that you comply with the standard of safety specified in the regulations (articles 10 & 11 and annex I). 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. 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 see: http://oxfordbiosciences.com/ click on safety on 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 it is a good idea to shop around on price. You can get this work done much cheaper from a company called Naturally Thinking at https://www.naturallythinking.com/ and in particular https://www.naturallythinking.com/lab.html.

There is also a requirement in the cosmetic regulation to notify cosmetic products 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 details can be found at http://www.ctpa.org.uk/content.aspx?pageid=427 including a very useful guide to the entire process. You will find all the links to the current cosmetic regulations and associated guidance at https://ec.europa.eu/growth/sectors/cosmetics/legislation_en.

However if your product does not meet the definition of a cosmetic product and many aromatherapy products don’t, then your product will be regulated by the General Products Safety Regulation (GPSR) 2005 http://www.legislation.gov.uk/uksi/2005/1803/contents/made. 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.

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 could 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. In addition to the cosmetic regulations other useful sources of information on safety assessment are the IFRA (international Fragrance Association) code of practice and standards. ​​​​​​​http://www.ifraorg.org/en-us/standards#.VKqE389yYdU and the EU guide lines on product safety assessment ​​​​​​​http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_006.pdf.

I should add that 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.

Further information on this can be found at ​​​​​​​http://ec.europa.eu/consumers/consumers_safety/product_safety_legislation/general_product_safety_directive/index_en.htm including a summary of the actual proposals at ​​​​​​​http://ec.europa.eu/consumers/archive/safety/psmsp/docs/psmsp-implementation-report_en.pdf and http://ec.europa.eu/consumers/archive/safety/psmsp/docs/psmsp-act_en.pdf the actual requirements starting on page 7.

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 an aromatherapy use then it is likely that your product will not meet the definition of a cosmetic product and will be regulated by the General Product Safety Regulations.

General products are subject to classification under chemicals legislation, the Classification, Labelling and Packaging of chemicals regulation, CLP for short (see​​​​​​​ http://www.hse.gov.uk/chemical-classification/legal/clp-regulation.htm and the regulation itself at  http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R1272-20131201&from=EN). There is guidance available at https://echa.europa.eu/guidance-documents/guidance-on-clp of which ​​​​​​​https://echa.europa.eu/documents/10162/13562/clp_en.pdf is the most useful for classification purposes together with the guide to labelling and packaging at ​​​​​​​https://echa.europa.eu/documents/10162/13562/clp_labelling_en.pdf . 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.

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. Products like aromatherapy room sprays and aura sprays are also subject to CLP classification 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.

Whichever regulations your product meets you will also have to comply with the weights and measures regulations https://www.gov.uk/guidance/packaged-goods-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 and how to avoid making them.

There is authoritative guidance on what is a medicinal product published by MHRA the UK medicines regulator available at

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/751227/012__GN8_-_final_2018_combined_doc_Oct.pdf

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. The link above has a useful annex with words and phrases that will be considered to be medicinal and that cannot be used to advertise a product for sale to the public without a medicines licence.

However should you want to consider product licensing under the medicines regulations this is the way to go about it https://www.gov.uk/guidance/apply-for-a-traditional-herbal-registration-thr, you can find products already granted a Traditional Herbal Registration (THR) at https://www.gov.uk/government/publications/herbal-medicines-granted-a-traditional-herbal-registration-thr and for products granted a full product license based on proof of efficacy http://www.mhra.gov.uk/spc-pil/. This database is searchable put an essential oil or other active ingredient of interest in the search box, this is what you get with eucalyptus for example http://www.mhra.gov.uk/spc-pil/?IdcService=SS_GET_PAGE&nodeId=%3C%25%3D+nodeId+%25%3E&searchFiled=eucalyp tus+oil&SubmitSearch=Search.

It is easier to get a license for a product that has already been licensed than it is to do everything from scratch.

Summary and additional information for cosmetic regulations
The cosmetic products regulations proper begin on page L342/64 with article 1. You should read through it all but the parts to pay particular attention to are as follows:

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 pageL342/68 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 are 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. You will have no problem with the oils and waxes you mentioned, some essential oils and their components 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.

Products supplied to clients
There is an exemption in the human Medicines Regulation 2012, regulation 3(6) http://www.legislation.gov.uk/uksi/2012/1916/regulation/3/made that allows practitioners like yourself to supply unlicensed herbal remedies subject to specific conditions as described in the regulation. This would mean 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 these 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).

Medicinal claims and how to avoid making them: specific examples
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.

You may well be aware of this source of this source of information but if not then I can recommend Tisserand and Young Essential oil safety 2nd ed. 2014 Churchill Livingstone Elsevier https://www.amazon.co.uk/Essential-Oil-Safety-Health-Professionals/dp/0443062412/ref=sr_1_1?adgrpid=52172866734&hvadid=259110378227&hvdev=c&hvlocphy=9046218&hvnetw=g&hvpos=1t1&hvqmt=b&hvrand=138402675821468 97565&hvtargid=aud-615477028278%3Akwd-304221585520&keywords=robert+tisserand+essential+oil+safety&qid=1552656012&s=gate way&sr=8-1&tag=googhydr-21.

The Tisserand Institute has additional information on the use of essential oils by children https://tisserandinstitute.org/learn-more/recommended-dilutions-for-children/ there is more at https://tisserandinstitute.org/infographics/ and elsewhere on the site. Robert Tisserand and the Tisserand Institute is no longer involved commercially or in any other way with the range of products that bears his name. This is independent and well-respected advice

​​​​​​​Disclaimer
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.

For more information please viit www.a-t-c-.org.uk​​​​​