Aromatherapy Products Europe Legislation
Current Legislation effective as of May 2015 regarding products supplied by aromatherapists to their clients as part of their clinical practice:
There is a widely held view that clinical aromatherapists rely on the provisions of Section 12(1) of the Medicines Act 1968 (now called Regulation 3 of The Human Medicines Regulation 2012) 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 patient following a one-to-one consultation. Following the implementation of the Traditional Herbal Medicinal Products Directive (THMPD) known in the UK as The Medicines Regulations 2005, (Traditional Herbal Medicinal products for human use) which came into full force on 30 April 2011, practitioners who supply unlicensed herbal remedies have been granted Statutory Regulation. 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. Until such time as this process is completed Section 12(1) remains in force and available to aromatherapists. Whether aromatherapists can continue to rely on Section 12(1) will depend on the criteria for registration with the Healthcare Professions Council and that will not be published until the consultation scheduled for later this year has taken place and the legislative framework for the reform of Section 12(1) is known. More information can be obtained from:
Medicines and Healthcare products Regulatory Agency (MHRA)
Department of Health
Healthcare Professions Council
Products supplied by aromatherapists to their clients and 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 and they are contained in the regulations, you can download a copy from the following link: http://www.legislation.gov.uk/uksi/2005/1803/contents/made
There is an excellent guide produced by the government department responsible for trade and industry BERR available at the following link: https://www.gov.uk/government/organisations/department-for-business-energy-and-industrial-strategy.
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. Aromatherapy products will only be regulated by the cosmetic regulation if they meet the definition of a cosmetic product and are made available on the market as defined in the regulations. The definition of a cosmetic product is largely based on its intended use.
The new European regulatory framework for cosmetics (EC) Regulation No. 1223/2009 was published in the Official Journal on 22 December 2009 and entered into force on 11 January 2010 with an implementation date of 11 July 2013.
The Cosmetic Regulation (EC) 1223/2009 can be downloaded at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF and have been amended as follows: (EU) 344/2013 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:114:0001:0059:EN:PDF
This amendment updates the Annexes II, III, V & VI to bring Regulation EC 1223/2009 up to date. The Annexes published in EC 1223/2009 were correct at the date of publication in 2008 this update is intended to bring the Regulation into line with the latest updates for the Cosmetic Products (Safety) Regulation 2008 (as amended) implementing the Cosmetics Directive 76/768/EEC (as amended).
(EU) 483/2013 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:139:0008:0010:EN:PDF. This amendment concerns Laureth-9 in Annex III and will be implemented following a period of transition on 1 April 2014. The Commission has now published a list of the common criteria to be applied to product claims for cosmetic products as Commission Regulation (EU) No. 655/2013 and is available to download at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:190:0031:0034:EN:PDF
There is a guide to this regulation available to download at: http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/guide_reg_claims_en.pdf
The previous Cosmetics Directive 76/768/EEC (as amended) implemented in UK as The Cosmetic Products Safety Regulations 2008 was repealed on 11 July 2013, it can be downloaded at: http://www.legislation.gov.uk/uksi/2008/1284/contents/made
There is an excellent guide to the cosmetics regulations 2008 available at the following link: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/39334/10-761-guide-to-cpsr.pdf. Many of the points in this guide are still relevant to (EC) 1223/2009
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) see http://www.hse.gov.uk/chemical-classification/legal/clp-regulation.htm.
There is also a code of practice operated by AISE for this class of product see: http://www.aise.eu/documents/document/20131030120712-airfreshenersproductstewardshipprogrammedescription.pdf
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) as follows: http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedicinesregulation/ and if they meet the definition of a veterinary product then the Veterinary Medicines Regulations apply as follows: http://www.legislation.gov.uk/uksi/2009/2297/contents/made
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 at:
The trade association for this product area is the British Candleamakers Federation http://www.britishcandles.org/?home.
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, see: http://www.hse.gov.uk/biocides/
In addition the UK weights and measures regulation apply to packaged products and is available at the following link: http://www.legislation.gov.uk/uksi/2006/659/contents/made
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 see: http://www.mhra.gov.uk/Howweregulate/Medicines/Doesmyproductneedalicence/Borderlineproducts/index.htm you can also down load a document on how MHRA suggest you construct websites (to avoid making medicinal claims) on the same page.
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.