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The Implications of Brexit on Aromatherapy Regulations

Posted by Lauren at 10:16 on 16 Oct 2017

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It has been over two years since our last legislation update and to be honest very little has changed, the various changes to the regulations that affect aromatherapists and the products they make for their clients and the general public that were expected then are still expected now. Whether or not we will see them implemented before the UK leaves the EU remains to be seen. In this article I will bring readers up to date with the regulations of interest to aromatherapists as they apply now and try to summarise what we know about the implications of Brexit.

Section 12(1) and the registration of herbalists
Section 12(1) of the 1968 medicines act, often called the ‘herbalist’s exemption’ permits herbalists and other practitioners to make and supply an unlicensed herbal remedy to their clients under specified conditions including a face to face consultation. This exemption was incorporated into the Human Medicines Regulation 2012 as Regulation 3(6) when it was revised to include the EU Traditional Herbal Medicines Directive. Since then there has been an ongoing debate on whether or not herbalists should be statutorily regulated, something supported by the Herbal Medicines professional associations representing the majority of herbalists, however it is not unanimous and the last five governments have not been able or willing to make a decision in spite of commissioning several enquiries. The last enquiry failed to support the registration of herbalists. It now looks likely that this is the end of the discussion and that the government is not going to take action especially as they are now preoccupied with Brexit. The herbal professions have not altogether given up on it and it may come back at some time in the future. At one time it was feared that if herbalists were not registered then the herbalist’s exemption would be withdrawn, but it does not appear that this is likely to happen now and so the herbalist’s exemption is available to any practitioner, including clinical aromatherapists who have traditionally relied on it.

What is Aromatherapy.jpg

Cosmetic Regulation (EC) No. 1223/2009 and fragrance allergens
In 2012 the EU Scientific Committee on Consumer Safety (SCCS) published a report that recommended that several severe fragrance allergens be banned in cosmetic products and several others be severely restricted, and an even larger group be included on the ingredients list on the labels of cosmetic products. Following a consultation and pressure from industry it was clear that the European Commission (EC) was not going to implement these recommendations in full. Three severe fragrance allergens have now been banned this year but they do not affect essential oils used in aromatherapy. In 2013 the cosmetic regulation was amended (EU 344/2013) to include a specification to restrict the peroxide content of a number of essential oils derived from species of pine, fir and cypress including Pinus sylvestris (Scots Pine oil), Cedrus atlantica (cedarwood atlas oil) and Cupressus sempervirens (cypress oil) the others listed are not typically used in aromatherapy, although they are used in cosmetic products. The full list is in annex III to the amendment above. The significance of the restriction on the level of peroxides is that when substances like limonene, linalool, and the pinenes are oxidised they break down to form hydroperoxides which makes the substances and the essential oils that contain them much more sensitising. This restriction means that for the listed essential oils they can only be used in a cosmetic product if the peroxide level is less than that specified in the regulations. However as the peroxide content of finished cosmetics is not specified by the regulation there is no way of knowing if the manufacturers are adhering to this restriction or not. ATC understands that this is an issue that is currently being investigated with a view to possibly including a maximum peroxide level in finished cosmetic products at some time in the future.  There is no indication whether the EC intends to implement the other parts of the SCCS opinion and if so when. It seems that it is unlikely to happen before the UK leaves the EU.

After Brexit, the cosmetic regulations will still be enforceable in the UK because EU regulations have to be enforced, as a condition of membership of the EU, by passing a law in each member state and the UK enforcement regulations will remain on the statue books until the UK removes it. At the moment we have no idea how the UK government is going to deal with the thousands of EU regulations and directives that have been enacted into UK law. The best guess is that as far as consumer safety regulations like cosmetics is concerned nothing will change in the foreseeable future and all current EU law will remain in force. In any case if aromatherapists and manufacturers of products regulated by the cosmetic regulations want to sell them in the EU they will have to comply with the EU regulations including the requirement that the ‘Responsible Person’ be based in the EU. Unless special arrangements are made, and that seems unlikely in the short term, UK based cosmetic product manufacturers will have to appoint another organisation that is based in the EU to be the ‘Responsible Person’ to take legal responsibility for those products.

General Product Safety Regulation 2005
There have been plans to revise this regulation for several years, draft regulations have been published and a consultation held and it has still not been implemented. It is possible that it may be implemented before the UK leaves the EU but that is not certain.

The implication for aromatherapists is that the new regulation will include the blends that aromatherapists make and use on their clients during a massage session. Currently these blends are subject to a safety assessment under the Control Of Substances Hazardous to Health (COSHH) regulations but under the new regulations they will be general products and there will be a requirement to make a written safety assessment for every blend and keep a dossier of information similar to the product information file required by the cosmetic regulation. This will not be a problem for aromatherapists as this is already part of your normal practice. As aromatherapists who make and supply aromatherapy products to the general public know, these products, unless they meet the definition of a cosmetic product are regulated by the general product regulations. Again this is a UK regulation based on an EU directive and is already enacted into UK law so it will continue in force in the UK whatever happens after Brexit. The new EU regulation is a regulation and not a directive so an enforcement regulation will have to be passed into UK law if the regulation is published before Brexit. If it isn’t then the current general product safety regulation will remain in force and the products that aromatherapists make and use on their clients will remain regulated by the COSHH regulation.   

As always if readers would like to discuss any of the issues raised please contact ATC by visiting: www.a-t-c.org.uk and to find out how ATC can help you call Ray Gransby on 01673 844 672 during office hours 10am to 4pm Monday to Friday or email info@a-t-c.org.uk.