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True Melissa Oil (Genuine Melissa Officinalis)
 
We recently had several enquiries concerning the use of Melissa Officinalis in cosmetic products and in the practice of aromatherapy in view of the fact that the IFRA Guidelines state that it should not be used as a fragrance ingredient. We therefore sought the view of the CTPA (Cosmetic, Toiletry & Perfumery Association) on this and you may find their response of interest.
 
They have confirmed that the IFRA Guidelines state that Melissa Officinalis (CAS 014-71-9) should not be used as a fragrance ingredient. However, this could be for one of two reasons: it has no use as a fragrance ingredient; or, data to substantiate its use has not been submitted to, or seen by, IFRA.
 
IFRA recommendations are not automatically incorporated into the cosmetics directive. Although the European Commission's expert body, the Scientific Committee on Consumer Products (SCCP) is slowly reviewing fragrance ingredients Melissa is not on its list of fragrance ingredients to evaluate at the moment. Before a ban or restriction is incorporated into the cosmetics directive, there has to be a risk assessment by the SCCP.
 
Cosmetic products must be labelled with a list of their ingredients. The regulations require that the ingredient names are in a specific format which is determined by the International Nomenclature Committee that has industry and government
representatives from the major international markets. The official list of approved INCI format for cosmetic ingredients is published by CTFA (Cosmetics, Toiletry & Fragrance Association, www.ctfa.org) in the International Cosmetic Ingredient
Dictionary & Handbook. The INCI listing can also be accessed from a searchable database via the European Commission's Cosmetics & Medical Devices website at http://pharmacos.eudra.org/F3/cosmetic/inci/incialf.htm
 
Melissa does have a number of INCI names and some are available as cosmetic ingredients in the UK:
INCI name Melissa Officinalis Extract; no CAS number; technical names - Balm Mint Extract or Melissa Officinalis (Balm Mint) Extract
INCI name Melissa Officinalis Flower/Leaf/Stem Extract; no CAS number; no other technical name
INCI name Melissa Officinalis Flower/Leaf/Stem Water; no CAS number; technical names Balm Mint Distillate or Melissa Officinalis Distillate
INCI name Melissa Officinalis Leaf Extract, CAS No. 84082-61-1, Technical names Balm Leaves Extract (Melissa officinalis L.) (RIFM), Balm Mint Extract, Balm Mint Leaf Extract, Lemon Balm Extract, Melissa Officinalis Extract
INCI name Melissa Officinalis Leaf Oil, CAS No. 8014-71-9, Technical names Balm (Melissa officinalis L.) (RIFM), Balm Mint Leaf Oil, Balm Mint Oil, Balm Oil (Melissa officinalis L.) (RIFM), Lemon Balm, Melissa Officinalis Oil
INCI name Melissa Officinalis Leaf Powder, no CAS number, Technical names none
INCI name Melissa Officinalis Seed Oil, CAS no. none, Technical name - Balm Mint Seed Oil
 
All of the above are from Melissa Officinalis. None of the reported uses are for the function of a fragrance ingredient. As Melissa Officinalis is not banned or restricted, it may be used in cosmetics as long as the final product is assessed as being safe. Safety information relating to the various ingredients of a cosmetic product is taken into account as part of the safety assessment.
 
Medicinal Claims and Borderline Section of the Medicines & Healthcare products Regulatory Agency (MHRA) Section 12(1) of the Medicines Act 1968 currently allows aromatherapists to use essential oils for a medicinal purpose under certain conditions. One of these conditions is that a consultation must have been undertaken with a client in that person's presence and a judgement made about the treatment required before the remedy is supplied. Section 12(1) is however currently under review by Ministers in the light of the implementation of The Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 and the statutory regulation of herbalists.
 
This current exemption from the requirement to obtain a marketing authorisation (product licence) does not apply to those therapists who sell their own retail brand of products direct to the consumer. Unless a face-to-face consultation with a client takes place, aromatherapists who sell essential oils and aromatherapy products to the public are subject to exactly the same legislation as any aromatherapy trader. This means that no medicinal claims whatsoever may be made for unlicensed products. This includes all product names, all advertising and promotional material and particularly websites, which are regarded exactly the same as any other advertising media.
 
The difficulty for those marketing products used in aromatherapy is actually in identifying what constitutes a medicinal claim. The courts have interpreted the definition of a medicinal product as meaning that even a product with no known therapeutic benefit could be rendered a medicinal product by virtue of the claims made for it. To assist with this, the MHRA publishes "Guidance Note No. 8 - A Guide to what is a Medicinal Product" on their website at www.mhra.gov.uk. In addition, the ATC offers a vetting service to review the legal text on labels and promotional material prior to printing for both members and non-members, to ensure compliance with the law.
 
As Code Administrator for the specialist aromatherapy essential oil industry, the ATC has over the years highlighted the problems of medicinal claims on the Internet at meetings between the MHRA and other Code Administrators. So many international companies are permitted to make these claims, thus leading to grossly unfair competition for UK companies.
 
We therefore warmly welcomed an initiative by the MHRA Borderline Section to clarify this situation by consulting with Code Administrators and issuing a Guidance Note, "The Medicines Borderline Section & The Internet," on their website to help companies avoid bringing unlicensed products within the definition of a medicinal product. This should assist UK companies to better inform their customers about the uses of the ingredients in their products and to better compete on the world-wide market.
 
It will be seen from this new Guidance Note that a company may set up its own separate generic website in addition to its commercial product site, to give the information on the ingredients, provided there are no references to actual products on the generic site. The entry page of the commercial site may give a link to this generic site BUT there must be no purchase facility on this entry page.

© Sylvia Baker, Aromatherapy Trade Council, Dept TT, PO Box 387, Ipswich IP2 9AN T/F: 01473 603630


Email: info@a-t-c.org.uk

Website: www.a-t-c.org.uk
 
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