- Aromatherapy
- True Melissa Oil (Genuine Melissa Officinalis)
- Interactions between Essential Oils and Medications
- The New European Chemicals Policy
- Article Guide
- How to study Anatomy, Physiology and Pathology?
- Massage Therapy UK - Article publishing guide
- How to approach practicing massage on family and friends?
- Ayurveda
- How to approach practicing massage on family and friends?
- Removing Toxins The Natural Way
- Chavutti Thirumal An Intoduction To A Unique Massage Therapy
- Bowen Technique
- Gentle Touch Produces Miracles
- How to approach practicing massage on family and friends?
- Business
- On Site Massage & Complementary Therapy in the workplace
- How are You?
- How to approach practicing massage on family and friends?
- Complementary Therapies
- The Importance of Sports Massage
- How to approach practicing massage on family and friends?
- What is sports massage?
- Education & Training
- Introduction to Massage Essentials for Health
- How to study Anatomy, Physiology and Pathology?
- The different between NHS and CAM meaning of health
- Fitness
- What is sports massage?
- The different between NHS and CAM meaning of health
- The Importance of Sports Massage
- Health
- On Site Massage & Complementary Therapy in the workplace
- How to approach practicing massage on family and friends?
- The Magic Pill Within
- Health & Nutrition
- So why have a Personal Trainer?
- How to approach practicing massage on family and friends?
- The different between NHS and CAM meaning of health
- Massage
- Thai Yoga Massage – An Ancient Therapy for a Modern World
- Benefits and effects of massage
- On Site Massage & Complementary Therapy in the workplace
The New European Chemicals Policy
04/05/2008 - By © Sylvia Baker REACH (Registration, Evaluation & Authorisation of Chemicals) and Aromatherapy, see http://ec.europa.eu/enterprise/
reach/docs/reach/reach_in_brief_revised_061212.pdfAs reported in the last issue, REACH is massive new chemicals' legislation, it is the biggest piece of legal text to ever come out of the European Commission and it will have a major impact on the entire essential oil industry. It is indeed mind blowing!
Essential oils are in REACH under category NCS - Natural Complex Substances. The really important action for importers, manufacturers and professional users of essential oils is to ensure that all essential oils are pre-registered with the new European Chemicals Agency in Helsinki between 1st June and 30th November 2008. Pre-registration is free although certain information - not yet finalised - will be required for this. If essential oils are not pre-registered then there will be no transitional protection and they will have to go straight to registration with all that entails, e.g. the submission of a full dossier. Failure to register means that the substance cannot be manufactured in, or imported into, the EU.
In order to keep abreast of developments, the ATC has been represented at various presentations organised recently to attempt to explain the complexities of REACH (which change as the Reach Implementation Products (RIPS) progress)! This includes that organised by REACHReady (a wholly owned subsidiary of the Chemical Industries Association - see www.reachready.co.uk), and the European Federation of Essential Oils (EFEO - see www.efeo-org.org) and it will be represented at the Commission's industry workshop to be held in Bonn on 21st June. ATC members will be advised on how to cope with the pre-registration phase as and when it is clarified.
Defra Consultation on the Enforcement of REACH in the UK: see http://www.defra.gov.uk/corporate
/consult/reach-enforce/index.htm
The Department for Environment, Food & Rural Affairs issued this consultation document in March 2007 with a response date of 4th June 2007. As it is a Regulation rather than a Directive, REACH applies as written across all EU member states. Member States are, however, required to provide for enforcement of the legislation and to set up a penalties regime which is "effective, proportionate and dissuasive". The Defra consultation sets out how the Government proposes to meet this requirement. The ATC has responded to this consultation, supporting Defra's proposed approach to enforcement and the allocation of responsibilities using the current regulatory authorities - Health & Safety Executive, Environment Agency and local authorities - as appropriate with their existing powers and legal penalties rather than setting up a new body or bodies. We see this as the lowest cost option.
The THMPD (The Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 The draft report on the European Commission's experience of the working of and possible extension to the simplified registration procedure under the THMPD is now available via the link below.
http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos
/docs/doc2007/2007_05/
herbals_draft_report_2007_05_29.pdf. Comment is due by 12th July and the Herbal Forum (a powerful lobbying body set up by industry, including the ATC, to protect the interests of manufacturers) will be discussing this at their meeting in early July prior to responding.
It is interesting to note that very few registrations have been made to date throughout the whole of the EU with only three being granted in the UK so far. Indeed the Report itself states that as of 31st March 2007, 79 applications had been introduced in 12 Member States (MS). Eight products had been authorised in three MS. Regarding four applications, the simplified registration application has been withdrawn in one MS before the final outcome of the procedure. A total of 68 applications are currently being processed. The number of applications is very unevenly distributed among MS. In some MS more than 20 applications have been introduced and 16 are currently under assessment. In most MS, however, at this stage, no or very few applications have been introduced.
USA Food & Drug Administration (FDA) Guidance for CAM Products and Regulation see http://www.ahpa.org/Portals/0/pdfs/
06_1200_CAM_Draft_Guidance_FDA.pdf
Cropwatch recently drew attention to the upcoming US Draft Guidance for Industry on CAM products, which is seen in the US as a crisis in health freedom, with one-third of Americans using CAM therapies, including aromatherapy - very similar to the UK/EU position. The proposals could have a knock-on effect for the UK as the US situation appears to involve all alternative/CAM practices and refers for the first time in US to something called 'CAM products.' It was felt that the regulatory classification of aromatherapy products might change as a result of the FDA guidance. It could be that FDA is testing the water given that the US appears to be aligning themselves with EU legislation in a big way - a EU-US Summit took place in Washington on 30th April when a transatlantic economic partnership was signed.
Various campaigns within the USA were set up to fight the draft Guidance. The initial public consultation period was unusually short but due to extensive lobbying by the CAM community, it was extended until the end of May 2007. The Herbal Forum contacted the American Herbal Products Association (AHPA) for their take on it. The AHPA response seems to be very much in line with our own thinking and they called on the FDA to withdraw its draft Guidance. The full text of AHPA's comments can be found on their website at http://www.ahpa.org/Portals/0/pdfs/
07_0427_AHPAComments_FDA_CAM_Guidance.pdf.
Other American CAM associations have responded in much the same way. Although ATC members were requested to sign the on-line petitions at the time, with so many indigenous associations now involved, it was felt the ATC should take no further action on this at the present time and a watching brief will be kept on further developments.
© Sylvia Baker, ATC - Dept TT,
PO Box 387, Ipswich IP2 9AN
Email: info@a-t-c.org.uk
Website: www.a-t-c.org.uk
Tel/Fax: 01473 603630