Regulatory concerns within the UK

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Regulatory concerns within the UK

Sylvia Baker, Administrator, Aromatherapy Trade Council (ATC), P.O. Box 387, Ipswich IP2 9AN, UK.

S y lv i a B a k e r

The regulation of both aromatherapists and the aromatherapy essential oils industry within the UK is very complex and at times, still uncertain because when the legislation was laid, it did not take account of aromatherapy. Draft legislation proposed by the European Commission may have an impact upon the use and sale of essential oils in the near future. © 2002 Elsevier Science Ltd. All rights reserved.

BACKGROUND he Local Authorities co-ordi-

T

nating body on Food & Trading Standards (LACOTS) issued

Product Safety Advice on Aromatherapy Products in October 1996, setting out the various categories into which they fall. They stated that ‘aromatherapy products have a wide range of intended functions and properties. For this reason, it is thought impossible to categorize aromatherapy products as all being ‘medicines’ or ‘cosmetics’ etc. Rather the view is taken that each product will have to be considered on an individual basis with regard being given to its presentation, its stated function, the ingredients used and any claims that are made.’

during the course of their business

legislation such as the Biocides Directive

without the normal marketing autho-

may also be applicable.

rization (licensing) procedures, under

Since aromatherapists’ right to

certain conditions. One of these condi-

practice and use essential oils for a

tions is that the person carrying on the

medicinal purpose are laid down in the

business must have undertaken a con-

Medicines Act, it follows that any

sultation with a client or patient and

changes in the law governing cosmetics

made a judgement about the treatment

or other legislation does not affect aro-

required before selling or supplying

matherapists unless they become a

the remedy. The legislation therefore

manufacturer and supply to the general

allows aromatherapists to practise so

public without a personal consultation

long as the conditions in 12(1) are met,

taking place.

the treatment they provide falls within the definition of a herbal remedy and a

DIRECTIVE ON TRADITIONAL

personal consultation takes place with

HERBAL MEDICINAL PRODUCTS

the patient or client before the treatment commences.

What may well affect aromatherapists

The retail supply of aromatherapy

in the future is the fall-out from the

products does not enjoy the same

Traditional Use Directive currently in

exemptions from licensing. No medici-

draft form with the EC. This draft

MEDICINES FOR HUMAN USE (MARKETING AUTHORIZATIONS ETC.) REGULATIONS 1994 AS AMENDED AND THE MEDICINES ACT 1968

nal claims are permitted for unlicensed

Directive emerged from the European

products and the aromatherapy trade

Commission’s (EC’s) study on herbal

cannot make any references to medical

medicines, published in 1998, which

conditions, treatment or alleviation of

revealed that all member states have

adverse conditions, or correcting,

herbal medicines and each deals with

So far as aromatherapists are con-

restoring or modifying physiological

them differently. Since there should be

cerned, their right to practice and use

function. Aromatherapy products sold

mutual recognition and free trade

essential oils as medicines during the

to the general public will therefore be

across all borders, the EC’s Pharma-

course of their business is laid down in

considered under the Cosmetics (Safety)

ceutical Committee formed an Expert

Section 12 of the Medicines Act 1968.

Regulations if they are pre-blended or

Working

Section 12(1) allows a person to make,

the General Product (Safety) Regulation

Traditional Use of Herbal Medicines

sell and supply any herbal remedy

if they are pure essential oils. Other

to

0962-4562/02/$ - see front matter © 2002 Elsevier Science Ltd.

All Rights Reserved.

60

Group

regulate

this

(EWG)

on

situation.

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Medicines Control Agency (MCA) as

patients to obtain herbal remedies and

7th Amendment is concerned, it is

the UK competent authority is repre-

treatment go back to the time of Henry

expected that in addition to legislating

sented on this EWG and was responsi-

VIII and were specifically laid down by

for animal testing, it will include aller-

ble to some degree for ‘driving’ the ini-

the 1968 Medicines Act. Although

gen labelling of the 26 fragrance iso-

tial stages of discussion.

Section 12 gives exemption from licens-

lates that have been identified by the

The MCA has been consulting

ing for herbal medicines provided no

European Scientific Committee on

with industry on two formal EC drafts

medicinal claims are made, these

Cosmetic & Non-food Products as

and a third informal draft and the EC

exemptions have major weaknesses in

being responsible for most allergic

has confirmed that it proposes to

law and the MCA has been reviewing

reactions. Out of these 26 ingredients,

adopt formal proposals soon.

them since early 1999 to try to find a

16 occur naturally in essential oils.

way of safeguarding the continued

So far as implementation of the aller-

availability of herbal medicines with

gen labelling is concerned, it is under-

appropriate information about the use

stood that the Directive is unlikely to

of the product.

be completed until towards the end of

HERBAL REGISTRATION FORUM (HRF) The industry has formed the HRF to liaise with the MCA and respond collectively to proposals for the future regulatory arrangements for herbal medicines. The Forum consists of:



Aromatherapy Trade Council Ayurvedic Company of Great

It should be noted that there are

this year. Even if the regulation goes

national arrangements in place for

through on 1 January 2003, the UK

medicines in all member states.

would still have at least a year after that

Section 12(1) is firmly under the UK

in which to implement it and possibly

national government control so far as

more. The likelihood is that the prod-

one-to-one consultation is concerned.

uct will need to be labelled simply,

The MCA is reviewing the legisla-

indicating the presence of the fragrance

Britain

tion that affects individual herbalists and

allergies under the parfum section of




Ayurvedic Trade Association

aromatherapists alongside the statutory

the wording, and the wording will not




British




regulation of herbalists and will be con-

be a warning statement. However,

Association

sulting widely on this. At the moment,

none of this will affect an aromathera-

Chinese

the law does not define who can prac-

pist on a one-to-one basis.

Herbal Medicine

Medicines Suppliers

Association

tice, or any specific quality or safety




Council for Responsible Nutrition

requirement. The advantage of statutory




European Herbal Practitioners

regulation means there is a group of

Association

people defined in law who have a recog-




Health

Food

Manufacturers




PRODUCTS

The

nized degree of competence.

General

Product

Safety

It is therefore vitally important

Regulations is the legislation that

Natural Medicines Manufacturers

that the aromatherapy profession fully

relates to pure essential oils. For the

Association

supports the AOC’s move towards statu-

past 3 years or longer, the ATC have

Proprietary Association of Great

tory regulation. Geoffrey Lawler has

had correspondence with the Health &

Britain

now been officially appointed as Lay

Safety Executive (HSE) and a joint

Chairman of the Working Party and the

meeting with the British Essential Oil

Foundation for Integrated Medicine

Association (BEOA), LACOTS, the

has awarded the AOC a substantial

DTI and the ATC to try to determine if

grant to help fund the Lay Chairman.

in fact CHIP relates to aromatherapy

More information can be obtained from

products. The ATC’s recent correspon-

the AOC at PO Box 19835, London

dence with the HSE (July of last year)

SE25 6WF, Tel: ;1 (0)208 251 7912,

has not led to any definitive statement

Web site: www.aoc.uk.net

as to whether CHIP does apply and the

Association


CHIP & AROMATHERAPY

The coalition is primarily a manufacturers’ group and is important in terms of having the ‘teeth’ to bring political pressure to bear. There are concerns that if the proposals contained in the draft form a firm proposal, the resultant Directive may not cover UK needs.

HSE has suggested that in order to reach this, expert advice may be neces-

UK’S UNIQUE SITUATION

COSMETICS DIRECTIVE

Running alongside the Directive is

This relates to all pre-blended aroma-

the need to regulate the UK’s unique

therapy products, e.g. lotions, creams,

situation in Europe. The rights of

bath products, etc. So far as the

sary. Again, this does not affect aromatherapists on a one-to-one basis. For further information, please contact the ATC: www.a-t-c.org.uk

© 2002 Elsevier Science Ltd.

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