. /.WORLD TRADE
ORGANIZATIONG/SPS/N/GBR/3
13 November 2002
(02-6254)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION OF EMERGENCY MEASURES
1. Member to Agreement notifying:   UNITED KINGDOM
If applicable, name of local government involved:   England
2. Agency responsible:   Food Standards Agency in Engla nd, Scotland, Wales, Northern Ireland
3. Products covered (provide tariff item number(s) as specified in national schedules
deposited with the WTO; ICS numbers should be provided in addition, where
applicable):   Any food consisting of or containing Piper methysticum  (known also as
Kava-kava of Combined Nomenclature heading 1211 90 98).
4. Regions or countries likely to be affected, to the extent relevant or practicable:
Kava-kava producing countries e.g. Fiji, Samoa, Tonga, Vanuatu.
5. Title, language  and number of pages of the notified document:  The Kava-Kava in
Food (England) Regulations 2002 (5 pages in English).
6. Description of content:   Under Section 16 of the Food Safety Act 1990, these pr oposed
Regulations will prohibit the sale, possession for sale, offer, exposure or advertisement for
sale, and the importation into England from outside the United Kingdom, of any food
consisting of, or containing, Kava–Kava (being a plant or part of a plant, or an extract fromsuch a plant, belonging to the species Piper methysticum ).  Similar Regulations will be
made in Scotland, Wales and Northern Ireland.
7. Objective and rationale:  [  X ] food safety, [   ] animal health, [   ] plant protection,
[   ] protect humans from animal/plant pest or disease, [   ]  protect territory from other
damage from pests
8. Nature of the urgent problem(s) and reason for urgent action:   Evidence has emerged
that, in rare cases, consumption of products containing Kava-kava may be associated with
liver damage.
The UK's Committee on Safety of Medicines (CSM) has reviewed a total of 68 case reports
of suspected liver toxicity associated with consumption of Kava-kava.  The severity of theliver damage suffered varies and includes abnormal liver function, jaundice, hepatitis, liver
failure and death.  In six cases the patients suffered irreversible liver failure and received
liver transplants.  Three patients died, including one who had received a transplant.
The CSM advised that there was sufficient evidence to conclude that Kava-kava is
associated with rare cases of liver toxicity that may be serious in nature.
The UK Medicines Control Agency is consulting on a proposed Order that would prohibit
the use of Kava-kava in unlicensed medicinal products.
There are also a number of food products containing Kava-kava on the market in the UK.
Currently there are no specific controls on the inclusion of Kava-kava in foods.  A number
of the case reports reviewed by the CSM concerned patients who were consuming foodG/SPS/N/GBR/3
Page 2
products containing Kava-kava as well as medicinal products containing Kava-kava.  The
advice from CSM also requires action on food uses of Kava-kava because there is no clear
understanding of the nature of the hepatotoxicity, including its mechanism.  Consequently,
the FSA is proposing to prohibit food uses of Kava-kava.
The proposed Regulations are considered necessary to protect consumers against the risk
that consumption of foods containing or consisting of Kava-kava may cause liver damage.
9. International standard, gu ideline or recommendation:
[   ] Codex Alimentarius Commission, [   ] Office International des Epizooties,
[   ] International Plant Prot ection Convention, [ X ] None
If an international standard , guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:
10. Relevant documents and language(s ) in which these are available:   The package of
consultation documents (consultation letter, draft Regulations and draft Regulatory Impact
Assessment) is available free of charge from the Food Standards Agency.  The documents
are available in English. If the Regulations become law, they will be published on thewebsite of the Stationery Office www.hmso.gov.uk .
11. Date of entry into force/period of application (as applicable):   In England, consultation
on the proposed Regulations ended on 27 September 2002.  If, after consideration of
comments received, the Food Standards Agency considers that it is necessary to bring in
the proposed legislation in order to protect public health, the Food Standards Agency's
recommendation to the Secretary of State will be that he make the Regulations as soon as
possible.  The date of entry into force is then likely to be 21 days after the Regulations aremade.
The United Kingdom's Medicines Control Agency has proposed that, for human health
reasons, the use of Kava-kava in unlicensed medicines should also be prohibited.  This
intention was notified under the TBT Agreement on 21 August 2002.  Mention is made
here for transparency.
12. Agency or authority designated to handl e comments:  [   ] National notification
authority, [ X ] National enquiry point, or address, fax number and E-mail address (if
available) of other body:
13. Texts available from:  [   ] National notification authority, [ X ]  National enquiry point,
or address, fax number and E-mail address (if available) of other body: