Toksikologi makanan

2. SYARAHAN
10
APPLICATION OF TOXICOLOGY
STUDY: MARDI’S EXPERIENCES IN
HERBAL RESEARCH

3. PART 1
HERBS AS TRADITIONAL
MEDICINE : MARKET
POTENTIAL AND ITS
SAFETY ISSUES

4. FOOD TECHNOLOGY RESEARCH CENTRE
(MARDI)
FOOD SCIENCE &
FOOD SAFETY
-hadijah
-noor fadilah
FOOD
PACKAGING
FOOD
PROCESSING &
PRODUCT
DEVELOPMENT

5. FOOD SCIENCE & FOOD SAFETY
RESEARCH AREAS:
FOOD ANALYSIS
HERBS – MARKER COMPOUND
DETERMINATION, TOXICITY STUDY, EFFICACY STUDY
FUNCTIONAL FOOD/INGREDIENTS – HIGH
ANTIOXIDANT JUICE
POLYSACHARIDE – RESISTANT STARCH
FOOD SAFETY – MICROBIOLOGY,
HACCP,MYCOTOXINS,
ACRYLAMIDE
NUTRITION – BABY FOOD

6. Herb and Herbal Medicine - Definition
•Herb is a general term for a plant that is small and
usually has soft fleshy stems.
•The use of herb is related to the therapeutic properties
that have been claimed from old generations- well
known for it uses as traditional herbal medicine.
•Herbal medicine is a type of medicine that uses roots,
stems, leaves, flowers, or seeds of herbs to improve
health, prevent disease, and treat illness.
•It is also known as botanical medicine, medical
herbalism, herbalogy, and phytotherapy.

7. Market Potential of herbal products
•World Health Organization (WHO) reported
-80% of the world’s population depends on
herbal medicine, so the market potential is
very huge.
•Herbal medicines continue to be a major
market in U.S. pharmacies and constitute a
multi-billion dollar industry. This is due to
strong consumer interest in preventative
medicine, disappointment with allopathic
medicine and the perception that botanicals
are safe and free from side effects.

8. •The global herbal market is valued at USD70
billion (nutraceuticals) and USD20 billion for
phytomedicines. The current estimates for this
market ranges between USD40 to 100 billion-an
average growth rate of 15-20 % annually.
•According to World Bank, the global market for
herbal products is estimated to US$200 billion
(2008) and will be achieved to US$5 trillion
(RM18.25tril) by 2050.

9. Government of Malaysia encourages :
• Alternative medicine / complementary medicine and
herbal products has the potential to be develop as a
new industry and should be explored (one of the
component in Biotech. Policy)
• Herbal industry in Malaysia is estimated to
be RM8 billion and growing at 10% per
Year. Research in herbs can tap the estimated about
RM380 bil. global pharmaceutical market (Bussines
Times, 3 January, 2006)
HERBAL SCENARIO IN MALAYSIA

10. WHO have highlighted that :
•The use of TM is increasing rapidly in developed countries.
In many parts of the world, policy-makers, health
professionals and the public are wrestling with questions
about the safety, quality, availability, preservation and further
development of this type of health care.
•Although many TM therapies have promising potential, and
are increasingly used, many of them are untested and their
use not monitored. As a result, knowledge of their potential
side-effects is limited.
•This makes identification of the safest and most effective
therapies, and promotion of their rational use more difficult.
(WHO Traditional Medicine Strategy 2002-2005)
SAFETY ISSUES

11. Adverse effects of herbs
• Contamination – heavy metals,alfatoxins
• Adulteration – other chemicals
• Actions of herb itself – toxic compounds such
as
alkaloid
• Herb-drug interaction
– Interference with anesthesia
– Interference with clinical effects of drugs
- Interference with CYP 450 (metabolism enzyme
in liver)

12. If TM is to be promoted as a source of healthcare,
efforts must be made to promote its rational use, and
identification of the safest and most effective therapies
will be crucial.’
TOXICOLOGY
TESTING
PHARMACEUTICALS/
DRUGS
GMO PRODUCTS
FOOD ADDICTIVES
HERBS/HERBAL
PRODUCTS

13. HERBS-WHY TOXICOLOGY STUDY?
•Acute renal failure is one of the most serious complications
resulting from the use of traditional remedies in Africa (Luyckx et
al. 2002).
•Some herbs used as alternative medicines also may be
hepatotoxic (Lin et al. 2003; Shad 1999).
•Antinutritional and toxic compounds are also present in many
plants (Guil et al. 1997).
•Several substances in plants express cytotoxic and show
correlation with the incidence of tumors (Ames, 1983).
•Ur-Rahman & Zaman (1989) reported that a number of highly
toxic compounds have been isolated from plants.

14. The safety study also will increase the acceptability
and commercial viability of local herbs. `We need
more research, documentation and validation’
(opening address, Minister of Health, WHAT Medicine
Conference, 28th
July 2006)
•Research to resolve safety and effectiveness issue of
herbal products in Malaysia.
•To capitalize on biodiversity (Mlsia:one of the 12
countries in the world with mega diversity) and
commercialize discoveries in health-related natural
and bio-generic drugs.
NST 18/08/2006
Our Aim

15. •Our government also support the traditional herbal
medicine is to be optimally integrated into the
Malaysian healthcare system (allocation funding of
RM1.5 mil) in order to achieve a holistic approach
towards enhancing health and the quality of life.
•Currently, 3 hospitals have been identified which are
Hospital Putrajaya, Hospital Kepala Batas (Kedah)
and Hospital Sultan Ismail (Johor).
Understanding the health benefits and the potential
toxicity of medicinal plants is very important. Although
most of the herbs have been used for many generations
and are considered safe, scientific toxicological trials are
still necessary.

19. Standard Requirements - For Marketing of Herbal
Products
•The manufacturer should meet the requirements set by most of countries
before the products can be exported. A lot of documents need to be prepared
to fulfill the requirements
Example : Common documents needed for export market (based on Phytes Biotek
Sdn Bhd experiences):
•Product Registration Certicate
•Copy of GMP Certificate
•Free Sales Certicate
•Label which complied to legal requirements
•Master Formula
•Heavy Metal Test report
•Pesticide Residues Test Report
•Microbial Limit Test Report
•Acute Toxicity test Report
•Long Term Toxicity Test Report
•Local Toxicity Test Report
•Shelf Life Studies
•Clinical Studies
•Production Flow Chart
•Product Origin Certificate/ Product Declaration Document

20. THANK
YOU
Hadijah Hassan
hadijah@mardi.gov.my
Contact:
03-89437201 – office
03-89435648 – toxicology lab
03-894@5648