Research for Eunice (due 13/5)

A client (foreign manufacturer) is considering conducting consumer testing of their food products in
Malaysia. The products are not for sale and are merely samples. You may assume that the products
are not banned foods in Malaysia.

As the products will need to be imported into Malaysia, please research into the following:

 Do food products need to be registered in Malaysia?

 What is the legal framework, steps and requirements to lawfully import products intended
for consumer testing in Malaysia? What information needs to be provided?
 Is it mandatory to have the testing products fully labeled or do the regulations provide any
exemption e.g., is it possible to import them in a low quantity as “samples not for sale”, with
no need to fully label them? What is the mandatory information that has to be provided to
the consumers?

Points of Research
 Do food products need to be registered in Malaysia?

Answer:

- Yes, food products need to be registered in Malaysia to ensure safety and quality. The
registration process is overseen by the Malaysian Ministry of Health (MOH) to regulate
food products available in the market.
- There is a distinction between "foods," which are regulated by the Food Safety and Quality
Division of the Ministry of Health Malaysia ("FSQD"), and "drugs," which are regulated by
the National Pharmaceutical Regulatory Agency of the Ministry of Health Malaysia
("NPRA").
- However, it may sometimes be difficult to determine whether a product is a "food" or a
"drug." These products are termed as "Food-Drug Interface products." Generally, the main
criteria in deciding whether a product is regulated by the FSQD or the NPRA are
the ingredients used in the product. Other relevant criteria include the product's intended
use and dosage form.
-

- Overall, the registration of food products in Malaysia is a crucial step to ensure compliance
with regulations and maintain food safety standards.

Food products intended for consumer testing in Malaysia do not need to be registered with the
Ministry of Health. However, certain foods may require specific documentation like Health
Certificates, Certificates of Analysis, Licenses, or Special Approvals for importation.

Do we need to register imported food used for consumer testing?

  What is the legal framework, steps and requirements to lawfully import products intended
for consumer testing in Malaysia? What information needs to be provided?

Requirements under the Food Act 1983

s. 29 – Importation

(1) Subject to subsections (2) and (3), the importation of any food which does not comply
with the provisions of this Act or any regulation made thereunder is prohibited.
(2) Where food which is sought to be imported into Malaysia is processed food in a finished
form and if sold in Malaysia constitutes an offence relating to labelling, the food may be
imported into Malaysia for the purpose of relabelling it so that it complies with the
provisions of this Act related to labelling.
(3) Where food which is sought to be imported into Malaysia is raw or semi-processed food
and if sold in Malaysia constitutes an offence, the food may be imported into Malaysia for
the purpose of reprocessing or reconditioning it so that it complies with the provisions of
this Act.
(4) Where such food is imported into Malaysia for the purposes of relabelling, reprocessing or
reconditioning it and the food is not relabeled, reprocessed or reconditioned within three
months of the importation, the food shall be exported by the importer within a period of
two months or such other period as the Minister may determine and, where it is not so
exported, it shall be forfeited and disposed of as the Minister may direct.
(5) The Director may require the importer to relabel, reprocess or recondition the food in a
designated area under the supervision of an authorized officer to ensure that the
relabelling, reprocessing, or reconditioning of the food comply with the provisions of this
Act.
(6) The Minister may exempt any food or class of food from the provisions of this section. 1

Food Import Requirements of Malaysia

- Compliance to Food Act 1983 and its regulations
- Labelling requirements
- Other related legislations (Quarantine/ Halal certified)
- FoSIM

Food Safety and Quality Division

Food Import Activity
- Generally, the importation of food under the control of the Food Act 1983 and its
regulations are not subject to import permits (However, there are some foods which need
to have Health Certificate, Certificate of Analysis, License and Special Approval for
importation). Approval for the importation of food will be given by the Ministry of Health
(MOH) Authority Officer at the entrance through the Malaysian Food Safety Information
System (Food Safety Information System of Malaysia – FoSIM).
- Import requirement for certain type of foods

1
The Food Act 1983
 Health Certificate (HC) 1. Acid-hydroyzed vegetable protein
(HVP)
2. Shrimps and prawns, crabs and
lobsters
Certificate of Analysis (COA) 1. Cheese
2. Seaweed and seaweed product
HC & COA 1. Peanut butter
2. Honey
Groundnut
License 1. Natural mineral water and
packaged drinking water
Written Approval 1. Special purpose food (other than
Reg. 389 – 393)2

- The main objective of the control of imported food is to ensure that food imported into
the country is safe and in compliance with all the provisions of the Food Act 1983 and its
regulations. Imported food control activities carried out at the entrance of the country
include inspection and sampling of food consignments as well as enforcement activities
such as detention, retraction, rejection, prosecution, destruction of consignments in
violation of food laws.

Import authority
- Some types of food are regulated by specific authorities. For example, the DVS and the
MAQIS are in charge of regulating the import of food such as raw meat, milk and dairy
products.
- In general, the DVS is in charge of ensuring that the products originate from a country
which complies with the required standards. MAQIS on the other hand, has the
responsibility of enforcing compliance with the import requirements through the conduct
of spot-checks at the point of importation.
- In this case, an E-Permit, once issued, will be valid for one consignment and for 30 days.
This can be extended to 60 days upon request. 3

Importation of food not for sale

- The importation of food not intended for sale (not for sale) such as for personal use, gifts,
research, samples, trade exhibitions and so on must be declared in writing to the Health
Officer at the entrance involved before the clearance process is carried out.4

Flow Chart of Importation of Foods Under the Control of the Food Act 1983 and Food
Regulations 1985

2
file:///C:/Users/anila/Downloads/FOOD_IMPORT_CONTROL_IN_MALAYSIA.pdf
3
https://resourcehub.bakermckenzie.com/en/resources/asia-pacific-food-law-guide/asia-pacific/malaysia/topics/
licensing-and-approvals-requirements-to-importexport-food
4
https://fsq.otaiwebsite.com/import
 5

FOOD IMPORT CONTROL IN MALAYSIA – Food Import Control Programme (to regulate food
imports into the country)
Food Safety Information System of Malaysia (FoSIM)
- Food Import Control Programme is supported by FoSIM, a nerwork system that links up
every entry point and the Food Safety and Quality Division.
- The FoSIM system which is interfaced with the Customs Information System (SMK),
enables the enforcement officers at every point in the country to carry out continuous
monitoring of all food consignments that enter the country.
- This allows importers, forwarding agents and authorized offices to manage food
importation activities electronically.

Steps

1. To access FoSIM, all food importers or agents must register with the Ministry of Health

5
file:///C:/Users/anila/Downloads/c9851fd25e0ecd4830688dc0e6cd2cd9%20(3).pdf
 (MOH) and obtain identification number and password.
2. Importers and agents have to log on to FoSIM to give prior notice of import or make
enquiry on examination level of a particular food item.
3. For import notification, importers or agents will have to first declare their imports through
Custom Information System then log on to FoSIM and complete the notification module.
4. The import notification will be transmitted online to the authorized officers of MOH for
action which will be guided by the examination level. The final decision will be transmitted
electronically to the importers or agents and customs.

Registration of importers/agents

Inspection Levels
1. Level 1: Auto clearance
2. Document Examination
- Verify notification information
- May request for further information
- Physical inspection/examination if necessary before release
3. Monitoring Examination
- Inspection and random sampling (10% of consignment inspected)
4. Surveillance examination
- Inspection and sampling
5. Hold test and release
- Detain and sample
6. Auto rejection

Inspection and testing of imported foods

Imported foods will first be checked by MAQIS officers or another relevant body (depending on
 the identity of the foods and the body regulating their import/export). Upon the matching of their
documents/permits with the imported food, and assuming that there are no further issues, the
inspection by the MAQIS officers is concluded.

Another inspection round will then be conducted by Customs. This will be done on a random basis
rather than on every imported food. Customs is usually more lenient in terms of inspection of food
when the imported food arrives at the Malaysian border. Customs understands that the food,
especially fresh food, should not be delayed too long at the border.

The only way to minimize delay at the border is to ensure that the permits and documents are
prepared properly and are readily available to avoid giving rise to any doubts and/or suspicion on
the part of the officers, which would lead to further investigations and unavoidable delays.6

Summary of the food importation process in Malaysia

 Is it mandatory to have the testing products fully labeled or do the regulations provide any
exemption e.g., is it possible to import them in a low quantity as “samples not for sale”,
with no need to fully label them? What is the mandatory information that has to be
provided to the consumers?

Exemptions of food from labelling

1. Food that is weighed, counted or measured and packed on the retail premises in the
presence of purchaser (and is of the nature, quality quantity, origin or brand requested by
the purchaser) is exempted from the labelling requirements.
6
https://resourcehub.bakermckenzie.com/en/resources/asia-pacific-food-law-guide/asia-pacific/malaysia/topics/
licensing-and-approvals-requirements-to-importexport-food
7
 2. Perishable cooked food ready for consumption which is packed on retail premises as
requested by the purchaser (Eg. Purchased from retail premises, hawkers, takeaways, day
or night market) is also exempted from labelling requirements. 8
3. Based on the Food Act 1983, s. 29(6), the Minister may exempt any food or class of food
from the provisions of this section.

The regulations for labelling products do not typically provide exemptions for products imported
as “samples not for sale”. Products, even when imported in small quantities, are generally required
to be fully labelled with specific information. The mandatory information that must be provided to
consumers includes details like:
- Ingredient declarations
- Warnings
- Directions for use
- Other relevant safety information
It is crucial to comply with these labelling requirements to ensure consumer safety and regulatory
adherence.

8
https://www.mfca.org.my/articles/Information%20on%20Food%20Labeling%20Requirements%20in
%20Malaysia.pdf