The regulation of food quality and integrity in Malaysia is governed primarily by the Food Act 1983 ("Act") and its subsidiary legislation, the most pertinent of which is the Food Regulations 1985 ("Regulations"). Compliance with the Act and the Regulations is mandatory, except in relation to
any food prepared, produced or packaged for export outside Malaysia.

The term "food" is defined broadly in the Act as including "every article manufactured, sold or represented for use as food or drink for human consumption or which enters into or is used in the composition, preparation or preservation of any food or drink and includes confectionery, chewing substances and any ingredient of such food, drink, confectionery or chewing substances."

The Regulations are very prescriptive as to what can or cannot be added to foods, and in what amounts. Additives, processing aids, vitamins, minerals, novel food substances and nutritive substances must not be added to foods unless expressly permitted under the Regulations. Where permitted, such substances may only be used in accordance with the limits expressly set by the Regulations.

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.

In addition, the Department of Veterinary Services of the Ministry of Agriculture and Agro-Based Industry Malaysia ("DVS") is empowered by the Animal Rules 1962 and regulates the importation of live animals or birds and livestock products into Malaysia.

The importation of milk and milk products is regulated by two authorities: the DVS and the Malaysian Quarantine & Inspection Services Section of the Ministry of Agriculture and Agro-Based Industry Malaysia ("MAQIS").

In general, the DVS is in charge of ensuring that the products originate from a country which complies with the required standards, whilst the MAQIS has the responsibility of enforcing compliance with the import requirements through the conduct of spot-checks at Customs.

Food identification
The Regulations require that, unless expressly exempted, every package containing food for sale must include a label containing the appropriate designation of the food or a description of the food containing the common name of its principal ingredients. In some cases, specific statements are
further required. For example, in the case of food containing beef or pork, its derivatives, or lard, the label must contain a statement as to the presence of such beef, pork, its derivatives, or lard.

Content
The Regulations require the inclusion of a statement as to the minimum net weight or volume, or the number of the contents of the package on the label. In the case of food packed in liquid, a statement of the minimum drained weight of the food must be included on the label.

Labeling of ingredients
The Regulations require that, where the food consists of two or more ingredients, other than water, food additives or added nutrients, the appropriate designation of each of those ingredients in descending order of proportion by weight and, wherever required by the Regulations, a declaration of the proportion of such ingredients, be included on the label.

Additionally, if the food contains ingredients known to cause hypersensitivity, the ingredients must be declared on the label.

Where the food contains food additives, a statement as to the presence in that food of such food additives must be included on the label.

Where the food contains vitamins and minerals, the label of the food may contain writing stating the amount of said vitamins and minerals in accordance with the criteria expressly laid down in the Regulations.

Supplier details
In the case of locally manufactured or packed foods, the name and business address of the manufacturer or packer, or the owner of the rights of manufacture or packing (or the agent
of any of them) must be included on the label.

In the case of imported food, the name and business address of the manufacturer or packer, or the owner of the rights to manufacture or pack (or the agent of any of them), and the name and business address of the importer in Malaysia and the name of the country of origin of the food must be included on the label.

In relation to a package of food, "nutrition labeling" is defined under the Regulations as meaning "a description intended to inform the customer of the nutrient content of a food." Except where expressly provided otherwise under the Regulations, the label of the food must include its nutrient content, including, but not limited to, the following:

• the amount of energy, expressed in kilocalorie (kcal) or kilojoule (kJ) or both per 100 g or 100 ml or per package if the package contains only a single portion and per serving
  as quantified on the label;
• the amount of protein, available carbohydrate (that is carbohydrate excluding dietary fiber) and fat, expressed in g per 100 g or per 100 ml (or per package if the package
  contains only a single portion) and per serving as quantified on the label; and
• on a package of ready-to-drink beverage, the amount of total sugars in the prescribed form.

The following list of information, among others, may also be included:

• the amount of vitamins and minerals in accordance with the prescribed criteria;
• the amount of cholesterol and sodium expressed in mg per 100 g or per 100 ml (or per package if the package contains only a single portion) and per serving as quantified on the
  label; and
• the amount of dietary fiber expressed in g per 100 g or per 100 ml (or per package if the package contains only a single portion) and per serving as quantified on the label.

The particulars required to be set out must appear conspicuously and prominently on the label of a food product.

Font size
The size of the letters to be used on labels may be prescribed by the Regulations in respect of certain foods. If not specifically prescribed, the following general rules are applicable:

• the font must be written in no smaller than 10-point lettering; but
• the statement of ingredients must be written in no smaller than 4-point lettering.

Position
If not expressly provided otherwise under the Regulations, the lettering for the particulars that are required to appear on a label must be so prominent in height, visual emphasis and position as to be conspicuous by comparison with any other matter appearing on the label.

Every label required by the Regulations to be borne on a package must be legibly and durably marked either on the material of the package or on material firmly or permanently attached to the package.

However, a label may be firmly placed inside a package if:

• the package is made of clear transparent material; and
• the food contained in the package: (i) is not ready for direct consumption; or (ii) in the case of food ready for direct consumption, is completely enclosed in its natural shell or pod or interior wrapper such that it has no direct contact or is not likely to come into contact with the label.

No label must appear on the extra wrapper of any food, pursuant to the Regulations.

Language
Except as otherwise provided in the Regulations, any word, statement, information or direction that is required by the Regulations to appear on the label of any package of food must:

• in the case of food produced, prepared or packaged in Malaysia, be in Bahasa Malaysia; or
• in the case of imported food, be in Bahasa Malaysia or English.

In either case, the language used may include a translation in any other language.

In the case of imported food, the Regulations require that the name of the country of origin of the food must be included on the label.

Under the Regulations, no person must import, prepare, sell or advertise for sale any food or food ingredients obtained through modern biotechnology without the prior written approval of the Deputy Director General of Health (Public Health) of the Ministry of Health Malaysia ("Director").

Labeling
Generally, these labeling requirements do not apply to food which contains, consists of or is produced from a GMO in a proportion not more than 3% of the food ingredients considered individually or food consisting of a single ingredient, provided that this presence is adventitious or technically unavoidable.

Specifically for food or ingredients known to cause hypersensitivity, the origin of food and food ingredients obtained through modern biotechnology must be stated as "gene derived from (origin)."

As for food and food ingredients obtained through modern biotechnology, they must be labeled as follows:

a) in the case of food and food ingredients that are composed of or contain genetically modified organisms, the words "genetically modified (name of the ingredient)" must appear on the label;

b) in the case of food and food ingredients that are produced from, but do not contain, genetically modified organisms, the words "produced from genetically modified (name of the ingredient)" must appear on the label;

c) for the purpose of paragraphs (a) and (b), in the case of single-ingredient foods, the information must appear on the principal display panel close to the name of the food and must be in at least 10-point lettering;

d) for the purpose of paragraphs (a) and (b), in the case of multi-ingredient foods, the information must appear in the list of ingredients immediately following the ingredients; and

e) for the purpose of paragraph (d), the statement "contains genetically modified ingredient" must be stated on the principal display panel close to the name of the food and must be in at least 10-point lettering.

Under the Regulations, claims which highlight the absence or non-addition of a particular substance in or to food may be included on the label provided that the claims are able to be substantiated, are not misleading and the substance:

• is not subject to specific requirements in the Regulations;
• is one which consumers would normally expect to find in the food;
• has not been substituted by another substance giving the food equivalent characteristics unless the nature of the substitution is clearly stated with equal prominence; and
• the presence or addition is permitted in the food.

Claims about the physiological role of the nutrient in the growth, development and normal functions of the body are also regulated by the Regulations. These are termed "nutrient function claims," and they must not imply or include any statement to the effect that the nutrient would afford a cure or treatment for or protection from a disease. The Regulations are further prescriptive as to what nutrient function claims may be made, and even then, such claims may only be made in relation to specific prescribed nutrients.

The Regulations provide that if a food contains ingredients known to cause hypersensitivity, the ingredients must be declared on the label. Specific foods or ingredients known to cause hypersensitivity are prescribed in the Regulations and include:

• cereal containing gluten including wheat, rye, barley and oat;
• nut and nut products including peanut and soybean;
• fish and fish products;
• milk and milk products (including lactose); and
• egg and egg products.

Where the food contains beef or pork, or its derivatives, or lard, a statement as to the presence of beef or pork, or its derivatives or lard, in the prescribed form must be included on the label.

Pursuant to the Weights and Measures Act 1972, the only units of measurement which may be used are those prescribed in the National Measurement System Act 2007. Generally, these are units accepted internationally for use with the International System of Units (SI).

Under the Act, where any food is found to have contravened, or is reasonably suspected to have contravened, any provision of the Act or any regulations made under the Act, the Director or any officer authorized by the Director may, by notice in writing, order that the food be recalled, removed
or withdrawn from sale from any food premises within such time as may be specified in the notice.

The Act also imposes a duty on any person who prepares, packages, labels, advertises or sells any food to recall, remove or withdraw from sale any food if such person knows or has reason to believe that any such food imported, manufactured, packed, farmed, prepared or sold by him/her:

• contains substances injurious to health;
• is unfit for human consumption; or
• has been adulterated.

There is currently no mandatory reporting regime for the reporting of illness or injury caused by the use or foreseeable misuse of foods. This is an entirely voluntary act and such reporting may be made to the Food Safety and Quality Division of the Ministry of Health Malaysia, State Health Department, or directly to the Ministry of Health itself.

The Act prohibits any person who, for the purpose of affecting or promoting the sale of any food, publishes or causes to be published, either on his/her own account or as an agent, any advertisement likely to cause any person to believe that it relates to such food, or to any ingredient or constituent thereof, which:

(a) directly or indirectly qualifies or is inconsistent with or contrary to any particulars required by the regulations made under the Act to be marked on or attached to such food or marked on or attached to any package containing such food;

(b) is prohibited by any such regulations from being marked on or attached to such food or marked on or attached to any package containing such food;

(c) omits from the name or description of any food any word or words required by regulations made under the Act to be included in the name or description marked on or attached to such food or marked on or attached to any package containing such food; or

(d) is likely to deceive a purchaser with regard to the character, nature, value, substance, quality, strength, purity, composition, merit or safety, weight, proportion, origin, age or effects of any food or of any ingredient or constituent thereof.

The Act also prohibits any person from publishing any advertisement which does not contain a statement setting forth the true name of the person by whom or on whose behalf the advertisement is published and the address of his/her place of business or residence.

The Regulations prohibit any claims which highlight the absence or non-addition of a particular substance in or to food, unless the claims are not misleading and the substance:

(a) is not subject to specific requirements in this Regulation;

(b) is one which consumers would normally expect to find in the food;

(c) has not been substituted by another substance giving the food equivalent characteristics unless the nature of the substitutions is clearly stated with equal prominence; and

(d) the presence or addition is permitted in the food.

The Regulations provide that food labels should not include the words "organic," "biological," "ecological," "biodynamic" or any other words of the same significance unless the food conforms to the requirements specified in the Malaysian Standards MS 1529: The Production, Processing, Labeling and Marketing of Plant-Based Organically Produced Foods. This standard contains provisions and requirements in practice for organically produced products and the type of food treatments that can be carried out and be considered organic.

Organic claims
For locally produced organic food, an "Organic Certificate" must first be obtained from the Department of Agriculture of the Ministry of Agriculture and Agro-Based Industry Malaysia for such food to be labeled as "organic." If the food is imported, the Organic Alliance of Malaysia has the mandate to determine whether the food is organically produced.

Natural claims
There is no legislation or guidelines in place that govern natural claims for food. Nevertheless, in practice, the use of such claims is generally not allowed by the FSQD. If a person makes a "natural" claim, he/she must ensure that the food is actually a natural product; failure to do this may result in action being taken by the FSQD for false, misleading or deceptive labeling of the food under the Act.

While there are no laws or guidelines, either voluntary or mandatory, which regulate the front of pack labeling scheme with respect to health ratings, please note that Regulation 18(1) provides that no descriptive matter appearing on or attached to or supplied with any package of food shall include
any comment on, reference to or explanation of any statement or label required by these Regulations to be borne on any package of food if such comment, reference, or explanation, either directly or by implication, contradicts, qualifies or modifies the statement or the content of that label.

As such, the inclusion of foreign health rating scheme logos on the products imported into Malaysia may contravene Regulation 18 by indirectly qualifying, modifying or contradicting nutrition content on the label, as the foreign health rating scheme may imply that the product has a higher nutrition content than its actual nutrition content stated on the label.

Several amendments were recently introduced to the Regulations. In particular:

1. Food (Amendment) Regulations 2016 ("Amendment No. 1")
The key changes in Amendment No. 1 are as follows:

• The insertion of compounded hard liquor into the Regulations. Compounded hard liquor is defined as any alcoholic beverage, apart from those prescribed in regulations 377 to 384, with a blend of two or more types of spirits containing added ethyl alcohol of agricultural origin or distillates of agricultural origins and equal to or greater than 32.5% volume per volume of alcohol.
• The revision of the general standards for alcoholic beverages. Particularly, alcoholic beverages are to be labeled with the words "MEMINUM ARAK BOLEH MEMBAHAYAKAN KESIHATAN" (Translation: Drinking alcoholic beverages can endanger your health) and similar notices have to be placed at locations where alcoholic beverages are offered for sale. Furthermore, the age limit of the person to whom alcoholic beverages can legally be sold has been increased from 18 to 21 and sellers are required to conspicuously display a sign on the prohibition of sale of alcoholic beverages to anyone under the age of 21.

Amendment No. 1 came into effect on 1 December 2017.

2. Food (Amendment) (No. 2) Regulations 2016 ("Amendment No. 2")
Amendment No. 2 expands the permitted food additives to include those permitted in the Codex Alimentarius. Prior to Amendment No. 2, only the preservatives permitted under the Sixth Schedule could be added into food. Amendment No. 2 came into force on 1 September 2016.

3. Food (Amendment) (No. 2) Regulations 2017 ("Amendment No. 2 2017")
Amendment No. 2 2017 has amended the Regulations, among others, to broaden the type of incidental constituent, which may be permitted to be found in food, to include those specified in the Codex Alimentarius. This change came into force on 15 April 2017.

4. Food (Amendment) (No. 4) Regulations 2017 ("Amendment No. 4")
Amendment No. 4 came into force on 1 December 2017, and has amended the Regulations to facilitate enforcement as follows:

• an authorized officer now has the additional option of delivering samples to an analyst for microbiological, physical or chemical analysis through registered mail or by courier services, provided that the officer obtains an acknowledgement of receipt for the delivery. Under the previous provisions, an officer must deliver samples to an analyst for physical and chemical analysis, personally by hand; and
• the general penalty for contravening the Regulations has doubled from RM 5,000 (approx. USD 1,200) to RM 10,000 (approx. USD 2,400).

5. Food (Compounding of Offenses) Regulations 2017
Effective since 1 December 2017, certain offenses under the Regulations may now be compounded if the Public Prosecutor gives his or her written consent in a prescribed form.