Food Law Guide - Malaysia

Malaysia Food product and safety regulation Overview 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, 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 National Pharmaceutical Control Bureau of the Ministry of Health Malaysia ("NPCB"). However, it may sometimes be difficult to determine whether a product is a "food" or a "drug". Such products are termed as 'Food-Drug Interface products'. Generally, the main criteria in deciding whether a product is regulated by the FSQD or the NPCB is 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. Malaysia Basic labelling requirements Food identification The Food Regulations 1985 (Regulations) require that, unless expressly exempt, 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. Labelling of ingredients The Regulations require that where the food consists of two (2) 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 additive must be included on the label. Where the food contains vitamins and minerals, the amount of the said vitamins and minerals must be disclosed on the label in accordance with the criteria laid down in the Regulations. Supplier details In the case of locally manufactured or packed foods, the name and business address of the local 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 foreign manufacturer or packer, or the owner of the rights of the manufacturer 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. Nutrition labelling In relation to a package of food, “Nutrition labelling” 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 fibre) 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, amongst 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 fibre 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. Malaysia Language and legibility requirements The particulars required to be set out must appear conspicuously and prominently in a label on 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 Food Regulations 1985 (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. Malaysia Country of origin labelling In the case of imported food, the Food Regulations 1985 require that the name of the country of origin of the food be included on the label. Malaysia Genetically modified foods Under the Food Regulations 1985, no person must import, prepare, sell or advertise for sale any food and 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"). Labelling Generally, these labelling 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 labelled as follows: ● 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; ● 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; ● for the purpose of paragraphs (a) and (b), in the case of single-ingredient foods, the information must appear on the principal display panel in close proximity with the name of the food and must be in not less than 10 point lettering; ● for the purpose of paragraphs (a) and (b), in the case multi-ingredient foods, the information must appear in the list of ingredients immediately following the ingredients; and ● for the purpose of paragraph (d), the statement “contains genetically modified ingredient” must be stated on the principal display panel in close proximity with the name of the food and must be in not less than 10 point lettering. Malaysia Nutrition content claims and health claims Under the Food Regulations 1985 (Regulations), claims which highlight the absence or nonaddition 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 of the relevant substance is permitted in the food. Also regulated by the Regulations are claims about the physiological role of the nutrient in the growth, development and normal functions of the body. These are termed as “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. Malaysia Mandatory warnings and advisory statements The Food Regulations 1985 (Regulations) provide that if a food contains ingredients known to cause hypersensitivity, those 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. Malaysia Trade measurement markings 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). Malaysia Product recalls Under the Food Act 1983 ("Act"), where any food is found to have contravened, or 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 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 such food if such person knows or has reason to believe that any such food imported, manufactured, packed, farmed, prepared or sold by him: ● contains substances injurious to health; ● is unfit for human consumption; or ● has been adulterated. Malaysia Food safety 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 Malaysia itself. Malaysia Advertising claims The Food Act 1983 ("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 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: ● 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; ● 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; ● 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 ● 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. It 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 place of business or residence. The Food Regulations 1985 (“Regulations”) prohibits 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: ● is not subject to specific requirements in this Regulation; ● 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 substitutions is clearly stated with equal prominence; and ● the presence or addition of the relevant substance is permitted in the food. Malaysia Credence claims The Food Regulations 1985 (Regulations) provide that no label which describes any food should include the word "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, Labelling 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 done and be considered organic. Organic claims For locally produced organic food, one must first obtain an "Organic Certificate" from the Department of Agriculture of the Ministry of Agriculture and Agro-Based Industry Malaysia for such food to be labelled 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 usage of such claims is generally not allowed by the Food Safety and Quality Division of the Ministry of Health Malaysia ("FSQD"). If one uses it, the person must ensure that the food is indeed a natural product, failure of which may result in action being taken by the FSQD for, false, misleading or deceptive labelling of the food under the Act. Malaysia Licensing and approvals requirements to import/export food Customs registration Registration with the Royal Malaysian Customs Department ("Customs") must occur when the food arrives at the Malaysian border. Usually, delay and trouble will be minimised by appointing an agent, rather than declaring personally at the border, as the agent will have all the relevant documents and information as well as an agent code, which will speed things up at the border. Naturally, this will incur cost on the part of the importer. Malaysia Import permit Whether or not an import permit is required depends on the identity of the food being imported. There is a list of food by the FSQD which contains special and additional requirements that need to be fulfilled. This list is available on the FSQD's website. Non-residents are permitted to obtain import permits. Importation of food must always be registered with the Food Safety Information System of Malaysia ("FOSIM"), which is essentially the database for importers. Import Authority Some types of food are regulated by specific authorities. For example, the DVS and the Ministry of Agriculture and Agro-Based Industry Malaysia ("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 (1) consignment and for thirty (30) days, though it can be extended to sixty (60) days upon request. Malaysia Inspection and testing of imported foods Imported foods will first be checked by the Ministry of Agriculture and Agro-Based Industry Malaysia ("MAQIS") officers or other relevant body (depending on the identity of food and the body which regulates their import/export). Upon the matching of their documents/permits with the imported food, assuming there are no further issues, that inspection by the MAQIS officers is concluded. Another round of inspection will then be completed by Royal Malaysian Customs Department ("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. They understand that the food, especially fresh food, should not be delayed too long at the border. The only way to minimise delay at the border is to ensure that the permits and documents are prepared properly and are readily available to avoid any doubts and/or suspicion on the part of the officers, where in such event further investigations will be conducted and will result in delay. Malaysia Export permits/clearances Export requirements differ depending on the product and destination country. For example, food regulated by MAQIS requires an export permit to be applied by submitting the relevant documents and registering on the online registration system called DagangNet. It is understood that export permits are much easier to obtain than import permits. Malaysia Other notifications/approvals/licences Depending on the food identity, certain foods may require additional licences or certificates before they can be imported into Malaysia. The list of such foods and any additional requirements is continuously updated on the Food Safety Information System of Malaysia ("FOSIM") website. For example, a Health Certificate from the importing country will be required for food like meat and poultry. In the event such requirements are not complied with, the consignment will be placed under Level 5 of the FOSIM and be subjected to a "Hold, Test and Release" procedure where sampling would be conducted on the consignment. Malaysia Enforcement Enforcement authorities and key responsibilities The main bodies/agencies responsible for enforcement of food related laws in Malaysia are outlined below: 1. Malaysian Quarantine & Inspection Services Section ("MAQIS") Responsibility includes enforcement of the Malaysian Quarantine and Inspection Services Act 2011. Other legislative responsibilities exist relating to inspection, quarantine and enforcement at entry points, quarantine stations and quarantine premises for plants, animals, carcasses, fish, agricultural products, soil, micro-organisms and Malaysia's imported and exported food which adheres to the requirements of human, animal, plant and fish health and food safety. Other legislation enforced by MAQIS includes: ● Plant Quarantine Act 1976 ● Animals Act 1953 ● Fisheries Act 1983 ● Federal Agricultural Marketing Authority Act 1965 ● Lembaga Kemajuan Ikan Malaysia Act 1971 ● Food Act 1985 2. Royal Malaysian Customs Department ("Customs") Responsibilities include combating all forms of smuggling and fraud so as to ensure that all laws and regulations administered by the department are fully complied with. Customs carries out the following tasks: ● prevention and seizure ● investigation ● prosecution ● intelligence 3. Department of Agriculture Develop the Agriculture Food and Soil Information Centre for planning purposes and implement development programmes for the sector. 4. Ministry of Domestic Trade, Co-operatives and Consumerism ("MDTCC") The key areas of enforcement by the MDTCC include: ● the protection of intellectual property rights ● the eradication of the exploitation of subsidised items ● the protection of consumer rights ● the monitoring of supplies and prices of goods based on the following laws and subsidiary legislations: ● Control of Supplies Act 1961; ● Hire Purchase Act 1967; ● Weights and Measures Act 1972; ● Copyright Act 1987; ● Consumer Protection Act 1999; ● Price Control and Anti-profiteering Act 2011; ● Trade Descriptions Act 2011; and ● Anti Money Laundering and Anti Terrorism Financing and Proceeds of Unlawful Activities Act 2001 5. Local Food Authorities Local food authorities in each state and territory are responsible for enforcing the relevant food laws in Malaysia. Malaysia Penalties for non-compliance Malaysian Quarantine and Inspection Services Act 2011 Section 11: Requirement for permit, licence and certificate Fine not exceeding RM100,000 or imprisonment for a term not exceeding six (6) years or both. For a second or subsequent offence, a fine not exceeding RM150,000 or imprisonment for a term not exceeding seven (7) years or both. Section 13: False permit, licence and certificate Fine not exceeding RM50,000 orimprisonment for a term not exceeding two (2) years, or both. For a second or subsequent offence; a fine not exceeding RM75,000 or imprisonment for a term not exceeding five (5) years or both. Section 14: Import of plant, animal, carcass, etc. with pests, diseases or contaminants Fine not exceeding RM100,000 or imprisonment for a term not exceeding six (6) years, or both. For a second or subsequent offence, a fine not exceeding RM150,000 or imprisonment for a term not exceeding seven (7) years or both. Section 15: Compliance with import and export conditions Fine not exceeding RM100,000 or imprisonment for a term not exceeding six (6) years, or both. For a second or subsequent offence; a fine not exceeding RM150,000 or imprisonment for a term not exceeding seven (7) years, or both. Customs Act 1967 Section 133: Making incorrect declarations and falsifying documents Fine not exceeding RM500,000 or imprisonment for a term not exceeding five (5) years, or both. Section 134: Refusing to answer questions or giving false information Fine not exceeding RM1,000 or imprisonment for a term not exceeding six (6) months, or both. Section 136: Assaulting or obstructing officers of customs and rescuing goods For a first conviction; fine not exceeding RM10,000 or imprisonment for a term not exceeding three (3) years, or both. For second or subsequent conviction; a fine not exceeding RM20,000 or imprisonment for a term not exceeding five (5) years, or both. Food Regulations 1985 Section 397: Matter forbidden on any label Fine not exceeding RM5,000 or imprisonment for a term not exceeding two (2) years. Consumer Protection Act 1999 Section 9: Misleading conduct For body corporates, fine not exceeding RM250,000. For a second or subsequent offence; a fine not exceeding RM500,000. In the case of a continuing offence, fine not exceeding RM100,000 for each day or part of a day during which the offence continues after conviction. Section 10: False or misleading representation For body corporates, fine not exceeding RM250,000. For a second or subsequent offence; a fine not exceeding RM500,000. In the case of a continuing offence, fine not exceeding RM100,000 for each day or part of a day during which the offence continues after conviction. Section 16: Demanding or accepting payment without intending to supply For body corporates, fine not exceeding RM250,000. For a second or subsequent offence; a fine not exceeding RM500,000. In the case of a continuing offence, fine not exceeding RM100,000 for each day or part of a day during which the offence continues after conviction. Food Act 1983 Section 13: Food containing substances injurious to health Fine not exceeding RM100,000 or imprisonment for a term not exceeding ten (10) years, or both. Section 13A: Food unfit for human consumption Fine not exceeding RM30,000 or imprisonment for a term not exceeding five (5) years, or both. Section 13B: Adulterated food Fine not exceeding RM20,000 or imprisonment for a term not exceeding five (5) years, or both. Section 15: Labelling, etc., not complying with standard of food Fine or imprisonment for a term not exceeding three (3) years, or both. Section 16: False labelling, etc. Fine or imprisonment for a term not exceeding three (3) years, or both. Section 17: False advertisement Fine or imprisonment for a term not exceeding three (3) years, or both.