Food Packaging regulation in India,
China & South East Asia
Learn how food packaging issues are handled in India, China and many different countrys in South East Asia like Indonesia, Malaysia, Philippines, Singapore, Thailand, Vietnam and Japan. Our ePapers contain detailed country-specific information.
In India, the Food Safety and Standards Authority of India (FSSAI) is responsible for protecting and promoting public health through the regulation and supervision of food safety. FSSAI has been established under the Food Safety and Standards Act, 2006.
The FSSAI has raised the bar on packaging safety by introducing Food Safety and Standards (Packaging) Regulations 2018, which came into force on 1st July 2019. The regulation has made brand owners responsible to ensure that packaging materials are manufactured accordingly and it prescribes that any material which comes into direct contact (or likely to come in contact) with food shall be of food grade quality, when it is used for packaging, preparation, storing, wrapping, transportation, sale or service of food. In this new regulation, food grade means material, that is made of substances which are safe and suitable for their intended use and which do not endanger human health or result in an unacceptable change of the composition or the organoleptic characteristics of the food. The regulation lays down specific requirements for food packaging including plastics, glass, metal, paper and board. As per the new regulation, printing inks for the use on food packages shall conform to IS:15495. Furthermore, the printed surface of packaging material shall not come into direct contact with food products.
As per the new norms specified by the FSSAI, printing inks for the use on food packaging shall conform to the Indian Standard IS:15495 "Printing Ink for food packaging – Code of practice”. The standard differentiates between four categories of packaging applications and gives guidance on the formulation of the respective inks:
- Printing inks on external food packaging: They can be formulated freely, but must not contain substances from the exclusion list or contain toxic substances.
- Printing inks on Immediate Food Wrappings: Those must be applied to the outside of the food wrapper, comply with the exclusion list and must not contain toxic substances. Inks have to be printed in such a manner as to avoid set-off. The final intended articles need to be manufactured, that under normal or foreseeable condition of use, they shall not transfer their constituents to the food in quantities, which may endanger human health, cause a deterioration in the organoleptic characteristics or an unacceptable change in the nature, substance and/or quality of the food.
- Printing inks for direct food contact: They must be formulated only with food additives under the appropriate regulation of the Government of India.
- Printing inks for disposables (e.g. paper plates, drinking straws or table napkins): Those inks must not contain substances from the exclusion list or those, which are otherwise known to be toxic. Furthermore, they shall be formulated to avoid bleeding onto the food.
Toluene (methylbenzene) is an aromatic hydrocarbon (C6H5CH3; CAS 108-88-3), which is a colorless, flammable liquid. Toluene occurs naturally in crude oil and in the tolu tree. It is produced in the process of making gasoline and other fuels from crude oil and in making coke from coal. Toluene is used as an industrial solvent, in aircraft and motor fuels and in making paints, paint thinners, fingernail polish, lacquers, adhesives, and rubber as well as in some printing and leather tanning processes. Furthermore, it is being widely used as solvent in printing inks, including for those in food packaging materials.
Toxicological profile of Toluene
Toluene has earned disrepute globally for its bad toxicological profile. The manifold adverse effects make it an issue related to consumer safety, occupational safety and environmental safety. Due to its developmental toxicity toluene is classified as CMR category 2 (suspected of damaging the unborn child). Moreover, residual toluene in packaging also impacts the organoleptic properties of the product thus leading to food quality and legal issues. Toluene is also known to be (mis)used as a sniffing drug and the practice is widespread among children and adolescents globally.
Toluene ban at Siegwerk and at Brand Owners
Therefore, Siegwerk already committed globally many years ago not to manufacture any inks for NPH (“Nutrition, Pharma and Hygiene”) packaging applications with toluene as intentionally added substance. Moreover, Siegwerk India committed in November 2017 the non-use of toluene in its complete manufacturing facility.
The unfavorable toxicological properties of toluene is the reason why global brand owners like Ferrero, Mars/Wrigley’s, Nestlé, Perfetti etc. have restricted or even completely banned the usage of toluene in ink formulations intended for food packaging material of their products.
Ban of Toluene and other hazardous substances in India
In India, the BIS (Bureau of Indian Standards) finally published the revision of the Indian Standard IS 15945 in July 2020. The committee, which is responsible for the development of the standard, has reviewed it in regard to the overall impact of constituent chemicals in ink formulations. This included considerations about their reported toxicological profile, their hazardous to the environment and health of human being and the possible contamination of food products, which are being packed in the printed packages.
The committee decided to revise this standard by incorporating the ban of toluene under the “solvents” category and additionally phthalates (di-n-butylphthalate, di-isononyl phthalate) under “plasticizers” and titanium acetylacetonate under the “various compounds” category in Annex A of the exclusion list:
The new China National Standard GB 4806.1-2016 (“General Safety Requirements of Food Contact Materials and Articles”) applies to all FCM's and came into force on October 19th, 2017. In the corresponding articles, this standard establishes, amongst others, some specific requirements.
In Article 3 the following basic requirements are specified:
- No harm to human health
- No changes to food properties (e.g. composition, structure, color, taste or odor)
- No technical function in food
- Dosage of substances in FCM’s as low as possible
Furthermore a functional barrier layer concept is established. This means that a barrier of one or more layers of materials in FCM’s should be used in order to prevent the migration of substances into the food behind it. The use of unlisted substances will be possible as long as there is no direct food contact, an effective barrier available and the migration is ≤ 0.01 mg/kg (or 10 ppb). Furthermore the unlisted substance must not be classified as carcinogenic, mutagenic or toxic to reproduction (CMR) or is to be considered as a nanomaterial. The manufacturer has to comply with these restrictions by performing corresponding risk assessments and controls. Finally the production of FCM’s should comply with the requirements of the “General Hygienic Standard” GB 31603-2015.
Subordinated to the GB 4806.1-2016 are:
- The amended China National Standard GB 9685-2016 (“Standard for Uses of Additives in Food Contact Materials and Articles“)
- Various “Product Standards” (GB 4806.2 – 4806.11)
- Various “Test Method Standards” (GB 31604.1 – 31604.49)
The most important part of the amended GB 9685-2016 is the Appendix A (“Permissible Additives in Food Contact Materials & Articles and Requirements for Uses”), with a positive list of permissible additives for FCM’s. These are subdivided to seven different tables, depending on their scope of use to specific types of materials (Tables A.1 – A.7). For many of them, maximum usage levels (QM’s) per type of material are fixed, partly based on the European Regulation (EU) No 10/2011, and many are restricted by Specific Migration Limits (SML’s), that are predominantly identical to those in Europe. In the amended version the number of additives increased from 958 (GB 9685-2008) to 1294 (GB 9685-2016), but in Table A.4, which is relevant for printing inks, the number of additives decreased from 193 to 189. In regard to the huge variety of FCM’s and their specific uses, it will be impossible to cover the wide range of requirements with only these 189 additives. Thus, this list must be considered as incomplete.
Based on government announcements of the National Health and Family Planning Commission (NHFPC), it is known, that several new National Standards are planned, including one for printing inks. The announcement NHFPC  No. 1358 from end of 2016 mentioned, that the intention of drafting a specific ink standard has been approved now, hence this new regulation is expected within the next 2 years.
Food packaging materials in Hong Kong are currently not required to comply with Chinese food law. Food contact materials are regulated in a shared responsibility of the Food and Environmental Hygiene Department (FEHD) and the Customs and Excise Department (C&ED).
The basic food law in Hong Kong is laid down in Part V of the Public Health and Municipal Services Ordinance (Chap. 132). It stipulates that all food for sale in Hong Kong must be fit for human consumption. The migration of packaging components that may render food injurious to health is prohibited.
Under the “Act Governing Food Sanitation”, Art. 13 states: Food utensils, food containers, food packaging or food cleansers under any of the following circumstances shall not be manufactured, sold, imported, exported or used:
- those that are toxic;
- those that tend to cause unfavorable chemical reactions; or
- those that are otherwise harmful to health.
The related “Sanitation Standard for Food Utensils, Containers and Packages” provides migration limits (overall migration and SMLs) for food contact materials. In particular, some plasticizers for plastics, which are also usable or used in printing inks, are restricted with the same SMLs as in Regulation (EU) No 10/2011.
BPOM’s (Indonesia Food and Drugs Administration) regulation number HK.03.1.23.07.11.6664 Year 2011 on Food Packaging Supervision, Annex 1, chapter 1.2 specifically restricts the formulation of packaging inks and varnishes. It is an exclusion list of toxic substances (i.e. colorants, stabilizers, solvents), which is of course met by Siegwerk’s inks as they have long been compliant with the more stringent and comprehensive substance bans of the EuPIA Exclusion Policy. This regulation number also provides positive lists of authorized substances for plastics and several other food contact materials, but not for printing inks. Moreover it lays down maximum permissible amounts of extractives for the specific food contact material which are equivalent to those applicable in the USA and (as an overall migration limit) in the EU. Furthermore, the regulation contains a positive list for additives for food packaging as well as some specific migration limits with the respective migration test methods. These limits are only valid for the packaging materials, but not including the effect of printing inks. However, some printing ink components are included in the positive list because they are also used as additives for food packaging.
Regulation number 16 Year 2014 about the change of Regulation Number HK.03.1.23.07.11.6664 added migration test procedures by using food simulants but didn't change anything in regard to the corresponding negative or positive lists.
Based on the Food Act of 1983, Packages for Food are regulated in Part VI of the "Food Regulations 1985". In particular, point 27 “Use of harmful packages prohibited”, bans any package “which yields or could yield to its contents, any toxic, injurious or tainting substance, or which contributes to the deterioration of the food”. A new Draft Regulation 27B (amending the 1985 Food Regulations) was notified to the WTO in March 2015. This draft has been revised subsequently and based on the latest draft received from the authority, it includes migration limits for certain metals and other substances (22 substances, including Formaldehyde, Phthalates, epoxidized Soybean Oil and Tri-n-butyl acetyl citrate (ATBC)) from plastic food contact materials and articles that come into contact with food.
Food safety in the Philippines is regulated by the Republic Act No. 10611 (an act to strengthen the food safety regulatory system in the country to protect consumer health and facilitate market access of local foods and food products, and for other purposes), shortly known as the "Food Safety Act of 2013". In Section 18 a) it is stated that “The DOH (Department of Health) shall ensure the safety of all food processing and product packaging activities.” Packaging components that may become part of the food are regarded as food additives and regulated by Bureau Circular No. 2006-016 (Updated List of Food Additives). This list contains several tables of permitted food additives with maximum allowed amounts in different food categories.
The "Food Regulations" are based on Chapter 283, Section 56 (1) of the "Sale of Food Act". Part III, section 37 deals with "Containers for food". In addition to providing limits for the vinyl chloride monomer, this section prohibits “any package or container” which “yields, or is likely to yield, to its contents any compounds known to be carcinogenic, mutagenic or teratogenic or any other poisonous or injurious substance”.
Food packaging in Thailand is regulated by the Food Act, B.E. 2522 (1979). Section 26 of the "Food Act B.E. 2522" states:
“Food of the following description shall be deemed impure;
(1) Food which contains anything likely to be dangerous to health […]
(5) Food in containers made of materials which are likely to be dangerous to health.”
According to the Ministerial Notification No 92, B.E. 2528 (1985), food containers must be clean and free of germs, must not emit any heavy metals or other substances that contaminate food at levels that may be harmful to health and must not emit any color to food.
In 2005, the Ministry of Public Health released the Notification No. 295 B.E. 2548 (2005) on qualities or standards for containers made from plastic. In addition to the requirements of the above mentioned Notification from 1985, there are some content and extraction limit requirements for different types of plastic materials and containers.
Furthermore, there are several standards proposed by the Thai Industrial Standards Institute (TISI) regarding packaging material. As example, the TISI 1069-2549 (Colorants for plastics for food contact use) which sets similar limits as the Council of Europe Resolution AP (89) 1. Nevertheless, these standards are voluntary; merely the standard of Sterile pharmaceutical product is a compulsory standard.
The Law on Food Safety (Law No. 55/2010/QH12) is the framework guidance for food safety and came into force on 1st of July 2011. It specifies the rights and obligations of organizations and individuals in respect to food safety. Responsibilities for testing and enforcement of food safety are divided amongst the Ministries of Agriculture and Rural Development (MARD), Health (MOH) and Industry and Trade (MOIT). Article 18 of this law stated, that food packaging and containers must meet the following requirements:
- Made of safe materials, do not release toxic substances, do not change the flavor and the taste of the food, ensure the quality of food within its use expiry date
- Conform with the relevant technical regulations
In Vietnam, prior market registration of the regulatory conformity declaration with competent state agencies is mandatory. The use of food packaging and containers is only allowed upon completion of this registration. With regard to the technical regulations, the Ministry of Health has released four national regulations (QCVN 12-1(2,3):2011/BYT and QCVN 12-4:2015/BYT) for different types of packaging material in direct contact with food.
As a general requirement for all types of packaging covered in this regulation it specifies the maximum limit of heavy metals (lead and cadmium) in the packaging. Furthermore it sets different migration limits and maximum limits for certain substances based on the nature of the synthetic resins.
Under the Food Sanitation Law, Chapter III “Apparatus and Containers and Packaging”, Article 16, the inertness of food packaging must be ensured. Packaging which contains or “is covered” with toxic or harmful substances and involves a risk for human health, and food contact materials that “have a harmful effect on food” and involve a risk for human health, are banned. The Japanese Printing Ink Manufacturers Association (JPIMA) has issued the Voluntary Regulations Concerning Printing Inks (Negative List ("NL")). Actually, Japan's Ministry of Health, Labour and Welfare is discussing the introduction of a positive list system in 2020.