Module 4. Legal requirement

Lesson 16

16.1 Introduction

Most of the packaging related regulatory initiatives are concerned to the Product quality, Public Health and Hygiene, Safety, Export Promotion, Transportation and Consumer protection.
Packaging needs to communicate clearly all the mandatory information about the product to the consumer. Wrong information given on the package could mislead the consumer. Moreover, the packaging must communicate the way to handle the package or the product. This helps in protecting the consumers from accidents that could occur while opening the pack or during disposal, as in the case of glass bottles.

The international markets are governed by various packaging rules and regulations that make it mandatory for an exporting country to abide by them. Therefore, packaging for exports should comply with global norms to match with international standards. Government of India has instituted various laws and regulations. All these legislations are classified into two types i.e. Compulsory and Voluntary Standards.

To ensure product quality and provide safety to the consumer, it is important to regulate manufacturing, distribution, marketing and retailing of packaged products. This can be achieved by mandating rules and regulations. The Government of India has formulated a number of laws pertaining to packaging in the past years. Due to the sensitive nature of food, stringent rules and regulations have been mandated to address specific issues that could arise due to faulty packaging.

16.2 Negative Effects of Plastics as Packaging Material

16.2.1 Negative health effects

Following plastics have been associated with negative health effects:
PVC (polyvinyl chloride) contains numerous toxic chemicals called adipates and Phthalates ("plasticizers"), which are used to soften brittle PVC into a more flexible form.
The World Health Organization's International Agency for Research on Cancer (IARC) has recognized the chemical used to make PVC, vinyl chloride, as a known human carcinogen.
  • Plasticizers used to make soft PVC for toys can leach out into the mouths of the children chewing on the toys. In 2006, the EU placed a ban on six types of phthalate softeners, including DEHP (diethylhexyl phthalate), used in toys. An alternative plasticizer, DINP (diisononyl phthalate) is also found to be risky.
  • PVC plastic has been used safely for more than 70 years in a variety of medical and commercial applications and humans. No reports of adverse human health effects have been reported from intravenous (IV) bags and medical tubing made with PVC.
  • Vinyl chloride monomer: The carcinogenicity of vinyl chloride monomer to humans who were exposed to very high VCM levels, routinely, for many years have been linked. Vinyl chloride is a known human carcinogen that causes a rare cancer of the liver.
  • Dioxins: The dioxin is produced as a byproduct of vinyl chloride manufacture and from incineration of waste PVC in domestic garbage
  • Dioxins are a global health threat because they persist in the environment and can travel long distances
At very low levels, dioxins have been linked to immune system suppression, reproductive disorders, a variety of cancers, and endometriosis
PS (polystyrene) is one of the toxins the EPA (Environmental Protection Agency) monitors in America's drinking water. Its production also pollutes the atmosphere, destroying the ozone layer. Some compounds leaching from Styrofoam food containers interfere with hormone functions. It's a possible human carcinogen.
Other (usually polycarbonate - PC) group that consists mainly of polycarbonates, whose primary building block is bisphenol A (BPA), a hormone disrupter that releases into food and liquid and acts like estrogen. Research in Environmental Health Perspectives finds that BPA (leached from the lining of tin cans, dental sealants and polycarbonate bottles) can increase body weight of lab animals' offspring, as well as impact hormone levels. A more recent animal study suggests that even low-level exposure to BPA results in insulin resistance, which can lead to inflammation and heart disease.

16.2.2 Negative effects on environment
  • Plastics are durable and degrade very slowly.
  • In some cases, burning plastic can release toxic fumes.
  • The manufacturing of plastics often creates large quantities of chemical pollutants.
  • Thermoplastics can be remelted and reused, and thermoset plastics can be ground up and used as filler, though the purity of the material tends to degrade with each reuse cycle.
  • To assist recycling of disposable items, the Plastic Bottle Institute of the Society of the Plastics Industry devised a now-familiar scheme to mark plastic bottles by plastic type. A recyclable plastic container using this scheme is marked with a triangle of three "chasing arrows", which encloses a number giving the plastic type i.e. Resin identification code.
  • Unfortunately, recycling plastics has proven difficult. The biggest problem with plastic recycling is that it is difficult to automate the sorting of plastic waste, and so it is labor intensive.
Recycling certain types of plastics can be unprofitable, as well, e.g. polystyrene is rarely recycled because it is usually not cost effective. These unrecyclable wastes can be disposed of in landfills, incinerated or used to produce electricity at waste-to-energy plants.

16.3 Residual Toxic Components Present in Plastics

This is a plastic era and lot many plastics are used for foods. Packaging materials are made up of polymers which are insoluble in beverages as well as pharmaceutical products and foods. Great number of substances are extracted by food such as plasticizers, pigments, catalyst, adhesives and monomers or low molecular weight, polymer/oligomers and these are hazardous and toxic for human health. Even leaching of plasticizers by liquid product from packaging material results into embrittlement of the packaging material itself. The preservatives in food/pharmaceutical are absorbed into plastic and therefore the resulting unprotected product leads to spoilage.

In case of PE bottles, the milk fat gets into plastic by absorption and it results into rancidity of the product and therefore such bottles can’t be reused. Also product and packaging material reacts with each other. Human health is affected by continuous consumption of such product which increases the level of undesirable components in blood.

Therefore, for food grade plastics, two types of limits are fixed:

1. Global migration: Includes all substances (from plastics) transferred to food i.e. sum of all mobile packaging components transferred to food. They may be toxic/non-toxic, even substances physiologically harmless and even unknown also.

2. Specific migration: Includes one or two individual, identifiable components only. For these reasons Toxicological substances and Labeled components are used.

Overall migration units are fixed at 10 mg/cm2 of the surface of the packaging material or articles in the following cases as per BIS:
  • Containers or articles which are similar to containers or which in any case may be filled to a capacity of less than 250 ml provided it is possible to calculate the surface area of contact with the food stuff.
  • Sheets, foils and other non-fillable articles for which ratio between the surface areas of the material or article and the quality of food stuffs in contact may not be calculated.
  • Rigorous scrutiny and list “Food Grade materials” is to be made. Global migration limits of 60 mg/kg of food stuff or 10 mg/cm2 is been suggested by EEC. Typical food simulating solvents suggested are water, 3% acetic acid, 50/80% ethanol, Rectified spirit or heptane. Extraction conditions are high temperature, short duration or moderate temperature and long duration.
  • India: BIS and CCFS (Central committee on Food Standards) Guide lines prepared.
  • PVC: The VC monomer content limit:1 ppm ( max).
  • PS: Styrene monomer limit: 0.2% by mass of polymer.
  • Test method specified (IS: 9845 Revised 1986): With a view to help both manufacturer and health authorities, CFTRI and IIP (Indian Institute of packaging, Bombay) have built up infrastructural facilities to assess the compatibility of plastics and also to estimate the migration.
16.3.1 Residual toxic compounds likely to be transferred to food through plastics
  • Monomers and oligomers: Polymers have very high molecular weight and hence not assimilated by the body. Monomers being small may be assimilated by the body and therefore may pose health problems.
  • Polymerization residues: There may be presence of catalysts, solvents, emulsifiers and wetting agents having low molecular weight. During film container manufacturing a variety of processing aids are added which are:
a. Antioxidants: To prevent fading of colour and prevent cracking, viz. BHA/BHT etc.

b. Antiblock agents: To avoid blocking of film i.e. when it is drawn rolled the film surfaces should not adhere to each other.

c. Antistatic agents: They are important in packaging industries, when two materials/surfaces are in contact, the electrons on the surface atoms intermingle and may move from one material to another.The nature of plastic will determine the degree to which this takes place e.g. PS is most active followed by Acrylic and PE. Friction between the materials increases movement of electrons when they are separated. Absence of antistatic agents may lead to:

1. Fire/spark hazard

2. Dust attraction and

3. Difficulty in Derolling

Presence of moisture in air causes ionization resulting into neutralized electrons. The antistatic agents absorb moisture from air.

d. Plasticizers: At lower processing temperature they avoids decomposition of polymer and modify processing characteristics like flexibility. They do these functions by acting as lubricant. They allow the molecules of plastic to slide over one another freely or by acting as a partial solvent for the resin. Plasticizers tend to ooze out during long contact or high temp and they may migrate from one plastic to another (e.g. from vinyl to PS if they are in contact). They may also leach out by solvents or by liquid product. Even some plastic becomes stiff and brittle when cold. Greatest use of plasticizers is in PVC – PVA. For e.g. Dioctyl phthalate (DOP), therefore PVC has poor resistance to oil. About 33% of DOP migrate into oil products.

e. Lubricants: Internal lubricants such as Fatty acid glycerides reduce friction between plastic molecules, and External lubricants like Montanic acid reduce friction with processing equipments.

f. Slip agents: like Silicon components helps in easy rolling/derolling of film

Many additives used, may migrate to food. Therefore limit has to be specified along with list of safe components.

However, in case of recycled materials, it is almost impossible to have migration within the prescribed unit, hence should never be used for food materials.

16.3.2 Methods of reducing migration from packaging material to food

1. Use of new migration resistant plasticizers.

2. Improvement in formulation to reduce greatly their use.

3. Surface treatment of finished plastic products to reduce plasticizer migration (U.V. light, laser radiation treatments given).

4. Plasticizers related to cancer by International Agency for Research on Cancer are:

DEHA- BIS-2-Ethyl Hexyl Adipate BBP: Butyl Phenyl Methyl or Butyl Benzyl Phthalate

DEHP- Bis-2- Ethyl Myxyl or Di-Ethyl Hexyl Phthalate

16.3.3 Factors involved in migration

1. Composition and properties of packaging materials

2. Composition and properties of food stuffs

3. Surface (plastic) to volume (food) ratio

4. Temperature conditions

5. Duration of contact

6. Influence of light

16.4 (43-A) Restriction on Advertisement

There shall be no advertisement of any food which is misleading or contravening the provisions of Prevention of Food Adulteration Act, 1954 (37 of 1954) or the rules made thereunder.
Explanation: The term 'Advertisement' means any visible representation or announcement made by means of any light, sound, smoke gas, print, electronic media, internet or website"

Test procedures that are applicable for general classes of materials or packages are available and published in standardized form. The institutions involved are:


(E) List of Approved Indian Standards Under BIS Laboratory Recognition Scheme


Last modified: Thursday, 11 October 2012, 10:00 AM