Printing Inks are based on a complex formulation of various raw materials such as binder, pigment, solvents and additives. Pigment is the “HEART” of any ink formulation as this is the key raw material that imparts color to the printed image in any packaging material; and thereby initiates the visual communication with the consumers. However, unfortunately, pigment is one of the major sources of unwanted migrants those have to be purified by carefully optimizing the pigment manufacturing process and their formulations.
Pigments are one of the most expensive raw material utilized in a printing ink formula. The Global Organic Pigment Market is projected to reach a value of over USD 4.97 billion by 2027 at a CAGR of around 4.6%.
Drivers & Challenges Market Driver:
The packaging is an essential tool utilized by the food business operators to differentiate the products from others. Beyond shelf appeal, packaging also provides protection to the products form physical, chemical, and microbiological hazards. Packaging materials can be a source of chemical contamination and may impact food safety and food quality. Among the different components of packaging material, packaging inks play a vital role as they might hamper product and consumer safety. Each packaging ink is a mixture of different chemicals and some of these chemicals might be harmful while holding the potential to migrate to the foodstuff when getting in contact. In terms of risk, the chemicals could be toxic, carcinogenic, mutagenic, repro-toxic and even endocrine disruptors. The government has imposed stringent regulations to protect consumers from the harmful effects of printing ink used. Thus, growing stringent regulation to use organic pigments had expected to boost the market growth.
Inorganic Pigments are cheaper to produce, especially large quantities of production due to it has a relatively simple chemical reaction. While organic pigments require a great deal of chemical processing to produce, especially for synthetic organic pigments, thus it is expensive to manufacture in a large amount. Thus, organic pigments are more expensive than inorganic pigments which may be one of the factor restraining the growth of market.
Pigments are one of the most crucial ingredients of the food contact materials that should be toxicologically evaluated prior use in the manufacturing of food packaging materials.
Indian Standard IS 15495:2020
The Bureau of Indian Standards (BIS) has issued IS 15495:2020 which contains a “code of practice” for printed food packaging and “establishes guidelines on how food contact packaging and wrappings are to be used, specifying the responsibilities of the printers of packaging materials and the food industry packing their products. The draft excluded few colorants to be used in the formulation of printing inks for food packaging.
Pigments and compounds based on antimony, cadmium, arsenic, chromium (VI), lead, mercury and selenium;
Dye colorants such as auramine (basic yellow 2), chrysoidine (basic orange 2), cresylene brown (basic brown 4), fuchsine (basic violet 14), and induline (solvent blue 7), as well as “azo dyes which can decompose in the body to bioavailable aromatic amines that are classified as category 1 or 2 carcinogens”;
Swiss Printing Inks Ordinance
Switzerland is currently the only European country with specific legislation that regulates food packaging inks. The requirements for pigments and fillers in printing inks are set out in Articles 33, 34 and 35.
Resolutions of the Council of Europe AP(89) 1
The use of colorants is not yet regulated by a dedicated EU Directive or Regulation. In preparation for a common regulation, the Council of Europe adopted Resolution AP(89) 1 containing purity requirements for colorants in plastic materials intended to come into contact with foodstuffs. It suggests that all colorants used in the manufacture of packaging inks have to comply with the specifications of the Council of Europe Resolution AP (89)1.
The EuPIA exclusion policy for printing inks and related products (current edition) explicitly excluded Dye/colorants Auramine (Basic Yellow 2 CI 41000), Chrysoidine (Basic Orange 2 CI 11270), Fuchsine (Basic Violet 14 CI 42510), Induline (Solvent Blue 7 CI 50400), Cresylene Brown (Basic Brown 4 CI 21010) and Other soluble azo dyes which can decompose in the body to bio-available carcinogenic aromatic amines of Category 1A and 1B according to the CLP Regulation (EC) No.1272/2008 for intentional use.
A list of carcinogenic primary aromatic amines along with their CAS numbers is provided in the REACH Regulation (EC) No 1907/2006, which are produced by reductive cleavage of one or more azo groups present in the azo dyes. These should not be used in the ink formulations.
REGULATIONS FOLLOWED BY OTHER COUNTRIES
The Food and Drug Administration in United States (US FDA) regulates color in cosmetics, medical devices, drugs, and food (including food additives in food packaging and articles). However, the USFDA does not approve printing inks or any other specific products for direct or indirect food contact. In the event of migration, any component of printing ink or coating e.g. colorants etc. may potentially become an indirect food additive and would be regulated under 21 CFR 170-190. Detailed regulatory information for colorants for polymers will be found in § 178.3297.
In Japan, the use of printing inks for food packaging is restricted by a negative list, which is produced by the Japan Printing Ink Makers Association (JPIMA). In China, there is a positive list available such GB9685-2008. The Australian regulation practically requires that the colorant product should fulfill the purity criteria of the CoE Resolution AP (89)1 and the additives should be listed in Regulation (EU) No. 10/2011.
MAJOR MIGRANTS PRESENT IN THE PIGMENTS
Unsulfonated primary aromatic amines (unsulfonated PAA’s) are particularly be evaluated for Pigment Yellows, pigment reds and pigment oranges. For sulfonated primary aromatic amines (sulfonated PAA’s) will be of particular interest for pigment Reds such as PR48:1, PR48:2, PR 49:1, PR 49:2, PR 53:1 & PR 57:1; and pigment orange such as PO46. Polychlorinated biphenyls (PCB’s) can be evaluated in most of the pigment variants for flexible packaging inks. Hexachlorobenzene (HCB’s), Dioxins, and furans can be determined for Pigment pthalo Blues, green and violets. 4-Nitro biphenyls are of prime importance for pthalocyanines.