Food safety has been a topic of discussion among the packaging industry stakeholders for a while now, with everyone, from regulatory agencies to ink and substrate manufacturers to converters waking up not just to the importance of safe packaging for food items, but also its legal implications.
Packaging is a critical component which plays a crucial role in food safety process by safeguarding the products from external contaminants, tampering during transportation or any other means as much as possible. However, a lesser known fact is that the same packaging material could also be a source of chemical contaminants and hence may impact food safety as well as food quality. Among the different components of packaging material, packaging inks play a critical 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.
Changing Regulatory Landscape:
Food Safety and Standards Authority of India (FSSAI) has raised the bar on packaging safety by updating the norms on packaging materials for food wrapping. FSSAI had also redefined the food-grade concept for primary packages, regulated inks as per IS 15495, and mentioned packaging inks as a legal obligation for the packaging supply chain among other regulations.
In India, FSSAI has given the primary responsibility to food business operators to ensure that the packaging material complies with the Food Safety and Standard (Packaging) Regulations, 2018. Also, the Indian Standard IS 15495 clearly states the responsibility of the printer: “The responsibility of the printer and the converter is to ensure that the food packages are manufactured and stored in a manner by which any preventable transfer of material from the ink or coating to the food contents is avoided, even if such transfer is unobjectionable on the grounds of health, odour and flavour.”
FSSAI also defined the term “Food Grade”. The standard clearly indicates that a packaging material is to be considered food grade when the material is made of substances which are safe and suitable for their intended use, and shall not endanger human health or result in unacceptable change in the composition of the food or organoleptic characteristics. IS 15495 also in its current form re-iterates the concept of food grade.
Recently, BIS has also upgraded the IS 15495 making following amendments, which are now enforced since 1st July 2021:
• Sum of concentration levels of lead, cadmium, mercury and chromium (VI) shall not exceed 100 ppm for printing inks.
• Addition of toluene, DBP, DiNP, titanium acetylacetonate to the existing Annex A, which lists the materials and substances that needs to be excluded from printing ink formulations.
As per the amendments made, toluene will no longer be allowed to be used as a solvent in printing inks intended for food applications thus ensuring safe packaging for consumers. The group that will ultimately benefit the most are the workers in printing companies as their occupational exposure to toluene will be significantly reduced, while the risk to consumers as well as environment will also be minimized. Upholding to its strong commitment to product safety, Siegwerk India operates in a toluene free environment to rule out any possibility of any cross contamination occurring on its toluene free inks.
NT or NTNK Inks – A Marketing gimmick
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). Furthermore, residual toluene in packaging also impacts the organoleptic properties of the product thus leading to food quality and safety issues. Odour threshold varies from 0.5 –100 mg/m3(130 ppb –26 ppm) depending on the source. This level in comparison to other solvents is very low.
The unfavourable toxicological properties of toluene are the reasons why global brand owners like Nestle, Ferrero, etc. have restricted or even completely banned the usage of toluene in ink formulations intended for food packaging material of their products. For years, European market and US market have been using toluene free inks for food packaging while China has also imposed a legal ban on toluene, so that it cannot be used as a solvent in printing inks for food packaging.
In the Indian market, there is a demand for the so- called NT (Non-Toluene) inks, NTNK (Non- toluene Non Ketone) inks, etc. However, safe inks should not be misled with such terminology adopted by the market, as such inks may not be actually safe. Each printing ink consists of several chemicals (and not just one or two solvents) categorized into four general components: binder/resin, solvent, additives and pigment/colorant. By excluding single/couple of solvent like Toluene, Ketone, etc. ; one cannot assume and be assured that the inks are safe. Moreover , just for clarity Toluene is banned as per IS 15495 and not Ketones.
Let’s deploy an alternate approach to understand the marketing gimmick. For instance, let us assume you procure NT or NTNK inks from a supplier. In such a case you only have the assurance that the ink doesn’t contain toluene or ketone as the solvents. However, this doesn’t give you any assurance that the ink doesn’t contain other solvents like benzene, Monochlorobenzene ( regulated under IS 15495) , heavy metals , formaldehyde ( regulated by few brand owners) , CMR (carcinogenic, mutagenic , toxic to reproduction) category chemicals (regulated by self-commitment from ink manufacturer) . In totality, NT or NTNK inks do not give you an assurance that the inks are compliant to legal requirements, applicable brand owner requirements as well as self-commitments from a responsible ink manufacturer.
Safe inks (or migration optimized inks) are inks with careful selection of raw materials in all four categories so that none of the components of the printing ink formulations impact consumer safety. Safe inks cannot be created by substitution of one or two or three solvents. We recommend to use only Migration optimized inks for sensitive applications like Food, Pharma and Hygiene to be safe and legally compliant.
Siegwerk – Your Reliable partner to meet Ink Compliances
Siegwerk compliances are substantiated by systematic processes which give consistently safe and quality products. These include processes like Raw Material Introduction process, Formulation Guidelines and Good Manufacturing practices. It becomes very critical to choose reliable partners in this regard as final validation of packaging material is not exercised normally in the Indian packaging industry. Siegwerk has launched its Transparency label to mark its unconditional commitment to product safety.
An Ink Manufacturer responsibility begins with the proper selection of suitable raw materials for various packaging applications. Hence, Siegwerk has established a centrally coordinated process for introducing raw materials used in the ink formulations globally, which is steered from our headquarters in Germany by our global product safety and regulatory team. This Raw Material Introduction Process (RMIP) ensures that each raw material goes through a screening process based on regularly updated specifications, which in most cases are beyond the legal requirements, as they are regularly checked in spot-check testing campaigns run by the company.
The RMIP is complemented by Siegwerk’s formulation guideline, also supervised by the global Siegwerk regulatory experts team. “Like a recipe for cooking, it gives clear instructions and limitations of use to our ink formulators worldwide to safeguard compliance in whatever region we are operating.
Finally, ink formulation, manufacturing and shipment are executed on the basis of good manufacturing practices, either based on existing legislation or following the EuPIA GMP guidelines. Besides the systematic processes, it is important to collaborate with stakeholders up and down in the supply chain (printers and brand owners) and share relevant information. We provide information on potentially migrating substances present in our inks via a Statement of Composition (SoC). This allows our customers to assume their shared responsibility in the supply chain and perform the necessary risk assessment on migration and assess the legal compliance of the packaging structures they are manufacturing. These SoC’s are in line with EuPIA recommendations and are based on current regulatory frameworks.
Role of Packaging Supply chain
While ink manufacturers are responsible for and can certify in principle the suitability of an ink series for food packaging applications, they cannot warrant the legal compliance of the final printed packaging.
There are several other parameters beyond the control of ink manufacturers, such as the substrate being used, the printing and converting process, type of food packed and the storage conditions, among others. Thus, to avoid problems within the packaging supply chain arising from the use of non-suitable inks, it is important that all parties involved in the industry collaborate. The first step, to clearly define the packaging specifications, is usually the responsibility of the food industry.
Packaging manufacturers and fillers are responsible for the material selection, its permeation, scalping and food contact properties, while the ink suppliers are responsible for supplying safe ink formulations along with transparent information regarding its conversion. These principles of shared responsibility are embedded in a multitude of food contact material regulations worldwide including the European regulations for food contact materials.
For more details on FSSAI norms for packaging inks, Revized IS 15495 specifications and its implementation methodology , you can connect with us at email@example.com
About the Author:
Head – Product Safety & Regulatory,
Siegwerk India Private Limited
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