Regulations and requirements regarding food packaging products and materials are generally intended to preserve the physical, chemical and sanitary integrity of food products
By: Mr.Utsab Choudhuri*
Unsafe food packaging indicates that human health is endangered. There is a legal obligation which cannot be verified at the time of printing/converting. It may take weeks to validate a producer’s conformity with the regulations. The legal obligation is not uniform across territories. Europe has the most advanced set of regulatory frameworks with regard to food packaging. In none of the territories is the legal obligation regarding fibre-based packaging unquestioned. Europe applies the “Plastic Implementation Measure PIM”, also for paper/board, because of the lack of an own directive. Some brand owners try to fill the gap with specific guidelines. Food incidents become public very fast. Once media becomes aware of such an incident, a fact-based discussion becomes almost impossible.
Before Packing Food, We Must Know the Following:
- Which product is to be packed?
- What is the design of the package?
- Is the food in direct contact with the packaging or not?
- Is there a “functional barrier” to protect the food?
- What is the shelf life of the product?
- What is the sensitivity of the market (by geography)?
Materials and articles shall be manufactured so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could:
- Endanger Human Health
Some of the chemicals are regulated, but people come into contact with them almost every day through packaged or processed foods. The exposure is low, but it is chronic, as many of us eat such foods throughout our lives.
Food contact materials (FCMs) are usually made of plastic, or contain a synthetic material that is in direct contact with foods. This includes coating, laminate in beverage cartons or the closures of glass jars.
The first cause for concern is that certain “known toxicants” are used legally. Plastic bottles used for carbonated drinks, for example, usually contain low levels of formaldehyde. Certain hormone production-disrupting chemicals, such as bisphenol A (BPA), tributyltin, triclosan and phthalates, can also be present.
What is a Food Contact Material?
Any material intended to come into contact with food, that is already in contact with food, or that can reasonably be expected to come into contact with food, is considered to be a food contact material (FCM). This includes packaging materials, cutlery, dishes, containers, processing machinery, cutting boards, etc. Materials and articles which are in contact with water intended for human consumption from the point at which they enter a food business premises, are also considered to be food contact materials. All FCMs can potentially contaminate food by transferring substance into it, so FCMs have to be made and used so that they don’t cause unsafe levels of contamination (FCMs also have to be used hygienically – this is a requirement of food hygiene legislation).
Migration testing for metals and alloys in contact with foodstuffs are defined as “materials in contact”, which are intended to come into contact with food (cooking utensils and tableware such as pots, cutlery, plates and cups, containers, film-sheets, etc). This term also includes those materials and objects that are in contact with water, with the exception of fixed public or private water supply.
This brings about deterioration in the organoleptic characteristics of the food and, therefore, this must be measured.
The Maximum Migration Allowance of:
a) a specific substance (e.g. from the packaging)
b) within a specific time period (e.g. within the supposed shelf life)
c) into a specific foodstuff (food simulant)
Efsa has been assigning specific migration limits (SML) to those substances where toxicological data are available. These levels are subject to continuous review and exclude damage to human health to a very high degree.
If toxicological data is not complete, the worst case is assumed. This results in a migration limit of 10 ppb (= 0.01 mg per kg food).
In no case shall migration exceed 60 mg per kg food (= 60 ppm), even if the substance does not represent any health risk (GML or OML).
Good Business and Manufacturing Practice:
- Involvement in cross-industry committees to develop a common legal understanding;
- Clear definition of the product specifications, starting from the packaged food;
- Co-operation with brand owners who might have developed their own guidelines or exclusion lists;
- Issue “Statements of Composition” where potential migratables from printing inks and coatings to be shared with customer;
- These “supporting documents” contain the chemical identity (e.g. CAS No. or PIM registration No.), the SML value and the proportion in the formulation;
- They go far beyond standard Safety Data Sheets. If necessary, disclose formulae under the protection of NDAs;
- These Statements of Composition (SoC) are an important contribution for risk assessment studies;
- A positive list is an inventory of chemical compounds from which the manufacturer of consumables selects the raw materials;
- In general, it is a challenge to keep a positive list updated and to incorporate technical innovation in a timely manner.
Typical Inventory Lists Are:
a. Swiss ordinance SR 817.023.21
b. Reach (for Europe), TSCA (for USA), DSL/NDSL (for Canada)
c. There are more than 15 inventory lists worldwide
EuPIA and the Japanese ink association have also compiled negative lists (“exclusion list”). The compliance with inventory lists can be a valuable element for additional re-assurance.
European GMP guideline 2023/2006:
“Printing inks shall be formulated and/or applied such that substances are not transferred to the food-contact side.” This (again) shares the responsibility between the process and the products part.
Food packaging products and materials are an important element in the overall effort to provide consumers worldwide with safe and nutritious food. However, packaging manufacturers must be prepared to deal with a complex global regulatory landscape, in which individual jurisdictions have adopted different regulatory frameworks for the review and approval of food packaging materials. Manufacturers seeking worldwide acceptance for their food packaging products and materials will benefit from a thorough understanding of all of the substances used in their products and materials, and a detailed analysis of the regulations and standards applicable to those substances.
Sr. Vice President, Head-Technology, DIC India Limited