Migration From Food Packaging – A View From the Swiss Enforcement

Koni Grob

Switzerland is not a member of the European Union (EU), but is associated by various agreements. Legislation on food contact materials (FCMs) is independent, but intended to be equivalent.

Switzerland plays an active role. Recently it implemented the resolutions of the Council of Europe on silicone and printing inks into its legislation. For printing inks this means that all components used must be listed, with list A for those that have been toxicologically evaluated and list B for those not evaluated. The migration of list B substances must be below 0.01 mg/kg. The list delivered by the European Printing Ink Association (EuPIA) in summer 2009 comprised almost 6000 substances, most of which have not been evaluated. Enforcement of this legislation is expected to become a delicate issue.

Compliance of FCMs with the basic requirement that human health must not be endangered is widely considered as a work in progress; the problems associated with migration were underestimated for a long time. The turning point might have been the discovery in 1996 of bisphenol A diglycidyl ether (BADGE) in oily foods (e.g. fish in oil) from the internal coatings of tinplate cans at concentrations reaching 80 mg/kg, whereas the legal limit was 0.02 mg/kg: millions of cans were subsequently removed from the Swiss market and it was a disturbing experience that industry had no valid solution (Biedermann et al. 1996). It was just as disturbing to note that there were many more migrants, most of which have not even been identified (Grob et al. 1999). In 2004 it was detected that no lids on the market reliably respected the limits for the plasticisers migrating from the PVC gaskets into oily foods; up to 2000 mg/kg phthalate were measured in the food, which corresponded to about half a gram in the jar contents (Fankhauser-Noti et al. 2006, Grob 2008). In 2009 up to 1.5 mg/kg of di-(2-ethylhexyl) maleate was found in foods in paperboard boxes, for which no toxicological data was available (unpublished data). It was also noted that foods packed in paperboard boxes from recycled fibers contained mineral oil in quantities far beyond the tolerable limits according to the evaluation by the FAO/WHO Joint Expert Committee on Food Additives (JECFA).

Migration from FCMs might be the quantitatively largest source of food contamination. It is, for instance, 2-3 orders of magnitude higher than that from pesticides and at the same time less controlled (Grob et al. 2006). Consumers mistrusting toxicology and insisting on organic foods are not aware of this. Today, an analytical laboratory could produce a scandal every few weeks, which is an unacceptable situation for all involved: for the food industry which does not want to be in negative headlines, as well as for enforcement agencies which fail to implement the rules.

The situation is difficult also for the producers of FCMs: they should guarantee compliance, but often know little about the materials they use. The declaration they receive from their suppliers usually does not disclose the composition and nonetheless the suppliers generally refuse to take responsibility. Fundamental changes are needed to overcome these problems.

Recently the EU Commission introduced legislation insisting on production by good manufacturing practice (GMP) as required by Article 3 of Regulation 1935/2004 (and previous legislation) and requested compliance declarations as well as supporting documentation rendering compliance work traceable. It gives no detailed instructions, but provides the grounds for a promising new approach to solve several of the basic problems in this industry (Grob et al. 2009a,b, Grob and Marmiroli 2009):

• It emphasises the general requirements and moves away from the concept that specific legislation will be provided for every type of FCM. All migrants from all FCMs have to respect the basic requirements.
• All business operators in the manufacturing supply chain carry responsibility for the compliance of the final product. This means that a producer within the chain has to specify potential end uses of his product and investigate whether he can show that the substances he uses comply with the requirements for these applications. Otherwise he has to delegate the compliance work (such as the measurement of migration, investigation of impurities, reaction products and toxicological data) to his customer with clear instructions. If he does not delegate work, responsibility automatically falls on him. Confidentiality is supported unless information is needed for compliance work at later production stages.
• At each production stage, the compliance work must be documented and enforcement authorities have to check whether the arguments used to conclude compliance work were valid.

With this new approach, everyone in the manufacturing supply chain is informed about the compliance work needing to be done: it is the work regarding newly introduced substances and that delegated with the products purchased – nothing more and nothing less. Perhaps even more important: it is expected that market forces will drive towards the use of starting components with simple compliance work; the customer not only buys the product, but also the compliance work which is delegated to him. If he can get a product which does not require migration testing, this is a distinct advantage, which will favor the use of toxicologically well investigated substances of low concern. In fact, many of the present problems could be solved at early stages of the product design.

Even though the EU GMP regulation 2023/2006 has been in place since 2008, these major changes, primarily the involvement of the producers of the starting and intermediate materials, still need to be implemented. The difficulty of the system results from the protected confidentiality for the documentation supporting the declaration provided to the customer: business operators do not have to disclose to their customer on which grounds they concluded compliance work. Only the competent authorities have legal access, which means that intense control of the supporting documentation by authorities is a prerequisite to build up trust within industry.

The Swiss producers of FCM took the initiative to implement this system by information campaigns and a tool box. Coordinated with Germany and Austria, enforcement is building up the resources to collect and evaluate the many documentations belonging to a finished packaging material, most of which will be from abroad. Switzerland plays an active role on this construction site.

References

Biedermann, M, Grob, K, Bronz, M, Curcio, R, Huber, M and Lopez-Fabal, F. (1996) Bisphenol-A-Diglycidyl Ether (BADGE) in edible-oil-containing canned foods: determination by LC-LC-fluorescence detection. Mitt. Gebiete Lebensm. Hyg. 87: 547-558.

Fankhauser-Noti, A, Biedermann-Brem, S and Grob, K (2006) PVC plasticisers/additives migrating from the gaskets of metal closures into oily food: Swiss market survey June 2005. Eur. Food Res. Technol. 223: 447-453.

Grob, K, Spinner, Ch, Brunner, M and Etter, R (1999) The migration from the internal coatings of food cans; summary of the findings and call for more effective regulation of polymers in contact with foods: a review. Food Add. Contam. 16: 579-590

Grob, K (2008) Uncontrolled migration from the gaskets of lids into oily foods – and what we should learn from it. New Food 1: 48-53.

Grob, K, Biedermann, M, Scherbaum, E, Roth, M and Rieger, K (2006) Food contamination with organic materials in perspective: packaging materials as the largest and least controlled source? A view focusing on the European situation. Crit. Rev. Food Sci. Nutr. 46: 529-536.

Grob, K, Stocker, J and Colwell, R (2009a) Assurance of compliance within the production chain of food contact materials by good manufacturing practice and documentation - Part 1: legal background in Europe and compliance challenges. Food Control 20: 476-482.

Grob, K, Stocker, J and Colwell, R (2009b) Assurance of compliance within the production chain of food contact materials by good manufacturing practice and documentation - Part 2: implementation by the compliance box; call for guidelines. Food Control 20: 483-490.

Grob, K and Marmiroli, G (2009) Assurance of compliance within the production chain of food contact materials by good manufacturing practice and documentation - Part 3: lids for glass jars as an example. Food Control 20: 491-500.

Dr Koni Grob is an Analyst at the Official Food Control Authority of the Canton of Zurich, PO Box, CH-8032 Zurich, Switzerland; E-mail: koni@grob.org