In June 2017, Koni Grob from the Official Food Control Authority of the Canton of Zurich, Zurich, Switzerland, published two articles presenting a proposal for a new approach to the safety control of food contact materials (FCMs) in Europe.
An article published on June 19, 2017 in the peer-reviewed journal Food Additives & Contaminants: Part A, provided a thorough review of historical developments and current status of the European system for the control of FCM safety. Due to the “lack of resources by the authorities,” it appears unrealistic to expect that all 17 types of FCMs could be covered in the near future by a legislation based on the initial concept of issuing a positive list for the substances used, implemented for example in the Plastics Regulation (EU) No 10/2011. Therefore, concluding that the current system “needs improvement” (a conclusion that is also in line with the 2016 report of the European Parliament), Grob proposes to “implement better the self-control by the producers through improved official control and more attractive listing of approved substances and materials.”
This approach has in principle already been embedded in EU legislation. For example, the Framework Regulation (EC) No 1935/2004 introduced the Declaration of Compliance (DoC), essentially becoming “a first step in shifting the emphasis from the authorities telling industry what to do towards assigning responsibility for compliance work to the business operators.” Further, the Good Manufacturing Practice (GMP) Regulation (EC) No 2023/2006 put forth as its basic concept “the systematic design and build-up of FCMs to ensure the safety of the materials used and the chemical reactions applied or occurring unintendedly.” Thus, European legislation requiring that the compliance work be carried out by the business operators and recorded in the in-house documentation and DoC is already in place.
However, so far this approach “has not been properly implemented”. According to Grob, this is “partly due to lack [of] or unsuccessful control by authorities.” To support the authorities in carrying out their control tasks, Grob proposed that “specialized document-collection centres working with dedicated tools harmonized throughout Europe be created,” that “the toxicological evaluation reported by industry […] be checked by risk-assessment authorities,” and that “effective and harmonized” measures should become available to the authorities to allow proper reaction and enforcement in case of non-compliance.
Further, to bridge the “currently large gap between the legal requirements and reality,” Grob proposed that industry should be able to submit ‘work plans’ (discussed in more detail in a 2014 publication by Grob). Provided an adequate work plan for performing the non-compliance work has been submitted, temporary status of being compliant may be issued. Grob also suggested “to encourage certified private institutes to approve compliance work, driven by the attractive listing of approved materials and exploiting market forces.” He concluded that, in the long run, “the focus of the authorities might change from evaluating the substances used and regulating migration testing to the evaluation of the compliance work performed by industry.”
A second article, published on June 1, 2017 in the Journal of Consumer Protection and Food Safety (opinion article, not peer-reviewed), discussed in detail the proposed system for listing the approved substances and materials. Grob highlighted that the present approach to the listing of the safety evaluations performed is of “little use” for manufacturers other than the petitioner, because only the substance is listed. Helpful minor changes in the present listing proposed by Grob include “adding the date of listing, the assessment body in case of national lists and a link to the EFSA [European Food Safety Authority] opinion or analogous report, if existing, that describes what the evaluation covers.”
The more major potential development may include the production of lists that cover all types of FCMs and where the listing of approved individual substances should be separated from the listing of materials, which may also cover intermediate products and final FCMs. Entries in this database may originate from petitioning process or from the official control of industry-performed compliance work. But, apart from these, “the main input might come from private bodies that are certified to evaluate according to EFSA guidance, given that these are named in the list and their approval is spot-checked by authorities,” so Grob. Since it can be expected that “many business operators prefer buying approved (listed) materials,” such lists could “become a driver for improved compliance work.”
Publication of Grob’s idea for a new approach to FCM regulation is timely. The topic is presently being discussed at the European Commission, and one possible option for a legislation to be implemented in the “Union measure on printed FCMs” has recently been made public (FPF reported).
Koni Groh (2017). “The European system for the control of the safety of food-contact materials needs restructuring: a review and outlook for discussion. ” Food Additives & Contaminants: Part A (published June 19, 2017).
Koni Grob (2017). “Listing approved substances and materials for food contact in Europe: ideas for a better use and further evolvement of the present system. A contribution for discussion.” Journal of Consumer Protection and Food Safety (published June 1, 2017).
Koni Grob (2014). “Work plans to get out of the deadlock for the safety assurance of migration from food contact materials? A proposal.” Food Control 46:312-318.