On February 26, 2020, the European Commission (EC) published documents from a meeting held by the working group on food contact materials (FCM) of the toxicological safety section of the Standing Committee on Plants, Animals, Food and Feed (SC-PAFF). The two-day meeting on February 24-25, 2020, facilitated discussions on many developing regulatory topics related to FCMs in the EU including amendments to the plastic FCM regulation (EU) No 10/2011, phthalates in FCMs, recycling plastic FCMs, and managing newly encountered FCMs including plastics containing bamboo and corn flours.
Regarding regulation No 10/2011 on plastic FCMs, the EC published presentation slides from the meeting introducing the 15th amendment (FPF reported) to the regulation, which includes clarifications on changes to application of specific migration limits, detection limits, and testing of appliances and equipment, among others. The EC expects the amendment to enter into force in June 2020 with a six-month transition period before applying to new FCMs on the market, and a one-year transition period before applying to existing products on the market.
The group also addressed an upcoming 16th amendment to the regulation that included: presentations and discussions on wood as well as corn/bamboo flour in plastic FCMs, a possible approach to biocides, and introduction of a template for declarations of compliance (DoC). Following the updated European Food Safety Authority (EFSA) risk assessment on wood flour and fibers (FPF reported), the EC stated that the present authorization of wood based on inertness can no longer continue and that in the future plant materials must be evaluated on a case-by-case basis. Businesses would have a transition period in which they can register and apply for evaluation before products would become illegal on the market. The EC also outlined two options for addressing FCMs made with bamboo and corn flour. The first option would be that such FCMs are recognized as not being wood and therefore not be allowed the same transition period for evaluation and subsequently removed from the market. The second option would be that such plant-based flours remain under the same transition rules as wood, and enforcement would become based on migration limits or an alternative approach involving registration dossiers and evaluations.
Concerning phthalates under the 16th amendment, the group discussed: the ongoing mandate to EFSA for re-evaluation, risk management of phthalates in plastic FCMs through specific authorized uses by phthalate, potential options for grouping phthalates, and the use of allocation factors. The EC further presented the results of a survey of business operators completed in October 2019 concerning the use of phthalates in FCMs (FPF reported). The survey results reflect a small and not-representative sample size of just 35, with feedback mostly from business operators and with a lack of input from importers of FCMs. DBP (CAS 84-74-2) and DEHP (CAS 117-81-7) were identified as being the most commonly used phthalates to aid in polymerization. Phthalates according to one industry association are possibly used in flexible vinyl FCMs used for food processing, and a small number of business operators identified the use of DINP (CAS 28553-12-0) or BBP (CAS 85-68-7) together with DIBP (CAS 84-69-5) as a support agent for catalysis. The EU rubber industry also identified the use of phthalates as plasticizers and reported to be phasing out lower weight phthalates. Survey respondents identified multiple substances being used to replace phthalates following increased pressure from consumers to do so.
The use of biocides in plastic FCMs was also a topic for discussion under the 16th amendment, and the group considered the advantages and disadvantages of removing the current provisional list of additives and instead only allowing biocides approved for FCM use under the biocidal products regulation (BPR). A template-based approach for declarations of compliance (DoC) was also discussed as a way to provide a clear format for authorities and allow for a future digital approach.
Later in the meeting, the EC presented in detail on the topic of recycling plastic FCMs and the ongoing development of future legislation specifically for recycling polyethylene terephthalate (PET). Following feedback received during a consultation in November and December 2019, the EC presented updates it made to draft regulatory text related to: plastic inputs, quality assurance of sorting, monitoring contaminant levels of inputs, official controlling methods, and compliance monitoring. The EC clarified that once these regulations come into force, all relevant FCM recycling will no longer be subject to national provisions and instead must directly comply with the EU regulation. The group also discussed uncertain aspects related to managing the recycling of materials composed of layers of both virgin plastic and recycled plastic from non-food contact sources.
Going forward, the EC informed participants that in the next few weeks they will further update the draft text on recycling regulations and will consult both internally and with industry stakeholders. For the first and second quarters of 2020, the EC’s focus will remain on developing regulations related to PET recycling. In the second half of 2020, work will begin on drafting regulations for recycling FCMs made of high density polyethylene (HDPE) and for closed loop quality criteria. All other recycling processes are outside the scope of the EC’s work until 2021.
EC (February 26, 2020). “FCM Document Library.”
Luke Buxton (March 11, 2020). “New EU plastic FCM chemical restrictions expected in June.” Chemical Watch
SGS (March 24, 2020). “EU Proposes to Revise Food Contact Plastics Regulation.”