In August 2020, the European Commission (EC) published an updated summary “of discussions of the Expert Working Group on Food Contact Materials (‘FCM’) on the use and placing on the market of plastic food contact materials and articles containing ground bamboo or other similar constituents.” This update is based on the discussion of the agenda point A.08 (“Bamboo as food contact material (endorsement of a common position)”) held on June 23, 2020, during the meeting of the Novel Food and Toxicological Safety of the Food Chain section of the European Commission’s (EC) Standing Committee on Plants, Animals, Food and Feed (SC PAFF).
The original summary of the EC’s discussions on this topic was published in July 2019 (FPF reported). Back then, it was concluded that the use of bamboo as an additive in plastic FCMs does not have an explicit authorization in the Regulation (EU) No 10/2011 for plastic FCMs in the EU, but bamboo additives could be potentially covered by the authorization for untreated wood flour and fibers (FCM Number 96). However, this needed further clarification because bamboo originates “from the Poaceae (grass) family, whereas wood is derived from the trunk or branches of various other families of the tree or shrub.”
Since then, the European Food Safety Authority (EFSA) has published an opinion on the FCM no. 96 (FPF reported), which concluded that currently available information supporting the authorization of wood flour and fibers (FCM Number 96) for use in plastic FCMs is “insufficient.” Therefore, the safety of constituents and migrants needs to be evaluated on a “case-by-case basis, considering beyond species also origin, processing, treatment for compatibilization with the host polymer and assessment of the low molecular weight constituents migrating into food.” According to EFSA, this conclusion “applies to other plant materials as well.”
The EC’s Expert Working Group on FCMs (WG-FCM) interpreted EFSA’s opinion as “not support[ing] the application of the existing authorization of FCM [Number] 96 to additives derived from the grass family” and therefore concluded that “no legal basis exists for the use of bamboo flour as an additive in plastics.” The WG-FCM then explicitly stated that when “additives [such as ground bamboo or bamboo flour] are used in a polymer, the resulting material is [still] a plastic” and needs to comply with the existing regulation for plastic FCMs. Therefore, the use of currently unauthorized additives would render such material non-compliant “with the compositional requirements set out in chapter II or Regulation (EU) No 10/2011” for placement on the EU market. This conclusion also applies to “other non-wood species if no species-specific authorization is provided for.”
The WG-FCM clarified that “additives from a natural origin such as bamboo in a plastic matrix may themselves constitute a low health risk.” However, health risks may arise “if the quality of those natural additives is poor, if they contain impurities or contaminants, if they contain or contribute to the formation of reaction or decomposition products which constitute a health risk, or if the material swells and thus result in adverse surface alterations.” Compatibility issues may be of particular concern, because, as EFSA’s opinion has also emphasized, “when an additive is used at high levels, it may influence the migration properties of the host plastic, also in case of other plant materials.” The EC explained that “in such cases, the material may not be fit for purpose and may lead to elevated levels of substances from the plastic, including melamine and formaldehyde, migrating into foods,” and noted that several recent studies focused on bamboo-melamine products “have shown such effects.”
Following these discussions, the WG-FCM agreed that “it is the responsibility of business operators to ensure” that bamboo-containing plastic FCMs as well as “the substances used for their production are suitable for the intended and foreseeable use of the [food contact] materials or articles.” This specifically means that, “if an article can foreseeably contain foods such as soups that are hot, liquid, and fatty, they should also be compliant when in contact with such foods and for example where necessary, tested accordingly using the correct simulants,” and “documentary evidence shall be presented to the competent authorities upon their request that support the Declaration of Compliance.”
The WG-FCM also drew attention to the fact that there have been cases where market controls have revealed some bamboo-melamine food contact products for which compliance with Regulation (EU) No 10/2011 has not been verified at all, because their manufacturers or importers did not “consider these materials as being plastic materials and articles by mistake or by lack of knowledge over the applicable legislation.” As a result, some of these products were found to leach melamine (CAS 108-78-1) or formaldehyde (CAS 50-00-0) at levels above the specific migration limits set by the legislation. For example, there are “over 50 RASFF [(Rapid Alert System for Food and Feed)] notifications concerning high levels of formaldehyde migration from such products, of which over 10% were found to be exceeding the specific migration limit by more than a factor of 10.” The WG-FCM further stated that “in certain cases, the labeling and advertising of these FCMs may also be considered misleading by enforcement authorities and therefore not in compliance with the Regulation.”
The Summary Report from the SC-PAFF’s June meeting informed that “several Member States” noted that the EC’s position “does not fully clarify how to address enforcement in practice, in particular as a potential temporary derogation could be considered, provided an application for the authorization would be received.” The EC explained that the resulting document only “establishes the common interpretation of the experts” but “cannot . . . provide a legal text that would establish such a derogation.” However, “if the market situation in several Member States would justify introducing such a derogation, that should be established in a next amendment to Regulation (EU) No 10/2011.”
References
EC (2020). “Summary Report. Standing Committee on Plants, Animals, Food and Feed. Section Novel Food and Toxicological Safety of the Food Chain. 23 June 2020.” sante.ddg2.g.5(2020)4661897 (pdf)
Read More
Emma Davies (September 3, 2020). “Bamboo not a legal additive for plastic FCMs, experts confirm.” Chemical Watch
