GlassFibre Europe, an association of European glass fiber producers, recently published guidance on how to apply the requirements of the European Union Plastics Regulation (EU) No 10/2011 to sizing components of products used in glass fiber reinforced plastics (GFRP) intended to contact food.
By way of background, GFRP, which are composite materials made of a polymer matrix reinforced with glass fibers, were brought within the scope of the Plastics Regulation initially when it superseded the Plastics Directive and its amendments in May 2011. As a practical matter, this meant that most substances used in the manufacture of GFRP would have to comply with the positive list requirements of the Plastics Regulation (i.e., be the subject of a listing in the Union list set out in Annex I). The Plastics Regulation, however, provided a transitional period until December 31, 2015, during which time additives used in glass fiber sizing agents for GFRP were not be required to be listed.
The European Commission had considered whether to extend the transitional period for compliance of sizing components beyond January 1, 2016, but ultimately declined to do so. Thus, as of January 1, 2016, the EU shifted its manner of regulating certain components of glass reinforced plastics for food-contact applications to require that additives used in glass fiber sizing agents for GFRP be contained on the Plastics Regulation positive list.
The challenge with regulating additives in glass fiber sizing agents in this manner is that not all substances that are used as “additives in glass fiber sizing agents” are properly considered to be “additives” under the Plastics Regulation. An “additive” is defined in Article 3 of the Plastics Regulation as a substance which is intentionally added to plastics to achieve a physical or chemical effect during processing of the plastic or in the final material or article, and which is intended to be present in the final material or article. GlassFibre Europe’s guidance provides clarification on how to classify the various sizing components based on their intended technical function, and what impact the classifications have with respect to compliance obligations under the Plastics Regulation.
The guidance explains that the main glass fiber sizing components are coupling agents and film formers. Coupling agents and reactive polymers used in film formers—both of which are intended to chemically react with the plastic matrix and provide adhesion between the plastic and glass—must be contained on the Union list. Coupling agents (silanes, for example) are listed as monomers or other starting substances and reactive polymers (including polyurethanes, epoxy resins, and others) are regulated based on their starting monomers. Unreactive polymers in film formers are not capable of reacting with the plastic matrix and considered to be functionally similar to polymer production aids and other processing aids. They are not regarded as having a technical effect in the reinforced plastic and, thus, substances not listed in Annex I may be used, subject a risk assessment.
The guidance document comments that there are no particular health risks expected from use of sizing agents in food-contact applications, given the low expected levels of migration of sizings from GFRP and low consumer exposure. More information on GlassFibre Europe’s guidance, titled, “Compliance Scheme regarding products of Continuous Filament Glass Fibre (CFGF) used in Glass Fibre Reinforced Plastic (GFRP) intended to come into contact with food,” can be found on the association’s website.