Review and priority setting for substances that are listed without a specific migration limit in Table 1 of Annex 1 of Regulation 10/2011 on plastic materials and articles intended to come into contact with food

Abstract

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids ( CEP ) was requested by the European Commission to review the substances for which a Specific Migration Limit ( SML ) is not assigned in Regulation ( EU ) No 10/2011. These substances had been covered by the Generic SML of 60 mg/kg food, but with Regulation ( EU ) 2016/1416 it was removed, necessitating their re‐examination. EFSA was requested to identify those substances requiring an SML to ensure the authorisation is sufficiently protective to health, grouping them in high, medium and low priority to serve as the basis for future re‐evaluations of individual substances. The CEP Panel established a stepwise procedure. This took into account existing hazard assessments for each substance on carcinogenicity/mutagenicity/reprotoxicity ( CMR ), bioaccumulation and endocrine disruptor ( ED ) properties along with the use of in silico generated predictions on genotoxicity. Molecular weights and boiling points were considered with regard to their effect on potential consumer exposure. This prioritisation procedure was applied to a total of 451 substances, from which 78 substances were eliminated at the outset, as they had previously been evaluated by EFSA as food contact substances. For 89 substances, the Panel concluded that a migration limit should not be needed. These are in the lists 0 and 1 of the Scientific Committee for Food ( SCF ), defined as substances for which an Acceptable Daily Intake ( ADI ) does not need to be established, along with substances that are controlled by existing restrictions and/or generic limits. Of the remaining 284 substances, 179 were placed into the low priority group, 102 were placed into the medium priority group and 3 were placed into the high priority group, i.e. salicylic acid ( FCM No 121), styrene ( FCM No 193) and lauric acid, vinyl ester ( FCM No 436).

Migration of Styrene in Yogurt and Dairy Products Packaged in Polystyrene: Results from Market Samples

“…Regarding styrene, it is an authorized monomer, listed in the European Food Packaging Legislation without a specific restriction, except for the requirement of sensorial inertness as styrene is a potent sensory active compound. Recently, the European Food Safety Authority’s (EFSA) classified styrene in the high priority group of substances needing re-evaluation among those that are authorized for use in food contact material without a specific migration limit [ 7 ]. Additionally, on the basis of human occupational and animal studies, both concerning exposure to styrene by inhalation, the International Agency for Research on Cancer (IARC) revised in 2019 the classification of styrene from “possibly carcinogenic to humans” (2B) to “probably carcinogenic to humans” (2A) [ 8 ].…”

Zinc Polyaleuritate Ionomer Coatings as a Sustainable, Alternative Technology for Bisphenol A-Free Metal Packaging

“…Zinc oxide (ZnO) is generally recognized as a safe (GRAS) material by the U.S. Food and Drug Administration (FDA) . A similar behavior is proposed by the European Food Safety Authority. , It is used as an additive of food packaging materials due to its antimicrobial features and its improvement in the mechanical, barrier, and thermal properties . However, the migration of ZnO nanoparticles to food can be a health issue for consumers.…”

Dietary Exposure Estimation to Chemicals Transferred from Milk and Dairy Products Packaging Materials in Spanish Child and Adolescent Population

“…2-Heptanone was found only in one sample (LE01), and this compound has been identified in paper and board samples [15]. Benzaldehyde and benzoic acid are included in the European Union positive list of substances authorized in plastic materials [5]. They were found in eight (LE01, LE02, LS01, LS02, QF02_P, YN01_P/L, YS01_P/L, FN03_P/L) and three samples (YN01_P/L, YS01_P/L, FN02_P), respectively.…”

“…Regarding their applications, even though this group of chemicals is used mainly as plasticizers to provide flexibility to plastics, particularly to polyvinyl chloride (PVC), they can also be present in printing inks and adhesives [2,4]. Some of them, such as dibutyl phthalate (DiBP) and bis(2-ethylhexyl) phthalate (DEHP), among others, are included in the list of additives authorized for plastic food contact materials with restrictions, including specific migration limits (SML) of 0.3 mg/kg and 1.5 mg/kg, respectively [5].…”

“…In food packaging materials, benzophenone is widely used as an initiator in UV-cured inks. It is included in the European Union positive list of authorized substances for plastic materials and articles intended to come into contact with food as additive with an SML of 0.6 mg/kg [5,6].…”