Assessment of the impact of the IARC Monograph Vol. 121 on the safety of the substance styrene (FCM No 193) for its use in plastic food contact materials

Silano, Vittorio; Baviera, José Manuel Barat; Bolognesi, Claudia; Chesson, Andrew; Cocconcelli, Pier Sandro; Crebelli, Riccardo; Gott, David Michael; Grob, Konrad; Lambré, Claude; Lampi, Evgenia; Mengelers, Marcel; Mortensen, Alicja; Steffensen, Inger‐Lise; Tlustos, Christina; Loveren, Henk Van; Vernis, Laurence; Zorn, Holger; Castle, Laurence; Consiglio, Emma Di; Franz, Roland; Hellwig, Nicole; Milana, Maria Rosaria; Pfaff, Karla; Carfì, Maria; Haver, Ellen Van; Rivière, Gilles

doi:10.2903/j.efsa.2020.6247

Cited by 21 publications

(19 citation statements)

References 25 publications

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“…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 ]. Following this, in 2020, the EFSA published an assessment on the safety of styrene for use in plastic food contact materials [ 9 ], stating that the IARC conclusions cannot be “directly applied” to the evaluation of risks for consumers from oral exposure to styrene. However, it added that, “a concern for genotoxicity associated with oral exposure to styrene cannot be excluded” and a systematic review of the data is further required for assessing the safety of styrene and styrene oligomers presence in food contact materials.…”

Section: Introductionmentioning

confidence: 99%

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

Guazzotti

Hendrich

Gruner

et al. 2022

Foods

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The European Food Safety Authority is re-evaluating styrene for assessing the safety of food contact materials (FCM) such as polystyrene (PS) and started a systematic review of the data on migration levels in food. A restriction for styrene is expected in the near future. The main food contact application of PS is dairy packaging, mainly at refrigerated storage. In this study, seventeen dairy products packed in PS taken from the Italian and German markets were investigated. Styrene concentrations in the refrigerated dairy products (yogurt, cream) ranged from 5 to 30 µg/kg at the best before date, while in single serving portions of coffee creamer, which were stored at room temperature until the best before date of approx. 190 days, 401 µg/kg were measured. Among several parameters, the ratio between the surface contact area of the package and the quantity of the food packed, the time/temperature conditions of production/filling and storage of the products were identified as the main factors influencing styrene migration into food under realistic conditions. Yogurts fermented in the pots for approximately 8 h at 40–50 °C showed higher styrene levels than those fermented in an incubator and filled at 20 °C. The fat content might influence the styrene level but the effect, if any, was too small in relation to the variability of other parameters. Levels of styrene migrating into 50% ethanol food simulant under standardized condition (10 days/40 °C) were found to be much higher than levels in refrigerated foods. This raises the question as to whether compliance testing for PS plastics should be adapted taking into consideration the correlation between migration testing by laboratory simulations and migration into real food.

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Section: Introductionmentioning

confidence: 99%

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

Guazzotti

Hendrich

Gruner

et al. 2022

Foods

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“…The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) evaluated the impact of the conclusions of IARC on the safety assessment of the substance styrene (FCM No 193) for its use in plastic food contact materials (EFSA CEP Panel, 2020 ).…”

Section: Assessmentmentioning

confidence: 99%

Safety and efficacy of feed additives consisting of essential oils from the bark and the leaves of Cinnamomum verum J. Presl (cinnamon bark oil and cinnamon leaf oil) for use in all animal species (FEFANA asbl)

Bampidis¹,

Azimonti²,

Bastos³

et al. 2022

EFS2

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Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of essential oils from the bark and the leaves of Cinnamomum verum J. Presl (cinnamon bark oil and cinnamon leaf oil), when used as sensory additives (flavourings) in feed and water for drinking for all animal species. Owing to the presence of styrene in the essential oils under assessment, the FEEDAP Panel is not in the position to conclude on the safety for long‐living animals and animals for reproduction. For ‘short‐living’ animals, the FEEDAP Panel concluded that cinnamon bark oil and cinnamon leaf oil are considered as safe up to the maximum proposed use levels in complete feed. For ‘short‐living’ animals, the Panel considered the use of cinnamon bark oil in water for drinking as safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. For cinnamon leaf oil, the proposed use level in water for drinking of 3 mg/L is considered as safe for ‘short‐living’ animals. No concerns for consumers were identified following the use of the additives at the use level considered safe in feed for the target species. Based on the presence of safrole ≥0.1%, cinnamon leaf oil and bark oil are classified as carcinogen (category 1B) and handled accordingly. The use of the additives under the proposed conditions in animal feed was not expected to pose a risk for the environment. Since C. verum and its preparations are recognised to flavour food and its function in feed would be essentially the same, no further demonstration of efficacy is considered necessary for cinnamon essential oils.

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“…Considering SiO 2 low systemic bioavailability, its physico‐chemical properties, the product formulations and application types, the submission of oral toxicological studies was waived for short‐term toxicity, genotoxicity, long‐term toxicity and carcinogenicity, reproductive and developmental toxicity, neurotoxicity, immunotoxicity studies and studies to assess endocrine‐disrupting potential. It is noted that a similar approach has been used for Kieselgur, another silica‐based active substance 10 (EFSA, 2020 ).…”

Section: Mammalian Toxicitymentioning

confidence: 99%

“…2 according to Regulation (EC) No 1272/2008 12 . Additionally, EFSA has recently re‐assessed styrene safety for use as a food contact material (EFSA CEP Panel, 2020 ) and concluded that a concern for genotoxicity associated with oral exposure to styrene cannot be excluded.…”

Section: Mammalian Toxicitymentioning

confidence: 99%

Peer review of the pesticide risk assessment of the active substance quartz sand

Álvarez¹,

Arena²,

Auteri³

et al. 2022

EFS2

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The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Latvia, and co-rapporteur Member State, Romania, for the pesticide active substance quartz sand and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative field uses of quartz sand as a game repellent on deciduous and coniferous trees (professional use and non-professional use), orchards, ornamental shrubs and trees in forestry (professional use and non-professional use) and seedlings of conifer and deciduous trees in forestry (professional use). The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. No concerns are identified.

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Assessment of the impact of the IARC Monograph Vol. 121 on the safety of the substance styrene (FCM No 193) for its use in plastic food contact materials

Cited by 21 publications

References 25 publications

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

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

Safety and efficacy of feed additives consisting of essential oils from the bark and the leaves of Cinnamomum verum J. Presl (cinnamon bark oil and cinnamon leaf oil) for use in all animal species (FEFANA asbl)

Peer review of the pesticide risk assessment of the active substance quartz sand

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