Risks for animal and human health related to the presence of polychlorinated naphthalenes (PCNs) in feed and food

Dieter Schrenk; Margherita Bignami; Laurent Bodin; James Kevin Chipman; Jesús del Mazo; Bettina Grasl-Kraupp; Christer Hogstrand; Laurentius (Ron) Hoogenboom; Jean-Charles Leblanc; Carlo Stefano Nebbia; Evangelia Ntzani; Annette Petersen; Salomon Sand; Tanja Schwerdtle; Christiane Vleminckx; Heather Wallace; Jerzy Falandysz; Andrew Hart; Martin Rose; Maria Anastassiadou; Chantra Eskes; Petra Gergelova; Matteo Innocenti; Elena Rovesti; Ben Whitty; Elsa Nielsen

doi:10.2903/j.efsa.2024.8640

Risks for animal and human health related to the presence of polychlorinated naphthalenes (PCNs) in feed and food

Dieter Schrenk, Margherita Bignami, Laurent Bodin, James Kevin Chipman, Jesús del Mazo, Bettina Grasl-Kraupp, Christer Hogstrand, Laurentius (Ron) Hoogenboom, Jean-Charles Leblanc, Carlo Stefano Nebbia, Evangelia Ntzani, Annette Petersen, Salomon Sand, Tanja Schwerdtle, Christiane Vleminckx, Heather Wallace, Jerzy Falandysz, Andrew Hart, Martin Rose, Maria AnastassiadouChantra Eskes, Petra Gergelova, Matteo Innocenti, Elena Rovesti, Ben Whitty, Elsa Nielsen

King's College London

Research output: Contribution to journal › Article › peer-review

5 Citations (Scopus)

Abstract

EFSA was asked for a scientific opinion on the risks for animal and human health related to the presence of polychlorinated naphthalenes (PCNs) in feed and food. The assessment focused on hexaCNs due to very limited data on other PCN congeners. For hexaCNs in feed, 217 analytical results were used to estimate dietary exposures for food-producing and non-food-producing animals; however, a risk characterisation could not be performed because none of the toxicological studies allowed identification of reference points. The oral repeated dose toxicity studies performed in rats with a hexaCN mixture containing all 10 hexaCNs indicated that the critical target was the haematological system. A BMDL ₂₀ of 0.05 mg/kg body weight (bw) per day was identified for a considerable decrease in the platelet count. For hexaCNs in food, 2317 analytical results were used to estimate dietary exposures across dietary surveys and age groups. The highest exposure ranged from 0.91 to 29.8 pg/kg bw per day in general population and from 220 to 559 pg/kg bw per day for breast-fed infants with the highest consumption of breast milk. Applying a margin of exposure (MOE) approach, the estimated MOEs for the high dietary exposures ranged from 1,700,000 to 55,000,000 for the general population and from 90,000 to 230,000 for breast-fed infants with the highest consumption of breast milk. These MOEs are far above the minimum MOE of 2000 that does not raise a health concern. Taking account of the uncertainties affecting the assessment, the Panel concluded with at least 99% certainty that dietary exposure to hexaCNs does not raise a health concern for any of the population groups considered. Due to major limitations in the available data, no assessment was possible for genotoxic effects or for health risks of PCNs other than hexaCNs.

Original language	English
Article number	e8640
Pages (from-to)	e8640
Journal	EFSA Journal
Volume	22
Issue number	3
DOIs	https://doi.org/10.2903/j.efsa.2024.8640
Publication status	Published - Mar 2024

Keywords

feed
food
PCNs
Polychlorinated naphthalenes
risk assessment

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10.2903/j.efsa.2024.8640

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Schrenk, D., Bignami, M., Bodin, L., Chipman, J. K., del Mazo, J., Grasl-Kraupp, B., Hogstrand, C., Hoogenboom, L., Leblanc, J.-C., Nebbia, C. S., Ntzani, E., Petersen, A., Sand, S., Schwerdtle, T., Vleminckx, C., Wallace, H., Falandysz, J., Hart, A., Rose, M., ... Nielsen, E. (2024). Risks for animal and human health related to the presence of polychlorinated naphthalenes (PCNs) in feed and food. EFSA Journal, 22(3), e8640. Article e8640. https://doi.org/10.2903/j.efsa.2024.8640

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title = "Risks for animal and human health related to the presence of polychlorinated naphthalenes (PCNs) in feed and food",

abstract = "EFSA was asked for a scientific opinion on the risks for animal and human health related to the presence of polychlorinated naphthalenes (PCNs) in feed and food. The assessment focused on hexaCNs due to very limited data on other PCN congeners. For hexaCNs in feed, 217 analytical results were used to estimate dietary exposures for food-producing and non-food-producing animals; however, a risk characterisation could not be performed because none of the toxicological studies allowed identification of reference points. The oral repeated dose toxicity studies performed in rats with a hexaCN mixture containing all 10 hexaCNs indicated that the critical target was the haematological system. A BMDL 20 of 0.05 mg/kg body weight (bw) per day was identified for a considerable decrease in the platelet count. For hexaCNs in food, 2317 analytical results were used to estimate dietary exposures across dietary surveys and age groups. The highest exposure ranged from 0.91 to 29.8 pg/kg bw per day in general population and from 220 to 559 pg/kg bw per day for breast-fed infants with the highest consumption of breast milk. Applying a margin of exposure (MOE) approach, the estimated MOEs for the high dietary exposures ranged from 1,700,000 to 55,000,000 for the general population and from 90,000 to 230,000 for breast-fed infants with the highest consumption of breast milk. These MOEs are far above the minimum MOE of 2000 that does not raise a health concern. Taking account of the uncertainties affecting the assessment, the Panel concluded with at least 99% certainty that dietary exposure to hexaCNs does not raise a health concern for any of the population groups considered. Due to major limitations in the available data, no assessment was possible for genotoxic effects or for health risks of PCNs other than hexaCNs.",

keywords = "feed, food, PCNs, Polychlorinated naphthalenes, risk assessment",

author = "Dieter Schrenk and Margherita Bignami and Laurent Bodin and Chipman, {James Kevin} and {del Mazo}, Jes{\'u}s and Bettina Grasl-Kraupp and Christer Hogstrand and Hoogenboom, {Laurentius (Ron)} and Jean-Charles Leblanc and Nebbia, {Carlo Stefano} and Evangelia Ntzani and Annette Petersen and Salomon Sand and Tanja Schwerdtle and Christiane Vleminckx and Heather Wallace and Jerzy Falandysz and Andrew Hart and Martin Rose and Maria Anastassiadou and Chantra Eskes and Petra Gergelova and Matteo Innocenti and Elena Rovesti and Ben Whitty and Elsa Nielsen",

note = "Publisher Copyright: {\textcopyright} 2024 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.",

year = "2024",

month = mar,

doi = "10.2903/j.efsa.2024.8640",

language = "English",

volume = "22",

pages = "e8640",

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Schrenk, D, Bignami, M, Bodin, L, Chipman, JK, del Mazo, J, Grasl-Kraupp, B, Hogstrand, C, Hoogenboom, L, Leblanc, J-C, Nebbia, CS, Ntzani, E, Petersen, A, Sand, S, Schwerdtle, T, Vleminckx, C, Wallace, H, Falandysz, J, Hart, A, Rose, M, Anastassiadou, M, Eskes, C, Gergelova, P, Innocenti, M, Rovesti, E, Whitty, B & Nielsen, E 2024, 'Risks for animal and human health related to the presence of polychlorinated naphthalenes (PCNs) in feed and food', EFSA Journal, vol. 22, no. 3, e8640, pp. e8640. https://doi.org/10.2903/j.efsa.2024.8640

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T1 - Risks for animal and human health related to the presence of polychlorinated naphthalenes (PCNs) in feed and food

AU - Schrenk, Dieter

AU - Bignami, Margherita

AU - Bodin, Laurent

AU - Chipman, James Kevin

AU - del Mazo, Jesús

AU - Grasl-Kraupp, Bettina

AU - Hogstrand, Christer

AU - Hoogenboom, Laurentius (Ron)

AU - Leblanc, Jean-Charles

AU - Nebbia, Carlo Stefano

AU - Ntzani, Evangelia

AU - Petersen, Annette

AU - Sand, Salomon

AU - Schwerdtle, Tanja

AU - Vleminckx, Christiane

AU - Wallace, Heather

AU - Falandysz, Jerzy

AU - Hart, Andrew

AU - Rose, Martin

AU - Anastassiadou, Maria

AU - Eskes, Chantra

AU - Gergelova, Petra

AU - Innocenti, Matteo

AU - Rovesti, Elena

AU - Whitty, Ben

AU - Nielsen, Elsa

PY - 2024/3

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AB - EFSA was asked for a scientific opinion on the risks for animal and human health related to the presence of polychlorinated naphthalenes (PCNs) in feed and food. The assessment focused on hexaCNs due to very limited data on other PCN congeners. For hexaCNs in feed, 217 analytical results were used to estimate dietary exposures for food-producing and non-food-producing animals; however, a risk characterisation could not be performed because none of the toxicological studies allowed identification of reference points. The oral repeated dose toxicity studies performed in rats with a hexaCN mixture containing all 10 hexaCNs indicated that the critical target was the haematological system. A BMDL 20 of 0.05 mg/kg body weight (bw) per day was identified for a considerable decrease in the platelet count. For hexaCNs in food, 2317 analytical results were used to estimate dietary exposures across dietary surveys and age groups. The highest exposure ranged from 0.91 to 29.8 pg/kg bw per day in general population and from 220 to 559 pg/kg bw per day for breast-fed infants with the highest consumption of breast milk. Applying a margin of exposure (MOE) approach, the estimated MOEs for the high dietary exposures ranged from 1,700,000 to 55,000,000 for the general population and from 90,000 to 230,000 for breast-fed infants with the highest consumption of breast milk. These MOEs are far above the minimum MOE of 2000 that does not raise a health concern. Taking account of the uncertainties affecting the assessment, the Panel concluded with at least 99% certainty that dietary exposure to hexaCNs does not raise a health concern for any of the population groups considered. Due to major limitations in the available data, no assessment was possible for genotoxic effects or for health risks of PCNs other than hexaCNs.

KW - feed

KW - food

KW - PCNs

KW - Polychlorinated naphthalenes

KW - risk assessment

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JF - EFSA Journal

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ER -

Risks for animal and human health related to the presence of polychlorinated naphthalenes (PCNs) in feed and food

Abstract

Keywords

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