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Committee Advice Document on Calcium tert-butylphosphonate as an additive for use in the manufacture of plastic food contact materials and articles

Conclusions of the FCMJEG

Last updated: 24 June 2025

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Conclusions of the FCMJEG 

112. Satisfactory information regarding the identity of the substance, its physical and chemical properties, the intended application of the substance, data on migration of the substance and toxicological data were submitted.  

113. Results from the overall and specific migration test demonstrated that the migration of calcium tert-butylphosphonate was close to or below the limit of detection (up to 10 μg/kg). 

114. Owing to the low migration of calcium tert-butylphosphonate as an additive under the conditions of use specified in the application, only limited toxicology testing was required.  

115. Overall, there is unlikely to be a genotoxicity risk to health from the use of calcium tert-butylphosphonate as an additive in the manufacture of plastic materials and articles intended to be in food contact with food.   

116. A potential health risk to infants (<16 weeks old) via feeding bottles, based on neurotoxic effects could not be assessed due to lack of available data for this age group. 

117. Overall, the FCMJEG considered the information and data provided was sufficient to conclude that there was no concern for the general population from the use of calcium tert-butylphosphonate as an additive for use in food contact materials and articles. Use in contact with infant formula and human milk was excluded due to the lack of neurotoxicity data and the potentially sensitive nature of the infant group (<16 weeks).  

118. Calcium tert-butylphosphonate was therefore recommended for approval for use as an additive as outlined in the application and specified above.   

Abbreviations

Abbreviation 

Definition 

ATR-IR 

Attenuated total reflection infrared 

CoA 

Certificate of analysis 

CytB 

Cytochalasin B 

DMSO 

Dimethyl sulfoxide 

DMF 

Dimethylformamide 

EFSA 

European Food Standards Agency 

FCM 

Food contact material 

FCMJEG 

Food Contact Materials Joint Expert Group 

FCN 

Food contact notification  

FCS 

Food contact substance 

FSA 

Food Standards Agency 

GC 

Gas chromatography 

GLP 

Good laboratory practice 

HDPE 

High-density polyethylene 

LC-MS 

Liquid chromatography-mass spectrometry 

LDPE 

Low-density polyethylene 

LLDPE 

Linear low-density polyethylene 

LOD 

Limit of detection 

MN 

Micronucleus 

NIAS 

Non-intentionally added substance 

NMR 

Nuclear magnetic resonance 

PP 

Polypropylene 

SIR 

Selected ion recording 

TGA 

Thermogravimetric analysis  

Glossary

Susceptor  

A piece of metallic film on a package of microwaveable food that helps cook and brown the food by producing and concentrating energy on the food’s outer surface (Dictionary, 2024) 

 

Nucleating agent 

Nucleating agents are inorganic materials added to polymers to increase the crystallinity and shorten the cycle times. They speed up the transition from melted to solid material. Changing the crystallinity of plastics changes properties like density and clarity (Special Chem, 2024). 

References

Dictionary (2024) Susceptor: https://www.dictionary.com/browse/susceptor  

European Food Safety Authority (2024) Scientific Opinion: Safety assessment of the substance calcium tert-butylphosphonate for use in food contact materials: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.8705  

European Food Safety Authority (2017) Guidance on the risk assessment of  substances present in food intended for infants below 16 weeks of age: https://www.efsa.europa.eu/sites/default/files/consultation/170220.pdf  

Feigenbaum, A.E., Riquet, A.M. & Scholler, D. (2000). Fatty Food Simulants: Solvents to Mimic the Behaviour of Fats in Contact with Packaging Plastics. ACS Symposium Series. 753. 71-81. 10.1021/bk-2000-0753.ch007. 

Franz RD (2001). Comparisons of pKa and log P values of some carboxylic and phosphonic acids: synthesis and measurement. AAPS PharmSci. 2001;3(2):E10. doi: 10.1208/ps030210. PMID: 11741262; PMCID: PMC2779558.  

Special Chem (2024) Polymer Additives – Nucleating Agents: https://polymer-additives.specialchem.com/product-categories/additives-nucleating-agents#:~:text=Nucleating%20agents%20are%20inorganic%20materials,properties%20like%20density%20and%20clarity  

Worek, F., Thiermann, H. & Wille, T (2020). Organophosphorus compounds and oximes: a critical review. Arch Toxicol 94, 2275–2292 (2020). https://doi.org/10.1007/s00204-020-02797-0 

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