The EFSA Panel on food additives, flavourings, processing aids and materials in contact with food adopted this opinion on 7 January 2004. It evaluates a second list of food-contact substances. The antimony entry is antimony trioxide, REF 35760, CAS 001309-64-4, SCF list 3. A DOI of 10.2903/j.efsa.2004.24 did not resolve, and a suffixed candidate was not confirmed against the DOI resolver, so no DOI is assigned. The access address is the one printed on the opinion. Other substances on the same list (ethylene carbonate, a methacrylic acid ester, a bicyclic salt, and calcium pimelate) are not metal analytes and are not given numbers here.
Key numbers
The restriction the Panel applies is 0.04 mg/kg of food as antimony. A previous SCF classification from 1999, quoted as background, was 0.01 mg/kg with a specific migration limit of 0.02 mg/kg as antimony including analytical tolerance. That earlier pair is the previous evaluation, not the 2004 restriction. Use is as an additive or initiator in PET, maximum 0.035% as antimony. The petitioner’s migration data, as reported by the Panel, used PET with 350 mg Sb/kg and found the highest result in 3% acetic acid: 31.8 µg as antimony per kg of food simulant. The opinion cites the WHO draft drinking-water guidelines, 3rd edition, 2003: NOAEL 6.0 mg Sb/kg body weight per day from potassium antimony tartrate, uncertainty factor 1000, TDI 0.006 mg Sb/kg body weight per day. The 0.04 mg/kg restriction is described as allocating 10% of that TDI to food-contact materials. A remark says the migration limit might be exceeded at very high temperature. IARC group 2B is cited for inhalation, not for oral exposure.
Methods (brief)
Scientific opinion on a petitioner dossier. Not a market survey of bottles.
Evidence fitness
The 0.04 mg/kg figure is the Panel’s restriction for antimony from this substance. The 31.8 µg/kg figure is the petitioner result as relayed by the opinion. The TDI is WHO’s, as cited.
Limitations
No resolved DOI. There is no PET-bottle product page to route to, so the matrix is recorded as PET food-contact material without a product slug.
Related evidence
Update history
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