Issue: 2-EHA Ernährungsphysiologie und angewandte Biochemie T.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober Issue: Ethylhexanoic Acid Again a contaminant found in food jars

Issue: 2-EHA Ernährungsphysiologie und angewandte Biochemie T.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober Ethylhexanoic Acid (2-EHA) Chemical Data zChemical Names Ô2-Ethyl hexanoic acid - CAS Nr ethylhexanoic acid - formula C 8 H 16 O 2 - MW 144,2 g/Mol :use - metal salts (Ca-, Zn-, Ba-salts) as PVC co-stabilizers - Zn-dihexylhexanate as catalyst for foamed plastic and hardener for silicone resins - intermediate in the production of + plasticizers + lubricants (as decylester)

Issue: 2-EHA Ernährungsphysiologie und angewandte Biochemie T.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober Ethylhexanoic Acid (2-EHA) Toxicology zToxicity 1 (available information 10/2004) ÔLow acute toxicity (LD 50, rat : 2000 – 3500 mg/kg) ÔAbsorption via skin, oral or inhalation ÔWeak irritant on skin and eyes, no sensitizing effect ÔAccording to 67/548/EWG possibly fetotoxic :NOAEL rats: 100mg/kg, 250 mg/kg :NOAEL rabbits: 25mg/kg, > 250 mg/kg ÔMutagenicity Assays :negative in bacterial mutagenicity tests :Neg, in diverse micronucleus tests :questionable positive sister chromatid exchange-test on human lymphocytes ÔRepeated Dose Toxicity (subacute, rats) :liver alteration (increasing weight) :NOAEL rats: 62 mg/kg

Issue: 2-EHA Ernährungsphysiologie und angewandte Biochemie T.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober Ethylhexanoic Acid (2-EHA) Exposition zFood Sources ÔDetection of 2-EHA in lid gaskets 2 :2-EHA was detected in 80% of the investigated baby foods (n=20) and 70 % of the fruit juices (n = 15) :the amounts ranged from 0,25 to 3,2 mg/kg (baby food) and 0,01 – 0,59 mg/kg (fruit juices), respectively :The plastic gaskets inside the metal lids was revealed as the origin of 2-EHA ÔOther sources :Endogenous formation of EHA from 2-ethylhexanol, which is part of most plasticizers (human metabolisation pathway)

Issue: 2-EHA Ernährungsphysiologie und angewandte Biochemie T.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober Ethylhexanoic Acid (2-EHA) Design of a glass jar zBasic parts of a glass jar

Issue: 2-EHA Ernährungsphysiologie und angewandte Biochemie T.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober Ethylhexanoic Acid (2-EHA) Gasket design zClosures for glass containers ÔTwist-off cap ÔPress-On Twist-Off ® (PT) closures Top seal Safety Button Flip Panel Top and side seal

Issue: 2-EHA Ernährungsphysiologie und angewandte Biochemie T.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober Ethylhexanoic Acid (2-EHA) Exposition zExposition Ôinfant, 4 months :Worst case: 0,2 mg/kg body weight* (daily intake of 360g jar food (= 3 glass jar á 125g), contaminated with 3,2 mg/kg 2-EHA for a 6 kg weight baby) = 0,2 mg EHA/kg  Margin of Safety (MOS): NOAEL repeated dose toxicity, rat : 62 mg/kg = 62/0,2= 310 is not sufficient, expecially with the view on other sources of contamination :Not worst case: 0,019 mg/kg body weight (daily intake of 190g jar food (= 1 glass jar), contaminated with 0,6 ppm 2-EHA of a 6 kg weight baby) = 0,02 mg EHA/kg  MOS = 62/0,02 > 3000 (sufficient)

Issue: 2-EHA Ernährungsphysiologie und angewandte Biochemie T.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober Ethylhexanoic Acid (2-EHA) Exposition zExposition ÔAppraisal of the BfR/Germany :High amounts like 3,2 mg EHA/kg baby food may be critical in view of additional exposure from plasticisers :Contaminations in most of the samples were below 0,6 mg/kg  this should be unobjectionable

Issue: 2-EHA Ernährungsphysiologie und angewandte Biochemie T.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober Ethylhexanoic Acid (2-EHA) View of Critical Press*,3 *Ökotest, Oct. 2004, p ‚Ökotest‘ adopted the opinion of the BfR and devaluates only EHA con- tents > 1 mg/kg (1 of 16 samples)

Issue: 2-EHA Ernährungsphysiologie und angewandte Biochemie T.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober Ethylhexanoic Acid (2-EHA) Conclusion Ô2-EHA was detected in different types of baby food in glass jars ÔAmounts ranged from not detectable to 3,2 mg/kg Ôthe plastic gasket was identified as the contaminant source ÔMetal salts of 2-EHA are used as PVC heat stabilizers and therefore are the source of contamintion Ô2-EHA is a weak teratogen and provides a low subcute toxicity ÔConsidering worst case (and contmination from other sources) infants exposure the margin of safety for 2-EHA might be small ÔSince 2-EHA is not used by all manufacturers, technological inevitableness is not given, formulations should be modified and 2-EHA excluded

Issue: 2-EHA Ernährungsphysiologie und angewandte Biochemie T.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober Ethylhexanoic Acid (2-EHA) The Issue - Chronology ÔJune 2004Publication of Elss et al. is submitted Information is passed to the surveillance (BFR) several meetings with industry representatives follow Ô Juli 2004BfR publishes ist opinion

Issue: 2-EHA Ernährungsphysiologie und angewandte Biochemie T.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober References Ethylhexansäure in glasverpackter Babynahrung und in Fruchtsäften Stellungnahme des BfR vom 20. Juli 2004http:// 2.S. Elss, L. Grünewald, E. Richling, P. Schreier: Occurrence of 2-ethylhexanoic acid in foods packed in glass jars, Food Addit. Contam., in press 3.Ausgelöffelt: Test Babymenüs mit Geflügel, Ökotest Okt. 2004, 62-65