Issue Ethylhexanoic Acid Issue 2 EHA Again a

Issue: Ethylhexanoic Acid Issue: 2 -EHA Again a contaminant found in food jars Ernährungsphysiologie und angewandte Biochemie T. J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004 1

2 -Ethylhexanoic Acid (2 -EHA) Chemical Data z. Chemical Names Ô 2 -Ethyl hexanoic acid - CAS Nr. 149 -57 -5 ethylhexanoic acid - formula C 8 H 16 O 2 - MW 144, 2 g/Mol Issue: 2 -EHA : 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) http: //www. basf. com/businesses/chemicals/intermediates/pdfs/2 -ethylh. pdf Ernährungsphysiologie und angewandte Biochemie T. J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004 2

2 -Ethylhexanoic Acid (2 -EHA) Toxicology z. Toxicity 1 (available information 10/2004) Ô Low acute toxicity (LD 50, rat: 2000 – 3500 mg/kg) Ô Absorption via skin, oral or inhalation Ô Weak irritant on skin and eyes, no sensitizing effect Ô According to 67/548/EWG possibly fetotoxic : NOAEL rats: 100 mg/kg, 250 mg/kg : NOAEL rabbits: 25 mg/kg, > 250 mg/kg Issue: 2 -EHA Ô Mutagenicity Assays : negative in bacterial mutagenicity tests : Neg, in diverse micronucleus tests : questionable positive sister chromatid exchange-test on human lymphocytes Ô Repeated Dose Toxicity (subacute, rats) : liver alteration (increasing weight) : NOAEL rats: 62 mg/kg Ernährungsphysiologie und angewandte Biochemie T. J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004 3

2 -Ethylhexanoic Acid (2 -EHA) Exposition z. Food Sources Ô Detection 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 Issue: 2 -EHA Ô Other sources : Endogenous formation of EHA from 2 -ethylhexanol, which is part of most plasticizers (human metabolisation pathway) Ernährungsphysiologie und angewandte Biochemie T. J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004 4

2 -Ethylhexanoic Acid (2 -EHA) Design of a glass jar Issue: 2 -EHA z. Basic parts of a glass jar http: //www. ehcan. com/Jars. Closure. html Ernährungsphysiologie und angewandte Biochemie T. J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004 5

2 -Ethylhexanoic Acid (2 -EHA) Gasket design z. Closures for glass containers Ô Twist-off cap Top seal Ô Press-On Twist-Off® (PT) closures Issue: 2 -EHA Safety Button Flip Panel Top and side seal http: //www. ehcan. com/Jars. Closure. html Ernährungsphysiologie und angewandte Biochemie T. J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004 6

2 -Ethylhexanoic Acid (2 -EHA) Exposition z. Exposition Ô infant, 4 months : Worst case: 0, 2 mg/kg body weight* Issue: 2 -EHA (daily intake of 360 g jar food (= 3 glass jar á 125 g), contaminated with 3, 2 mg/kg 2 -EHA for a 6 kg weight baby) = 0, 2 mg EHA/kg Margin of Safety (MOS): NOAELrepeated 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 190 g 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) Ernährungsphysiologie und angewandte Biochemie T. J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004 7

2 -Ethylhexanoic Acid (2 -EHA) Exposition z. Exposition Ô Appraisal of the Bf. R/Germany : High amounts like 3, 2 mg EHA/kg baby food may be critical in view of additional exposure from plasticisers Issue: 2 -EHA : Contaminations in most of the samples were below 0, 6 mg/kg this should be unobjectionable Ernährungsphysiologie und angewandte Biochemie T. J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004 8

2 -Ethylhexanoic Acid (2 -EHA) View of Critical Press*, 3 Issue: 2 -EHA ‚Ökotest‘ adopted the opinion of the Bf. R and devaluates only EHA contents > 1 mg/kg (1 of 16 samples) *Ökotest, Oct. 2004, p. 62 -65 Ernährungsphysiologie und angewandte Biochemie T. J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004 9

2 -Ethylhexanoic Acid (2 -EHA) Issue: 2 -EHA Conclusion Ô 2 -EHA was detected in different types of baby food in glass jars Ô Amounts ranged from not detectable to 3, 2 mg/kg Ô the plastic gasket was identified as the contaminant source Ô Metal salts of 2 -EHA are used as PVC heat stabilizers and therefore are the source of contamintion Ô 2 -EHA is a weak teratogen and provides a low subcute toxicity Ô Considering worst case (and contmination from other sources) infants exposure the margin of safety for 2 -EHA might be small Ô Since 2 -EHA is not used by all manufacturers, technological inevitableness is not given, formulations should be modified and 2 -EHA excluded Ernährungsphysiologie und angewandte Biochemie T. J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004 10

2 -Ethylhexanoic Acid (2 -EHA) The Issue - Chronology Issue: 2 -EHA Ô June 2004 Publication of Elss et al. is submitted Information is passed to the surveillance (BFR) several meetings with industry representatives follow Ô Juli 2004 Bf. R publishes ist opinion Ernährungsphysiologie und angewandte Biochemie T. J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004 11

References Issue: 2 -EHA 1. http: //www. bgvv. de/cm/208/2_ethylhexansaeure_in_babynahrung. pdf 2 -Ethylhexansäure in glasverpackter Babynahrung und in Fruchtsäften Stellungnahme des Bf. R vom 20. Juli 2004 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 Ernährungsphysiologie und angewandte Biochemie T. J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004 12