BASF Petrochemicals The Heart of Your Products. Istanbul E-CPW/MD Heidrun Goth

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Clarence Arnold
5 years ago
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1 Istanbul E-CPW/MD Heidrun Goth

2 Plasticizers General Aspects Plasticizers of different structural classes are available The availability of the toxicological data varies The concentration of plasticizers in PVC may reach up to 40 %) higher than concentration of any other additives in other polymers Plasticizers are lipophilic Plasticizers are not covalently bonded The migration of plasticizers is determined by: Molecular weight, Structure Properties of contacted medium Hexamoll DINCH Team 2

3 Desired Technical Plasticizer Properties Compatibility with PVC Processability Low volatility Oxygen permeability Temperature effects /cold flexibility Low migration No interference with other technical requirements Biocompatibility Hexamoll DINCH Team 3

4 The Way Forward Seeking for a Solution Option I: Stay with PVC Keep your production hardware Change to another plasticizer Abandon the hazard Reduce the exposure Option II: Change to another polymer Discard your production hardware Lose your knowledge in the polymer What are the topics with the new polymer? Hexamoll DINCH Team 4

5 Hexamoll DINCH The Innovation Hexamoll Di-Iso Nonyl Cyclo Hexandicarboxylate 1,2 Cyclohexandicarboxylic acid diisononyl ester The Highest Level of Safety where it counts! Hexamoll DINCH Team 5

6 BASF : Hexamoll DINCH Reason for Development of BASF: Demand on toxicological indisputable plasticizer Responsible Care Procedure : Hydrogenation of phthalates Change of toxicology Maintenance of the technical properties Hexamoll DINCH (Core hydrogenated C9- Phthalate) Hexamoll DINCH Team 6

7 What is Hexamoll DINCH? New innovative non-phthalate Toxicologically favorable profile Core hydrogenation of DINP Di-IsoNonyl-CycloHexane-dicarboxylate O O O isononyl O isononyl 25 kt plant in LU since July 2002 Expansion up to 100 kt May 2007 Patents: Process, Compound, Appl Hexamoll DINCH Team 7

8 Targets BASF offers an innovative solution for soft PVC applications: Medical devices (Bags, Tubings) Toys Food packaging Hexamoll DINCH Team 8

9 Hexamoll DINCH Tox Profile Environmental hazards Peroxisome proliferation Reproductive hazard Testicular toxicity Impairment of fertility Developmental toxicity Teratogenicity Endocrine action Accumulation within the body Carcinogencity Hexamoll DINCH Team 9

10 Hexamoll DINCH Food Migration Migration test method is available solubility low in water and acetic acid: <<< 0,1 mg/l 15 % ethanol: ca. 0,1 mg/l also recommended for artifical wine corks Fresh meat packaging Migration TDI 1 mg/kg/bw/day = 60 mg /kg food Hexamoll DINCH Team 10

11 Target market regulatory approval status Applications Toys Food contact Regulation EN 71-3 EN 71-5 EN /59/EC (Residual Phthalates less than 0,1 %) Ger: BfR-recommendation 207 EFSA: 2002/72/EC Migration Limit: TDI 1mg/kg/bw/day Compliance Yes Yes Yes Yes Yes Yes FDA: 21CFRXXX.XX In progress Medical Devices DIN ISO *) EN ISO *) *) Device has to be tested Duty at device producers Hexamoll DINCH Team 11

12 Alternatives for Packaging under Discussion ESBO Epoxidized soybeanoil EFSA-Opinion: TDI (tolerable daily intake) => 1 mg/kg bw./day [Organ weight increase in 2 years study, AEL: 140 mg/kg bw.] Constant exceeding of the TDI by factor 4 5 Semicarbazide made from the blowing agent Azodicarbonamide Carcinogenic: mouse, genotoxicity not sufficiently proved 2004/1/EC: Ban effective August 2 nd Ethyl Hexanoic Acid - made from Ca/Zn-Stabilizers Discussion ongoing Hexamoll DINCH Team 12

13 Issues to be considered Type of stabilizer you are using 2-Ethylhexanoic acid in baby food in Europe is a big issue 4,2 mg/kg of 2-ethylhexanoic acid identified Cross contamination during your production Hexamoll DINCH is a Non-phthalate Check your other components Check cross contamination during production Hexamoll DINCH Team 13

14 Applications: Food PVC-Closures and Sealants: Baby-Food Beverages with Carbon Dioxide (low DINCH-Migration) Wine corks Hexamoll DINCH Team 14

15 Applications: Food Cling-film (high Oxygen Permeability) Hexamoll DINCH Team 15

16 Hexamoll DINCH Summary THE CHEMICAL COMPANY has taken up the challenge Our new plasticizer is offering significant advantages available all over the world Additional applications are developed in cooperation with our customers With Hexamoll DINCH our customers are well prepared for the future Hexamoll DINCH Team 16

17 Hexamoll DINCH Hexamoll DINCH Team 17

Introduction to E&Ls 1

Introduction to E&Ls 1 Overview What industries need to determine E&Ls Define extractables and leachables Basic overview of an E&L study Regulatory landscape 2 A leader in plastics analysis Jordi Labs