European Conference on substitution of hazardous chemicals in products and processes 13-14 June 2002

1. Working Group 1 Plasticisers in Polymers Introduction by: K. Heitmann, Ökopol European Conference on substitution of hazardous chemicals in products and processes 13-14 June 2002 Substitution of Hazardous Chemicals in Products and Processes

2. The use of plasticisers flexible properties for polymers like PVC: • In-door applications: • Flooring • Wall covering • Cables • Out-door applications: • Fabric coating • Car undercoating • Cable and wire • Shoe soles • and • toys • Foodwrapping • Medical devices PVC-Products contain between 10 and 60% of plasticisers Substitution of Hazardous Chemicals in Products and Processes

3. Plasticiser consumption in Europe • total consumption of plasticisers 100% 970,000 tpa • main use: in PVC 90% 870,000 tpa • main type of plasticisers: phthalates 92% 890,000 tpa • most common phthalate: DEHP 49% 480,000 tpa • indoor PVC: 74% • outdoor PVC: 21% • plasticiser in other polymers: 2% • sealants, adhesives, paints, printing inks: 3% Substitution of Hazardous Chemicals in Products and Processes

4. When did phthalates become an issue and why? 1977: Testicular effects of DEHP observed by GRAY et al. 1982: DEHP identified as carcinogenic in rodents by NTP/IARC 1983: Release of DEHP from toys investigated by CPSC in 80s: DEHP was found in various environmental media from mid 80s: Developmental and fertility effects in rodents 1990: Denmark´s Intention to classify DEHP as carcinogenic was rejected by the Commission 1997: Release of phthalates from toys investigated by the Danish authorities and by Greenpeace 2001: DEHP classified reproductive toxicant category II in EU 2002: Ongoing discussion on level of risk Substitution of Hazardous Chemicals in Products and Processes

5. 5 phthalates are subject to EU RA under 793/93: DEHPˆ DINP DIDP DBP BBPˆ Classification R 60 R61 (R. Cat. 2)R61 (R. Cat. 2)*(28th ATP 67/548) R 61 R62 (R. Cat. 3)R62 (R. Cat. 3)* (R. Cat.2) R50 Labelling T T,N T, Xn* ConclusionsConsumers: iii) ii) ii) (toys) ii) ii)Workers: iii) ii) ii) iii) ii)Environment: i); ii) ii) ii) i) ? Prior. sett. WFD yes Marketing and yes yesuse restrictions Product related --------- toys and food contact material --------------requirements ˆin progress* proposal of the rapporteur Substitution of Hazardous Chemicals in Products and Processes

6. 2002 - Views on the level of risk • CMR I or II should not be used in processes and products where exposure could be expected. Occurrence of DEHP in breastmilk (10-160 ng/g fat) and all environmental media is a serious concern. =>Elimination of DEHP from all articles needed. • For most sources of DEHP the exposure is much lower than the effect level. The margin of safety is big enough not to give reasons for concern=>No need to reduce the risk • The MOSs for exposure of children via toys, indoor air, breastmilk, infant formula and other food are too low (e.g. < 275)=>broad risk reduction needed Substitution of Hazardous Chemicals in Products and Processes

7. Alternatives for the use of DEHP as plasticiser1 DEHP DINP DIDP DEHA ATBC DINCH ASPE TETM TXIB ESBO Phthalates Adipate Citrate Trimellitate Acute? ? CMR? Sens.  ? P[] [] []  ? B**°*° ?? Taqu?? Secondary plasticisers: DBP, BBP, MCCP Plasticisers with flame retardant properties: MCCP, Phosphates Other materials: PU, EVA, LDPE * BCF(fish)>100 ° approach based on data for DEHP : Log Pow>3, BCF not available

8. Explanations 1 based on COWI (2001): Environmental an Health Assessment of Alternatives to Phthalates and to flexible PVC, Environmental Project No. 590 acute toxicity, CMR, sensitisation and aquatic toxicity: Classification based on 67/ 548: green = no hazard classification P = Persistence green = ready biodegradable B = Bioaccumulation green = LogPow < 3 and BCF > 100  /  full dot = classification/no classification is based on sufficient information / circle = available data are not sufficient, but indicate a tendency towards hazard/non hazard properties ? available data are insufficient for classification [] conflicting results from tests on biodegradability Substitution of Hazardous Chemicals in Products and Processes

9. DEHP: Examples for alternatives • Car undercoating: • Substitution by DINP and DIDP • Substitution of PVC-plastisol by a PP-hardcover • Car interiors: • Substitution by trimellitates and long chain phthalates • Substitution of PVC • Sealing with lacquer • Toys: • Substitution by other plasticisers (Citrate, ASPE) • Substitution of soft PVC by polyolefins or EVA Substitution of Hazardous Chemicals in Products and Processes

10. DEHP: Examples for alternatives • Food wrapping material: • Substitution by adipates and citrates • Substitution of PVC • Flooring: • Substitution by DINP possible • Sealing with acryl- or PU-layers • Substitution of PVC by polyolefins Substitution of Hazardous Chemicals in Products and Processes

11. Key Factors for Substitution of DEHP Technical functionality • plasticisers with comparable technical properties are available Economics • DEHP´s high production volume results in low price • substitution needs investment costs for machinery adaptation Communication / awareness • sensitive issue regarding consumer awareness Risk information • classification of DEHP as toxic • hazard information on alternatives is lacking • hazard information on alternatives is lacking • no consensus yet about the level of risk Regulative frame • use restriction based on the precautionary principle • classification and labelling of DEHP as toxic • Priority setting under Water Framework Directive Substitution of Hazardous Chemicals in Products and Processes

12. Substitution of DEHP? ... after 25 years of scientific research, hundreds of publications and 15 years of public debate? Substitution in which areas? and what is needed to promote substitution in these areas? Substitution of Hazardous Chemicals in Products and Processes

13. abbrevations Phthalates: BBP: Butyl benzyl phthalate DBP: Dibutyl phthalate DEHP: Di(2ethylhexyl) phthalate DIDP: Diisodecyl phthalate DINP: Diisononyl phthalate BCF: Bioconcentration Factor CMR: Cancerogenic, Mutagenic or toxic for Reproduction CPSC: US Consumer Product Safety Commission FDA: Food and Drug Administration IARC: International Agency for Research on Cancer NTP: US National Toxic Program Other substances: ATBC: Acetyl Tributyl Citrate ASPE: Alkylsulfonic Phenyl ester DEHA: Di(2-ethylhexyl) adipate DINCH: Diisononyl Cyclohexane dicarboxylilate ESBO: epoxidiced soybeanoil EVA: Ethylen Vinyl Acetate LDPE: Low Density Polyethylen MCCP: Medium Chained Chlorinated Paraffins PU: Polyurethan TETM: Triethyl rimellitate TXIB: Trimethyl pentanediol diisobutyrate Outcome of EU Risk Assessment i) There is need for further information and/or testing ii) There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account Substitution of Hazardous Chemicals in Products and Processes

14. Molecular strukture of Di(2-ethylhexyl) phthalate = DEHP Substitution of Hazardous Chemicals in Products and Processes