. Action Programme Environment and Health Marike Kolossa-Gehring, Kerstin Becker, Ulrike Fiddicke, Christine Schulz, Gerda Schwedler, Margarete Seiwert, Chr HBM Experiences in Europe, Brussels, Belgium HBM SURURVEILLANCE PROGRAM IN GERMANY, IMPACT ON ENVIRONMENTAL POLICY & VCI BMU INITIATIVE: PARTNERSHIP BETWEEN INDUSTRY AND GOVERNMENT Federal Environment Agency- Toxicology, Health-related Environmental Monitorin
Percentage [%] Concern about the environmental impact on health How does the environment influence your children s health? 60 50 40 today in the future 30 20 10 0 not at all little highly very much Source: GerES IV; question answered by parents HBM experiences in Europe, November 30 th 2011, Brussels 2
Two complementary approaches used in Germany German Environmental Survey (GerES) Environmental Specimen Bank (ESB) Survey Period Sample size Greifswald (since 1995) GerES I 1985-1986 2,700 adults Münster (since 1977) GerES II GerES III 1990-1992 1997-1999 4,000 adults 730 children 4,800 adults Halle/S. (since 1995) GerES IV 2003-2006 1,790 children 150 sampling locations of GerES IV Ulm (since 1997) Yearly sampling of 150 students in each sampling location HBM experiences in Europe, November 30 th 2011, Brussels 3
Instruments GerES ESB HBM experiences in Europe, November 30 th 2011, Brussels 4
geometric mean (µg/l) Identification of higher exposed susceptible sub-groups 120 100 80 60 40 20 0 MnBP MiBP MBzP 5OH/5oxo- MEHP OH/oxo/cx- MiNP HBM experiences in Europe, November 30 th 2011, Brussels 5 * * Age groups 3-5 y. 6-8 y. * p<0.05 ** p<0.01 N = 599 9-11 y. 12-14 y. 20-29 y. specimen bank Metabolites of the phthalates DnBP, DiBP,BBzP, DEHP, and DINP *
Identification of a possible impact on health I Phthalates metabolites in urine of children aged 3 to 14 DEHP - Diethylhexylphthalat TDI*: 50 µg/(kg KG d) 1.4% DnBP - Di-n-butylphthalat TDI*: 10 µg/(kg KG d) DiBP - Di-iso-butylphthalat TDI*: 10 µg/(kg KG d) 9.1% 11.7 % * TDI: Tolerable Daily Intake 0,0 2,0 4,0 6,0 8,0 10,0 12,0 14,0 Percentages [%] exceeding the TDI* value HBM experiences in Europe, November 30 th 2011, Brussels 6
% of values Identification of a possible impact on health II weighted intake rates of 5 phthalates 85% Exceedance of TDI (DnBP) 25% 23% 20% 18% 15% 14% 13% 10% 10% 7% 5% 0% 1% up to 5 4% 3% 2% 2% 1% >5 >10 >15 >20 >25 >30 >35 >40 >45 >50 >55 to to to to to to to to to to to 10 15 20 25 30 35 40 45 50 55 60 4% >60 Phthalate intake (µg/kg BW/d) GerES (2003-2006): children aged 3 to 14 Weighting according to factors decribed by Earl Gray, US-EPA Intake rates: daily intake related to volume calculated by Wittassek HBM experiences in Europe, November 30 th 2011, Brussels 7
MiBP in urine (µg/l) MnBP in urine (µg/l) DnBP/DiBP consumption (kt/year) HBM best exposure data available DnBP/DiBP consumption and MnBP, MiBP in urine: 1988-2008 toys cosmetics toys restricted not restricted 1987 1989 1991 1993 1995 1997 1999 2001 2003 2005 2007 2009 data from ESB (Munster, n=60/year, analysed by Koch/Göen Univerity Erlangen), median; annual consumption of DnBP and DiBP in Western Europe. HBM experiences in Europe, November 30 th 2011, Brussels 8
BPA production, Germany (kt/year) BPA in urine (µg/l) HBM best exposure data available BPA production and BPA in urine: 1995-2008 1995 1997 1999 2001 2003 2005 2007 2009 data from ESB (Munster, n=60/ year, analysed by Holger Koch, IPA-DGUV), median; total annual volume of the production of manufactured goods, Germany. HBM experiences in Europe, November 30 th 2011, Brussels 9
Level in urine (µ/l) BPA in urine of children and young adults 5,0 P.50 2,5 0 GerES IV n = 599 aged 3-14 ESB (2006) n = 60 aged 20-29 NHANES (2003-2004) n = 314 aged 6-11 NHANES (2003-2004) n = 2.517 aged 6 60 HBM experiences in Europe, November 30 th 2011, Brussels 10
German Initiative to Support HBM German Chemical Industry Association (VCI) Federal Ministry for the Environment, Nature Conservation and Nuclear Safety Federal Environment Agency Steering Group: Representatives from industry, ministry and agency Expert Group: Scientists from research institutes, industry and federal agencies Communication Team: Representatives from industry, ministry and agency Development of chemical-analytical methods sensitive enough to detect environmental exposure HBM experiences in Europe, November 30 th 2011, Brussels 11
Systematizations of chemicals to be evaluated by HBM 120 chemicals with a) a potential health relevance or b) to which the general population might potentially be exposed to a considerable extent - Phthalates - Nano particles - Flame retardants - Aromatic amines - PFC and FC - Benzothiazoles - Chemicals used in cosmetics - Metales - Contaminants in food -... - Musk fragrances - Allergenic substances - SVHC candidates (Art. 57) Germany s next HBM candidates HBM experiences in Europe, November 30 th 2011, Brussels 12
Method development under work Substance Group 1: Phthalates and substitutes Substance Group 2: Flame retardent Substance Group 4: Cosmetics ingredients Substance Group 6: Sensitizing agents Substance Group 7: Benzothialzoles Substance Group 13: Others DPHP DINCH HBCD 3-(4-Methylbenzyliden)- campher (4-MBC) Methylendiphenyldiisocyanate (MDI) Mercaptobenzothiazol (MBT) 4-Nonylphenole tert-octylphenole Additional substances: VCI proposals Pyrrolidones NMP, NEP HBM experiences in Europe, November 30 th 2011, Brussels 13
DINCH (Diisononylcyclohexan-1,2-dicarboxylat) Use: substitute for DEHP and DINP, plasticiser in medical devices, toys, child care articles, products with food contact Production volume (EU): 100,000 t/y Toxicology: not mutagenic, carcinogenic or repro-toxic no peroxisome proliferation subchronic toxicity (rat) at 1000 mg/kg bw/d : - effects on kidneys - increased rates of thyroid hyperplasia TDI: 1 mg/kg bw/d (EFSA) CAS-Nr: 166412-78-8 Evaluation of a DEHP substitute Holger Koch, A Schütze, C Pälmke, J Angerer & T Brüning: HBM of DINCH, a phthalate substitute HBM experiences in Europe, November 30 th 2011, Brussels 14
geometric mean (µg/l) Germany/USA: Phthalate metabolites in urine of children 120 100 80 60 40 20 0 MnBP MiBP MBzP 5OH/5oxo-MEHP GerES (2003/06), age: 3-14 years NHANES III (2001/02), age: 6-11 years HBM experiences in Europe, November 30 th 2011, Brussels 15
COPHES partners 24 European Member States a well as Norway, Croatia and Switzerland Active DEMOCOPHES partners: 17 countries: BE, CY, DE, DK, PL, RO, SI, ES, HU, SE, UK, PT, CZ, SK, LU, IE, CH NO, FR, AT, HR involved as ad hoc partners HBM experiences in Europe, November 30 th 2011, Brussels 16 16
Thank you for your attention Information! Education! Regulation! USA, 2011, Washington marike.kolossa@uba.de HBM experiences in Europe, November 30 th 2011, Brussels 17