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2010 | OriginalPaper | Buchkapitel

17. European Regulations

verfasst von : Eleftheria Kampa, Thomas Dworak, Cornelius Laaser, Rodrigo Vidaurre

Erschienen in: Green and Sustainable Pharmacy

Verlag: Springer Berlin Heidelberg

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Abstract

This chapter reviews key existing policy instruments and approaches at EU level that are relevant to limiting the discharge of pharmaceutical products (PPs) into the aquatic environment. EU policies treated in this review address issues of authorisation of PPs, pollution prevention, wastewater treatment as well as monitoring of environmental quality. The analysis serves as a basis for the identification of potential gaps in current approaches. Future policy action might build on this assessment in order to reduce the risk of harmful impacts to the environment.

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Fußnoten
1
Guideline on the environmental risk assessment of medicinal products for human use. European Medicines Agency. London, 01 June 2006. Doc. Ref. EMEA/CHMP/SWP/4447/00.
 
2
Guidance for industry: Environmental Impact Assessment (EIAs) for veterinary medicinal products (VMPs). VICH International Cooperation for on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products. Phase I (VICH GL6) and Phase II (VICH GL38).
 
3
Minor changes to a drug marketing authorisation are in fact notifications, i.e. applicants just inform regulatory authorities and implement the changes without delay or approval. Examples are change in the name or address of the marketing authorisation holder or the manufacturer, change in the name of the medicinal product, change in the name of the active substance, minor change in the manufacturing process of the active substance, etc.
Examples of major changes to a drug marketing authorisation include change in the manufacturing process of the active substance that could affect efficacy, deletions in security information, deletions of contraindications, changes in adverse reactions, etc.
 
4
List I and II of Council Directive 76/464/EEC, Annex 1A and 1D of the Third North Sea Conference (3. NSC), Priority lists 1−3 identified under Council Regulation No 793/93, OSPAR list of individual candidate substances, HELCOM lists of priority substances, Pesticides prioritised under Council Directive 91/414/EEC, Monitored substances not mentioned on any of the lists above (based on the monitoring data obtained from Member States) (Klein et al. 1999, p. 7).
 
5
For example, trichloromethane (chloroform), trichloroethylene, tetrachloromethane, nonylphenol, naphthalene, mercury, dicloromethane, cadmium, chlorobenzene, anthracene, dicloroethane.
 
6
COM(2006) 398 final: Proposal for a Directive of the European Parliament and of the Council on environmental quality standards in the field of water policy and amending Directive 2000/60/EC.
 
7
European Parliament, Committee on the Environment, Public Health and Food Safety 2007: Compromise Amendments 1−3. Proposal for a Directive of the European Parliament and of the Council on environmental quality standards in the field of water policy and amending Directive 2000/60/EC. Draft report (PE 378.719v01-00), Anne Laperrouze. PE 386.558v01-00. 26.3.2007. http://​www.​europarl.​europa.​eu/​meetdocs/​2004_​2009/​documents/​dv/​659/​659305/​659305en.​pdf
 
8
Directive 2008/105/EC on environmental quality standards in the field of water policy, amend-ing and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC.
 
9
“Main” in terms of amount introduced to the aquatic environment.
 
10
Bavaria has included as an aim in its waste management plan and in its development programme to abandon the use of sewage sludge in agriculture (cf. speech of State Secretary Dr. Otmar Bernhard at the international symposium on sewage sludge in June 2008, http://​www.​stmugv.​bayern.​de/​aktuell/​reden/​detailansicht.​htm?​tid=​14883)
 
11
Nordrhein-Westphalen aims to increase the amount of sewage sludge disposed of thermally, cf. Europäischer Wirtschaftsdienst Wasser und Abwasser, Nr. 11, 11.03.2008.
 
Literatur
Zurück zum Zitat Callréus T (2005) The precautionary principle and pharmaceutical risk management. Drug Saf 28, 465−471 Callréus T (2005) The precautionary principle and pharmaceutical risk management. Drug Saf 28, 465−471
Zurück zum Zitat CEC – Commission of the European Communities (2004) Commission Staff Working Document on implementation of the Community Strategy for Endocrine Disrupters – a range of substances suspected of interfering with the hormone systems of humans and wildlife. COM (1999) 706 CEC – Commission of the European Communities (2004) Commission Staff Working Document on implementation of the Community Strategy for Endocrine Disrupters – a range of substances suspected of interfering with the hormone systems of humans and wildlife. COM (1999) 706
Zurück zum Zitat CHMP – Committee for Medicinal Products for Human Use (2006) Guideline on the environmental risk assessment of medicinal products for human use. CPMP/SWP/4447/00. European Medicines Agency, London CHMP – Committee for Medicinal Products for Human Use (2006) Guideline on the environmental risk assessment of medicinal products for human use. CPMP/SWP/4447/00. European Medicines Agency, London
Zurück zum Zitat Council Directive of 12 June 1986 on the protection of the environment, and in particular of the soil, when sewage sludge is used in agriculture (86/278/EEC). Official J L 181, 4/7/1986 Council Directive of 12 June 1986 on the protection of the environment, and in particular of the soil, when sewage sludge is used in agriculture (86/278/EEC). Official J L 181, 4/7/1986
Zurück zum Zitat Council Directive of 21 May 1991 concerning urban waste water treatment (91/271/EEC). Official J L 135, 30/5/1991 Council Directive of 21 May 1991 concerning urban waste water treatment (91/271/EEC). Official J L 135, 30/5/1991
Zurück zum Zitat Council Directive 96/29/EURATOM of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation. Official J L 159, 29/6/1996 Council Directive 96/29/EURATOM of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation. Official J L 159, 29/6/1996
Zurück zum Zitat Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control. Official J L 257, 10/10/1996 Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control. Official J L 257, 10/10/1996
Zurück zum Zitat Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure, and repealing Directive 84/466/Euratom. Official J L 180, 9/7/1997, 22–27 Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure, and repealing Directive 84/466/Euratom. Official J L 180, 9/7/1997, 22–27
Zurück zum Zitat Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption. Official Journal L 330, 5/12/1998 Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption. Official Journal L 330, 5/12/1998
Zurück zum Zitat Council Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Official J L 136, 30/4/2004 Council Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Official J L 136, 30/4/2004
Zurück zum Zitat CVMP – Committee for Medicinal Products for Veterinary Use 2007 Guideline on environmental impact assessment for veterinary medicinal products – in support of the VICH guidelines GL6 and GL38. EMEA/CVMP/ERA/418282/2005. European Medicines Agency, London CVMP – Committee for Medicinal Products for Veterinary Use 2007 Guideline on environmental impact assessment for veterinary medicinal products – in support of the VICH guidelines GL6 and GL38. EMEA/CVMP/ERA/418282/2005. European Medicines Agency, London
Zurück zum Zitat Directive 2000/60/EC of the European Parliament and of the Council establishing a framework for the Community action in the field of water policy. Official J L 327, 22/12/2000 Directive 2000/60/EC of the European Parliament and of the Council establishing a framework for the Community action in the field of water policy. Official J L 327, 22/12/2000
Zurück zum Zitat Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products. Official J L 311, 28/11/2001, 1–66 Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products. Official J L 311, 28/11/2001, 1–66
Zurück zum Zitat Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Official J L 311, 28/11/2001 pp. 67–128 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Official J L 311, 28/11/2001 pp. 67–128
Zurück zum Zitat Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. Official J L 136, 30/4/2004, 34–57 Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. Official J L 136, 30/4/2004, 34–57
Zurück zum Zitat Directive 2004/28/EC of the European Parliament and of the Council of (31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products. Official J L 136, 30/04/2004, 58–84 Directive 2004/28/EC of the European Parliament and of the Council of (31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products. Official J L 136, 30/04/2004, 58–84
Zurück zum Zitat Directive 2006/7/EC of the European Parliament and of the Council of 15 February 2006 concerning the management of bathing water quality and repealing Directive 76/160/EEC. Official J L 64, 4/3/2006 Directive 2006/7/EC of the European Parliament and of the Council of 15 February 2006 concerning the management of bathing water quality and repealing Directive 76/160/EEC. Official J L 64, 4/3/2006
Zurück zum Zitat Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration Official J L 372, 27/12/2006, pp. 19–31 Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration Official J L 372, 27/12/2006, pp. 19–31
Zurück zum Zitat Doerr-MacEwen NA, Haight ME (2006) Expert stakeholders’ views on the management of human pharmaceuticals in the environment. Environ Manag 38, 853–866CrossRef Doerr-MacEwen NA, Haight ME (2006) Expert stakeholders’ views on the management of human pharmaceuticals in the environment. Environ Manag 38, 853–866CrossRef
Zurück zum Zitat Holzmann T (2005) 2004 – ein wichtiges Jahr für die Umweltsicherheit von Arzneimitteln. Grußwort. In: Umweltbundesamt (ed.) 2005: Arzneimittel in der Umwelt – Zu Risiken und Nebenwirkungen fragen Sie das Umweltbundesamt. Texte 29-05. UBA. Dessau. 5–8 Holzmann T (2005) 2004 – ein wichtiges Jahr für die Umweltsicherheit von Arzneimitteln. Grußwort. In: Umweltbundesamt (ed.) 2005: Arzneimittel in der Umwelt – Zu Risiken und Nebenwirkungen fragen Sie das Umweltbundesamt. Texte 29-05. UBA. Dessau. 5–8
Zurück zum Zitat Jones OHA, Green PG, Voulvoulis N, Lester JN (2007) Questioning the excessive use of advanced treatment to remove organic micro-pollutants from waste water. Environ Sci Technol, 41 (14), 5085–5089CrossRef Jones OHA, Green PG, Voulvoulis N, Lester JN (2007) Questioning the excessive use of advanced treatment to remove organic micro-pollutants from waste water. Environ Sci Technol, 41 (14), 5085–5089CrossRef
Zurück zum Zitat Kemp R (2002) Treatment of an EU directive: UWWTD, Compliance with the Urban Waste Water Treatment in Germany, Spain, England and Wales, and The Netherlands. Books on Demand, Norderstedt, Germany Kemp R (2002) Treatment of an EU directive: UWWTD, Compliance with the Urban Waste Water Treatment in Germany, Spain, England and Wales, and The Netherlands. Books on Demand, Norderstedt, Germany
Zurück zum Zitat Klein W, Denzer S, Herrchen M, Lepper P, Mueller M, Sehrt R, Storm A, Volmer J (1999) Revised proposal for a list of priority substances in the context of the water framework directive (COMMPS Procedure). Schmallenberg (Deutschland), Fraunhofer-Insitut: 97 Klein W, Denzer S, Herrchen M, Lepper P, Mueller M, Sehrt R, Storm A, Volmer J (1999) Revised proposal for a list of priority substances in the context of the water framework directive (COMMPS Procedure). Schmallenberg (Deutschland), Fraunhofer-Insitut: 97
Zurück zum Zitat Knacker T, Liebig M, Moltmann JF (2006) Environmental risk assessment. In: Ternes TA, Joss A (eds.) Human Pharmaceuticals, Hormones and Fragrances. The Challenge of Micropollutants in Urban Water Management. IWA Publishing, London, Seattle, pp. 121–147 Knacker T, Liebig M, Moltmann JF (2006) Environmental risk assessment. In: Ternes TA, Joss A (eds.) Human Pharmaceuticals, Hormones and Fragrances. The Challenge of Micropollutants in Urban Water Management. IWA Publishing, London, Seattle, pp. 121–147
Zurück zum Zitat Koschorreck J, Apel P (2006) A brief overview on the legal background and the regulatory instruments of the environmental risk assessment for pharmaceuticals in the EU, USA, Japan, Australia and Canada. In: Ternes TA, Joss A (eds.) Human PharmaceuticalsHormones and Fragrances. The Challenge of Micropollutants in Urban Water Management. IWA Publishing, London, Seattle, pp. 107–119 Koschorreck J, Apel P (2006) A brief overview on the legal background and the regulatory instruments of the environmental risk assessment for pharmaceuticals in the EU, USA, Japan, Australia and Canada. In: Ternes TA, Joss A (eds.) Human PharmaceuticalsHormones and Fragrances. The Challenge of Micropollutants in Urban Water Management. IWA Publishing, London, Seattle, pp. 107–119
Zurück zum Zitat Kümmerer K (ed.) (2004) Pharmaceuticals in the Environment. Sources, Fate, Effects and Risks. 2nd edition, Springer, Berlin, Heidelberg, New York Kümmerer K (ed.) (2004) Pharmaceuticals in the Environment. Sources, Fate, Effects and Risks. 2nd edition, Springer, Berlin, Heidelberg, New York
Zurück zum Zitat Kümmerer K (ed.) (2008a) Pharmaceuticals in the Environment. Sources, Fate, Effects and Risks. 3rd edition, Springer, Berlin, Heidelberg, New York Kümmerer K (ed.) (2008a) Pharmaceuticals in the Environment. Sources, Fate, Effects and Risks. 3rd edition, Springer, Berlin, Heidelberg, New York
Zurück zum Zitat Kümmerer K (2008b).Strategies for reducing the input of pharmaceuticals into the environment. In: Kümmerer K (ed.) Pharmaceuticals in the Environment. Sources, Fate, Effects, and Risk. 3rd edition, Springer, Berlin, Heidelberg, New York, p. 411CrossRef Kümmerer K (2008b).Strategies for reducing the input of pharmaceuticals into the environment. In: Kümmerer K (ed.) Pharmaceuticals in the Environment. Sources, Fate, Effects, and Risk. 3rd edition, Springer, Berlin, Heidelberg, New York, p. 411CrossRef
Zurück zum Zitat Kümmerer K, Schuster A (2008) Substance flows associated with medical care – Significance of different sources. In: Kümmerer K (ed.) Pharmaceuticals in the Environment. Sources, Fate, Effects, and Risk. 3rd edition, Springer, Berlin, Heidelberg, New York, p. 43CrossRef Kümmerer K, Schuster A (2008) Substance flows associated with medical care – Significance of different sources. In: Kümmerer K (ed.) Pharmaceuticals in the Environment. Sources, Fate, Effects, and Risk. 3rd edition, Springer, Berlin, Heidelberg, New York, p. 43CrossRef
Zurück zum Zitat Montforts M (2005) Vorsorge vor Umweltrisiken in der Produktinformation von Veterinärpharmaka: Juristische Fallstricke und Methodologische Herausforderungen. In: Umweltbundesamt (ed.) Arzneimittel in der Umwelt – Zu Risiken und Nebenwirkungen fragen Sie das Umweltbundesamt. Texte 29-05, UBA, Dessau Montforts M (2005) Vorsorge vor Umweltrisiken in der Produktinformation von Veterinärpharmaka: Juristische Fallstricke und Methodologische Herausforderungen. In: Umweltbundesamt (ed.) Arzneimittel in der Umwelt – Zu Risiken und Nebenwirkungen fragen Sie das Umweltbundesamt. Texte 29-05, UBA, Dessau
Zurück zum Zitat Niquille A, Bugnon O (2008) Pharmaceuticals and environment: Role of community pharmacies. In: Kümmerer K (ed.) Pharmaceuticals in the Environment. Sources, Fate, Effects, and Risk. Springer, Berlin, Heidelberg, New York, p. 467CrossRef Niquille A, Bugnon O (2008) Pharmaceuticals and environment: Role of community pharmacies. In: Kümmerer K (ed.) Pharmaceuticals in the Environment. Sources, Fate, Effects, and Risk. Springer, Berlin, Heidelberg, New York, p. 467CrossRef
Zurück zum Zitat Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Official J L 136, 30/4/2004 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Official J L 136, 30/4/2004
Zurück zum Zitat Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. Official J L 396, 30/12/2006 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. Official J L 396, 30/12/2006
Zurück zum Zitat Schlimm J (2005) Umweltbewertung von Arzneimittel in Deutschland – ein kurzer Abriss. In: Umweltbundesamt (ed.) Arzneimittel in der Umwelt – Zu Risiken und Nebenwirkungen fragen Sie das Umweltbundesamt. Texte 29-05, UBA, Dessau, pp. 5–8 Schlimm J (2005) Umweltbewertung von Arzneimittel in Deutschland – ein kurzer Abriss. In: Umweltbundesamt (ed.) Arzneimittel in der Umwelt – Zu Risiken und Nebenwirkungen fragen Sie das Umweltbundesamt. Texte 29-05, UBA, Dessau, pp. 5–8
Zurück zum Zitat SRU – Sachverständigenrat für Umweltfragen (ed.) (2007) Arzneimittel in der Umwelt. Stellungnahme. Nr 12, April 2007. SRU, Berlin SRU – Sachverständigenrat für Umweltfragen (ed.) (2007) Arzneimittel in der Umwelt. Stellungnahme. Nr 12, April 2007. SRU, Berlin
Zurück zum Zitat Stuer-Lauridsen F, Birkved M, Hansen LP, LützhØft HC, Halling-Sørensen B (2000) Environmental risk assessment of human pharmaceuticals in Denmark after normal therapeutic use. Chemosphere, 40, 783–793CrossRef Stuer-Lauridsen F, Birkved M, Hansen LP, LützhØft HC, Halling-Sørensen B (2000) Environmental risk assessment of human pharmaceuticals in Denmark after normal therapeutic use. Chemosphere, 40, 783–793CrossRef
Zurück zum Zitat Umweltbundesamt (ed.) (2005) Arzneimittel in der Umwelt – Zu Risiken und Nebenwirkungen fragen Sie das Umweltbundesamt. Texte 29-05, UBA, Dessau Umweltbundesamt (ed.) (2005) Arzneimittel in der Umwelt – Zu Risiken und Nebenwirkungen fragen Sie das Umweltbundesamt. Texte 29-05, UBA, Dessau
Zurück zum Zitat Van-Camp L, Bujarrabal B, Gentile A-R, Jones RJA, Montanarella L, Olazabal C, Selvaradjou S-K (2004) Reports of the Technical Working Groups Established under the Thematic Strategy for Soil Protection. EUR 21319 EN/6, 872 pp. Office for Official Publications of the European Communities, Luxembourg Van-Camp L, Bujarrabal B, Gentile A-R, Jones RJA, Montanarella L, Olazabal C, Selvaradjou S-K (2004) Reports of the Technical Working Groups Established under the Thematic Strategy for Soil Protection. EUR 21319 EN/6, 872 pp. Office for Official Publications of the European Communities, Luxembourg
Zurück zum Zitat VICH (2001) Guidance for Industry – Environmental Impact Assessments (EIAs) for Veterinary Medicinal Products (VMPs) – Phase I, VICH GL6, Final Guidance. US Department of Health and Human Services, Food and Drug Administration, Rockville VICH (2001) Guidance for Industry – Environmental Impact Assessments (EIAs) for Veterinary Medicinal Products (VMPs) – Phase I, VICH GL6, Final Guidance. US Department of Health and Human Services, Food and Drug Administration, Rockville
Zurück zum Zitat Wenzel H, Larsen HF, Clauson-Kaas J, Høibye L, Jacobsen BN (2008) Weighing environmental advantages and disadvantages of advanced wastewater treatment of micro-pollutants using environmental life cycle assessment. Water Sci Technol 57(1), 27–32CrossRef Wenzel H, Larsen HF, Clauson-Kaas J, Høibye L, Jacobsen BN (2008) Weighing environmental advantages and disadvantages of advanced wastewater treatment of micro-pollutants using environmental life cycle assessment. Water Sci Technol 57(1), 27–32CrossRef
Metadaten
Titel
European Regulations
verfasst von
Eleftheria Kampa
Thomas Dworak
Cornelius Laaser
Rodrigo Vidaurre
Copyright-Jahr
2010
Verlag
Springer Berlin Heidelberg
DOI
https://doi.org/10.1007/978-3-642-05199-9_17