Ethics of synthetic biology Nielsen, Linda Published in: Ethics of synthetic biology by The European Group on Ethics in Science and New Technologies to the European Commission DOI: 10.2796/10789 Publication date: 2010 Document version Publisher's PDF, also known as Version of record Citation for published version (APA): Nielsen, L. (2010). Ethics of synthetic biology. In Ethics of synthetic biology by The European Group on Ethics in Science and New Technologies to the European Commission European Commission. Opinion, No. 25 https://doi.org/10.2796/10789 Download date: 07. apr.. 2020 KAAJ090253AC Ethics of synthetic biology Ethics of synthetic Ethics of Opinion No synthetic biology BRUSSELS , 17 NOVEMBER 2009 How to obtain EU publications Publications for sale: • via EU Bookshop (http://bookshop.europa.eu); • from your bookseller by quoting the title, the publisher and/or ISBN number; • by contacting one of our sales agents directly. 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ISBN 978-92-79-13829-4 doi: 10.2796/10789 Printed in Luxembourg PRINTED ON WHITE CHLORINE -FREE P A P ER OPINION OF THE EUROPEAN GROUP ON ETHICS IN SCIENCE AND NEW TECHNOLOGIES TO THE EUROPEAN COMMISSION Ethics of synthetic biology No 25 17/11/2009 Reference: Request from President Barroso Rapporteurs: Rafael Capurro, Julian Kinderlerer, Paula Martinho da Silva and Pere Puigdomenech Rosell THE EUROPEAN GROUP ON ETHICS IN SCIENCE AND NEW TECHNOLOGIES (EGE), Having regard to the Treaty establishing the European Community, and in particular Article 6 of the common provisions concerning respect for fundamental rights, Having regard to the EC Treaty, and in particular Article 152 on public health, Having regard to the Charter of Fundamental Rights of the European Union of 28 September 2000, approved by the European Council in Biarritz on 14 October 2000 and proclaimed sol- emnly in Nice by the European Parliament, the Council and the Commission on 7 December 2000, and in particular Article 1 (Human dignity) and Article 3 (Right to the integrity of the person), (1) Having regard to 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, (2) Having regard to the Convention on the grant of European patents (European Patent Convention) of 5 October 1973 (text as amended by the act revising Article 63 EPC of 17 December 1991 and by decisions of the Administrative Council of the European Patent Organisation of 21 December 1978, 13 December 1994, 20 October 1995, 5 December 1996, 10 December 1998 and 27 October 2005 and comprising the provisionally applicable provisions of the act revising the EPC of 29 No- vember 2000), (3) Having regard to Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use, (4) Having regard to Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, (5) as amended in 2003 and 2005, Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 No- vember 2001 on the Community code relating to medicinal products for human use, (6) Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, (7) Having regard to Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, (8) (1) Official Journal C 364 of 18 November 2000, pp. 1–22. (2) OJ L 136 of 30 April 2004, pp. 1–33. (3) http://www.european-patent-office.org/legal/epc/e/ma1.html. (4) OJ L 159 of 27 June 2003, pp. 46–94. (5) OJ L 121 of 1 May 2001, pp. 34–44. (6) OJ L 311 of 28 November 2001, pp. 67–128. (7) OJ L 169 of 12 July 1993, pp. 1–43. (8) OJ L 189 of 20 July 1990, pp. 17–36. 3 Having regard to Directive 76/768/EC of the European Parliament and of the Council of 27 July 1976 on the approximation of the laws of the Members States relating to cosmetic products, (9) Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Coun- cil of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restric- tion 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) Ethics synthetic of biology 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, Having regard to Council Directive 80/68/EEC of 17 December 1979 on the protection of ground- water against pollution caused by certain dangerous substances, (10) Having regard to Council Directive 85/337/EEC of 27 June 1985 on the assessment of the effects of certain public and private projects on the environment, (11) Having regard to the Treaty of Amsterdam of 17 June 1997, and in particular to the sustainable development strategy (SDS) and Article 152 thereof concerning public health, Having regard to Council Directive 90/219/EEC of 23 April 1990 on the contained use of geneti- cally modified micro-organisms, as amended by Directive 98/81/EC, 12( ) Having regard to Council Directive 91/676/EEC of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources (13) in order to reduce overall use of nitrates, Having regard to Council Regulation (EEC) No 2078/92 of 30 June 1992 on agricultural produc- tion methods compatible with the requirements of the protection of the environment and the maintenance of the countryside, (14) Having regard to the United Nations Convention on Biological Diversity of 6 June 1992, ratified by the European Union on 25 October 1993, and to the Cartagena Protocol on Biosafety, ap- proved by the European Community on 11 September 2003, Having regard to Council Directive 96/61/EC of 24 September 1996 concerning integrated pol- lution prevention and control, (15) Having regard to the Kyoto Protocol, adopted on 11 December 1997 with the aim of reducing greenhouse gas emissions in order to fight global climate change (for the period 2005-2012), Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 Febru- ary 1998 concerning the placing of biocidal products on the market, (16) Having regard to the Commission communication ‘Directions towards sustainable agriculture’, (17) Having regard to the World Trade Organisation (WTO) Sanitary and Phytosanitary (SPS) Agree- ments of 1995, in particular Article 5.1, 5.2 and 5.3 thereof on health risk assessments, Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients, (18) (9) Official Journal L 262, 27.9.1976, p. 169. (10) OJ L 20, 26.1.1980. (11) OJ L 175, 5.7.1985. (12) OJ L 117, 8.5.1990. (13) OJ L 375, 31.12.1991. (14) OJ L 215, 30.7.1992. (15) OJ L 257, 10.10.1996. (16) OJ L 123, 24.4.1998. (17) COM(1999) 22, 27.1.1999. (18) OJ L 42, 14.2.1997. 4 Having regard to Council Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, in particular Article 6 thereof, (19) Having regard to Directive 2001/42/EC of the European Parliament and of the Council of 27 June 2001 on the assessment of the effects of certain plans and programmes on the envi- ronment, (20) Having regard to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and re- pealing Council Directive 90/220/EEC, (21) Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, 22( ) Having regard to Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on Transboundary movements of genetically modified organisms, 23( ) Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing