Basic legislation
We have put together an extensive catalogue
of the various legislative strands governing the biosciences
at the European level. The resources listed below include
European Parliament and Council directives and regulations,
as well as other related documents such as background, preparatory or explanatory documents related to legislative items (they are available in PDF or HTML formats).
These cover a variety of biosociety-related
issues, such as genetically modified organisms (GMOs), the
labelling of foodstuffs, health and safety aspects, and the
protection of intellectual property rights in the biotechnology
sector. You will also find details of the European Convention
on Biodiversity.
- Charter
of Fundamental Rights of the EU
-
Directive 2004/23/EC [
]
of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for
the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
- 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
- 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 repealing Council
Directive 90/220/EEC
- Directive 98/95/EC [
]
of the Council of 14 December 1998 amending, in respect of the consolidation of the internal market, genetically modified plant varieties and plant genetic resources, Directives 66/400/EEC, 66/401/EEC, 66/402/EEC, 66/403/EEC, 69/208/EEC, 70/457/EEC and 70/458/EEC on the marketing of beet seed, fodder plant seed, cereal seed, seed potatoes, seed of oil and fibre plants and vegetable seed and on the common catalogue of varieties of agricultural plant species
- Directive
98/79/EC [
]
of the European Parliament and of the Council of 27 October
1998 on in vitro diagnostic medical devices
- Directive 98/58/EC [
]
of the Council of 20 July 1998 concerning the protection of animals kept of a farming purposes
- Directive
98/44/EC [
]
of the European Parliament and of the Council of 6 July
1998 on the legal protection of biotechnological inventions
- Directive
95/46/EC of the European Parliament and of
the Council of 24 October 1995 on the protection of individuals
with regard to the processing of personal data and on the
free movement of such data.
- Directive
90/219/EC of the Council of 23 April 1990 on the contained use of genetically modified micro-organisms
- Directive 90/220/EEC
of the Council of 23 April 1990 on the deliberate release into the environment of genetically modified organisms
- Directive 86/609/EC of the Council of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes
- Regulation 1830/2003/EC [
] of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms. Regulation amending Directive 2001/18/EC.
- Regulation
1829/2003/EC of the European Parliament and of the Council [
]
of 22 September 2003 on genetically modified food and feed
- Regulation 50/2000/EC [
]
of the Commission of 10 January 2000 on the labelling of foodstuffs and food ingredients containing additives and flavourings that have been genetically modified or have been produced from genetically modified organisms.
- Regulation 49/2000/EC [
]
of the Commission of 10 January 2000 amending Council Regulation (EC) No 1139/98 concerning the compulsory indication on the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 79/112/EEC
- Regulation 1139/98/EC [
]
of the Council of 26 May 1998 concerning the compulsory indication of the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 79/112/EEC.
- Regulation 258/97/EC of the European Parliament ond of the Council of 27 January 1997 concerning novel foods and novel food ingredients
- Regulation 2100/94/EC of the Council of 27 July 1994 on Community plant variety rights
- Regulation 1467/94/EC of the Council of 20 June 1994 on the conservation, the characterisation, the collection and the utilisation of genetic resources in agriculture
- Regulation 2309/93/EC of the Council of 22 July 1993 concerning authorization of medicinal products for human and veterinary use (including such derived from genetically modified organisms).
- Regulation 90/679/EEC of the Council of 26 November 1990 concerns protection of workers from the risk related to exposure to biological agents at work.
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