Biosafety Legislation

Access the main elements of the current regulations:

Spanish regulations
European regulations
International regulations
Technique with gloves and protective screen

Below you will find separated by areas of interest the most representative legislation in the field of biosafety:

Index:

European Regulations: Biological Risks

European legislation on biological risks.

  1. Directive 2000/54/EC of the European Parliament and of the Council on the protection of workers from risks related to occupational exposure to biological agents.
  2. Directive (EU) 2019/1833 amending Annexes I, III, V and VI of Directive 2000/54/EC of the European Parliament and of the Council.
  3. Recommendation (EU) 2020/403 on conformity assessment and market surveillance procedures in the context of the COVID-19 threat.
  4. Resolution of April 23, 2020 regarding personal protective equipment in the context of the health crisis caused by COVID-19.
  5. Directive (EU) 2020/739 amending Annex III of Directive 2000/54/EC of the European Parliament and of the Council as regards the inclusion of SARS-CoV-2 in the list of biological agents that are known human pathogens.
  6. Directive 2009/41/EC of the European Parliament and of the Council on the contained use of genetically modified microorganisms.

National Regulations: Biological Risks

Public and Labor Health

  1. Law 14/1986, General Health Law.
  2. Law 33/2011, General of Public Health.
  3. Law 31/1995, of Prevention of Labor Risks.
  4. RD 39/1997, Regulation of the Prevention Services
  5. Law 54/2003, of Prevention of Labor Risks
  6. Law 7/2003, of Health Protection.
  7. Law 18/2009, of Public Health.
  8. RD 664/1997, of protection of workers against the risks related to the Exposure to Biological Agents at work.
  9. RD 773/1997, of minimum safety and health provisions relating to the use by workers of personal protective equipment.
  10. RD 298/2009, on the protection of pregnant workers, who have given birth or are breastfeeding.
  11. Order ESS/1451/2013, establishing provisions for the prevention of injuries caused by sharp and cutting instruments in the health and hospital sector.

Genetically modified organisms

  1. Law 9/2003, which establishes the legal regime for the confined use, voluntary release and commercialization of genetically modified organisms.
  2. RD 178/2004, which approves the General Regulations for the development and execution of Law 9/2003, of April 25, 2003, which establishes the legal regime for the confined use, voluntary release and commercialization of genetically modified organisms.
  3. Decree 62/2015, establishing measures for the exercise of the competences of the Generalitat de Catalunya in the field of genetically modified organisms.

Animal and plant health and protection

  1. Law 8/2003, of animal health.
  2. Law 5/1995, of protection of animals used for experimentation and other scientific purposes.
  3. RD 53/2013, which establishes the basic rules applicable to the protection of animals used in experimentation and other scientific purposes, including teaching.
  4. Decree 214/1997, which regulates the use of animals for experimentation and other scientific purposes.
  5. Decree 2/2008, Rewriteen text of the Law for the protection of animals.
  6. Directive 2010/63/CE, on the protection of animals used for scientific purposes.
  7. Law 43/2002, of plant health.
  8. RD 58/2005, which establishes protection measures against the introduction and dissemination of harmful organisms for plants or plant products in the national territory and the European Community, as well as for export and transit to third countries.

Biological waste

  1. Law 22/2011, of waste and contaminated soil.
  2. Decree 27/1999, of sanitary waste management.
  3. Decree 1/2009, which approves the rewritten text of the Law regulating waste.
  4. Directive 2008/98/CE, of waste.

Transport of biological agents

  1. RD 97/2014, on the transport of perishable goods by road.
  2. RD 65/2006, requirements for the import and export of biological samples.

Bioprotection and Biocustody

  1. Law 8/2011, which establishes measures for the protection of critical infrastructures.
  2. RD 704/2011, which approves the Regulation for the protection of critical infrastructures.
  3. Order PCI/168/19, National Biocustody Plan.