Legal Basis

Work with genetically modified or pathogenic organisms is governed by several different laws and ordinances. The aim of this legal basis is on one side the protection of the population and the environment from hazardous effects of these organisms and on the other side the protection of the workers. Certain activities require consideration of other fields like chemical safety, radiation protection or production due to overlaps. The most important laws and ordinances (when working with organisms) are listed in the following text. The wordings of the laws and ordinances can also be found on the b-safe server. In addition, all herein mentioned internet addresses are also listed at the end of this document.

 

1.      Protection of the environment and of the population

Federal law on the control of transmissible diseases

Epidemiengesetz, (EpG)
Loi sur les épidémies

Legge sulle epidemie

Bundesamt für Gesundheit (BAG)
Office fédéral de la santé publique (OFSP)
Ufficio federale della sanità pubblica (UFSP)
Swiss Federal Office of Public Health (SFOPH)

Federal law on the protection of the environment

Umweltschutzgesetz (USG)
Loi sur la protection de l’environnement (LPE)
Legge sulla protezione dell’ambiente (LPAmb)

Federal law on the protection of the environment (not legally binding translation)

Bundesamt für Umwelt, Wald und Landschaft (BUWAL)
Office fédéral de l’environnement, des forêts et du paysage (OFEFP)
Ufficio federale dell’ambiente, delle foreste e del paesaggio (UFAFP)
Swiss Agency for the environment, forests and landscape (SAEFL)

Gene technology law German French Italian English (not legally binding translation)

The prime target of these three laws is the protection of humans, animals and the environment from hazardous effects of genetically modified or pathogenic organisms. Special consideration should be given to chapter 3 of the law on the protection of the environment: Hazardous effects to humans and the environment have to be prevented when working with organisms. Furthermore, the executive federal council foresees an authorization procedure or a mandatory registration of organisms when they are to be released into the environment or used for work in contained systems. The detailed description of the procedure is found in the ordinance on the contained use and in the ordinance on the release of organisms into the environment.

In the federal law on the control of transmissible diseases, special consideration should be given to articles 29 and 29a-e. This law regulates diseases that can be directly or indirectly transmitted by organisms to humans. For people working with or releasing these organisms into the environment, there is a notification or an authorization procedure, depending on the proposed use. Detailed information concerning this topic is given in the ordinance on the contained use and in the ordinance on the release of organisms into the environment.

Gene technology law: The purpose of this law is the protection of humans, animals and environment from abuses of gene technology. Moreover specific consideration should be taken in terms of biological diversity, dignity of living beings, freedom of choice for consumers or public information, just to mention a few. The law came into force on the 1st of January 2004. The adaptation of several ordinances is underway, including the ordinance on the contained use and the release of organisms.

Ordinance on the contained use

Einschliessungsverordnung (ESV)
Ordonnance sur l’utilisation confinée (OUC)
Ordinanza sull’impiego confinato (OIConf)
Ordinance on the contained use (CO, not legally binding translation)

Bundesamt für Gesundheit (BAG)
Office fédéral de la santé publique (OFSP)
Ufficio federale della sanità pubblica (UFSP)
Swiss Federal Office of Public Health (SFOPH)

Bundesamt für Umwelt, Wald und Landschaft (BUWAL)
Office fédéral de l’environnement, des forêts et du paysage (OFEFP)
Ufficio federale dell’ambiente, delle foreste e del paesaggio (UFAFP)
Swiss Agency for the environment, forests and landscape (SAEFL)

The ordinance on the contained use is based on the law of the protection of the environment and on the federal law on the control of transmissible diseases. It regulates the work with organisms in contained systems. For every work with organisms in research or diagnostic laboratories, in greenhouses, in animal and production facilities it is mandatory to notify, to record or to go through an authorization procedure, depending on the risk of the activity.. In every case a risk assessment has to be made and the hazards to humans and to the environment should be determined. Depending on the risk (class of activity) the proper safety measures have to be taken (Art. 10, appendix 4). The federal office of public health will give the authorization when the activities mainly endanger human health,. All other activities are authorized by the agency for the environment, forests and landscape. Supervision of the safety measures is done by cantonal authorities.

 

Ordinance on the release of organisms into the environment

Freisetzungsverordnung (FrSV)
Ordonnance sur la dissémination dans l’environnement (ODE)
Ordinanza sull’emissione deliberata nell’ambiente (OEDA)
Ordinance on the release of organisms into the environment (RO, not legally binding translation)

Bundesamt für Umwelt, Wald und Landschaft (BUWAL)
Office fédéral de l’environnement, des forêts et du paysage (OFEFP)
Ufficio federale dell’ambiente, delle foreste e del paesaggio (UFAFP)
Swiss Agency for the environment, forests and landscape (SAEFL)

The ordinance on the release of organisms into the environment covers all activities with organisms in the environment. Anybody releasing or using genetically modified or pathogenic organisms needs an authorization. The agency for the environment, forests and landscape is responsible for all releases into the environment (Art. 7). However, it can only authorize a field trial when the federal office of public health, the federal veterinary office and the federal office of agriculture agree. 

Anyone intending to place on the market genetically modified or pathogenic organisms for the use in the environment either for the first time or for a new use requires a permit. (Art. 13). The permit will be issued by the authority responsible for the corresponding product (e.g. vaccines: Swissmedic). However, the federal office of public health and the agency for the environment, forests and landscape have to agree. In certain cases the federal veterinary office and federal office of agriculture have to agree too.

 

Ordinance on the protection against hazards

Störfallverordnung (StFV)
Ordonnance sur les accidents majeurs (OPAM)
Ordinanza del 27 febbraio 1991 sulla protezione contro gli incidenti rilevanti (OPIR)

Bundesamt für Umwelt, Wald und Landschaft (BUWAL)
Office fédéral de l’environnement, des forêts et du paysage (OFEFP)
Ufficio federale dell’ambiente, delle foreste e del paesaggio (UFAFP)
Swiss Agency for the environment, forests and landscape (SAEFL)

This ordinance is based on the law of the protection of the environment. It regulates activities in facilities where work with genetically modified or pathogenic organisms of  the classes 3 and 4 are done (e.g. Bacillus anthracis, foot and mouth disease viruses, AIDS-virus etc.). The ordinance on the protection against hazards does not regulate the normal case, but is aimed to protect the general population and the environment of serious damage due to a hazard resulting from organisms. Any facility that falls under this ordinance, has to hand in a short report, which contains, besides other information, a risk assessment according to the ordinance on the contained use (Art. 5). Also important are the appendices 2.2 and 3.2, which regulate that e.g. a facility has to have a list where the organisms are stored and in which room work is done with them.

 

Ordinance on the examination of environment compatibility

Verordnung über die Umweltverträglichkeitsprüfung (UVPV)
Ordonnance relative à l’étude de l’impact sur l’environnement (OEIE)
Ordinanza concernente l’esame dell’impatto sull’ambiente (OEIA)

Bundesamt für Umwelt, Wald und Landschaft (BUWAL)
Office fédéral de l’environnement, des forêts et du paysage (OFEFP)
Ufficio federale dell’ambiente, delle foreste e del paesaggio (UFAFP)
Swiss Agency for the environment, forests and landscape (SAEFL)

For building or changing a facility where class 3 or 4 activities are performed, an examination of environment compatibility is necessary. The examination should demonstrate if the facility comply with the law of the protection of the environment (Art. 3). The report is submitted to the appropriate office (Art. 7-11). The proper procedure depends on cantonal laws (Art. 5, appendix point 80.8).

 

Laws on animal diseases

Bundesamt für Veterinärwesen (BVET)
Office vétérinaire fédéral (OVF)
Ufficio federale di veterinaria (UFV)
Federal veterinary office (FVO)

Institut für Viruskrankheiten und Immunprophylaxe (IVI)
Institute for virology and immunoprophylaxis (IVI)

Organisation mondiale de la santé animale
World organisation for animal health

Everybody who keeps or works with animal diseases has to take appropriate measures to ensure that no hazards for humans and animals can arise (according to article 27 paragraph 4 of the law on animal diseases). Special rules are in place for highly contagious animal diseases according to the ordinance on animal diseases (list A of the world organisation for animal health). In Switzerland, such organisms can be handled only at the institute for virology and immunoprophylaxis (Art.49,  ordinance on animal epidemics). In agreement with the involved cantons, the veterinary office can grant exemptions to this, however with the prescription of safety measures and controls. The procedures according to the ordinance on the contained use are the basis for granting the authorization.

 

2.   Protection of employees

Ordinance 4 of the working law

Staatssekretariat für Wirtschaft (SECO)
Secrétariat d’Etat à l’économie
Segretariato di Stato dell’economia
State Secretariat for Economic Affairs

Ordinance 4 of the working law regulates the procedures of planning and operating  a facility, in which group 3 and 4 micro-organisms are handled. Normally the responsible authority is the canton. Further information about the duties of the employers and the employees when working with or when exposed to pathogenic micro-organisms are regulated in the following ordinance:

Ordinance on the protection of employees against hazards generated by micro-organisms

Arbeitnehmerschutzverordnung (SAMV)
Ordonnance du 25 août 1999 sur la protection des travailleurs contre les risques liés aux microorganismes (OPTM)
Ordinanza del 25 agosto 1999 sulla protezione dei lavoratori dal pericolo derivante da microorganismi (OPLM)

SUVA German French Italian English

This ordinance stipulates a risk assessment and a notification to be combined with those of the ordinance of contained use. It regulates the duties of the employers and the employees. The work and exposition of employees to micro-organisms obliges the employer to apply the necessary safety measures. On a case to case basis further health protection measures for the employees have to be taken (e.g. vaccinations). The employer has to provide written instructions and has to regulate the procedure in case of an incident. The employees have to be informed about the hazards when working with micro-organisms and should receive an adequate training. The employees have to follow the instructions of the employer.

EKAS- and SUVA–guidelines

Eidgenössische Koordinationskommission für Arbeitssicherheit (EKAS)
Commission fédérale de coordination pour la sécurité au travail (CFST)
Commissione federale die coordinamento per la sicurezza sul lavoro (CFSL)
Federal coordination commission for occupational safety (FCOS)

The federal coordination commission for occupational safety (EKAS) and the SUVA can issue further guidelines for the work with pathogenic micro-organisms.

3.      Further legal documents to be considered on a case per case basis

Good manufacturing practice (GMP) at the production of pharmaceutical drugs

Good manufacturing practice (GMP) covers the production process of pharmaceutical drugs and ensures safe drugs. In Switzerland the legal basis is given by the law on pharmaceutical drugs. The controls of the production process of drugs are done by the Swissmedic.

Standards by Swissmedic German French Italian

Arzneimittelverordnung (VAM)
Ordonnance du 17 octobre 2001 sur les médicaments (OMéd)
Ordinanza del 17 ottobre 2001 sui medicamenti (OM)

International regulations for pharmaceuticals

If genetically modified or pathogenic organisms are used in the production process (e.g. production of insulin or of vaccines), the rules of the ordinance of contained use (ESV) and of the ordinance on the protection of employees against hazards generated by micro-organisms (SAMV) also apply, in addition to the rules of good manufacturing practice. The specific safety measures of production processes are found in appendix 4 table 4 of the ordinance of contained use.

Arbeitnehmerschutzverordnung (SAMV)
Ordonnance du 25 août 1999 sur la protection des travailleurs contre les risques liés aux microorganismes (OPTM)
Ordinanza del 25 agosto 1999 sulla protezione dei lavoratori dal pericolo derivante da microorganismi (OPLM)

Einschliessungsverordnung (ESV)
Ordonnance sur l’utilisation confinée (OUC)
Ordinanza sull’impiego confinato (OIConf)
Ordinance on the contained use (CO, not legally binding translation)

Ordinance on good laboratory practice (GLPV)

Verordnung über die gute Laborpraxis (GLPV)
Ordonnance sur les bonnes pratiques de laboratoire (OBPL)
Ordinanza sulla buona prassi di laboratorio (OBPL)

This ordinance lays down the principles of good laboratory practice (GLP) as quality requirements for tests in the production process. It also rules the surveillance of these requirements (Art. 1). It is based on the law on pharmaceutical drugs and on the law on chemicals. It represents a quality system to ensure the outflow of tests (e.g. animal testing of drugs). Furthermore it controls the conditions under which the test are planned, carried out and supervised. Finally, it  regulates the writing, archiving and reporting of the results of these tests (Art.3 Para. 1).

Gene therapy and clinical trials with drugs that contain genetically modified organisms (GMO)

Verordnung über klinische Versuche am Menschen (VKlin)
Ordonnance sur les essais cliniques de produits thérapeutiques (OClin)

Ordinanza sulle sperimentazioni cliniche con agenti terapeutici (OClin)

The legal basis for these trials is found in the ordinance on clinical trial with humans. Gene therapy trials and clinical trials with GMO need an authorization of Swissmedic. The application for the authorization has to cover the following topics (besides others): Quality management, safety assessment for the patients, safety assessment for the nursing staff, for the general population and the environment. Swissmedic issues an authorization if the quality and safety of the trial is ensured and if the swiss expert committee for biosafety, the federal office of public health and the agency for the environment, forests and landscape give a positive vote.

Ordinance on the swiss expert committee for biosafety (EFBS)

Eidgenössische Fachkommission für biologische Sicherheit (EFBS)
Commission fédérale d’experts pour la sécurité biologique (CFSB)
Commissione federale per la sicurezza biologica (CFSB)
Swiss expert committee for biosafety

The swiss expert committee for biosafety is a commission of the federal administration and advises the executive federal council and the administration with respect to questions of biological safety. The commission takes a stand in questions about work in contained systems, about releases into the environment and about the use of genetically modified organisms.

 

Radiation protection

Strahlenschutzverordnung (StSV)
Ordonnance du 22 juin 1994 sur la radioprotection (ORaP)
Ordinanza del 22 giugno 1994 sulla radioprotezione (ORaP)

Bundesamt für Gesundheit (BAG)
Office fédéral de la santé publique (OFSP)
Ufficio federale della sanità pubblica (UFSP)
Swiss Federal Office of Public Health (SFOPH)

Paul-Scherrer-Institut (PSI) German English

An important overlap with biosafety topics is radiation protection. Radioactive substances are very often used in research laboratories. According to the ordinance on radiation protection, all facilities working with radioactive substances are obliged to have a radiation protection officer. Instructions will be given to these people in a 2 week course with final exam. Further information is found in the ordinance on radiation protection and in the ordinance about activities with open radioactive sources.

Umgang mit offenen radioaktiven Strahlenquellen
Ordonnance du 21 novembre 1997 sur l’utilisation des sources radioactives non scellées
Ordinanza del 21 novembre 1997 concernente la manipolazione di sorgenti radioattive non sigillate

 

 Chemical safety

Bundesamt für Gesundheit (BAG)
Office fédéral de la santé publique (OFSP)
Ufficio federale della sanità pubblica (UFSP)
Swiss Federal Office of Public Health (SFOPH)

Giftverordnung (GV)
Ordonnance du 19 septembre 1983 sur les toxiques (Otox)
Ordinanza del 19 settembre 1983 sui veleni (OV)

Verordnung über Sicherheitsdatenblätter für Gifte vom 9. November 1998
Ordonnance du 9 novembre 1998 sur les fiches de données de sécurité relatives aux toxiques et aux substances dangereuses pour l’environnement
Ordinanza del 9 novembre 1998 sulle schede di dati di sicurezza per veleni e sostanze pericolose per l’ambiente

Very often chemicals underlying special rules are used in laboratories and production plants. The chemicals are divided in 5 hazard classes depending on the effect of the poison. Class 1 is the most hazardous class. The assignment of a chemical to a class is in most cases determined according to the acute-oral lethal dose in rats (e.g. class 1: up to 5 mg substance/kg bodyweight).

It is required that every facility has a person responsible for the proper use of chemicals. The responsible person should be trained in the field. Anybody using chemical substances of class 1 or 2 needs a certificate for chemicals and for repeated use a chemical handbook I or II is required (Art. 18). Anybody who wants to get a general permission or a chemical handbook, has to submit an application to the cantonal authority. Federal facilities have to apply at the federal office of public health.

„Material Safety Data Sheets“ for all chemicals are available from the manufacturer. In these data sheets all necessary information for the proper use with a certain substance is indicated.

 

Transport

Transport rules are according to national and international regulations.

Ordinance on the responsible person for the transport of dangerous goods on roads, by train and on the water:
Gefahrengutbeauftragtenverordnung, (GGBV)
Ordonnance sur les conseillers à sécurité (OCS)
Ordinanza sugli addetti alla sicurezza (OSAS)

Ordinance on the transport of dangerous goods on roads:
Beförderung gefährlicher Güter auf der Strasse (SDR)
Ordonnance du 29 novembre 2002 relative au transport des marchandises dangereuses par route (SDR)
Ordinanza del 29 novembre 2002 concernente il trasporto di merci pericolose su strada (SDR)

European agreement on the transport of dangerous goods on roads (ADR)

Ordinance on the transport of dangerous goods by train:
Beförderung gefährlicher Güter mit der Eisenbahn (RSD)
Ordonnance du 3 décembre 1996 relative au transport des marchandises dangereuses par chemin de fer (RSD)
Ordinanza del 3 dicembre 1996 concernente il trasporto di merci pericolose per ferrovia (RSD)

Ordinance for international transport of dangerous goods by train (RID)

Regulations for the transport by air traffic:
Lufttransportreglement (LTrR)
Règlement de transport aérien du 3 octobre 1952 (RTA)
Regolamento di trasporto aereo del 3 ottobre 1952 (RTrA)

Regulations of the International Civil Aviation Organisation (ICAO)

International Air Transport Association (IATA)

Responsibility for the enforcement of the rules is given to the following federal offices: The Swiss federal roads authority (ASTRA), the Federal office of transport and the Federal office for civil aviation (FOCA). The transport rules are valid for genetically modified organisms and infectious substances, which can spread diseases or if there is the possibility of an exposition. No specific rules apply when it can be assumed that no disease can be spread. Special packaging rules apply for genetically modified organisms and infectious substances. The World Health Organization (WHO) has issued guidelines for the transport and the packaging of infectious and diagnostic material. These guidelines are also valid in Switzerland.

Bundesamt für Strassen (ASTRA)
Office fédéral des routes
Ufficio federale delle strade
Swiss federal roads authority

Bundesamt für Verkehr (BAV)
Office fédéral des transports
Ufficio federale dei trasporti
Federal office of transport

Bundesamt für Zivilluftfahrt (BAZL)
Office fédéral de l’aviation civile (OFAC)
Ufficio federale dell’aviazione civile (UFAC)
Federal office for civil aviation (FOCA)

 

Transportfirmen – Entreprises de transport - Transport companies:

DHL

Natural AG

 

Verpackungsfirmen – Entreprises d’emballage – Packaging companies:

Air Sea Containers LTD

CDF Emballage SA, La Chaux-de-Fonds 

World health organisation (WHO)

 

Export

Staatssekretariat für Wirtschaft (SECO)
Secrétariat d’Etat à l’économie
Segretariato di Stato dell’economia
State Secretariat for Economic Affairs

Aus-, Ein- und Durchfuhr zivil und militärisch verwendbarer Güter (GKV)
Ordonnance du 25 juin 1997 sur l’exportation, l’importation et le transit des biens utilisables à des fins civiles et militaires et des biens militaires spécifiques (Ordonnance sur le contrôle des biens, OCB) 
Ordinanza del 25 giugno 1997 sull’esportazione, l’importazione e il transito dei beni utilizzabili a fini civili e militari e dei beni militari speciali (Ordinanza sul controllo dei beni a duplice impiego, OBDI)

For the export of pathogenic organisms, biologically active material and toxins a permission of the state secretariat for economic affairs (seco) is required. This is the case if they are mentioned in appendix 2 of the ordinance on export, import and transit of civil and military goods. Normally laboratories can apply for a general export permission. However, in most cases an import permission is required by the country of import. As a rule, the permission is supplied by the addressee.

Responsibilities:               

Sender:            Packaging, label, documentation (forms),
                        transport company, export permission

Addressee:       Permission for import

 

Import

According to the ordinance on the import, transit and export of animals and animal products (EADV) certain animal species as well as animal pathogens require a permission of the Federal veterinary office (Art. 57).

Bundesamt für Veterinärwesen (BVET)
Office vétérinaire fédéral (OVF)
Ufficio federale di veterinaria (UFV)
Federal veterinary office (FVO)

The import of plant pathogens is regulated in the ordinance on plant protection (Paragraph 1). Prohibited are the import of organisms that pose a special threat (Art.4). In these cases, exemptions can be granted by the federal office of agriculture for research, breeding, reproduction and diagnostic purposes according to appendix 1 part A and appendix 2 part A.. Permission can be combined with special requirements.

Ordinance on plant protection
Pflanzenschutzverordnung (PSV)
Ordonnance du 28 février 2001 sur la protection des végétaux (OPV)
Ordinanza del 28 febbraio 2001 sulla protezione dei vegetali (OPV)

The import of human pathogens is not strictly regulated. The federal office of public health can give an import statement if needed.

 

Food

According to the food ordinance (LMV, Art.15), all food stuffs which contain GMO or which are derived from them have to be authorized by the federal office of public health. Authorization is given when a hazard to human health and to the environment can be excluded according to the current scientific knowledge. The criteria for the risk assessment of genetically modified foodstuffs are to be found in the ordinance on the authorization procedure of genetically modified foodstuffs, food additives and food processing aids (VBGVO)

Verordnung vom 19 November über das Bewilligungsverfahren von GVO-Lebensmitteln, GVO-Zusatzstoffen und GVO-Verarbeitungshilfsstoffen (VBGVO)
Ordonnance du 19 novembre 1996 concernant la procédure d’autorisation relative aux denrées alimentaires OGM, aux additifs OGM et aux auxiliaires technologiques
OGM (OAOGM)

Ordinanza del 19 novembre 1996 concernente la procedura di autorizzazione per le derrate alimentari OMG, gli additivi OMG e le sostanze ausiliarie di lavorazione
OMG (OPOMG)

1.                                

Feed

Futtermittelverordnung
Ordonnance sur les aliments pour animaux
Ordinanza sugli alimenti per animali

Bundesamt für Landwirtschaft (BLW)
Office fédéral de l’agriculture
Ufficio federale dell’agricoltura

According to the ordinance on feedstuffs (Art. 6) genetically modified primary products and single feeds are permitted, if they appear in the list of authorized primary products and single feeds (GMO-feed list) and if they are in accordance with the appropriate regulations.

 

Standards:

Schweizerische Normenvereinigung (SNV)
Association Suisse de Normalisation avec service international

CEN: CEN is the european committee for standardization. For the realisation of a common market the European union needs common standards which all member countries comply with. These standards are an important source for information and are checked every 5 years if they are still up to date. The formal structure of the documents is standardized. CEN standards are enacted for different topics such as waste disposal, transport, environment etc. Switzerland is a member of CEN and introduces the same standards in Switzerland, when they are in force in the EU. Swiss standards are named as SN ENxxxx.

ISO: International Organization for Standardization: This organisation is constituted by representatives of 147 countries. The main office is located in Geneva. The standards of ISO and CEN are not all the time identical. However, the is a harmonization procedure going on. Especially, ISO standards are used for the development and production of products. Mostly known are the standards of the ISO 9000 family (quality management) and ISO14000 (environmental management). In due time, ISO has developed more than 13000 technical standards.

 

List of all Internet Links

Protection of the environment and of the population

Federal law on the control of transmissible diseases

Epidemiengesetz, (EpG): http://www.admin.ch/ch/d/sr/c818_101.html
Loi sur les épidémies
http://www.admin.ch/ch/f/rs/c818_101.html
Legge sulle epidemie: http://www.admin.ch/ch/i/rs/c818_101.html

Bundesamt für Gesundheit (BAG): http://www.bag.admin.ch
Office fédéral de la santé publique (OFSP): http://www.bag.admin.ch/f/index.htm
Ufficio federale della sanità pubblica (UFSP): http://www.bag.admin.ch/i/index.htm
Swiss Federal Office of Public Health (SFOPH): http://www.bag.admin.ch/e/index.htm

 

Federal law on the protection of the environment

Umweltschutzgesetz (USG): http://www.admin.ch/ch/d/sr/c814_01.html
Loi sur la protection de l’environnement (LPE): http://www.admin.ch/ch/f/rs/c814_01.html
Legge sulla protezione dell’ambiente (LPAmb): http://www.admin.ch/ch/i/rs/c814_01.html

Federal law on the protection of the environment (not legally binding translation):  http://www.umwelt-schweiz.ch/imperia/md/content/stobobio/biotech/divers/2.pdf

Bundesamt für Umwelt, Wald und Landschaft (BUWAL): http://www.umwelt-schweiz.ch/
Office fédéral de l’environnement, des forêts et du paysage (OFEFP): http://www.umwelt-schweiz.ch/buwal/fr/index.html
Ufficio federale dell’ambiente, delle foreste e del paesaggio (UFAFP): http://www.umwelt-schweiz.ch/buwal/it/index.html
Swiss Agency for the environment, forests and landscape (SAEFL): http://www.umwelt-schweiz.ch/buwal/eng/index.html

 

Gene technology law:

Deutsch: http://www.admin.ch/ch/d/sr/c814_91.html

Französisch: http://www.admin.ch/ch/f/rs/c814_91.html

Italienisch: http://www.admin.ch/ch/i/rs/c814_91.html

Englisch (not legally binding translation): http://www.umwelt-schweiz.ch/imperia/md/content/stobobio/biotech/17.pdf

 

Ordinance on the contained use

Einschliessungsverordnung (ESV): http://www.admin.ch/ch/d/sr/c814_912.html
Ordonnance sur l’utilisation confinée (OUC): http://www.admin.ch/ch/f/rs/c814_912.html
Ordinanza sull’impiego confinato (OIConf)
: http://www.admin.ch/ch/i/rs/c814_912.html
Ordinance on the contained use (CO, not legally binding translation): http://www.umwelt-schweiz.ch/imperia/md/content/stobobio/biotech/ouc/39.pdf

Bundesamt für Gesundheit (BAG): http://www.bag.admin.ch
Office fédéral de la santé publique (OFSP): http://www.bag.admin.ch/f/index.htm
Ufficio federale della sanità pubblica (UFSP): http://www.bag.admin.ch/i/index.htm
Swiss Federal Office of Public Health (SFOPH): http://www.bag.admin.ch/e/index.htm

Bundesamt für Umwelt, Wald und Landschaft (BUWAL): http://www.umwelt-schweiz.ch/
Office fédéral de l’environnement, des forêts et du paysage (OFEFP): http://www.umwelt-schweiz.ch/buwal/fr/index.html
Ufficio federale dell’ambiente, delle foreste e del paesaggio (UFAFP): http://www.umwelt-schweiz.ch/buwal/it/index.html
Swiss Agency for the environment, forests and landscape (SAEFL): http://www.umwelt-schweiz.ch/buwal/eng/index.html

 

Ordinance on the release of organisms into the environment

Freisetzungsverordnung (FrSV): http://www.admin.ch/ch/d/sr/c814_911.html
Ordonnance sur la dissémination dans l’environnement (ODE): http://www.admin.ch/ch/f/rs/c814_911.html
Ordinanza sull’emissione deliberata nell’ambiente (OEDA): http://www.admin.ch/ch/i/rs/c814_911.html
Ordinance on the release of organisms into the environment (RO, not legally binding translation):
http://www.umwelt-schweiz.ch/imperia/md/content/stobobio/biotech/odeb/14.pdf

Bundesamt für Umwelt, Wald und Landschaft (BUWAL): http://www.umwelt-schweiz.ch/
Office fédéral de l’environnement, des forêts et du paysage (OFEFP): http://www.umwelt-schweiz.ch/buwal/fr/index.html
Ufficio federale dell’ambiente, delle foreste e del paesaggio (UFAFP): http://www.umwelt-schweiz.ch/buwal/it/index.html
Swiss Agency for the environment, forests and landscape (SAEFL): http://www.umwelt-schweiz.ch/buwal/eng/index.html

 

Ordinance on the protection against hazards

Störfallverordnung (StFV): http://www.admin.ch/ch/d/sr/c814_012.html
Ordonnance sur les accidents majeurs (OPAM): http://www.admin.ch/ch/f/rs/c814_012.html
Ordinanza del 27 febbraio 1991 sulla protezione contro gli incidenti rilevanti (OPIR): http://www.admin.ch/ch/i/rs/c814_012.htmlhttp://www.admin.ch/ch/i/rs/c814_012.html

Bundesamt für Umwelt, Wald und Landschaft (BUWAL): http://www.umwelt-schweiz.ch/
Office fédéral de l’environnement, des forêts et du paysage (OFEFP): http://www.umwelt-schweiz.ch/buwal/fr/index.html
Ufficio federale dell’ambiente, delle foreste e del paesaggio (UFAFP): http://www.umwelt-schweiz.ch/buwal/it/index.html
Swiss Agency for the environment, forests and landscape (SAEFL): http://www.umwelt-schweiz.ch/buwal/eng/index.html

 

Ordinance on the examination of environment compatibility

Verordnung über die Umweltverträglichkeitsprüfung (UVPV): http://www.admin.ch/ch/d/sr/814_011/index.html
Ordonnance relative à l’étude de l’impact sur l’environnement (OEIE): http://www.admin.ch/ch/f/rs/814_011/index.html
Ordinanza concernente l’esame dell’impatto sull’ambiente (OEIA): http://www.admin.ch/ch/i/rs/814_011/index.html

Bundesamt für Umwelt, Wald und Landschaft (BUWAL): http://www.umwelt-schweiz.ch/
Office fédéral de l’environnement, des forêts et du paysage (OFEFP): http://www.umwelt-schweiz.ch/buwal/fr/index.html
Ufficio federale dell’ambiente, delle foreste e del paesaggio (UFAFP): http://www.umwelt-schweiz.ch/buwal/it/index.html
Swiss Agency for the environment, forests and landscape (SAEFL): http://www.umwelt-schweiz.ch/buwal/eng/index.html

 

Laws on animal diseases

Bundesamt für Veterinärwesen (BVET): http://www.bvet.admin.ch/
Office vétérinaire fédéral (OVF): http://www.bvet.admin.ch/0_navigation-f/0_index-intern.html
Ufficio federale di veterinaria (UFV): http://www.bvet.admin.ch/0_navigation-f/0_index-intern.html
Federal veterinary office (FVO): http://www.bvet.admin.ch/0_navigation-f/0_index-intern.html

Institut für Viruskrankheiten und Immunprophylaxe (IVI): http://adminsrv.admin.ch/ivi/
Institute for virology and immunoprophylaxis (IVI): http://adminsrv.admin.ch/ivi/index_en.html

Organisation mondiale de la santé animale: http://www.oie.int/fr/fr_index.htm
World organisation for animal health: http://www.oie.int/eng/en_index.htm

 

Protection of employees

Ordinance 4 of the working law

Staatssekretariat für Wirtschaft (SECO): http://www.seco-admin.ch/
Secrétariat d’Etat à l’économie: http://www.seco-admin.ch/index.html?lang=fr&PHPSESSID=766fdc89eb1341e90841c7003e815d1b
Segretariato di Stato dell’economia: http://www.seco-admin.ch/index.html?lang=it
State Secretariat for Economic Affairs: http://www.seco-admin.ch/index.html?lang=en

 

Ordinance on the protection of employees against hazards generated by micro-organisms

Arbeitnehmerschutzverordnung (SAMV): http://www.admin.ch/ch/d/sr/c832_321.html
Ordonnance du 25 août 1999 sur la protection des travailleurs contre les risques liés aux microorganismes (OPTM): http://www.admin.ch/ch/f/rs/c832_321.html
Ordinanza del 25 agosto 1999 sulla protezione dei lavoratori dal pericolo derivante da microorganismi (OPLM): http://www.admin.ch/ch/i/rs/c832_321.html

 

SUVA
Deutsch: http://www.suva.ch/
Französisch: http://www.suva.ch/fr/home.htm
Italienisch: http://www.suva.ch/it/home.htm
Englisch: http://www.suva.ch/en/home.htm

 

EKAS- and SUVA–guidelines

Eidgenössische Koordinationskommission für Arbeitssicherheit (EKAS): http://www.cfst.ch/index.php
Commission fédérale de coordination pour la sécurité au travail (CFST): http://www.cfst.ch/index-fr.php
Commissione federale die coordinamento per la sicurezza sul lavoro (CFSL): http://www.cfst.ch/index-it.php
Federal coordination commission for occupational safety (FCOS): http://www.cfst.ch/index-uk.php

 

Further legal documents to be considered on a case per case basis

Good manufacturing practice (GMP) at the production of pharmaceutical drugs

Standards by Swissmedic: http://www.swissmedic.ch/?lang=2&lang_old=4&lang_old=3
Deutsch: http://www.swissmedic.ch
Französisch: http://www.swissmedic.ch/?lang=3
Italienisch: http://www.swissmedic.ch/?lang=4&lang_old=3

Arzneimittelverordnung (VAM): http://www.admin.ch/ch/d/sr/c812_212_21.html
Ordonnance du 17 octobre 2001 sur les médicaments (OMéd): http://www.admin.ch/ch/f/rs/c812_212_21.html
Ordinanza del 17 ottobre 2001 sui medicamenti (OM): http://www.admin.ch/ch/i/rs/c812_212_21.html

International regulations for pharmaceuticals: http://pharmacos.eudra.org/

Arbeitnehmerschutzverordnung (SAMV): http://www.admin.ch/ch/d/sr/c832_321.html;
Ordonnance du 25 août 1999 sur la protection des travailleurs contre les risques liés aux microorganismes (OPTM): http://www.admin.ch/ch/f/rs/c832_321.html;
Ordinanza del 25 agosto 1999 sulla protezione dei lavoratori dal pericolo derivante da microorganismi (OPLM): http://www.admin.ch/ch/i/rs/c832_321.html;

Einschliessungsverordnung (ESV): http://www.admin.ch/ch/d/sr/c814_912.html
Ordonnance sur l’utilisation confinée (OUC): http://www.admin.ch/ch/f/rs/c814_912.html
Ordinanza sull’impiego confinato (OIConf)
: http://www.admin.ch/ch/i/rs/c814_912.html
Ordinance on the contained use (CO, not legally binding translation): http://www.umwelt-schweiz.ch/imperia/md/content/stobobio/biotech/ouc/39.pdf

Ordinance on good laboratory practice (GLPV)

Verordnung über die gute Laborpraxis (GLPV): http://www.admin.ch/ch/d/sr/c813_016_5.html
Ordonnance sur les bonnes pratiques de laboratoire (OBPL): http://www.admin.ch/ch/f/rs/c813_016_5.html
Ordinanza sulla buona prassi di laboratorio (OBPL):  http://www.admin.ch/ch/i/rs/c813_016_5.html

Good laboratory practice (GLP: http://www.glp.admin.ch/)

 

Gene therapy and clinical trials with drugs that contain genetically modified organisms (GMO)

Verordnung über klinische Versuche am Menschen (VKlin): http://www.admin.ch/ch/d/sr/c812_214_2.html
Ordonnance sur les essais cliniques de produits thérapeutiques (OClin):
http://www.admin.ch/ch/f/rs/c812_214_2.html
Ordinanza sulle sperimentazioni cliniche con agenti terapeutici (OClin):  http://www.admin.ch/ch/i/rs/c812_214_2.html

 

Ordinance on the swiss expert committee for biosafety (EFBS)

Eidgenössische Fachkommission für biologische Sicherheit (EFBS): http://www.efbs.ch
Commission fédérale d’experts pour la sécurité biologique (CFSB): http://www.umwelt-schweiz.ch/buwal/fr/fachgebiete/fg_efbs/index.html
Commissione federale per la sicurezza biologica (CFSB): http://www.umwelt-schweiz.ch/buwal/it/fachgebiete/fg_efbs/index.html
Swiss expert committee for biosafety: http://www.umwelt-schweiz.ch/buwal/eng/fachgebiete/fg_efbs/index.html

 

Radiation protection

Strahlenschutzverordnung (StSV): http://www.admin.ch/ch/d/sr/c814_501.html
Ordonnance du 22 juin 1994 sur la radioprotection (ORaP): http://www.admin.ch/ch/f/rs/c814_501.html
Ordinanza del 22 giugno 1994 sulla radioprotezione (ORaP):  http://www.admin.ch/ch/i/rs/c814_501.html

Bundesamt für Gesundheit (BAG): http://www.bag.admin.ch
Office fédéral de la santé publique (OFSP): http://www.bag.admin.ch/f/index.htm
Ufficio federale della sanità pubblica (UFSP): http://www.bag.admin.ch/i/index.htm
Swiss Federal Office of Public Health (SFOPH): http://www.bag.admin.ch/e/index.htm

Paul-Scherrer-Institut (PSI)
Deutsch: http://www.psi.ch/
Englisch: http://www.psi.ch/index_e.shtml

Umgang mit offenen radioaktiven Strahlenquellen: http://www.admin.ch/ch/d/sr/c814_554.html
Ordonnance du 21 novembre 1997 sur l’utilisation des sources radioactives non scellées: http://www.admin.ch/ch/f/rs/c814_554.html
Ordinanza del 21 novembre 1997 concernente la manipolazione di sorgenti radioattive non sigillate:  http://www.admin.ch/ch/i/rs/c814_554.html

 

 Chemical safety

Bundesamt für Gesundheit (BAG): http://www.bag.admin.ch
Office fédéral de la santé publique (OFSP): http://www.bag.admin.ch/f/index.htm
Ufficio federale della sanità pubblica (UFSP): http://www.bag.admin.ch/i/index.htm
Swiss Federal Office of Public Health (SFOPH): http://www.bag.admin.ch/e/index.htm

Giftverordnung (GV): http://www.admin.ch/ch/d/sr/c813_01.html
Ordonnance du 19 septembre 1983 sur les toxiques (Otox): http://www.admin.ch/ch/f/rs/c813_01.html
Ordinanza del 19 settembre 1983 sui veleni (OV): http://www.admin.ch/ch/i/rs/c813_01.html

Verordnung über Sicherheitsdatenblätter für Gifte vom 9. November 1998: http://www.admin.ch/ch/d/sr/c813_013_4.html
Ordonnance du 9 novembre 1998 sur les fiches de données de sécurité relatives aux toxiques et aux substances dangereuses pour l’environnement: 
 http://www.admin.ch/ch/f/rs/c813_013_4.html
Ordinanza del 9 novembre 1998 sulle schede di dati di sicurezza per veleni e sostanze pericolose per l’ambiente: http://www.admin.ch/ch/i/rs/c813_013_4.html

 

Transport

Gefahrengutbeauftragtenverordnung, (GGBV): http://www.admin.ch/ch/d/sr/c741_622.html
Ordonnance sur les conseillers à sécurité (OCS):
http://www.admin.ch/ch/f/rs/c741_622.html
Ordinanza sugli addetti alla sicurezza (OSAS):
http://www.admin.ch/ch/i/rs/c741_622.html

Ordinance on the transport of dangerous goods on roads:
Beförderung gefährlicher Güter auf der Strasse (SDR): http://www.admin.ch/ch/d/sr/c741_621.html
Ordonnance du 29 novembre 2002 relative au transport des marchandises dangereuses par route (SDR): http://www.admin.ch/ch/f/rs/c741_621.html
Ordinanza del 29 novembre 2002 concernente il trasporto di merci pericolose su strada (SDR): http://www.admin.ch/ch/i/rs/c741_621.html

Ordinance on the transport of dangerous goods by train:
Beförderung gefährlicher Güter mit der Eisenbahn (RSD): http://www.admin.ch/ch/d/sr/c742_401_6.html
Ordonnance du 3 décembre 1996 relative au transport des marchandises dangereuses par chemin de fer (RSD): http://www.admin.ch/ch/f/rs/c742_401_6.html
Ordinanza del 3 dicembre 1996 concernente il trasporto di merci pericolose per ferrovia (RSD): http://www.admin.ch/ch/i/rs/c742_401_6.html

Regulations for the transport by air traffic:
Lufttransportreglement (LTrR):
http://www.admin.ch/ch/d/sr/c748_411.html
Règlement de transport aérien du 3 octobre 1952 (RTA):
http://www.admin.ch/ch/f/rs/c748_411.html
Regolamento di trasporto aereo del 3 ottobre 1952 (RTrA):
http://www.admin.ch/ch/i/rs/c748_411.html

Bundesamt für Strassen (ASTRA): http://www.astra.admin.ch/
Office fédéral des routes:
http://www.astra.admin.ch/html/fr/news/index.php
Ufficio federale delle strade:
http://www.astra.admin.ch/html/it/news/index.php
Swiss federal roads authority:
http://www.astra.admin.ch/html/en/news/index.php

Bundesamt für Verkehr (BAV): http://www.bav.admin.ch/index.cfm?nav=intro&sprache=d
Office fédéral des transports: http://www.bav.admin.ch/index.cfm?nav=intro&sprache=f
Ufficio federale dei trasporti: http://www.bav.admin.ch/index.cfm?nav=intro&sprache=i
Federal office of transport: http://www.bav.admin.ch/index.cfm?nav=intro&sprache=e

Bundesamt für Zivilluftfahrt (BAZL): http://www.aviation.admin.ch/
Office fédéral de l’aviation civile (
OFAC): http://www.aviation.admin.ch/index.html?lang=fr
Ufficio federale desll’aviazione civile (UFAC):
Federal office for civil aviation (FOCA): http://www.aviation.admin.ch/index.html?lang=en

 

Transportfirmen – Entreprises de transport - Transport companies:

DHL: http://www.dhl.ch/

Natural AG: http://www.natural-transport.ch/

 

Verpackungsfirmen – Entreprises d’emballage – Packaging companies:

Air Sea Containers LTD: http://www.airsea.de/profile_d.htm

CDF Emballage SA, La Chaux-de-Fonds : http://www.cdf-emballage.ch/

World health organisation (WHO): http://www.who.int/csr/resources/publications/biosafety/WHO_EMC_97_3_EN/en/

 

Export

Staatssekretariat für Wirtschaft (SECO): http://www.seco-admin.ch/
Secrétariat d’Etat à l’économie: http://www.seco-admin.ch/index.html?lang=fr&PHPSESSID=766fdc89eb1341e90841c7003e815d1b
Segretariato di Stato dell’economia: http://www.seco-admin.ch/index.html?lang=it
State Secretariat for Economic Affairs: http://www.seco-admin.ch/index.html?lang=en

Aus-, Ein- und Durchfuhr zivil und militärisch verwendbarer Güter (GKV): http://www.admin.ch/ch/d/sr/c946_202_1.html
Ordonnance du 25 juin 1997 sur l’exportation, l’importation et le transit des biens utilisables à des fins civiles et militaires et des biens militaires spécifiques (Ordonnance sur le contrôle des biens, OCB) : http://www.admin.ch/ch/f/rs/c946_202_1.html
Ordinanza del 25 giugno 1997 sull’esportazione, l’importazione e il transito dei beni utilizzabili a fini civili e militari e dei beni militari speciali (Ordinanza sul controllo dei beni a duplice impiego, OBDI): http://www.admin.ch/ch/i/rs/c946_202_1.html

 

Import

Bundesamt für Veterinärwesen (BVET): http://www.bvet.admin.ch/
Office vétérinaire fédéral (OVF): http://www.bvet.admin.ch/0_navigation-f/0_index-intern.html
Ufficio federale di veterinaria (UFV): http://www.bvet.admin.ch/0_navigation-f/0_index-intern.html
Federal veterinary office (FVO): http://www.bvet.admin.ch/0_navigation-f/0_index-intern.html

Ordinance on plant protection
Pflanzenschutzverordnung (PSV)
: http://www.admin.ch/ch/d/sr/c916_20.html
Ordonnance du 28 février 2001 sur la protection des végétaux (OPV)
: http://www.admin.ch/ch/f/rs/c916_20.html
Ordinanza del 28 febbraio 2001 sulla protezione dei vegetali (OPV): http://www.admin.ch/ch/i/rs/c916_20.html

 

Food

Verordnung vom 19 November über das Bewilligungsverfahren von GVO-Lebensmitteln, GVO-Zusatzstoffen und GVO-Verarbeitungshilfsstoffen (VBGVO): http://www.admin.ch/ch/d/sr/c817_021_35.html
Ordonnance du 19 novembre 1996 concernant la procédure d’autorisation relative aux denrées alimentaires OGM, aux additifs OGM et aux auxiliaires technologiques
OGM (OAOGM): http://www.admin.ch/ch/f/rs/c817_021_35.html
Ordinanza del 19 novembre 1996 concernente la procedura di autorizzazione per le derrate alimentari OMG, gli additivi OMG e le sostanze ausiliarie di lavorazione
OMG (OPOMG): http://www.admin.ch/ch/i/rs/c817_021_35.html

1.                                

Feed

Futtermittelverordnung: http://www.admin.ch/ch/d/sr/c916_307.html
Ordonnance sur les aliments pour animaux: http://www.admin.ch/ch/f/rs/c916_307.html
Ordinanza sugli alimenti per animali: http://www.admin.ch/ch/i/rs/c916_307.html

Bundesamt für Landwirtschaft (BLW): http://www.blw.admin.ch
Office
fédéral de l’agriculture: http://www.blw.admin.ch/index.html?lang=fr
Ufficio federale dell’agricoltura: http://www.blw.admin.ch/index.html?lang=it

 

Standards:

CEN: http://www.cenorm.be/cenorm/index.htm

Schweizerische Normenvereinigung (SNV): http://www.snv.ch/
Association Suisse de Normalisation avec service international: http://www.snv.ch/default.cfm?spr=fr

ISO: http://www.iso.ch/iso/en/aboutiso/introduction/index.html