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.
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.
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 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:
Verpackungsfirmen –
Entreprises d’emballage – Packaging companies:
CDF Emballage SA, La
Chaux-de-Fonds
World
health
organisation (WHO)
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
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.
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
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
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
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/
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
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