¹ The purpose of this Act is:

a.

to protect human beings, animals and the environment from abuses of gene technology;

b.

to serve the welfare of human beings, animals and the environment in the application of gene technology.

² In particular, it shall:

a.

protect the health and safety of human beings, animals and the environment;

b.

conserve biological diversity and the fertility of the soil permanently;

c.

ensure respect for the dignity of living beings;

d.

enable freedom of choice for consumers;

e.

prevent product fraud;

f.

promote public information;

g.

take account of the significance of scientific research on gene technology for human beings, animals and the environment.

¹ Early precautions shall be taken to prevent hazards or harm that may be caused by genetically modified organisms.

² Any person who causes measures to be taken under the provisions of this Act shall bear the costs.

¹ This Act applies to the handling of genetically modified animals, plants and other organisms, as well as their metabolic products and wastes.

² For products obtained from genetically modified organisms, only the regulations on labelling and provision of public information (Art. 17 and 18) apply.

More detailed provisions in other federal laws concerning the protection of human beings, animals and the environment from hazards or harm caused by genetically modified organisms are reserved.

¹ Organisms means cellular or non-cellular biological entities capable of replication or of transferring genetic material. Mixtures, articles and products that contain such entities are also regarded as organisms.

² Genetically modified organism means organisms in which the genetic material has been altered in a way that does not occur under natural conditions by crossing or natural recombination.

³ Harm means any harmful effect or nuisance caused by genetically modified organisms to human beings, animals or the environment.

⁴ Handling means any activity undertaken in connection with organisms, in particular their production, experimental release, putting into circulation, import, export, keeping, use, storage, transport or disposal.

⁵ Putting into circulation means any supply of organisms to third parties in Switzerland, in particular by sale, exchange, giving as a gift, renting, lending or sending on approval, as well as their import; supply for activities in contained systems or experimental release does not count as putting into circulation.

⁶ Installations means buildings, traffic routes and other fixed installations, as well as modifications to the land. Appliances, machines, vehicles, ships and aircraft are also regarded as installations.

¹ The Confederation enforces this Act. The Federal Council enacts implementing regulations.

² The Federal Council may delegate certain enforcement tasks under this Act to the cantons insofar as these tasks have not already been allocated to them under other federal acts, relating in particular to the handling of articles and products.

³ The Federal Council may also pass on certain enforcement tasks to organisations and persons under public or private law.

⁴ The costs of measures that the authorities take to avert immediate hazards or harm, and the costs incurred in determining and remediating the same are passed on to the perpetrator.

¹ The federal authority carrying out the enforcement of regulations on genetically modified organisms on the basis of another federal act or an international treaty, is also responsible in doing so for enforcing this Act. The federal authorities make their decisions with the agreement of the other federal agencies concerned and, where federal law provides, after consulting the cantons concerned.

² If the handling of genetically modified organisms is subject, in addition to a federal notification or authorisation procedure, to a cantonal planning and authorisation procedure, the Federal Council designates a competent authority to coordinate these procedures.

¹ The Federal Council appoints a Swiss Expert Committee for Biosafety, comprising experts from the various interested sectors. The interests of protection and use must be appropriately represented.

² The Expert Committee advises the Federal Council on issues of biosafety that arise in enacting regulations, and the authorities on their enforcement. It is consulted on authorisation applications. It may publish recommendations on these applications; in important and justified cases, it may commission expert opinions and inquiries.

³ It collaborates with other federal and cantonal committees concerned with issues of biotechnology.

⁴ It engages in public dialogue, and makes periodic reports to the Federal Council about its activities.

¹ The Federal Council appoints a Federal Ethics Committee on Non-human Biotechnology. It comprises ethicists from outside the government and other persons from a range of subject areas who have scientific or practical knowledge of ethics. Different ethical approaches must be represented in the Committee.

² The Committee pursues and evaluates from an ethical point of view the developments and applications of biotechnology and issues statements on associated scientific and social issues from an ethical point of view.

³ It advises:

a.

the Federal Council on enacting regulations;

b.

federal and cantonal authorities on enforcement. In particular, it issues statements on authorisation applications or planned research of fundamental or exemplary significance; for this purpose it may view documents, request information and consult further experts.

⁴ It collaborates with other federal and cantonal committees concerned with issues of biotechnology.

⁵ It engages in public dialogue on ethical issues of biotechnology, and makes periodic reports to the Federal Council about its activities.

¹ Every person is obliged to provide the information required for enforcement to the authorities and if necessary to carry out or permit inquiries.

² The Federal Council may require registers with data about the type, quantity and evaluation of genetically modified organisms to be kept, stored and made available at the request of the authorities.

³ The Confederation carries out surveys of the handling of genetically modified organisms. The Federal Council determines which data about genetically modified organisms, recorded in pursuance of other federal acts, must be provided to the federal authority carrying out the survey.

⁴ Where there is a legitimate interest in keeping data secret, such as information about trade and manufacturing secrets, such data is treated as confidential.

¹ The Confederation shall organise the development and operation of a monitoring system that can detect the undesirable spread of genetically modified organisms and identify at an early stage potential effects on the environment and biological diversity of genetically modified organisms and their transgenic genetic material.

² The cantons shall provide the Confederation with available information and data that is of significance to the environmental monitoring.

The Federal Council sets the fees for enforcement by the federal authorities and may determine the framework for cantonal fees. It may grant exemptions from fee payment.

¹ The Confederation may commission or support research and technology assessments.

² It promotes public knowledge and public dialogue concerning the uses, opportunities and risks of biotechnology.

³ It may promote the basic and continuing education and training of persons entrusted with tasks under this Act.¹⁴

The appeal procedure is governed by the general provisions on the administration of federal justice.

¹ National environmental protection organisations have a right of appeal against authorisations for putting into circulation genetically modified organisms intended for lawful use in the environment, provided that the organisations were set up at least 10 years before the appeal is filed.

² The Federal Council designates the organisations with right of appeal.

¹ The Federal Office for the Environment¹⁶ has the right to avail itself of cantonal and federal law in contesting decisions by cantonal authorities in application of this Act and its implementing regulations.

² The same right of appeal is also accorded to the cantons, insofar as harm to their territory from neighbouring cantons is disputed.

¹ Any person subject to the authorisation or notification requirement who handles genetically modified organisms in contained systems, releases such organisms for experimental purposes or puts them into circulation without permission is liable for any loss or damage that occurs during this handling that is due to the genetic modification.

² The person subject to the authorisation requirement is solely liable for any loss or damage that occurs to agricultural or forestry enterprises or to consumers of products of these enterprises through the permitted putting into circulation of genetically modified organisms that is a result of the modification of genetic material if the organisms:

a.

are contained in agricultural or forestry inputs¹⁷; or

b.

stem from such inputs.

³ In relation to liability under paragraph 2, recourse against persons who have handled such organisms inappropriately or have otherwise contributed to the occurrence or exacerbation of the loss or damage is reserved.

⁴ If any loss or damage is caused by any other permitted putting into circulation of genetically modified organisms as a result of the modification of the genetic material, the person subject to the authorisation requirement is liable if the organisms are defective. He or she is also liable for a defect which, according to the state of knowledge and technology at the time when the organism was put into circulation, could not have been recognised.

⁵ Genetically modified organisms are defective if they do not provide the safety that is to be expected taking all circumstances into account; in particular:

a.

the way in which they are presented to the public;

b.

the use that can reasonably be expected;

c.

the time at which they were put into circulation.

⁶ A product made from genetically modified organisms is not considered defective for the sole reason that an improved product has later been put into circulation.

⁷ The loss or damage must have been caused as a result of:

a.

the new properties of the organisms;

b.

the reproduction or modification of the organisms; or

c.

the transmission of the modified genetic material of the organisms.

⁸ A person is exempt from liability if he or she can prove that the loss or damage was caused by an Act of God or through gross misconduct by the injured party or a third party.

⁹ Articles 42-47 and 49-53 of the Swiss Code of Obligations¹⁸ apply.

¹⁰ The Confederation, cantons and communes are also liable in accordance with paragraphs 1-9.

¹ The person who is liable for handling genetically modified organisms must also reimburse the costs of necessary and appropriate measures that are taken to repair destroyed or damaged environmental components, or to replace them with components of equal value.

² If the destroyed or damaged environmental components are not the object of a right in rem or if the eligible person does not take the measures that the situation calls for, the damages are awarded to the community responsible.

¹ The right to claim damages expires after three years from the time when the injured party becomes aware of the loss or damage and of the person liable, but at the latest after 30 years from:

a.

the time that the event that caused the loss or damage occurred in the company or installation, or ended; or

b.

the date on which the genetically modified organisms were put into circulation.

² The right to recourse is also limited in accordance with paragraph 1. The three-year term begins as soon as damages have been paid in full and the person who shares liability is known.

¹ It is the responsibility of the person claiming damages to prove a causal connection.

² If this proof cannot be provided with certainty or if production of proof cannot be expected of the claimant, the court may satisfy itself on the balance of probabilities. The court may also have the facts determined ex officio.

The Federal Council may, to protect the injured party:

a.

require the person subject to the notification or authorisation requirement to provide a guarantee for their liability by taking out insurance or in some other way;

b.

set the scope and duration of this guarantee or leave this to the authority to decide on a case-by-case basis;

c.

require those providing a guarantee for the liability to notify the enforcement authority of the existence, suspension or cessation of the guarantee;

d.

require that the guarantee is not suspended or does not cease until 60 days after receipt of the notification.

¹ Any person who wilfully:

a.

handles genetically modified organisms in such a way that the principles of Articles 6-9 are violated;

b.

in handling genetically modified or pathogenic organisms fails to take all necessary containment measures or carries out activities in contained systems without notification or authorisation (Art. 10);

c.

releases genetically modified organisms for experimental purposes or puts them into circulation without permission (Art. 11 para. 1 and 12 para. 1);

d.²¹

puts genetically modified organisms into circulation without informing and instructing the recipient appropriately (Art. 15 para. 1);

e.

handles genetically modified organisms contrary to instructions (Art. 15 para. 2);

f.

violates provisions on product flow segregation and on the precautions to prevent contamination (Art. 16);

g.²²

puts genetically modified organisms into circulation without labelling them as such for the recipient (Art. 17 para. 1);

h.

violates the provisions on the labelling of products obtained from genetically modified organisms (Art. 17 para. 4);

i.

puts genetically modified organisms into circulation and labels them as «not genetically modified» (Art. 17 para. 5);

j.

violates special provisions on the handling of genetically modified organisms (Art. 19).

is liable to a custodial sentence not exceeding three years or to a monetary penalty.²³

² …²⁴

³ If the offender acts through negligence, he or she is liable to a monetary penalty not exceeding 180 daily penalty units.²⁵

The following administrative measures may be taken in respect of infringements of this Act, its implementing provisions or decisions issued on the basis thereof:

a.

prohibition of activities;

b.

withdrawal of authorisations;

c.

substitute performance against reimbursement of costs;

d.

confiscation;

e.

forfeiture and destruction;

f.

a charge of up to CHF 10,000 or the value of the gross receipts from pro­ducts put unlawfully into circulation.

The amendment of current legislation is regulated in the Annex.

Resistance genes to antibiotics used in human and veterinary medicine may be used in field trials until 31 December 2008.

No authorisations may be granted until 31 December 2021 for putting into circulation genetically modified plants and parts of plants, genetically modified seeds and other plant propagation material and genetically modified animals for agricultural, horticultural or silvicultural purposes.

¹ This Act is subject to optional referendum.

² The Federal Council determines the commencement date.

Commencement date: 1 January 2004²⁸
Annex No. 4 Art. 54 para. 2 second sentence: 1 August 2005²⁹
Annex No. 3 Art. 7a, 7c and 29 No. 1 let. a^bis and a^quater: 2 May 2006³⁰
the other articles in Annex No. 3: at a later date