1. Biotechnology in Switzerland FOEN Federal Office for the Environment (FOEN) Activities Responsibilities and Competences Objectives of GMO Regulation Key Elements of Regulation Activities Responsibilities and Competences Objectives of GMO Regulation Key Elements of Regulation

2. General View FOEN A Marketing Seeds Food/Feed Pesticides Medical products Other Gene Therapies 1 since 1999 0 since 1999 4 0 1 0 5 since 2002 Number of notifications and authorisations Type Experimental Releases Contained Use Activities > 200 per year B C G

3. Competent Authorities FOEN Animal Vaccines Food Biocides Seeds Feed Fertilisers Pesticides Experimental Releases Gene Therapies Medicaments Vaccines Federal Office of Agriculture Federal Office of Agriculture Federal Office of Public Health + Swissmedic Federal Office of Public Health + Swissmedic Federal Veterinary Office Federal Veterinary Office Federal Office for the Environment Federal Office for the Environment

4. FOEN Coordination of enforcement FOEN is the competent authority: field release experiments FOEN Applicant Statement Swiss Expert Committee for Biosafety (SECB) Swiss Ethics Committee on Non-human Gene Technology (ECNH) Cantonal competent authority Human HealthAnimal Health SFOA SFOPH FVO Agriculture Application Decision Statement

5. FOEN Biotechnology Unit Areas of Activities FOEN Contained Use Accidents Prevention Secretariat Experts Committee Ethical Issues Secretariat Ethics Committee Biotechnology Coordination Centre Swiss Biosafety Clearing House Gene Therapies Environmental GMO Monitoring Website Public Information Releases and Marketing Access to Genetic Resources and Benefit Sharing

6. Federal Law on Non-human Gene Technology Containment Ordinance Ordinance on Transboundary Movements of GMO Legal Bases FOEN Federal Law on the Protection of the Environment Release Ordinance Ordinance on Accident Prevention Experts Committee Ordinance Ethics Committee Ordinance Federal Law on Epidemics

7. Objectives of GMO Regulation FOEN Safety Protect humans, animals and the environment Conserve biodiversity and sustainable use thereof Ethics Respect the dignity of living beings Quality Transparency Protect GMO-free production Enable freedom of choice for consumers Prevent product fraud Allow free access to non-confidential information Promote public information

8. Current situation in Switzerland FOEN On November 27, 2005, Switzerland voted a 5-year moratorium (ban) for commercial cultivation of genetically engineered plants and animals (= in agriculture). The moratorium does not apply:  For research using GMOs (even for field trials)  For import of GMOs for food or feed or for processing.