Ordinance
on the Handling of Organisms in the Environment
(Release Ordinance, RO)

¹ This Or­din­ance is in­ten­ded to pro­tect hu­man be­ings, an­im­als and the en­vir­on­ment, as well as bio­lo­gic­al di­versity and its sus­tain­able use, from haz­ards or harm caused by hand­ling or­gan­isms, their meta­bol­ic products and wastes.

² It also aims, dur­ing the hand­ling of ge­net­ic­ally mod­i­fied or­gan­isms, their meta­bol­ic products and wastes, to guar­an­tee con­sumers’ free­dom of choice and pro­tect pro­duc­tion that does not use ge­net­ic­ally mod­i­fied or­gan­isms.

1 This Or­din­ance reg­u­lates the hand­ling of or­gan­isms, their meta­bol­ic products and wastes in the en­vir­on­ment, in par­tic­u­lar the hand­ling of ge­net­ic­ally mod­i­fied, patho­gen­ic or ali­en or­gan­isms.

2 Hand­ling or­gan­isms in con­tained sys­tems is reg­u­lated by the Con­tain­ment Or­din­ance of 9 May 2012⁵ (Con­tainO).⁶

3 The pro­tec­tion of per­son­nel when work­ing with mi­croor­gan­isms is gov­erned by the Or­din­ance of 25 Au­gust 1999⁷ on Pro­tec­tion of Em­ploy­ees from Dan­ger­ous Or­gan­isms.

⁴ The mar­ket­ing of patho­gen­ic or­gan­isms:

a.

for ap­plic­a­tion as plant pro­tec­tion products in ag­ri­cul­ture is reg­u­lated by the Plant Pro­tec­tion Products Or­din­ance of 18 May 2005⁸;

b.

for ap­plic­a­tion as biocid­al products, the Biocid­al Products Or­din­ance of 18 May 2005⁹.

⁵ For the mar­ket­ing of ali­en in­sects, mites and nem­at­odes for use as plant pro­tec­tion products in ag­ri­cul­ture as well as for ex­per­i­ment­al re­leases of such or­gan­isms, the Or­din­ance of 18 May 2005 on Plant Pro­tec­tion Products ap­plies.

⁶ This Or­din­ance does not ap­ply to hand­ling or­gan­isms:

a.

in clin­ic­al tri­als on hu­man be­ings;

b.¹⁰

lis­ted in the Or­din­ance is­sued by the Fed­er­al De­part­ment of Eco­nom­ic Af­fairs, Edu­ca­tion and Re­search and the Fed­er­al De­part­ment of the En­vir­on­ment, Trans­port, En­ergy and Com­mu­nic­a­tions based on Art­icles 4 para­graph 3 of the Plant Health Or­din­ance of 31 Oc­to­ber 2018¹¹, or for which the two afore­men­tioned de­part­ments have des­ig­nated a pro­tec­ted area based on Art­icle 24 para­graph 2 of the Plant Health Or­din­ance;

c.¹²

that are lis­ted as po­ten­tial quar­ant­ine or­gan­isms in the or­din­ance is­sued by the Fed­er­al Of­fice for Ag­ri­cul­ture (FO­AG) and the Fed­er­al Of­fice for the En­vir­on­ment (FOEN) based on Art­icle 5 para­graph 2 of the Plant Health Or­din­ance.

¹ In this Or­din­ance:

a.

or­gan­isms means cel­lu­lar or non-cel­lu­lar bio­lo­gic­al en­tit­ies cap­able of rep­lic­a­tion or of trans­fer­ring ge­net­ic ma­ter­i­al. Mix­tures and art­icles and products con­tain­ing such en­tit­ies are also re­garded as or­gan­isms;

b.¹³mi­croor­gan­isms means mi­cro­bi­o­lo­gic­al en­tit­ies, in par­tic­u­lar bac­teria, al­gae, fungi, pro­to­zoa, vir­uses and viroids; cell cul­tures, para­sites, pri­ons and bio­lo­gic­ally act­ive ge­net­ic ma­ter­i­al are also re­garded as mi­croor­gan­isms;

c.

small in­ver­teb­rates meansarth­ro­pods, an­nelids, nem­at­odes and flat­worms;

d.

ge­net­ic­ally mod­i­fied or­gan­isms means or­gan­isms in which the ge­net­ic ma­ter­i­al has been altered by meth­ods of gene tech­no­logy in ac­cord­ance with An­nex 1 in a way that does not oc­cur un­der nat­ur­al con­di­tions by cross­ing or nat­ur­al re­com­bin­a­tion, as well as patho­gen­ic or ali­en or­gan­isms that have also been ge­net­ic­ally mod­i­fied;

e.¹⁴

patho­gen­ic or­gan­isms means or­gan­isms that can cause dis­eases in hu­man be­ings, live­stock and use­ful plants, in wild flora or fauna or oth­er or­gan­isms, as well as ali­en or­gan­isms that are also patho­gen­ic;

f.¹⁵

ali­en or­gan­isms means or­gan­isms of a spe­cies, sub-spe­cies or lower taxo­nom­ic level that:

1.

do not nat­ur­ally oc­cur in Switzer­land or in oth­er EFTA and EU mem­ber states (not in­clud­ing over­seas areas), and

2.

have not un­der­gone se­lec­tion for use in ag­ri­cul­ture or hor­ti­cul­tur­al pro­duc­tion to such an ex­tent that their vi­ab­il­ity in the wild is re­duced;

g.¹⁶

…

h.

in­vas­ive ali­en or­gan­isms means ali­en or­gan­isms of which it is known or must be as­sumed that they will spread in Switzer­land and could achieve such a high pop­u­la­tion dens­ity that bio­lo­gic­al di­versity or its sus­tain­able use could be harmed or hu­man be­ings, an­im­als and the en­vir­on­ment could be en­dangered;

i.

hand­ling of or­gan­isms in the en­vir­on­mentmeans any de­lib­er­ate activ­ity us­ing or­gan­isms that takes place out­side a con­tained sys­tem, in par­tic­u­lar cul­tur­ing, pro­cessing, mul­ti­plic­a­tion, modi­fic­a­tion, ex­per­i­ment­al re­lease, mar­ket­ing, trans­port, stor­age or dis­pos­al;

j.

dir­ect hand­ling of or­gan­isms in the en­vir­on­ment means hand­ling or­gan­isms in the en­vir­on­ment, not in­clud­ing the hand­ling of thera­peut­ic products, food­stuffs and an­im­al feed­stuffs;

k.

mar­ket­ing means the trans­fer of or­gan­isms to third parties in Switzer­land for use in the en­vir­on­ment, in par­tic­u­lar by sale, ex­change, giv­ing as a gift, rent­ing, lend­ing or send­ing on ap­prov­al, as well as their im­port for the use in the en­vir­on­ment.

2 Trans­fer of or­gan­isms in or­der to carry out an ex­per­i­ment­al re­lease does not count as mar­ket­ing.

1 Any per­son who in­tends to mar­ket or­gan­isms for use in the en­vir­on­ment must first:

a.

as­sess the pos­sible haz­ards and harm caused by the or­gan­isms, their meta­bol­ic products and wastes to hu­man be­ings, an­im­als or the en­vir­on­ment as well as to bio­lo­gic­al di­versity or the sus­tain­able use there­of; and

b.

ar­rive at a jus­ti­fi­able con­clu­sion that no such haz­ards and harm are to be ex­pec­ted.

2 The as­sess­ment re­ferred to in para­graph 1 let­ter a must in par­tic­u­lar con­sider:

a.

the or­gan­isms’ po­ten­tial for sur­viv­al, dis­sem­in­a­tion and rep­lic­a­tion in the en­vir­on­ment;

b.

pos­sible in­ter­ac­tions with oth­er or­gan­isms and com­munit­ies as well as im­pacts on hab­it­ats.

Any per­son mar­ket­ing or­gan­isms for use in the en­vir­on­ment must:

a.

in­form the re­cip­i­ent of the iden­tity of the or­gan­isms, their meta­bol­ic products and wastes, as well as of their prop­er­ties in re­la­tion to pub­lic health and the en­vir­on­ment;

b.

in­struct the re­cip­i­ent in such a way that hand­ling the or­gan­isms in the en­vir­on­ment in ac­cord­ance with the reg­u­la­tions and the in­struc­tions will not en­danger hu­man be­ings, an­im­als or the en­vir­on­ment, or harm bio­lo­gic­al di­versity or the sus­tain­able use there­of;

c.

in­struct the re­cip­i­ent as to the safety meas­ures to be taken in the event of un­in­ten­tion­al re­lease.

1 Any per­son hand­ling or­gan­isms in the en­vir­on­ment in ways oth­er than mar­ket­ing must take all due care to en­sure that or­gan­isms, their meta­bol­ic and waste products:

a.

can­not en­danger hu­man be­ings, an­im­als or the en­vir­on­ment;

b.

do not harm bio­lo­gic­al di­versity or its sus­tain­able use.

2 In par­tic­u­lar, the rel­ev­ant reg­u­la­tions and the dis­trib­ut­or's in­struc­tions and re­com­mend­a­tions must be ob­served.

¹ The hand­ling of ge­net­ic­ally mod­i­fied or­gan­isms in the en­vir­on­ment must be car­ried out in such a man­ner that it neither en­dangers hu­man be­ings, an­im­als and the en­vir­on­ment nor harms bio­lo­gic­al di­versity or the sus­tain­able use there­of, and in par­tic­u­lar so that:

a.

the health of hu­man be­ings and an­im­als can­not be en­dangered, in par­tic­u­lar by tox­ic or al­ler­gen­ic sub­stances or through the spread of an­ti­bi­ot­ic res­ist­ances;

b.

the ge­net­ic­ally mod­i­fied or­gan­isms can­not spread or mul­tiply in an un­con­trolled way in the en­vir­on­ment;

c.

no un­desired prop­er­ties can be per­man­ently passed on to oth­er or­gan­isms;

d.

pop­u­la­tions of pro­tec­ted or­gan­isms, in par­tic­u­lar those in­cluded in the Red Lists, or or­gan­isms that are im­port­ant for the eco­sys­tem in ques­tion, in par­tic­u­lar those that are im­port­ant for the growth and re­pro­duc­tion of plants, are not af­fected;

e.

no spe­cies of non-tar­get or­gan­isms can be en­dangered;

f.

the ma­ter­i­al bal­ance of the en­vir­on­ment is not severely or per­man­ently harmed;

g.

im­port­ant func­tions of the eco­sys­tem in ques­tion, in par­tic­u­lar the fer­til­ity of the soil, are not severely or per­man­ently harmed;

h.

in ex­per­i­ment­al re­leases, none of the new prop­er­ties based on ge­net­ic modi­fic­a­tion can be per­man­ently passed on to wild flora or fauna.

² Ge­net­ic­ally mod­i­fied or­gan­isms may not be dir­ectly handled in the en­vir­on­ment, if:

a.¹⁷ they are clas­si­fied in­to Group 3 or 4 in ac­cord­ance with Art­icle 6 Con­tainO¹⁸;

b.

they con­tain genes res­ist­ant to an­ti­bi­ot­ics in­ser­ted by gene tech­no­logy that are au­thor­ised for use in hu­man and veter­in­ary medi­cine;

c.

the re­cip­i­ent or­gan­isms used for the ge­net­ic modi­fic­a­tion are in­vas­ive.

¹ In hab­it­ats and land­scapes that are par­tic­u­larly sens­it­ive or worthy of pro­tec­tion, the dir­ect hand­ling of ge­net­ic­ally mod­i­fied or­gan­isms is per­miss­ible only if it serves to pre­vent or elim­in­ate haz­ards to hu­man be­ings, an­im­als, the en­vir­on­ment, bio­lo­gic­al di­versity or the sus­tain­able use there­of, or impair­ments to the same. For areas in ac­cord­ance with para­graph 2 let­ters a, e and f, de­vi­at­ing pro­vi­sions in the ap­plic­able pro­tec­tion reg­u­la­tions are re­served.

2 Hab­it­ats and land­scapes that are par­tic­u­larly sens­it­ive or worthy of pro­tec­tion are:

a.

areas that are des­ig­nated nature re­serves, on the basis of fed­er­al or can­ton­al law;

b.

sur­face wa­ters and a strip 3 m wide along or around them;

c.¹⁹

sub­ter­ranean wa­ters and catch­ment areas S1 and, for mi­croor­gan­isms, catch­ment areas S2 und S_h of ground­wa­ter pro­tec­tion zones;

d.

forests;

e.

pro­tec­ted areas in ac­cord­ance with Art­icle 11 of the Hunt­ing Act of 20 June 1986²⁰;

f.

areas un­der land­scape pro­tec­tion in ac­cord­ance with fed­er­al or can­ton­al law.

¹ Any per­son who handles ge­net­ic­ally mod­i­fied or­gan­isms dir­ectly in the en­vir­on­ment must take the re­quired tech­nic­al, or­gan­isa­tion­al and staff­ing meas­ures to pre­vent un­desired mix­ing with non-ge­net­ic­ally mod­i­fied or­gan­isms; in par­tic­u­lar, he or she must:

a.

ob­serve the re­quired dis­tances for pro­duc­tion that does not use ge­net­ic­ally mod­i­fied or­gan­isms;

b.

clean all equip­ment and ma­chines thor­oughly after use in ac­cord­ance with re­cog­nised meth­ods, if they are also used for non-ge­net­ic­ally mod­i­fied or­gan­isms;

c.

take pre­cau­tions to pre­vent losses of ge­net­ic­ally mod­i­fied or­gan­isms;

d.

keep the rel­ev­ant in­form­a­tion about the hand­ling and for­ward it to the re­cip­i­ents in an ap­pro­pri­ate form.

² Any per­son who handles ge­net­ic­ally mod­i­fied or­gan­isms dir­ectly in the en­vir­on­ment must, in ex­cep­tion­al events, doc­u­ment losses of ge­net­ic­ally mod­i­fied or­gan­isms and take ap­pro­pri­ate meas­ures to re­store the ori­gin­al con­di­tions.

³ Any per­son who mar­kets ge­net­ic­ally mod­i­fied or­gan­isms must have an ap­pro­pri­ate qual­ity con­trol sys­tem, which en­sures, in par­tic­u­lar, that:

a.

weak points at which mix­tures or con­fu­sions could oc­cur are re­cog­nised;

b.

the re­quired tech­nic­al, or­gan­isa­tion­al and staff­ing meas­ures to pre­vent mix­tures are es­tab­lished and en­forced;

c.

reg­u­lar checks are car­ried out to ex­am­ine the work­ab­il­ity of the meas­ures;

d.

the per­sons re­spons­ible are ad­equately trained;

e.

com­plete re­cords are kept.

⁴ Any per­son who mar­kets ge­net­ic­ally mod­i­fied or­gan­isms or products made from such or­gan­isms must:

a.

provide writ­ten in­form­a­tion of the cor­res­pond­ing unique iden­ti­fi­er, in ac­cord­ance with the An­nex to the Com­mis­sion Reg­u­la­tion (EC) No 65/2004 of 14 Janu­ary 2004²¹ es­tab­lish­ing a sys­tem for the de­vel­op­ment and as­sign­ment of unique iden­ti­fi­ers for ge­net­ic­ally mod­i­fied or­gan­isms, or, if this is lack­ing, the iden­tity of the or­gan­isms, giv­ing the es­sen­tial char­ac­ter­ist­ics, if the or­gan­isms and products re­quire la­belling in ac­cord­ance with Art­icle 10;

b.

provide the name and ad­dress of the per­son from whom fur­ther in­form­a­tion can be ob­tained;

c.

for­ward all fur­ther rel­ev­ant in­form­a­tion that comes from their own sup­pli­er, in par­tic­u­lar such in­form­a­tion about the prop­er­ties of the or­gan­isms, if it is sig­ni­fic­ant for the pro­tec­tion of pro­duc­tion that does not use ge­net­ic­ally mod­i­fied or­gan­isms, and in­form­a­tion about the hand­ling in the en­vir­on­ment, to pre­vent the pro­vi­sions on the pro­tec­tion of pro­duc­tion that does not use ge­net­ic­ally mod­i­fied or­gan­isms be­ing con­tra­vened.

⁵ Any per­son who mar­kets ge­net­ic­ally mod­i­fied or­gan­isms or products made from such or­gan­isms must keep the fol­low­ing de­tails for five years:

a.

the in­form­a­tion in ac­cord­ance with para­graph 4;

b.

the name and ad­dress of the re­cip­i­ent, but not those of the con­sumers;

c.

the name and ad­dress of the sup­pli­er.

⁶ Cor­res­pond­ing pro­vi­sions in the le­gis­la­tion on food­stuffs and ag­ri­cul­ture are re­served.

1 Any per­son who mar­kets ge­net­ic­ally mod­i­fied or­gan­isms must in­form the re­cip­i­ent of the nature of the or­gan­isms through an eas­ily re­cog­nis­able la­bel, with the note «ge­net­ic­ally mod­i­fied».

2 La­belling may be waived for mix­tures, art­icles and products that con­tain ge­net­ic­ally mod­i­fied or­gan­isms if it is demon­strated that the mix­tures, art­icles and products con­tain only un­in­ten­tion­al traces of au­thor­ised ge­net­ic­ally mod­i­fied or­gan­isms. The con­tent of such traces may not:

a.

ex­ceed 0.1 per­cent by mass for mix­tures, art­icles and products that are handled dir­ectly in the en­vir­on­ment;

b.

ex­ceed 0.9 per­cent by mass for all oth­er mix­tures, art­icles and products.

3 The cor­res­pond­ing re­quire­ments for the la­belling of mix­tures, art­icles and products that con­tain ge­net­ic­ally mod­i­fied or­gan­isms stip­u­lated by the reg­u­la­tions on thera­peut­ic products and ag­ri­cul­ture are re­served.

4 The re­quire­ments for food­stuffs guar­an­tee­ing free­dom of choice for con­sumers are reg­u­lated in the le­gis­la­tion on food­stuffs.

¹ Any per­son who in­tends to re­lease ge­net­ic­ally mod­i­fied or­gan­isms that re­quire a li­cence for ex­per­i­ment­al pur­poses (Art. 17) must guar­an­tee suf­fi­cient fin­an­cial re­serves for de­term­in­ing, pre­vent­ing or cor­rect­ing pos­sible haz­ards or impair­ments caused by ge­net­ic­ally mod­i­fied or­gan­isms.

² Any per­son who in­tends to re­lease ge­net­ic­ally mod­i­fied or­gan­isms that re­quire a li­cence for ex­per­i­ment­al pur­poses must guar­an­tee leg­al li­ab­il­ity:

a.

of 10 mil­lion Swiss francs to cov­er dam­age to per­sons or prop­erty (Art. 30 GTA); and

b.

of 1 mil­lion Swiss francs to cov­er dam­age to the en­vir­on­ment (Art. 31 GTA).

³ Any per­son who in­tends to mar­ket or­gan­isms for dir­ect hand­ling in the en­vir­on­ment for the first time must guar­an­tee leg­al li­ab­il­ity:

a.

of 20 mil­lion Swiss francs to cov­er dam­age to per­sons or prop­erty (Art. 30 GTA); and

b.

of 2 mil­lion Swiss francs to cov­er dam­age to the en­vir­on­ment (Art. 31 GTA).

⁴ The ob­lig­a­tion to guar­an­tee li­ab­il­ity can be ful­filled:

a.

by tak­ing out in­sur­ance from an in­sur­ance com­pany that is au­thor­ised to do busi­ness in Switzer­land;

b.

by provid­ing se­cur­it­ies of equi­val­ent value.

⁵ The fol­low­ing are ex­empt from this guar­an­tee of li­ab­il­ity:

a.

the Con­fed­er­a­tion, its pub­lic cor­por­a­tions and in­sti­tu­tions;

b.

the can­tons and their pub­lic cor­por­a­tions and in­sti­tu­tions, where the can­tons cov­er their li­ab­il­it­ies.

⁶ The per­son who guar­an­tees li­ab­il­ity must no­ti­fy the com­pet­ent ex­ec­ut­ive au­thor­ity of the start, sus­pen­sion and ter­min­a­tion of the guar­an­tee.²²

⁷ The sus­pen­sion and ter­min­a­tion of the guar­an­tee, un­less pre­vi­ously re­placed by a dif­fer­ent guar­an­tee, be­come ef­fect­ive 60 days after re­ceipt of no­ti­fic­a­tion by the com­pet­ent ex­ec­ut­ive au­thor­ity.²³

¹ The hand­ling of patho­gen­ic or­gan­isms in the en­vir­on­ment must be car­ried out in such a man­ner that it neither en­dangers hu­man be­ings, an­im­als or the en­vir­on­ment nor harms bio­lo­gic­al di­versity or the sus­tain­able use there­of, and in par­tic­u­lar so that:

a.

the health of hu­man be­ings and an­im­als can­not be en­dangered, in par­tic­u­lar not by tox­ic or al­ler­gen­ic sub­stances or through the spread of an­ti­bi­ot­ic res­ist­ances;

b.

the or­gan­isms can­not spread or mul­tiply in an un­con­trolled way in the en­vir­on­ment;

c.

pop­u­la­tions of pro­tec­ted or­gan­isms are not harmed, in par­tic­u­lar those in­cluded in the Red Lists, or or­gan­isms that are im­port­ant for the eco­sys­tem in ques­tion, in par­tic­u­lar those that are im­port­ant for the growth and re­pro­duc­tion of plants;

d.

no spe­cies of non-tar­get or­gan­isms spe­cies can be en­dangered;

e.

the ma­ter­i­al bal­ance of the en­vir­on­ment is not severely or per­man­ently harmed;

f.

im­port­ant func­tions of the eco­sys­tem in ques­tion, in par­tic­u­lar the fer­til­ity of the soil, are not severely or per­man­ently harmed.

² Patho­gen­ic or­gan­isms which are clas­si­fied in­to Groups 3 or 4 in ac­cord­ance with Art­icle 6 Con­tainO²⁴, or which are in­vas­ive, may not be handled dir­ectly in the en­vir­on­ment; the fore­go­ing does not ap­ply to their primary de­tec­tion in ac­cord­ance with Art­icle 5a Con­tainO.²⁵

¹ In hab­it­ats that are par­tic­u­larly sens­it­ive or worthy of pro­tec­tion in ac­cord­ance with Art­icle 8 para­graph 2 let­ters a–d, the dir­ect hand­ling of patho­gen­ic or­gan­isms is per­miss­ible only if it serves to pre­vent or elim­in­ate haz­ards to hu­man be­ings, an­im­als, the en­vir­on­ment, bio­lo­gic­al di­versity or the sus­tain­able use there­of, or impair­ments to the same.

2 For areas in ac­cord­ance with Art­icle 8 para­graph 2 let­ter a, de­vi­at­ing pro­vi­sions in the ap­plic­able pro­tec­tion reg­u­la­tions are re­served.

¹ Any per­son who in­tends to re­lease patho­gen­ic or­gan­isms that re­quire a li­cence for ex­per­i­ment­al pur­poses (Art. 17) must guar­an­tee suf­fi­cient fin­an­cial re­serves for de­term­in­ing, pre­vent­ing or cor­rect­ing pos­sible haz­ards or impair­ments caused by such or­gan­isms.

² Any per­son who in­tends to re­lease patho­gen­ic or­gan­isms that re­quire a li­cence for ex­per­i­ment­al pur­poses must guar­an­tee leg­al li­ab­il­ity:

a.

of 1 mil­lion Swiss francs to cov­er dam­age to per­sons or prop­erty (Art. 59abis para. 1 EPA); and

b.

of 100,000 Swiss francs to cov­er dam­age to the en­vir­on­ment (Art. 59abis para. 9 EPA).

³ Any per­son who in­tends to mar­ket such or­gan­isms for dir­ect hand­ling in the en­vir­on­ment for the first time must guar­an­tee leg­al li­ab­il­ity:

a.

of 2 mil­lion Swiss francs to cov­er dam­age to per­sons or prop­erty (Art. 59abis para. 1 EPA); and

b.

of 200,000 Swiss francs to cov­er dam­age to the en­vir­on­ment (Art. 59abis para. 9 EPA).

⁴ The ob­lig­a­tion to guar­an­tee li­ab­il­ity can be ful­filled:

a.

by tak­ing out in­sur­ance from an in­sur­ance com­pany that is au­thor­ised to do busi­ness in Switzer­land;

b.

by provid­ing se­cur­it­ies of equi­val­ent value.

⁵ The fol­low­ing are ex­empt from this guar­an­tee of li­ab­il­ity:

a.

the Fed­er­al Gov­ern­ment, its pub­lic cor­por­a­tions and in­sti­tu­tions;

b.

the can­tons as well as their pub­lic cor­por­a­tions and in­sti­tu­tions, where the can­tons cov­er their li­ab­il­it­ies.

6 The per­son who guar­an­tees li­ab­il­ity must no­ti­fy the com­pet­ent ex­ec­ut­ive au­thor­ity of the start, sus­pen­sion and ter­min­a­tion of the guar­an­tee.²⁶

⁷ The sus­pen­sion and ter­min­a­tion of the guar­an­tee, un­less pre­vi­ously re­placed by a dif­fer­ent guar­an­tee, shall be­come ef­fect­ive 60 days after re­ceipt of no­ti­fic­a­tion by the com­pet­ent ex­ec­ut­ive au­thor­ity.²⁷

¹ The hand­ling of ali­en or­gan­isms in the en­vir­on­ment must be car­ried out in such a man­ner that it neither en­dangers hu­man be­ings, an­im­als or the en­vir­on­ment nor harms bio­lo­gic­al di­versity or the sus­tain­able use there­of, and in par­tic­u­lar so that:

a.

the health of hu­man be­ings and an­im­als can­not be en­dangered, in par­tic­u­lar not by tox­ic or al­ler­gen­ic sub­stances;

b.

the or­gan­isms can­not spread or mul­tiply in an un­con­trolled way in the en­vir­on­ment;

c.

pop­u­la­tions of pro­tec­ted or­gan­isms are not harmed, in par­tic­u­lar those in­cluded in the Red Lists, or or­gan­isms that are im­port­ant for the eco­sys­tem in ques­tion, in par­tic­u­lar those that are im­port­ant for the growth and re­pro­duc­tion of plants;

d.

no spe­cies of non-tar­get or­gan­isms spe­cies can be en­dangered;

e.

the ma­ter­i­al bal­ance of the en­vir­on­ment is not severely or per­man­ently harmed;

f.

im­port­ant func­tions of the eco­sys­tem in ques­tion, in par­tic­u­lar the fer­til­ity of the soil, are not severely or per­man­ently harmed.

² In­vas­ive ali­en or­gan­isms in ac­cord­ance with An­nex 2 may not be handled dir­ectly in the en­vir­on­ment, oth­er than in the case of meas­ures to con­trol them. The FOEN may in ex­cep­tion­al cases grant a li­cence for dir­ect hand­ling in the en­vir­on­ment if the ap­plic­ant can prove that he or she has taken all the meas­ures re­quired to ob­serve para­graph 1.²⁸

³ Soil that has been re­moved that is con­tam­in­ated with in­vas­ive ali­en or­gan­isms in ac­cord­ance with An­nex 2 must be used only at the place of ex­cav­a­tion or dis­posed of so as to pre­vent the spread of such or­gan­isms.²⁹

⁴ The pro­vi­sions in the le­gis­la­tion on forests, hunt­ing and fish­ing are re­served.³⁰

¹ In hab­it­ats that are par­tic­u­larly sens­it­ive or worthy of pro­tec­tion in ac­cord­ance with Art­icle 8 para­graph 2 let­ters a–d, the dir­ect hand­ling of ali­en or­gan­isms is per­miss­ible only if it serves to pre­vent to elim­in­ate haz­ards to hu­man be­ings, an­im­als, the en­vir­on­ment, bio­lo­gic­al di­versity or the sus­tain­able use there­of, or impair­ments to the same.

2 For areas in ac­cord­ance with Art­icle 8 para­graph 2 let­ter a, de­vi­at­ing pro­vi­sions in the ap­plic­able pro­tec­tion reg­u­la­tions are re­served.

Any per­son who in­tends to re­lease the fol­low­ing or­gan­isms for ex­per­i­ment­al pur­poses shall re­quire a li­cence from the FOEN:

a.

ge­net­ic­ally mod­i­fied or­gan­isms;

b.

patho­gen­ic or­gan­isms;

c.

ali­en small in­ver­teb­rates that are in­ten­ded for use in the en­vir­on­ment and not as pets.

1 A li­cence is not re­quired for ex­per­i­ment­al re­leases in­volving ge­net­ic­ally mod­i­fied or­gan­isms, if they are au­thor­ised for a par­tic­u­lar dir­ect ap­plic­a­tion in the en­vir­on­ment in ac­cord­ance with Art­icle 25 and if the ex­per­i­ment­al re­lease aims to gath­er fur­ther in­form­a­tion for the same ap­plic­a­tion.

² A li­cence is not re­quired for ex­per­i­ment­al re­leases in­volving patho­gen­ic or­gan­isms if they:

a.

are au­thor­ised for a par­tic­u­lar dir­ect ap­plic­a­tion in the en­vir­on­ment in ac­cord­ance with Art­icle 25; or

b.

are not ali­en and are not patho­gen­ic to hu­man be­ings or ver­teb­rates.

³ A li­cence is not re­quired for ex­per­i­ment­al re­leases in­volving ali­en small in­ver­teb­rates if they are au­thor­ised for a par­tic­u­lar dir­ect ap­plic­a­tion in the en­vir­on­ment in ac­cord­ance with Art­icle 25.

¹ The li­cence ap­plic­a­tion for an ex­per­i­ment­al re­lease of ge­net­ic­ally mod­i­fied or­gan­isms must con­tain all the re­quired in­form­a­tion to prove that the ex­per­i­ment­al re­lease can­not con­tra­vene the re­quire­ments of Art­icles 7–9 and 11.

² The ap­plic­a­tion must con­tain the fol­low­ing doc­u­ments, in par­tic­u­lar:

a.

a de­scrip­tion of the ex­per­i­ment with at least the fol­low­ing de­tails:

1.

de­tails of the ob­ject­ive and con­text of the ex­per­i­ment,

2.

reas­ons why the in­form­a­tion sought can­not be ob­tained through ex­per­i­ments in con­tained sys­tems,

3.

a present­a­tion of the an­ti­cip­ated new sci­entif­ic res­ults in terms of the im­pacts on hu­man be­ings, an­im­als or the en­vir­on­ment, bio­lo­gic­al di­versity and the sus­tain­able use there­of and the ef­fic­acy of safety meas­ures which can be gained thanks to the ex­per­i­ment;

b.

a tech­nic­al dossier with the in­form­a­tion in ac­cord­ance with An­nexes IIIA or IIIB and IV of the Dir­ect­ive 2001/18/EC of the European Par­lia­ment and of the Coun­cil of 12 March 2001³² on the de­lib­er­ate re­lease in­to the en­vir­on­ment of ge­net­ic­ally mod­i­fied or­gan­isms and re­peal­ing Coun­cil Dir­ect­ive 90/220/EEC, but without de­tails of the mon­it­or­ing plans;

c.

the res­ults of pre­vi­ous ex­per­i­ments, in par­tic­u­lar:

1.

res­ults of pre­lim­in­ary ex­per­i­ments in con­tained sys­tems to de­term­ine bio­lo­gic­al safety,

2.

data, res­ults and eval­u­ations of ex­per­i­ment­al re­leases car­ried out with the same or­gan­isms or their host or­gan­isms un­der com­par­able cli­mat­ic con­di­tions and with com­par­able fauna and flora;

d.

the risk de­term­in­a­tion and as­sess­ment in ac­cord­ance with An­nex 4;

e.

a mon­it­or­ing plan to show how the ap­plic­ant will ex­am­ine wheth­er the as­sump­tions of the risk de­term­in­a­tion and as­sess­ment in ac­cord­ance with An­nex 4 are cor­rect and wheth­er the meas­ures to ad­here to the re­quire­ments of Art­icle 6 para­graphs 1 and 2 and Art. 7 GTA are suf­fi­cient, and which con­tains at least the fol­low­ing de­tails:

1.

the type, spe­cificity, sens­it­iv­ity and re­li­ab­il­ity of the meth­ods,

2.

the dur­a­tion and fre­quency of the mon­it­or­ing;

f.

an eval­u­ation of in­terests in ac­cord­ance with Art­icle 8 GTA that shows that the ge­net­ic modi­fic­a­tion of the ge­net­ic ma­ter­i­al of an­im­als or plants has not failed to re­spect the dig­nity of liv­ing be­ings;

g.

a pub­lic in­form­a­tion plan that gives in­form­a­tion about how, when and where the pub­lic will be in­formed about the ob­ject, time and place of the planned ex­per­i­ment­al re­lease;

h.

proof that the li­ab­il­ity guar­an­tee has been ful­filled.

³The doc­u­ment­a­tion of the res­ults of pre­vi­ous ex­per­i­ments in ac­cord­ance with para­graph 2 let­ter c sub­sec­tion 2 may refer to data or res­ults from an­oth­er ap­plic­ant if this per­son has giv­en writ­ten per­mis­sion.

⁴ The FOEN may waive cer­tain de­tails of the tech­nic­al dossier in ac­cord­ance with para­graph 2 let­ter b if the ap­plic­ant can prove that these de­tails are not ne­ces­sary for an eval­u­ation of the ap­plic­a­tion.

⁵ A single ap­plic­a­tion may be sub­mit­ted if an ex­per­i­ment­al re­lease is be­ing car­ried out for the same pur­pose and with­in a lim­ited peri­od:

a.

with a single ge­net­ic­ally mod­i­fied or­gan­ism at dif­fer­ent places;

b.

with a com­bin­a­tion of or­gan­isms at the same place or in dif­fer­ent places.

¹ The li­cence ap­plic­a­tion for an ex­per­i­ment­al re­lease of patho­gen­ic or­gan­isms must con­tain all the re­quired in­form­a­tion to prove that the ex­per­i­ment­al re­lease can­not con­tra­vene the re­quire­ments of Art­icles 12–14.

² The ap­plic­a­tion must con­tain the fol­low­ing doc­u­ments, in par­tic­u­lar:

a.

de­tails of the ob­ject­ive and con­text of the ex­per­i­ment;

b.

a tech­nic­al dossier with the in­form­a­tion in ac­cord­ance with An­nex 3.1;

c.

the res­ults of pre­vi­ous ex­per­i­ments, in par­tic­u­lar:

1.

res­ults of pre­lim­in­ary ex­per­i­ments in con­tained sys­tems to de­term­ine bio­lo­gic­al safety,

2.

data, res­ults and eval­u­ations of ex­per­i­ment­al re­leases car­ried out with the same or­gan­isms un­der com­par­able cli­mat­ic con­di­tions and with com­par­able fauna and flora;

d.

the risk de­term­in­a­tion and as­sess­ment in ac­cord­ance with An­nex 4;

e.

a mon­it­or­ing plan to show how the ap­plic­ant will ex­am­ine wheth­er the as­sump­tions of the risk de­term­in­a­tion and as­sess­ment in ac­cord­ance with An­nex 4 are cor­rect and wheth­er the meas­ures to ad­here to the re­quire­ments of Art­icles 12 and 13 are suf­fi­cient, and which con­tains at least the fol­low­ing de­tails:

1.

the type, spe­cificity, sens­it­iv­ity and re­li­ab­il­ity of the meth­ods,

2.

the dur­a­tion and fre­quency of the mon­it­or­ing;

f.

de­tails of wheth­er the pub­lic will be in­formed about the planned ex­per­i­ment­al re­lease;

g.

proof that the li­ab­il­ity guar­an­tee has been ful­filled.

³ The doc­u­ment­a­tion of the res­ults of pre­vi­ous ex­per­i­ments in ac­cord­ance with para­graph 2 let­ter c sub­sec­tion 2 may refer to data or res­ults from an­oth­er ap­plic­ant if this per­son has giv­en writ­ten per­mis­sion.

⁴ The FOEN may waive cer­tain de­tails of the tech­nic­al dossier in ac­cord­ance with para­graph 2 let­ter b if the ap­plic­ant can prove that these de­tails are not ne­ces­sary for an eval­u­ation of the ap­plic­a­tion.

⁵ A single ap­plic­a­tion may be sub­mit­ted if an ex­per­i­ment­al re­lease is be­ing car­ried out for the same pur­pose and with­in a lim­ited peri­od:

a.

with a single patho­gen­ic or­gan­ism at dif­fer­ent places;

b.

with a com­bin­a­tion of patho­gen­ic or­gan­isms at the same place or in dif­fer­ent places.

¹ The li­cence ap­plic­a­tion for an ex­per­i­ment­al re­lease of ali­en small in­ver­teb­rates must con­tain all the re­quired in­form­a­tion to prove that the ex­per­i­ment­al re­lease can­not con­tra­vene the re­quire­ments of Art­icles 15 and 16.

² The ap­plic­a­tion must con­tain the fol­low­ing doc­u­ments, in par­tic­u­lar:

a.

de­tails of the ob­ject­ive and con­text of the ex­per­i­ment;

b.

a tech­nic­al dossier with the in­form­a­tion in ac­cord­ance with An­nex 3.3;

c.

the res­ults of pre­vi­ous ex­per­i­ments, in par­tic­u­lar:

1.

res­ults of pre­lim­in­ary ex­per­i­ments in con­tained sys­tems to de­term­ine bio­lo­gic­al safety,

2.

data, res­ults and eval­u­ations of ex­per­i­ment­al re­leases car­ried out with the same or­gan­isms un­der com­par­able cli­mat­ic con­di­tions and with com­par­able fauna and flora;

d.

the risk de­term­in­a­tion and as­sess­ment in ac­cord­ance with An­nex 4;

e.

a mon­it­or­ing plan to show how the ap­plic­ant will ex­am­ine wheth­er the as­sump­tions of the risk de­term­in­a­tion and as­sess­ment in ac­cord­ance with An­nex 4 are cor­rect and wheth­er the meas­ures to ad­here to the re­quire­ments of Art­icles 15 and 16 are suf­fi­cient, and which con­tains at least the fol­low­ing de­tails:

1.

the type, spe­cificity, sens­it­iv­ity and re­li­ab­il­ity of the meth­ods,

2.

the dur­a­tion and fre­quency of the mon­it­or­ing;

f.

de­tails of wheth­er the pub­lic will be in­formed about the planned ex­per­i­ment­al re­lease.

³ The doc­u­ment­a­tion of the res­ults of pre­vi­ous ex­per­i­ments in ac­cord­ance with para­graph 2 let­ter c sub­sec­tion 2 may refer to data or res­ults from an­oth­er ap­plic­ant if this per­son has giv­en writ­ten per­mis­sion.

⁴ The FOEN may waive cer­tain de­tails of the tech­nic­al dossier in ac­cord­ance with para­graph 2 let­ter b if the ap­plic­ant can prove that these de­tails are not ne­ces­sary for an eval­u­ation of the ap­plic­a­tion.

⁵ A single ap­plic­a­tion may be sub­mit­ted if an ex­per­i­ment­al re­lease is be­ing car­ried out for the same pur­pose and with­in a lim­ited peri­od:

a.

with a single ali­en or­gan­ism at dif­fer­ent places;

b.

with a com­bin­a­tion of ali­en or­gan­isms at the same place or in dif­fer­ent places.

1 The ap­plic­ant may re­quest a sim­pli­fied li­cens­ing pro­ced­ure for ex­per­i­ment­al re­leases of ge­net­ic­ally mod­i­fied or­gan­isms, patho­gen­ic or­gan­isms or ali­en small in­ver­teb­rates if:

a.

an ex­per­i­ment­al re­lease with com­par­able pos­sible haz­ards and harm has been au­thor­ised in Switzer­land, in par­tic­u­lar, if it in­volves the same or­gan­isms;

b.

these or­gan­isms ori­gin­ate from the cross­ing of two or­gan­isms that have already been au­thor­ised for mar­ket­ing for dir­ect use in the en­vir­on­ment, and it can be shown that the sum of the prop­er­ties of the cross­ing do not dif­fer from the sum of the prop­er­ties of the au­thor­ised or­gan­isms.

² For a sim­pli­fied li­cens­ing pro­ced­ure, at least the doc­u­ments in ac­cord­ance with Art­icle 19 para­graph 2 let­ters a, d, e and h or in ac­cord­ance with Art­icle 20 para­graph 2 let­ters a, d, e and g or Art­icle 21 para­graph 2 let­ters a, d and e must be sub­mit­ted.

1 The ap­plic­ant or li­cence hold­er must in­form the FOEN without delay about:

a.

new find­ings and ob­ser­va­tions that might re­quire a re­as­sess­ment of the risk;

b.

changes to the ex­per­i­ment­al con­di­tions and the mon­it­or­ing plan.

² The ap­plic­ant or li­cence hold­er must ex­am­ine the meas­ures lis­ted in the li­cence and, if the ob­serv­ance of the re­quire­ments in ac­cord­ance with Art­icles 7–9, 12 and 13 or 15 and 16 is dir­ectly and ser­i­ously en­dangered, take the ad­di­tion­al meas­ures re­quired.

³ The FOEN shall in­form the spe­cial­ist agen­cies con­cerned (Art. 37 para. 1).

1 The li­cence hold­er must sub­mit a re­port to the FOEN with­in 4 months of com­ple­tion of the ex­per­i­ment­al re­lease. The FOEN may ex­tend the dead­line upon reas­on­able re­quest. The re­port shall be pub­licly ac­cess­ible and shall en­com­pass, in par­tic­u­lar, the fol­low­ing de­tails:

a.

the ac­tu­al course of the ex­per­i­ment­al re­lease;

b.

de­scrip­tion of the de­vi­ations from the planned course of the ex­per­i­ment and their eval­u­ation in terms of a haz­ard to hu­man be­ings, an­im­als or the en­vir­on­ment or an impair­ment of bio­lo­gic­al di­versity and the sus­tain­able use there­of;

c.

res­ults and con­clu­sions of the mon­it­or­ing.

² The ap­plic­ant or li­cence hold­er must sub­mit to the FOEN as soon as pos­sible the rest of the res­ults and find­ings of the ex­per­i­ment. If these are pub­lished in a sci­entif­ic or­gan, a copy of the art­icle must be sub­mit­ted to the FOEN on its pub­lic­a­tion.

³ The FOEN shall in­form the spe­cial­ist agen­cies (Art. 37 para. 1).

Any per­son who in­tends to mar­ket the fol­low­ing or­gan­isms for use in the en­vir­on­ment either for the first time or for a new use shall re­quire a li­cence from the FOEN:

a.

ge­net­ic­ally mod­i­fied or­gan­isms;

b.

patho­gen­ic or­gan­isms;

c.

ali­en small in­ver­teb­rates that are in­ten­ded for use in the en­vir­on­ment and not as pets

The li­cence in ac­cord­ance with Art­icle 25 shall be is­sued by one of the fol­low­ing au­thor­it­ies, in ac­cord­ance with the product, as part of the ap­plic­able li­cens­ing pro­ced­ure:

A li­cence is not re­quired for mar­ket­ing:

a.

plant re­pro­duct­ive ma­ter­i­al in ac­cord­ance with Art­icle 14a of the Seeds Or­din­ance of 7 Decem­ber 1998⁴⁴;

b.

an­im­al feed­stuffs in ac­cord­ance with Art­icle 21b Feed­stuffs Or­din­ance of 26 May 1999⁴⁵;

c.

food­stuffs, if the re­quire­ments of Art­icle 23 of the Food­stuffs and Util­ity Art­icles Or­din­ance of 23 Novem­ber 2005⁴⁶ have been ful­filled.

¹ The li­cence ap­plic­a­tion for pla­cing ge­net­ic­ally mod­i­fied or­gan­isms on the mar­ket, which must be sub­mit­ted as part of the ap­plic­able li­cens­ing pro­ced­ure in ac­cord­ance with Art­icle 26, must con­tain all the re­quired in­form­a­tion to prove that the hand­ling of the or­gan­isms can­not con­tra­vene the re­quire­ments of Art­icles 7–11.

² The ap­plic­a­tion must con­tain the fol­low­ing doc­u­ments, in par­tic­u­lar:

a.

a tech­nic­al dossier with the in­form­a­tion in ac­cord­ance with An­nexes IIIA or IIIB and IV of the Dir­ect­ive 2001/18/EC of the European Par­lia­ment and of the Coun­cil of 12 March 2001⁴⁷ on the de­lib­er­ate re­lease in­to the en­vir­on­ment of ge­net­ic­ally mod­i­fied or­gan­isms and re­peal­ing Coun­cil Dir­ect­ive 90/220/EEC;

b.

the res­ults of pre­vi­ous ex­per­i­ments us­ing the same or­gan­isms con­cern­ing haz­ards to hu­man be­ings or the en­vir­on­ment, or impair­ments caused to the same, in par­tic­u­lar, ex­per­i­ments in con­tained sys­tems or, pos­sibly, field tri­als;

c.

if avail­able, any li­cences and eval­u­ations from Swiss and for­eign au­thor­it­ies for ex­per­i­ment­al re­leases and mar­ket­ing of the same or­gan­isms;

d.

a risk de­term­in­a­tion and as­sess­ment in ac­cord­ance with An­nex 4;

e.

a mon­it­or­ing plan to show how the ap­plic­ant will ex­am­ine wheth­er the as­sump­tions of the risk de­term­in­a­tion and as­sess­ment in ac­cord­ance with An­nex 4 are cor­rect and wheth­er the meas­ures to ad­here to the prin­ciples of Art­icle 6 para­graphs 1 and 3 and Art. 7 GTA are suf­fi­cient, and which con­tains at least the fol­low­ing de­tails:

1.

the type, spe­cificity, sens­it­iv­ity and re­li­ab­il­ity of the meth­ods,

2.

the dur­a­tion and fre­quency of the mon­it­or­ing;

f.

an eval­u­ation of in­terests in ac­cord­ance with Art­icle 8 GTA that shows that the ge­net­ic modi­fic­a­tion of the ge­net­ic ma­ter­i­al of an­im­als or plants has not failed to re­spect the dig­nity of liv­ing be­ings;

g.

a pro­pos­al for the la­belling (Art. 10), in­form­ing the re­cip­i­ents (Art. 5), and for any pack­aging of the or­gan­isms;

h.

proof that the li­ab­il­ity guar­an­tee has been ful­filled;

i.⁴⁸

in re­spect of or­gan­isms that are used ge­net­ic re­sources or whose de­vel­op­ment is based on used ge­net­ic re­sources or on tra­di­tion­al know­ledge based there­on, the re­gister num­ber in ac­cord­ance with Art­icle 4 para­graph 3 or 8 para­graph 5 of the Nagoya Or­din­ance of 11 Decem­ber 2015⁴⁹.

³ The doc­u­ment­a­tion of the res­ults of pre­vi­ous ex­per­i­ments in ac­cord­ance with para­graph 2 let­ter b may refer to data or res­ults from an­oth­er ap­plic­ant, if this per­son has giv­en writ­ten per­mis­sion.

¹ The li­cence ap­plic­a­tion for pla­cing patho­gen­ic or­gan­isms on the mar­ket, which must be sub­mit­ted as part of the ap­plic­able li­cens­ing pro­ced­ure in ac­cord­ance with Art­icle 26, must con­tain all the re­quired in­form­a­tion to prove that the hand­ling of the or­gan­isms can­not con­tra­vene the re­quire­ments of Art­icles 12–14.

² The ap­plic­a­tion must con­tain the fol­low­ing doc­u­ments, in par­tic­u­lar:

a.

a tech­nic­al dossier with the in­form­a­tion in ac­cord­ance with An­nex 3.2;

b.

the res­ults of pre­vi­ous ex­per­i­ments us­ing the same or­gan­isms con­cern­ing haz­ards to hu­man be­ings or the en­vir­on­ment, or impair­ments caused to the same, in par­tic­u­lar, ex­per­i­ments in con­tained sys­tems or field tri­als;

c.

if avail­able, any li­cences and eval­u­ations from Swiss and for­eign au­thor­it­ies for ex­per­i­ment­al re­leases and mar­ket­ing of the same or­gan­isms;

d.

a risk de­term­in­a­tion and as­sess­ment in ac­cord­ance with An­nex 4;

e.

a mon­it­or­ing plan to show how the ap­plic­ant will ex­am­ine wheth­er the as­sump­tions of the risk de­term­in­a­tion and as­sess­ment in ac­cord­ance with An­nex 4 are cor­rect and wheth­er the meas­ures to ad­here to the prin­ciples of Art­icles 12 and 13 are suf­fi­cient, and which con­tains at least the fol­low­ing de­tails:

1.

the type, spe­cificity, sens­it­iv­ity and re­li­ab­il­ity of the meth­ods,

2.

the dur­a­tion and fre­quency of the mon­it­or­ing;

f.

a pro­pos­al for in­form­ing the re­cip­i­ents (Art. 5), and for any pack­aging of the or­gan­isms;

g.

proof that the li­ab­il­ity guar­an­tee has been ful­filled;

h.⁵⁰

in re­spect of or­gan­isms that are used ge­net­ic re­sources or whose de­vel­op­ment is based on used ge­net­ic re­sources or on tra­di­tion­al know­ledge based there­on, the re­gister num­ber in ac­cord­ance with Art­icle 4 para­graph 3 or 8 para­graph 5 of the Nagoya Or­din­ance of 11 Decem­ber 2015⁵¹.

³ The doc­u­ment­a­tion of the res­ults of pre­vi­ous ex­per­i­ments in ac­cord­ance with para­graph 2 let­ter b may refer to data or res­ults from an­oth­er ap­plic­ant, if this per­son has giv­en writ­ten per­mis­sion.

¹ The li­cence ap­plic­a­tion for pla­cing ali­en small in­ver­teb­rates on the mar­ket, which must be sub­mit­ted as part of the ap­plic­able li­cens­ing pro­ced­ure in ac­cord­ance with Art­icle 26, must con­tain all the re­quired in­form­a­tion to prove that the hand­ling of the or­gan­isms can­not con­tra­vene the re­quire­ments of Art­icles 15 and 16.

² The ap­plic­a­tion must con­tain the fol­low­ing doc­u­ments, in par­tic­u­lar:

a.

a tech­nic­al dossier with the in­form­a­tion in ac­cord­ance with An­nex 3.4;

b.

the res­ults of pre­vi­ous ex­per­i­ments us­ing the same or­gan­isms con­cern­ing haz­ards to hu­man be­ings or the en­vir­on­ment, or impair­ments caused to the same, in par­tic­u­lar, ex­per­i­ments in con­tained sys­tems or, pos­sibly, field tri­als;

c.

if avail­able, any li­cences and eval­u­ations from Swiss and for­eign au­thor­it­ies for ex­per­i­ment­al re­leases and mar­ket­ing of the same or­gan­isms;

d.

a risk de­term­in­a­tion and as­sess­ment in ac­cord­ance with An­nex 4;

e.

a mon­it­or­ing plan to show how the ap­plic­ant will ex­am­ine wheth­er the as­sump­tions of the risk de­term­in­a­tion and as­sess­ment in ac­cord­ance with An­nex 4 are cor­rect and wheth­er the meas­ures to ad­here to the prin­ciples of Art­icles 15 and 16 are suf­fi­cient, and which con­tains at least the fol­low­ing de­tails:

1.

the type, spe­cificity, sens­it­iv­ity and re­li­ab­il­ity of the meth­ods,

2.

the dur­a­tion and fre­quency of the mon­it­or­ing;

f.

a pro­pos­al for in­form­ing the re­cip­i­ents (Art. 5), and for any pack­aging of the or­gan­isms;

g.⁵²

in re­spect of or­gan­isms that are used ge­net­ic re­sources or whose de­vel­op­ment is based on used ge­net­ic re­sources or on tra­di­tion­al know­ledge based there­on, the re­gister num­ber in ac­cord­ance with Art­icle 4 para­graph 3 or 8 para­graph 5 of the Nagoya Or­din­ance of 11 Decem­ber 2015⁵³.

³The doc­u­ment­a­tion of the res­ults of pre­vi­ous ex­per­i­ments in ac­cord­ance with para­graph 2 let­ter b may refer to data or res­ults from an­oth­er ap­plic­ant, if this per­son has giv­en writ­ten per­mis­sion.

¹ The ap­plic­ant or the li­cence hold­er must in­form the li­cens­ing au­thor­ity without delay of new find­ings or ob­ser­va­tions that might re­quire a re­as­sess­ment of the risk.

² At the same time, the li­cence hold­er must ex­am­ine the meas­ures giv­en in the li­cence and, if ad­her­ence to any of the re­quire­ments of Art­icles 7–9, 12 and 13 or 15 and 16 is dir­ectly and ser­i­ously en­dangered, take the ad­di­tion­al meas­ures re­quired.

³ The FOEN shall in­form the spe­cial­ist agen­cies (Art. 43 para. 1).

¹ Any per­son who re­leases dir­ectly in the en­vir­on­ment ge­net­ic­ally mod­i­fied or­gan­isms that are au­thor­ised for mar­ket­ing must no­ti­fy the FOEN by two weeks after the re­lease at the latest of:

a.

his or her name and ad­dress;

b.

the unique iden­ti­fi­er of the ge­net­ic­ally mod­i­fied or­gan­isms, in ac­cord­ance with the An­nex to the Com­mis­sion Reg­u­la­tion (EC) No 65/2004 of 14 Janu­ary 2004⁵⁴ es­tab­lish­ing a sys­tem for the de­vel­op­ment and as­sign­ment of unique iden­ti­fi­ers for ge­net­ic­ally mod­i­fied or­gan­isms, or, if this is lack­ing, the iden­tity of the or­gan­isms, giv­ing the es­sen­tial char­ac­ter­ist­ics;

c.

the sites on which the or­gan­isms are be­ing re­leased;

d.

the time­frame, in par­tic­u­lar the be­gin­ning and end of the re­lease of the or­gan­isms;

e.

the type of use and re­lease of the or­gan­isms.

² Any per­son who re­leases ge­net­ic­ally mod­i­fied or­gan­isms dir­ectly in the en­vir­on­ment must keep re­cords of this; he or she must give the re­quired in­form­a­tion to the FOEN and carry out or tol­er­ate in­vest­ig­a­tions if ne­ces­sary.

1 Any per­son who ap­plies to re­lease or­gan­isms for ex­per­i­ment­al pur­poses or to place them on the mar­ket must have a res­id­ence or busi­ness premises in Switzer­land.

2 In re­la­tion to the pla­cing on the mar­ket of food­stuffs, the pro­vi­sions of the le­gis­la­tion on food­stuffs are re­served.

¹ The li­cence ap­plic­a­tion should be sub­mit­ted in the re­quired num­ber of cop­ies. For ex­per­i­ment­al re­leases, the ap­plic­a­tion should also be sub­mit­ted in the of­fi­cial lan­guage of the loc­al com­munity where the ex­per­i­ment­al re­lease will take place.

² Fur­ther cop­ies in the re­quired num­ber should be sub­mit­ted for pub­lic in­form­a­tion pur­poses; these must con­tain at least the de­tails in ac­cord­ance with Art­icle 54 para­graph 4.

¹ The leg­al suc­cessor of the hold­er of a li­cence for ex­per­i­ment­al re­leases or mar­ket­ing in ac­cord­ance with Art­icle 26 let­ters c and k, must re­quest trans­fer of the li­cence from the FOEN.

² The li­cence shall be trans­ferred once the con­di­tions for the li­cence have been ful­filled.

1 The FOEN shall ex­am­ine wheth­er the doc­u­ment­a­tion sub­mit­ted (Art. 19, 20 or 21) for eval­u­at­ing the ap­plic­a­tion is com­plete. If the doc­u­ment­a­tion is in­com­plete, it shall re­turn this to the ap­plic­ant for sup­ple­ment­a­tion or re­vi­sion, in­dic­at­ing which in­form­a­tion is lack­ing.

2 It shall give no­tice of re­ceipt of the ap­plic­a­tion in the Fed­er­al Gaz­ette, when the ap­plic­a­tion is com­plete, and shall en­sure that the non-con­fid­en­tial doc­u­ments are dis­played for 30 days for ex­am­in­a­tion:

a.

at the FOEN;

b.

in the loc­al com­mune where the ex­per­i­ment­al re­lease will take place.

3 Any per­son who claims party rights in ac­cord­ance with the the Fed­er­al Act of 20 Decem­ber 1968⁵⁵ on Ad­min­is­trat­ive Pro­ced­ure must ob­ject in writ­ing dur­ing the dis­play peri­od, giv­ing de­tails of their party status.

⁴ Dur­ing the dis­play peri­od all fur­ther per­sons may sub­mit a writ­ten state­ment on the files.

⁵ The FOEN may take part in pub­lic in­form­a­tion events to in­form the pub­lic about the pro­gress of the pro­ced­ure.

1 The FOEN shall ex­am­ine the ap­plic­a­tion. Con­com­it­antly with an­nounce­ment of the re­ceipt of the ap­plic­a­tion in the Fed­er­al Gaz­ette, the FOEN shall for­ward the ap­plic­a­tion to the fol­low­ing oth­er au­thor­it­ies, who shall eval­u­ate it in their field of re­spons­ib­il­ity and state their po­s­i­tion with­in 50 days:

a.

the FOPH, FS­VO and FO­AG;

b.

the Swiss Ex­pert Com­mit­tee for Biosafety (SECB) and the Fed­er­al Eth­ics Com­mit­tee on Non-hu­man Bi­o­tech­no­logy (ECNH);

c.

the des­ig­nated au­thor­ity of the can­ton in ques­tion for in­form­a­tion about loc­al fea­tures.

² The FOEN shall sup­ply the spe­cial­ist agen­cies with the sub­mis­sions in ac­cord­ance with Art­icle 36 para­graphs 3 and 4.

³ It shall sup­ply the spe­cial­ist agen­cies’ state­ments to the parties for their com­ments and the spe­cial­ist agen­cies re­cip­roc­ally for their in­form­a­tion.

⁴ If the ex­am­in­a­tion shows that the doc­u­ments sub­mit­ted are in­suf­fi­cient for as­sess­ing the ap­plic­a­tion, the FOEN shall re­quest ad­di­tion­al doc­u­ments from the ap­plic­ant, stat­ing the reas­ons there­for, and re­quest com­ments on them from the parties and the spe­cial­ist agen­cies. In this case the dead­line shall be ex­ten­ded ac­cord­ingly.

5 On re­quest, it shall in­form the State Sec­ret­ari­at for Eco­nom­ic Af­fairs (SECO) and the Swiss Ac­ci­dent In­sur­ance Or­gan­isa­tion (SUVA) of the ap­plic­a­tion.

¹ The FOEN shall au­thor­ise the ex­per­i­ment­al re­lease, tak­ing in­to con­sid­er­a­tion the state­ments re­ceived from the parties and the spe­cial­ist agen­cies, as a rule with­in 3 months of an­noun­cing the re­ceipt of the ap­plic­a­tion in the Fed­er­al Gaz­ette plus any ex­ten­sion of dead­line, if:

a.

ex­am­in­a­tion of the ap­plic­a­tion, in par­tic­u­lar the risk as­sess­ment in ac­cord­ance with An­nex 4, leads to the con­clu­sion that, giv­en the cur­rent state of sci­entif­ic know­ledge and ex­per­i­ence, the ex­per­i­ment­al re­lease can­not en­danger hu­man be­ings, an­im­als and the en­vir­on­ment or harm bio­lo­gic­al di­versity and the sus­tain­able use there­of (Art. 7 and 8, 12 and 13, or 15 and 16);

b.

the in­form­a­tion sought can­not be gained through fur­ther ex­per­i­ments in con­tained sys­tems;

c.

in the case of ge­net­ic­ally mod­i­fied or­gan­isms, ad­di­tion­ally:

1.

pro­duc­tion that does not use ge­net­ic­ally mod­i­fied or­gan­isms and con­sumers’ free­dom of choice are not harmed (Art. 9),

2.

the as­sess­ment of the ap­plic­a­tion, in par­tic­u­lar based on the eval­u­ation of in­terests in ac­cord­ance with Art­icle 8 GTA, leads to the con­clu­sion that the ge­net­ic modi­fic­a­tion has not failed to re­spect the dig­nity of liv­ing be­ings in the an­im­als or plants used,

3.

it has been shown that in terms of dir­ect hand­ling in the en­vir­on­ment, the ex­per­i­ment­al re­lease con­trib­utes to re­search­ing the biosafety of ge­net­ic­ally mod­i­fied or­gan­isms;

d.

based on the as­sess­ment of the ap­plic­a­tion, in par­tic­u­lar based on the risk as­sess­ment, the ex­per­i­ment­al re­lease is per­miss­ible un­der the laws en­forced by the FOPH, FS­VO and FO­AG, and if these of­fices ap­prove car­ry­ing out the ex­per­i­ment­al re­lease.

² The FOEN shall make the li­cence sub­ject to con­di­tions and stip­u­la­tions ne­ces­sary for pro­tect­ing hu­man be­ings, the en­vir­on­ment, bio­lo­gic­al di­versity and the sus­tain­able use there­of. It may in par­tic­u­lar:

a.

de­mand that the site of the ex­per­i­ment­al re­lease be marked, fenced in or spe­cially se­cured;

b.

or­der that, in ad­di­tion to the mon­it­or­ing plan (Art. 19 para. 2 let­ter e, 20 para. 2 let­ter e, or 21 para. 2 let­ter e), the site of the ex­per­i­ment­al re­lease and sur­round­ings be kept un­der ob­ser­va­tion dur­ing and after the ex­per­i­ment­al re­lease, and that samples be taken and tested, all at the ex­pense of the ap­plic­ant;

c.

or­der that the car­ry­ing out of and mon­it­or­ing of the ex­per­i­ment­al re­lease be in­spec­ted by a sup­port group (Art. 41 para. 2) at the ap­plic­ant’s ex­pense;

d.

de­mand in­ter­im re­ports;

e.

de­mand that the samples, de­tec­tion meth­ods and ma­ter­i­als re­quired for mon­it­or­ing be made avail­able free of charge.

³ The FOEN shall in­form the parties and the spe­cial­ist agen­cies of its de­cision (Art. 37 para. 1) and make it pub­licly ac­cess­ible via auto­mated in­form­a­tion and com­mu­nic­a­tion ser­vices.

¹ If the con­di­tions of Art­icle 22 have been ful­filled, the FOEN shall carry out a sim­pli­fied li­cens­ing pro­ced­ure.

² It may in par­tic­u­lar:

a.

waive the need to sub­mit the doc­u­ment­a­tion in ac­cord­ance with Art­icle 19 para­graph 2 let­ters b, c, f and g, or in ac­cord­ance with Art­icle 20 para­graph 2 let­ters b, c and f, or Art­icle 21 para­graph 2 let­ters b, c and f;

b.

shorten the dead­lines for state­ments to be sub­mit­ted.

¹ If any of the spe­cial­ist agen­cies in­volved in the pro­ced­ure (Art. 37 para. 1) comes in­to pos­ses­sion of new find­ings on the risks posed by the ex­per­i­ment­al re­lease after is­sue of the li­cence, it shall in­form the FOEN.

² In the case of in­form­a­tion in ac­cord­ance with para­graph 1 and Art­icle 23, the FOEN shall, with the con­sent of the fed­er­al agen­cies in­volved in the pro­ced­ure, pre­scribe ap­pro­pri­ate meas­ures. In par­tic­u­lar, it may re­quire that:

a.

the risk de­term­in­a­tion and as­sess­ment (Art. 19 para. 2 let­ter d, 20 para. 2 let­ter d, or 21 para. 2 let­ter d) be car­ried out again;

b.

the con­di­tions of the ex­per­i­ment­al re­lease be changed;

c.

the ex­per­i­ment­al re­lease be in­ter­rup­ted or if ne­ces­sary ter­min­ated and, as far as pos­sible, the ori­gin­al con­di­tions re­stored.

3 It shall con­sult the SECB and the ECNH.

¹ The FOEN shall mon­it­or the car­ry­ing out of ex­per­i­ment­al re­leases and or­der the ne­ces­sary meas­ures.

² For this pur­pose, it may ap­point a sup­port group with rep­res­ent­at­ives, in par­tic­u­lar, of the can­ton in which the ex­per­i­ment­al re­lease is tak­ing place. The sup­port group:

a.

shall mon­it­or the car­ry­ing out of the ex­per­i­ment­al re­lease by spot checks at the site and ex­am­ine, in par­tic­u­lar, ad­her­ence to the con­di­tions and stip­u­la­tions as­so­ci­ated with the li­cence; in par­tic­u­lar it shall have un­an­nounced ac­cess to the site of the ex­per­i­ment­al re­lease, it may take samples, and it may view all doc­u­ments;

b.

shall in­form the FOEN without delay about de­vi­ations from the con­di­tions and stip­u­la­tions as­so­ci­ated with the li­cence or about oth­er ob­ser­va­tions and find­ings rel­ev­ant to safety;

c.

may, with the agree­ment of the FOEN, provide pub­lic in­form­a­tion about its man­date and planned pro­ced­ure;

d.

shall keep re­cords of its activ­it­ies as well as its ob­ser­va­tions and find­ings;

e.

shall, after con­clu­sion of the ex­per­i­ment, draw up a re­port of the res­ults of the mon­it­or­ing and trans­mit it to the FOEN.

³ The FOEN shall in­form the spe­cial­ist agen­cies and the ap­plic­ant of the mon­it­or­ing res­ults.

¹ The li­cens­ing au­thor­ity un­der Art­icle 26 shall ex­am­ine wheth­er the doc­u­ment­a­tion sub­mit­ted (Art. 28, 29 or 30) is com­plete. If the doc­u­ment­a­tion is in­com­plete, it shall re­turn this to the ap­plic­ant for sup­ple­ment­a­tion or re­vi­sion, in­dic­at­ing which in­form­a­tion is lack­ing.

² If the ap­plic­a­tion con­cerns or­gan­isms that will be handled dir­ectly in the en­vir­on­ment, the li­cens­ing au­thor­ity shall an­nounce re­ceipt of the ap­plic­a­tion in the Fed­er­al Gaz­ette, once the ap­plic­a­tion is com­plete, and shall en­sure that the non-con­fid­en­tial doc­u­ments are dis­played for 30 days for ex­am­in­a­tion.

³ Dur­ing the dis­play peri­od, any per­son may sub­mit a writ­ten state­ment on the ap­plic­a­tion. Any per­son who makes use of this op­por­tun­ity does not ac­quire party rights in the li­cens­ing pro­ced­ure through this alone.

⁴ If the or­gan­isms con­cerned are ge­net­ic­ally mod­i­fied or patho­gen­ic or­gan­isms that will be handled dir­ectly in the en­vir­on­ment, the en­vir­on­ment­al pro­tec­tion or­gan­isa­tions in ac­cord­ance with Art­icle 28 GTA or in ac­cord­ance with Art­icle 55f EPA may re­gister their ob­jec­tions dur­ing the dis­play peri­od.

¹ The li­cens­ing au­thor­ity in ac­cord­ance with Art­icle 26 shall ex­am­ine the ap­plic­a­tion. It shall for­ward it to the fol­low­ing oth­er spe­cial­ist agen­cies, who shall eval­u­ate it in their field of re­spons­ib­il­ity and state their po­s­i­tion:

a.

the FOPH and FOEN;

b.

the FS­VO and FO­AG, if the ap­plic­a­tion falls with­in their area of re­spons­ib­il­ity;

c.

the SECB and the ECNH.

² The li­cens­ing au­thor­ity shall sup­ply the spe­cial­ist agen­cies with the de­tails in ac­cord­ance with Art­icle 42 para­graphs 3 and 4.

³ It shall sup­ply the spe­cial­ist agen­cies’ state­ments to the parties con­cerned for their com­ments and the spe­cial­ist agen­cies re­cip­roc­ally for their in­form­a­tion.

⁴ If the ex­am­in­a­tion shows that the doc­u­ments sub­mit­ted are in­suf­fi­cient for as­sess­ing the ap­plic­a­tion, the FOEN shall re­quest ad­di­tion­al doc­u­ments from the ap­plic­ant and re­quest com­ments on them from the parties and the spe­cial­ist agen­cies.

¹ The li­cens­ing au­thor­ity shall au­thor­ise mar­ket­ing, tak­ing in­to con­sid­er­a­tion the state­ments re­ceived from the parties and the spe­cial­ist agen­cies, if the as­sess­ment of the ap­plic­a­tion leads to the con­clu­sion that:

a.

the re­quire­ments of the ap­plic­able li­cens­ing pro­ced­ure have been ful­filled;

b.

mar­ket­ing can­not en­danger hu­man be­ings, an­im­als and the en­vir­on­ment or harm bio­lo­gic­al di­versity and the sus­tain­able use there­of (Art. 7 and 8, 12 and 13, or 15 and 16);

c.

in the case of ge­net­ic­ally mod­i­fied or­gan­isms, ad­di­tion­ally:

1.

pro­duc­tion that does not use ge­net­ic­ally mod­i­fied or­gan­isms (Art. 9) and con­sumers’ free­dom of choice are not im­paired,

2.

the as­sess­ment of the ap­plic­a­tion, in par­tic­u­lar based on the eval­u­ation of in­terests in ac­cord­ance with Art­icle 8 GTA, leads to the con­clu­sion that the ge­net­ic modi­fic­a­tion has not failed to re­spect the dig­nity of liv­ing be­ings in the an­im­als or plants used;

d.

mar­ket­ing is per­miss­ible un­der the laws en­forced by the FOPH and FOEN, and if ap­plic­able the FS­VO and FO­AG, and these of­fices there­fore ap­prove mar­ket­ing;

e.⁵⁶

in re­spect of or­gan­isms that are used ge­net­ic re­sources or whose de­vel­op­ment is based on used ge­net­ic re­sources or on tra­di­tion­al know­ledge based there­on, the duty to re­gister in terms of Art­icle 4 or 8 para­graph 3 of the Nagoya Or­din­ance of 11 Decem­ber 2015⁵⁷ has been com­plied with.

² The li­cens­ing au­thor­ity may make the li­cence sub­ject to con­di­tions, and may in par­tic­u­lar:

a.

lim­it the use of the or­gan­isms or per­mit the use only un­der cer­tain con­di­tions;

b.

de­mand, at the ap­plic­ant’s ex­pense, fur­ther in­vest­ig­a­tions in ad­di­tion to the mon­it­or­ing plan (Art. 28 para. 2 let­ter e 29 para. 2 let­ter e and 30 para. 2 let­ter e) to identi­fy pos­sible delayed con­sequences for hu­man be­ings, an­im­als or the en­vir­on­ment, for bio­lo­gic­al di­versity and the sus­tain­able use there­of, or for the pro­tec­tion of pro­duc­tion that does not use ge­net­ic­ally mod­i­fied or­gan­isms; and the pro­duc­tion of a re­port.

³ A li­cence is val­id for up to 10 years. It may be ex­ten­ded for a fur­ther 10 years max­im­um if the com­pet­ent au­thor­ity and the spe­cial­ist agen­cies, tak­ing in­to ac­count pos­sible new find­ings, con­clude that the con­di­tions giv­en in para­graph 1 con­tin­ue to be met.

¹ If one of the spe­cial­ist agen­cies in­volved in the pro­ced­ure comes in­to pos­ses­sion of new find­ings about the risks posed by the mar­ket­ing, it shall in­form the li­cens­ing au­thor­ity.

² The spe­cial­ist agen­cies whose agree­ment is ne­ces­sary for the is­sue of a li­cence may de­mand that the li­cens­ing au­thor­ity, in par­tic­u­lar:

a.

change the con­di­tions im­posed for the mar­ket­ing;

b.

if ne­ces­sary, pro­hib­it the mar­ket­ing tem­por­ar­ily or in­def­in­itely;

c.

in ser­i­ous cases, or­der the re­turn of or­gan­isms placed on the mar­ket.

³ If the li­cens­ing au­thor­ity comes in­to pos­ses­sion of such new find­ings or if such new find­ings are re­por­ted by the ap­plic­ant or li­cence hold­er (Art. 31), it shall or­der the ne­ces­sary meas­ures after con­sult­ing the SECB and the ECNH, and with the agree­ment of the fed­er­al agen­cies in­volved in the pro­ced­ure. No con­sulta­tion is re­quired for pre­cau­tion­ary meas­ures if the risk is im­min­ent. The li­cens­ing au­thor­ity shall in­form without delay the spe­cial­ist agen­cies about the new find­ings and the meas­ures taken.

1 For or­gan­isms that may be mar­keted without a li­cence, the FOEN may de­mand evid­ence from the dis­trib­ut­or that he or she is ex­er­cising self-su­per­vi­sion, to­geth­er with doc­u­ment­a­tion, if there is reas­on to be­lieve that or­gan­isms placed on the mar­ket could en­danger hu­man be­ings, an­im­als or the en­vir­on­ment, or could harm bio­lo­gic­al di­versity or the sus­tain­able use there­of. It shall give the dis­trib­ut­or suf­fi­cient time to re­spond. The FOEN shall con­sult fur­ther fed­er­al agen­cies as re­quired.

2 The FOEN may:

a.

de­mand that the per­son mar­ket­ing the or­gan­isms re­peat the self-su­per­vi­sion with­in a cer­tain peri­od and, if ne­ces­sary, sup­ple­ment or amend it;

b.

pre­scribe the form and the con­tent of the in­form­a­tion sup­plied to re­cip­i­ents, in par­tic­u­lar the de­tails of the or­gan­isms’ prop­er­ties and the re­com­mend­a­tions and in­struc­tions for their hand­ling in the en­vir­on­ment;

c.

de­mand that the per­son mar­ket­ing the or­gan­isms re­move in­ap­pro­pri­ate or mis­lead­ing la­belling or in­form­a­tion.

3 If the dis­trib­ut­or does not com­ply with the de­mands with­in the dead­line set, the FOEN may then pro­hib­it mar­ket­ing of the or­gan­isms in ques­tion.

4 The FOEN shall in­form the can­tons of the meas­ures pre­scribed.

1 Sub­sequent mon­it­or­ing (su­per­vising the mar­ket) shall be car­ried out:

a.

for thera­peut­ic products in ac­cord­ance with the Thera­peut­ic Products Act of 15 Decem­ber 2000⁵⁸;

b.

for food­stuffs and utensils in ac­cord­ance with the Food­stuffs Act of 9 Oc­to­ber 1992⁵⁹;

c.

for plant propaga­tion ma­ter­i­als ex­clus­ively for use in forests in ac­cord­ance with the Forests Or­din­ance of 30 Novem­ber 1992⁶⁰;

d.

for plant propaga­tion ma­ter­i­als for all oth­er uses in ac­cord­ance with the Seeds Or­din­ance of 7 Decem­ber 1998⁶¹;

e.

for plant pro­tec­tion products in ac­cord­ance with the Plant Pro­tec­tion Products Or­din­ance of 18 May 2005⁶²;

f.

for fer­til­isers in ac­cord­ance with the Fer­til­isers Or­din­ance of 10 Janu­ary 2001⁶³;

g.

for an­im­al feed­stuffs in ac­cord­ance with the Feed­stuffs Or­din­ance of 26 May 1999⁶⁴;

h.

for im­mun­o­lo­gic­al products for veter­in­ary use in ac­cord­ance with the Thera­peut­ic Products Act of 15 Decem­ber 2000;

i.⁶⁵

…

j.

for biocid­al products in ac­cord­ance with the Biocid­al Products Or­din­ance of 18 May 2005⁶⁶.

2 The re­spons­ible au­thor­ity shall in­form the FOEN and FOPH about or­ders it has is­sued, if the re­quire­ments of this Or­din­ance are af­fected.

³ The samples, de­tec­tion meth­ods and ma­ter­i­als re­quired for mon­it­or­ing shall be made avail­able to the com­pet­ent au­thor­it­ies.

⁴ If the mon­it­or­ing shows that pro­vi­sions of this Or­din­ance have been con­tra­vened, the per­son re­spons­ible shall bear the costs of the mon­it­or­ing.

1 The can­tons are re­spons­ible for sub­sequent mon­it­or­ing (su­per­vising the mar­ket) of or­gan­isms placed on the mar­ket which are not sub­ject to the con­trols stip­u­lated by Art­icle 47.

2 The can­ton­al au­thor­it­ies shall mon­it­or by spot checks or at the re­quest of the FOEN, in par­tic­u­lar, wheth­er:

a.

the reg­u­la­tions re­gard­ing the in­form­ing of re­cip­i­ents (Art. 5) are be­ing ob­served;

b.

the mar­ket­ing of ge­net­ic­ally mod­i­fied or patho­gen­ic or­gan­isms has been au­thor­ised;

c.

the hand­ling of par­tic­u­lar or­gan­isms is not pro­hib­ited;

d.

the con­di­tions and stip­u­la­tions linked to the is­sue of the mar­ket­ing li­cence are be­ing ob­served;

e.

ge­net­ic­ally mod­i­fied or­gan­isms are cor­rectly la­belled (Art. 10);

f.

the meas­ures pre­scribed by the FOEN in ac­cord­ance with para­graph 4 are be­ing im­ple­men­ted.

3 If the mon­it­or­ing shows that the pro­vi­sions of para­graph 2 let­ters b-f are be­ing con­tra­vened, the can­ton in which the dis­trib­ut­or is res­id­ent or has busi­ness premises shall pre­scribe the ne­ces­sary meas­ures and in­form the FOEN and the oth­er can­tons.

4 If the mon­it­or­ing shows that pro­vi­sions of this Or­din­ance con­cern­ing mar­ket­ing are be­ing con­tra­vened, the can­ton shall in­form the FOEN. The FOEN shall con­duct the ne­ces­sary in­vest­ig­a­tions, and pre­scribe the ne­ces­sary meas­ures. If the or­gan­isms in ques­tion may be placed on the mar­ket without a li­cence, Art­icle 46 ap­plies.

5 The samples, de­tec­tion meth­ods and ma­ter­i­als re­quired for mon­it­or­ing shall be made avail­able to the com­pet­ent au­thor­it­ies.

6 If the mon­it­or­ing shows that re­quire­ments in this Or­din­ance are be­ing con­tra­vened, the per­sons re­spons­ible shall pay the costs of the mon­it­or­ing. The mon­it­or­ing au­thor­it­ies shall is­sue an in­voice dir­ectly to these per­sons.

1 The can­ton­al au­thor­it­ies shall mon­it­or ob­serv­ance of the duty of care when hand­ling or­gan­isms in the en­vir­on­ment, in ac­cord­ance with Art­icles 6–9, 12, 13, 15 and 16.

2 If the mon­it­or­ing shows cause for com­plaint, the can­ton in ques­tion shall or­der the ne­ces­sary meas­ures to be taken.

¹ The FOEN shall carry out sur­veys that are ne­ces­sary to as­sess the en­vir­on­ment­al pol­lu­tion caused by par­tic­u­lar or­gan­isms, by par­tic­u­lar prop­er­ties of or­gan­isms, or by par­tic­u­lar ge­net­ic ma­ter­i­al.

² For this pur­pose it shall en­sure, as re­quired:

a.

the de­vel­op­ment of ap­pro­pri­ate meth­ods to de­tect these or­gan­isms, these prop­er­ties or this ge­net­ic ma­ter­i­al in the en­vir­on­ment;

b.

the tar­geted in­vest­ig­a­tion of en­vir­on­ment­al samples for the pres­ence of these or­gan­isms, these prop­er­ties or this ge­net­ic ma­ter­i­al.

¹ The FOEN shall en­sure the es­tab­lish­ment of a mon­it­or­ing sys­tem for the early re­cog­ni­tion of pos­sible haz­ards to the en­vir­on­ment and impair­ments of bio­lo­gic­al di­versity by ge­net­ic­ally mod­i­fied or­gan­isms and their trans­gen­ic ge­net­ic ma­ter­i­al, or by in­vas­ive ali­en or­gan­isms.

² For this pur­pose, it shall des­ig­nate the spe­cif­ic mon­it­or­ing ob­ject­ives and shall stip­u­late the re­quired meth­ods, in­dic­at­ors and as­sess­ment cri­ter­ia. Be­fore es­tab­lish­ing the meth­ods, in­dic­at­ors and as­sess­ment cri­ter­ia, it shall con­sult the fed­er­al agen­cies and can­tons con­cerned and the stake­hold­ers.

³ For the mon­it­or­ing, it shall use, as far as pos­sible, data from ex­ist­ing mon­it­or­ing sys­tems in the en­vir­on­ment­al and ag­ri­cul­tur­al sec­tor, and shall also ex­am­ine par­tic­u­lar ob­ser­va­tions of third parties.

⁴ The fed­er­al and can­ton­al au­thor­it­ies re­spons­ible for en­for­cing this Or­din­ance shall provide the FOEN with the ne­ces­sary in­form­a­tion on re­quest; in par­tic­u­lar the FO­AG shall sup­ply the data on the basis of the Or­din­ance of 23 Oc­to­ber 2013⁶⁷ on In­form­a­tion Sys­tems in the Ag­ri­cul­ture Sec­tor, the Dir­ect Sub­sidies Or­din­ance of 23 Oc­to­ber 2013⁶⁸, the Or­gan­ic Farm­ing Or­din­ance of 22 Septem­ber 1997⁶⁹ and the Or­din­ance of 7 Decem­ber 1998⁷⁰ on the Eval­u­ation of Sus­tain­ab­il­ity in Ag­ri­cul­ture.⁷¹

⁵ If the ana­lys­is of the data and ob­ser­va­tions pro­duces in­dic­a­tions of dam­age or impair­ment:

a.

the FOEN, to­geth­er with oth­er af­fected fed­er­al agen­cies, shall in­vest­ig­ate sci­en­tific­ally wheth­er a caus­al con­nec­tion could ex­ist between these dam­age or impair­ments and the pres­ence of the mon­itored or­gan­isms in ac­cord­ance with para­graph 1;

b.

the FOEN shall in­form the can­tons.

1 If or­gan­isms ap­pear that could en­danger hu­man be­ings, an­im­als or the en­vir­on­ment or could harm bio­lo­gic­al di­versity and the sus­tain­able use there­of, the can­ton­al au­thor­it­ies shall pre­scribe ap­pro­pri­ate con­trol meas­ures and, if ne­ces­sary and use­ful, meas­ures to pre­vent their fu­ture oc­cur­rence.

2 The can­ton­al au­thor­it­ies shall in­form the FOEN and oth­er af­fected fed­er­al agen­cies about the oc­cur­rence and con­trol of such or­gan­isms. They may draw up a pub­licly ac­cess­ible ca­das­tral re­gister of the sites of the or­gan­isms.

³ The FOEN shall co­ordin­ate, as far as is ne­ces­sary, the con­trol meas­ures and shall de­vel­op, to­geth­er with the oth­er af­fected fed­er­al agen­cies and the can­tons, a na­tion­al strategy to con­trol the or­gan­isms.

⁴ Reg­u­la­tions in oth­er fed­er­al le­gis­la­tion on the con­trol of harm­ful or­gan­isms are re­served.

¹ If sci­entif­ic in­vest­ig­a­tions lead to the con­clu­sion that it may be as­sumed with suf­fi­cient prob­ab­il­ity that there is a caus­al con­nec­tion between dam­age to hu­man be­ings, an­im­als or the en­vir­on­ment or impair­ments of bio­lo­gic­al di­versity and the sus­tain­able use there­of and the pres­ence of patho­gen­ic, ali­en or ge­net­ic­ally mod­i­fied or­gan­isms or their trans­gen­ic ma­ter­i­al, the li­cence hold­er shall bear the costs:

a.

of de­term­in­ing the dam­age, the impair­ment and the caus­al con­nec­tion;

b.

of the pre­ven­tion and re­medi­ation of the dam­age and the impair­ment.

² The costs in ac­cord­ance with para­graph 1 shall also be borne by per­sons who carry out ex­per­i­ment­al re­leases that are not sub­ject to a li­cence or who place or­gan­isms not sub­ject to a li­cence on the mar­ket, if it can be shown with suf­fi­cient prob­ab­il­ity that they have caused the dam­age.

¹ In­form­a­tion ob­tained in the en­force­ment of this Or­din­ance or oth­er fed­er­al le­gis­la­tion on the hand­ling of ge­net­ic­ally mod­i­fied or­gan­isms or products ob­tained from them, or of patho­gen­ic or ali­en or­gan­isms, shall be made pub­lic, in the ab­sence of any le­git­im­ate and over­rid­ing private or pub­lic in­terests.

² The FOEN shall provide pub­lic in­form­a­tion about the res­ults of the sur­veys (Art. 50), of the mon­it­or­ing (Art. 51) and the con­trol (Art. 52), in the ab­sence of any le­git­im­ate and over­rid­ing private or pub­lic in­terests.

³ In par­tic­u­lar, the pro­tec­tion of busi­ness and pro­duc­tion secrets shall be worthy of pro­tec­tion.

4 The fol­low­ing in­form­a­tion shall in every case be made pub­lic:

a.

the names and ad­dresses of those re­spons­ible for the ex­per­i­ment­al re­lease or the mar­ket­ing;

b.

a gen­er­al de­scrip­tion of the or­gan­isms and their prop­er­ties;

c.

the aim of the ex­per­i­ment­al re­lease or the use of the or­gan­isms to be placed on the mar­ket;

d.

the site of the ex­per­i­ment­al re­lease;

e.

the site where ge­net­ic­ally mod­i­fied or­gan­isms au­thor­ised for mar­ket­ing are dir­ectly re­leased (Art. 32 para. 1 let­ter c);

f.

meth­ods and plans for mon­it­or­ing the ge­net­ic­ally mod­i­fied or patho­gen­ic or­gan­isms in the en­vir­on­ment and emer­gency meas­ures;

g.

a sum­mary of the risk de­term­in­a­tion and as­sess­ment in ac­cord­ance with An­nex 4;

h.

the re­port in ac­cord­ance with Art­icle 24 para­graph 1, in which the FOEN has de­term­ined cor­rect­ness and com­plete­ness.

1 The au­thor­it­ies re­spons­ible for the en­force­ment of this Or­din­ance shall treat in­form­a­tion as con­fid­en­tial where there is a le­git­im­ate and over­rid­ing in­terest in do­ing so. They shall clas­si­fy this in­form­a­tion as such when for­ward­ing it to oth­er au­thor­it­ies.

2 Any per­son sub­mit­ting doc­u­ments to the au­thor­it­ies must:

a.

in­dic­ate in­form­a­tion which is to be treated as con­fid­en­tial; and

b.

jus­ti­fy the need for con­fid­en­ti­al­ity.

3 An au­thor­ity that does not wish to ac­cede to a re­quest for con­fid­en­ti­al­ity shall in­vest­ig­ate wheth­er the grounds giv­en for con­fid­en­ti­al­ity are jus­ti­fi­able. If its as­sess­ment dif­fers from the pro­pos­al of the per­sons sup­ply­ing the in­form­a­tion, the au­thor­ity, after hear­ing these per­sons, shall in­form them in a rul­ing which in­form­a­tion they do not find worthy of pro­tec­tion.

1 The FOEN shall main­tain a re­gister of all au­thor­ised ex­per­i­ment­al re­leases. The re­gister shall re­cord wheth­er, when, where, by whom and with what an ex­per­i­ment­al re­lease was car­ried out.

2 It shall also main­tain a re­gister of ge­net­ic­ally mod­i­fied or­gan­isms au­thor­ised for mar­ket­ing. The fed­er­al and can­ton­al au­thor­it­ies re­spons­ible for en­for­cing this Or­din­ance shall provide the ne­ces­sary in­form­a­tion.

3 It shall main­tain a re­gister of ge­net­ic­ally mod­i­fied or­gan­isms au­thor­ised for mar­ket­ing that are re­leased dir­ectly (Art. 32); the re­gister shall re­cord what, when, where and for what pur­pose the re­lease was car­ried out.

4 The re­gisters shall con­tain no con­fid­en­tial in­form­a­tion and shall be pub­licly ac­cess­ible via auto­mated in­form­a­tion and com­mu­nic­a­tion ser­vices. They may be pub­lished in full or in part.

¹ Fees shall be charged for or­ders and ser­vices provided by the FOEN in ac­cord­ance with the Or­din­ance of 3 June 2005⁷² on the Fees charged by the FOEN.

² A fee shall be charged for state­ments from fed­er­al agen­cies that sub­mit a state­ment as part of the is­su­ing of or­ders and the pro­vi­sion of ser­vices by the FOEN in ac­cord­ance with Art­icle 8 of the Gen­er­al Or­din­ance on Charges of 8 Septem­ber 2004⁷³.

1 The FOEN may is­sue guidelines on the en­force­ment of this Or­din­ance if re­quired. It shall first con­sult the spe­cial­ist agen­cies con­cerned.

2 The FOEN to­geth­er with the FOPH shall en­sure ba­sic and con­tinu­ing pro­fes­sion­al edu­ca­tion events are held reg­u­larly for per­sons who carry out du­ties un­der this Or­din­ance.

DE­TEC shall modi­fy the lists in An­nex 2 after con­sult­ing the fed­er­al agen­cies con­cerned and the stake­hold­ers if it comes in­to pos­ses­sion of new find­ings about the in­vas­ive­ness of ali­en or­gan­isms.

The Re­lease Or­din­ance of 25 Au­gust 1999⁷⁴ is re­pealed.

The amend­ment of cur­rent le­gis­la­tion is reg­u­lated in An­nex 5.

Genes in­ser­ted by gene tech­no­logy meth­ods and in­du­cing res­ist­ance to an­ti­bi­ot­ics that are au­thor­ised for use in hu­man and veter­in­ary medi­cine may be used in field tri­als up to 31 Decem­ber 2008.

This Or­din­ance comes in­to force on 1 Oc­to­ber 2008.