Federal Act
on Protection against Dangerous Substances and Preparations
(Chemicals Act, ChemA)

This Act is in­ten­ded to pro­tect the lives and health of hu­man be­ings against harm­ful ef­fects arising from sub­stances and pre­par­a­tions.

¹ This Act ap­plies to the hand­ling of sub­stances and pre­par­a­tions.

² The hand­ling of mi­croor­gan­isms is deemed equi­val­ent to the hand­ling of sub­stances and pre­par­a­tions in so far as they are used in biocid­al products or plant pro­tec­tion products.

³ The Fed­er­al As­sembly may by means of an or­din­ance ex­tend the scope of this Act or of in­di­vidu­al pro­vi­sions to in­clude:

a.

or­gan­isms that have, or may have, dan­ger­ous prop­er­ties with­in the mean­ing of this Act;

b.

the pro­tec­tion of the lives and health of farm and house­hold an­im­als.

⁴ The Fed­er­al Coun­cil shall provide for ex­emp­tions from the scope or from in­di­vidu­al pro­vi­sions of this Act in cases where:

a.

lives and health are ad­equately pro­tec­ted by oth­er fed­er­al le­gis­la­tion against harm­ful ef­fects arising from sub­stances and pre­par­a­tions;

b.

sub­stances and pre­par­a­tions are in­ten­ded solely for through trans­it or ex­port;

c.

gen­er­al de­fence or the tasks of the po­lice and cus­toms au­thor­it­ies ne­ces­sit­ate such ex­emp­tions.

¹ Sub­stances and pre­par­a­tions are deemed dan­ger­ous if they are cap­able of present­ing a haz­ard to life or health as a res­ult of physico-chem­ic­al or tox­ic ef­fects.

² The Fed­er­al Coun­cil shall spe­cify the prop­er­ties deemed dan­ger­ous and define cat­egor­ies of danger.

¹ In this Act:

a.

sub­stances means chem­ic­al ele­ments and their com­pounds in the nat­ur­al state or ob­tained by any pro­duc­tion pro­cess. A dis­tinc­tion is drawn between ex­ist­ing and new sub­stances:

1.

sub­stances shall be deemed to be ex­ist­ing sub­stances if they are des­ig­nated as such by the Fed­er­al Coun­cil,

2.

all oth­er sub­stances shall be deemed new;

b.

act­ive sub­stances means sub­stances and mi­croor­gan­isms in­clud­ing vir­uses which on ac­count of their ac­tion are de­signed to be used as biocid­al products or plant pro­tec­tion products;

c.

pre­par­a­tions means mix­tures or solu­tions com­posed of two or more sub­stances;

d.

biocid­al products means act­ive sub­stances and pre­par­a­tions that are not plant pro­tec­tion products and which are de­signed to:

1.

de­ter, render harm­less, des­troy or oth­er­wise con­trol harm­ful or­gan­isms, or

2.

pre­vent dam­age from be­ing caused by harm­ful or­gan­isms;

e.

plant pro­tec­tion products means act­ive sub­stances and pre­par­a­tions that are de­signed to:

1.

pro­tect plants and plant products against harm­ful or­gan­isms or pre­vent the ac­tion of such or­gan­isms,

2.

in­flu­ence the life pro­cesses of plants oth­er than as a nu­tri­ent,

3.

pre­serve plant products,

4.

des­troy un­wanted plants or parts of plants, or

5.

con­trol the un­desired growth of plants;

f.

man­u­fac­turer means any nat­ur­al or leg­al per­son who, by way of pro­fes­sion or trade, pro­duces or ex­tracts sub­stances or pre­par­a­tions, or im­ports them for pro­fes­sion­al or com­mer­cial pur­poses;

g.

no­ti­fi­er means any nat­ur­al or leg­al per­son who no­ti­fies new sub­stances to the no­ti­fic­a­tion au­thor­ity, sub­mits doc­u­ment­a­tion on ex­ist­ing sub­stances un­der re­view, or re­quests au­thor­isa­tion for act­ive sub­stances or pre­par­a­tions;

h.

no­ti­fic­a­tion au­thor­ity means the fed­er­al au­thor­ity that re­ceives in par­tic­u­lar no­ti­fic­a­tions of new sub­stances, doc­u­ment­a­tion on ex­ist­ing sub­stances un­der re­view, or re­quests for au­thor­isa­tion for act­ive sub­stances and pre­par­a­tions, as well as oth­er sub­mis­sions, co­ordin­ates the pro­ced­ures and is­sues the ne­ces­sary rul­ings;

i.

pla­cing on the mar­ket means provid­ing for or sup­ply­ing to third parties and im­port­ing for pro­fes­sion­al or com­mer­cial pur­poses;

j.

hand­ling means any activ­ity in con­nec­tion with sub­stances or pre­par­a­tions, in par­tic­u­lar, pro­duc­tion, im­port, ex­port, pla­cing on the mar­ket, stor­age, keep­ing, trans­port, use or dis­pos­al.

² The Fed­er­al Coun­cil may define more pre­cisely the terms spe­cified in para­graph 1, as well as oth­er terms used in this Act, draw fur­ther dis­tinc­tions, and, in the light of new sci­entif­ic and tech­no­lo­gic­al know­ledge and in line with in­ter­na­tion­al de­vel­op­ments, make ad­just­ments and grant ex­emp­tions.

¹ Any man­u­fac­turer who places sub­stances or pre­par­a­tions on the mar­ket shall be re­spons­ible for en­sur­ing that they do not en­danger life or health. In par­tic­u­lar, the man­u­fac­turer shall:

a.

as­sess and clas­si­fy sub­stances and pre­par­a­tions ac­cord­ing to their prop­er­ties;

b.

pack­age and la­bel them in ac­cord­ance with the type of haz­ard con­cerned.

² The Fed­er­al Coun­cil shall is­sue reg­u­la­tions on the nature, ex­tent and re­view of self-reg­u­la­tion. In par­tic­u­lar, it shall spe­cify:

a.

test meth­ods, the prin­ciples of Good Labor­at­ory Prac­tice (GLP) and the cri­ter­ia for as­sess­ment and clas­si­fic­a­tion;

b.

pack­aging and la­belling re­quire­ments.

Hav­ing com­pleted the ap­pro­pri­ate self-reg­u­la­tion pro­ced­ures, the man­u­fac­turer shall be en­titled to place sub­stances and pre­par­a­tions on the mar­ket without the pri­or con­sent of the au­thor­it­ies. The fol­low­ing ex­cep­tions ap­ply:

a.

no­ti­fic­a­tion is re­quired for pla­cing new sub­stances on the mar­ket as such or as a con­stitu­ent of a pre­par­a­tion (Art. 9);

b.

au­thor­isa­tion is re­quired for pla­cing biocid­al products or plant pro­tec­tion products on the mar­ket (Art. 10 and 11).

¹ Any per­son who places sub­stances or pre­par­a­tions on the mar­ket must in­form pur­chasers about prop­er­ties and haz­ards rel­ev­ant to health, and about the ap­pro­pri­ate pre­cau­tions and pro­tect­ive meas­ures.

² The Fed­er­al Coun­cil shall is­sue reg­u­la­tions con­cern­ing the nature, con­tent and scope of such in­form­a­tion, in par­tic­u­lar the dis­tri­bu­tion and con­tent of a safety data sheet.

Any per­son in­volved in the hand­ling of sub­stances or pre­par­a­tions must pay due re­gard to their dan­ger­ous prop­er­ties and take any meas­ures ne­ces­sary to pro­tect life and health. In par­tic­u­lar, due con­sid­er­a­tion must be giv­en to the rel­ev­ant in­form­a­tion provided by the man­u­fac­turer.

¹ The no­ti­fic­a­tion au­thor­ity shall re­view and as­sess the doc­u­ments sub­mit­ted in con­junc­tion with the fed­er­al au­thor­it­ies re­spons­ible for the tech­nic­al mat­ters in ques­tion (as­sess­ment au­thor­it­ies) and shall in­form the no­ti­fi­er of the out­come with­in a peri­od spe­cified by the Fed­er­al Coun­cil.

² A sub­stance for which no­ti­fic­a­tion has been sub­mit­ted may be placed on the mar­ket if the no­ti­fic­a­tion au­thor­ity has ac­cep­ted the no­ti­fic­a­tion or if it has not re­ques­ted any fur­ther doc­u­ments or in­form­a­tion con­cern­ing the no­ti­fic­a­tion with­in the above-men­tioned peri­od.

³ The Fed­er­al Coun­cil shall is­sue reg­u­la­tions on the re­quire­ments and the pro­ced­ure for the no­ti­fic­a­tion of new sub­stances. It shall spe­cify any ex­emp­tions from man­dat­ory no­ti­fic­a­tion, tak­ing in­to ac­count in par­tic­u­lar the in­ten­ded use, the type of sub­stance or pre­par­a­tion and the quant­it­ies that are to be pro­duced or placed on the mar­ket.

¹ The no­ti­fic­a­tion au­thor­ity shall re­view and as­sess the doc­u­ments sub­mit­ted in con­junc­tion with the as­sess­ment au­thor­it­ies and shall is­sue its de­cision – tak­ing the risk as­sess­ment in­to con­sid­er­a­tion (Art. 16) – with­in a peri­od spe­cified by the Fed­er­al Coun­cil.

² Au­thor­isa­tion shall be gran­ted for a biocid­al product in par­tic­u­lar if, when used as in­ten­ded:

a.

it is suf­fi­ciently ef­fect­ive;

b.

it does not have any un­ac­cept­able ad­verse ef­fects on the health of hu­mans or of farm or house­hold an­im­als.

³ Au­thor­isa­tion may be with­held or re­voked if the health risks give rise to con­cern and if an­oth­er act­ive sub­stance is avail­able for which au­thor­isa­tion has been gran­ted for biocid­al products of the same type, which is as­so­ci­ated with a con­sid­er­ably lower health risk and which does not en­tail any sig­ni­fic­ant eco­nom­ic or prac­tic­al dis­ad­vant­ages for users.

⁴ The Fed­er­al Coun­cil shall spe­cify the types of au­thor­isa­tion and the au­thor­isa­tion pro­ced­ures, as well as any ex­emp­tions from man­dat­ory au­thor­isa­tion for biocid­al products. Au­thor­isa­tion shall be gran­ted for lim­ited peri­ods.

¹ Au­thor­isa­tion shall be gran­ted for a plant pro­tec­tion product in par­tic­u­lar if, when used as in­ten­ded, it does not have any un­ac­cept­able ad­verse ef­fects on the health of hu­mans or of farm or house­hold an­im­als.

² In oth­er re­spects, the types of au­thor­isa­tion and the au­thor­isa­tion pro­ced­ures, as well as any ex­emp­tions from man­dat­ory au­thor­isa­tion for plant pro­tec­tion products, shall be de­term­ined by the rel­ev­ant ag­ri­cul­tur­al le­gis­la­tion. When is­su­ing the ap­pro­pri­ate im­ple­ment­ing reg­u­la­tions, the Fed­er­al Coun­cil shall give due con­sid­er­a­tion to the pro­tec­tion of health with­in the mean­ing of this Act.

Be­fore no­ti­fi­ers con­duct the an­im­al ex­per­i­ments re­quired for no­ti­fic­a­tion or au­thor­isa­tion, they must en­quire at the no­ti­fic­a­tion au­thor­ity as to wheth­er the sub­stance or pre­par­a­tion con­cerned has already been no­ti­fied or au­thor­isa­tion has already been gran­ted.

¹ No­ti­fic­a­tion or au­thor­isa­tion in ac­cord­ance with Art­icles 9–11 shall also be re­quired in cases where sub­stances or pre­par­a­tions sub­ject to man­dat­ory no­ti­fic­a­tion or au­thor­isa­tion have already been no­ti­fied by an­oth­er no­ti­fi­er or au­thor­isa­tion has already been gran­ted to an­oth­er no­ti­fi­er.

² The Fed­er­al Coun­cil shall es­tab­lish a spe­cial pro­ced­ure for second no­ti­fic­a­tion or au­thor­isa­tion and, giv­ing due con­sid­er­a­tion to the in­terests of the ori­gin­al no­ti­fi­er, shall spe­cify the con­di­tions un­der which:

a.

the second no­ti­fi­er may refer to no­ti­fic­a­tion doc­u­ments already sub­mit­ted;

b.

the ori­gin­al no­ti­fi­er, in the in­terests of an­im­al wel­fare, has to ac­cept the use of its no­ti­fic­a­tion doc­u­ments.

Sub­ject to the pro­vi­sions of Art­icle 13 para­graph 2, the fed­er­al au­thor­it­ies in­volved in the no­ti­fic­a­tion or au­thor­isa­tion pro­ced­ure shall not be en­titled to use in­form­a­tion or doc­u­ments provided by a no­ti­fi­er for the be­ne­fit of a dif­fer­ent no­ti­fi­er without the former’s con­sent. The Fed­er­al Coun­cil shall spe­cify the peri­od of pro­tec­tion and de­term­ine any ex­emp­tions, giv­ing due con­sid­er­a­tion to the con­fid­en­ti­al­ity of the in­form­a­tion con­cerned.

¹ The Fed­er­al Coun­cil shall is­sue reg­u­la­tions con­cern­ing the re­view and as­sess­ment of in­di­vidu­al ex­ist­ing sub­stances.

² The no­ti­fic­a­tion au­thor­ity may re­quest man­u­fac­tur­ers to carry out in­vest­ig­a­tions or tests or to provide doc­u­ments re­lat­ing to ex­ist­ing sub­stances that:

a.

in view of the quant­it­ies pro­duced or placed on the mar­ket or in view of their dan­ger­ous char­ac­ter may pose a par­tic­u­lar risk to life or health; or

b.

are be­ing re­viewed in con­nec­tion with in­ter­na­tion­al ef­forts and pro­grammes.

¹ The no­ti­fic­a­tion au­thor­ity, in con­junc­tion with the as­sess­ment au­thor­it­ies, shall identi­fy pos­sible haz­ards presen­ted by sub­stances or pre­par­a­tions (risk as­sess­ment). For this pur­pose, the no­ti­fi­er may be re­ques­ted to provide ad­di­tion­al in­form­a­tion and, if ne­ces­sary, to carry out fur­ther tests.

² A risk as­sess­ment shall be re­quired for:

a.

new sub­stances (Art. 9);

b.

sub­stances and pre­par­a­tions sub­ject to man­dat­ory au­thor­isa­tion (Art. 10 and 11);

c.

ex­ist­ing sub­stances un­der re­view in ac­cord­ance with Art­icle 15 para­graph 2 let­ter b.

³ On the basis of the risk as­sess­ment, hav­ing first con­sul­ted the no­ti­fi­er, the no­ti­fic­a­tion au­thor­ity may re­com­mend or or­der that the no­ti­fi­er should take meas­ures to re­duce the risks.

⁴ If no meas­ures can be taken to re­duce the risks or if the risks can­not be ad­equately re­duced by such meas­ures, the au­thor­it­ies re­spons­ible shall take ap­pro­pri­ate steps to amend the rel­ev­ant leg­al reg­u­la­tions.

⁵ Risk as­sess­ments shall be re­viewed and, if ne­ces­sary, re­vised in the light of new find­ings. In ad­di­tion, re­views shall be car­ried out peri­od­ic­ally in the case of biocid­al products and plant pro­tec­tion products.

The no­ti­fi­er must in­form the no­ti­fic­a­tion au­thor­ity without delay and if ne­ces­sary sub­mit new doc­u­ments if new find­ings emerge re­lat­ing to the sub­stance or pre­par­a­tion con­cerned or if sig­ni­fic­ant changes oc­cur with re­gard to es­sen­tial points such as prop­er­ties, in­ten­ded use, or the quant­it­ies pro­duced or placed on the mar­ket.

¹ In cases where dan­ger­ous sub­stances or pre­par­a­tions not sub­ject to a man­dat­ory no­ti­fic­a­tion or au­thor­isa­tion pro­ced­ure are placed on the mar­ket, the man­u­fac­turer shall in­form the no­ti­fic­a­tion au­thor­ity of the fol­low­ing:

a.

the name and ad­dress of the man­u­fac­turer;

b.

the es­sen­tial de­tails con­cern­ing the iden­tity of the product;

c.

the clas­si­fic­a­tion and la­belling;

d.

the sub­stances rel­ev­ant to the clas­si­fic­a­tion.

² In the case of cer­tain sub­stances and pre­par­a­tions, the Fed­er­al Coun­cil may waive, in part or in full, the re­quire­ment to provide such in­form­a­tion, par­tic­u­larly if:

a.

on ac­count of their prop­er­ties or the in­ten­ded use, in­form­a­tion on the sub­stances or pre­par­a­tions con­cerned is of little im­port­ance for the iden­ti­fic­a­tion of risks or for pre­ven­tion;

b.

they are sup­plied ex­clus­ively to pro­fes­sion­al or com­mer­cial users; or

c.

they are sup­plied in small amounts to a re­stric­ted circle of users.

³ It may, if this is im­port­ant for the iden­ti­fic­a­tion of risks or for pre­ven­tion:

a.

stip­u­late that ad­di­tion­al de­tails be re­por­ted for cer­tain sub­stances and pre­par­a­tions, spe­cific­ally con­cern­ing their com­pos­i­tion;

b.

ex­tend the scope of man­dat­ory re­port­ing to in­clude pre­par­a­tions that are not dan­ger­ous but con­tain dan­ger­ous sub­stances.

¹ The Fed­er­al Coun­cil may is­sue spe­cial reg­u­la­tions:

a.

for cer­tain sub­stances and pre­par­a­tions that may en­danger life or health;

b.

for art­icles con­tain­ing sub­stances or pre­par­a­tions as spe­cified un­der let­ter a that may en­danger life or health when they are used as in­ten­ded or in a fore­see­able way.

² It may:

a.

im­pose re­stric­tions on the way in which they are handled, and in par­tic­u­lar pro­duced, placed on the mar­ket and used;

b.

im­pose re­stric­tions on the in­ten­ded use for which a sub­stance or pre­par­a­tion is placed on the mar­ket, and on the qual­ity and form there­of;

c.

pro­hib­it any hand­ling if life and health can­not oth­er­wise be pro­tec­ted;

d.

at­tach spe­cial con­di­tions to ex­ports;

e.

re­quire art­icles to be la­belled if cer­tain sub­stances are con­tained in or may be re­leased from them;

f.

re­quire cer­tain pois­on­ous plants and an­im­als to be la­belled as such if they are placed on the mar­ket;

g.

spe­cify the clas­si­fic­a­tion and la­belling of in­di­vidu­al dan­ger­ous sub­stances and set threshold con­cen­tra­tions for the clas­si­fic­a­tion and la­belling of pre­par­a­tions that con­tain these sub­stances.

¹ The pro­mo­tion and of­fer­ing for sale of dan­ger­ous sub­stances and pre­par­a­tions, and of pre­par­a­tions con­tain­ing dan­ger­ous sub­stances, must not give rise to mis­ap­pre­hen­sions re­gard­ing the haz­ards or en­cour­age in­ap­pro­pri­ate hand­ling. In the case of biocid­al products, no mis­lead­ing claims may be made re­gard­ing ef­fic­acy.

² The Fed­er­al Coun­cil shall is­sue reg­u­la­tions on how ref­er­ence is to be made to the haz­ards in such pro­mo­tion and of­fer­ing for sale.

Dan­ger­ous sub­stances and pre­par­a­tions shall be kept and stored se­curely ac­cord­ing to the type of haz­ard in­volved. In par­tic­u­lar, they must:

a.

be pro­tec­ted against haz­ard­ous ex­tern­al in­flu­ences;

b.

be in­ac­cess­ible to un­au­thor­ised parties;

c.

be kept or stored in such a way as to pre­vent any risk of con­fu­sion, spe­cific­ally with food­stuffs, or of their be­ing used by mis­take.

¹ Any per­son who sup­plies dan­ger­ous sub­stances or pre­par­a­tions shall be ob­liged to ac­cept them when re­turned by non-com­mer­cial users for ap­pro­pri­ate dis­pos­al. Small quant­it­ies shall be re­turn­able free of charge.

² In the case of par­tic­u­larly dan­ger­ous sub­stances and pre­par­a­tions, the Fed­er­al Coun­cil may stip­u­late that they are to be re­turned by the own­er for dis­pos­al.

The Fed­er­al Coun­cil shall is­sue reg­u­la­tions con­cern­ing the meas­ures that are to be taken when dan­ger­ous sub­stances or pre­par­a­tions have been stolen, lost, or placed on the mar­ket by mis­take.

¹ The Fed­er­al Coun­cil shall spe­cify the per­son­al and tech­nic­al qual­i­fic­a­tions re­quired by per­sons wish­ing to handle sub­stances and pre­par­a­tions with par­tic­u­larly dan­ger­ous prop­er­ties or in spe­cif­ic cat­egor­ies of danger or car­ry­ing spe­cial risks. It shall es­tab­lish a li­cens­ing re­quire­ment if this is ne­ces­sary to pro­tect life and health.

² It shall spe­cify how the ne­ces­sary ex­pert­ise may be ac­quired.

¹ Any per­son who is in­volved in the hand­ling of sub­stances and pre­par­a­tions by way of pro­fes­sion or trade shall be ob­liged to take such meas­ures to pro­tect the life and health of em­ploy­ees as are ne­ces­sary in the light of ex­per­i­ence, prac­tic­able ac­cord­ing to the state of tech­no­lo­gic­al de­vel­op­ment and ap­pro­pri­ate to the cir­cum­stances of the es­tab­lish­ment con­cerned. Sub­ject to the pro­vi­sions of Art­icles 42 and 45, the present pro­vi­sion shall be im­ple­men­ted in ac­cord­ance with the La­bour Law of 13 March 1964³ and the Fed­er­al Law of 20 March 1981⁴ on Ac­ci­dent In­sur­ance.

² In com­mer­cial and edu­ca­tion­al es­tab­lish­ments where dan­ger­ous sub­stances or pre­par­a­tions are handled by way of pro­fes­sion or trade, a per­son is to be des­ig­nated who is re­spons­ible for ques­tions of ap­pro­pri­ate hand­ling and who can provide the en­force­ment au­thor­it­ies with the ne­ces­sary in­form­a­tion (Art. 42 Para. 2). This per­son shall be re­quired to have the ne­ces­sary tech­nic­al qual­i­fic­a­tions and op­er­a­tion­al au­thor­ity. The can­ton­al au­thor­ity re­spons­ible for en­force­ment shall be no­ti­fied of the name of the per­son des­ig­nated.

¹ The no­ti­fic­a­tion au­thor­ity shall be re­spons­ible for the man­age­ment of cross-sec­tor­al doc­u­ment­a­tion on sub­stances and pre­par­a­tions. To this end, it shall main­tain a product re­gister.

² The as­sess­ment au­thor­it­ies shall be re­spons­ible for ob­tain­ing the doc­u­ment­a­tion re­quired to ful­fil their tasks.

¹ The product re­gister shall con­tain the in­form­a­tion on sub­stances and pre­par­a­tions that:

a.

has been ac­quired or com­piled by the no­ti­fic­a­tion au­thor­ity and the as­sess­ment au­thor­it­ies in the course of the no­ti­fic­a­tion or au­thor­isa­tion pro­ced­ure as spe­cified in Chapter 2;

b.

has been re­por­ted by the man­u­fac­turer in ac­cord­ance with Art­icle 18.

² The Fed­er­al Coun­cil shall reg­u­late the pro­cessing of data con­tained in the product re­gister, par­tic­u­larly its use and dis­clos­ure, giv­ing due con­sid­er­a­tion to the in­terests of the man­u­fac­turer; it shall spe­cify the type of in­form­a­tion that may be dis­closed to en­force­ment au­thor­it­ies im­ple­ment­ing reg­u­la­tions on sub­stances and pre­par­a­tions on the basis of oth­er leg­al in­stru­ments.

¹ The fed­er­al gov­ern­ment shall in­form the pub­lic and au­thor­it­ies about the risks and haz­ards in­volved in hand­ling sub­stances and pre­par­a­tions and shall re­com­mend meas­ures to re­duce the risks.

² It shall is­sue tech­nic­al guidelines and pub­lish the lists of sub­stances and pre­par­a­tions that are re­quired for the ap­plic­a­tion of this Act.

³ The can­tons shall provide in­form­a­tion with­in their areas of re­spons­ib­il­ity.

The fed­er­al gov­ern­ment shall provide in­form­a­tion on haz­ards arising from in­door pol­lut­ants. It may in par­tic­u­lar is­sue re­com­mend­a­tions on the lim­it­a­tion or pre­ven­tion of ex­pos­ures haz­ard­ous to health and on the im­prove­ment of in­door air qual­ity.

¹ The Fed­er­al Coun­cil shall es­tab­lish a pois­ons in­form­a­tion centre and en­sure that it is fin­an­cially com­pensated for car­ry­ing out the tasks as­signed to it.

² The in­form­a­tion centre shall provide in­form­a­tion on the pre­ven­tion and treat­ment of pois­on­ing and shall re­com­mend ap­pro­pri­ate meas­ures; to this end, it shall col­lect and pro­cess the ne­ces­sary in­form­a­tion, in­clud­ing de­tails of cases of pois­on­ing.

³ It shall have un­res­tric­ted ac­cess to the data in the product re­gister (Art. 27) and shall be en­titled to re­quest the man­u­fac­turer dir­ectly to provide any ad­di­tion­al in­form­a­tion on sub­stances and pre­par­a­tions that may be re­quired for the ful­fil­ment of its tasks.

⁴ The Fed­er­al Coun­cil shall take ap­pro­pri­ate meas­ures to en­sure that the data made avail­able in ac­cord­ance with para­graph 3 is treated con­fid­en­tially and that com­mer­cial and in­dus­tri­al secrets are pro­tec­ted. It shall spe­cify in par­tic­u­lar the con­di­tions un­der which and the ex­tent to which the in­form­a­tion centre may, for med­ic­al pur­poses of a pre­vent­ive or cur­at­ive nature, dis­close de­tails of the com­pos­i­tion and prop­er­ties of sub­stances and pre­par­a­tions.

¹ In so far as the fed­er­al gov­ern­ment is not re­spons­ible, this Act shall be en­forced by the can­tons. They shall en­sure that the au­thor­it­ies re­spons­ible for en­for­cing this Act co­ordin­ate their activ­it­ies with the en­force­ment au­thor­it­ies re­spons­ible for work­place safety and for en­vir­on­ment­al pro­tec­tion.

² They shall im­ple­ment de­cisions is­sued by the fed­er­al au­thor­it­ies, when re­ques­ted to do so by the lat­ter.

The can­tons shall is­sue the or­gan­isa­tion­al reg­u­la­tions for en­force­ment and shall no­ti­fy the fed­er­al gov­ern­ment there­of.

¹ The fed­er­al gov­ern­ment shall su­per­vise the en­force­ment of this Act.

² It shall co­ordin­ate can­ton­al en­force­ment meas­ures in so far as uni­form en­force­ment is deemed de­sir­able. To this end, it may in par­tic­u­lar:

a.

im­pose a duty on the can­tons to in­form the fed­er­al gov­ern­ment about en­force­ment meas­ures;

b.

pre­scribe meas­ures to en­sure uni­form en­force­ment by the can­tons;

c.

in ex­cep­tion­al cir­cum­stances, or­der the can­tons to take spe­cif­ic en­force­ment meas­ures;

d.⁵

sup­port con­tinu­ing edu­ca­tion and train­ing for the en­force­ment au­thor­it­ies.

¹ The fed­er­al gov­ern­ment shall en­force:

a.

Art­icle 5 para­graph 1 let­ter a (as­sess­ment and clas­si­fic­a­tion of sub­stances and pre­par­a­tions) and the re­quire­ments based on Art­icle 5 para­graph 2 let­ter a;

b.

Art­icle 7 (man­u­fac­turer’s ob­lig­a­tion to in­form pur­chasers);

c.

Art­icles 9–17 (no­ti­fic­a­tion of and au­thor­isa­tion for spe­cif­ic sub­stances and pre­par­a­tions);

d.

Art­icle 18 (re­port­ing of de­tails of sub­stances and pre­par­a­tions);

e.

Art­icle 19 para­graph 2 let­ter d (ex­ports);

f.

Art­icles 26–30 (doc­u­ment­a­tion and in­form­a­tion), with the ex­cep­tion of Art­icle 28 para­graph 3.

² It may del­eg­ate re­spons­ib­il­ity to the can­tons for in­di­vidu­al parts of the tasks spe­cified in para­graph 1 or re­quest their par­ti­cip­a­tion in spe­cif­ic parts of tasks.

³ The fed­er­al gov­ern­ment is re­spons­ible for en­force­ment with re­gard to the fol­low­ing mat­ters:

a.

in­stall­a­tions, activ­it­ies, sub­stances and pre­par­a­tions re­quired for the pur­poses of na­tion­al de­fence;

b.

im­ports, through trans­it or ex­ports.

¹ The Fed­er­al Coun­cil shall de­term­ine which as­sess­ment au­thor­it­ies are to be in­volved in the pro­ced­ures and re­views spe­cified in Chapter 2.

² If un­der dif­fer­ent items of le­gis­la­tion sub­stances or pre­par­a­tions must be no­ti­fied to or au­thor­isa­tion gran­ted by more than one fed­er­al au­thor­ity, it shall des­ig­nate a joint no­ti­fic­a­tion au­thor­ity.

³ The Fed­er­al Coun­cil shall reg­u­late the co­oper­a­tion between the fed­er­al au­thor­it­ies in­volved.

The Fed­er­al Coun­cil may del­eg­ate en­force­ment tasks to pub­lic or private or­gan­isa­tions and per­sons.

¹ The fed­er­al gov­ern­ment shall en­sure that the sci­entif­ic re­quire­ments ne­ces­sary for the ap­plic­a­tion of this Act are ful­filled.

² It may carry out sur­veys it­self or in co­oper­a­tion with the can­tons, or with ap­pro­pri­ate in­sti­tu­tions or ex­perts.

³ With­in the frame­work of in­ter­na­tion­al co­oper­a­tion, it may fin­ance in­vest­ig­a­tions of sub­stances and pre­par­a­tions in whole or in part.

⁴ It shall pro­mote sci­entif­ic teach­ing and re­search in the field of dan­ger­ous prop­er­ties of sub­stances and pre­par­a­tions.

The Fed­er­al Coun­cil shall is­sue the im­ple­ment­ing pro­vi­sions. Where pos­sible, it shall com­bine these with the im­ple­ment­ing pro­vi­sions for oth­er fed­er­al acts if the lat­ter in­clude pro­vi­sions re­lat­ing to sub­stances and pre­par­a­tions.

¹ When is­su­ing its pro­vi­sions, the Fed­er­al Coun­cil shall give due con­sid­er­a­tion to in­ter­na­tion­ally har­mon­ised guidelines and re­com­mend­a­tions, and in­ter­na­tion­ally har­mon­ised tech­nic­al reg­u­la­tions and stand­ards.

² It may de­clare cer­tain in­ter­na­tion­ally har­mon­ised tech­nic­al reg­u­la­tions and stand­ards to be ap­plic­able in con­nec­tion with this Act. It may au­thor­ise the rel­ev­ant fed­er­al of­fice to make sub­sequent ad­just­ments to tech­nic­al de­tails of minor im­port­ance in the reg­u­la­tions and stand­ards that have been de­clared ap­plic­able.

³ In ex­cep­tion­al cases, it may de­cide that the reg­u­la­tions and stand­ards de­clared ap­plic­able are to be pub­lished in a spe­cial form and that trans­la­tion in­to the of­fi­cial lan­guages is not re­quired.

¹ By way of amend­ment to the pro­vi­sions of Art­icle 18 of the Fed­er­al Act of 6 Oc­to­ber 1995⁶ on Tech­nic­al Bar­ri­ers to Trade (TBA), the Fed­er­al Coun­cil may ap­prove the re­cog­ni­tion in par­tic­u­lar of tests, in­spec­tions or as­sess­ments car­ried out abroad and of for­eign re­ports or cer­ti­fic­ates.

² With­in the scope of the au­thor­ity gran­ted by this Act, it may con­clude in­ter­na­tion­al agree­ments over and above the pro­vi­sions of Art­icle 14 para­graph 1 TBA.

³ The fed­er­al au­thor­it­ies shall co­oper­ate with for­eign au­thor­it­ies and in­sti­tu­tions, and with in­ter­na­tion­al or­gan­isa­tions.

If the no­ti­fic­a­tion au­thor­ity has good reas­on to be­lieve that sub­stances or pre­par­a­tions rep­res­ent a health haz­ard, al­though they com­ply with the re­quire­ments of this Act, in par­tic­u­lar if their clas­si­fic­a­tion, pack­aging or la­belling is no longer ap­pro­pri­ate, it may, hav­ing first con­sul­ted the man­u­fac­turer, pro­vi­sion­ally re­clas­si­fy the sub­stances or pre­par­a­tions, pro­hib­it their pla­cing on the mar­ket or make them sub­ject to spe­cial con­di­tions. In such cases, the meas­ures re­quired to amend the reg­u­la­tions con­cerned shall be taken without delay.

¹ In or­der to mon­it­or com­pli­ance with the pro­vi­sions of this Act, the en­force­ment au­thor­it­ies shall be au­thor­ised to test sub­stances, pre­par­a­tions and art­icles as spe­cified in Art­icle 19 Para­graph 1 let­ter b and to ex­am­ine pro­ced­ures for the hand­ling there­of.

² For this pur­pose, they shall be au­thor­ised to re­quest that any per­sons in­volved in the hand­ling of such sub­stances, pre­par­a­tions or art­icles should, free of charge:

a.

provide the ne­ces­sary in­form­a­tion;

b.

carry out or sub­mit to in­vest­ig­a­tions;

c.

grant ac­cess to pro­duc­tion and stor­age fa­cil­it­ies;

d.

per­mit sampling or provide samples on re­quest.

³ They shall be au­thor­ised, at the ex­pense of the per­son re­spons­ible, to take any meas­ures ne­ces­sary to rem­edy ir­reg­u­lar­it­ies with re­gard to such sub­stances, pre­par­a­tions or art­icles. In par­tic­u­lar, they shall be au­thor­ised to:

a.

pro­hib­it any fur­ther hand­ling of such sub­stances, pre­par­a­tions or art­icles;

b.

or­der them to be re­called or re­turned;

c.

or­der them to be rendered harm­less or des­troyed;

d.

or­der their seizure.

Any per­son car­ry­ing out tasks in ac­cord­ance with this Act is bound to main­tain secrecy.

¹ In­form­a­tion shall be treated as con­fid­en­tial if its dis­clos­ure would be det­ri­ment­al to an in­terest deemed worthy of pro­tec­tion. In par­tic­u­lar, one such in­terest is that of man­u­fac­tur­ers in the pre­ser­va­tion of their com­mer­cial and in­dus­tri­al secrets.

² The Fed­er­al Coun­cil shall define the types of in­form­a­tion for which pre­ser­va­tion of secrecy can­not be as­ser­ted to be an in­terest deemed worthy of pro­tec­tion.

¹ If sev­er­al dif­fer­ent fed­er­al au­thor­it­ies are in­volved in en­force­ment, they shall be re­spons­ible for en­sur­ing that data is ex­changed in so far as this is ne­ces­sary for the ful­fil­ment of their tasks.

² The Fed­er­al Coun­cil may ap­prove the ex­change of data with ad­di­tion­al au­thor­it­ies or with pub­lic or private or­gan­isa­tions and per­sons if this is ne­ces­sary for the en­force­ment of this Act.

³ The fed­er­al au­thor­it­ies shall dis­close to the rel­ev­ant can­ton­al en­force­ment au­thor­it­ies any data re­quired for the ful­fil­ment of their en­force­ment tasks.

⁴ The can­ton­al en­force­ment au­thor­it­ies shall com­mu­nic­ate to the rel­ev­ant fed­er­al au­thor­it­ies any data that they have col­lec­ted in ac­cord­ance with this Act.

⁵ For the pur­poses of data ex­change, auto­mated re­call pro­ced­ures may be es­tab­lished. In this case, the Fed­er­al Coun­cil, giv­ing due con­sid­er­a­tion to the in­terests of the parties con­cerned deemed worthy of pro­tec­tion, shall de­term­ine who is per­mit­ted to call up data, what data may be called up, and for what pur­poses.

¹ The Fed­er­al Coun­cil shall es­tab­lish re­spons­ib­il­it­ies and pro­ced­ures for the ex­change of data with for­eign au­thor­it­ies and in­sti­tu­tions and with in­ter­na­tion­al or­gan­isa­tions.

² Con­fid­en­tial in­form­a­tion may only be dis­closed to for­eign au­thor­it­ies and in­sti­tu­tions or to in­ter­na­tion­al or­gan­isa­tions if:

a.

this is re­quired by in­ter­na­tion­al agree­ments or the res­ol­u­tions of in­ter­na­tion­al or­gan­isa­tions; or

b.

it is im­per­at­ive in or­der to avert an im­min­ent haz­ard to life or health.

The Fed­er­al Coun­cil shall set the Fees to be levied for en­force­ment by the fed­er­al au­thor­it­ies. It may grant ex­emp­tions from the li­ab­il­ity to pay fees.

¹ A pen­alty of im­pris­on­ment or a fine of up to 200,000 Swiss francs shall be im­posed on man­u­fac­tur­ers who wil­fully:

a.

place sub­stances or pre­par­a­tions on the mar­ket for a use that poses an im­me­di­ate threat to life or health, if they are aware or should be aware of this fact (Art. 5 para. 1);

b.

fail to cor­rectly clas­si­fy, pack­age or la­bel sub­stances or pre­par­a­tions (Art. 5 para. 1), fail to pro­duce a safety data sheet, or in­clude in­ac­cur­ate or in­com­plete in­form­a­tion in such a sheet (Art. 7);

c.

place sub­stances or pre­par­a­tions on the mar­ket:

1.

without hav­ing no­ti­fied them (Art. 6 and Art. 13 para. 1),

2.

be­fore the no­ti­fic­a­tion has been ac­cep­ted or the spe­cified peri­od has elapsed (Art. 9 para. 2),

3.

without au­thor­isa­tion hav­ing been gran­ted (Art. 6 and Art. 13 para. 1);

d.

with­hold in­form­a­tion on sub­stances or pre­par­a­tions from, or give false in­form­a­tion to, the au­thor­it­ies re­spons­ible (Art. 9 para. 3, Art. 10 para. 4, Art. 11 para. 2, Art. 15 para. 2, Art. 16 para. 1, Art. 17, Art. 30 para. 3 and Art. 42 para. 2);

e.

in­fringe reg­u­la­tions con­cern­ing sub­stances (Art. 19 para. 2 let. a–c, e and g);

f.

con­tra­vene meas­ures ordered pur­su­ant to the safe­guard clause (Art. 41).

² The pen­alty shall be im­pris­on­ment of up to five years or a fine of up to 500,000 Swiss francs if hu­man life is severely en­dangered as a res­ult of the of­fences spe­cified in para­graph 1.

³ A pen­alty of im­pris­on­ment or a fine shall be im­posed on any­one who wil­fully:

a.

places dan­ger­ous sub­stances or pre­par­a­tions on the mar­ket without duly in­form­ing the pur­chaser about the prop­er­ties there­of or the ap­pro­pri­ate pre­cau­tions and pro­tect­ive meas­ures, or without sup­ply­ing the pur­chaser with a safety data sheet (Art. 7);

b.

breaches the duty of care in the hand­ling of dan­ger­ous sub­stances and thereby know­ingly en­dangers hu­man life or health (Art. 8, Art. 21, Art. 23 and Art. 25 para. 1);

c.

con­tra­venes the ob­lig­a­tion to re­quest in­form­a­tion in ad­vance (Art. 12);

d.

in­fringes reg­u­la­tions con­cern­ing sub­stances (Art. 19 para. 2 let. a and c);

e.

in­fringes reg­u­la­tions con­cern­ing ex­ports (Art. 19 para. 2 let. d);

f.

handles sub­stances or pre­par­a­tions without due au­thor­isa­tion (Art. 24 para. 1);

g.

sup­plies dan­ger­ous sub­stances or pre­par­a­tions to un­au­thor­ised parties (Art. 19 para. 2 let. a and Art. 24 para. 1);

h.

breaches the duty of secrecy (Art. 30 para. 4, Art. 43 and Art. 44);

i.

con­tra­venes meas­ures ordered pur­su­ant to the safe­guard clause (Art. 41).

⁴ The pen­alty shall be im­pris­on­ment of up to five years or a fine of up to 100,000 Swiss francs if hu­man life is severely en­dangered as a res­ult of the of­fences spe­cified in para­graph 3.

⁵ In cases of neg­li­gence, the pen­alty shall be im­pris­on­ment of up to one year or a fine of up to 100,000 Swiss francs for of­fences spe­cified in Para­graph 1 and im­pris­on­ment of up to six months or a fine for of­fences spe­cified in Para­graph 3.

¹ A pen­alty of de­ten­tion or a fine of up to 20,000 Swiss francs shall be im­posed to any per­son who wil­fully:

a.

in­fringes the pro­vi­sions con­cern­ing self-reg­u­la­tion (Art. 5);

b.

breaches the duty of care in the hand­ling of sub­stances or pre­par­a­tions (Art. 8, Art. 21, Art. 23 and Art. 25 para. 1);

c.

fails to re­port de­tails of sub­stances or pre­par­a­tions or gives false in­form­a­tion (Art. 18);

d.

con­tra­venes the la­belling re­quire­ments for pois­on­ous plants and an­im­als (Art. 19 para. 2 let. f);

e.

in­fringes the reg­u­la­tions con­cern­ing ad­vert­ising (Art. 20);

f.

re­fuses to ac­cept the re­turn of dan­ger­ous sub­stances or pre­par­a­tions (Art. 22 para. 1);

g.

breaches the duty to provide in­form­a­tion to the can­ton­al en­force­ment au­thor­it­ies (Art. 25 para. 2);

h.

breaches the duty to provide in­form­a­tion or mis­in­forms the en­force­ment au­thor­it­ies (Art. 42 para. 2);

i.

con­tra­venes an in­junc­tion is­sued with spe­cif­ic ref­er­ence to the sanc­tions of the present art­icle.

² In cases of neg­li­gence, the pen­alty shall be a fine.

³ In cases where in­fringe­ments of im­ple­ment­ing reg­u­la­tions do not con­sti­tute an of­fence un­der para­graph 1 or Art­icle 49, the Fed­er­al Coun­cil may im­pose sanc­tions of de­ten­tion or a fine of up to 20,000 Swiss francs for wil­ful acts, or a fine in cases of neg­li­gence.

⁴ At­tempt and aid­ing and abet­ting are also of­fences.

⁵ In par­tic­u­larly minor cases, pro­sec­u­tion and pen­al­ties may be waived.

⁶ The right to pro­sec­ute con­tra­ven­tions pre­scribes after two years, and pen­al­ties for con­tra­ven­tions after five years.

Art­icles 6 and 7 of the Fed­er­al Act of 22 March 1974⁹ on Ad­min­is­trat­ive Crim­in­al Law ap­ply to of­fences un­der this Act.

¹ The can­tons shall be re­spons­ible for the pro­sec­u­tion and ad­ju­dic­a­tion of of­fences.

² If there are ad­equate grounds to sus­pect that an of­fence has been com­mit­ted with­in the area of fed­er­al en­force­ment, the fed­er­al agency re­spons­ible shall re­port this to the can­ton­al au­thor­ity. In par­tic­u­larly minor cases, a com­plaint may be dis­pensed with.

The re­peal and amend­ment of ex­ist­ing le­gis­la­tion is reg­u­lated in the An­nex.

¹ Data col­lec­ted un­der ex­ist­ing le­gis­la­tion by the Tox­ic­o­logy Doc­u­ment­a­tion Of­fice (Art. 18 of the Tox­ic Sub­stances Act of 21 March 1969¹⁰), in par­tic­u­lar that in­cluded in the list of tox­ic sub­stances (Art. 4 of the Tox­ic Sub­stances Act), may be in­cluded in the product re­gister (Art. 27) and con­tin­ue to be used, in so far as it is rel­ev­ant to the en­force­ment of this Act.

² After the com­mence­ment of this Act, sub­stances and pre­par­a­tions that are pack­aged and la­belled in ac­cord­ance with ex­ist­ing le­gis­la­tion may still be placed on the do­mest­ic mar­ket by the man­u­fac­turer for one year and may be sup­plied to fi­nal users for two years. For these sub­stances and pre­par­a­tions, the pre­par­a­tion and sup­ply of safety data sheets shall be gov­erned by ex­ist­ing law.

³ For sub­stances and pre­par­a­tions sub­ject to man­dat­ory no­ti­fic­a­tion or au­thor­isa­tion that are already on the mar­ket when this Act comes in­to force, the Fed­er­al Coun­cil shall spe­cify a fa­cil­it­ated no­ti­fic­a­tion or au­thor­isa­tion pro­ced­ure. At the same time, for such cases, it shall grant an ap­pro­pri­ate ex­ten­sion of the peri­ods spe­cified in para­graph 2.

⁴ Au­thor­isa­tion pro­ced­ures for sub­stances and pre­par­a­tions which are pending when this Act comes in­to force shall be pur­sued and con­cluded by the fed­er­al au­thor­ity that is re­spons­ible un­der this Act in ac­cord­ance with the pro­vi­sions of this Act.

⁵ The Fed­er­al Coun­cil shall de­term­ine to what ex­tent and for how long per­sons li­censed to deal with tox­ic sub­stances un­der ex­ist­ing law are en­titled to handle dan­ger­ous sub­stances and pre­par­a­tions.

¹ This Act shall be sub­ject to an op­tion­al ref­er­en­dum.

² The Fed­er­al Coun­cil shall set the com­mence­ment date.

Com­mence­ment date: 1 Au­gust 2005¹¹
Art. 19 para. 2 let. a and d, 34 para. 1 let. e, 38, 49 para. 3 let. e and An­nex No. II 2
(Art. 39 para. 1^bisof the En­vir­on­ment­al Pro­tec­tion Act): 1 Janu­ary 2005¹²