Ordinance
on Protection against Dangerous Substances and Preparations
(Chemicals Ordinance, ChemO)

¹ By way of cla­ri­fic­a­tion of the defin­i­tions giv­en in the Chem­ic­als Act, in this Or­din­ance:

a.

sub­stancemeans a chem­ic­al ele­ment and its com­pounds in the nat­ur­al state or ob­tained by any man­u­fac­tur­ing pro­cess, in­clud­ing any ad­dit­ive ne­ces­sary to pre­serve its sta­bil­ity and any im­pur­ity de­riv­ing from the pro­cess used, but ex­clud­ing any solvent which may be sep­ar­ated without af­fect­ing the sta­bil­ity of the sub­stance or chan­ging its com­pos­i­tion;

b.

man­u­fac­turer means:

1.

any nat­ur­al or leg­al per­son dom­i­ciled in Switzer­land or with a re­gistered of­fice or branch in Switzer­land, who man­u­fac­tures, ex­tracts or im­ports sub­stances, pre­par­a­tions or ob­jects in a pro­fes­sion­al or com­mer­cial ca­pa­city, and

2.²⁰

any per­son who ob­tains sub­stances, pre­par­a­tions or ob­jects in Switzer­land and sup­plies them on a com­mer­cial basis, without al­ter­ing their com­pos­i­tion:

–

un­der his own name, without spe­cify­ing the name of the ori­gin­al man­u­fac­turer,

–

un­der his own trade name,

–

in pack­aging oth­er than that provided by the ori­gin­al man­u­fac­turer,

–

for a dif­fer­ent in­ten­ded use, or

–

at a loc­a­tion where the la­belling in ac­cord­ance with Art­icle 10 para­graph 3 let­ter b has not been ap­plied in the of­fi­cial lan­guage by the ori­gin­al man­u­fac­turer,

3.²¹

a per­son is deemed to be the sole man­u­fac­turer if he ar­ranges for the man­u­fac­ture of a sub­stance, pre­par­a­tion or ob­ject in Switzer­land by a third party, and if he is dom­i­ciled or has a re­gistered of­fice or branch in Switzer­land; if he has neither his dom­i­cile, a re­gistered of­fice or branch in Switzer­land, the third party is the sole man­u­fac­turer.

² In ad­di­tion, in this Or­din­ance:

a.

pro­fes­sion­al user means:

1.

any nat­ur­al or leg­al per­son who ob­tains sub­stances, pre­par­a­tions or ob­jects in Switzer­land for use in pro­fes­sion­al activ­it­ies,

2.

also deemed to be a pro­fes­sion­al user is:

–

any nat­ur­al or leg­al per­sonwho ob­tains sub­stances, pre­par­a­tions or ob­jects in Switzer­land for use in the course of train­ing or for re­search pur­poses,

–

any leg­al per­sonwho ob­tains sub­stances, pre­par­a­tions or ob­jects in Switzer­land for use in char­it­able activ­it­ies;

b.

private user means any nat­ur­al per­sonwho ob­tains or uses sub­stances, pre­par­a­tions or ob­jects for non-pro­fes­sion­al pur­poses;

c.

trader means any nat­ur­al or leg­al per­son who ob­tains sub­stances, pre­par­a­tions or ob­jects in Switzer­land and sup­plies them un­changed on a com­mer­cial basis;

d.

ex­clus­ive rep­res­ent­at­ive means any nat­ur­al or leg­al per­son that is au­thor­ised by a man­u­fac­turer whose dom­i­cile or re­gistered of­fice is loc­ated abroad to no­ti­fy a sub­stance in Switzer­land and rep­res­ents sev­er­al im­port­ers des­ig­nated by that man­u­fac­turer;

e.

ob­ject means an art­icle, con­sist­ing of one or more sub­stances or pre­par­a­tions, which dur­ing pro­duc­tion is giv­en a spe­cial shape, sur­face or design which de­term­ines its end use func­tion to a great­er de­gree than does its chem­ic­al com­pos­i­tion;

f.²²

ex­ist­ing sub­stance means the sub­stance that is re­gistered in ac­cord­ance with Art­icle 5 of Reg­u­la­tion (EC) No 1907/2006 (REACH Reg­u­la­tion)²³, with the ex­cep­tion of sub­stances that:

1.²⁴

are placed on the mar­ket in lar­ger quant­it­ies than those re­gistered in the European Eco­nom­ic Area (EEA), or

2.

are re­gistered solely as in­ter­me­di­ates, un­less they are monomers;

g.

poly­mermeans a sub­stance con­sist­ing of mo­lecules char­ac­ter­ised by the se­quence of one or more types of monomer units and com­pris­ing:

1.

a simple weight ma­jor­ity of mo­lecules con­tain­ing at least three monomer units which are co­va­lently bound to at least one oth­er monomer unit or oth­er re­act­ant, and

2.

less than a simple weight ma­jor­ity of mo­lecules of the same mo­lecu­lar weight; these mo­lecules must be dis­trib­uted over a range of mo­lecu­lar weights wherein dif­fer­ences in the mo­lecu­lar weight are primar­ily at­trib­ut­able to dif­fer­ences in the num­ber of monomer units;

h.

monomer means a sub­stance which is cap­able of form­ing co­va­lent bonds with a se­quence of ad­di­tion­al like or un­like mo­lecules un­der the con­di­tions of the rel­ev­ant poly­mer-form­ing re­ac­tion used for the par­tic­u­lar pro­cess;

i.

monomer unitmeans the re­acted form of a monomer sub­stance in a poly­mer;

j.

in­ter­me­di­ate means a sub­stance man­u­fac­tured and used solely for chem­ic­al pro­cessing dur­ing which it is trans­formed in­to one or more oth­er sub­stances;

k.

sec­ond­ary product means any sub­stance formed by chem­ic­al or bio­chem­ic­al trans­form­a­tion dur­ing the stor­age, use or dis­pos­al of a sub­stance or pre­par­a­tion;

l.

sci­entif­ic re­search and de­vel­op­ment means any sci­entif­ic ex­per­i­ment­a­tion, ana­lys­is or chem­ic­al re­search car­ried out un­der con­trolled con­di­tions and in­volving quant­it­ies of less than 1 tonne per year;

m.

product and pro­cess-ori­ent­ated re­search and de­vel­op­mentmeans any sci­entif­ic de­vel­op­ment re­lated to product de­vel­op­ment or the fur­ther de­vel­op­ment of a sub­stance on its own, in pre­par­a­tions or in ob­jects in the course of which pi­lot plant or pro­duc­tion tri­als are used to define the pro­duc­tion pro­cess or test the fields of ap­plic­a­tion of the sub­stance;

n.

ro­bust study sum­mary means a de­tailed sum­mary of the ob­ject­ives, meth­ods, res­ults and con­clu­sions of a full study re­port provid­ing suf­fi­cient in­form­a­tion to make an in­de­pend­ent as­sess­ment of the study, min­im­ising the need to con­sult the full study re­port;

o.

ex­pos­ure scen­ario means the set of con­di­tions, in­clud­ing op­er­a­tion­al con­di­tions and risk man­age­ment meas­ures, that de­scribe how the sub­stance is man­u­fac­tured or used dur­ing its life-cycle and how the man­u­fac­turer con­trols, or re­com­mends cus­tom­ers to con­trol, ex­pos­ures of hu­mans and the en­vir­on­ment. These ex­pos­ure scen­ari­os may cov­er one spe­cif­ic pro­cess or use or sev­er­al pro­cesses or uses as ap­pro­pri­ate;

p.

haz­ard class means the nature of the phys­ic­al, health or en­vir­on­ment­al haz­ard;

q.

nan­o­ma­ter­i­al means a ma­ter­i­al con­tain­ing particles in an un­bound state or as an ag­greg­ate or as an ag­glom­er­ate, where one or more ex­tern­al di­men­sions is in the size range 1–100 nm, or a ma­ter­i­al where the spe­cif­ic sur­face area by volume is great­er than 60 m²/cm³. A ma­ter­i­al is only con­sidered to be a nan­o­ma­ter­i­al if it is de­lib­er­ately pro­duced to util­ise the prop­er­ties arising from the defined ex­tern­al di­men­sions of the particles it con­tains, or from the defined sur­face area by volume of the ma­ter­i­al. Fullerenes, graphene flakes and single-wall car­bon nan­otubes with one or more ex­tern­al di­men­sions be­low 1 nm are con­sidered to be nan­o­ma­ter­i­als;

r.²⁵

col­or­ants means sub­stances and pre­par­a­tions that primar­ily con­tain col­our­ing agents, col­our pig­ments and ef­fect-pro­du­cing pig­ments which are ad­ded solely for the pur­pose of col­our­ing or pro­du­cing ef­fects.

³ Any oth­er terms which are used in vari­ous senses in the le­gis­la­tion un­der­ly­ing this Or­din­ance are used here as defined in the Chem­ic­als Act.

⁴ The equi­val­ence of ex­pres­sions between the REACH Reg­u­la­tion, Reg­u­la­tion (EC) No 1272/2008 (CLP Reg­u­la­tion)²⁶ and Dir­ect­ive 75/324/EEC²⁷, and this Or­din­ance as spe­cified in An­nex 1 num­ber 1 ap­plies.²⁸

⁵ If in this Or­din­ance ref­er­ence is made to pro­vi­sions of the REACH Reg­u­la­tion, the CLP Reg­u­la­tion or Dir­ect­ive 75/324/EECwhich in turn refer to oth­er pro­vi­sions of these acts, these oth­er pro­vi­sions also ap­ply; the ap­plic­able ver­sion of the act in ques­tion is that spe­cified in the foot­note to para­graph 2 let­ter f or, as ap­plic­able, para­graph 4 or, in the case of ref­er­ences to an­nexes to the CLP Reg­u­la­tion or the REACH Reg­u­la­tion, the ver­sion spe­cified in An­nex 2 num­ber 1 or, as ap­plic­able, An­nex 4 num­ber 3. An ex­cep­tion are pro­vi­sions re­ferred to in pro­vi­sions of the REACH Reg­u­la­tion and the CLP Reg­u­la­tion, as spe­cified in An­nex 1 num­ber 2; here, the pro­vi­sions of the Swiss le­gis­la­tion lis­ted in An­nex 1 num­ber 2 ap­ply in­stead.²⁹

⁶ If in this Or­din­ance ref­er­ence is made to pro­vi­sions of the REACH Reg­u­la­tion or the CLP Reg­u­la­tion which in turn refer to oth­er EU le­gis­la­tion, the Swiss le­gis­la­tion spe­cified in An­nex 1 num­ber 3 ap­plies in­stead of the EU le­gis­la­tion.

⁷ The pro­vi­sions of the Nagoya Or­din­ance of 11 Decem­ber 2015³⁰ are re­served with re­spect to the pla­cing on the mar­ket of sub­stances and pre­par­a­tions the de­vel­op­ment of which is based on the use of ge­net­ic re­sources or on tra­di­tion­al know­ledge as­so­ci­ated there­with.³¹