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

¹ This Or­din­ance reg­u­lates:

a.

the de­term­in­a­tion and as­sess­ment of dangers and risks that sub­stances and pre­par­a­tions may pose to hu­man life and health and to the en­vir­on­ment;

b.

the con­di­tions un­der which sub­stances and pre­par­a­tions that may en­danger people or the en­vir­on­ment are placed on the mar­ket;

c.

the hand­ling of sub­stances and pre­par­a­tions that may en­danger people or the en­vir­on­ment;

d.

the way in which data re­lat­ing to sub­stances and pre­par­a­tions is pro­cessed by the en­force­ment au­thor­it­ies.

² This Or­din­ance ap­plies to biocid­al products and the act­ive sub­stances con­tained therein, and to plant pro­tec­tion products and the act­ive sub­stances and co-for­mu­lants con­tained therein, in­so­far as they are re­ferred to in the Or­din­ance of 18 May 2005 on Biocid­al Products⁷ or the Or­din­ance of 12 May 2010⁸ on Plant Pro­tec­tion Products.

³ This Or­din­ance ap­plies to ra­dio­act­ive sub­stances and pre­par­a­tions, ex­clud­ing ef­fects at­trib­ut­able to the ra­dio­act­ive nature of these sub­stances and pre­par­a­tions.

⁴ Only Art­icles 5–7 and 81 ap­ply to cos­met­ic products with­in the mean­ing of Art­icle 53 para­graph 1 of the Or­din­ance of 16 Decem­ber 2016⁹ on Food­stuffs and Util­ity Art­iclesin the form of fin­ished products in­ten­ded for private or pro­fes­sion­al users, and only with re­gard to en­vir­on­ment­al pro­tec­tion and to clas­si­fic­a­tion or as­sess­ment in re­la­tion to risks to the en­vir­on­ment.¹⁰

⁵ This Or­din­ance does not ap­ply to:

a.

the trans­port of sub­stances and pre­par­a­tions by road, rail, wa­ter, air or pipelines, with the ex­cep­tion of Art­icle 10 para­graph 1 let­ter b;

b.

the trans­it of sub­stances and pre­par­a­tions un­der cus­toms su­per­vi­sion, provided that this does not in­volve any pro­cessing or trans­form­a­tion;

c.

sub­stances and pre­par­a­tions in the form of fin­ished products ready for sup­ply to private and pro­fes­sion­al users that fall in­to the fol­low­ing cat­egor­ies:¹¹

1.¹²

food­stuffs as defined by Art­icle 4 of the Food­stuffs Act of 20 June 2014¹³ (FoodA),

2.

medi­cin­al products as defined by Art­icle 4 para­graph 1 let­ter a and med­ic­al devices as defined by Art­icle 4 para­graph 1 let­ter b of the Thera­peut­ic Products Act of 15 Decem­ber 2000¹⁴,

3.

an­im­al feed­ing­stuffs as defined by Art­icle 3 para­graph 1 of the Feed­stuffs Or­din­ance of 26 Oc­to­ber 2011¹⁵;

d.

weapons and am­muni­tion as defined by Art­icle 4 para­graphs 1 and 5 of the Weapons Act of 20 June 1997¹⁶;

e.

sub­stances, pre­par­a­tions and ob­jects which are waste ac­cord­ing to Art­icle 7 para­graph 6 of the EPA.

⁶ Art­icles 57, 62 and 67 ap­ply to im­por­ted sub­stances and pre­par­a­tions that are simply re­la­belled and then ex­por­ted without al­ter­a­tion.¹⁷

⁷ Dan­ger­ous sub­stances and pre­par­a­tions that are ex­por­ted are also gov­erned by the PIC Or­din­ance of 10 Novem­ber 2004¹⁸.¹⁹

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

Sub­stances and pre­par­a­tions are dan­ger­ous if they ful­fil the cri­ter­ia for clas­si­fic­a­tion of phys­ic­al, health, en­vir­on­ment­al or oth­er haz­ards spe­cified in the tech­nic­al pro­vi­sions re­ferred to in An­nex 2 num­ber 1.

¹ Sub­stances are con­sidered per­sist­ent, bioac­cu­mu­lat­ive and tox­ic (PBT) if they ful­fil the cri­ter­ia defined in Sec­tions 1.1.1–1.1.3 of An­nex XIII to the REACH Reg­u­la­tion³².

² Sub­stances are con­sidered very per­sist­ent and very bioac­cu­mu­lat­ive (vPvB) if they ful­fil the cri­ter­ia defined in Sec­tions 1.2.1 and 1.2.2 of An­nex XIII to the REACH Reg­u­la­tion³³.

¹ The self-reg­u­la­tion sys­tem in­tro­duced by Art­icle 5 of the Chem­ic­als Act and Art­icle 26 of the EPA re­quires man­u­fac­tur­ers to as­sess wheth­er sub­stances or pre­par­a­tions may en­danger hu­man life or health or the en­vir­on­ment. To this end, man­u­fac­tur­ers must clas­si­fy, pack­age and la­bel sub­stances and pre­par­a­tions and pre­pare ex­pos­ure scen­ari­os and com­pile safety data sheets in ac­cord­ance with this Or­din­ance.

² In the case of ob­jects con­tain­ing dan­ger­ous sub­stances, sub­stances con­sidered PBT or vPvB, or sub­stances lis­ted in An­nex 3, self-reg­u­la­tion un­der Art­icle 26 of the EPA re­quires man­u­fac­tur­ers to as­sess wheth­er these sub­stances may en­danger the en­vir­on­ment or in­dir­ectly en­danger hu­man health when these ob­jects are used as in­ten­ded, or in a fore­see­able man­ner, or when they are ap­pro­pri­ately dis­posed of.

³ In the case of ob­jects con­tain­ing sub­stances lis­ted in An­nex 3, man­u­fac­tur­ers must as­sess wheth­er these sub­stances may en­danger hu­man health when these ob­jects are used as in­ten­ded, or in a fore­see­able man­ner, or when they are ap­pro­pri­ately dis­posed of.

⁴ Man­u­fac­tur­ers must col­lect all avail­able data of rel­ev­ance to the ob­lig­a­tions re­ferred to in para­graphs 1 and 2.

⁵ Any per­son im­port­ing sub­stances, pre­par­a­tions or ob­jects with dan­ger­ous con­stitu­ents in a pro­fes­sion­al or com­mer­cial ca­pa­city must com­ply with the ob­lig­a­tions lis­ted un­der para­graphs 1 and 2 be­fore sup­ply­ing them to a third party for the first time or, if they are for the im­port­er’s own use, be­fore us­ing them for the first time.

¹ Man­u­fac­tur­ers must clas­si­fy sub­stances in ac­cord­ance with Art­icles 5, 7–13 and 15 of the CLP Reg­u­la­tion³⁴.

² If a har­mon­ised clas­si­fic­a­tion is spe­cified for a sub­stance in An­nex VI to the CLP Reg­u­la­tion, inthe ap­plic­able ver­sion re­ferred to in An­nex 2 num­ber 1, the man­u­fac­turer must ad­di­tion­ally clas­si­fy this sub­stance in ac­cord­ance with Art­icle 4 para­graph 3 of the CLP Reg­u­la­tion.

³ Clas­si­fic­a­tion must be based:

a.

in the case of ex­ist­ing sub­stances: on data col­lec­ted in ac­cord­ance with Art­icle 5 para­graph 4;

b.³⁵

in the case of new sub­stances: on the data as spe­cified in Art­icle 5 para­graph 4 and on data in the tech­nic­al dossier as spe­cified in Art­icle 27 para­graph 2 let­ter b.

⁴ The Fed­er­al De­part­ment of Home Af­fairs (FDHA), in con­sulta­tion with the Fed­er­al De­part­ment of the En­vir­on­ment, Trans­port, En­ergy and Com­mu­nic­a­tions (DE­TEC) and the Fed­er­al De­part­ment of Eco­nom­ic Af­fairs, Edu­ca­tion and Re­search (EAER), may pre­scribe a har­mon­ised clas­si­fic­a­tion and the as­so­ci­ated la­belling for cer­tain haz­ard classes of a sub­stance if, for the sub­stance in ques­tion, a har­mon­ised clas­si­fic­a­tion is not spe­cified for the rel­ev­ant haz­ard class in An­nex VI to the CLP Reg­u­la­tion, in the ap­plic­able ver­sion re­ferred to in An­nex 2 num­ber 1.

Man­u­fac­tur­ers must clas­si­fy pre­par­a­tions in ac­cord­ance with Art­icles 6–15 of the CLP Reg­u­la­tion³⁶.

Man­u­fac­tur­ers mak­ing avail­able or sup­ply­ing dan­ger­ous sub­stances or pre­par­a­tions to third parties must pack­age them in ac­cord­ance with Art­icle 35 of the CLP Reg­u­la­tion³⁷.

Aer­o­sol dis­pensers not covered by the FoodA³⁸ are sub­ject both to the pack­aging pro­vi­sions of this Or­din­ance and to Art­icles 1 and 2, and points 2.1, 2.3, 3, 4, 5 and 6 of the An­nex to Dir­ect­ive 75/324/EEC³⁹.

¹ Man­u­fac­tur­ers mak­ing avail­able or sup­ply­ing dan­ger­ous sub­stances or pre­par­a­tions to third parties must la­bel them in ac­cord­ance with the fol­low­ing pro­vi­sions:

a.⁴⁰

Art­icle 17 para­graph 1, Art­icle 18 with the ex­cep­tion of the last sen­tence of para­graph 2, Art­icles 19–23, Art­icle 25 para­graphs 1, 3 and 4, Art­icles 26–28, Art­icle 29 para­graphs 1–4, Art­icle 31 and Art­icle 32 para­graphs 1–5 of the CLP Reg­u­la­tion⁴¹;

b.

the spe­cif­ic rules for la­belling of out­er pack­aging, in­ner pack­aging and single pack­aging set out in Art­icle 33 of the CLP Reg­u­la­tion.

² Pre­par­a­tions with par­tic­u­lar haz­ards re­ferred to in Art­icle 4 para­graph 7 of the CLP Reg­u­la­tion must ad­di­tion­ally be la­belled in ac­cord­ance with Art­icle 25 para­graph 6 of the CLP Reg­u­la­tion.

³ In ad­di­tion to para­graphs 1 and 2, the la­belling must meet the fol­low­ing re­quire­ments:

a.

The name, ad­dress and tele­phone num­ber of the man­u­fac­turer are to be in­cluded.

b.⁴²

The la­belling must be in an of­fi­cial lan­guage of the loc­a­tion at which the sub­stance or pre­par­a­tion is sup­plied to private or pro­fes­sion­al users. With the agree­ment of in­di­vidu­al pro­fes­sion­al users, a sub­stance or a pre­par­a­tion for sup­ply to these users may be la­belled in an­oth­er of­fi­cial lan­guage or in Eng­lish.

c.

Where la­belling is in lan­guages oth­er than those re­quired un­der let­ter b, all in­form­a­tion shall be giv­en in all lan­guages used.⁴³

^3bis In the case of sub­stances or pre­par­a­tions im­por­ted from a mem­ber state of the EEA, the man­u­fac­turer’s name may be re­placed on the la­belling by the name of the per­son re­spons­ible for pla­cing on the mar­ket in the EEA, if the sub­stances or pre­par­a­tions:⁴⁴

a.

are not in­ten­ded for dis­tri­bu­tion to private users; or

b.

are sup­plied to private users, are con­tained in an in­ner pack­aging in por­tions of no more than 125ml or g and are marked on the out­er pack­aging with the name, ad­dress and tele­phone num­ber of the man­u­fac­turer.⁴⁵

⁴ If fur­ther la­bel ele­ments are re­quired in or­der to com­ply with oth­er le­gis­la­tion, these are to be in­cluded in the sec­tion for sup­ple­ment­al in­form­a­tion in ac­cord­ance with Art­icle 25 of the CLP Reg­u­la­tion.

⁵ Where the name in the IUPAC no­men­clature⁴⁶ ex­ceeds 100 char­ac­ters, an­oth­er name may be used, provided that the re­port in ac­cord­ance with Art­icle 49 in­cludes both the name giv­en in the IUPAC no­men­clature and the oth­er name used.

⁶ The re­quire­ments of para­graph 1 are deemed to have been met if the in­ner pack­aging is la­belled be­fore the ap­plic­a­tion of or im­me­di­ately after the re­mov­al of the trans­port pack­aging. Re­spons­ib­il­ity for pack­aging and la­belling rests with the man­u­fac­turer.

The of­fi­cial lan­guages are Ger­man, French and Itali­an.

¹ Aer­o­sol dis­pensers not covered by the FoodA⁴⁸ are sub­ject both to the pro­vi­sions of this Or­din­ance and to Art­icles 1, 2 and 8 para­graphs 1 and 1a, and points 1.8, 1.9 and 1.10, the in­tro­duct­ory pro­vi­sion of num­ber 2, and points 2.2 and 2.3 of the An­nex to Dir­ect­ive 75/324/EEC⁴⁹.⁵⁰

² In the case of aer­o­sol dis­pensers not deemed to be dan­ger­ous un­der Art­icle 3, the man­u­fac­turer’s name and ad­dress must be in­dic­ated. If such an aer­o­sol dis­penser is im­por­ted from an EEA mem­ber state, the man­u­fac­turer’s name may be re­placed by the name of the per­son re­spons­ible for pla­cing it on the mar­ket in the EEA.

¹ The No­ti­fic­a­tion Au­thor­ity may, after con­sulta­tion with the as­sess­ment au­thor­it­ies, per­mit derog­a­tions from the la­belling re­quire­ments for cer­tain sub­stances or pre­par­a­tions, or for cer­tain groups of sub­stances or pre­par­a­tions, and al­low these not to be la­belled or to be la­belled in some oth­er suit­able form if:

a.

the pack­ages are too small or oth­er­wise un­suit­able for la­belling in ac­cord­ance with Art­icle 10;

b.

the sub­stance or pre­par­a­tion is sup­plied in such small quant­it­ies that, tak­ing the par­tic­u­lar haz­ards in­to ac­count, it poses no risk to hu­mans or the en­vir­on­ment; or

c.

the sub­stance or pre­par­a­tion does not fall with­in the scope of the CLP Reg­u­la­tion⁵¹.

² It shall is­sue a rul­ing in re­sponse to a jus­ti­fied ap­plic­a­tion or is­sue a gen­er­al rul­ing.

³ It shall main­tain a list of the derog­a­tions that have been per­mit­ted and pub­lish this on its web­site.

¹ Man­u­fac­tur­ers of pre­par­a­tions may use an al­tern­at­ive chem­ic­al name for a sub­stance if:

a.

they demon­strate that dis­clos­ing the name of the sub­stance on the la­bel or in the safety data sheet would put the con­fid­en­tial nature of their busi­ness, in par­tic­u­lar their in­tel­lec­tu­al prop­erty rights, at risk; and

b.

the sub­stance meets the cri­ter­ia spe­cified in Sec­tion 1.4 of An­nex I to the CLP Reg­u­la­tion, in the ap­plic­able ver­sion re­ferred to in An­nex 2 num­ber 1.

² The al­tern­at­ive chem­ic­al name shall be a name that iden­ti­fies the most im­port­ant func­tion­al groups or serves as an al­tern­at­ive des­ig­na­tion.

³ If the European Chem­ic­als Agency has ap­proved the use of an al­tern­at­ive chem­ic­al name in ac­cord­ance with Art­icle 24 of the CLP Reg­u­la­tion, the use of the name is deemed ap­proved in Switzer­land from the date on which the No­ti­fic­a­tion Au­thor­ity ac­know­ledges the fol­low­ing doc­u­ments and data:

a.

the de­cision of the European Chem­ic­als Agency;

b.

de­tails of the sub­stance iden­tity in ac­cord­ance with Art­icle 49 let­ter c num­bers 1–3.⁵³

^3bis Where the name and iden­ti­fic­a­tion num­ber in the clas­si­fic­a­tion and la­belling in­vent­ory in ac­cord­ance with Art­icle 42 of the CLP Reg­u­la­tion is used when the chem­ic­al name in ac­cord­ance with Art­icle 18 para­graph 2 let­ter b of the CLP Reg­u­la­tion is used, if the No­ti­fic­a­tion Au­thor­ity so re­quests, the sub­stance iden­tity in ac­cord­ance with An­nex VI Sec­tions 2.1–2.3 of the REACH Reg­u­la­tion⁵⁴must be provided.⁵⁵

⁴ The use of an al­tern­at­ive chem­ic­al name may be re­ques­ted for a pre­par­a­tion:

a.

in a spe­cif­ic com­pos­i­tion;

b.

with a spe­cif­ic trade name or a spe­cif­ic des­ig­na­tion; and

c.

re­served for cer­tain uses.

⁵ Au­thor­isa­tion to use an al­tern­at­ive chem­ic­al name is gran­ted to the man­u­fac­turer and is non-trans­fer­able.

⁶ The use of an al­tern­at­ive chem­ic­al name by the man­u­fac­turer and pro­fes­sion­al users in the same sup­ply chain is per­mit­ted without au­thor­isa­tion for the first six years after:

a.

the re­port­ing, de­clar­a­tion or no­ti­fic­a­tion of a new sub­stance;

b.

the re­gis­tra­tion of a sub­stance that falls un­der Art­icle 119 para­graph 2 let­ter f of the REACH Reg­u­la­tion and in re­spect of which proof of re­gis­tra­tion and de­tails of the sub­stance iden­tity in ac­cord­ance with Art­icle 49 let­ter c num­bers 1–3 are sub­mit­ted to the No­ti­fic­a­tion Au­thor­ity.⁵⁶

⁷ If no re­quest to use an al­tern­at­ive chem­ic­al name and no de­cision from the European Chem­ic­als Agency nor the in­form­a­tion in ac­cord­ance with para­graph 3 are sub­mit­ted with­in the peri­od spe­cified in para­graph 6, on ex­piry of the peri­od the chem­ic­al name in ac­cord­ance with Art­icle 18 para­graph 2 of the CLP Reg­u­la­tion must be used.⁵⁷

¹ Re­quests to use an al­tern­at­ive chem­ic­al name for a sub­stance in a pre­par­a­tion must be writ­ten in an of­fi­cial lan­guage or in Eng­lish and be sub­mit­ted elec­tron­ic­ally in the format re­quired by the No­ti­fic­a­tion Au­thor­ity. The ac­com­pa­ny­ing let­ter must be writ­ten in an of­fi­cial lan­guage.

² Re­quests must con­tain:

a.

the man­u­fac­turer’s name, ad­dress and tele­phone num­ber;

b.

the fol­low­ing in­form­a­tion re­lat­ing to the sub­stances whose iden­tity is to re­main con­fid­en­tial on the la­bel:

1.

the chem­ic­al name,

2.

the Chem­ic­al Ab­stracts Ser­vice (CAS) re­gistry num­ber⁵⁸,

3.

the EC num­ber;

c.

the al­tern­at­ive name of the sub­stance;

d.

the reas­ons for the re­quest;

e.

the trade name or des­ig­na­tion of the pre­par­a­tion;

f.

the in­form­a­tion on the con­stitu­ents in ac­cord­ance with the pro­vi­sions re­lat­ing to the safety data sheet;

g.

the clas­si­fic­a­tion of the pre­par­a­tion;

h.

the la­belling of the pre­par­a­tion;

i.

the in­ten­ded uses of the pre­par­a­tion;

j.

the phys­ic­al state;

k.

if ap­plic­able, the safety data sheet.

³ The No­ti­fic­a­tion Au­thor­ity shall de­cide on the re­quest in con­sulta­tion with the as­sess­ment au­thor­it­ies.

¹ If a man­u­fac­turer places a pre­par­a­tion on the mar­ket which is clas­si­fied as dan­ger­ous be­cause of the phys­ic­al or health haz­ards it poses, the man­u­fac­turer must la­bel the pre­par­a­tion with a unique for­mula iden­ti­fi­er (UFI).

² He must gen­er­ate the UFI us­ing the elec­tron­ic sys­tem provided by the No­ti­fic­a­tion Au­thor­ity. Gen­er­at­ing the UFI us­ing the elec­tron­ic sys­tem is not re­quired if the pre­par­a­tion already has a UFI that has been gen­er­ated on the basis of the CLP Reg­u­la­tion⁶⁰.

³ The UFI, pre­ceded by the ac­ronym "UFI:" in cap­it­al let­ters, must be prin­ted or af­fixed in a clearly vis­ible, legible and in­delible man­ner in the fol­low­ing loc­a­tion:

a.

on the la­bel in the sec­tion for sup­ple­ment­al in­form­a­tion in ac­cord­ance with Art­icle 2525 of the CLP Reg­u­la­tion; or

b.

on the in­ner pack­aging to­geth­er with the oth­er la­bel ele­ments; if the in­ner pack­aging is of such a nature or so small that the UFI can­not be prin­ted or af­fixed there­on, it may be prin­ted or af­fixed with the oth­er la­bel ele­ments on the out­er pack­aging.

⁴ In the case of pre­par­a­tion that are not pack­aged, the UFI must be in­dic­ated on the safety data sheet or, in the case of sup­ply to private users, in a copy of the la­bel ele­ments in ac­cord­ance with Art­icle 29 para­graph 3 of the CLP Reg­u­la­tion, to­geth­er with the oth­er la­bel ele­ments.

⁵ Para­graphs 1–4 do not ap­ply if the pre­par­a­tion is not sub­ject to the ob­lig­a­tion to no­ti­fy in ac­cord­ance with Art­icle 54.

¹ The man­u­fac­turer of an ex­ist­ing sub­stance that ful­fils the cri­ter­ia spe­cified in Art­icle 14 para­graph 4 of the REACH Reg­u­la­tion⁶¹ and is sup­plied on its own to third parties in a total quant­ity of 10 tonnes per year or more must pre­pare an ex­pos­ure scen­ario for each iden­ti­fied use of the sub­stance.

² Any per­son who ob­tains a sub­stance for which ex­pos­ure scen­ari­os have been pre­pared and sup­plies it to third parties on a com­mer­cial basis in quant­it­ies of 1 tonne per year or more as a sub­stance or in a pre­par­a­tion for a use not de­scribed in the safety data sheet must pre­pare an ex­pos­ure scen­ario for this use.

³ Para­graph 2 does not ap­ply in cases where:

a.

the ex­pos­ure scen­ario for the new use would ex­clus­ively cov­er con­di­tions de­scribed in an ex­pos­ure scen­ario in­cluded in the safety data sheet;

b.

the sub­stance is present in the pre­par­a­tion in a con­cen­tra­tion be­low the lim­its re­ferred to in Art­icle 27 para­graph 3; or

c.

the sub­stance is used for pur­poses of product and pro­cess-ori­ent­ated re­search and de­vel­op­ment.

The ex­pos­ure scen­ari­os must be pre­pared in ac­cord­ance with the pro­vi­sions of Sec­tion 5.1 of An­nex I to the REACH Reg­u­la­tion⁶².

Safety data sheets are de­signed to en­able pro­fes­sion­al users or traders to take the meas­ures re­quired for health pro­tec­tion, oc­cu­pa­tion­al safety and en­vir­on­ment­al pro­tec­tion.

Where the pro­vi­sion of a safety data sheet is re­quired un­der Art­icle 21, the man­u­fac­turer must com­pile a safety data sheet for the fol­low­ing sub­stances and pre­par­a­tions:

a.

dan­ger­ous sub­stances and pre­par­a­tions;

b.⁶³

PBT or vPvB sub­stances;

c.

sub­stances lis­ted in An­nex 3;

d.

pre­par­a­tions which are not dan­ger­ous with­in the mean­ing of Art­icle 3 and con­tain at least one of the fol­low­ing sub­stances:

1.

a sub­stance that is dan­ger­ous to health or to the en­vir­on­ment in an in­di­vidu­al con­cen­tra­tion of ≥1.0 per cent by weight (non-gaseous pre­par­a­tions) or ≥0.2 per cent by volume (gaseous pre­par­a­tions),

2.⁶⁴

a cat­egory 2 car­ci­no­gen­ic sub­stance, a cat­egory 1A, 1B or 2 tox­ic for re­pro­duc­tion sub­stance, a cat­egory 1 skin al­ler­gen, a cat­egory 1 in­hal­a­tion al­ler­gen, a sub­stance hav­ing ef­fects on or through lacta­tion, or a PBT or vPvB sub­stance in an in­di­vidu­al con­cen­tra­tion of ≥0.1 per cent by weight,

3.

a sub­stance lis­ted in An­nex 3 in an in­di­vidu­al con­cen­tra­tion of ≥0.1 per cent by weight,

4.⁶⁵

a sub­stance for which an oc­cu­pa­tion­al ex­pos­ure lim­it value has been laid down in Dir­ect­ives 2000/39/EC⁶⁶, 2006/15/EC⁶⁷, 2009/161/EU⁶⁸ (EU) 2017/164⁶⁹ or (EU) 2019/1831⁷⁰.

¹ Safety data sheets must be com­piled in ac­cord­ance with the tech­nic­al pro­vi­sions re­ferred to in An­nex 2 Num­ber 3.

² The ex­pos­ure scen­ari­os pre­pared in ac­cord­ance with Art­icle 16 or in­cluded in the chem­ic­al safety re­port (Art. 28) must be at­tached to the safety data sheet; the in­form­a­tion in sec­tions 1, 7, 8 and 13 of the safety data sheet must cor­res­pond to the uses de­scribed in the ex­pos­ure scen­ari­os.

³ The FDHA may, in con­sulta­tion with DE­TEC and the EAER, define the tech­nic­al ex­pert­ise re­quired for the com­pil­a­tion of safety data sheets.

¹ Any­one who sup­plies sub­stances or pre­par­a­tions as spe­cified in Art­icle 19 to pro­fes­sion­al users or traders in a com­mer­cial ca­pa­city must provide them with a cur­rent safety data sheet. In re­tail out­lets, the safety data sheet must be provided on re­quest.

² The safety data sheet must be provided:

a.

when sup­ply­ing a sub­stance or pre­par­a­tion as spe­cified in Art­icle 19 let­ters a–c: at the latest at the time it is first sup­plied and on re­quest with sub­sequent de­liv­er­ies;

b.

when sup­ply­ing a pre­par­a­tion as spe­cified in Art­icle 19 let­ter d: on re­quest.

³ Safety data sheets must be provided as fol­lows:

a.

free of charge;

b.

in the of­fi­cial lan­guages re­ques­ted by the pro­fes­sion­al user or trader or, by mu­tu­al agree­ment, in an­oth­er lan­guage; the an­nex to the safety data sheet may be writ­ten in Eng­lish;

c.

on pa­per or in elec­tron­ic form; the safety data sheet is to be provided on pa­per if this is re­ques­ted by the pro­fes­sion­al user or trader.

¹ If im­port­ant new in­form­a­tion on a sub­stance or pre­par­a­tion be­comes avail­able, the man­u­fac­turer must up­date the safety data sheet without delay.

² The sup­pli­er must make the up­dated safety data sheet avail­able to all pro­fes­sion­al users or traders sup­plied with the sub­stance or pre­par­a­tion con­cerned with­in the pre­vi­ous twelve months.

³ Para­graph 2 does not ap­ply to safety data sheets provided through re­tail out­lets.

Pro­fes­sion­al users or traders are re­quired to re­tain the safety data sheet for as long as the sub­stance or pre­par­a­tion con­cerned con­tin­ues to be handled at their work­place.

¹ Man­u­fac­tur­ers of a new sub­stance or their ex­clus­ive rep­res­ent­at­ive must no­ti­fy the new sub­stance to the No­ti­fic­a­tion Au­thor­ity be­fore pla­cing it on the mar­ket for the first time:

a.

on its own;

b.

in a pre­par­a­tion; or

c.

in an ob­ject from which the new sub­stance may be re­leased un­der nor­mal or reas­on­ably fore­see­able con­di­tions of use.

² If a new sub­stance is con­tained in a poly­mer as a monomer or as an­oth­er sub­stance in the form of monomer units or chem­ic­ally bound, para­graph 1 ap­plies for the sub­stance on its own.

³ The No­ti­fic­a­tion Au­thor­ity may re­quire the no­ti­fic­a­tion of a sub­stance con­tained in an ob­ject if it has reas­on to be­lieve that the sub­stance may be re­leased when the ob­ject is used.

If a sub­stance is sub­ject to the ob­lig­a­tion to no­ti­fy be­cause it is no longer re­gistered in ac­cord­ance with Art­icle 5 of the REACH Reg­u­la­tion⁷², the man­u­fac­turer may con­tin­ue to place it on the mar­ket without no­ti­fic­a­tion un­til the end of the cal­en­dar year fol­low­ing that in which its re­gis­tra­tion status changes. The No­ti­fic­a­tion Au­thor­ity may ex­tend the peri­od by a max­im­um of two years in re­sponse to a jus­ti­fied re­quest.

¹ No­ti­fic­a­tion is not re­quired for:

a.

poly­mers or sub­stances con­tained as monomer units or chem­ic­ally bound to the poly­mer in a con­cen­tra­tion of less than 2 per cent by weight;

b.⁷³

…

c.

sub­stances placed on the mar­ket in quant­it­ies of less than 1 tonne per year;

d.

sub­stances placed on the mar­ket by a man­u­fac­turer:

1.

ex­clus­ively for product and pro­cess-ori­ent­ated re­search and de­vel­op­ment pur­poses,

2.

in quant­it­ies not ex­ceed­ing those re­quired for the spe­cified pur­pose, and

3.

for a peri­od not ex­ceed­ing five years; in re­sponse to a jus­ti­fied re­quest, the No­ti­fic­a­tion Au­thor­ity may, in con­sulta­tion with the as­sess­ment au­thor­it­ies, ex­tend this peri­od by an ad­di­tion­al five or ten years;

e.

sub­stances used ex­clus­ively as raw ma­ter­i­als, act­ive in­gredi­ents or ad­dit­ives in food­stuffs, thera­peut­ic products and an­im­al feed­ing­stuffs;

f.

sub­stances ob­tained in Switzer­land;

g.

in­ter­me­di­ates, provided that they are not monomers;

h.⁷⁴

sub­stances lis­ted in An­nex IV or An­nex V to the REACH Reg­u­la­tion⁷⁵;

i.

sub­stances already no­ti­fied and ex­por­ted by the man­u­fac­turer, and re-im­por­ted by the same or an­oth­er man­u­fac­turer in the same sup­ply chain who can show that:

1.

the sub­stance be­ing re-im­por­ted is the same as the ex­por­ted sub­stance,

2.

he has been provided with a safety data sheet in ac­cord­ance with Art­icle 20 for the ex­por­ted sub­stance, if this is re­quired un­der Art­icle 19;

j.⁷⁶

sub­stances lis­ted in An­nex 7, up to the max­im­um quant­ity spe­cified therein.

² If there are reas­ons to sup­pose that a giv­en sub­stance that is ex­empt from no­ti­fic­a­tion in ac­cord­ance with para­graph 1 may en­danger hu­mans or the en­vir­on­ment, the No­ti­fic­a­tion Au­thor­ity shall, if so re­ques­ted by an as­sess­ment au­thor­ity, re­quire the man­u­fac­turer to present cer­tain test re­ports. The in­form­a­tion re­quired for these test re­ports must not go bey­ond that which must be sub­mit­ted for the tech­nic­al dossier in ac­cord­ance with An­nex 4 num­ber 8 let­ter a, num­ber 9 let­ter a and num­ber 10 let­ter a.

³ Dan­ger­ous sub­stances and PBT or vPvB sub­stances that are ex­empt from the ob­lig­a­tion to no­ti­fy in ac­cord­ance with para­graph 1 let­ters a, c, g, h and j must be re­por­ted in ac­cord­ance with Art­icle 48.⁷⁷

¹ The no­ti­fic­a­tion must be writ­ten in an of­fi­cial lan­guage or in Eng­lish and be sub­mit­ted elec­tron­ic­ally in the format re­quired by the No­ti­fic­a­tion Au­thor­ity. The ac­com­pa­ny­ing let­ter must be writ­ten in an of­fi­cial lan­guage.

² The no­ti­fic­a­tion must con­tain the fol­low­ing in­form­a­tion and doc­u­ments:

a.⁷⁸

the quant­ity which the no­ti­fi­er in­tends to place on the mar­ket;

b.

a tech­nic­al dossier with the fol­low­ing in­form­a­tion fur­ther spe­cified in An­nex 4:

1.

the iden­tity of the no­ti­fi­er,

2.

the iden­tity of the sub­stance,

3.

in­form­a­tion on man­u­fac­ture and use,

4.

clas­si­fic­a­tion and la­belling,

5.

guid­ance on safe use,

6.

ex­pos­ure as­sess­ment,

7.

ro­bust study sum­mar­ies and fur­ther data on the phys­ic­al and chem­ic­al prop­er­ties,

8.

ro­bust study sum­mar­ies with re­gard to the prop­er­ties dan­ger­ous to health,

9.

ro­bust study sum­mar­ies with re­gard to the prop­er­ties dan­ger­ous to the en­vir­on­ment;

c.

if the quant­ity placed on the mar­ket⁷⁹ amounts to 10 tonnes per year or more: a chem­ic­al safety re­port in ac­cord­ance with Art­icle 28;

d.

a pro­posed safety data sheet in the case of dan­ger­ous sub­stances or PBT or vPvB sub­stances;

e.⁸⁰

all avail­able doc­u­ments and in­form­a­tion on the prop­er­ties, ex­pos­ure and the ad­verse ef­fects of the sub­stance on hu­mans and the en­vir­on­ment, in­so­far as these are not already ap­par­ent from the tech­nic­al dossier re­ferred to in let­ter b.

³ Para­graph 2 let­ter c does not ap­ply to new sub­stances that are placed on the mar­ket in the form of pre­par­a­tions if the con­cen­tra­tion of the sub­stance is lower than the fol­low­ing val­ues:

a.

the cut-off val­ues in ac­cord­ance with Art­icle 11 para­graph 3 of the CLP Reg­u­la­tion⁸¹; or

b.

0.1 per cent by weight for PBT or vPvB sub­stances.

⁴ ...⁸²

⁵ The No­ti­fic­a­tion Au­thor­ity may re­quest the no­ti­fi­er to fur­nish test re­ports that go bey­ond the tech­nic­al dossier and are rel­ev­ant for the as­sess­ment of the sub­stance, provided that they are avail­able and can be ob­tained by the no­ti­fi­er with reas­on­able ef­fort.

The chem­ic­al safety re­port con­tains the chem­ic­al safety as­sess­ment in ac­cord­ance with An­nex I to the REACH Reg­u­la­tion⁸³. A chem­ic­al safety as­sess­ment in­cludes the fol­low­ing steps:

a.

a hu­man health haz­ard as­sess­ment;

b.

a hu­man health haz­ard as­sess­ment of physi­co­chem­ic­al prop­er­ties;

c.

an en­vir­on­ment­al haz­ard as­sess­ment;

d.

PBT and vPvB as­sess­ment;

e.

if the sub­stance ful­fils the cri­ter­ia spe­cified in Art­icle 14 para­graph 4 of the REACH Reg­u­la­tion:

1.

an ex­pos­ure as­sess­ment, cov­er­ing all iden­ti­fied uses,

2.

a risk char­ac­ter­isa­tion, cov­er­ing all iden­ti­fied uses.

¹ If the No­ti­fic­a­tion Au­thor­ity finds that a new sub­stance has already been no­ti­fied in Switzer­land, it shall in­form the no­ti­fi­er of the names and ad­dresses of the earli­er no­ti­fi­ers.⁸⁴

^1bis The No­ti­fic­a­tion Au­thor­ity may refer to data from a pre­vi­ous no­ti­fi­er in­stead of data pro­duced by the no­ti­fi­er if:

a.

the new no­ti­fi­er proves with a let­ter of ac­cess from a pre­vi­ous no­ti­fi­er that the lat­ter agrees to the No­ti­fic­a­tion Au­thor­ity con­sult­ing its data; or

b.

the data pro­tec­tion peri­od has ex­pired.⁸⁵

² The no­ti­fi­er must not refer to data from pre­vi­ous no­ti­fi­ers re­gard­ing:

a.

the iden­tity and pur­ity of the sub­stance and the nature of any im­pur­it­ies;

b.

ac­tion to render the sub­stance harm­less.

³ The rules of com­pet­i­tion and in­tel­lec­tu­al prop­erty law are not af­fected by the pro­vi­sions of this sec­tion.

¹ The data pro­tec­tion peri­od is 12 years.⁸⁶

² For ad­di­tion­al data which must be sub­mit­ted in ac­cord­ance with Art­icle 47, the pro­tec­tion peri­od is 5 years. If the data pro­tec­tion peri­od spe­cified in para­graph 1 has not yet ex­pired, the pro­tec­tion peri­od for ad­di­tion­al data is ex­ten­ded ac­cord­ingly.

¹ Any­one plan­ning tests on ver­teb­rates for no­ti­fic­a­tion pur­poses must con­tact the No­ti­fic­a­tion Au­thor­ity to en­quire wheth­er data from such tests is already avail­able. The en­quiry must be made in the format stip­u­lated by the No­ti­fic­a­tion Au­thor­ity.⁸⁸

² This en­quiry must con­tain in­form­a­tion on:

a.

the iden­tity of the sub­stance in ac­cord­ance with Art­icle 27 para­graph 2 let­ter b num­ber 2;

b.

the quant­ity of sub­stance the ap­plic­ant in­tends to place on the mar­ket.

³ If the No­ti­fic­a­tion Au­thor­ity already has ad­equate data from pre­vi­ous tests on ver­teb­rates, and none of the con­di­tions of Art­icle 29 para­graph 1^bis is met, then:

a.

it shall no­ti­fy the former no­ti­fi­ers of the in­ten­ded use of the data by the new no­ti­fi­er and of his name and ad­dress, and

b.

it shall dis­close the names and ad­dresses of the former no­ti­fi­ers to the new no­ti­fi­er.

⁴ Stud­ies on tests with ver­teb­rates may not be re­peated.

¹ The pre­vi­ous no­ti­fi­ers are en­titled to re­ceive fair re­mu­ner­a­tion from the new no­ti­fi­er for the use of their data from pre­vi­ous tests on ver­teb­rates if the term of pro­tec­tion for such data has not yet ex­pired.

² The no­ti­fi­ers shall take steps in­de­pend­ently to reach an agree­ment on data shar­ing and re­mu­ner­a­tion. They may seek an ar­bit­rat­or’s re­port.

³ If no agree­ment is reached, the new no­ti­fi­er may ap­ply to the No­ti­fic­a­tion Au­thor­ity for a rul­ing on the amount of the re­mu­ner­a­tion; the re­quest may be made no earli­er than four months after re­ceipt of the no­ti­fic­a­tion re­ferred to in Art­icle 31 para­graph 3. The new no­ti­fi­er shall in­form the pre­vi­ous no­ti­fi­ers of his/her ap­plic­a­tion.

⁴ The No­ti­fic­a­tion Au­thor­ity shall is­sue a rul­ing on the amount of the re­mu­ner­a­tion no later than 60 days after the re­quest re­ferred to in para­graph 3. If an ar­bit­rat­or’s re­port has been sub­mit­ted, the No­ti­fic­a­tion Au­thor­ity is bound by it un­less the parties raise ob­jec­tions with­in 30 days in terms of Art­icle 189 para­graph 3 of the Civil Pro­ced­ure Code⁹⁰. In the ab­sence of an ar­bit­rat­or’s re­port, the No­ti­fic­a­tion Au­thor­ity shall take par­tic­u­lar ac­count in its rul­ing of:

a.

the costs in­curred by the pre­vi­ous no­ti­fi­ers in ob­tain­ing the test res­ults;

b.

the re­main­ing peri­od of pro­tec­tion for the data con­cerned.

The No­ti­fic­a­tion Au­thor­ity shall use data from pre­vi­ous tests on ver­teb­rates for no­ti­fic­a­tion un­der Art­icle 24, un­less oth­er­wise agreed between no­ti­fi­ers, as soon as:

a.

the new no­ti­fi­er and the pre­vi­ous no­ti­fi­ers have con­cluded an agree­ment on the shar­ing of data and the re­mu­ner­a­tion, or the No­ti­fic­a­tion Au­thor­ity has is­sued a cor­res­pond­ing rul­ing, and

b.

the new no­ti­fi­er pays the re­mu­ner­a­tion or has un­der­taken to do so by ac­know­ledge­ment of debt con­firmed by sig­na­ture.

If the sub­stance quant­ity placed on the mar­ket is 1 tonne per year or more and if the new sub­stance is ex­empt from no­ti­fic­a­tion un­der Art­icle 26 para­graph 1 let­ter d, the man­u­fac­turer or his ex­clus­ive rep­res­ent­at­ive must de­clare the new sub­stance to the No­ti­fic­a­tion Au­thor­ity be­fore pla­cing it on the mar­ket for the first time either on its own or as a con­stitu­ent in a pre­par­a­tion or ob­ject from which the sub­stance is in­ten­ded to be re­leased un­der nor­mal or reas­on­ably fore­see­able con­di­tions of use.

¹ The de­clar­a­tion must be writ­ten in an of­fi­cial lan­guage or in Eng­lish and be sub­mit­ted elec­tron­ic­ally in the format re­quired by the No­ti­fic­a­tion Au­thor­ity. The ac­com­pa­ny­ing let­ter must be writ­ten in an of­fi­cial lan­guage.

² The de­clar­a­tion must con­tain the fol­low­ing in­form­a­tion and doc­u­ments:

a.

the name and ad­dress of the man­u­fac­turer;

b.

if the man­u­fac­turer has im­por­ted the sub­stance: the name and ad­dress of the for­eign man­u­fac­turer;

c.

es­sen­tial data re­lat­ing to the iden­tity of the sub­stance;

d.

the in­ten­ded uses;

e.

the amount of the sub­stance that the man­u­fac­turer ex­pects to place on the mar­ket each year in Switzer­land;

f.

pro­posed clas­si­fic­a­tion and la­belling;

g.

the re­search pro­gramme and a list of the people to whom the sub­stance is to be sup­plied;

h.

in the case of dan­ger­ous sub­stances or PBT or vPvB sub­stances: a pro­posed safety data sheet.

³ The No­ti­fic­a­tion Au­thor­ity may re­quest the man­u­fac­turer or ex­clus­ive rep­res­ent­at­ive to fur­nish test re­ports that are rel­ev­ant for the as­sess­ment of the sub­stance, provided that they are avail­able and can be ob­tained with reas­on­able ef­fort.

¹ The No­ti­fic­a­tion Au­thor­ity shall con­firm to the man­u­fac­turer or the ex­clus­ive rep­res­ent­at­ive the date on which the no­ti­fic­a­tion or de­clar­a­tion was re­ceived.

² If the doc­u­ments are not ob­vi­ously in­com­plete, the No­ti­fic­a­tion Au­thor­ity shall for­ward them to the as­sess­ment au­thor­it­ies.

¹ The as­sess­ment au­thor­it­ies, with­in their area of com­pet­ence, shall as­sess wheth­er:

a.

the sub­mis­sion is com­plete or if not, wheth­er the reas­ons giv­en by the no­ti­fi­er are val­id;

b.

the data is sci­en­tific­ally plaus­ible;

c.

the test re­ports are based on tests meet­ing the re­quire­ments spe­cified in Art­icle 43.

² If, when re­view­ing the no­ti­fic­a­tion dossier, an as­sess­ment au­thor­ity de­term­ines that a sub­stance poses a par­tic­u­lar risk for hu­man health or the en­vir­on­ment, on ac­count of its dan­ger­ous nature, its prop­er­ties, its fore­see­able use or the quant­ity placed on the mar­ket, the au­thor­ity may con­duct a tar­geted risk as­sess­ment be­fore ac­cept­ing the no­ti­fic­a­tion.

³ The as­sess­ment au­thor­it­ies shall re­port the res­ults of their re­view to the No­ti­fic­a­tion Au­thor­ity.

¹ If the No­ti­fic­a­tion Au­thor­ity de­term­ines that the doc­u­ments are ob­vi­ously in­com­plete, it shall in­form the man­u­fac­turer or ex­clus­ive rep­res­ent­at­ive ac­cord­ingly without delay.

² If an as­sess­ment au­thor­ity de­term­ines that the doc­u­ments are in­com­plete or in­ac­cur­ate, or that fur­ther data or tests are re­quired for an as­sess­ment of the haz­ards and risks as­so­ci­ated with the sub­stance, it shall in­form the No­ti­fic­a­tion Au­thor­ity ac­cord­ingly. The No­ti­fic­a­tion Au­thor­ity shall re­quest the man­u­fac­turer or ex­clus­ive rep­res­ent­at­ive to sub­mit ad­di­tions or cor­rec­tions.

³ If a ro­bust study sum­mary in ac­cord­ance with Art­icle 27 para­graph 2 let­ter b num­bers 7–9 does not per­mit an in­de­pend­ent as­sess­ment of a spe­cif­ic test, the No­ti­fic­a­tion Au­thor­ity may re­quest the full study re­port.

⁴ The No­ti­fic­a­tion Au­thor­ity shall con­firm to the man­u­fac­turer or ex­clus­ive rep­res­ent­at­ive the date of re­ceipt of ad­di­tions and cor­rec­tions.

¹ In con­sulta­tion with the as­sess­ment au­thor­it­ies, the No­ti­fic­a­tion Au­thor­ity shall is­sue a rul­ing on the ac­cept­ance of the no­ti­fic­a­tion or de­clar­a­tion if the re­view has shown that the no­ti­fic­a­tion or de­clar­a­tion doc­u­ments are com­plete and suf­fi­cient to per­mit as­sess­ment of the haz­ards and risks as­so­ci­ated with the sub­stance.

² If a tar­geted risk as­sess­ment was con­duc­ted, the rul­ing shall in­clude the risk mit­ig­a­tion meas­ures ordered.

Sub­stances sub­ject to no­ti­fic­a­tion re­quire­ments may be placed on the mar­ket if:

a.

the No­ti­fic­a­tion Au­thor­ity has ac­cep­ted the no­ti­fic­a­tion there­of; or

b.

60 days have elapsed since the con­firmed date of re­ceipt of the no­ti­fic­a­tion and of any ad­di­tions or cor­rec­tions re­quired there­after, without the No­ti­fic­a­tion Au­thor­ity hav­ing is­sued any re­sponse.

Sub­stances sub­ject to de­clar­a­tion re­quire­ments may be placed on the mar­ket if:

a.

the No­ti­fic­a­tion Au­thor­ity has ac­cep­ted the de­clar­a­tion there­of; or

b.

30 days have elapsed since the con­firmed date of re­ceipt of the de­clar­a­tion and of any ad­di­tions or cor­rec­tions re­quired there­after, without the No­ti­fic­a­tion Au­thor­ity hav­ing is­sued any re­sponse.

¹ Man­u­fac­tur­ers must en­sure that the con­duct of the tests re­quired for as­sess­ment of the haz­ards and risks of sub­stances and pre­par­a­tions, the meth­ods used and the as­sess­ment of test res­ults are in ac­cord­ance with the cur­rent state of sci­entif­ic and tech­nic­al know­ledge.

^1bis They must not carry out tests on ver­teb­rates if the haz­ards can be as­sessed by oth­er meth­ods or if the test is not ne­ces­sary from a sci­entif­ic point of view.⁹²

² The FDHA, DE­TEC and the EAER may reg­u­late tech­nic­al de­tails in their re­spect­ive areas of com­pet­ence.

¹ Tests de­signed to de­term­ine the prop­er­ties of sub­stances and pre­par­a­tions must be car­ried out in ac­cord­ance with the test meth­ods spe­cified in the tech­nic­al pro­vi­sions re­ferred to in An­nex 2 num­ber 2.

² Oth­er test meth­ods may be used if:

a.

no meth­od is spe­cified in ac­cord­ance with para­graph 1;

b.

the man­u­fac­turer can show that a spe­cified meth­od is not suit­able for the de­term­in­a­tion of a giv­en physi­co­chem­ic­al prop­erty; or

c.

the meth­od is re­cog­nised in the EU in ac­cord­ance with Art­icle 13 para­graph 3 of the REACH Reg­u­la­tion⁹³.

³ If oth­er test meth­ods are used, the man­u­fac­turer must show that they:

a.

pro­duce val­id res­ults; and

b.

take due ac­count of an­im­al pro­tec­tion in the case of tests on an­im­als.

⁴ Non-clin­ic­al tests de­signed to de­term­ine prop­er­ties dan­ger­ous to health or the en­vir­on­ment must be car­ried out in ac­cord­ance with the prin­ciples of Good Labor­at­ory Prac­tice (GLP) spe­cified in the Or­din­ance of 18 May 2005⁹⁴ on Good Labor­at­ory Prac­tice.

⁵ If cer­tain tests do not, or do not fully, com­ply with GLP prin­ciples, the per­son sub­mit­ting the test re­ports must state the reas­ons. The No­ti­fic­a­tion Au­thor­ity, in con­sulta­tion with the as­sess­ment au­thor­it­ies, shall de­cide wheth­er to ac­cept these test res­ults.

Man­u­fac­tur­ers must re­as­sess or fur­ther as­sess sub­stances, pre­par­a­tions and ob­jects con­tain­ing dan­ger­ous con­stitu­ents and, where ne­ces­sary, re­clas­si­fy, re­la­bel and re­pack­age them if:

a.

they are to be sup­plied for dif­fer­ent pur­poses;

b.

they are to be used in a dif­fer­ent way;

c.

they are to be used in much lar­ger quant­it­ies than be­fore;

d.

vari­ations arise in the nature and quant­ity of im­pur­it­ies, which could have ad­verse ef­fects on hu­man health or the en­vir­on­ment;

e.

the as­sess­ment of the risks they pose to hu­man health or the en­vir­on­ment needs to be mod­i­fied in the light of prac­tic­al ex­per­i­ence, new data or new in­form­a­tion.

¹ Man­u­fac­tur­ers are re­quired to up­date doc­u­ments con­tinu­ously with new in­form­a­tion rel­ev­ant to health and the en­vir­on­ment for as long as they con­tin­ue to place on the mar­ket the sub­stance, pre­par­a­tion or ob­ject con­tain­ing dan­ger­ous con­stitu­ents.

² They must re­tain or en­sure the avail­ab­il­ity of the main doc­u­ments used in the as­sess­ment and clas­si­fic­a­tion, to­geth­er with the res­ults of the as­sess­ment and clas­si­fic­a­tion, for at least ten years after the products are last placed on the mar­ket. They must re­tain samples and spe­ci­mens for as long as their con­di­tion al­lows them to be ana­lysed.

¹ No­ti­fi­ers must in­form the No­ti­fic­a­tion Au­thor­ity in writ­ing without delay if:

a.

there are any changes in the in­form­a­tion re­ferred to in Art­icle 27 para­graph 2 let­ter b num­bers 1–6 or Art­icle 35 para­graph 2;

b.

the quant­ity placed on the mar­ket is likely to have reached one of the thresholds laid down in Art­icle 47 para­graph 1; in this case, no­ti­fi­ers shall spe­cify which tests they in­tend to con­duct in or­der to pro­duce the ad­di­tion­al in­form­a­tion spe­cified in Art­icle 47 para­graph 1;

c.

the quant­ity placed on the mar­ket has in­creased or de­creased by a factor of more than two com­pared with the quant­ity last no­ti­fied;

d.

new in­form­a­tion comes to their at­ten­tion re­gard­ing the ef­fects of the sub­stance on hu­man health or the en­vir­on­ment;

e.

they place the sub­stance on the mar­ket for a new use or be­come aware that this sub­stance is be­ing used for pur­poses oth­er than those in­dic­ated to the No­ti­fic­a­tion Au­thor­ity;

f.

they com­pile, or have com­piled for them, test re­ports go­ing bey­ond the tech­nic­al dossier re­ferred to in Art­icle 27 para­graph 2 let­ter b for the sub­stance in ques­tion;

g.

they are able to ob­tain oth­er test re­ports go­ing bey­ond the tech­nic­al dossier re­ferred to in Art­icle 27 para­graph 2 let­ter b.

² The up­dated in­form­a­tion in ac­cord­ance with para­graph 1 must be writ­ten in an of­fi­cial lan­guage or in Eng­lish and be sub­mit­ted elec­tron­ic­ally in the format re­quired by the No­ti­fic­a­tion Au­thor­ity. The ac­com­pa­ny­ing let­ter must be writ­ten in an of­fi­cial lan­guage.

³ Only rep­res­ent­at­ives must en­sure that they have ac­cess to up­dated data, par­tic­u­larly as re­gards the quant­it­ies of sub­stances im­por­ted an­nu­ally by the im­port­ers they rep­res­ent.

⁴ Im­port­ers rep­res­en­ted by an ex­clus­ive rep­res­ent­at­ive in the no­ti­fic­a­tion of a new sub­stance must in­form the rep­res­ent­at­ive an­nu­ally of the quant­it­ies of the sub­stance im­por­ted.

¹ No­ti­fi­ers must provide the No­ti­fic­a­tion Au­thor­ity with the fol­low­ing ad­di­tion­al in­form­a­tion based on the quant­ity placed on the mar­ket:

a.

for quant­it­ies of 10 tonnes per year or more: the in­form­a­tion spe­cified in An­nex 4 num­ber 9 let­ter b and num­ber 10 let­ter b and a chem­ic­al safety re­port in ac­cord­ance with Art­icle 28;

b.

for quant­it­ies of 100 tonnes per year or more: the in­form­a­tion spe­cified in An­nex 4 num­ber 8 let­ter b, num­ber 9 let­ter c and num­ber 10 let­ter c and a chem­ic­al safety re­port in ac­cord­ance with Art­icle 28;

c.

for quant­it­ies of 1,000 tonnes per year or more: the in­form­a­tion spe­cified in An­nex 4 num­ber 9 let­ter d and num­ber 10 let­ter d and a chem­ic­al safety re­port in ac­cord­ance with Art­icle28.

² After re­ceiv­ing the in­form­a­tion spe­cified in Art­icle 46 para­graph 1 let­ter b, the No­ti­fic­a­tion Au­thor­ity shall, in ac­cord­ance with Art­icle 31 para­graph 3⁹⁵, in­form the no­ti­fi­er of the data that it already holds.

³ If the risks as­so­ci­ated with a giv­en sub­stance can­not be ad­equately as­sessed, the No­ti­fic­a­tion Au­thor­ity shall, if so re­ques­ted by an as­sess­ment au­thor­ity, re­quire the no­ti­fi­er to sub­mit ad­di­tion­al in­form­a­tion or carry out ad­di­tion­al tests re­lat­ing to the sub­stance or its trans­form­a­tion products.

⁴ The No­ti­fic­a­tion Au­thor­ity, after con­sult­ing the no­ti­fi­er and with the agree­ment of the as­sess­ment au­thor­it­ies, shall draw up a timetable for the per­form­ance of the ad­di­tion­al tests.

⁵ If the no­ti­fi­er fails to sub­mit the ad­di­tion­al test re­ports by the spe­cified dead­line, the No­ti­fic­a­tion Au­thor­ity may ar­range for the re­quired tests to be car­ried out at the no­ti­fi­er’s ex­pense and, if ne­ces­sary, pro­hib­it the no­ti­fi­er from con­tinu­ing to place the sub­stance on the mar­ket.

¹ Man­u­fac­tur­ers must re­port the fol­low­ing sub­stances and pre­par­a­tions to the No­ti­fic­a­tion Au­thor­ity with­in 3 months after first pla­cing them on the mar­ket:

a.

the sub­stances and pre­par­a­tions spe­cified in Art­icle 19, ir­re­spect­ive of wheth­er a safety data sheet has to be com­piled for them;

b.

nan­o­ma­ter­i­als, oth­er than those re­ferred to in let­ter a, which spe­cific­ally con­tain bi­op­er­sist­ent fibres or tubes ex­ceed­ing 5µm in length.

² Ma­ter­i­als with a wa­ter sol­u­bil­ity of less than 100mg per litre or with a half-life in the lungs of 40 days or more are con­sidered to be bi­op­er­sist­ent.

¹ The re­port must in­clude the fol­low­ing in­form­a­tion:

a.

the man­u­fac­turer’s name and ad­dress;

b.

the name of the per­son re­spons­ible for pla­cing the sub­stance or pre­par­a­tion on the mar­ket in the EEA in ac­cord­ance with Art­icle 17 para­graph 1 let­ter a of the CLP Reg­u­la­tion⁹⁷, if the man­u­fac­turer’s iden­tity is not men­tioned on the la­bel;

c.

in the case of sub­stances:

1.

the chem­ic­al name in ac­cord­ance with Art­icle 18 para­graph 2 let­ters a–d of the CLP Reg­u­la­tion,

2.

the CAS num­ber,

3.

the EC num­ber,

4.

the clas­si­fic­a­tion and la­belling,

5.

the in­ten­ded uses,

6.

in the case of sub­stances dan­ger­ous to the en­vir­on­ment: the quant­ity likely to be placed on the mar­ket an­nu­ally ac­cord­ing to one of the fol­low­ing cat­egor­ies: less than 1 tonne, 1–10 tonnes, 10–100 tonnes, more than 100 tonnes,

7.⁹⁸

in the case of nan­o­ma­ter­i­als:

–

the com­pos­i­tion, particle form and mean particle size and, where avail­able, the num­ber size dis­tri­bu­tion, spe­cif­ic sur­face area by volume, crys­tal struc­ture, ag­greg­a­tion status, sur­face coat­ing and sur­face func­tion­al­isa­tion, and

–

the quant­ity ex­pec­ted to be placed on the mar­ket an­nu­ally ac­cord­ing to one of the fol­low­ing cat­egor­ies: less than 1 kilo­gramme, 1–10 kilo­grammes, 10–100 kilo­grammes, 100–1000 kilo­grammes, 1–10 tonnes, 10–100 tonnes, more than 100 tonnes,

8.

an in­dic­a­tion of wheth­er the sub­stance is con­sidered to be PBT or vPvB,

9.

the chem­ic­al safety re­port avail­able in the EEA, provided that it can be ob­tained by the man­u­fac­turer with reas­on­able ef­fort;

d.

in the case of pre­par­a­tions:

1.

the trade name,

1a.⁹⁹

the UFI,

2.

data re­lat­ing to the con­stitu­ents in ac­cord­ance with the pro­vi­sions con­cern­ing the safety data sheet,

3.

the clas­si­fic­a­tion and la­belling,

4.

the in­ten­ded uses,

5.

the phys­ic­al state,

6.

in the case of pre­par­a­tions dan­ger­ous to the en­vir­on­ment: the quant­ity likely to be placed on the mar­ket an­nu­ally, ac­cord­ing to one of the fol­low­ing cat­egor­ies: less than 1 tonne, 1–10 tonnes, 10–100 tonnes, more than 100 tonnes,

7.¹⁰⁰

in the case of pre­par­a­tions con­tain­ing nan­o­ma­ter­i­als: the fol­low­ing data, provided they are spe­cified in the safety data sheet: the com­pos­i­tion of the nan­o­ma­ter­i­als, their particle form and mean particle size and, where avail­able, the num­ber size dis­tri­bu­tion, spe­cif­ic sur­face area by volume, crys­tal struc­ture, ag­greg­a­tion status, sur­face coat­ing and sur­face func­tion­al­isa­tion.

² If the con­stitu­ents in terms of para­graph 1 let­ter d num­ber 2 that are ad­ded to the pre­par­a­tion are solely a per­fume or a col­or­ant, the gen­er­ic product iden­ti­fi­er «per­fume» or «col­or­ant» may be in­dic­ated provided the fol­low­ing con­di­tions are met:

a.

The fol­low­ing con­cen­tra­tions are not ex­ceeded:

1.

for per­fumes: a total of 5 per cent by weight,

2.

for col­or­ants: a total of 25 per cent by weight;

b.

Sub­stances of very high con­cern in ac­cord­ance with An­nex 3 in an in­di­vidu­al con­cen­tra­tion of ≥ 0.1 per cent by weight are in­dic­ated in the no­ti­fic­a­tion.¹⁰¹

In the case of dan­ger­ous pre­par­a­tions sold to private users, the No­ti­fic­a­tion Au­thor­ity must be in­formed of the full com­pos­i­tion. Con­stitu­ents which are not deemed to be dan­ger­ous un­der Art­icle 3 may be des­ig­nated by a name that iden­ti­fies the most im­port­ant func­tion­al groups.

The re­port and ex­ten­ded re­port shall be sub­mit­ted as fol­lows:

a.

elec­tron­ic­ally in the format re­quired by the No­ti­fic­a­tion Au­thor­ity;

b.

in an of­fi­cial lan­guage or in Eng­lish.

¹ Any modi­fic­a­tions to the in­form­a­tion spe­cified in Art­icles 49 and 50 must be re­por­ted with­in 3 months.

² If the quant­ity of sub­stances and pre­par­a­tions dan­ger­ous to the en­vir­on­ment ac­tu­ally sup­plied in a year falls out­side the re­por­ted cat­egory of quant­it­ies placed on the mar­ket, the quant­ity placed on the mar­ket in the pre­vi­ous year must be re­por­ted by 31 March of the fol­low­ing year in ac­cord­ance with the cat­egor­ies spe­cified in Art­icle 49 para­graph 1¹⁰³ let­ter c num­ber 6 and let­ter d num­ber 6.

The re­quire­ments to re­port pre­par­a­tions in ac­cord­ance with Art­icle 48 are deemed to have been met if a re­quest to use an al­tern­at­ive chem­ic­al name (Art. 15) has been sub­mit­ted and the No­ti­fic­a­tion Au­thor­ity pos­sesses the in­form­a­tion re­quired un­der Art­icle 49 para­graph 1¹⁰⁴ let­ters a, b and d and, if ap­plic­able, Art­icle 50.

¹ The re­port­ing re­quire­ments spe­cified in this Chapter do not ap­ply to:

a.¹⁰⁵

in­ter­me­di­ates that:

1.

are not giv­en to third parties,

2.

do not leave the man­u­fac­tur­ing site, or

3.

are placed on the mar­ket in quant­it­ies less than 100kg per year;

b.¹⁰⁶

sub­stances and pre­par­a­tions which are placed on the mar­ket solely for the pur­poses of ana­lys­is, re­search or de­vel­op­ment;

b^bis.¹⁰⁷ sub­stances that are placed on the mar­ket solely for train­ing pur­poses;

c.

sub­stances and pre­par­a­tions used ex­clus­ively for food­stuffs, thera­peut­ic products or an­im­al feed­ing­stuffs;

d.¹⁰⁸

…

e.

ex­plos­ives and pyro­tech­nic devices which re­quire au­thor­isa­tion un­der the Ex­plos­ives Or­din­ance of 27 Novem­ber 2000¹⁰⁹;

f.

sub­stances ob­tained in Switzer­land;

g.

pre­par­a­tions ob­tained in Switzer­land and sup­plied in pack­aging oth­er than that provided by the ori­gin­al man­u­fac­turer, provided that:

1.¹¹⁰

the trade name, com­pos­i­tion, the UFI and the in­ten­ded use are un­changed, and

2.

the name of the ori­gin­al man­u­fac­turer is also in­dic­ated;

h.

gas mix­tures con­sist­ing ex­clus­ively of re­por­ted gases;

h^bis.¹¹¹

gases and gas mix­tures that are clas­si­fied in the «gases un­der pres­sure» haz­ard cat­egory;

i.

pre­par­a­tions not deemed to be dan­ger­ous un­der Art­icle 3 which are in pack­ages con­tain­ing no more than 200 ml, if they are man­u­fac­tured in Switzer­land and sup­plied dir­ectly to pro­fes­sion­al or private users;

j.

pre­par­a­tions placed on the mar­ket in quant­it­ies of less than 100 kg per year and in­ten­ded ex­clus­ively for pro­fes­sion­al users;

k.¹¹²

sub­stances no­ti­fied by the man­u­fac­turer in ac­cord­ance with Art­icle 24;

l.¹¹³

paints for­mu­lated on de­mand in lim­ited quant­it­ies for an in­di­vidu­al con­sumer or pro­fes­sion­al user at the point of sale by tint­ing or mix­ing col­ours, provided that:

1.

the re­quire­ments of Art­icle 25 para­graph 8 of the CLP Reg­u­la­tion¹¹⁴ are com­plied with, or

2.

the po­ten­tially haz­ard­ous col­or­ants are in­dic­ated in the no­ti­fic­a­tion of the base col­our in the max­im­um con­cen­tra­tion in which they are ad­ded; in this case, the product must be la­belled with the UFI of the base col­our;

m.¹¹⁵

fresh and ready-mix con­crete, plaster and ce­ment that cor­res­pond to the stand­ard for­mu­la­tions in An­nex VIII Part D of the CLP Reg­u­la­tion and that bear the UFI re­quired by the No­ti­fic­a­tion Au­thor­ity.

² Not ex­emp­ted from the re­port­ing re­quire­ments of this chapter are:

a.

in­ter­me­di­ates in ac­cord­ance with para­graph 1 let­ter a in the form of monomers that are new sub­stances;

b.

pre­par­a­tions in ac­cord­ance with para­graph 1 let­ters b, c, h, i and j that have a UFI.¹¹⁶

¹ Sub­stances, pre­par­a­tions and ob­jects may be pro­moted, offered or sup­plied pro­fes­sion­ally or com­mer­cially only for the uses and meth­ods of dis­pos­al stated by the man­u­fac­turer.

² The in­form­a­tion and in­struc­tions giv­en on the pack­age and la­belling and in the safety data sheet must be taken in­to ac­count.

¹ Sub­stances and pre­par­a­tions may be re­leased dir­ectly in­to the en­vir­on­ment only to the ex­tent that is ne­ces­sary for the in­ten­ded use.

² To this end, users must:

a.

use equip­ment al­low­ing cor­rect and ac­cur­ate ap­plic­a­tion;

b.

take meas­ures to pre­vent sub­stances and pre­par­a­tions, as far as pos­sible, from en­ter­ing sur­round­ing areas or wa­ter­bod­ies; and

c.

take meas­ures to en­sure that, as far as pos­sible, an­im­als, plants, their bio­lo­gic­al com­munit­ies and hab­it­ats are not threatened.

³ Pre­par­a­tions may be re­leased dir­ectly in­to the en­vir­on­ment only for the uses spe­cified by the man­u­fac­turer.

¹ When sub­stances and pre­par­a­tions are stored, the in­form­a­tion and in­struc­tions giv­en on the pack­age and la­belling and, if ap­plic­able, in the safety data sheet must be taken in­to ac­count.

² Dan­ger­ous sub­stances and pre­par­a­tions and their con­tain­ers must be pro­tec­ted against haz­ard­ous, es­pe­cially mech­an­ic­al, im­pacts.

³ Dan­ger­ous sub­stances and pre­par­a­tions must be clearly iden­ti­fi­able and kept sep­ar­ate from oth­er goods. No food­stuffs, an­im­al feed­ing­stuffs or thera­peut­ic products may be kept in the im­me­di­ate vi­cin­ity.

⁴ Para­graphs 1–3 also ap­ply to ob­jects from which sub­stances or pre­par­a­tions are re­leased in quant­it­ies that may en­danger hu­man health or the en­vir­on­ment.

⁵ Sub­stances and pre­par­a­tions that may re­act dan­ger­ously with each oth­er must be stored sep­ar­ately.

⁶ Dan­ger­ous sub­stances and pre­par­a­tions may only be filled in­to and stored in con­tain­ers which meet the fol­low­ing re­quire­ments:

a.

They must not be cap­able of be­ing con­fused with pack­aging con­tain­ing food­stuffs, cos­met­ics, thera­peut­ic products or an­im­al feed­ing­stuffs.

b.

The name of the sub­stance or pre­par­a­tion must be giv­en in the la­belling of the con­tain­ers.

c.

They must com­ply with the re­quire­ments of Art­icle 35 para­graphs 1 and 3 of the CLP Reg­u­la­tion¹¹⁷.

d.

Their design must not be likely to at­tract or arouse the curi­os­ity of chil­dren.

Any­one who sup­plies a sub­stance or pre­par­a­tion in a com­mer­cial ca­pa­city and is re­quired to provide a safety data sheet must be fa­mil­i­ar with and cap­able of in­ter­pret­ing the con­tent of the safety data sheet.

¹ Com­mer­cial and edu­ca­tion­al es­tab­lish­ments must no­ti­fy the can­ton­al en­force­ment au­thor­it­ies of their chem­ic­als con­tact per­son, des­ig­nated un­der Art­icle 25 para­graph 2 of the Chem­ic­als Act.

² The FDHA shall reg­u­late man­dat­ory no­ti­fic­a­tion in ac­cord­ance with para­graph 1; it shall define the form and con­tent of the no­ti­fic­a­tion.

³ It shall define the re­quire­ments that the chem­ic­als con­tact per­son must meet, par­tic­u­larly with re­gard to tech­nic­al qual­i­fic­a­tions and op­er­a­tion­al re­spons­ib­il­it­ies.

¹ Ad­vert­ising for sub­stances, pre­par­a­tions and ob­jects must not give a mis­lead­ing im­pres­sion as to the risks posed to hu­man health and the en­vir­on­ment or as to their en­vir­on­ment­al ac­cept­ab­il­ity, and must not en­cour­age in­ap­pro­pri­ate or il­le­git­im­ate use or dis­pos­al.

² Terms such as «de­grad­able», «not harm­ful to the en­vir­on­ment», «non-pol­lut­ing» and «non-wa­ter-pol­lut­ing» may be used in ad­vert­ising only if the prop­er­ties thus de­scribed are at the same time ex­plained in more de­tail.

³ Any­one who ad­vert­ises dan­ger­ous sub­stances or pre­par­a­tions that private users can pur­chase without see­ing the la­belling be­fore­hand must in­dic­ate their haz­ard­ous prop­er­ties in a com­pre­hens­ible and clearly legible or aud­ible man­ner.

⁴ Para­graph 3 also ap­plies to pre­par­a­tions la­belled in ac­cord­ance with Art­icle 25 para­graph 6 of the CLP Reg­u­la­tion¹¹⁸.

⁵ Sub­stances and pre­par­a­tions must not be pro­moted for uses for which they are not to be placed on the mar­ket.

¹ Sub­stances and pre­par­a­tions are deemed to be­long to Group 1:

a.

if their la­belling in ac­cord­ance with the CLP Reg­u­la­tion¹¹⁹ con­tains at least one ele­ment spe­cified in num­ber 1.1 of An­nex 5 to this Or­din­ance; or

b.

if they are not yet la­belled in ac­cord­ance with the CLP Reg­u­la­tion and their la­belling con­tains at least one ele­ment spe­cified in num­ber 2.1 of An­nex 5 to this Or­din­ance.

² Sub­stances and pre­par­a­tions are deemed to be­long to Group 2:

a.

if their la­belling in ac­cord­ance with the CLP Reg­u­la­tion con­tains at least one ele­ment spe­cified in num­ber 1.2 of An­nex 5 to this Or­din­ance; or

b.

if they are not yet la­belled in ac­cord­ance with the CLP Reg­u­la­tion and their la­belling con­tains at least one ele­ment spe­cified in num­ber 2.2 of An­nex 5 to this Or­din­ance.

¹ For the stor­age of sub­stances or pre­par­a­tions in Groups 1 and 2, Art­icle 57 ap­plies.

² Any­one who stores sub­stances or pre­par­a­tions in Groups 1 and 2 must en­sure that they are not ac­cess­ible to un­au­thor­ised per­sons.

³ Sub­stances and pre­par­a­tions in Groups 1 and 2 may only be filled in­to and stored in con­tain­ers if these are la­belled with the ap­pro­pri­ate danger sym­bols or haz­ard pic­to­grams.

¹ Sub­stances and pre­par­a­tions in Group 2 which are in­ten­ded for private users must not be offered on a self-ser­vice basis.

² The pro­hib­i­tion spe­cified in para­graph 1 does not ap­ply to mo­tor fuels.

¹ Sub­stances and pre­par­a­tions in Group 1 must not be com­mer­cially sup­plied to private users.

² Sub­stances and pre­par­a­tions in Groups 1 and 2 may be com­mer­cially sup­plied only to per­sons hav­ing ca­pa­city to act.

³ Sub­stances and pre­par­a­tions in Groups 1 and 2 may be sup­plied to minors if they are cap­able of judge­ment and have to handle these sub­stances or pre­par­a­tions in the course of their train­ing or in a pro­fes­sion­al or com­mer­cial ca­pa­city.

⁴ The sup­ply re­stric­tions spe­cified in para­graphs 1 and 2 do not ap­ply to mo­tor fuels.

¹ Any­one who com­mer­cially sup­plies a sub­stance or pre­par­a­tion in Group 1 to pro­fes­sion­al users or traders must, at the time of sup­ply, ex­pli­citly in­form them of the pre­cau­tions re­quired and the cor­rect meth­od of dis­pos­al.

² Any­one who com­mer­cially sup­plies a sub­stance or pre­par­a­tion in Group 2 to private users must, at the time of sup­ply, ex­pli­citly in­form them of the pre­cau­tions re­quired and the cor­rect meth­od of dis­pos­al.

³ Sub­stances and pre­par­a­tions may be sup­plied in ac­cord­ance with para­graph 2 only to per­sons who can be as­sumed by the sup­pli­er to be cap­able of judge­ment and able to com­ply with the duty of care spe­cified in Art­icle 8 of the Chem­ic­als Act and the re­quire­ments set out in Art­icle 28 of the EPA.

⁴ The ob­lig­a­tions spe­cified in para­graphs 1 and 2 do not ap­ply to the sup­ply of mo­tor fuels.

¹ Spe­cial know­ledge is re­quired by any­one who, in a com­mer­cial ca­pa­city:

a.

sup­plies sub­stances and pre­par­a­tions in Group 1 to per­sons who ob­tain them in or­der to use them pro­fes­sion­ally, but without pla­cing them on the mar­ket in a dif­fer­ent form;

b.

sup­plies sub­stances and pre­par­a­tions in Group 2 to private users.

² The FDHA may reg­u­late:

a.

how the know­ledge re­quire­ments are to be met; in this con­nec­tion, it shall take pro­fes­sion­al train­ing and ex­per­i­ence in­to ac­count;

b.

the con­tent, dur­a­tion and or­gan­isa­tion of courses for people seek­ing to ac­quire such know­ledge.

³ Art­icles 10 and 11 of the Chem­ic­al Risk Re­duc­tion Or­din­ance of 18 May 2005¹²⁰ (OR­RChem) ap­ply mu­tatis mutandis.

⁴ Para­graph 1 does not ap­ply to mo­tor fuels.

¹ In the event of theft or loss of sub­stances or pre­par­a­tions in Group 1, the per­son suf­fer­ing the theft or loss must no­ti­fy the po­lice without delay.

² The po­lice must in­form the can­ton­al au­thor­ity re­spons­ible for en­for­cing this Or­din­ance as well as the Fed­er­al Of­fice of Po­lice.

³ Any­one who er­ro­neously places on the mar­ket a sub­stance or a pre­par­a­tion in Group 1 or 2 must im­me­di­ately in­form the can­ton­al au­thor­ity re­spons­ible for en­for­cing this Or­din­ance and provide the fol­low­ing in­form­a­tion:

a.

all the data re­quired for pre­cise iden­ti­fic­a­tion of the sub­stance or pre­par­a­tion;

b.

a com­pre­hens­ive de­scrip­tion of the danger which the sub­stance or pre­par­a­tion may pose;

c.

all the avail­able in­form­a­tion as to the source from which the sub­stance or pre­par­a­tion was ob­tained and to whom the sub­stance or pre­par­a­tion has been sup­plied;

d.

the meas­ures taken to avert any danger, such as warn­ings, sus­pen­sion of sales, with­draw­al from the mar­ket or re­call.

⁴ The can­ton­al au­thor­ity shall de­cide wheth­er and in what way the pub­lic needs to be warned of any danger.

Sub­stances and pre­par­a­tions in Groups 1 and 2 may be provided for pro­mo­tion­al pur­poses only to pro­fes­sion­al users or traders.

¹ For the hand­ling of sub­stances and pre­par­a­tions in­ten­ded for self-de­fence, Art­icle 62, Art­icle 64 para­graphs 2 and 3, Art­icle 65 para­graphs 2 and 3, Art­icle 66 para­graph 1 let­ter b, Art­icle 67 para­graphs 3 and 4 and Art­icle 68 ap­ply mu­tatis mutandis.

² Sub­stances and pre­par­a­tions in­ten­ded for self-de­fence must not be offered on a self-ser­vice basis.

¹ Sub­stances re­ferred to in Art­icle 57 of the REACH Reg­u­la­tion¹²¹ are deemed to be of very high con­cern if they are in­cluded in An­nex 3 (can­did­ate list).

² The Fed­er­al Of­fice for the En­vir­on­ment (FOEN) shall de­cide, in con­sulta­tion with the Fed­er­al Of­fice of Pub­lic Health (FOPH) and the State Sec­ret­ari­at for Eco­nom­ic Af­fairs (SECO), wheth­er a can­did­ate list sub­stance lis­ted in An­nex XIV to the REACH Reg­u­la­tion is to be in­cluded in An­nex 1.17 to the OR­RChem¹²².

¹ Any­one who com­mer­cially sup­plies an ob­ject con­tain­ing a sub­stance of very high con­cern in a con­cen­tra­tion great­er than 0.1 % by weight must provide the fol­low­ing in­form­a­tion:

a.

the name of the sub­stance con­cerned;

b.

all the in­form­a­tion re­quired to al­low safe use of the ob­ject, in­so­far as this is avail­able to the sup­pli­er.

² This in­form­a­tion must be provided free of charge:

a.

to pro­fes­sion­al users or traders: without be­ing so re­ques­ted;

b.

to private users: on re­quest with­in 45 days.

¹ The No­ti­fic­a­tion Au­thor­ity shall main­tain a re­gister of sub­stances and pre­par­a­tions that fall with­in the scope of the fol­low­ing Or­din­ances:

a.

this Or­din­ance;

b.

the OR­RChem¹²³;

c.

the Biocid­al Products Or­din­ance of 18 May 2005¹²⁴;

d.

the Plant Pro­tec­tion Products Or­din­ance of 12 May 2010¹²⁵;

e.¹²⁶

Fer­til­isers Or­din­ance of 1 Novem­ber 2023¹²⁷.

² The re­gister shall be com­piled on the basis of data:

a.

that has been col­lec­ted or pro­duced by a Swiss au­thor­ity un­der one of the or­din­ances cited in para­graph 1;

b.

that is made avail­able by for­eign au­thor­it­ies or by in­ter­na­tion­al or­gan­isa­tions.

¹ The en­force­ment au­thor­it­ies shall treat data as con­fid­en­tial when an in­terest in its con­fid­en­ti­al­ity is worthy of pro­tec­tion, un­less there is an over­rid­ing pub­lic in­terest in its dis­clos­ure.

² The No­ti­fic­a­tion Au­thor­ity shall des­ig­nate the con­fid­en­tial data in con­sulta­tion with the as­sess­ment au­thor­it­ies. It shall do so be­fore passing it on to the com­pet­ent can­ton­al or fed­er­al au­thor­it­ies spe­cified in Art­icle 75 para­graph 2.

³ In par­tic­u­lar, shall be deemed worthy of pro­tec­tion the in­terest in main­tain­ing com­mer­cial/man­u­fac­tur­ing secrecy, in­clud­ing:

a.

in­form­a­tion on the iden­tity of in­ter­me­di­ates;

b.

the com­plete com­pos­i­tion of a pre­par­a­tion;

c.

the quant­it­ies of a sub­stance of a pre­par­a­tion placed on the mar­ket;

d.

the in­form­a­tion on nan­o­ma­ter­i­als re­ferred to in Art­icle 49 para­graph 1¹²⁸ let­ter c, 7 and let­ter d, 7.¹²⁹

⁴ If the No­ti­fic­a­tion Au­thor­ity dis­cov­ers that data deemed to be con­fid­en­tial has sub­sequently been law­fully dis­closed, this data shall no longer be treated as con­fid­en­tial.

⁵ The fol­low­ing are not deemed con­fid­en­tial un­der any cir­cum­stances:

a.

the trade name;

b.

the name and ad­dress of the per­son sub­ject to no­ti­fic­a­tion, de­clar­a­tion or re­port­ing re­quire­ments;

c.

the physi­co­chem­ic­al prop­er­ties;

d.

pro­ced­ures for prop­er dis­pos­al, for pos­sible re­cyc­ling or re­use, and for oth­er ways of ren­der­ing ma­ter­i­als harm­less;

e.

the sum­mary of res­ults of tox­ic­o­lo­gic­al and eco­tox­ic­o­lo­gic­al tests;

f.

the de­gree of pur­ity of a sub­stance and the iden­tity of the im­pur­it­ies and ad­dit­ives that are rel­ev­ant for clas­si­fic­a­tion;

g.

re­com­mend­a­tions re­gard­ing pre­cau­tions dur­ing use and emer­gency meas­ures in the event of an ac­ci­dent;

h.¹³⁰

in­form­a­tion that ap­pears in the safety data sheet, with the ex­cep­tion of the iden­tity of in­ter­me­di­ates;

i.

suit­able ana­lyt­ic­al meth­ods for de­term­in­ing the ex­pos­ure of hu­man be­ings and pres­ence in the en­vir­on­ment.

⁶ The No­ti­fic­a­tion Au­thor­ity and as­sess­ment au­thor­it­ies may pub­lish data in the re­gister of products which is not deemed con­fid­en­tial un­der any cir­cum­stances.

At the re­quest of the No­ti­fic­a­tion Au­thor­ity and the as­sess­ment au­thor­it­ies and if ne­ces­sary for en­force­ment of this Or­din­ance, the fol­low­ing data con­cern­ing sub­stances, pre­par­a­tions and ob­jects must be passed on:¹³¹

a.

data col­lec­ted by the FO­AG un­der:

1.

the Fer­til­isers Or­din­ance of 10 Janu­ary 2001¹³²,

2.

the An­im­al Feed­stuffs Or­din­ance of 26 Oc­to­ber 2011¹³³,

3.

the Plant Pro­tec­tion Products Or­din­ance of 12 May 2010¹³⁴;

b.¹³⁵

data on con­tam­in­ants and con­stitu­ents in food­stuffs and on sub­stances in art­icles of daily use col­lec­ted by the Fed­er­al Food Safety and Veter­in­ary Of­fice (FS­VO) un­der the Or­din­ance of 27 May 2020¹³⁶ on the Im­ple­ment­a­tion of Food­stuffs Le­gis­la­tion;

c.

data col­lec­ted by the Fed­er­al Of­fice for Cus­toms and Bor­der Se­cur­ity¹³⁷ from cus­toms de­clar­a­tions;

d.

data col­lec­ted by SECO, by the Swiss Na­tion­al Ac­ci­dent In­sur­ance Fund (SUVA) or by can­ton­al em­ploy­ment in­spect­or­ates un­der le­gis­la­tion on the pro­tec­tion of work­ers;

e.

data col­lec­ted by the pois­ons in­form­a­tion centre (Art. 79);

f.

data col­lec­ted by ex­amin­ing bod­ies un­der Art­icle 12 para­graph 3 of the OR­RChem¹³⁸;

g.

data col­lec­ted by can­tons in con­nec­tion with the en­force­ment of this Or­din­ance or of oth­er le­gis­la­tion gov­ern­ing the pro­tec­tion of hu­man health or the en­vir­on­ment against sub­stances, pre­par­a­tions or ob­jects.

¹ The No­ti­fic­a­tion Au­thor­ity and as­sess­ment au­thor­it­ies shall, in­so­far as is re­quired for the per­form­ance of their du­ties, make avail­able to each oth­er the data that they have col­lec­ted or have had col­lec­ted on their be­half un­der this Or­din­ance or any oth­er le­gis­la­tion gov­ern­ing the pro­tec­tion of hu­man health or the en­vir­on­ment against sub­stances, pre­par­a­tions or ob­jects. To this end, they may es­tab­lish auto­mated re­triev­al pro­ced­ures.

² They shall make avail­able to the can­ton­al and fed­er­al au­thor­it­ies re­spons­ible for en­for­cing le­gis­la­tion gov­ern­ing the pro­tec­tion of hu­man health or the en­vir­on­ment against sub­stances, pre­par­a­tions or ob­jects the data re­quired for the per­form­ance of their du­ties.

³ They may make data con­cern­ing man­u­fac­tur­ers and the sub­stances or pre­par­a­tions that they have placed on the mar­ket ac­cess­ible via re­triev­al pro­ced­ures to the au­thor­it­ies lis­ted be­low, if these au­thor­it­ies re­quire the data for en­force­ment pur­poses:

a.

the cus­toms au­thor­it­ies;

b.

the au­thor­it­ies spe­cified in para­graph 2;

c.

the pois­ons in­form­a­tion centre (Art. 79).

⁴ They may, in spe­cial cases, pass on data re­lat­ing to sub­stances, pre­par­a­tions and ob­jects to bod­ies oth­er than those spe­cified in para­graph 2, if these bod­ies re­quire the data in or­der to per­form their du­ties.

⁵ With re­gard to con­fid­en­tial data re­lat­ing to the com­pos­i­tion of pre­par­a­tions, the fol­low­ing ap­plies:

a.

In the re­triev­al pro­ced­ure, the data may only be made avail­able to the can­ton­al au­thor­it­ies in ac­cord­ance with para­graph 2 and only for the pur­pose of veri­fy­ing the UFI.

b.

Dis­clos­ure to the au­thor­it­ies and bod­ies in ac­cord­ance with para­graphs 2, 3 and 4 is only per­mit­ted if:

1.

it is re­quired by a crim­in­al pro­sec­u­tion au­thor­ity;

2.

it serves to an­swer med­ic­al quer­ies, par­tic­u­larly in cases of emer­gency; or

3.

it serves to an­swer med­ic­al quer­ies, par­tic­u­larly in cases of emer­gency or to pre­vent an im­min­ent danger to hu­man life or health or to the en­vir­on­ment.¹³⁹

⁶ The can­tons shall in­form the FOPH of the res­ults of sur­veys and ana­lyses re­gard­ing the qual­ity of in­door air and pass on avail­able data on in­door air to the FOPH.

¹ The No­ti­fic­a­tion Au­thor­ity and as­sess­ment au­thor­it­ies may pass on data that is not con­fid­en­tial to for­eign au­thor­it­ies and in­sti­tu­tions, and to in­ter­na­tion­al or­gan­isa­tions.

² They may pass on con­fid­en­tial data if:

a.

this is re­quired by in­ter­na­tion­al agree­ments or de­cisions of in­ter­na­tion­al or­gan­isa­tions; or

b.

it is ne­ces­sary to pre­vent an im­min­ent danger to hu­man life or health or to the en­vir­on­ment.

¹ The No­ti­fic­a­tion Au­thor­ity is ad­min­is­trat­ively at­tached to the FOPH.

² A steer­ing com­mit­tee is ap­poin­ted for the No­ti­fic­a­tion Au­thor­ity. It is com­posed of the dir­ect­ors of the fol­low­ing fed­er­al of­fices:

a.

FOPH;

b.

FO­AG;

c.

FOEN;

d.

SECO;

e.¹⁴⁰

FS­VO.

³ The steer­ing com­mit­tee has the fol­low­ing du­ties and powers:

a.

ap­point­ing the man­age­ment of the No­ti­fic­a­tion Au­thor­ity;

b.

de­fin­ing the strategy of the No­ti­fic­a­tion Au­thor­ity;

c.

in­spec­tion and ap­plic­a­tion rights con­cern­ing the budget of the No­ti­fic­a­tion Au­thor­ity.

⁴ The steer­ing com­mit­tee makes de­cisions by con­sensus.

The as­sess­ment au­thor­it­ies are:

a.

the FOPH, for mat­ters con­cern­ing the pro­tec­tion of hu­man life and health;

b.

the FOEN, for mat­ters con­cern­ing the pro­tec­tion of the en­vir­on­ment and in­dir­ect pro­tec­tion of hu­man be­ings;

c.

SECO, for mat­ters con­cern­ing the pro­tec­tion of work­ers.

¹ The pois­ons in­form­a­tion centre es­tab­lished un­der Art­icle 30 of ChemA is Tox Info Suisse.

² The FOPH shall enter in­to an agree­ment with Tox Info Suisse set­ting the amount of re­mu­ner­a­tion that it re­ceives for ser­vices provided un­der Art­icle 30 para­graph 2 of ChemA.

¹ The as­sess­ment au­thor­it­ies may re­view any ex­ist­ing sub­stances which:

a.¹⁴¹

may rep­res­ent a par­tic­u­lar risk to hu­man life or health or to the en­vir­on­ment, ow­ing to the quant­it­ies man­u­fac­tured or placed on the mar­ket or ow­ing to their dan­ger­ous nature or the dan­ger­ous nature of their sec­ond­ary products or wastes; or

b.

are in­cluded in an in­ter­na­tion­al ex­ist­ing sub­stances pro­gramme.

² If an ex­ist­ing sub­stance is to be re­viewed, the No­ti­fic­a­tion Au­thor­ity, at the re­quest of an as­sess­ment au­thor­ity, shall re­quire all the man­u­fac­tur­ers con­cerned to provide the fol­low­ing in­form­a­tion:

a.

the name and ad­dress of the man­u­fac­turer, and the name and ad­dress of the for­eign man­u­fac­turer if the man­u­fac­turer im­ports the sub­stance;

b.

all doc­u­ments used in as­sess­ing and es­tab­lish­ing the haz­ard­ous prop­er­ties of the sub­stance;

c.

the known uses;

d.

in­form­a­tion on the quant­it­ies placed on the mar­ket by the man­u­fac­tur­ers;

e.

the re­gis­tra­tion dossier sub­mit­ted to the European Chem­ic­als Agency, provided it is avail­able and can be ob­tained by the no­ti­fi­er with reas­on­able ef­fort.

³ If re­ques­ted by an as­sess­ment au­thor­ity, the No­ti­fic­a­tion Au­thor­ity shall re­quest one of the man­u­fac­tur­ers to carry out in­vest­ig­a­tions or stud­ies. The costs in­curred by the man­u­fac­turer shall be borne jointly by all the man­u­fac­tur­ers con­cerned.

¹ The as­sess­ment au­thor­it­ies shall re­view, in their area of com­pet­ence, for sub­stances, pre­par­a­tions and ob­jects:

a.

the as­sess­ment and clas­si­fic­a­tion;

b.

the in­form­a­tion that ap­pears in the safety data sheet.

² They may in­struct the No­ti­fic­a­tion Au­thor­ity:

a.

to veri­fy the com­pos­i­tion and the physi­co­chem­ic­al prop­er­ties of sub­stances, pre­par­a­tions and ob­jects;

b.

to ask can­ton­al en­force­ment au­thor­it­ies to take samples.

³ If there is reas­on to sup­pose that as­sess­ment or clas­si­fic­a­tion has not been car­ried out or has not been car­ried out cor­rectly, the No­ti­fic­a­tion Au­thor­ity, at the re­quest of an as­sess­ment au­thor­ity, shall re­quire the man­u­fac­turer con­cerned to provide:

a.

all the doc­u­ments used in es­tab­lish­ing the haz­ard­ous prop­er­ties or in the as­sess­ment;

b.

the safety data sheet, if ap­pro­pri­ate.

⁴ At the re­quest of an as­sess­ment au­thor­ity, the No­ti­fic­a­tion Au­thor­ity shall re­quire the man­u­fac­turer to per­form tests or ad­di­tion­al as­sess­ments if there are in­dic­a­tions that:

a.

sub­stances or pre­par­a­tions and their sec­ond­ary products or wastes may en­danger hu­man health or the en­vir­on­ment;

b.

ob­jects, their sec­ond­ary products or their wastes may en­danger the en­vir­on­ment.

⁵ Moreover, the en­force­ment au­thor­it­ies have the powers as­signed to them by Art­icle 42 of the Chem­ic­als Act and, in the case of a danger to the en­vir­on­ment, also Art­icle 41 of the Chem­ic­als Act.

⁶ If a man­u­fac­turer does not com­ply with an of­fi­cial or­der, the No­ti­fic­a­tion Au­thor­ity shall, if so re­ques­ted by an as­sess­ment au­thor­ity, pro­hib­it it from con­tinu­ing to sup­ply the sub­stances, pre­par­a­tions or ob­jects con­cerned.

⁷As re­gards cos­met­ic products, and raw ma­ter­i­als and ad­dit­ives in­ten­ded ex­clus­ively for these products, the body re­spons­ible for these products shall or­der the ne­ces­sary meas­ures. The par­ti­cip­a­tion of the FOEN is gov­erned by Art­icles 62a and 62b of the Fed­er­al Act of 21 March 1997¹⁴² on the Or­gan­isa­tion of the Gov­ern­ment and the Ad­min­is­tra­tion.

In mat­ters con­cern­ing na­tion­al de­fence, the No­ti­fic­a­tion Au­thor­ity shall ex­am­ine, in con­sulta­tion with the as­sess­ment au­thor­it­ies, wheth­er the pro­vi­sions of this Or­din­ance are be­ing re­spec­ted.

¹ Cus­toms of­fices shall, at the re­quest of the No­ti­fic­a­tion Au­thor­ity, check wheth­er sub­stances, pre­par­a­tions or ob­jects com­ply with the pro­vi­sions of this Or­din­ance

² The as­sess­ment au­thor­it­ies may call upon the No­ti­fic­a­tion Au­thor­ity to sub­mit a re­quest in ac­cord­ance with para­graph 1.

³ In cases of sus­pec­ted in­fringe­ment, the cus­toms of­fices are au­thor­ised to de­tain goods at the bor­der and call in the oth­er en­force­ment au­thor­it­ies in ac­cord­ance with this Or­din­ance. These au­thor­it­ies shall carry out fur­ther in­vest­ig­a­tions and take the ne­ces­sary meas­ures.

In con­sulta­tion with the FOEN and SECO, the FOPH shall ad­apt the fol­low­ing an­nexes:

a.

An­nex 2:

1.

It shall spe­cify the ap­plic­able ver­sion of the an­nexes to the CLP Reg­u­la­tion¹⁴³.

2.¹⁴⁴

It shall take in­to ac­count amend­ments to the Guidelines for the Test­ing of Chem­ic­als drawn up by the Or­gan­iz­a­tion for Eco­nom­ic Co­oper­a­tion and De­vel­op­ment (OECD) and spe­cify the ap­plic­able ver­sion of Reg­u­la­tion (EC) No 440/2008¹⁴⁵, and of the UN Manu­al of Tests and Cri­ter­ia¹⁴⁶.

3.

It shall spe­cify the ap­plic­able ver­sion of An­nex II to the REACH Reg­u­la­tion¹⁴⁷.

b.

An­nex 3 (can­did­ate list). It shall take in­to ac­count amend­ments to the list of sub­stances for even­tu­al in­clu­sion in An­nex XIV to Reg­u­la­tion (EC)
No 1907/2006 in ac­cord­ance with Art­icle 59 para­graph 1 of the REACH Reg­u­la­tion.

c.

An­nex 4. It shall take in­to ac­count amend­ments to An­nexes III and VII–XI to the REACH Reg­u­la­tion.

d.¹⁴⁸

An­nex 7. It shall take in­to ac­count de­vel­op­ments in Europe.

¹ The com­pet­ent fed­er­al bod­ies may del­eg­ate to ap­pro­pri­ate pub­lic cor­por­a­tions or private per­sons all or some of the du­ties and powers as­signed to them by this Or­din­ance.

² To the ex­tent that en­force­ment of health pro­tec­tion is con­cerned, del­eg­a­tion is lim­ited to the fol­low­ing:

a.

re­view of self-reg­u­la­tion;

b.

as­sess­ment as part of a re­view of no­ti­fic­a­tion and up­dated in­form­a­tion;

c.

pro­vi­sion of in­form­a­tion un­der Art­icle 28 of the Chem­ic­als Act;

d.

risk as­sess­ment un­der Art­icle 16 of the Chem­ic­als Act.

The ob­lig­a­tion to pay charges and the cal­cu­la­tion of charges for ad­min­is­trat­ive ac­tions by the fed­er­al en­force­ment au­thor­it­ies in ac­cord­ance with this Or­din­ance are based on the Chem­ic­al Charges Or­din­ance of 18 May 2005¹⁴⁹.

¹ By means of ran­dom sampling, the can­ton­al en­force­ment au­thor­it­ies shall in­spect sub­stances, pre­par­a­tions and ob­jects placed on the mar­ket.

² With­in the frame­work of these in­spec­tions, the can­ton­al en­force­ment au­thor­it­ies shall veri­fy:

a.

that the no­ti­fic­a­tion, de­clar­a­tion and re­port­ing re­quire­ments (Art­icles 24, 34, 48, 52, 53) and the pro­vi­sions gov­ern­ing up­dated in­form­a­tion (Art. 46) have been re­spec­ted;

b.

that pack­aging con­forms to the pro­vi­sions on pack­aging (Art­icles 8 and 9);

c.¹⁵¹

that the la­belling and the UFI con­form to the pro­vi­sions on la­belling (Art­icles 10–13) and on the UFI (Art. 15a);

d.

that the re­quire­ments con­cern­ing the pro­vi­sion, up­dat­ing and re­ten­tion of the safety data sheet (Art­icles 21–23) are be­ing com­plied with and that the in­form­a­tion in the safety data sheet is not ob­vi­ously in­cor­rect;

e.

that the pro­vi­sions on ad­vert­ising (Art. 60) and samples (Art. 68) are be­ing re­spec­ted;

f.

that the re­quire­ment to provide in­form­a­tion when sup­ply­ing ob­jects con­tain­ing sub­stances of very high con­cern (Art. 71) has been com­plied with.

¹ The No­ti­fic­a­tion Au­thor­ity, on its own ini­ti­at­ive or at the re­quest of an as­sess­ment au­thor­ity, shall in­struct the can­ton­al en­force­ment au­thor­it­ies to in­spect cer­tain sub­stances, pre­par­a­tions or ob­jects, es­pe­cially in ac­cord­ance with Art­icle 81 para­graph 1.

² The can­ton­al en­force­ment au­thor­it­ies shall col­lect samples at the re­quest of the No­ti­fic­a­tion Au­thor­ity.

³ If the in­spec­tions identi­fy ser­i­ous con­cerns, the au­thor­ity that per­formed the in­spec­tions shall in­form the No­ti­fic­a­tion Au­thor­ity and the au­thor­it­ies re­spons­ible for or­ders in ac­cord­ance with Art­icle 90a.¹⁵²

⁴ If there are grounds for sus­pect­ing in­cor­rect clas­si­fic­a­tion, the au­thor­ity that per­formed the in­spec­tions shall in­form the No­ti­fic­a­tion Au­thor­ity.

¹ The can­ton­al en­force­ment au­thor­it­ies shall mon­it­or com­pli­ance with the spe­cif­ic pro­vi­sions re­lat­ing to hand­ling (Art­icles 55–59, 61–67 and 69). Art­icle 25 para­graph 1 second sen­tence of the Chem­ic­als Act ap­plies ac­cord­ingly.

² The can­tons shall pro­mote en­vir­on­ment­ally sound prac­tices.

If the in­spec­tion re­veals in­fringe­ments of the pro­vi­sions re­ferred to in Art­icles 87 para­graph 2, 88 para­graph 1 and 90 para­graph 1, the com­pet­ent au­thor­ity of the can­ton in which the in­fringing party is dom­i­ciled or has its re­gistered of­fice shall or­der any ne­ces­sary meas­ures. In the case of in­fringe­ments of the pro­vi­sions re­ferred to in Art­icle 90 para­graph 1, the com­pet­ent au­thor­ity in the can­ton in which the in­fringe­ment took place may also is­sue the or­der. The can­tons shall co­ordin­ate the re­quired meas­ures.

The Chem­ic­als Or­din­ance of 18 May 2005¹⁵⁶ shall be re­pealed.

The amend­ment of oth­er le­gis­la­tion is reg­u­lated in An­nex 6.

¹ For pre­par­a­tions that were pack­aged and la­belled in ac­cord­ance with Art­icles 35–50 of the Chem­ic­als Or­din­ance of 18 May 2005¹⁵⁷ be­fore the com­mence­ment of this Or­din­ance, the fol­low­ing trans­ition­al pro­vi­sions ap­ply:

a.

They may be sup­plied un­til 31 May 2017 if a safety data sheet was com­piled for them in ac­cord­ance with Art­icle 19 of this Or­din­ance and they were re­por­ted in ac­cord­ance with Art­icle 48 of this Or­din­ance; if the pre­par­a­tions con­cerned are li­quid laun­dry de­ter­gents con­tained in sol­uble pack­aging for private users which do not meet the re­quire­ments of Reg­u­la­tion (EU)
No 1297/2014¹⁵⁸, they may only be sup­plied un­til 31 Decem­ber 2015.

b.

Double la­belling in ac­cord­ance with Art­icles 35–50 of the Chem­ic­als Or­din­ance of 18 May 2005 and with Art­icle 10 of the present Or­din­ance is not per­miss­ible.

c.

For hand­ling, the pro­vi­sions of Title 4 of this Or­din­ance ap­ply.

² Aer­o­sol dis­pensers that were pack­aged and la­belled be­fore the com­mence­ment of this Or­din­ance, do not fall with­in the scope of the FoodA¹⁵⁹ and do not meet the re­quire­ments of Art­icles 9 and 11 may be sup­plied un­til 31 May 2017.

³ If a pre­par­a­tion that was la­belled in ac­cord­ance with Art­icles 39–50 of the Chem­ic­als Or­din­ance of 18 May 2005 in the ver­sion of 1 Decem­ber 2012 be­fore the com­mence­ment of this Or­din­ance is re­filled from the ori­gin­al pack­aging in­to smal­ler pack­ages, without the com­pos­i­tion or the in­ten­ded use be­ing changed, it may also be sup­plied in these smal­ler pack­ages with the ex­ist­ing la­belling un­til 31 May 2017.

⁴ For sub­stances that are placed on the mar­ket in quant­it­ies of 10 to 100 tonnes per year, the man­u­fac­turer must com­ply with the ob­lig­a­tion to pre­pare ex­pos­ure scen­ari­os in ac­cord­ance with Art­icle 16 by 1 June 2018.

¹ Man­u­fac­tur­ers of sub­stances, pre­par­a­tions and nan­o­ma­ter­i­als re­ferred to in Art­icle 48 which have already been placed on the mar­ket at the date of entry in­to force of the amend­ment of 31 Janu­ary 2018 and which are placed on the mar­ket again after the entry in­to force of the amend­ment of 31 Janu­ary 2 shall com­ply with the no­ti­fic­a­tion re­quire­ment laid down in Art­icles 48–54 no later than three months after they are placed on the mar­ket again.

² ...¹⁶¹

Man­u­fac­tur­ers may con­tin­ue to place the fol­low­ing pre­par­a­tions on the mar­ket un­til 31 Decem­ber 2025 at the latest without in­dic­at­ing the UFI in ac­cord­ance with Art­icle 15a, not­with­stand­ing that these do not have a UFI on 1 Janu­ary 2022:

a.

pre­par­a­tions in­ten­ded for pro­fes­sion­al users;

b.

pre­par­a­tions in­ten­ded for private users that are placed on the mar­ket be­fore 1 Janu­ary 2022.

¹ Sub­stances and pre­par­a­tions may be sup­plied to third parties with the pre­vi­ous la­belling un­til 31 Decem­ber 2025.

² If a man­u­fac­turer in­tends to con­duct tests on ver­teb­rates, it must by 31 Oc­to­ber 2023 com­ply with the ad­vance en­quiry ob­lig­a­tion in ac­cord­ance with Art­icle 31 para­graphs 1 and 2 for any sub­stance that was placed on the mar­ket be­fore this amend­ment comes in­to force and which is now sub­ject to the no­ti­fic­a­tion ob­lig­a­tion. If it com­plies with this ob­lig­a­tion, it may con­tin­ue to place the sub­stance on the mar­ket without no­ti­fic­a­tion un­til 30 April 2027. The No­ti­fic­a­tion Au­thor­ity may ex­tend the peri­od by a max­im­um of two years. If two or more man­u­fac­tur­ers in­tend to give no­ti­fic­a­tion of the same sub­stance, the No­ti­fic­a­tion Au­thor­ity shall in­form the man­u­fac­tur­ers of this im­me­di­ately on ex­piry of the dead­line for the ad­vance en­quiry. Art­icle 31 para­graph 4 ap­plies by ana­logy.

³ New sub­stances for which no­ti­fic­a­tion was not giv­en be­fore this amend­ment comes in­to force and which do not fall un­der para­graph 2 may con­tin­ue to be placed on the mar­ket without no­ti­fic­a­tion un­til 30 April 2024. The No­ti­fic­a­tion Au­thor­ity may ex­tend the peri­od by a max­im­um of one year.

⁴ The fol­low­ing ap­plies to ex­ist­ing sub­stances for which no­ti­fic­a­tion was giv­en be­fore this amend­ment comes in­to force:¹⁶⁴

a.¹⁶⁵

The no­ti­fi­er is not bound by the ob­lig­a­tions in Art­icles 46 and 47, and the ex­clus­ive rep­res­ent­at­ive and the im­port­er are not bound by ob­lig­a­tion in Art­icle 46.

b.

The ex­emp­tion in Art­icle 54 para­graph 1 let­ter k does not ap­ply.

This Or­din­ance comes in­to force on 1 Ju­ly 2015.