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

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.⁶⁴

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 mar­ket⁶⁵ 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.⁶⁶

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 Reg­u­la­tion⁶⁷; or

b.

0.1 per cent by weight for PBT or vPvB sub­stances.

⁴ ...⁶⁸

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.