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

English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

of 5 June 2015 (Status as of 1 February 2022)

Art. 27 Form and content of the notification

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.

64 Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 801).

65 Ex­pres­sion in ac­cord­ance with No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 801). This change has been made throughout the text.

66 Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 801).

67 See foot­note to Art. 2 para. 4.

68 Re­pealed by No I of the O of 31 Jan. 2018, with ef­fect from 1 March 2018 (AS 2018 801).