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


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Art. 46 Updated information

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.

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