Federal Act
on Protection against Dangerous Substances and Preparations
(Chemicals Act, ChemA)

of 15 December 2000 (Status as of 1 July 2023)


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Art. 16 Risk assessment

1 The no­ti­fic­a­tion au­thor­ity, in con­junc­tion with the as­sess­ment au­thor­it­ies, shall identi­fy pos­sible haz­ards presen­ted by sub­stances or pre­par­a­tions (risk as­sess­ment). For this pur­pose, the no­ti­fi­er may be re­ques­ted to provide ad­di­tion­al in­form­a­tion and, if ne­ces­sary, to carry out fur­ther tests.

2 A risk as­sess­ment shall be re­quired for:

a.
new sub­stances (Art. 9);
b.
sub­stances and pre­par­a­tions sub­ject to man­dat­ory au­thor­isa­tion (Art. 10 and 11);
c.
ex­ist­ing sub­stances un­der re­view in ac­cord­ance with Art­icle 15 para­graph 2 let­ter b.

3 On the basis of the risk as­sess­ment, hav­ing first con­sul­ted the no­ti­fi­er, the no­ti­fic­a­tion au­thor­ity may re­com­mend or or­der that the no­ti­fi­er should take meas­ures to re­duce the risks.

4 If no meas­ures can be taken to re­duce the risks or if the risks can­not be ad­equately re­duced by such meas­ures, the au­thor­it­ies re­spons­ible shall take ap­pro­pri­ate steps to amend the rel­ev­ant leg­al reg­u­la­tions.

5 Risk as­sess­ments shall be re­viewed and, if ne­ces­sary, re­vised in the light of new find­ings. In ad­di­tion, re­views shall be car­ried out peri­od­ic­ally in the case of biocid­al products and plant pro­tec­tion products.

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