Art. 24 ChemO : Manufacturers (this definition includes importers) of a new substance must notify new substances to the Chemicals Notification Authority before placing it on the market for the first time.
- This concerns the substance either as such, within a preparation or within an object from which it should be released when used.
- 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, Article 24 Paragraph 1 (Obligation to notify) applies for the substance as such (Article 24 Paragraph 2 ChemO).
- Furthermore, the Notification Authority may request the notification of a substance contained in an object, if it assumes that the substance can be released during use of the object (Art. 24 para. 3 ChemO).
- Substances with an EC-Nr. beginning with 4 (ELINCS) are new substances
- Those with a list number beginning with 6, 7, 8 or nine are mostly new substances, too (unless the manufacturer can prove that the identity corresponds to a substance listed in EINECS).
- Substances with an EC-Nr. beginning with 5 are no-longer polymers (NLP) and considered be-ing new substances, too. Pursuant to art. 26 par. 1 let. c there is no notification obligation for these (classified NLP however must be reported, see Exceptions to the requirement to notify substances and Reporting of new substances that are exempt from the obligation to notify).
New substances that are subject to notification may be placed on the market if:
- the Notification Authority has accepted their notification; or
- the Notification Authority has not issued any statement according to the article 40 ChemO.
The authorities have a period of 60 days in which to examine a notification (article 40 ChemO). The period begins on the day after the complete technical dossier is received by the notification authority for chemicals. It ends at the end of the last day of the period.
The period stands still (articel 22 federal act on administrative procedure):
- from the 7th day before Easter till the 7th day after Easter
- from 15th July till 15th August
- from 18th December till 2nd January