Reporting of new substances that are exempt from the obligation to notify
Manufacturers of new substances that are exempt from notification according to article 26, let. a, c, g, h, j ChemO (see Chapter 3 of the guidelines), must report these within 3 months after first placing them on the market and independently of the obligation to establish a SDS (art. 48, art. 19 ChemO), if the assessment under the self-regulation has shown that they fall into one of the following categories:
a. dangerous substances
b. substances assessed as PBT or vPvB;
c. substances in annex 3 ChemO (candidate list).
d. nanomaterials purposefully containing fibres or tubes with a length of more than 5 μm. Materials with a water solubility of less than 100 mg per liter or with a half-life of 40 days or more in the lungs are considered being biopersistent.
The reporting application must contain the following data:
a. the manufacturer's name and address;
b. name of the person responsible for placing on the market in the EEA in accordance with art. 17 par. 1 let. a CLP, if the manufacturer's identity is not mentioned on the label;
c. the chemical name according to art. 18 par. 2 let a-d CLP
d. the CAS number,
e. the EC number,
f. the classification and labelling;
g. uses
h. for substances dangerous to the environment: the annual quantity placed on the market
i. for nanomaterials:
- composition, particle shape and average particle size as well as, if available, particle size distribution, specific surface to volume ratio, surface coating and surface functionalisation
- the estimated quantity to be placed on the market in one of the following categories: less than 1 kg 1–10 kg, 10–100 kg, 100–1000 kg, 1–10 t, 10–100 t, more than 100 t,
j. if applicable, the identification as a PBT or vPvB substance
k. the chemical safety report available in the EEA, provided the manufacturer can reasonably be expected to obtain it;