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, 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.

Report is to be submitted to the notification authority for chemicals using the E-application for chemicals (RPC):

Although the authorities do not issue any order, they can evaluate the submitted data. According to article 26, paragraph 2, ChemO, they can require certain test reports from the notifier, if there is reason to assume that a substance may represent a danger to humans or the environment.

Exemptions to the obligation to register are listed in Article 54 ChemO.

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;

Last modification 03.12.2019

Top of page