New
substance
notification
Notification is a procedure of adding new substances to the Register after the enactment of the TR EAEU 041/2017
This information is preliminary – the documents which regulate the procedure of registration are not approved yet
The new substance notification procedure is comprised of 4 main steps:
** During the first two years after the TR is enacted testing can be performed in any laboratory, after that – only in GLP-compliant laboratories
Submitting documents
Submitting the set of documents to the authorized body. It’s possible to provide documents both as a part of permissive state registration procedure, as well as separately from it
Checking documents and data comprehensiveness 5 workdays
The authorized body checks the completeness of documents and comprehensiveness of data
Providing missing data (if requested) 5 workdays
(Optional)
The authorized body sends a request in case of missing documents or issues with the provided data. The request must be answered in 20 workdays
Decision on notification 25 workdays
Inclusion of the substance into the Register of chemicals and mixtures of the EAEU or denial
Denial is possible in the following cases:
1) the provided data is not comprehensive, not authentic or contradictory;
2) absence of documents which confirm the authenticity and the right to use the provided data;
3) the timelines of conducting further research are unreasonably high
The procedure of notification is somewhat similar to REACH registration
Joint document submission for notification by separate legal entities is possible
Before June 2, 2023, notification can be avoided, if data on a substance is provided under the framework of inventorying, as well as evidence documents which confirm that the substance was present on the territory of the EAEU prior to the enactment of the TR EAEU 041/2017
Select an analogueof the new chemical substance
250 000 €
2 years
Before June 2, 2023, notification can be avoided, if data on a substance is provided under the framework of inventorying, as well as evidence documents which confirm that the substance was present on the territory of the EAEU prior to the enactment of the TR EAEU 041/2017
This information is preliminary – the documents which regulate the procedure of registration are not approved yet
TR EAEU 041/2017
PART I
- Information about the applicant
- Data on the chemical substance
- Hazard classification and labelling
- Guideline for safe use
- Physical and chemical properties
- Ecotoxicological properties
- Suggestions for further research
- Information about hazards for human health and life, animals, plants, environment, and property
- Assessment of the possibility of using safe substances as alternative components of the product which is being registered
PART II
- Assessment of hazard to human health
- Fire and explosion hazard assessment
- Assessment of hazard to environment
EU REACH
PART A
- Summary of risk management measures
- Declaration that risk management measures are implemented
- Declaration that risk management measures are communicated
PART B
- Identity of the substance and physical and chemical properties
- Manufacture and uses
- Classification and labelling
- Environmental fate properties
- Human health hazard assessment
- Human health hazard assessment of physicochemical properties
- Environmental hazard assessment
- PBT and vPvB assessment
- Exposure assessment
- Risk characterisation