Review period for downstream user Authorisations: ECHA’s answers

June 20, 2019

The specific case of downstream users

EcoMundo looked into the situation of downstream users already covered by an upstream application for authorisation. It means that an upstream actor in the supply chain has applied for and was granted or is awaiting an authorisation for a given period. The downstream user is consequently still covered for their specific use until the expiration of the authorisation or the refusal of the application.

These downstream users also have the possibility to submit an application for authorisation individually, before the expiry of the one that covers them. The situation raised the question of knowing when the authorisation would start, if it were granted, and what criteria would be used to determine the review period.

Questions to ECHA

ECHA gave the following answers to the above-mentioned questions from EcoMundo:

  • Regarding the starting date of the review period for the application for authorisation, several scenarios are possible and awaiting clarifications from the European Commission. However, as a general rule, for a decision on an application for authorisation delivered after the sunset date of the substance, the review period should start on the date of entry into force of the Commission’s decision.
  • As for the criteria to evaluate the duration of the review period, ECHA indicated that they would be the same ones as those already in use for initial applications for authorisation.

EcoMundo’s recommendations

Our experts, with their combined expertise, help companies elaborate a strategy for their application for authorisation, specifically adapted to each case. EcoMundo’s unique methodology allows companies we represent to be systematically granted the review periods sought for their authorisation, since 2015.

Encore +

Articles similaires

REACH Registration

Understanding the REACH regulation n°1907/2006 on chemical substances

Manufacturers, importers and downstream users of chemical substances are required to comply with the European REACH regulation, which came into force in 2007. EcoMundo gives you an update on the different aspects of the regulation that concern you.

AGEC Law - Mandatory Reporting of Endocrine Disruptors

On October 13, 2023, the French government published three crucial decrees under the AGEC law - Article 13. These decrees mandate the disclosure of information regarding the presence of known, suspected, or alleged endocrine disruptors (EDs) in everyday products.
REACH Authorization

Postponement of the DEHP ban in medical devices: new dates

The European Commission recently announced a postponement of the ban on the use of bis(2-ethylhexyl) phthalate (DEHP) in medical devices (MDs).