Compliance checks
ECHA may examine any registration dossier to verify if the information submitted by registrants is in compliance with the legal requirements. Compliance checks evaluate the substance identity description, the safety information in the dossier including the chemical safety report or specific parts of the dossier, for example the information related to the protection of human health.
According to REACH, ECHA must check at least 5% of the registration dossiers of each tonnage band.
There are three possible results of the compliance check:
a) No action towards the registrant
There is no administrative action if the dossier is considered compliant with the information requirements provided in REACH. However, this does not necessarily mean that there are no shortcomings in the dossier. A new additional compliance check can still start at any time.
b) Quality observation letter
ECHA may identify shortcomings that are not necessarily related to a lack of information. For example, the risk management measures proposed by the registrant may be inadequate or the proposed classification and labelling does not reflect the reported study results.
In these cases, ECHA will send a quality observation letter and invite the registrant to update the dossier. A quality observation letter may also be sent to clarify certain aspects of the dossier.
ECHA informs Member States about these letters and on the response of the registrants. If the registrant does not clarify the issue, the Member States may initiate some processes, for example, a proposal for harmonised classification and labeling.
c) Decisions to request additional information
Following the compliance check, ECHA may conclude that additional testing or other information is required. In these cases, it prepares a draft decision to be sent to the registrant for comments.
A draft decision requesting additional information can be combined with an issue of quality observation letter.