Dictámenes de evaluación de expedientes
Dictámenes de evaluación de expedientes
ECHA’s dossier evaluation process covers compliance checks and the examination of testing proposals. By consulting the table below, you can find out whether ECHA has started to evaluate dossiers for a particular substance and follow the progress through the evaluation process.
The table below displays the type, scope and status of the assessment undertaken for a given dossier. The decision date and the non-confidential version of the decision are published shortly after the decision has been adopted.
Before publishing the non-confidential version of an adopted decision on its website, ECHA consults the addressees of the decision on this version. ECHA systematically removes any personal data from the non-confidential version of a decision. Some sections may also be redacted based on justified claims by registrants, regarding information confidential or deemed to harm their commercial interest if disclosed.
Check the expandable boxes below for more details.
Identifiers of the substance: Name (as on the Dissemination website); EC/List number (European Community number / List number assigned by ECHA); CAS number (also called the Chemical Abstract Service Registry Number or CAS RN).
Decision type can be ‘CCH’ for Compliance Check Evaluation and ‘TPE’ for Testing Proposal Evaluation.
Scope refers to the scope of the evaluation and can be:
- Targeted: The compliance check focuses only on some endpoints.
- Comprehensive: The compliance check focuses on all relevant endpoints under ECHA’s strategy.
- Testing proposal: The assessment focuses on the testing proposals submitted by the registrants.
Status reports the current position of the dossier in the dossier evaluation process and can be:
- Under assessment: The evaluation of the dossier has formally started.
- Ongoing: The registrants have received the draft decision - The dossier retains this status until the decision is adopted or the evaluation is otherwise concluded.
- Information requested: The registrants have received the adopted decision with the deadline for providing the requested information.
- Follow-up: The deadline set in the adopted decision has passed, and ECHA is assessing whether the information requested in the decision has been provided in the dossier update - This follow-up may also involve the national enforcement authorities.
- Concluded: The evaluation is closed.
In most cases, this means that the registrant has responded to the adopted decision with compliant information. However, as in some cases an evaluation is concluded at an earlier stage, an adopted decision is not always available for every evaluation marked as concluded.
Decision date reports the date on which the adopted decision was sent to the registrants.
Decision displays a non-confidential version of the adopted decision once available.
Latest update indicates the date of the latest automatic update carried out by ECHA’s information systems.
You can access the disseminated registration dossier, available in the ‘Registered substances’ section of ECHA’s website, by clicking on the magnifying glass icon. Except when confidentiality is claimed on the substance identifiers, the adopted decision is directly linked to the disseminated dossier.
You can access additional information in ‘Details’ view, by clicking on the eye icon:
- Substance identifiers
- Decision type (CCH or TPE), scope and status of the evaluation, as in the main table
- Decision’s deadline(s): The deadline(s) for requested information contained in the decision, should the decision contain more than one deadline
- Appeal information: If the registrants have appealed against the adopted decision, a link to the Board of Appeal’s announcement document is provided.
ECHA’s information systems automatically update the status of dossier evaluations during the process. For transparency reasons, all dossier evaluation decisions will remain published. This also applies if the registrants have appealed or have updated the registration dossier as requested in the decision.
It is for the reader to verify the status of an evaluation: check the deadline of the decision, the indicated status of the evaluation, and the content of the registration dossier. The most recent data on a substance is available in the ‘Registered substances’ section of ECHA’s website; check also whether the Board of Appeal has taken a decision regarding any appeal.
- The dossier evaluation decisions may not apply to all registrants that are part of a joint registration.
- There may be a delay between the decision date and the actual publication of the adopted decision, which corresponds to the consultation on its non-confidential version and addressing any comments from the registrants.
- The information in the disseminated registration dossier is obtained from all registration dossiers which are part of the joint submission of a substance, including the names of the registrants, unless claimed confidential.
Last updated 10 diciembre 2018. Database contains 2703 unique substances/entries.