Q&As
Q&As
Q&A info
Θέλετε αναζητήσετε τη σχετική ερώτηση και απάντηση στη γλώσσα σας; Αλλάξτε τη γλώσσα στο αναπτυσσόμενο μενού ανωτέρω.
Επιστροφή
The decision making process continues on the basis of the draft CAR (i.e. BPC opinion) and there will be no opportunity for anyone else to take over the role of participant.
Updates of the Article 95 list are foreseen to take place once a month. ECHA intends to take all changes within that month into account.
Article 95 only applies to "relevant substances" i.e. substances for which the application for approval of the active substance has been submitted and validated by the evaluating Competent Authority. Therefore, the submission of a compliant notification to take over the role of participant, has no impact on the Article 95 list until an active substance application is submitted (for the notified substance) and validated by the evaluating Competent Authority has validated the active substance application.
Any natural or legal person can submit a notifications to take over the role of participant.
The notification can be for one active substance in one or more PTs. The notification fee is per notification of an active subsance and covers all PTS notified. The fee is then deducted from the active substance approval fee.
It is the responsibility of the notifier to provide all the necessary data. If the data is not complete (following one request for additional information) the notification will not be compliant. A recovery of fees is not provided for in the legislation.
Yes, a group of companies (e.g. a taskforce) can submit one notification. The active substance will become relevant for Article 95 when the application for approval of the active substance is submitted and validated by the eCA. The companies which apply jointly for the approval of the active substance will then appear on the Article 95 list individually.
If no eCA is mentioned in Annex II of the Review Programme Regulation (EU) No 1062/2014 for the active substance/product-type in question, the applicant may choose any competent authority, as defined under Article 81 of the BPR, that would agree to evaluate the application for approval.
Part II of Annex II of the Review Programme Regulation lists review active substances that are no longer supported which means that these substance are existing active substances (on the market on 14 May 2000). The notification for taking over the role of participant for these substances does not require evidence that the substance is an existing one.