Renewal of active substances
Renewal of active substances
To support the renewal of an approval of an active substance, companies have to submit an application to ECHA at the latest 550 days (approximately 1.5 years) before the current expiry date of the approval.
If several companies are interested in supporting the same active substance, they should preferably cooperate and submit a single common application.
Since the approval of active substances relates to specific product-types, an approval application also relates to a specific active substance/product-type combination.
To facilitate this process, ECHA makes a list of upcoming deadlines available.
Application for renewing approval of an active substance
Applications must contain:
- a written confirmation signed by the evaluating competent authority (eCA) that agrees to evaluate the application for renewal;
- all data required under Article 20 of the BPR that have been generated since the initial approval or previous renewal has been granted;
- a reasoned assessment of whether the conclusions of the initial or previous assessment of the active substance are still valid; and
- any supporting information related to that assessment.
Within 90 days of ECHA’s acceptance of the application, the evaluating competent authority (eCA) has to decide whether a full evaluation is necessary. If the eCA decides that a full evaluation is not necessary, it has to provide a recommendation on the approval within 180 days. If a full evaluation is necessary, the eCA provides the recommendation within 365 days of the acceptance of the application.
On the basis of the eCA’s recommendation, the Biocidal Products Committee (BPC) must adopt an opinion within 270 days of the recommendation being submitted in the case of a full evaluation or within 90 days if a full evaluation is not necessary.
The BPC’s opinion serves as a basis for decision-making by the European Commission. The European Commission may grant the renewal of the approval of an active substance for a defined number of years, not exceeding 10 years.
Some principles for the management of the process for renewal of approval have been discussed and agreed between the Member State competent authorities during the 73rd CA meeting of July 2017 (CA-July17-Doc.5.3-Final), which should be carefully considered by prospective applicants.
Among other principles the document indicates general deadlines to be met, describes the agreement process for companies to apply jointly for the renewal of the approval and the agreement process with the eCA. Furthermore, it describes the scenario in which more than one active substance/product-type combination approval needs to be renewed at the same time and gives an indication on the procedure to follow for amending the harmonised classification and labelling.
The European Commission may extend the validity of the approval if it is needed to carry out the examination of the renewal of approval, and conclude whether or not the conditions for approval are still met.
Submission of intentions to renew an approval
To facilitate cooperation between different companies sharing an interest in supporting the renewal of the same active substance, ECHA makes a public list of intentions available. This list also indicates the evaluating competent authority (eCA) for the active substance, which will assess the application for renewing the active substance.
The list of intentions will also help ECHA and the eCAs to plan resources and eCAs to organise pre-submission meetings with potential applicants (e.g. to discuss the data requirements or specific issues).
Companies are requested to express their intention to renew the active substance approval to ECHA at least one year before the legal deadline for submitting the application for renewal by using the available form.