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- Priešregistracinės informacijos sesijos
Priešregistracinės informacijos sesijos
Future applicants for authorisation may request a pre-submission information session with ECHA to clarify regulatory and procedural issues related to the authorisation application process.
Purpose and scope
The pre-submission information sessions aim to give future applicants for authorisation the opportunity to ask case-specific questions regarding the regulatory and procedural aspects of the authorisation application process.
In addition, the sessions aim to clarify critical elements for the public consultation on alternative substances or technologies. This will facilitate the development by ECHA of "broad information on uses" applied for, which in turn will contribute to streamlining the processing of the applications by reducing the number of clarification requests to applicants and third parties submitting information on alternatives during the 10-month opinion-making period specified in the REACH Regulation.
The purpose of the pre-submission information sessions is not to provide consulting services or advice on the preparation of applications or to pre-empt the evaluation of the conformity and the content of the application. The assessment of these elements of the application can only commence once ECHA is in receipt of the application for authorisation.
Requesting a pre-submission information session
Pre-submission information sessions should be held the latest six months before the planned submission of the application for authorisation. One such session is envisaged per application.
Applicants need to send the request for a pre-submission information session at least two months before the requested meeting date in order for ECHA to make the necessary arrangements and to ensure the availability of the necessary resources. The request for a pre-submission information session can be done together with the notification of intention to submit an application for authorisation.
After submitting the request, applicants will receive a PSIS request number. Any subsequent communication between the applicant and ECHA regarding the pre-submission information sessions needs to include a reference to this PSIS request number.
Based on the request, ECHA will contact the applicants to schedule the pre-submission information session at a mutually agreed date and time, taking into account the availability of the applicant and the representatives of the ECHA Secretariat. Pre-submission information sessions can be either in person (in ECHA's premises in Helsinki, Finland) or via a tele/video conference. Applicants should indicate their preference in their request.
Although efforts will be made to accommodate the preferences of the applicants, ECHA reserves the right to postpone or decline a request for a pre-submission information session, particularly in circumstances where the outlined timelines are not observed or due to limited availability of resources.
Documents for the session
Future applicants are requested to provide the following documents to facilitate the discussions:
- Information on uses applied for:
- detailed use name(s) (i.e., draft of the information that is to be included in the application in Section 3.10 of IUCLID)
- use descriptor system (i.e. draft information to be included in the application in Section 3.5 of IUCLID)
- information on the substance function, including tasks and conditions (i.e., draft of the information to be included in the application in the Analysis of Alternatives, Section 2. Analysis of Substance Function)
- exposure scenarios covering the use(s) of the Annex XIV substance (i.e., draft of the information to be included in the application in the Chemical Safety Report, Section 9. Exposure Assessment)
- "Broad Information on Uses": proposal for (non-confidential) information to be published on ECHA's website to launch a public consultation on alternatives once the application is received by ECHA.
- Use name, list of descriptors (including function), and key elements on the conditions of use
- Public version of exposure scenarios
- Draft public version of AoA
- Draft public summary of SP and SEA (if already available and relevant)
- List of applicant's specific and key questions (maximum 15) and any documentation that will provide the ECHA Secretariat with sufficient background to answer these questions.
- If relevant, documentary evidence supporting the eligibility for the Small and medium-sized enterprise (SME). During the PSIS it is possible to clarify whether a potential applicant would indeed be eligible for an SME fee reduction. See also SME verification pages.
This information will give ECHA the necessary minimum background regarding the scope of the future application, and will also enable ECHA to discuss with the applicants their proposed "broad information on uses". A well-defined "broad information on uses" will ensure the public consultation on alternatives is meaningful, effective, and will minimise the need for clarifying questions from the Committees on Risk Assessment and Socio-economic Analysis to the applicant and third parties submitting information.
For further details on "broad information on uses", read section 5.18.8 and 5.23 of the Data submission manual 22: How to prepare and submit an application for authorisation using IUCLID 5 See also - Publication of information on applications during the opinion-making process.
ECHA may agree as an exception to hold the pre-submission information session even if not all information is submitted. Applicants should send the relevant documents at least one month prior to the pre-submission information session.
These documents should be submitted using the applicant's PSIS request number via the following web form.
Applicants are asked to inform ECHA who will represent them in the session. ECHA will not cover the travel or other costs of these representatives to attend the session.
The applicants will be informed prior to the meeting who will represent ECHA.
The pre-submission information session is envisaged to take two and half hours:
- Brief presentation by the applicant (about 15 min)
- Response to applicant's questions (maximum 15) as outlined in the list of questions submitted to ECHA (about 1 hour)
- Discussion on Broad Information on Uses (about 30 min)
- Presentation by ECHA of key technical and procedural elements for applications for authorisation and concluding remarks (about 30 min)
The applicant will be responsible for taking brief meeting minutes, containing key conclusions of the meeting. The minutes need to be provided to ECHA within two weeks of the pre-submission information session. ECHA will subsequently review the minutes and agree on their final (amended) content with the applicant. The purpose of the meeting minutes is to ensure a mutual understanding of the conclusions of the pre-submission information session.
The pre-submission information session will not prejudice the outcome of the actual processing of applications for authorisation or the positions taken by the responsible ECHA committees on the issues discussed in their opinions.
ECHA does not accept any liability with regard to the contents of this web page. In order to correct any errors or inaccuracies that may appear in the text or if otherwise necessary, ECHA is entitled to modify or revise the information at any time.
Please note that the above mentioned information applies only in the context of the pre-submission information sessions. It does not create or alter any existing rights or obligations as set out in the Treaty on the Functioning of the European Union, the REACH or the Fee Regulations as amended. Nor does it alter the relevant Commission's interpretative notices or ECHA guidance documents.
Request a pre-submission information session no later than eights months before the planned submission of your application.
Send the request for a pre-submission information at least two months before the requested meeting date.
Upload and send the relevant documents at least one month prior to the pre-submission information session.
Your intended submission is 19 Nov - 3 Dec 2012:
- request a pre-submission information session by March 2012
- send relevant documents by April 2012
- hold the session in May 2012.