1 / 12

Generic guidelines & procedures for the technical reviews of dossiers of new substances

Generic guidelines & procedures for the technical reviews of dossiers of new substances Leena Ylä-Mononen European Commission - DG Environment Unit C.4 Biotechnology and Pesticides UNECE CLRTAP Task Force on POPs 1-3 March 2004, The Hague. « Marching order » and timing.

drea
Download Presentation

Generic guidelines & procedures for the technical reviews of dossiers of new substances

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Generic guidelines & procedures for the technical reviews of dossiers of new substances Leena Ylä-Mononen European Commission - DG Environment Unit C.4 Biotechnology and Pesticides UNECE CLRTAP Task Force on POPs 1-3 March 2004, The Hague

  2. « Marching order » and timing • A Party / several Parties together submit a proposal • EB decides: • Whether the risk profile is acceptable • Whether further consideration is warranted • If yes, to mandate the POP Task Force to conduct one or more technical reviews • Task Force on POPs conducts reviews and submits a report in writing to WGSR • EB completes the evaluation of the proposal

  3. Requirements for the proposal • A Party / several Parties together submit a proposal (EB Decision 1998/2, para 1) • Content: • Risk profile (« comprehensive review of the scientific information … to provide suitable information for the assessment of risks associated with LRTAP» • Summary report (to include data on production, uses, emissions, socio-economic factors related to alternatives etc.)

  4. Requirements for the proposal QUESTION 1: HOW THE PROPOSING PARTY CAN ENSURE THE SMOOTH HANDLING OF THE PROPOSAL? Timing? Content? Pre-work? Consultation in advance?

  5. EB decision I EB decides: • Whether the risk profile is acceptable • Need to agree on minimum requirements • Whether further consideration is warranted • Need to agree on general lines in the cases of e.g. proposals on « dead chemicals » and incomplete data • If yes, to mandate the POP Task Force to conduct one or more technical reviews • Risk assessment; socio-economic assessment

  6. EB Decision I Question 2: HOW COMPREHENSIVE THE RISK PROFILE HAS TO BE IN ORDER TO BE ACCEPTED BY THE EB ? What is the role of the Task Force? To give general recommendations? Request for submission of relevant information prior to the EB Meeting?

  7. EB Decision I QUESTION 3: WHEN FURTHER ACTION WOULD NOT BE WARRANTED? What is the role of the Task Force? To give general recommendations?

  8. TASK FORCE ON POPS Tasks: • Conducts one or several technical reviews on a proposal as mandated by the EB • Submits a report in writing to WGSR

  9. TASK FORCE ON POPS • QUESTIONS…: • Is a Lead country approach appropriate? Could a Party who has proposed the substance act as a Lead? • Role of the Secretariat? • Comments by whome and when? Role of questionnaires? • Collection of additional information? • How to tackle borderline questions, cases with conflicting or missing data?

  10. TASK FORCE ON POPS • … QUESTIONS: • Time lines for concluding a review? • Several parallel reviews – possibilities for prioritisation of the work? • When to invite experts? • Role of observers in the meetings? • Written procedures? • Possible conflict of interest situations? • How to handle confidential data?

  11. EB Decision II • EB completes the evaluation of the proposal after having received the technical reviews from the WGSR together with a draft decision • Will there be a new commenting round, if necessary (e.g. if data is regarded insufficient for the ultimate decision making or there are conflicting views?)

  12. Timing problems • EB meets only once a year • Documents to be submitted 90 days before the EB meeting • Task Force reports to WGSR – dead line 90 days before the meeting • Time for collecting comments on the proposal and the reviews scarce • Risk of delays in the procedure

More Related