1107 Vademecum 2020
The working life of European pesticides regulatory professionals is running at a different pace, in a changed world dominated by the corona virus. Most people are working from their home offices: industry, Commission, EFSA and Regulatory competent authorities alike. Yet, there are 47 new substances under evaluation, and the renewal programme continues with hundreds of substances being reviewed under Regulation 1107/2009 and (re-)classified under the CLP Regulation.
In addition to the continuing operational work under the Regulation, the corona crisis has not stopped the new Commission from critically reviewing the functioning of existing legislation and developing new strategies: on 20 May the REFIT report, the Sustainable Use report, the Farm to Fork Strategy and the Biodiversity Strategy were published.
The Farm to Fork Strategy and the Biodiversity Strategy announce that “the Commission will take additional action to reduce the overall use and risk of chemical pesticides by 50% and the use of more hazardous pesticides by 50% by 2030“. How the use will be measured, or how the risk will be quantified..? This will have to be worked out in the months and years ahead. In all the upcoming debate, the 7th edition of the 1107 Vademecum will be your reference point. Whether it is today’s implementation of the European pesticides legislation, or the development of tomorrow’s rules and regulations, the 1107 Vademecum provides all the background information, plus the annotated legal texts of:
- Regulation 1107/2009,
- the Renewal Regulation (844/2012),
- the Residues Regulation,
- the Sustainable Use Directive,
- the Pesticides Statistics Regulation, and
- the (relevant parts of) the General Food Law ( including the new transparency rules)
The General Food Law was recently updated with the “Transparency Regulation”. In spite of the Corona crisis, EFSA is now working hard to develop all the “practical arrangements”, and to be ready by 27 March 2021 to apply all the new rules. The notification of new studies as soon as they are commissioned, new consultation rounds on planned studies and on submitted reports, electronic dossier transfer, new arrangements for access to documents: with the new 1107 Vademecum you have all the relevant sections of the amended General Food Law at hand during Stakeholder Meetings, Technical Expert Meetings and workshops during 2020.
What can you find in the 7th edition of the 1107 Vademecum?
Regulation 1107/2009
The 2020 edition of the 1107 Vademecum contains as always the complete text of the Regulation, with footnotes guiding you to all new and updated Guidance Documents, with editorial notes, and with the latest amendments (Fertiliser Regulation, Transparency Regulation).
In the 7th edition of the 1107 Vademecum you will find:
- the European decision process explained, the voting system (with the consequences of Brexit) and the comitology rules; the Member State “weights” in the voting process in 2020, the role of Commission, Council and Parliament.
detailed descriptions of the timelines for the approval and renewal processes, as well as the timelines for classification of substances.- Explanation of the document structure of
- dossiers,
- assessment reports,
- EFSA peer review
- EFSA Conclusions, and
- Review/Renewal reports,
and explains where and how the different documents can be found on the different websites and databases.
- The Review Programme (“AIR process”), and the renewal procedures, with the complete text of Regulation 844/2012, amended with the “CLP amendment”, with new timelines for applicant, RMS and EFSA, and the “glyphosate amendment” (introduction of the “group of memberstates” acting as RMS). Description of the “stop-the-clock” process for the identification of endocrine properties of substances already in the review process;
- The Residues Regulation: the complete text of Regulation 396/2005, description of procedures of MRL and import tolerance setting
PIC Regulation: The number of non-approved substances keeps growing, and so does the list of substances subject to the “PIC Regulation”. For companies importing or exporting substances that are (EU-) PIC-listed, the 1107 Vademecum provides an overview of the procedures and an overview of all substances for which specific legal obligations apply.- Classification: explanation of the process of notifying intentions to classify, the submission of CLH reports, the evaluation by the RAC Committee, and the adoption of new classifications, through ATPs to the CLP Regulation. A complete overview of the different hazard classes, with corresponding danger symbols and H & P phrases.
- Guidance Documents: schematic overviews of the current Guidance Documents, split between Procedural Guidance Documents arranged by the corresponding articles of the Regulation, Technical Guidance Documents arranged by section of the dossier, and Residue
Guidance Documents. In a separate section all Guidance Documents are listed, sorted by the initial year of publication (as found in the Guidance Document number), with short explanation of the content, and cross-reference to related Guidance Documents and external Guidance (EPPO, OECD) - Overview tables:
- the status of each pending or approved substance in one table, with references to application and submission deadlines, dates of Assessment Reports, public consultations, and all published EFSA peer review report, allowing you to estimate for any substance the remaining time until a decision for renewal. Information on the different steps in the process of classification will give further insight in the future prospects of each substance. And new in the 2019 edition: you can now see which companies are involved directly in the approval or renewal process, either individually or in task forces.
- Grouping of substances: Major groups, categories and chemical classes of substances according to the Statistics Regulation.
- CLP table, with an overview of the different stages of classification, including EFSA’s proposals. The table provides insight in the current (proposed) classification and on-going evaluations, proposals for changes in classification, and differences between EFSA proposals, CLH proposals, and RAC opinions.
- the status of each pending or approved substance in one table, with references to application and submission deadlines, dates of Assessment Reports, public consultations, and all published EFSA peer review report, allowing you to estimate for any substance the remaining time until a decision for renewal. Information on the different steps in the process of classification will give further insight in the future prospects of each substance. And new in the 2019 edition: you can now see which companies are involved directly in the approval or renewal process, either individually or in task forces.
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For only €30.00 (ex. VAT), you can have half a kilo of regulatory knowhow on your desk. It will save you many hours of searching for information!
Submit the completed order form, and your 1107 Vademecum will be on its way within 2 working days.