The legislation concerning the placing of PPPs on the European single market is enshrined in Regulation (EC) No. 1107/2009, with the specific data requirements for ASs and PPPs contained in Regulations (EU) No. 283/2013 and No. 284/2013. The authorization of ASs generally expires after ten years. To enable continued marketing and sales of PPPs, a renewal of authorization of the ASs must be sought. This renewal procedure is covered by Commission implementing Regulation (EU) No. 844/2012 and is a European-level process.
Article 43 of Regulation (EC) No. 1107/2009 also provides the framework for the renewal of PPPs following the re-approval of an AS. This process is further elaborated on in a European Commission guidance document. The renewal of PPPs is the responsibility of the individual European Member States.
The programs for renewal of ASs in the EU are known as the AIR (Annex I Renewal) programs. ASs are assigned to a program, group and/or batch, based on their expiration dates and level of priority, in order to manage and spread the workload of the renewal process. The AIR programs also assign each AS a ‘Rapporteur Member State’ (RMS) to undertake the task of evaluating the renewal application.
There are four AIR programs, as outlined in the table below.
Timelines and Extensions
For the current AIR4 substances, applicants must apply for renewal three years before the expiration date of an approved AS. Article 17 of Regulation 1107/2009 allows for extensions to the expiration dates of ASs, where it would not be possible to take a decision before the curret expiration date, for reasons beyond the control of the applicant.
The main reasons these extensions are required are:
- delays in assessment
- delays in decision-making – this is true for highly complex cases
- facilitation of the review through the Member States by balancing capacity – this is the case for AIR4.
The AIR Renewal Process
- Application (36 months before expiration)
Registrants submit an application containing limited information to indicate their intent of submitting a dossier to pursue active substance renewal.
2. Application review
RMS conducts admissibility check. Registrant must respond within 14 days to calls for missing information.
3. Submission (30 months before expiration)
Registrants create and submit a renewal dossier. For most ASs, the dossier must be submitted 6 months post application. For AIR4, some groups’ expiration dates have been extended by 1 to 3 years to allow more time for dossier submission.
4. RAR evaluation (RAR issued 12 months post submission)
RMS conducts an initial review check; registrants must respond to any data requests within 14 days. A draft Renewal Assessment Report (RAR) is issued 12 months after dossier submission. Requests for additional information may be made.
5. Peer-review (Review 8.5 – 11 months)
The RAR is passed to the European Food Safety Authority for publication and consultation.
6. Renewal decision (~9 months duration)
The final decision is made by a vote of the Standing Committee on the Food Chain and Animal Health. Renewal is officially adopted by the Commission and the results are published.
Other Important Elements of EU AS Review
Literature review: Covance has access to a number of free and subscription databases, allowing for a comprehensive literature search that meets the criteria in the EFSA Guidance. A tiered approach is taken in order to identify those papers that are both relevant and reliable and so merit inclusion and consideration of the results in the renewal dossier.
Harmonized classification and labeling (CLH) of ASs are the responsibility of the European Chemicals Agency (ECHA). Covance is able to prepare dossiers (including IUCLID technical dossiers) for CLH under Regulation (EC) No. 1272/2008 (CLP Regulation), prepare expert statements on technical and scientific issues regarding toxicity of ASs and support customers at ECHA risk assessment committee meetings.
Maximum residue levels (MRLs): It is important to have appropriate MRLs (and/or import tolerances [ITs]) in place for all uses, not just the representative uses included in the renewal dossier. MRL application and setting is covered by Regulation (EC) No. 396/2005. Covance is able to prepare the specific addendum to the renewal dossier if new or amended MRLs/ITs are required.
Everywhere you go, crop protection businesses face an ever-changing commercial and regulatory landscape. But with a good CRO in place, you can supercharge your time-to-market.
The final blog in the series “The Simple Steps to Successful Active Substance Renewal” provides practical advice to tackle the renewal process.
To learn more about “Preserving lifecycles: renewing existing plant protection active substances” download this informative e-book.
About the author
Gary started his career at Covance in 1985 and is currently the Business Lead Consultant for Crop Protection. As business lead, Gary provides regulatory advice to Covance’s clients to ensure their programs of work and applications for active substance approval or product registration meet the highest possible scientific and regulatory standards set by global authorities.
Covance provides essential research services, models and products for pharmaceutical, crop protection, and chemical companies, as well as universities, governments, and other research organizations. For more information about Covance’s regulatory services for crop protection, click here.