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How to get ready for the EU Transparency Regulation

December 18, 2020

What will the requirement to use IUCLID (the International Uniform Chemical Information Database) mean for the crop protection industry? And how can you prepare? Keep reading for expert tips from our team.

Transparency Regulation requirements

The EU Transparency Regulation (2019/1381) comes into effect on 27 March 2021, with the stated objective to improve the quality and transparency of risk assessment in the food chain. As part of this development, a transition to the IUCLID platform will now be applicable for two key processes associated with plant protection:

  • Submission and management of active substance dossiers (Regulation (EC) No 1107/2009)
  • Maximum residue limit (MRL) and import tolerance (IT) applications (Regulation (EC) No 396/2005)

EU support for using IUCLID

IUCLID is a sizeable software tool, with multiple fields, templates and its own terminologies. New or occasional users may find it daunting. General support is available via the dedicated IUCLID website and further more dedicated targeted support will be available in 2021 from EFSA and the European Commission to aid the transition:

  • Webinars and video tutorials on the Transparency Regulation implementation tools including IUCLID
  • An IUCLID user manual for plant protection submissions
  • The ‘IUCLID HYPERCARE Programme’, which will run throughout 2021, to support initial 2021 scheduled submissions of active substance renewal dossiers in IUCLID

Key requirements of the Transparency Regulation

Companies will need to submit existing and new active substance datasets and representative product datasets via IUCLID.

Initially, we anticipate that dossier submissions will take a Minimum Viable Product approach. We also expect Rapporteur Members States to at least initially require submissions to include the existing largely OECD dossier format (plus CADDY where required) in addition to the IUCLID submission. This will mean a duplication of effort.

There is some uncertainty surrounding how all the risk assessments contained in Plant Protection Product (PPP) active substance dossiers on will be accommodated in IUCLID. The availability of OECD study summary Harmonised Templates (OHTs) for certain plant protection requirements study types is also unclear at present.

Next steps

Regular users – if your organisation is likely to use IUCLID frequently, make time for team members who will handle submissions and data entry to familiarise themselves with the platform. Download the software and start practicing, using the support provided in the user manuals and 2021 training webinars.

Occasional users – if you only expect to use IUCLID intermittently, it may not be cost-effective to invest time learning about it. The platform is continually developing and being updated , meaning you will have to get up-to-speed with functionality changes each time you make a submission or enter information. Instead of managing this in-house, it could be worth contracting a more experienced third party such as TSG to handle your IUCLID work.

IUCLID is linked to many other IT tools, such as REACH-IT which can perform automated checks on dossiers and extract information for dissemination. Knowing how this all works is important when preparing submissions to avoid unwanted surprises such as inadvertent dissemination of confidential information.

Support from TSG

Our regulatory experts routinely use IUCLID for Biocidal Products Regulation and REACH submissions. We hold core knowledge and expertise in the use and application of the software. We can advise on the transfer of dossiers to the IUCLID format and provide guidance on formatting requirements, as well as offering experienced support for the IUCLID platform.

Get in touch via [email protected] to learn more about TSG’s IUCLID services.