Vali CONSULTING GmbH

๐๐ž๐ฐ ๐Œ๐š๐ง๐๐š๐ญ๐จ๐ซ๐ฒ ๐ƒ๐†๐– ๐‘๐ž๐ช๐ฎ๐ข๐ซ๐ž๐ฆ๐ž๐ง๐ญ๐ฌ ๐Ÿ๐ซ๐จ๐ฆ ๐€๐ฉ๐ซ๐ข๐ฅ

From April onward, ๐ƒ๐†๐– (๐ƒ๐ซ๐ข๐ง๐ค๐ข๐ง๐  ๐–๐š๐ญ๐ž๐ซ ๐†๐ฎ๐ข๐๐ž๐ฅ๐ข๐ง๐ž/๐†๐จ๐š๐ฅ) ๐š๐ฌ๐ฌ๐ž๐ฌ๐ฌ๐ฆ๐ž๐ง๐ญ๐ฌ ๐›๐ž๐œ๐จ๐ฆ๐ž ๐ฆ๐š๐ง๐๐š๐ญ๐จ๐ซ๐ฒ in EU authorization dossiers for ๐›๐ข๐จ๐œ๐ข๐๐ž๐ฌ ๐š๐ง๐ ๐ฉ๐ฅ๐š๐ง๐ญ ๐ฉ๐ซ๐จ๐ญ๐ž๐œ๐ญ๐ข๐จ๐ง ๐ฉ๐ซ๐จ๐๐ฎ๐œ๐ญ๐ฌ. This shift fundamentally changes how we assess metabolites, transformation products, and drinkingโ€‘water exposure.

Official DWG information:https://food.ec.europa.eu/system/files/2024-10/pesticides_ppp_app-proc_guide_dwg.pdf (food.ec.europa.eu in Bing)

Regulators will now expect ๐Ÿ๐ฎ๐ฅ๐ฅ ๐ƒ๐†๐–โ€‘๐›๐š๐ฌ๐ž๐ ๐ž๐ฏ๐š๐ฅ๐ฎ๐š๐ญ๐ข๐จ๐ง๐ฌ  for all relevant metabolites, including those formed during ๐ฐ๐š๐ญ๐ž๐ซ ๐ญ๐ซ๐ž๐š๐ญ๐ฆ๐ž๐ง๐ญ ๐ฉ๐ซ๐จ๐œ๐ž๐ฌ๐ฌ๐ž๐ฌ  such as chlorination, ozonation, and activated carbon filtration. The longโ€‘standing โ€œ0.1 ยตg/Lโ€ default is no longer sufficient on its own.

๐ƒ๐จ๐ฌ๐ฌ๐ข๐ž๐ซ ๐จ๐ฐ๐ง๐ž๐ซ๐ฌ:

  • You must provide ๐œ๐จ๐ฆ๐ฉ๐ฅ๐ž๐ญ๐ž ๐ƒ๐†๐– ๐š๐ฌ๐ฌ๐ž๐ฌ๐ฌ๐ฆ๐ž๐ง๐ญ๐ฌย for parent compounds and all relevant metabolites.
  • ๐–๐š๐ญ๐ž๐ซ ๐ญ๐ซ๐ž๐š๐ญ๐ฆ๐ž๐ง๐ญ ๐ฌ๐ญ๐ฎ๐๐ข๐ž๐ฌ become essential. Missing data will render dossiers incomplete.
  • ๐“๐จ๐ฑ๐ข๐œ๐จ๐ฅ๐จ๐ ๐ข๐œ๐š๐ฅ ๐ž๐ฏ๐š๐ฅ๐ฎ๐š๐ญ๐ข๐จ๐ง๐ฌ of transformation products are now unavoidable.
  • Ongoing renewals may face ๐š๐๐๐ข๐ญ๐ข๐จ๐ง๐š๐ฅ ๐๐š๐ญ๐š ๐ซ๐ž๐ช๐ฎ๐ž๐ฌ๐ญ๐ฌ, new ๐ซ๐ข๐ฌ๐คโ€‘๐ฆ๐ข๐ญ๐ข๐ ๐š๐ญ๐ข๐จ๐ง ๐ฆ๐ž๐š๐ฌ๐ฎ๐ซ๐ž๐ฌ, or even ๐ฎ๐ฌ๐ž ๐ซ๐ž๐ฌ๐ญ๐ซ๐ข๐œ๐ญ๐ข๐จ๐ง๐ฌย if DGW criteria are not met.

๐ˆ๐Ÿ ๐ฒ๐จ๐ฎ ๐š๐ซ๐ž ๐ฉ๐ซ๐ž๐ฉ๐š๐ซ๐ข๐ง๐  ๐š ๐๐จ๐ฌ๐ฌ๐ข๐ž๐ซ ๐ข๐ง ๐Ÿ๐ŸŽ๐Ÿ๐Ÿ”, ๐ญ๐ก๐ข๐ฌ ๐ข๐ฌ ๐ฒ๐จ๐ฎ๐ซ ๐œ๐š๐ฅ๐ฅ ๐ญ๐จ ๐š๐œ๐ญ๐ข๐จ๐ง.Reassess your ๐ฆ๐ž๐ญ๐š๐›๐จ๐ฅ๐ข๐ญ๐ž ๐ซ๐ž๐ฅ๐ž๐ฏ๐š๐ง๐œ๐ž ๐ฌ๐ญ๐ซ๐š๐ญ๐ž๐ ๐ฒ. Confirm whether ๐ฐ๐š๐ญ๐ž๐ซ ๐ญ๐ซ๐ž๐š๐ญ๐ฆ๐ž๐ง๐ญ ๐ญ๐ซ๐š๐ง๐ฌ๐Ÿ๐จ๐ซ๐ฆ๐š๐ญ๐ข๐จ๐ง has been fully evaluated. And update your ๐ž๐ฑ๐ฉ๐จ๐ฌ๐ฎ๐ซ๐ž ๐ฆ๐จ๐๐ž๐ฅ๐ฌ and ๐ญ๐จ๐ฑ๐ข๐œ๐จ๐ฅ๐จ๐ ๐ข๐œ๐š๐ฅ ๐ฉ๐š๐œ๐ค๐š๐ ๐ž๐ฌ accordingly.

The deadline is approaching quickly, and dossiers submitted without DGWโ€‘compliant data will face delays or regulatory pushback.

At @ibacon GmbH, @Vali Consulting and @LabAnalysis Life Science we support you in navigating these new requirements, from study design to regulatory strategy.

๐Ÿ“„ ๐–๐š๐ง๐ญ ๐ญ๐จ ๐ฅ๐ž๐š๐ซ๐ง ๐ฆ๐จ๐ซ๐ž?
Download our white paper for a detailed overview of the DGW framework and practical guidance: (https://www.ibacon.com/news/current-insights/water-treatment-transformation-products-what-new-eu-guidance-means)

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