Revised EU Data Rules Set to Reshape Active Substance Approvals for Plant Protection Products
The EU is updating data requirements for active substances in plant protection products, raising safety standards and regulatory expectations.
The European Commission has recently announced an extension of the approval periods for several active substances used in plant protection products. This decision, in line with Regulation (EC) No 1107/2009, is a response to the need for comprehensive risk assessments and regulatory compliance in the agricultural sector. The regulation will enter into force on 12th December 2023.
Key substances such as 2-phenylphenol, dicamba, and sulphur are among those with extended approval periods, varying from 12 to 49.5 months. This extension is crucial for manufacturers and farmers, allowing the continued use of these substances while awaiting further assessment from the European Food Safety Authority (EFSA).
The regulation also addresses substances like 8-hydroxyquinoline, classified as toxic for reproduction category 1B, ensuring alignment with current safety standards.
| Row Number | Substance | Expiration Date |
|---|---|---|
| 169 | Amidosulfuron | 15 August 2025 |
| 170 | Nicosulfuron | 31 March 2027 |
| 172 | Dicamba | 31 March 2027 |
| 173 | Difenoconazole | 15 March 2026 |
| 176 | Lenacil | 15 August 2025 |
| 178 | Picloram | 15 February 2028 |
| 180 | Bifenox | 31 March 2027 |
| 181 | Diflufenican | 15 January 2026 |
| 182 | Fenoxaprop-P | 15 August 2025 |
| 183 | Fenpropidin | 15 May 2027 |
| 284 | Dimethachlor | 15 October 2026 |
| 285 | Etofenprox | 31 March 2027 |
| 287 | Penconazole | 15 October 2026 |
| 288 | Tri-allate | 31 March 2027 |
| 292 | Sulphur | 15 April 2025 |
| 293 | Tetraconazole | 31 March 2027 |
| 294 | Paraffin oils | 31 March 2027 |
| 295 | Paraffin oil | 15 August 2025 |
| 299 | 2-phenylphenol (incl. its salts such as sodium salt) | 15 November 2027 |
| 310 | Napropamide | 31 March 2027 |
| 6 (Part B) | Prohexadione | 31 May 2026 |
| 7 (Part B) | Spiroxamine | 31 May 2026 |
| 12 (Part B) | 1-naphthylacetamide | 31 May 2026 |
| 13 (Part B) | 1-naphthylacetic acid | 31 May 2026 |
| 15 (Part B) | Fluazifop P | 31 May 2026 |
| 18 (Part B) | 8-hydroxyquinoline | 31 December 2024 |
| 25 (Part B) | Fenpyrazamine | 31 May 2026 |
| 2 (Part E) | Esfenvalerate | 31 May 2026 |
Stakeholders are advised to monitor these changes closely and ensure compliance with the new timelines. Foresight offers solutions for regulatory compliance and risk management to assist in navigating these updates.
For more detailed analysis and industry insights, stay tuned to Signal, your go-to source for chemicals legislation news.
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