Algae related regulation & legislation

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algae:plant_protection

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algae:plant_protection [2026-09-13 22:02] – [Plant Protection Products] robertalgae:plant_protection [2026-09-13 22:07] (current) – [Level 1: Approval of the active substance at EU level] robert
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 === Low-risk active substances and basic substances === === Low-risk active substances and basic substances ===
  
-Regulation (EC) No 1107/2009 contains two provisions relevant to algae-derived PPPs that offer a lighter pathway:+Regulation (EC) No 1107/2009 [[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009R1107-20221121|EURlex]] contains two provisions relevant to algae-derived PPPs that offer a lighter pathway:
  
   * __Low-risk active substances__ (Article 22): substances that pose a low risk to human health, animal health and the environment may be approved with reduced data requirements and faster timelines. To qualify, the substance must be non-toxic, non-mutagenic and not a persistent organic pollutant, among other criteria. Several algae-derived substances could potentially qualify, but approval still requires a full application to EFSA.   * __Low-risk active substances__ (Article 22): substances that pose a low risk to human health, animal health and the environment may be approved with reduced data requirements and faster timelines. To qualify, the substance must be non-toxic, non-mutagenic and not a persistent organic pollutant, among other criteria. Several algae-derived substances could potentially qualify, but approval still requires a full application to EFSA.
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 Before any PPP containing an algae-derived active substance can be authorised in any member state, the active substance itself must be approved at EU level. The procedure: Before any PPP containing an algae-derived active substance can be authorised in any member state, the active substance itself must be approved at EU level. The procedure:
  
-  1. Applicant submits a complete dossier (including identity, physical/chemical properties, efficacy data, toxicological studies, ecotoxicological studies, environmental fate and behaviour, residue data in crops, and analytical methods) to a Rapporteur Member State and to EFSA. +  -   Applicant submits a complete dossier (including identity, physical/chemical properties, efficacy data, toxicological studies, ecotoxicological studies, environmental fate and behaviour, residue data in crops, and analytical methods) to a Rapporteur Member State and to EFSA. 
-  2. The Rapporteur Member State prepares a Draft Assessment Report (DAR). +  -   The Rapporteur Member State prepares a Draft Assessment Report (DAR). 
-  3. EFSA conducts a peer review of the DAR, including a public consultation. +  -   EFSA conducts a peer review of the DAR, including a public consultation. 
-  4. EFSA issues a conclusion on the active substance. +  -   EFSA issues a conclusion on the active substance. 
-  5. The European Commission adopts an implementing regulation approving or not approving the active substance, with specified conditions of use.+  -   The European Commission adopts an implementing regulation approving or not approving the active substance, with specified conditions of use.
  
 This process takes a minimum of 3–5 years and costs several million euros in study generation and application fees for conventional chemistry. For biological substances (including algae-derived materials), data requirements may be somewhat reduced — particularly for toxicological endpoints where a long history of safe use can substitute for some animal studies — but the fundamental structure of the dossier remains the same. This process takes a minimum of 3–5 years and costs several million euros in study generation and application fees for conventional chemistry. For biological substances (including algae-derived materials), data requirements may be somewhat reduced — particularly for toxicological endpoints where a long history of safe use can substitute for some animal studies — but the fundamental structure of the dossier remains the same.
algae/plant_protection.1789336964.txt.gz · Last modified: by robert