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Data requirements for safeners and synergists; work programme for the gradual review of safeners and synergists.

Food safety

Regulation (EC) No 1107/2009 mandates the approval of safeners and synergists within plant protection products for authorization. Article 25(1) of this Regulation requires that safeners and synergists meet the same data requirements as active substances, augmented by additional criteria. Furthermore, a systematic plan for the phased reassessment of safeners and synergists already in the market at the regulation's commencement should be initiated under Article 26 of that Regulation.

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Public consultation

ID: 13975

Lobbying Activity

6 responses

CropLife Europe Urges End to Double Regulation for Pesticide Additives

CropLife Europe, 18 Dec 2023

The group wants safeners treated as new substances for ten years of data protection. They also seek to end overlapping regulations requiring tests under multiple chemical laws. Finally, they suggest extending market access if the official approval process is delayed.
This would shield their research from competition while reducing their regulatory compliance burden.
Generic manufacturers lose the ability to compete until the ten-year data exclusivity expires.

PAN Europe urges faster safety reviews for pesticide additives

Pesticide Action Network Europe, 19 Dec 2023

PAN Europe calls for shortening the review period to three years and setting safety limits for food residues. They also demand the immediate withdrawal of products containing unapproved or unregistered additives.
Rapid removal of potentially harmful chemicals from the market strengthens the group's environmental protection mission.
Chemical manufacturers would lose revenue from products withdrawn without the proposed lengthy transition period.

Ecologistas en Accion Slams Delayed Review for Pesticide Additives

Ecologistas en Accion, 19 Dec 2023

The group demands a shorter review period for safeners and synergists currently on the market. They also call for setting Maximum Residue Levels for these substances in food.
This would accelerate stricter health protections by closing gaps in pesticide safety assessments.
Chemical manufacturers would face quicker product bans and increased data submission requirements.

Consultation response

PETA Science Consortium International e.V., 20 Dec 2023

The PETA Science Consortium International e.V. promotes robust non-animal testing methods that protect human health and the environment. We welcome the opportunity to comment on the initiative Plant protection products-data requirements and gradual review of safeners and synergists. Please find our…

Consultation response

Internationale Arbeitsgemeinschaft der Wasserwerke im Rheineinzugsgebiet, 19 Dec 2023

Comments on proposed legislation on Safeners and Synergists: Safeners and synergists are released into the environment just as active substances and therefore need to be as thoroughly assessed as active substances. PMT/vPvM criteria also need to be taken into account (cf. CLP Regulation). PFAS…

Consultation response

European Crop Care Association, 20 Dec 2023

ECCA wishes to comment that the draft Regulation is not in compliance with the requirements of Article 26 of Regulation (EU) No 1107/2009, since it does not include the establishment of measures to minimise animal testing, nor evaluation, assessment and decision-making procedures as required by…