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Plant protection products containing Propineb will withdraw from EU market Featured

On 1 March 2018, a decision concerning the non-renewal of approval of the active substance Propineb was published on Official Journal of the European Union which has been come into force recently.

According to this decision, Propineb has been removed from the approved active substance checklist (EU) No 540/2011. For plant protection products containing Propineb, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 22 June 2019.

During the evaluation, the information available indicates that the approval criteria as set out in Article 4(1) to (3) of Regulation (EC) No 1107/2009 are not satisfied as it cannot be concluded whether the residues of the plant protection products consequent on application consistent with good plant protection practice and having regard to realistic conditions of use shall not have any harmful effects on human health including that of vulnerable groups or animal health;

The information available is insufficient to satisfy the requirements set out in Article 4(1) to (3) of Regulation (EC) No 1107/2009, in particular with regard to:

· the consumers risk assessment cannot be conducted for the missing data on the magnitude of different compounds included in the plant residue definition for risk assessment, to address the toxicity of the metabolite propane - 1,2 - diamine (PDA) and to perform a comprehensive livestock exposure assessment;

· the impact on non-target species, as it could not be excluded an unacceptable risk for honeybee brood.

Additionally, EFSA concludes propineb has potential endocrine disrupting properties related to the hazards of its major metabolite 4-methylimidazolidine-2-thione (PTU). PTU has endocrinemediated adverse effects on the thyroid and is classified in accordance with Regulation (EC) No 1272/2008 as Reprotoxic cat 2, H361d suspected of damaging the unborn child.

In summary, the approval of propineb in accordance with Regulation (EC) No 1107/2009 should therefore not be renewed.

Besides, endocrine disrupters have attracted more and more attention from regulatory specialists, toxicologists as well as pesticides manufacturers in the industry. Early in December, 2017, EFSA and ECHA published a draft guidance on evaluation of endocrine disrupters and conducted public consultation under EU BPR regulation and PPP regulation. Now this guidance under BPR regulation has been in effect, and it is expected to come into force under the PPP regulation in the near future.

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