Chemical name: tetramethylthiuram disulfide or bis( dimethylthiocarbamoyl) disulfide bis( dimethylthiocarbamoyl) disulfide tetramethylthiuram disulfide or bis( dimethylthiocarbamoyl) disulfide Final regulatory action has been taken for the category: Pesticide Final regulatory action: The chemical is Banned Use or uses prohibited by the final regulatory action: All applications as a plant protection product Pesticide use or uses that remain allowed: Not relevant. The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: It is prohibited to place on the market or use plant protection products containing the active substance thiram because thiram is not approved as active substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market. EU Member States had to withdraw all authorisations for plant protection products containing thiram as active substance by 30 January 2019 at the latest. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing thiram is prohibited as of 1 May 2019. Placing on the market and use of seeds treated with plant protection products containing thiram is prohibited as of 31 January 2020. The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: In conclusion from the assessments made on the basis of the submitted information, no plant protection products containing thiram is expected to satisfy in general the requirements laid down in Article 29(1) of Regulation (EC) No 1107/2009 and the uniform principles laid down in Regulation (EU) No 546/2011. According to the evaluation related to human health the following concerns were identified: -A high dietary risk was identified for mammals The information available was insufficient to satisfy the requirements set out in Article 4(1) to (3) of Regulation (EC) No 1107/2009. In more detail: -The consumer risk assessment through dietary intake cannot be finalised for the products of plant origin considering the outstanding data to finalise the residue definitions in primary and rotational crops and in processed commodities. Furthermore and considering the agreed toxicological reference values for thiram and the complete residue datasets on thiram for apple, pear and strawberry, an acute dietary intake concern for the consumers was identified for these representative uses. -The consumer risk assessment from the consumption of drinking water could not be finalised, while a complete evaluation of the information to address the effect of water treatment processes on the nature of the residues that might be present in surface water, when surface water is abstracted for drinking water was not available, noting that the applicant has indicated that the hazardous compound NDMA has the potential to be formed if thiram or DMCS are present in the raw water treated. -During the pesticides peer review, the experts proposed the classification for thiram as Carcinogen category 2 but not as reproductive toxicant, in accordance with the provisions of Regulation (EC) No 1272/2008, and therefore the conditions of the interim provisions of Annex II, Point 3.6.5 of Regulation (EC) No 1107/2009 concerning human health for the consideration of endocrine disrupting properties are not met. However, on the basis of the available data and current knowledge (EFSA Scientific Committee, 2013), the endocrine disrupting potential of thiram could not be concluded. Expected effect of the final regulatory action in relation to human health: Reduction of risk for human health from the use of plant protection products containing thiram. Summary of known hazards and risks to the environment: In conclusion from the assessments made on the basis of the submitted information, no plant protection products containing thiram is expected to satisfy in general the requirements laid down in Article 29(1) of Regulation (EC) No 1107/2009 and the uniform principles laid down in Regulation (EU) No 546/2011. According to the evaluation related to environment the following concerns were identified: -A high dietary risk was identified for birds and mammals Expected effect of the final regulatory action in relation to the environment: Reduction of risk for the environment from the use of plant protection products containing thiram. Date of entry into force of the final regulatory action: 09/10/2018 Entry into force of provisions of Commission Implementing Regulation (EU) No 2018/1500 of 9 October 2018 concerning the non-renewal of approval of the active substance thiram, in accordance with Regulation (EC) No 1107/2009 was by 29 October 2018. Entry into force of provisions of Commission Implementing Regulation (EU) No 2018/1500 of 9 October 2018 concerning the prohibition of the use and sale of seeds treated with plant protection products containing thiram, in accordance with Regulation (EC) No 1107/2009 was by 31 January 2020. |