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Beetamine Ban June 27, 2019, the European Union issued an official announcement (EU) 2019/1100, decided not to approve the re-evaluation application of the active substance beetamine (desmedipham), while revising the active substance approval list (EU) No 540/2011.
announcement will take effect on June 30, 2019.
the announcement, EU member states should revoke all beetamine-containing product authorizations by 1 January 2020 at the latest.
same time, under article 46 of the European Union Regulation (EC) No 1107/2009, there is a six-month grace period for preparation products containing beetamine, which should expire by 1 July 2020.
1-Methyl cyclopropylene re-evaluation was approved on June 25, 2019, the European Union issued an official announcement (EU) 2019/1085 approving the re-evaluation application of the active substance 1-methylcyclopropene (1-methylcyclopropene, 1-MCP).
also revise the Active Substances Approval List (EU) No 540/2011, which will take effect on 15 July 2019.
is valid from 1 August 2019 to 31 July 2034.
In accordance with this announcement, newly submitted data from this re-review show that the ADI value of 1-MCP (daily allowable intake) has significantly increased and no longer meets the conditions for candidate alternative substances and should therefore be removed from the list of candidate alternatives.
noteworthy that the original drug specification for approval in this re-evaluation has been increased from 960 g/kg previously to 980 g/kg.
associated impurities have not increased, but the limits for related impurities 1-chloro-2-methylpropene and 3-chloro-2-methylpropene have been changed to 0.2 g/kg from the previous 0.5g/kg.
addition, this re-evaluation, Janssen Pharmaceuticals submitted in-place production of 1-MCP files, ethyl propane and methyl cyclohexane as related impurities, the content should be less than 10%.
requirements of Chapter 43 of the EU Pesticide Regulation, product authorization applications may be submitted within 3 months of formal approval (November 1, 2019).
on June 27, 2019, the European Union issued an official announcement (EU) 2019/1101, deciding to approve the re-evaluation application for the active substance methyl lysate (tolclofos-methyl), but only for ornamental plants and potatoes.
approved product specifications are 960g/kg and the associated impurities are methanol, limited to 1 g/kg.
also revise the Active Substances Approval List (EU) No 540/2011, which will take effect on 18 July 2019.
is valid from 1 September 2019 to 31 August 2034.
was approved under the old EU Plant Protection Product Regulation (Directive 91/414/EEC) and this re-evaluation was conducted under the new Regulation (EC) No 1107/2009.
re-evaluation process, consumer risk assessment could not be carried out due to the lack of data on representative use dates, and studies have shown that metabolites of the substance are potentially at risk to aquatic organisms and wild mammals.
, the EFSA argues that only ornamental plants and potatoes are used in accordance with the approval requirements under the new regulations.
the requirements of Chapter 43 of the EU Pesticide Regulation, preparation products for ornamental plants and potatoes may be submitted within 3 months of formal approval (1 December 2019).
addition, registration for purposes other than ornamental plants and potatoes shall be revoked within a specified period of time.