EUROPE – EFSA: Guidance document on active substance applications for approval and renewal and on MRL applications
12 March 2021
EUROPE – EFSA: Public consultation: Updated guidance on the assessment of human exposure in risk assessment for plant protection products
17 March 2021
Following the public consultation of 16 January 2020 on the draft list of co-formulants banned in plant protection products and its revision in May 2020 (see our previous articles), the Commission published on 4 March 2021 on the Official Journal of the European Union the Regulation (EU) 2021/383 amending Annex III to Regulation (EC) No 1107/2009 listing co-formulants which are not accepted for inclusion in plant protection products.
The Regulation (EU) 2021/383 thus lists the co-formulants which are banned in the composition of plant protection products and adjuvants. Member states must then review the composition of the products currently authorised and withdraw or amend as soon as possible the authorisations of products containing these banned co-formulants, with a maximum deadline of 24 March 2023. Grace periods are set at a maximum of 3 months for sale and distribution and 9 additional months for the disposal, storage and use from the date of amendment or withdrawal of the authorisation.
However, the co-formulants listed in the annex may be present as unintentional impurities in other authorised co-formulants at a concentration not exceeding 0.1 % w/w in the finished plant protection product or adjuvant. For one co-formulant (Benzo[def]chrysene, CAS number 50-32-8, EC number 200-028-5), this limit is lowered to 0.01 % w/w in the finished product (specific concentration limit related to CMR properties).
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See also our previous articles:
EUROPE – COM: Update of the draft list of co-formulants banned in PPP
EUROPE – COM / Public Consultation: Draft List of Co-formulants Banned in PPP
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