1, 2, 4 The official date of approval is 1 The available data on authorised The AS can be used in 3 PT for which 1 2 3 December 2016. Pre-submissions can products of the indicates that the industry declared intention to opt still be received until 1 June 2016. around 55 BPs containing DCPP are for UA (PT2 in particular but also 1 and DCPP is considered to be a candidate currently on the market. These are 4). BPs falling under PT02 are only DCPP for substitution. No comments were understimates as the data of the eligible for UA from 2017 onwards. received during the public consultation. MSCAs are not complete and a A comparative assessment is thus number of MS data was not available required when authorisation is at this level of detail. requested. 1 L-(+)- lactic acid is a new active New, currently no BPs on the market. substance under the BPD. L-(+)- lactic There is thus also no deadline for UA L-(+)-lactic acid acid is not considered a candidate for applications. substitution. Estimates for the year 2017 Table 02 Reasoning supporting estimates for Union Authorisation in 2017 Active substances PTs Outcome RP Results from MSCA data on approved Results from survey Estimates 2017 with deadline in (based on the Commission BPs 2017 Implementing Regulations) 1,2,3,4,6,13 2-biphenylol is not a candidate for The available data on authorised The AS can be used in 4 PT for which 1 + 1 2 + 2 4 + 3 substitution. products of the indicates that the industry declared intention to opt for family family family 2-biphenylol around 250 BPs are currently on the UA (PT2 in particular but also 1,3 and market. This number is an underestimate 4). No interest declared for UA for PT 6 due the regulatory transition period and and 13
DCPP 1, 2, 4 The official date of approval is 1 December 2016. Pre-submissions can still be received until 1 June 2016. DCPP is considered to be a candidate for substitution. No comments were received during the public consultation. A comparative assessment is thus required when authorisation is requested. The available data on authorised products of the indicates that around 55 BPs containing DCPP are currently on the market. These are understimates as the data of the MSCAs are not complete and a number of MS data was not available at this level of detail. The AS can be used in 3 PT for which the industry declared intention to opt for UA (PT2 in particular but also 1 and 4). BPs falling under PT02 are only eligible for UA from 2017 onwards. 1 2 3 L-(+)-lactic acid 1 L-(+)- lactic acid is a new active substance under the BPD. L-(+)- lactic acid is not considered a candidate for substitution. New, currently no BPs on the market. There is thus also no deadline for UA applications. Estimates for the year 2017 Table 02 Reasoning supporting estimates for Union Authorisation in 2017 Active substances with deadline in 2017 PTs Outcome RP (based on the Commission Implementing Regulations) Results from MSCA data on approved BPs Results from survey Estimates 2017 2-biphenylol 1,2,3,4,6,13 2-biphenylol is not a candidate for substitution. The available data on authorised products of the indicates that around 250 BPs are currently on the market. This number is an underestimate due the regulatory transition period and The AS can be used in 4 PT for which the industry declared intention to opt for UA (PT2 in particular but also 1,3 and 4). No interest declared for UA for PT 6 and 13 1 + 1 family 2 + 2 family 4 + 3 family
CA-May16-Doc.7.8%20-%20BPR%20fee%20model%20final%20report.docx