PMID- 32874214
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231112
IS  - 1831-4732 (Electronic)
IS  - 1831-4732 (Linking)
VI  - 18
IP  - 2
DP  - 2020 Feb
TI  - Evaluation of confirmatory data following the Article 12 MRL review and 
      modification of the existing maximum residue levels for prothioconazole in 
      celeriacs and rapeseeds.
PG  - e05999
LID - 10.2903/j.efsa.2020.5999 [doi]
LID - e05999
AB  - In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Bayer 
      SAS Crop Science and the Agriculture and Horticulture Development Board submitted 
      two requests to the competent national authority in the United Kingdom to modify 
      the existing maximum residue levels (MRLs) for prothioconazole in rapeseeds and 
      celeriacs, respectively. The data submitted in support of the requests were found 
      to be sufficient to derive MRL proposals for these crops. The applicant Bayer SAS 
      Crop Science additionally submitted a request to the competent national authority 
      in the United Kingdom to evaluate the confirmatory data identified in the 
      framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as 
      not available. To address the data gaps, residue trials on carrots, onions, 
      rapeseeds and wheat, and storage stability studies were submitted. The data gaps 
      are considered fully addressed for the root and tuber vegetables, the oilseeds 
      concerned and wheat. The data gaps have been partially addressed for onions, 
      shallots, flowering brassica, Brussels sprouts, head cabbages, leeks, rye, barely 
      and oat. The data gaps were not addressed for pulses and grass. Based on the risk 
      assessment results, EFSA concluded that the short-term and long-term intake of 
      residues resulting from the existing and intended uses of prothioconazole 
      according to the reported agricultural practices is unlikely to present a risk to 
      consumer health. For the triazole derivative metabolites (TDMs), only an 
      indicative exposure assessment was performed considering celeriacs and rapeseeds; 
      the results showed that the expected exposure to TDMs in these commodities is 
      well below the toxicological reference values derived for the TDMs.
CI  - (c) 2020 European Food Safety Authority. EFSA Journal published by John Wiley and 
      Sons Ltd on behalf of European Food Safety Authority.
CN  - EFSA (European Food Safety Authority)
FAU - Anastassiadou, Maria
AU  - Anastassiadou M
FAU - Bernasconi, Giovanni
AU  - Bernasconi G
FAU - Brancato, Alba
AU  - Brancato A
FAU - Carrasco Cabrera, Luis
AU  - Carrasco Cabrera L
FAU - Greco, Luna
AU  - Greco L
FAU - Jarrah, Samira
AU  - Jarrah S
FAU - Kazocina, Aija
AU  - Kazocina A
FAU - Leuschner, Renata
AU  - Leuschner R
FAU - Magrans, Jose Oriol
AU  - Magrans JO
FAU - Miron, Ileana
AU  - Miron I
FAU - Nave, Stefanie
AU  - Nave S
FAU - Pedersen, Ragnor
AU  - Pedersen R
FAU - Reich, Hermine
AU  - Reich H
FAU - Rojas, Alejandro
AU  - Rojas A
FAU - Sacchi, Angela
AU  - Sacchi A
FAU - Santos, Miguel
AU  - Santos M
FAU - Stanek, Alois
AU  - Stanek A
FAU - Theobald, Anne
AU  - Theobald A
FAU - Vagenende, Benedicte
AU  - Vagenende B
FAU - Verani, Alessia
AU  - Verani A
LA  - eng
PT  - Journal Article
DEP - 20200221
PL  - United States
TA  - EFSA J
JT  - EFSA journal. European Food Safety Authority
JID - 101642076
PMC - PMC7448029
OTO - NOTNLM
OT  - Celeriacs
OT  - MRL
OT  - Prothioconazole
OT  - Rapeseeds
OT  - confirmatory data
OT  - consumer risk assessment
OT  - pesticide
EDAT- 2020/09/03 06:00
MHDA- 2020/09/03 06:01
PMCR- 2020/02/21
CRDT- 2020/09/03 06:00
PHST- 2020/09/03 06:00 [entrez]
PHST- 2020/09/03 06:00 [pubmed]
PHST- 2020/09/03 06:01 [medline]
PHST- 2020/02/21 00:00 [pmc-release]
AID - EFS25999 [pii]
AID - 10.2903/j.efsa.2020.5999 [doi]
PST - epublish
SO  - EFSA J. 2020 Feb 21;18(2):e05999. doi: 10.2903/j.efsa.2020.5999. eCollection 2020 
      Feb.