PMID- 37077298
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230421
IS  - 1831-4732 (Electronic)
IS  - 1831-4732 (Linking)
VI  - 21
IP  - 4
DP  - 2023 Apr
TI  - Evaluation of confirmatory data following Article 12 MRL review and modification 
      of the existing MRLs in pome fruits for pyridaben.
PG  - e07970
LID - 10.2903/j.efsa.2023.7970 [doi]
LID - e07970
AB  - In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nissan 
      Chemical Europe SAS submitted a request to the competent national authority in 
      the Czech Republic to modify the existing maximum residue levels (MRLs) in pome 
      fruits and 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 on residue trials, new trials according to the Good 
      Agricultural Practices (GAPs) on apples, pears, medlars, quinces, 
      loquats/Japanese medlars, apricots, peaches and beans with pods evaluated during 
      the MRL review were not provided. These data gaps are not addressed. However, 
      residue trials on apples and pears for an alternative GAP were provided and 
      resulted by extrapolation in an MRL proposal for pome fruits lower than the 
      current (tentative) MRL in EU legislation. The provided information may require a 
      revision of the existing MRLs for pome fruits, apricots, peaches and beans with 
      pods. Information on storage temperature of samples from the feeding study and a 
      validated analytical method for animal commodities were submitted. The two data 
      gaps on animal commodities were satisfactorily addressed. Adequate analytical 
      methods for enforcement are available to control the residues of pyridaben in 
      plant matrices under consideration and in all animal matrices, where currently an 
      limit of quantification (LOQ) of 0.02 mg/kg is considered at the validated LOQ of 
      0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the 
      short-term and long-term intake of residues resulting from the uses of pyridaben 
      according to the reported agricultural practices is unlikely to present a risk to 
      consumer health.
CI  - (c) 2023 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH 
      on behalf of European Food Safety Authority.
CN  - European Food Safety Authority (EFSA)
FAU - Bellisai, Giulia
AU  - Bellisai G
FAU - Bernasconi, Giovanni
AU  - Bernasconi G
FAU - Brancato, Alba
AU  - Brancato A
FAU - Cabrera, Luis Carrasco
AU  - Cabrera LC
FAU - Castellan, Irene
AU  - Castellan I
FAU - Del Aguila, Monica
AU  - Del Aguila M
FAU - Ferreira, Lucien
AU  - Ferreira L
FAU - Santonja, German Giner
AU  - Santonja GG
FAU - Greco, Luna
AU  - Greco L
FAU - Jarrah, Samira
AU  - Jarrah S
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 - Robinson, Tobin
AU  - Robinson T
FAU - Ruocco, Silvia
AU  - Ruocco S
FAU - Santos, Miguel
AU  - Santos M
FAU - Scarlato, Alessia Pia
AU  - Scarlato AP
FAU - Theobald, Anne
AU  - Theobald A
FAU - Verani, Alessia
AU  - Verani A
LA  - eng
PT  - Journal Article
DEP - 20230417
PL  - United States
TA  - EFSA J
JT  - EFSA journal. European Food Safety Authority
JID - 101642076
PMC - PMC10108001
OTO - NOTNLM
OT  - MRL
OT  - MRL review confirmatory data
OT  - consumer risk assessment
OT  - pesticide
OT  - pome fruits
OT  - pyridaben
EDAT- 2023/04/20 06:42
MHDA- 2023/04/20 06:43
PMCR- 2023/04/17
CRDT- 2023/04/20 02:16
PHST- 2023/04/20 06:43 [medline]
PHST- 2023/04/20 06:42 [pubmed]
PHST- 2023/04/20 02:16 [entrez]
PHST- 2023/04/17 00:00 [pmc-release]
AID - EFS27970 [pii]
AID - 10.2903/j.efsa.2023.7970 [doi]
PST - epublish
SO  - EFSA J. 2023 Apr 17;21(4):e07970. doi: 10.2903/j.efsa.2023.7970. eCollection 2023 
      Apr.