Comments of identifier on the draft/assessment report/additional report on active substance(dd.mm.yyyy) 1/15

Section 1–Physical/Chemical Properties; Details of Uses and Further Information; Methods of analysis (B.1 – B.5)

[v1]

  1. Physical/Chemical Properties; Details of Uses and Further Information; Methods of Analysis (B.1-B.5[v2])

Example (to be deleted):

(1) / Vol. 3, B.2.1.3.1, vapour pressure / DK: Volume I on page 4, 1.5.2, it is stated: “….and is vapour active”.
On page 8, 2.1.2 it is stated “ and its vapour pressure indicates that it is not volatile”.
Are these two statements compatible? / (Please note that embedded or attached files will not be accepted.)
Identity (B.1, Annex C)
No. / Column 1[v3]
Reference to assessment report / Column 2[v4]
Comment (restricted to 500 characters, ca.10 lines) / Column 3[v5]
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Physical and chemical properties of the active substance (B.2.1)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Physical, chemical and technical properties of the formulation (B.2.2)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Further information (B.3)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Methods of analysis (B.5)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Effectiveness against target organisms
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / <MS/notifier/applicant>: <comment>
Occurrence of Resistance, Effects on quality/Processes/Yield/Phytotoxicity/Succeeding and Adjacent crops/Plants for propagation
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / <MS/notifier/applicant>: <comment>
Other comments
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>

Comments of identifier on the draft/assessment report/additional reporton active substance(dd.mm.yyyy) 1/15

Section 2 - Mammalian toxicology (B.6)

  1. Mammalian toxicology (B.6)

Example (to be deleted):

(1) / Vol. 3, B.6.1.2 through B.6.1.4, Absorption, excretion and distribution studies / UK: Justification for the adequacy of the use of a single radiolabel in these studies may be necessary. / (Please note that embedded or attached files will not be accepted.)
Toxicokinetics (B.6.1)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier: <comment>
Acute toxicity (B.6.2)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Short-term toxicity (B.6.3)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Genotoxicity (B.6.4)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Long-term toxicityand carcinogenicity (B.6.5)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Reproductive toxicity (B.6.6)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Neurotoxicity (B.6.7)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Other toxicological studies & Medical data (B.6.8-B.6.9)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Summary of mammalian toxicology and setting ADI, AOEL, ARfD (B.6.10)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Toxicity of the product(s) (B.6.11)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Dermal absorption (B.6.12)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Toxicity of non-active substances (B.6.13)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Exposure data (B.6.14)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Other comments
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>

Comments of identifier on the draft/assessment report/additional report on active substance(dd.mm.yyyy) 1/15

Section 3 - Residues (B.7)

  1. Residues (B.7)

Example (to be deleted):

(1) / Vol. 3, B.7.1.2, Proposed MRLs / UK: It is considered that MRLs should not be proposed for non-cereal food crops or poultry products (as intakes in poultry are not significant). / (Please note that embedded or attached files will not be accepted.)
Storage Stability (B.7.0)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier: <comment>
Metabolism in plants (B.7.1)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Metabolism in livestock (B.7.2)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Residue definition (B.7.3)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Use pattern, critical GAP, residues trials (B.7.4 to B.7.6)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Processing (B.7.7)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Livestock feeding (B.7.8)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Succeeding/Rotational crops (B.7.9)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
MRLs related issues and Consumer Risk Assessment (B.7.10 to B.7.15)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Other comments
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>

Comments of identifier on the draft/assessment report/additional report on active substance(dd.mm.yyyy) 1/15

Section 4 - Environmental fate and behaviour (B.8)

  1. Environmental fate and behaviour (B.8)

Example (to be deleted):

(1) / Vol. 3, B.8.1, Route and rate of degradation / DK: On page 20 of volume I it is mentioned that the glasshouse study seems to indicate a rather longer halflife than the other lab studies – a little shorter than 197 d. However on page 22-23 of volume I the glasshouse study is not mentioned in calculating DT50 values.
Could it be explained why this is so? / (Please note that embedded or attached files will not be accepted.)
Route and rate of degradation in soil (B.8.1)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier: <comment>
Adsorption, desorption and mobility in soil (B.8.2)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
PEC in soil (B.8.3)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Fate and behaviour in water and impact on water treatment procedures (B.8.4 – B.8.5)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
PEC in surface water and ground water (B.8.6)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Fate and behaviour in air and PEC in air (B.8.7 – B.8.8)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Definition of the residues (B.8.9)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Other comments
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>

Comments of identifier on the draft/assessment report/additional report on active substance(dd.mm.yyyy) 1/15

Section 5 - Ecotoxicology (B.9)

  1. Ecotoxicology (B.9)

Example (to be deleted):

(1) / Vol. 3, B.9.1.4 / DK: Mean residues are used for risk assessment for birds. Realistic worst case values should be used. / (Please note that embedded or attached files will not be accepted.)
Birds and mammals (B.9.1 and B.9.3)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier: <comment>
Aquatic organisms (B.9.2)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Bees and non-target arthropods (B.9.4 and B.9.5)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Earthworms and other soil non-target organisms (macro and micro) (B.9.6, B.9.7 and B.9.8)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Other non-target organisms (flora and fauna), sewage treatment (B.9.9 and B.9.10)
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>
Other comments
No. / Column 1
Reference to assessment report / Column 2
Comment (restricted to 500 characters, ca.10 lines) / Column 3
Further explanations
(1) / Vol. #, <data point>, <description> / Identifier>: <comment>

[v1]Please insert in each header, the originator of the comments (<identifier>), the type of the assessment report (e.g. draft assessment report/additional report), the name of the active substance (<active substance>) and the date (dd.mm.yyyy).

[v2]Each section contains separate subsections with 4-column tables for comments relevant to that subsection. The first column serves as numerical counter of the comments of each subsection. For any subsequent comments, additional rows should be added with corresponding numbers inserted in the first column.

[v3]In column 1, the reference to the assessment report corresponding to the comment should be given by indicating the Volume number, the chapter and a short description (e.g. Vol. 3, B.8.1, Route and rate of degradation)

[v4]In column 2, the comment should be given preceded by an abbreviated identification of the originator. Comments should be summarised and restricted to less than 500 characters for each comment.

[v5]Further explanations can be provided separately in column 3 of the template.