MT
Plant Protection Products (Amendment) (No.3) Regulations,
Table of Provisions (7)
Statutory Text (7 Articles)
L.N. 385 of 2011
PESTICIDES CONTROL ACT
(CAP. 430)
Plant Protection Products (Amendment) (No.3) Regulations,
IN exercise of the powers conferred by articles 4
and 5 of the Pesticides Control Act, the Minister for Resources and
Rural Affairs, in consultation with the Prime Minister and with the
Minister for Health, the Elderly and Community Care, has made
the following regulations :-
(1) The title of these regulations is the Plant Protection Title and scope.
Products (Amendment) (No. 3) Regulations, 2011 and they shall L.N. 358 of 2009.
be read and construed as one with Plant Protection Products
Regulations, 2009, hereinafter referred to as “the principal
regulations”.
(2) The scope of these regulations is to transpose
Commission Directive 2011/2/EU of 7 January 2011 amending
Council Directive 91/414/EEC to include myclobutanil as active
substance and amending Decision 2008/934/EC, Commission
Directive 2011/4/EU of 20 January 2011 amending Council
Directive 91/414/EEC to include cycloxydim as active substance
and amending Decision 2008/934/EC, Commission Directive
2011/5/EU of 20 January 2011 amending Council Directive
91/414/EEC to include hymexazol as active substance and
amending Decision 2008/934/EC, Commission Directive 2011/6/
EU of 20 January 2011 amending Council Directive 91/414/EEC
to include buprofezin as active substance, Commission Directive
2011/9/EU of 1 February 2011 amending Council Directive
91/414/EEC to include dodine as active substance and amending
Decision 2008/934/EC, Commission Directive 2011/14/EU of
24 February 2011 amending Council Directive 91/414/EEC to
include profoxydim as active substance, Commission Directive
2011/19/EU of 2 March 2011 amending Council Directive 91/414/
EEC to include tau-fluvalinate as active substance and amending
Decision 2008/934/EC, Commission Directive 2011/20/EU of 2
March 2011 amending Council Directive 91/414/EEC to include
fenoxycarb as active substance and amending Decision 2008/934/
EC, Commission Directive 2011/21/EU of 2 March 2011 amending
Council Directive 91/414/EEC to include clethodim as active
substance and amending Decision 2008/934/EC, Commission
Directive 2011/22/EU of 3 March 2011 amending Council
Directive 91/414/EEC to include bispyribac as active substance,
Commission Directive 2011/23/EU of 3 March 2011 amending
Council Directive 91/414/EEC to include triflumuron as active
substance, Commission Directive 2011/25/EU of 3 March 2011
amending Council Directive 91/414/EEC to include bupirimate as
active substance and amending Commission Decision 2008/934/
EC, Commission Directive 2011/26/EU of 3 March 2011 amending
Council Directive 91/414/EEC to include diethofencarb as active
substance and amending Decision 2008/934/EC, Commission
Directive 2011/27/EU of 4 March 2011 amending Council
Directive 91/414/EEC to include oryzalin as active substance and
amending Decision 2008/934/EC, Commission Directive 2011/28/
EU of 4 March 2011 amending Council Directive 91/414/EEC
to include indolylbutyric acid as active substance and amending
Commission Decision 2008/941/EC, Commission Directive
2011/29/EU of 7 March 2011 amending Council Directive 91/414/
EEC to include etridiazole as active substance and amending
Commission Decision 2008/934/EC, Commission Directive
2011/30/EU of 7 March 2011 amending Council Directive 91/414/
EEC to include fenbutatin oxide as active substance and amending
Commission Decision 2008/934/EC, Commission Directive
2011/31/EU of 7 March 2011 amending Council Directive 91/414/
EEC as regards a restriction of the use of the active substance
pirimiphos-methyl, Commission Directive 2011/32/EU of 8
March 2011 amending Council Directive 91/414/EEC to include
isoxaben as active substance and amending Commission Decision
2008/934/EC, Commission Directive 2011/33/EU of 8 March 2011
amending Council Directive 91/414/EEC to include 1-decanol as
active substance and amending Commission Decision 2008/941/
EC, Commission Directive 2011/34/EU of 8 March 2011 amending
Council Directive 91/414/EEC to include flurochloridone as active
substance and amending Commission Decision 2008/934/EC,
Commission Implementing Directive 2011/39/EU of 11 April 2011
amending Council Directive 91/414/EEC to include fenazaquin as
active substance and amending Commission Decision 2008/934/
EC, Commission Implementing Directive 2011/40/EU of 11 April
2011 amending Council Directive 91/414/EEC to include sintofen
as active substance and amending Commission Decision 2008/934/
EC, Commission Implementing Directive 2011/41/EU of 11
April 2011 amending Council Directive 91/414/EEC to include
dithianon as active substance and amending Commission Decision
2008/934/EC, Commission Implementing Directive 2011/42/
EU of 11 April 2011 amending Council Directive 91/414/EEC to
include flutriafol as active substance and amending Commission
Decision 2008/934/EC, Commission Implementing Directive
2011/43/EU of 13 April 2011 amending Council Directive 91/414/
EEC to include lime sulphur as active substance and amending
Commission Decision 2008/941/EC, Commission Implementing
Directive 2011/44/EU of 13 April 2011 amending Council
Directive 91/414/EEC to include azadirachtin as active substance
and amending Commission Decision 2008/941/EC, Commission
Implementing Directive 2011/45/EU of 13 April 2011 amending
Council Directive 91/414/EEC to include diclofop as active
substance and amending Commission Decision 2008/934/EC,
Commission Implementing Directive 2011/46/EU of 14 April 2011
amending Council Directive 91/414/EEC to include hexythiazox as
active substance and amending Commission Decision 2008/934/
EC, Commission Implementing Directive 2011/47/EU of 15
April 2011 amending Council Directive 91/414/EEC to include
aluminium sulphate as active substance and amending Commission
Decision 2008/941/EC, Commission Implementing Directive
2011/48/EU of 15 April 2011 amending Council Directive 91/414/
EEC to include bromadiolone as active substance and amending
Commission Decision 2008/941/EC, Commission Implementing
Directive 2011/49/EU of 18 April 2011 amending Council
Directive 91/414/EEC to include pencycuron as active substance
and amending Commission Decision 2008/934/EC, Commission
Implementing Directive 2011/50/EU of 19 April 2011 amending
Council Directive 91/414/EEC to include carbetamide as active
substance and amending Commission Decision 2008/934/
EC, Commission Implementing Directive 2011/52/EU of 20
April 2011 amending Council Directive 91/414/EEC to include
carboxin as active substance and amending Commission Decision
2008/934/EC, Commission Implementing Directive 2011/53/
EU of 20 April 2011 amending Council Directive 91/414/EEC to
include dazomet as active substance and amending Commission
Decision 2008/934/EC, Commission Implementing Directive
2011/54/EU of 20 April 2011 amending Council Directive 91/414/
EEC to include metaldehyde as active substance and amending
Commission Decision 2008/934/EC, Commission Implementing
Directive 2011/55/EU of 26 April 2011 amending Council
Directive 91/414/EEC to include paclobutrazol as active substance
and amending Commission Decision 2008/934/EC, Commission
Implementing Directive 2011/56/EU of 27 April 2011 amending
Council Directive 91/414/EEC to include cyproconazole as active
substance and amending Commission Decision 2008/934/EC,
Commission Implementing Directive 2011/57/EU of 27 April 2011
amending Council Directive 91/414/EEC to include fluometuron
as active substance and amending Commission Decision
2008/934/EC, Commission Directive 2011/58/EU of 10 May 2011
amending Council Directive 91/414/EEC to renew the inclusion of
carbendazim as active substance and Commission Implementing
Directive 2011/60/EU of 23 May 2011 amending Council Directive
91/414/EEC to include tebufenozide as active substance and
amending Commission Decision 2008/934/EC.
Schedule I to the principal regulations shall be amended
as follows: -
— 0,25 kg active substance per hectare per
Particular attention must be paid to the
Only uses as fungicide on the following crops
— 0,075 kg active substance per hectare per
— 0,1 kg active substance per hectare per
— knapsack and handheld applications
neither by amateur nor by professional
Member States shall ensure that all appropriate
application for sugar and fodder beet,
application for cereals and rape seed,
The following uses must not be authorised
risk mitigation measures are applied.
Specific provisions
— sugar and fodder beet,
application for maize.
— home gardening.
— air application,
at rates not exceeding
may be authorised
— rape seed,
— cereals,
— maize,
users,
PART A
Further details on identity and specification of active substances are provided in the review report.
of inclusion
November
Expiration
June 30
(a) for item number 149 there shall be substituted the following
Entry into
force
e (AHP): not
more than 0,0005
(DAP): not more
diaminophenazine
hydroxyphenazin
than 0,003 g/kg
Purity !
2-amino-3-
! 980 g/kg
impurities
Relevant
g/kg
2,3-
CAS No 10605- benzimidazol-2-
IUPAC Name
ylcarbamate
Methyl
Common Name,
Identification
CIPAC No 263
Numbers
Carbendazim
21-7
!
“149
No
mitigation measures must be applied to
minimise the exposure of surface water
surface water bodies alone or in
such as the selection of the most
timing of application, and, if necessary,
the degree of concentration of the active
minimise the exposure may become
protective clothing, in particular gloves,
coveralls, rubber boots and face
mixing, loading, application and cleaning
— aquatic organisms. Appropriate drift
bodies. This should include keeping a
distance between treated areas and
combination with the use of drift-
— earthworms and other soil macro-
organisms. Conditions of authorisation
shall include risk mitigation measures,
appropriate combination of numbers and
— birds (long-term risk). Depending on the
results of the risk assessment for specific
uses, targeted mitigation measures to
— operators, who must wear suitable
protection or safety glasses during
of the equipment, unless the exposure to
reducing techniques or devices
Specific provisions
substance,
necessary,
protection of
of inclusion
Expiration
Entry into
force
Purity !
IUPAC Name
Common Name,
Identification
Numbers
No
the substance is adequately precluded by
the design and construction of the
equipment itself or by the mounting of
specific protective components on such
For the implementation of the uniform principles
of Annex VI, the conclusions of the review
report on carbendazim, and in particular
Appendices I and II thereof, shall be taken into
The Member States concerned shall request that
the applicant provides the following to the
— by 1 December 2011 at the latest,
information as regards the toxicological
and ecotoxicological relevance of the
— by 1 June 2012 at the latest, the
examination of the studies included in the
list in the draft re-assessment report of 16
July 2009 (Volume 1, Level 4 “Further
— by 1 June 2013 at the latest, information
on the fate and behaviour (route of
aerobic degradation in soil) and the long-
information”, pp. 155-157),
Specific provisions
impurity AEF037197,
term risk to birds.”
equipment.
Commission
PART B
account.
of inclusion
Expiration
Entry into
force
Purity !
IUPAC Name
Common Name,
Identification
Numbers
No
Only uses as insecticide for post harvest storage
In assessing applications to authorise plant
protection products containing pirimiphos-
methyl for uses other than applications with
automated systems in empty cereals storehouses,
Member States shall pay particular attention to
the criteria in Article 4(1)(b), and shall ensure
that any necessary data and information is
For the implementation of the uniform principles
of Annex VI, the conclusions of the review
report on pirimiphos- methyl, and in particular
Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and
Animal Health on 16 March 2007 shall be taken
In this overall assessment Member States must
Authorised
provided before such an authorisation is granted.
Hand-held applications shall not be authorised.
safety.
Specific provisions
pay particular attention to
operators
can be authorised.
into account.
— the
PART A
PART B
Further details on identity and specification of active substances are provided in the review report.
September
of inclusion
Expiration
1 October 30
(b) for item number 162 there shall be substituted the following
Entry into
force
Purity !
! 880 g/kg
O,O-
dimethylphosphor
methylpyrimidin-
diethylamino-6-
IUPAC Name
othioate
O-2-
4-yl
CAS No 29232-93-
pirimiphos-methyl
Common Name,
Identification
CIPAC No 239
Numbers
!
“162
No
personal
including
respiratory protective equipment and risk
mitigation measures to reduce the
— the dietary exposure of consumers in
view of future revisions of Maximum
conditions of use must prescribe the
adequate
equipment
Specific provisions
Residue Levels.”
of
application
protective
exposure,
of inclusion
Expiration
Entry into
force
Purity !
IUPAC Name
Common Name,
Identification
Numbers
No
For the implementation of the uniform principles
VI, the conclusions of the review report on
myclobutanil, and in particular Appendices I and
In this overall assessment Member States shall
pay particular attention to the operator safety and
ensure that conditions of use prescribe the
application of adequate personal protective
shall include risk mitigation measures, where
residues of myclobutanil and its metabolites in
confirming that the available residue data cover
of II thereof, as finalised in the Standing Annex
Committee on the Food Chain and Animal
Health on 23 November 2010 shall be taken into
equipment where appropriate. Conditions of use
The Member States concerned shall request the
submission of confirmatory information on the
following growing seasons and information
The Member States concerned shall ensure that
Only uses as fungicide may be authorised.
all compounds of the residue definition.
Specific provisions
(c) immediately after item number 323 “Bromuconazole” there shall be added the following new items
appropriate.
PART A
PART B
account.
Further details on identity and specification of active substances are provided in the review report.
May
of inclusion
Expiration
June 31
Entry into
force
The impurity 1- 2011
2-one shall not
exceed 1g/kg in
technical
methylpyrrolidin-
Purity !
! 925 g/kg
material
the
1,2,4-
ylmethyl)hexaneni
chlorophenyl)-2-
IUPAC Name
(RS)-2-(4-
triazol-1-
(1H-
trile
CAS No: 88671-
Common Name,
CIPAC No: 442
Identification
Numbers
Myclobutanil
89-0
!
“324
No
Only uses as insecticide and acaricide may be
For the implementation of the uniform principles
the applicant submits such confirmatory
information to the Commission by 31 January
of Annex VI the conclusions of the review report
on buprofezin, and in particular Appendices I
and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal
Health on 23 November 2010, shall be taken into
In this overall assessment Member States shall
(a) the operators’ and workers’ safety and ensure
that conditions of use impose adequate personal
(b) the dietary exposure of consumers to the
(c) the application of an appropriate waiting
(d) the risk to aquatic organisms and ensure that
conditions of use impose adequate risk
buprofezin (aniline) metabolites in processed
period for rotational crops in greenhouses;
protective equipment where appropriate;
mitigation measures, where appropriate.
Specific provisions
pay particular attention to
authorised.
1 February 31 January PART A
PART B
account.
2013. food;
of inclusion
Expiration
Entry into
force
Purity !
! 985 g/kg
IUPAC Name
thiadiazinan-4-
butylimino-3-
phenyl-1,3,5-
isopropyl-5-
(Z)-2-tert-
one
CAS No: 953030-
Common Name,
CIPAC No: 681
Identification
Numbers
Buprofezin
84-7
No
The Member States concerned shall request the
submission of confirmatory information as
regards the processing and conversion factors for
The Member States concerned shall ensure that
the applicant submits such confirmatory
information to the Commission by 31 January
For the implementation of the uniform principles
of Annex VI, the conclusions of the review
report on dodine, and in particular Appendices I
and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal
Health on 23 November 2010 shall be taken into
In this overall assessment Member States shall
(a) the potential long-term risk to birds and
(b) the risk to aquatic organisms and ensure that
conditions of use impose adequate risk
(c) the risk to non-target plants in the off-field
area and ensure that conditions of use impose
Only uses as fungicide may be authorised.
Specific provisions
consumer risk assessment.
pay particular attention to
mitigation measures;
mammals;
May PART A
PART B
account.
2013. of inclusion
Expiration
June 31
Entry into
force
Purity !
! 950 g/kg
CAS No: 2439-10- dodecylguanidini
IUPAC Name
um acetate
1-
Common Name,
CIPAC No: 101
Identification
Numbers
Dodine
No
For the implementation of the uniform principles
report on cycloxydim, and in particular
Standing Committee on the Food Chain and
(d) the monitoring of residue levels in pome
The Member States concerned shall request the
submission of confirmatory information as
(a) long-term risk assessment for birds and
(b) risk assessment in natural surface water
systems where major metabolites have
The Member States concerned shall ensure that
the applicant submits such confirmatory
of Annex VI, the conclusions of the review
Appendices I and II thereof, as finalised in the
Animal Health on 23 November 2010 shall be
In this overall assessment Member States shall
pay particular attention to the risk to non-target
plants. Conditions of use shall include risk
information to the Commission by 31 May 2013.
Only uses as herbicide may be authorised.
adequate risk mitigation measures;
Specific provisions
potentially formed.
taken into account.
mammals;
May PART A
PART B
regards
fruit.
of inclusion
Expiration
June 31
Entry into
force
Purity !
! 940 g/kg
l]-3- hydroxy-5-
(ethoxyimino)buty
yl]cyclohex-2-en-
5RS)-2-[(EZ)-1-
[(3RS)-thian-3-
IUPAC Name
1-one
CAS No: 101205-
Common Name,
CIPAC No: 510
Identification
Numbers
Cycloxydim
02-1
No
The Member States concerned shall request the
submission of further information concerning the
methods for analysis of residues of cycloxydim
The Member States concerned shall ensure that
the applicant submits such methods of analysis
For the implementation of the uniform principles
of Annex VI the conclusions of the review report
on triflumuron, and in particular Appendices I
and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal
Health on 28 January 2011, shall be taken into
In this overall assessment, Member States shall
— the protection of honeybees. Conditions
of authorisation shall include risk
Conditions of authorisation shall include risk
The Member States concerned shall ensure that
— the protection of the aquatic environment,
mitigation measures, where appropriate.
Only uses as insecticide may be authorised.
mitigation measures, where appropriate.
mitigation measures, where appropriate.
to the Commission by 31 May 2013.
Specific provisions
in plant and animal products.
pay particular attention to
April 31 March PART A
PART B
account.
of inclusion
Expiration
Entry into
force
— N,N’-bis-[4-
)phenyl]urea: not
4-trifluoro-
not more than 5
(trifluoromethoxy
more than 1 g/kg,
methoxyaniline
Purity !
Impurities
! 955 g/kg
g/kg.
—
trifluoromethoxyp
chlorobenzoyl)-3-
IUPAC Name
henyl]urea
1-(2-
[4-
CAS No: 64628-
Common Name,
CIPAC No: 548
Identification
Numbers
Triflumuron
44-0
No
B
by
For the implementation of the uniform principles
Standing Committee on the Food Chain and
the applicant submits to the Commission
confirmatory information as regards the long-
term risk to birds, the risk to aquatic inver-
The Member States concerned shall ensure that
the applicant submits such information to the
of Annex VI, the conclusions of the review
report on bispyribac, and in particular
Appendices I and II thereof, as finalised in the
Animal Health on 28 January 2011, shall be
In this overall assessment, Member States must
pay particular attention to the protection of
groundwater, when the active substance is
applied in regions with vulnerable soil and/or
Conditions of authorisation shall include risk
The Member States concerned shall request the
submission of further information as regards the
Only uses as herbicide in rice may be authorised.
tebrates and the risk to bee brood development.
contamination
mitigation measures where appropriate.
Specific provisions
Commission by 31 March 2013.
groundwater
climatic conditions.
taken into account.
July PART A
PART B
possible
of inclusion
Expiration
1 August 31
Entry into
force
(referred to as
Purity !
bispyribac-
! 930 g/kg
sodium)
dimethoxypyrimi
IUPAC Name
yloxy)benzoic
2,6-bis(4,6-
din-2-
acid
CAS No 125401-
Common Name,
Identification
CIPAC No 748
Numbers
Bispyribac
75-4
No
(2-hydroxy-4,6-
dimethoxypyrimidine), M04 (2,4- dihydroxy-6-
methoxypyrimidine) and M10 (sodium 2-
They shall ensure that the applicant provides
such information to the Commission by 31 July
For the implementation of the uniform principles
of Annex VI, the conclusions of the review
report on profoxydim, and in particular
Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and
Animal Health on 28 January 2011 shall be taken
— the protection of groundwater when the
active substance is applied in regions with
Conditions of authorisation shall include risk
Only uses as herbicide in rice may be authorised.
Member States must pay particular attention to
— the long term risk to non-target organisms.
vulnerable soil and/or climatic conditions,
hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-
Only uses as fungicide may be authorised.
mitigation measures where appropriate.
into account. In this overall assessment,
Specific provisions
yl) oxybenzoate).
metabolites
July PART A
May PART A
PART B
2013. of inclusion
Expiration
1 August 31
June 31
Entry into
force
Purity !
CAS No: 87130- diethoxycarbanila Impurities
2 – [(1 E/Z) – [(2 ! 940 g/kg
3,4- ! 970 g/kg
R S) – 2 – (4 –
butyl] – 3 –
hydroxy – 5 – [(3
R S; 3 S R) –
tetrahydro – 2 H –
thiopyran – 3 –
yl] cyclohex – 2 –
chlorophenoxy)
IUPAC Name
propoxyimino]
isopropyl
enone
CAS No 139001-
49-3 CIPAC No
Common Name,
Identification
Diethofencarb
Numbers
Profoxydim
No
For the implementation of the uniform principles
pay particular attention to the risk to aquatic
of Annex VI the conclusions of the review report
on diethofencarb, and in particular Appendices I
and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal
Health on 28 January 2011, shall be taken into
In this overall assessment Member States shall
organisms and non-target arthropods and shall
ensure that conditions of use include the
The Member States concerned shall request the
submission of confirmatory information as
(a) the potential uptake of the metabolite 6-NO
(b) the risk assessment for non-target arthropod
The Member States concerned shall ensure that
the applicant submits such information to the
Only uses as fungicide in non-soil bound
application of adequate risk mitigation measures.
systems in greenhouse may be authorised.
Specific provisions
Commission by 31 May 2013.
2-DFC in succeeding crops;
May PART A
PART B
PART B
account.
regards
species.
of inclusion
Expiration
June 31
Entry into
force
not
more than 1 g/kg
Purity !
! 970 g/kg
Toluene
1,2,4-thiadiazol-
trichloromethyl-
IUPAC Name
5-yl ether
ethyl-3-
te
CAS No: 2593-15-
Common Name,
CIPAC No: 513
CIPAC No: 518
Identification
Numbers
Etridiazole
20-9
No
In assessing applications to authorise plant
protection products containing etridiazole for
uses other than on ornamental plants, Member
States shall pay particular attention to the criteria
in Article 4(1)(b), and shall ensure that any
necessary information is provided before such an
For the implementation of the uniform principles
of Annex VI the conclusions of the review report
on etridiazole, and in particular Appendices I and
II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 28
1. pay particular attention to the risk to operators
and workers and ensure that conditions of use
include the application of appropriate risk
2. ensure that appropriate waste management
practices are applied as regards waste water from
irrigation of non-soil bound growing systems;
Member States permitting the release of waste
water into the sewage system or into natural
water bodies, shall ensure that an appropriate
pay particular attention to the risk to aquatic
organisms and ensure that conditions of use
include the application of appropriate risk
In this overall assessment Member States shall
January 2011, shall be taken into account.
Specific provisions
risk assessment is carried out;
authorisation is granted.
mitigation measures;
of inclusion
Expiration
Entry into
force
Purity !
IUPAC Name
Common Name,
Identification
Numbers
No
B
3-
dwelling organisms to etridiazole and to its soil
The Member States concerned shall request the
submission of confirmatory information as
1. the specification of the technical material, as
commercially manufactured, by appropriate
3. the equivalence between the specifications of
the technical material, as commercially
manufactured, and those of the test material used
the relevance of the plant metabolites 5-
indirect exposure of groundwater and soil-
metabolites dichloro-etridiazole and etridiazole
long-range and short-range transport through
The Member States concerned shall ensure that
the applicant submits to the Commission the
information set out in points 1, 2 and 3 by 1
December 2011 and the information set out in
Only uses as plant growth regulator in
and
acid
the atmosphere of etridiazole acid.
points 4, 5 and 6 by 31 May 2013.
2. the relevance of the impurities;
Specific provisions
in the ecotoxicity dossiers;
hydroxy-ethoxyetridiazole
hydroxymethyletridiazole;
mitigation measures.
analytical data;
May PART A
regards
acid;
of inclusion
Expiration
June 31
Entry into
force
Purity !
! 994 g/kg
IUPAC Name
4-(1H-indol-3-
yl)butyric acid
Indolylbutyric acid
CAS No 133-32-4
Common Name,
Identification
Numbers
No
For the implementation of the uniform principles
of Annex VI, the conclusions of the review
report on indolylbutyric acid, and in particular
Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and
Animal Health on 28 January 2011 shall be taken
In this overall assessment Member States shall
pay particular attention to the operators and
workers safety. Conditions of authorisation shall
include the application of adequate personal
protective equipment and risk mitigation
measures to reduce the exposure. The Member
States concerned shall request the submission of
(a) the absence of clastogenicity potential of
(b) the vapour pressure of indolylbutyric acid
(c) the natural background concentration of
The Member States concerned shall ensure that
the applicant submits such confirmatory
information to the Commission by 31 May 2013.
and, consequently, an inhalation toxicity study;
Specific provisions
ornamentals may be authorised.
further information to confirm
indolylbutyric acid in the soil.
indolylbutyric acid;
into account.
May PART A
PART B
of inclusion
Expiration
June 31
Entry into
force
Purity !
! 960 g/kg
IUPAC Name
3,5-dinitro-
Common Name,
Identification
CIPAC No 830
Numbers
Oryzalin
No
For the implementation of the uniform principles
of Annex VI the conclusions of the review report
on oryzalin, and in particular Appendices I and II
thereof, as finalised in the Standing Committee
In this overall assessment Member States shall
of use include the application of adequate
3. the protection of groundwater, where the
Conditions of authorisation shall include risk
The Member States concerned shall carry out
monitoring programmes to verify potential
groundwater contamination from the metabolites
on the Food Chain and Animal Health on 28
1. the operator safety and ensure that conditions
2. the protection of aquatic organisms and non-
active substance is applied in regions with
(2-ethyl-7-nitro-1-propyl-1H-
benzimidazole-5-sulfonamide) and OR15 (2-
4. the risk to herbivorous birds and mammals;
5. the risk to bees, in the flowering season.
vulnerable soil and/or climatic conditions;
Only uses as herbicide may be authorised.
January 2011, shall be taken into account.
mitigation measures, where appropriate.
Specific provisions
personal protective equipment;
pay particular attention to
target plants;
PART B
OR13
of inclusion
Expiration
Entry into
force
0,1
Toluene: " 4 g/kg
nitrosodipropyla
Purity !
"
mg/kg
mine
N-
dipropylsulfanila
IUPAC Name
CAS No: 19044- N4,N4-
mide
Common Name,
CIPAC No: 537
Identification
Numbers
88-3
No
ethyl-7-nitro- 1H-benzimidazole-5-sulfonamide)
in vulnerable zones, where appropriate. The
Member States concerned shall request the
submission of confirmatory information as
1. the specification of the technical material, as
commercially manufactured, by appropriate
analytical data, including information on the
relevance of the impurities which for
confidentiality reasons are referred to as
2. the relevance of the test material used in the
4. the relevance of the metabolites OR13 and
OR15, and the corresponding groundwater risk
assessment, provided that oryzalin becomes
classified under Regulation (EC) No 1272/2008
of the European Parliament and of the Council
The Member States concerned shall ensure that
the applicant submits to the Commission the
December 2011, and the information set out in
point 3 by 31 May 2013. The information set out
in point 4 shall be submitted within 6 months of
toxicity dossiers in view of the specification of
(OJ L 353, 31.12.2008, p. 1) as “suspected of
information set out in points 1 and 2 by 1
3. the risk assessment for aquatic organisms;
Specific provisions
impurities 2, 6, 7, 9, 10, 11, 12;
the technical material;
causing cancer”.
regards
of inclusion
Expiration
Entry into
force
Purity !
IUPAC Name
Common Name,
Identification
Numbers
No
For the implementation of the uniform principles
Only uses as insecticide and acaricide may be
of Annex VI, the conclusions of the review
report on tau-fluvalinate, and in particular
Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and
Animal Health on 28 January 2011 shall be taken
In this overall assessment Member States shall
(a) the risk to aquatic organisms and ensure that
conditions of use prescribe the application of
(b) the risk to non-target arthropods and ensure
that conditions of use prescribe the application of
(c) the test material used in the toxicity dossiers
shall be compared and verified against the
specification of the technical material
The Member States concerned shall request the
submission of confirmatory information as
notification of a decision classifying oryzalin.
adequate risk mitigation measures;
adequate risk mitigation measures;
Specific provisions
commercially manufactured.
pay particular attention to
into account.
authorised.
PART A
PART B
regards
May
of inclusion
Expiration
June 31
Entry into
force
ratio of R-#- 2011
! 920 g/kg (1:1 1
cyano and S-#-
isomers)
not
more than 5 g/kg
Purity !
Impurities
Toluene
cyano
tolyl)-D- valinate
N-(2-chloro- #,#
trifluoro-p-
(Isomer ratio 1:1)
(RS)-#-cyano-3-
IUPAC Name
phenoxybenzyl
#-
CAS No: 102851-
Common Name,
CIPAC No: 786
Identification
Tau-fluvalinate
Numbers
06-9
No
B
of
bioaccumulation/biomagnification in the
Member States concerned shall ensure that
information to the Commission by 31 May
The Member States concerned shall ensure that
the applicant submits confirmatory information,
two years after the adoption of specific
guidance, as regards: the possible impact on the
Only uses as herbicide on sugar beet may be
of Annex VI the conclusions of the review report
on clethodim, and in particular Appendices I and
II thereof, as finalised in the Standing Committee
Member States shall pay particular attention to
the protection to aquatic organisms, birds and
— the risk to non-target arthropods. The
the applicant submits such confirmatory
environment of the potential enantio-selective
For the implementation of the uniform principles
on the Food Chain and Animal Health on 28
January 2011, shall be taken into account. In this
degradation in environmental matrices.
Specific provisions
risk
aquatic environment,
overall assessment
authorised.
2013. May PART A
PART B
— the
of inclusion
Expiration
June 31
Entry into
force
g/kg 1
toluene max. 4
Purity !
Impurities
oxyimino]propyl} g/kg
!
hydroxycyclohex-
(ethylthio)propyl]
(5RS)-2-{(1EZ)-
IUPAC Name
-5-[(2RS)-2-
chloroallyl-
2- en-1-one
CAS No: 99129- 1-[(2E)-3-
-3-
Common Name,
CIPAC No: 508
Identification
Numbers
Clethodim
21-2
No
mammals, and shall ensure that conditions of use
For the implementation of the uniform principles
Standing Committee on the Food Chain and
include the application of adequate risk
The Member States concerned shall request the
submission of confirmatory information, on the
basis of most recent scientific knowledge, as
— the soil and groundwater exposure
The Member States concerned shall ensure that
the applicant submits such confirmatory
information to the Commission by 31 May
of Annex VI, the conclusions of the review
report on bupirimate, and in particular
Appendices I and II thereof, as finalised in the
Animal Health on 28 January 2011 shall be taken
In this overall assessment Member States shall
— the protection of aquatic organisms.
— the residue definition for risk assessment.
Only uses as fungicide may be authorised.
Specific provisions
pay particular attention to
mitigation measures.
assessments,
into account.
May PART A
PART B
regards
2013. of inclusion
Expiration
June 31
Entry into
force
Ethirimol: max. 2
Toluene
Purity !
max. 3 g/kg
Impurities
! 945 g/kg
g/kg
4-yl
methylpyrimidine
dimethylsulfamat
IUPAC Name
ethylamino-6-
5-butyl-2-
e
-
CAS No: 41483-
Common Name,
CIPAC No: 261
Identification
Numbers
Bupirimate
43-6
No
Conditions of au- thorisation shall include
— the protection of the groundwater, when the
active substance is applied in regions with
vulnerable soil and/or climatic conditions.
Conditions of authorisation shall include
The Member States concerned shall request the
submission of confirmatory information as
(1) the specification of the technical material, as
commercially manufactured, by appropriate
analytical data; including information on the
(2) the equivalence between the specifications of
the technical material; as commercially
manufactured, and those of the test material used
(3) the kinetic parameters, the soil degradation
and the adsorption and desorption parameter for
the major soil metabolite DE-B (de-ethyl-
The Member States concerned shall ensure that
the applicant submits such confirmatory data and
information to the Commission set out in points
(1) and (2) by 30 November 2011 and the
risk mitigation measures, where appropriate,
information set out in point (3) by 31 May 2013.
— the in-field risk to non-target arthropods.
risk mitigations, where appropriate,
Specific provisions
relevance of the impurities;
in the toxicity dossiers;
bupirimate).
regards
of inclusion
Expiration
Entry into
force
Purity !
IUPAC Name
Common Name,
Identification
Numbers
No
Only uses as acaricide in greenhouses may be
For the implementation of the uniform principles
of Annex VI, the conclusions of the review
report on fenbutatin oxide, and in particular
Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and
Animal Health on 28 January 2011 shall be taken
In this overall assessment Member States shall
— the technical specification of the impurity
— the residue levels in small tomato varieties
— the operator safety. Conditions of use shall
prescribe the application of adequate
personal protective equipment, where
Conditions of authorisation shall include risk
The Member States concerned shall request the
submission of information confirming the
results of the risk assessment, on the basis of
mitigation measures, where appropriate.
— the risk to aquatic organisms.
Specific provisions
pay particular attention to
(cherry tomatoes),
appropriate,
into account.
content,
authorised.
PART A
PART B
May
of inclusion
Expiration
June 31
Entry into
force
(SD
31723): not more
bis[hydroxybis(2-
phenylpropyl)tin]
Purity !
than 3 g/kg
! 970 g/kg
mpurities
methyl-2-
oxide
bis[tris(2-methyl-
CAS No: 13356- 2-phenylpropyl)-
IUPAC Name
tin]oxide
Common Name,
Fenbutatin oxide
CIPAC No: 359
Identification
Numbers
08-6
No
most recent scientific knowledge, as regards the
That information shall concern the following
(c) spectra, storage stability and methods of
The Member States concerned shall ensure that
the applicant submits such confirmatory
information to the Commission by 31 May
For the implementation of the uniform principles
of Annex VI, the conclusions of the review
report on fenoxycarb, and in particular
Appendices I and II thereto, as finalised in the
Standing Committee on the Food Chain and
Animal Health on 28 January 2011 shall be taken
In this overall assessment Member States shall
— the protection of aquatic organisms.
Conditions of authorisation shall include
risk mitigation measures, where appropriate,
Only uses as insecticide may be authorised.
Specific provisions
(a) genotoxicological potential;
(b) ecotoxicological relevance;
analysis in the formulation.
pay particular attention to
impurity SD 31723.
into account.
May PART A
PART B
points
2013. of inclusion
Expiration
June 31
Entry into
force
g/kg 1
Toluene: max. 1
Purity !
CAS No: 79127- phenoxyphenoxy) Impurities
g/kg
2-(4- !
ethyl-carbamate
IUPAC Name
Ethyl
Common Name,
CIPAC No: 425
Identification
Numbers
Fenoxycarb
80-3
No
The Member States concerned shall ensure that
For the implementation of the uniform principles
Standing Committee on the Food Chain and
Animal Health on 28 January 2011 shall be taken
— the risk to bees and non-target arthropods.
Conditions of authorisation shall include
The Member States concerned shall request the
submission of information confirming the risk
assessment for non- target arthropods and for
the applicant submits such information to the
of Annex VI, the conclusions of the review
report on 1-decanol, and in particular
Appendices I and II thereof, as finalised in the
In this overall assessment Member States shall
— the risk to consumers from residues in case
— the risk for operator and ensure that
conditions of use prescribe the application
of adequate personal protective equipment
risk mitigation measures, where appropriate.
Only uses as plant growth regulator.
of use on food or feed crops,
Specific provisions
Commission by 31 May 2013.
pay particular attention to
into account.
bee brood.
May PART A
PART B
of inclusion
Expiration
June 31
Entry into
force
Purity !
! 960 g/kg
IUPAC Name
Decan-1-ol
CAS No: 112-30-1
Common Name,
CIPAC No: 831
Identification
Numbers
1-decanol
No
— the protection of groundwater when the
active substance is applied in regions with
— the risk to non-target arthropods and bees
that may be exposed to the active substance
by visiting flowering weeds present in the
Risk mitigation measures shall be applied,
The Member States concerned shall request the
information confirming the groundwater,
surface water and sediment exposure
The Member States concerned shall ensure that
the applicant submits such confirmatory
information to the Commission by 31 May
For the implementation of the uniform principles
of Annex VI the conclusions of the review report
on isoxaben, and in particular Appendices I and
submission of confirmatory information, as
regards the risk to aquatic organisms and of
vulnerable soil and/or climatic conditions,
Only uses as herbicide may be authorised.
— the risk to aquatic organisms,
Specific provisions
crop at time of application.
where appropriate,
where appropriate.
assessments.
May PART A
PART B
2013. of inclusion
Expiration
June 31
Entry into
force
Toluene: " 3g/kg
Purity !
! 910 g/kg
1,2- oxazol-5-yl]-
dimethoxybenza
N-[3-(1-ethyl-1-
IUPAC Name
methylpropyl)-
mide
2,6-
CAS No: 82558-
Common Name,
CIPAC No: 701
Identification
Numbers
Isoxaben
50-7
No
II thereof, as finalised in the Standing Committee
In this overall assessment Member States shall
pay particular attention to the risk to aquatic
organisms, the risk to non-target terrestrial plants
and the potential leaching of metabolites to
The Member States concerned shall request the
(a) the specification of the technical material, as
The Member States concerned shall ensure that
the applicant submits to the Commission the
information set out in points (a) and (b) within 6
months from the entry into force of the Directive
of inclusion and the information set out in points
on the Food Chain and Animal Health on 28
Conditions of use shall include risk mitigation
submission of confirmatory information as
(d) the potential risk to aquatic organisms.
Only uses as herbicide may be authorised.
January 2011, shall be taken into account.
(c) the residues in rotational crops;
(b) the relevance of the impurities;
Specific provisions
measures, where appropriate.
commercially manufactured;
(c) and (d) by 31 May 2013.
groundwater.
May PART A
PART B
regards
of inclusion
Expiration
June 31
Entry into
force
Toluene: max 8
Purity !
! 940 g/kg.
impurities
Relevant
(3RS,4RS;3RS,4S
chloromethyl-1-
(#,#,#-trifluoro-
IUPAC Name
R)-3-chloro-4-
CAS No: 61213-
Common Name,
Flurochloridone
CIPAC No: 430
Identification
Numbers
25-0
No
For the implementation of the uniform principles
of Annex VI, the conclusions of the review
report on flurochloridone, and in particular
Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and
Animal Health on 4 February 2011 shall be taken
In this overall assessment Member States shall
1. the risk for non-target plants and aquatic
2. the protection of the groundwater, when the
active substance is applied in regions with
Conditions of authorisation shall include risk
The Member States concerned shall ensure that
the applicant submits to the Commission further
2. the compliance of ecotoxicological test
3. the relevance of the groundwater metabolite
R42819 (R42819: (4RS)-4- (chloromethyl)-1-[3-
4. the potential endocrine disrupting properties
The Member States concerned shall ensure that
1. the relevance of impurities other than toluene;
(trifluoromethyl)phenyl]pyrrolidin-2-one);
vulnerable soil and/or climatic conditions.
material with the technical specifications;
mitigation measures, where appropriate.
confirmatory information as regards
Specific provisions
pay particular attention to
of flurochloridone.
into account.
organisms;
of inclusion
Expiration
Entry into
force
Purity !
g/kg
IUPAC Name
pyrrolidone
m-tolyl)-2-
Common Name,
Identification
Numbers
No
the applicant submits to the Commission the
in point (4) within 2 years after the adoption of
principles of Annex VI, the conclusions of the
climatic conditions; they shall ensure that
information set out in points (1) and (2) by 1
December 2011, the information set out in point
(3) by 31 May 2013 and the information set out
the OECD test guidelines on endocrine
Only uses as herbicide on cotton may be
For the implementation of the uniform
review report on fluometuron, and in particular
Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and
Animal Health on 11 March 2011 shall be taken
(a) pay particular attention to the protection of
the operators and workers and ensure that
conditions of use include the application of
(b) pay particular attention to the protection of
the groundwater where the active substance is
applied in regions with vulnerable soil and/or
In this overall assessment Member States shall
adequate personal protective equipment;
Specific provisions
into account.
authorised.
disruption.
May PART A
PART B
of inclusion
Expiration
June 31
Entry into
force
Purity !
! 940 g/kg
CAS No: 2164-17- (#,#,# -trifluoro-
1,1-dimethyl-3-
IUPAC Name
m-tolyl)urea
Common Name,
CIPAC No: 159
Identification
Numbers
Fluometuron
No
B
and
and
conditions of authorisation include risk
mitigation measures and the obligation to carry
out monitoring programmes to verify potential
leaching of fluometuron and soil metabolites
trifluoromethylaniline in vulnerable areas,
(c) pay particular attention to the risk to non-
target soil macro-organisms others than
earthworms and non-target plants, and ensure
that conditions of au- thorisation include risk
The Member States concerned shall ensure that
the applicants submit to the Commission
(a) the toxicological properties of the plant
(b) the analytical methods for the monitoring of
(c) the analytical methods for the monitoring of
the soil metabolite trifluo- romethylaniline in
(d) the relevance for ground water of the soil
trifluoromethylaniline, if fluometuron is
classified under Regulation (EC) No 1272/2008
The Member States concerned shall ensure that
mitigation measures, where appropriate.
desmethyl-fluometuron
confirmatory information as regards
as “suspected of causing cancer”.
Specific provisions
metabolite trifluoroacetic acid;
desmethyl-fluometuron
fluometuron in air;
where appropriate;
soil and water;
metabolites
of inclusion
Expiration
Entry into
force
Purity !
IUPAC Name
Common Name,
Identification
Numbers
No
the applicants submit to the Commission the
31 March 2013 and the information set out in
point (d) within 6 months from the notification
For the implementation of the uniform principles
report on dithianon, and in particular Appendices
I and II thereof, as finalised in the Standing
Health on 11 March 2011 shall be taken into
(a) pay particular attention to the protection of
include risk mitigation measures, where
(b) pay particular attention to the operator safety;
adequate personal protective equipment, where
to birds; conditions of use shall include risk
information set out in points (a), (b) and (c) by
of Annex VI, the conclusions of the review
Committee on the Food Chain and Animal
aquatic organisms; conditions of use shall
conditions of use shall include the application of
(c) pay particular attention to the long-term risks
In this overall assessment Member States shall
Only uses as fungicide may be authorised.
of the decision classifying fluometuron.
mitigation measures, where appropriate.
Specific provisions
appropriate;
appropriate;
May PART A
PART B
account.
of inclusion
Expiration
June 31
Entry into
force
Purity !
! 930 g/kg
-b]-1,4- dithiine-
dioxonaphtho[2,3
2,3-dicarbonitrile
IUPAC Name
5,10-dihydro-
5,10-
CAS No: 3347-22-
Common Name,
CIPAC No: 153
Identification
Numbers
Dithianon
No
The Member States concerned shall request the
submission of confirmatory information as
(a) the storage stability and the nature of residues
(b) the aquatic and groundwater exposure
(c) the risk assessment for aquatic organisms
with respect to phthalic acid, phthalaldehyde and
The Member States concerned shall ensure that
the applicant submits such information to the
Only uses as acaricide on ornamentals in
For the implementation of the uniform principles
of Annex VI, the conclusions of the review
report on fenazaquin, and in particular
Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and
Animal Health on 11 March 2011 shall be taken
(1) pay particular attention to the protection of
In this overall assessment Member States shall
Specific provisions
greenhouses may be authorised.
Commission by 31 May 2013.
assessment for phthalic acid;
1,2 benzenedimethanol.
in processed products;
aquatic organisms;
into account.
May PART A
PART B
regards
of inclusion
Expiration
June 31
Entry into
force
Purity !
! 975 g/kg
quinazolin-4-yl
IUPAC Name
butylphenethyl
4-tert-
ether
CAS No: 120928-
Common Name,
CIPAC No: 693
Identification
Numbers
Fenazaquin
09-8
No
(2) pay particular attention to the risk to
(3) pay particular attention to the protection of
For the implementation of the uniform principles
II thereof, as finalised in the Standing Committee
(1) pay particular attention to the protection of
the workers’ safety and ensure that conditions of
(2) pay particular attention to the protection of
operators and ensure that conditions of use
include the application of adequate personal
bees and ensure that conditions of use include
(4) provide for conditions of use which ensure
that there are no residues of fenazaquin in crops
of Annex VI the conclusions of the review report
on flutriafol, and in particular Appendices I and
on the Food Chain and Animal Health on 11
use include the application of adequate personal
the groundwater, when the active substance is
applied in regions with vulnerable soil and/or
In this overall assessment Member States shall
risk mitigation measures, where appropriate;
Only uses as fungicide may be authorised.
March 2011, shall be taken into account.
for human and animal consumption.
Specific provisions
protective equipment;
protective equipment;
May PART A
PART B
of inclusion
Expiration
June 31
Entry into
force
g/kg 1
max
de: max content 1
max
dimethylformami
content 0,1 g/kg
content 1 g/kg
Purity !
impurities
(racemate)
methanol
sulphate
Relevant
dimethyl
g/kg
!
1,2,4- triazol-1-
ylmethyl)benzhyd
difluoro-#-(1H-
IUPAC Name
ryl alcohol
(RS)-2,4$-
CAS No: 76674-
Common Name,
CIPAC No: 436
Identification
Numbers
Flutriafol
21-0
No
(3) pay particular attention to the long-term risk
Conditions of authorisation shall include risk
The Member States concerned shall ensure that
the applicant submits to the Commission
(a) the relevance of the impurities present in the
(b) the residues of triazole derivative metabolites
(TDMs) in primary crops, rotational crops and
The Member States concerned shall ensure that
the applicant submits to the Commission the
information set out in point (a) by 1 December
2011, the information set out in points (b) and (c)
Only uses as a plant growth regulator on wheat
for hybrid seed production not intended for
For the implementation of the uniform principles
of Annex VI, the conclusions of the review
report on sintofen, and in particular Appendices I
(c) the long-term risk to insectivorous birds.
mitigation measures, where appropriate.
human consumption may be authorised.
confirmatory information as regards
Specific provisions
products of animal origin;
technical specifications;
to insectivorous birds.
climatic conditions;
by 31 May 2013.
May PART A
PART B
of inclusion
Expiration
June 31
Entry into
force
not more than
de, not more than
dimethylformami
methoxyethanol,
Purity !
Impurities
! 980 g/kg
0,25 g/kg
N,N-
2-
1,4-dihydro- 5-(2-
4- oxocinnoline-
3-carboxylic acid
methoxyethoxy)-
IUPAC Name
chlorophenyl)-
1-(4-
CAS No 130561-
Common Name,
Identification
CIPAC No 717
Numbers
Sintofen
48-7
No
Health on 11 March 2011 shall be taken into
pay particular attention to the risk to operators
and workers and shall ensure that conditions of
use include the application of adequate risk
mitigation measures. They shall ensure that
(1) the specification of the technical material, as
commercially manufactured, supported by
and II thereto, as finalised in the Standing
Committee on the Food Chain and Animal
In this overall assessment Member States shall
wheat treated with sintofen does not enter the
The Member States concerned shall request the
submission of confirmatory information as
(2) the relevance of the impurities present in the
technical specifications, except of the impurities
(3) the relevance of the test material used in the
toxicity and ecotoxicity dossiers in view of the
(4) the metabolic profile of sintofen in rotational
The Member States concerned shall ensure that
the applicant submits to the Commission: the
information set out in points (1) (2) and (3) by 1
2-methoxyethanol and N,N-dimethylformamide;
specification of the technical material;
Specific provisions
appropriate analytical data;
food and feed chain.
account.
regards
crops.
of inclusion
Expiration
Entry into
force
Purity !
1,5 g/kg
IUPAC Name
Common Name,
Identification
Numbers
No
December 2011 and the information set out in
For the implementation of the uniform principles
of Annex VI, the conclusions of the review
report on diclofop, and in particular Appendices
I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal
Health on 11 March 2011 shall be taken into
— pay particular attention to the operators and
workers safety and include as a condition
for authorisation the application of adequate
— pay particular attention to the risk to aquatic
organisms and non-target plants and require
The Member States concerned shall request the
submission of confirmatory information as
(b) an update of the risk assessment concerning
the possible environmental impact of the
preferential degradation/conversion of the
In this overall assessment Member States shall
risk mitigation measures to be applied.
Only uses as herbicide may be authorised.
personal protective equipment,
(a) a metabolism study on cereals;
Specific provisions
point (4) by 31 May 2013.
May PART A
PART B
regards
account.
of inclusion
Expiration
June 31
Entry into
force
as 2011
g/kg 1
dichlorophenoxy) diclofop-methyl)
Purity !
(expressed
!
CIPAC No 358.201 methyl (RS)-2-[4-
phenoxy]propiona
CAS No 257-141-8 phenoxy]propioni
dichlorophenoxy)
Diclofop-methyl
IUPAC Name
CAS No 40843-25- (RS)-2-[4-(2,4-
Diclofop
c acid
(2,4-
te
CIPAC No 358
(diclofop-methyl)
(diclofop-methyl)
Common Name,
Identification
Numbers
2 (parent)
Diclofop
(parent)
No
The Member States concerned shall ensure that
information set out in point (a) by 31 May 2013
and the information set out in point (b) at latest
For the implementation of the uniform principles
Health on 11 March 2011, shall be taken into
the applicant submits to the Commission the
2 years after the adoption of a specific guidance
of Annex VI the conclusions of the review report
on lime sulphur, and in particular Appendices I
and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal
In this overall assessment Member States shall
— operator safety and shall ensure that the
include
— to the protection of aquatic organisms and
non-target arthropods and shall ensure that
the conditions of use include risk mitigation
document on evaluation of isomers mixtures.
Only uses as insecticide may be authorised.
Only uses as fungicide may be authorised.
authorisation
appropriate protective measures,
Specific provisions
measures as appropriate.
pay particular attention to
of
conditions
isomers.
May PART A
May PART A
PART B
account.
of inclusion
Expiration
June 31
June 31
Entry into
force
as 1
azadirachtin A
Purity !
! 290 g/Kg.
Expressed
Azadirachtin A
IUPAC Name
CAS No: 1344 – 81 polysulfide
Calcium
CAS No: 11141-
Common Name,
Identification
CIPAC No: 17
Numbers
Lime sulphur
Azadirachtin
– 6
No
For the implementation of the uniform principles
of Annex VI the conclusions of the review report
on azadirachtin, and in particular Appendices I
and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal
Health on 11 March 2011, shall be taken into
In this overall assessment Member States shall
— the dietary exposure of consumers in view
— the protection of non-target arthropods and
mitigation
measures shall be applied where
The Member States concerned shall request the
submission of confirmatory information as
— the relationship between azadirachtin A and
the rest of the active components in the
neem seeds extract with respect to amount,
biological activity and persistence, in order
to confirm the lead active compound
approach with regard to azadirachtin A and
to confirm specification of the technical
of future revisions of Maximum Residue
Risk
Specific provisions
organisms.
pay particular attention to
appropriate.
Levels,
aquatic
PART B
regards
account.
of inclusion
Expiration
Entry into
force
the
aflatoxins B 1, B
must not exceed
300 µg/kg of the
A
2, G 1 and G 2
Purity !
azadirachtin
of
! 111 g/kg
content.
Sum
10- acetoxy-3,5-
6a-
n-1a(2H)- yl]-4-
2- methylbut-2-
[(1aR,2S,3aS,6aS,
c:4,5-b$c$]difuran-
b]oxireno[e]oxepi
enoyl]oxy}octahy
(2aR,3S,4S,4aR,5
methanofuro[2,3-
10R,10aS,10bR)-
methyl-8-{[(2E)-
IUPAC Name
tetrahydro-2,7-
dicarboxylate.
naphtho[1,8a-
dihydroxy-4-
hydroxy-7a-
3a,6a,7,7a-
5,10a(8H)-
S,7aS,8S,
dimethyl
7S,7aS)-
dro-1H-
methyl-
as
CIPAC No: 627 as
Common Name,
Identification
azadirachtin A
azadirachtin A
Numbers
17-6
No
The Member States concerned shall ensure that
For the implementation of the uniform principles
report on aluminium sulphate, and in particular
Standing Committee on the Food Chain and
material, as commercially manufactured, in the
the applicant submits such information to the
prepared baits placed into the rodent tunnels may
material, residue definition and groundwater
the applicant submits such information to the
Only indoor uses as post-harvest bactericide for
of Annex VI, the conclusions of the review
Appendices I and II thereof, as finalised in the
Animal Health on 11 March 2011 shall be taken
The Member States concerned shall request the
submission of confirmatory information as
regards the specification of the technical
The Member States concerned shall ensure that
Only uses as rodenticide in the form of pre-
ornamental plants may be authorised.
Commission by 31 December 2013.
form of appropriate analytical data.
Commission by 1 December 2011
Specific provisions
risk assessment.
into account.
May PART A
May PART A
PART B
of inclusion
Expiration
June 31
June 31
Entry into
force
Purity !
! 970 g/kg
970 g/kg
3-(4$-
CAS No: 28772- [(1RS,3RS;1RS,3
IUPAC Name
Aluminium
sulphate
SR)-
3-
CAS No: 10043-
not
Common Name,
Identification
Numbers
bromadiolone
Aluminium
available
sulphate
CIPAC
01-3
56-7
No
The nominal concentration of the active
substance in the plant protection products shall
Authorisations shall be granted for uses by
For the implementation of the uniform principles
of Annex VI, the conclusions of the review
report on bromadiolone, and in particular
Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and
Animal Health on 11 March 2011 shall be taken
— pay particular attention to the risk to
professional operators and ensure that
conditions of use include the application of
adequate personal protective equipment
— pay particular attention to the risk to birds
and non-target mammals from primary and
Conditions of authorisation shall include risk
The Member States concerned shall request the
submission of confirmatory information as
In this overall assessment Member States shall
mitigation measures, where appropriate.
Specific provisions
secondary poisoning.
professional users only.
where appropriate,
not exceed 50 mg/kg.
be authorised.
into account.
PART B
of inclusion
Expiration
Entry into
force
Purity !
bromobiphenyl-4-
hydroxycoumarin
phenylpropyl]-4-
yl)-3-hydroxy-1-
IUPAC Name
Common Name,
CIPAC No: 371
Identification
Numbers
No
The Member States concerned shall ensure that
For the implementation of the uniform principles
Standing Committee on the Food Chain and
(a) the specification of the technical material, as
commercially manufactured, in the form of
(c) the determination of bromadiolone in water
(d) the effectiveness of proposed mitigation
measures to reduce risk to birds and non- target
(e) the groundwater exposure assessment in
the applicant submits to the Commission the
information set out in points (a), (b) and (c) by
30 November 2011 and the information set out
Only uses as plant growth regulator may be
of Annex VI, the conclusions of the review
report on paclobutrazol, and in particular
Appendices I and II thereof, as finalised in the
Animal Health on 11 March 2011 shall be taken
with a limit of quantification of 0,01 µg/l;
in points (d) and (e) by 31 May 2013.
(b) the relevance of the impurities;
Specific provisions
appropriate analytical data;
respect of metabolites.
mammals;
authorised.
May PART A
regards
PART B
of inclusion
Expiration
June 31
Entry into
force
Purity !
! 930 g/kg
(1H-1,2,4-triazol-
1- yl)pentan-3-ol
(2RS,3RS)-1-(4-
4,4-dimethyl-2-
IUPAC Name
chlorophenyl)-
CAS No: 76738-
Common Name,
CIPAC No: 445
Identification
Numbers
Paclobutrazol
62-0
No
In this overall assessment Member States shall
pay particular attention to the risk to aquatic
plants and ensure that conditions of use include
The Member States concerned shall request the
submission of confirmatory information as
(1) the specification of the technical material, as
(2) the analytical methods in soil and surface
(3) the residues of triazole derivative metabolites
(TDMs) in primary crops, rotational crops and
(4) the potential endocrine disrupting properties
(5) the potential adverse effects of breakdown
products of the different optical structures of
paclobutrazol and its metabolite CGA 149907 on
the environmental compartments soil, water and
The Member States concerned shall ensure that
the applicant submits to the Commission the
information set out in points (1) and (2) by 30
November 2011, the information set out in points
(3) by 31 May 2013, the information set out in
point (4) within two years after the adoption of
the risk mitigation measures, where appropriate.
water for the metabolite NOA457654;
Specific provisions
commercially manufactured;
products of animal origin;
of paclobutrazol;
into account.
regards
air.
of inclusion
Expiration
Entry into
force
Purity !
IUPAC Name
Common Name,
Identification
Numbers
No
For the implementation of the uniform principles
Standing Committee on the Food Chain and
pay particular attention to the protection of large
(1) the fate and behaviour in soil of the
(2) the fate and behaviour in natural surface
the OECD test guidelines on endocrine
disruption and the information set out in point
(5) within two years after the adoption of
of Annex VI, the conclusions of the review
report on pencycuron, and in particular
Appendices I and II thereof, as finalised in the
Animal Health on 11 March 2011 shall be taken
In this overall assessment Member States shall
Conditions of use shall include risk mitigation
The Member States concerned shall request the
submission of confirmatory information as
chlorophenyl and cyclopentyl portions of
water and sediment systems of the chlorophenyl
Only uses as fungicide may be authorised.
Specific provisions
measures, where appropriate.
omnivorous mammals.
specific guidance.
into account.
pencycuron;
May PART A
PART B
regards
of inclusion
Expiration
June 31
Entry into
force
Purity !
! 980 g/kg
chlorobenzyl)-1-
IUPAC Name
cyclopentyl-3-
phenylurea
1-(4-
CAS No 66063-05-
Common Name,
Identification
CIPAC No 402
Numbers
Pencycuron
No
the applicant submits to the Commission the
information set out in points (1), (2) and (3) by
For the implementation of the uniform principles
of Annex VI, the conclusions of the review
report on tebufenozide, and in particular
Standing Committee on the Food Chain and
(1) pay particular attention to the safety of
operators and workers after re-entry and ensure
(2) pay particular attention to the protection of
(3) pay particular attention to the protection of
(3) the long-term risk to large omnivorous
The Member States concerned shall ensure that
Appendices I and II thereof, as finalised in the
Animal Health on 11 March 2011 shall be taken
that conditions of authorisation prescribe
groundwater, when the active substance is
applied in regions with vulnerable soil and/or
In this overall assessment Member States shall
Only uses as insecticide may be authorised.
and phenyl portions of pencycuron;
appropriate protective equipment;
Specific provisions
climatic conditions;
31 May 2013.
into account.
mammals.
May PART A
PART B
of inclusion
Expiration
June 31
Entry into
force
Relevant impurity 2011
t-butyl hydrazine
< 0,001 g/kg
Purity !
! 970 g/kg
(4-ethylbenzoyl)-
dimethylbenzohy
N-tert-butyl-N$-
IUPAC Name
drazide
3,5-
CAS No: 112410-
Common Name,
CIPAC No: 724
Identification
Numbers
Tebufenozide
23-8
No
Health on 11 March 2011, shall be taken into
aquatic organisms and ensure that conditions of
(4) pay particular attention to the risk to
Conditions of authorisation shall include risk
The Member States concerned shall request the
submission of confirmatory information, as
(1) the relevance of metabolites RH-6595, RH-
(2) the degradation of tebufenozide in anaerobic
The Member States concerned shall ensure that
the applicant submits to the Commission the
information set out in points (1) and (2) by 31
For the implementation of the uniform principles
of Annex VI the conclusions of the review report
on carbetamide, and in particular Appendices I
and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal
use prescribe adequate mitigation measures;
Only uses as herbicide may be authorised.
mitigation measures, where appropriate.
Specific provisions
Lepidoptera non- target insects.
soils and soils of alkaline pH.
May 2013.
2651, M2;
May PART A
PART B
account.
regards
of inclusion
Expiration
June 31
Entry into
force
Purity !
! 950 g/kg
CAS No: 16118- (Ethylcarbamoyl)
ethyl carbanilate
IUPAC Name
(R)-1-
Common Name,
Identification
CIPAC No: 95
Numbers
Carbetamide
49-3
No
(a) the protection of groundwater, when the
Only uses as fungicide for seed treatment may be
Member States shall ensure that authorisations
exclusively in professional seed treatment
facilities and that these facilities apply the best
report on carboxin, and in particular Appendices
I and II thereof, as finalised in the Standing
Health on 11 March 2011 shall be taken into
In this overall assessment Member States shall
active substance is applied in regions with
Conditions of use shall include risk mitigation
provide that seed coating be performed
available techniques to exclude the release of
dust clouds during storage, transport and
For the implementation of the uniform principles
of Annex VI, the conclusions of the review
Committee on the Food Chain and Animal
vulnerable soil and/or climatic conditions;
Specific provisions
(c) the risk to aquatic organisms.
(b) the risk to non-target plants;
measures, where appropriate.
pay particular attention to
application.
authorised.
May PART A
PART B
account.
of inclusion
Expiration
June 31
Entry into
force
Purity !
! 970 g/kg
IUPAC Name
5,6-dihydro-2-
carboxanilide
oxathiine-3-
methyl-1,4-
CAS No: 5234-68-
Common Name,
CIPAC No: 273
Identification
Numbers
Carboxin
No
B
[2-
(a) the specification of the technical material, as
(e) additional values regarding the period
In this overall assessment Member States shall
(b) the protection of groundwater, when the
active substance is applied in regions with
Conditions of use shall include risk mitigation
The Member States concerned shall request the
submission of confirmatory information as
including
(c) comparison and verification of the test
material used in the mammalian toxicity and
ecotoxicity dossiers against the specification of
(d) analytical methods for the monitoring of the
{[anilino(oxo)acetyl]sulfanyl}ethyl acetate.] in
soil, groundwater and surface water and for the
monitoring of metabolite M9 [(2RS)-2-hydroxy-
vulnerable soil and/or climatic conditions;
carboxamide 4-oxide.] in groundwater;
2-methyl-N-phenyl-1,4-oxathiane-3-
(b) the relevance of the impurities;
(c) the risk to birds and mammals.
manufactured,
Specific provisions
measures, where appropriate.
appropriate analytical data;
pay particular attention to
(a) the risk to operators;
the technical material;
commercially
metabolite
regards
of inclusion
Expiration
Entry into
force
Purity !
IUPAC Name
Common Name,
Identification
Numbers
No
required for 50 percent dissipation in soil for the
soil metabolites P/V-54 [2-methyl-5,6-dihydro-
1,4-oxathiine-3-carboxamide 4-oxide] and P/V-
[2-methyl-5,6-dihydro-1,4-oxathiine-3-
(g) the long-term risk to granivorous birds,
herbivorous
(h) the relevance for ground water of the soil
metabolites P/V-54, P/V-55 and M9 if carboxin
is classified under Regulation (EC) No
The Member States concerned shall ensure that
the applicant submits to the Commission the
information set out in points (a), (b) and (c) by 1
December 2011, the information set out in points
(d), (e), (f) and (g) by 31 May 2013 and the
information set out in point (h) within six months
after the notification of the Decision classifying
For the implementation of the uniform principles
of Annex VI, the conclusions of the review
report on cyproconazole, and in particular
1272/2008 as “suspected of causing cancer”.
Only uses as fungicide may be authorised.
and
Specific provisions
(f) rotational crop metabolism;
carboxamide 4,4-dioxide.];
mammals
granivorous
mammals;
carboxin.
May PART A
PART B
of inclusion
Expiration
June 31
Entry into
force
Purity !
(2RS,3RS;2RS,3S ! 940 g/kg
(1H-1,2,4- triazol-
chlorophenyl)-3-
IUPAC Name
1-yl)butan-2-ol
cyclopropyl-1-
R)-2-(4-
CAS No: 94361-
Common Name,
CIPAC No: 600
Identification
Cyproconazole
Numbers
06-5
No
Standing Committee on the Food Chain and
residues of triazole derivative metabolites
use shall include risk mitigation measures, where
(a) the toxicological relevance of the impurities
(c) residues of triazole derivative metabolites
(e) the possible environmental impact of the
preferential degradation and/or conversion of the
the applicant submits to the Commission the
Appendices I and II thereof, as finalised in the
Animal Health on 11 March 2011 shall be taken
In this overall assessment Member States shall
(a) the dietary exposure of consumers to the
(b) the risk to aquatic organisms. Conditions of
The Member States concerned shall request the
submission of confirmatory information as
(b) analytical methods for the monitoring of
(TDMs) in primary crops, rotational crops and
The Member States concerned shall ensure that
(d) the long-term risk to herbivorous mammals;
cyproconazole in soil, body fluids and tissues;
Specific provisions
in the technical specification;
pay particular attention to
products of animal origin;
mixture of isomers.
into account.
appropriate.
(TDMs);
regards
of inclusion
Expiration
Entry into
force
Purity !
IUPAC Name
Common Name,
Identification
Numbers
No
information set out in point (a) by 1 December
2011, the information set out in points (b), (c)
out in point (e) within two years after the
Only uses as nematicide, fungicide, herbicide
and insecticide may be authorised. Only
application as soil fumigant may be authorised.
Use shall be limited to one application every
For the implementation of the uniform principles
of Annex VI, the conclusions of the review
report on dazomet, and in particular Appendices
I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal
Health on 11 March 2011 shall be taken into
In this overall assessment Member States shall
(b) the protection of groundwater, when the
active substance is applied in regions with
Conditions of use shall include risk mitigation
and (d) by 31 May 2013 and the information set
(a) the risk to operators, workers and bystanders;
vulnerable soil and/or climatic conditions;
Specific provisions
(c) the risk to aquatic organisms.
adoption of specific guidance.
pay particular attention to
third year.
May PART A
PART B
account.
of inclusion
Expiration
June 31
Entry into
force
Purity !
! 950 g/kg
or
dimethyl- 1,3,5-
thiadiazinane-2-
IUPAC Name
tetrahydro-3,5-
thiadiazine-2-
3,5-dimethyl-
thione
thione
1,3,5-
CAS No: 533-74-4
Common Name,
CIPAC No: 146
Identification
Numbers
Dazomet
No
The Member States concerned shall request the
submission of confirmatory information as
(a) the potential groundwater contamination by
(b) the assessment of the long range atmospheric
transport potential of methyl isothiocyanate and
The Member States concerned shall ensure that
the applicant submits to the Commission the
information set out in points (a), (b), (c) and (d)
For the implementation of the uniform principles
of Annex VI, the conclusions of the review
report on metaldehyde, and in particular
Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and
Animal Health on 11 March 2011 shall be taken
In this overall assessment Member States shall
Only uses as molluscicide may be authorised.
(d) the long term risk to birds and mammals.
(c) the acute risk to insectivorous birds;
Specific provisions
measures, where appropriate.
related environmental risks;
pay particular attention to
methyl isothiocyanate;
by 31 May 2013.
into account.
May PART A
PART B
regards
of inclusion
Expiration
June 31
Entry into
force
max. 1,5 g/kg
acetaldehyde
Purity !
r-2, c-4, c-6, c-8- ! 985 g/kg
IUPAC Name
tetramethyl-
tetroxocane
1,3,5,7-
CAS No: 108-62-3
(tetramer) 9002-91-
9 (homopolymer)
Common Name,
Identification
CIPAC No: 62
Numbers
Metaldehyde
No
(b) the dietary exposure situation of consumers
in view of future revisions of maximum residue
(c) the acute risk and long-term risk to birds and
Member States shall ensure that authorisations
shall contain an effective dog repellent agent.
Conditions of use shall include risk mitigation
For the implementation of the uniform principles
of Annex VI, the conclusions of the review
report on hexythiazox, and in particular
Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and
Animal Health on 11 March 2011 shall be taken
In this overall assessment Member States shall
— the protection of aquatic organisms.
Conditions of use shall include risk
— the operators and workers safety.
Conditions of use shall include protective
mitigation measures, where appropriate,
Only uses as acaricide may be authorised.
(a) the risk to operators and workers;
Specific provisions
measures, where appropriate
pay particular attention to
into account.
mammals.
May PART A
PART B
levels;
of inclusion
Expiration
June 31
Entry into
force
CAS No 78587-05- chlorophenyl)-N- (1:1 mixture of 2011
(4R, 5R) and (4S,
Purity !
! 976 g/kg
methyl-2-oxo-1,3- 5S))
(4RS,5RS)-5-(4-
IUPAC Name
thiazolidine-3-
cyclohexyl-4-
carboxamide
Common Name,
Identification
CIPAC No 439
Numbers
Hexythiazox
No
The Member States concerned shall request the
submission of confirmatory information as
(b) the potential occurrence of the metabolite
(c) the potential adverse effects of hexythiazox
(d) the possible impact of the preferential
degradation and/or conversion of the mixture of
isomers on the worker risk assessment, the
The Member States concerned shall ensure that
the applicant submits to the Commission the
information set out in points (a), (b) and (c) by
31 May 2013 and the information set out in
point (d) 2 years after the adoption of specific
Only uses as fungicide for seed pelleting of sugar
beets in professional seed treatment facilities
consumer risk assessment and the environment.
(a) the toxicological relevance of the metabolite
chlorophenyl)-4-methyl-1,3-thiazolidin-2-one.];
PT-1-3 [(4S,5S)-5-(4-chlorophenyl)-4-methyl-
1,3-thiazolidin-2-one and (4R,5R)-5-(4-
PT-1-3 in processed commodities;
measures, where appropriate.
Specific provisions
may be authorised.
on bee brood;
guidance.
May PART A
regards
PART B
of inclusion
Expiration
June 31
Entry into
force
Purity !
5-methylisoxazol- ! 985 g/kg
CAS No: 10004- 3-ol (or 5-methyl-
1,2-oxazol-3-ol)
IUPAC Name
Common Name,
CIPAC No: 528
Identification
Numbers
Hymexazol
44-1
No
For the implementation of the uniform principles
of Annex VI, the conclusions of the review
report on hymexazol, and in particular
Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and
Animal Health on 23 November 2010 shall be
In this overall assessment Member States shall
of authorisation shall include protective
— the risk to granivorous birds and mammals.
Conditions of use shall include risk mitigation
The Member States concerned shall request the
regards the nature of residues in root crops and
the risk for granivorous birds and mammals. The
Member States concerned shall ensure that the
applicant submits such confirmatory information
— the operators and workers safety. Conditions
submission of confirmatory information as
to the Commission by 31 May 2013.”
Specific provisions
measures, where appropriate,
measures, where appropriate.
pay particular attention to
taken into account.
of inclusion
Expiration
Entry into
force
Purity !
IUPAC Name
Common Name,
Identification
Numbers
No
€5.22