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30.8.2013 Official
Journal
of
the
European
Union L
232/23
COMMISSION IMPLEMENTING REGULATION (EU) No 828/2013
of 29 August 2013
approving the active substance emamectin, in accordance with Regulation (EC) No 1107/2009 of the
European Parliament and of the Council concerning the placing of plant protection products on the
market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Health and finalised on 16 July 2013 in the format of
the Commission review report for emamectin.
Having regard to the Treaty on the Functioning of the European
Union,
(5)
It has appeared from the various examinations made that
plant protection products containing emamectin may be
Having regard to Regulation (EC) No 1107/2009 of the
expected to satisfy, in general, the requirements laid
European Parliament and of the Council of 21 October 2009
down in Article 5(1)(a) and (b) and Article 5(3) of
concerning the placing of plant protection products on the
Directive 91/414/EEC, in particular with regard to the
market and repealing Council Directives 79/117/EEC and
uses which were examined and detailed in the
91/414/EEC ( 1 ), and in particular Article 13(2) and Article 78(2)
Commission review report. It is therefore appropriate
thereof,
to approve emamectin.
Whereas:
(6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No 1107/2009 in conjunction with Article 6 thereof
and in the light of current scientific and technical
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No 1107/2009, Council Directive 91/414/EEC (
knowledge, it is, however, necessary to include certain

2 ) is to
apply, with respect to the procedure and the conditions
conditions and restrictions. It is, in particular, appropriate
for approval, to active substances for which a decision
to require further confirmatory information.
has been adopted in accordance with Article 6(3) of that
Directive before 14 June 2011. For emamectin the
(7) A
reasonable
period
should
be
allowed
to
elapse
before
conditions of Article 80(1)(a) of Regulation (EC) No
approval in order to permit Member States and the
1107/2009 are fulfilled by Commission Decision
interested parties to prepare themselves to meet the
2007/669/EC (
new requirements resulting from the approval.

3 ).
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC (8) Without
prejudice
to
the
obligations
provided
for
in
the Netherlands received on 23 June 2006 an application
Regulation (EC) No 1107/2009 as a consequence of
from Syngenta Crop Protection AG for the inclusion of
approval, taking into account the specific situation
the active substance emamectin in Annex I to Directive
created by the transition from Directive 91/414/EEC to
91/414/EEC. Decision 2007/669/EC confirmed that the
Regulation (EC) No 1107/2009, the following should,
dossier was ‘complete’ in the sense that it could be
however, apply. Member States should be allowed a
considered as satisfying, in principle, the data and
period of six months after approval to review authori
information requirements of Annexes II and III to
sations of plant protection products containing
Directive 91/414/EEC.
emamectin. Member States should, as appropriate, vary,
replace or withdraw authorisations. By way of derogation
from that deadline, a longer period should be provided
(3) For
that
active
substance,
the
effects
on
human
and
for the submission and assessment of the complete
animal health and the environment have been assessed,
Annex III dossier, as set out in Directive 91/414/EEC,
in accordance with the provisions of Article 6(2) and (4)
of each plant protection product for each intended use
of Directive 91/414/EEC, for the uses proposed by the
in accordance with the uniform principles.
applicant. The designated rapporteur Member State

submitted a draft assessment report on 6 March 2008.
(9) The
experience
gained
from
inclusions
in
Annex
I
to
Directive 91/414/EEC of active substances assessed in
(4) The
draft
assessment
report
was
reviewed
by
the
Member
the framework of Commission Regulation (EEC) No
States and the European Food Safety Authority (here
3600/92 of 11 December 1992 laying down the
inafter ‘the Authority’). The Authority presented to the
detailed rules for the implementation of the first stage
Commission its conclusion ( 4 ) on the pesticide risk
of the programme of work referred to in Article 8(2) of
assessment of the active substance emamectin on
Council Directive 91/414/EEC concerning the placing of
13 November 2012. The draft assessment report and
plant protection products on the market (
the conclusion of the Authority were reviewed by the

5 ) has shown
that difficulties can arise in interpreting the duties of
Member States and the Commission within the
holders of existing authorisations in relation to access
Standing Committee on the Food Chain and Animal
to data. In order to avoid further difficulties it therefore
appears necessary to clarify the duties of the Member
( 1 ) OJ L 309, 24.11.2009, p. 1.
States, especially the duty to verify that the holder
( 2 ) OJ L 230, 19.8.1991, p. 1.
of an authorisation demonstrates access to a dossier
( 3 ) OJ L 274, 18.10.2007, p. 15.
( 4 ) EFSA Journal 2012; 10(11):2955. Available online: www.efsa.europa.
eu
( 5 ) OJ L 366, 15.12.1992, p. 10.

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L 232/24
EN
Official Journal of the European Union
30.8.2013
satisfying the requirements of Annex II to that Directive.
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
However, this clarification does not impose any new
orised plant protection product containing emamectin as either
obligations on Member States or holders of authori
the only active substance or as one of several active substances,
sations compared to the Directives which have been
all of which were listed in the Annex to Implementing Regu
adopted until now amending Annex I to that Directive
lation (EU) No 540/2011 by 30 April 2014 at the latest,
or the Regulations approving active substances.
Member States shall re-evaluate the product in accordance
with the uniform principles, as referred to in Article 29(6) of
(10) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
Regulation (EC) No 1107/2009, on the basis of a dossier
1107/2009, the Annex to Commission Implementing
satisfying the requirements of Annex III to Directive
Regulation (EU) No 540/2011 of 25 May 2011 imple
91/414/EEC and taking into account the column on specific
menting Regulation (EC) No 1107/2009 of the European
provisions of Annex I to this Regulation. On the basis of that
Parliament and of the Council as regards the list of
evaluation, they shall determine whether the product satisfies
approved active substances
(
the conditions set out in Article 29(1) of Regulation (EC)

1 ) should be amended
accordingly.
No 1107/2009.
Following that determination Member States shall:
(11) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
(a) in the case of a product containing emamectin as the only
Committee on the Food Chain and Animal Health,
active substance, where necessary, amend or withdraw the
authorisation by 31 October 2015 at the latest; or
HAS ADOPTED THIS REGULATION:
(b) in the case of a product containing emamectin as one of
Article 1
several active substances, where necessary, amend or
withdraw the authorisation by 31 October 2015 or by
Approval of active substance
the date fixed for such an amendment or withdrawal in
The active substance emamectin, as specified in Annex I, is
the respective act or acts which added the relevant
approved subject to the conditions laid down in that Annex.
substance or substances to Annex I to Directive 91/414/EEC
or approved that substance or those substances, whichever
is the latest.
Article 2
Re-evaluation of plant protection products
Article 3
1. Member
States
shall
in
accordance
with
Regulation
(EC)
Amendments to Implementing Regulation (EU)
No 1107/2009, where necessary, amend or withdraw existing
No 540/2011
authorisations for plant protection products containing
The Annex to Implementing Regulation (EU) No 540/2011 is
emamectin as an active substance by 31 October 2014.
amended in accordance with Annex II to this Regulation.
By that date they shall in particular verify that the conditions in
Article 4
Annex I to this Regulation are met, with the exception of those
Entry into force and date of application
identified in the column on specific provisions of that Annex,
and that the holder of the authorisation has, or has access to, a
This Regulation shall enter into force on the twentieth day
dossier satisfying the requirements of Annex II to Directive
following that of its publication in the Official Journal of the
91/414/EEC in accordance with the conditions of Article 13(1)
European Union.
to (4) of that Directive and Article 62 of Regulation (EC)
No 1107/2009.
It shall apply from 1 May 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 August 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 153, 11.6.2011, p. 1.

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30.8.2013 Off
ANNEX I
Common name,
IUPAC name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
identification numbers
Emamectin
Emamectin B1a:
≥ 950 g/kg
1 May 2014 30
April
2024
For the implementation of the uniform principles as
EN
referred to in Article 29(6) of Regulation (EC) No

CAS No
as emamectin benzoate
(10.,14E,16E)-
1107/2009, the conclusions of the review report on
emamectin: 119791-41-2
anhydrous
(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,2
emamectin, and in particular Appendices I and II thereof,
(a mixture of min. 920 g/kg
as finalised in the Standing Committee on the Food Chain
(formerly 137335-79-6)
1R,24S)-6′-[(S)-sec-butyl]-21,24-dihy
emamectin B1a benzoate
and Animal Health on 16 July 2013 shall be taken into
and 123997-28-4
droxy-5′,11,13,22-tetramethyl-2-oxo-
(3,7,19-trioxatetra
and max. 50 g/kg
account.
emamectin benzoate:
cyclo[15.6.1.14,8 .020,24 ]pentacosa-
emamectin B1b benzoate)
In this overall assessment Member States shall pay particular
155569-91-8
10,14,16,22-tetraene)-6-spiro-2′-
(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-
attention to:
(formerly 137512-74-4
dideoxy-3-O-methyl-4-O-(2,4,6-
— the risk to non-target invertebrates;
and 179607-18-2)
trideoxy-3-O-methyl-4-methylamino-
α-L-lyxo-hexapyranosyl)-α-L-arabino-
icial
— the protection of workers and operators.
emamectin B1a benzoate: hexapyranoside
Jour
138511-97-4
Conditions of use shall include risk mitigation measures,
Emamectin B1b:
where appropriate.
nal
emamectin B1b benzoate:
138511-98-5
of
(10E,14E,16E)-
The applicant shall submit confirmatory information as
the
regards the risk of enantio-selective metabolisation or degra
CIPAC No
(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,2
dation.
European
emamectin: 791
1R,24S)-21,24-dihydroxy-6′-
isopropyl-5′,11,13,22-tetramethyl-2-
The applicant shall submit to the Commission, Member
emamectin benzoate:
oxo-(3,7,19-trioxatetra
States and the Authority the relevant information two
791.412
cyclo[15.6.1.14,8 .020,24 ]pentacosa-
10,14,16,22-tetraene)-6-spiro-2′-
years after adoption of the pertinent guidance document
Union
(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-
on evaluation of isomer mixtures.
dideoxy-3-O-methyl-4-O-(2,4,6-
trideoxy-3-O-methyl-4-methylamino-
α-L-lyxo-hexapyranosyl)-α-L-arabino-
hexapyranoside
Emamectin B1a benzoate:
(10E,14E,16E)-
(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,2
1R,24S)-6′-[(S)-sec-butyl]-21,24-dihy
droxy-5′,11,13,22-tetramethyl-2-oxo-
(3,7,19-trioxatetra
cyclo[15.6.1.14,8 .020,24 ]pentacosa-
10,14,16,22-tetraene)-6-spiro-2′-
(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-
dideoxy-3-O-methyl-4-O-(2,4,6-
L
trideoxy-3-O-methyl-4-methylamino-
232/25
α-L-lyxo-hexapyranosyl)-α-L-arabino-
hexapyranoside benzoate

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L 232/26
Common name,
IUPAC name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
identification numbers
Emamectin B1b benzoate:
(10E,14E,16E)-
(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,2
1R,24S)-21,24-dihydroxy-6′-
EN

isopropyl-5′,11,13,22-tetramethyl-2-
oxo-(3,7,19-trioxatetra
cyclo[15.6.1.14,8 .020,24 ]pentacosa-
10,14,16,22-tetraene)-6-spiro-2′-
(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-
dideoxy-3-O-methyl-4-O-(2,4,6-
trideoxy-3-O-methyl-4-methylamino-
α-L-lyxo-hexapyranosyl)-α-L-arabino-
hexapyranoside benzoate
Off
(1 ) Further details on identity and specification of active substance are provided in the review report.
icial
Jour
nal
of
the
European
Union
30.8.2013

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30.8.2013 Off
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Number
Common name,
identification numbers
IUPAC name Purity
(1 ) Date
of
approval
Expiration of
approval
Specific provisions
EN
‘49 Emamectin
Emamectin B1a:
≥ 950 g/kg
1 May 2014 30
April
2024 For the implementation of the uniform principles as referred to in

Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the
CAS No
(10E,14E,16E)-
as emamectin
review report on emamectin, and in particular Appendices I and II
emamectin: 119791-41-2 (1R,4S,5′S,6S,6′R,8R,12S,13S,20
benzoate anhydrous
thereof, as finalised in the Standing Committee on the Food Chain and
R,21R,24S)-6′-[(S)-sec-butyl]-
Animal Health on 16 July 2013 shall be taken into account.
(formerly 137335-79-6)
21,24-dihydroxy-5′,11,13,22-tetra (a mixture of min.
and 123997-28-4
methyl-2-oxo-(3,7,19-trioxatetra
920 g/kg emamectin
In this overall assessment Member States shall pay particular attention
cyclo[15.6.1.14,8 .020,24 ]pentacosa-
B1a benzoate and
to:
emamectin benzoate:
10,14,16,22-tetraene)-6-spiro-2′-
max. 50 g/kg
155569-91-8
(5′,6′-dihydro-2′H-pyran)-12-yl
emamectin B1b
— the risk to non-target invertebrates;
2,6-dideoxy-3-O-methyl-4-O-
benzoate)
(formerly 137512-74-4
(2,4,6-trideoxy-3-O-methyl-4-
— the protection of workers and operators.
and 179607-18-2)
icial
methylamino-α-L-lyxo-hexapyr
anosyl)-α-L-arabino-hexapyranoside
Conditions of use shall include risk mitigation measures, where
emamectin B1a benzoate:
appropriate.
Jour
138511-97-4
Emamectin B1b:
nal
The applicant shall submit confirmatory information as regards the risk
emamectin B1b benzoate: (10E,14E,16E)-
of enantio-selective metabolisation or degradation.
of
138511-98-5
(1R,4S,5′S,6S,6′R,8R,12S,13S,20
the
R,21R,24S)-21,24-dihydroxy-6′-
The applicant shall submit to the Commission, Member States and the
European
CIPAC No
isopropyl-5′,11,13,22-tetramethyl-
Authority the relevant information two years after adoption of the
emamectin: 791
2-oxo-(3,7,19-trioxatetra
pertinent guidance document on evaluation of isomer mixtures.’
cyclo[15.6.1.14,8 .020,24 ]pentacosa-
emamectin benzoate:
10,14,16,22-tetraene)-6-spiro-2′-
Union
791.412
(5′,6′-dihydro-2′H-pyran)-12-yl
2,6-dideoxy-3-O-methyl-4-O-
(2,4,6-trideoxy-3-O-methyl-4-
methylamino-α-L-lyxo-hexapyr
anosyl)-α-L-arabino-hexapyranoside
Emamectin B1a benzoate:
(10E,14E,16E)-
(1R,4S,5′S,6S,6′R,8R,12S,13S,20
R,21R,24S)-6′-[(S)-sec-butyl]-
21,24-dihydroxy-5′,11,13,22-tetra
methyl-2-oxo-(3,7,19-trioxatetra
cyclo[15.6.1.14,8 .020,24 ]pentacosa-
10,14,16,22-tetraene)-6-spiro-2′-
(5′,6′-dihydro-2′H-pyran)-12-yl
2,6-dideoxy-3-O-methyl-4-O-
(2,4,6-trideoxy-3-O-methyl-4-
L
methylamino-α-L-lyxo-hexapyr
232/27
anosyl)-α-L-arabino-hexapyranoside
benzoate

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L 232/28
Number
Common name,
identification numbers
IUPAC name Purity
(1 ) Date
of
approval
Expiration of
approval
Specific provisions
Emamectin B1b benzoate:
(10E,14E,16E)-
(1R,4S,5′S,6S,6′R,8R,12S,13S,20
R,21R,24S)-21,24-dihydroxy-6′-
EN
isopropyl-5′,11,13,22-tetramethyl-

2-oxo-(3,7,19-trioxatetra
cyclo[15.6.1.14,8 .020,24 ]pentacosa-
10,14,16,22-tetraene)-6-spiro-2′-
(5′,6′-dihydro-2′H-pyran)-12-yl
2,6-dideoxy-3-O-methyl-4-O-
(2,4,6-trideoxy-3-O-methyl-4-
methylamino-α-L-lyxo-hexapyr
anosyl)-α-L-arabino-hexapyranoside
benzoate
Off
(1 ) Further details on identity and specification of active substance are provided in the review report.
icial
Jour
nal
of
the
European
Union
30.8.2013

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