HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 209/18
EN
Official Journal of the European Union
17.8.2011
COMMISSION IMPLEMENTING REGULATION (EU) No 820/2011
of 16 August 2011
approving the active substance terbuthylazine, 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
and Commission Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
substances in Annex I to Council Directive 91/414/EEC
and the withdrawal of authorisations for plant protection
Having regard to the Treaty on the Functioning of the European
products containing these substances ( 7 ) was adopted on
Union,
the non-inclusion of terbuthylazine.
Having regard to Regulation (EC) No 1107/2009 of the
(4) Pursuant
to
Article
6(2)
of
Directive
91/414/EEC
the
European Parliament and of the Council of 21 October 2009
original notifier (hereinafter ‘the applicant’) submitted a
concerning the placing of plant protection products on the
new application requesting the accelerated procedure to
market and repealing Council Directives 79/117/EEC and
be applied, as provided for in Articles 14 to 19 of Regu
91/414/EEC (
lation (EC) No 33/2008 laying down detailed rules for

1 ), and in particular Article 13(2) and
Article 78(2) thereof,
the application of Directive 91/414/EEC as regards a
regular and an accelerated procedure for the assessment
of active substances which were part of the programme
Whereas:
of work referred to in Article 8(2) of that Directive but
have not been included into its Annex I.
(1) In
accordance
with
Article
80(1)(c)
of
Regulation
(EC)
No
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply
(5) The
application
was
submitted
to
the
United
Kingdom,
to active substances for which completeness has been
which had been designated rapporteur Member State by
established in accordance with Article 16 of Commission
Regulation (EC) No 1490/2002. The time period for the
Regulation (EC) No 33/2008 ( 3 ), with respect to the
accelerated procedure was respected. The specification of
procedure and the conditions for approval. Terbuthy
the active substance and the supported uses are the same
lazine is an active substance for which completeness
as were the subject of Decision 2008/934/EC. That appli
has been established in accordance with that Regulation.
cation also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation (EC)
(2) Commission
Regulations
(EC)
No
451/2000
(
No 33/2008.

4 ) and (EC)
No 1490/2002 ( 5 ) lay down the detailed rules for the
implementation of the second and third stages of the
(6) The
United
Kingdom
evaluated
the
additional
data
programme of work referred to in Article 8(2) of
submitted by the applicant and prepared an additional
Directive 91/414/EEC and establish a list of active
report. It communicated that report to the European
substances to be assessed, with a view to their possible
Food Safety Authority (hereinafter ‘the Authority’) and
inclusion in Annex I to Directive 91/414/EEC. That list
to the Commission on 3 February 2010. The Authority
included terbuthylazine.
communicated the additional report to the other Member
States and the applicant for comments and forwarded the
comments it had received to the Commission. In
(3) In
accordance
with
Article
3(2)
of
Commission
Regu
lation (EC) No 1095/2007 of 20 September 2007
accordance with Article 20(1) of Regulation (EC) No
amending Regulation (EC) No 1490/2002 laying down
33/2008 and at the request of the Commission, the
further detailed rules for the implementation of the third
Authority presented its conclusion on terbuthylazine to
stage of the programme of work referred to in
the Commission on 20 December 2010 ( 8 ). The draft
Article 8(2) of Council Directive 91/414/EEC and Regu
assessment report, the additional report and the
lation (EC) No 2229/2004 laying down further detailed
conclusion of the Authority were reviewed by the
rules for the implementation of the fourth stage of the
Member States and the Commission within the
programme of work referred to in Article 8(2) of Council
Standing Committee on the Food Chain and Animal
Directive 91/414/EEC
(
Health and finalised on 17 June 2011 in the format of

6 ) the notifier withdrew its
support of the inclusion of that active substance in
the Commission review report for terbuthylazine.
Annex I to Directive 91/414/EEC within two months
from entry into force of that Regulation. Consequently,
(7)
It has appeared from the various examinations made that
Commission Decision 2008/934/EC of 5 December
plant protection products containing terbuthylazine may
2008 concerning the non-inclusion of certain active
be expected to satisfy, in general, the requirements laid
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 7 ) OJ L 333, 11.12.2008, p. 11.
( 3 ) OJ L 15, 18.1.2008, p. 5.
( 8 ) European Food Safety Authority, Conclusion on the peer review of
( 4 ) OJ L 55, 29.2.2000, p. 25.
the pesticide risk assessment of the active substance terbuthylazine.
( 5 ) OJ L 224, 21.8.2002, p. 23.
EFSA Journal 2011; 9(1):1969 [133 pp.], doi:10.2903/j.efsa.2010.
( 6 ) OJ L 246, 21.9.2007, p. 19.
1969. Available online: www.efsa.europa.eu

---

EN
17.8.2011 Official
Journal
of
the
European
Union L
209/19
in particular as regards the uses which were examined
(14) Decision
2008/934/EC
provides
for
the
non-inclusion
of
and detailed in the Commission review report. It is
terbuthylazine and the withdrawal of authorisations for
therefore appropriate to approve terbuthylazine in
plants protection products containing that substance by
accordance with Regulation (EC) No 1107/2009.
31 December 2011. It is necessary to delete the line
concerning terbuthylazine in the Annex to that
(8) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
Decision. It is therefore appropriate to amend Decision
1107/2009 in conjunction with Article 6 thereof and in
2008/934/EC accordingly.
the light of current scientific and technical knowledge, it
is, however, necessary to include certain conditions and
restrictions.
(15) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
(9) Without
prejudice
to
the
conclusion
that
terbuthylazine
Committee on the Food Chain and Animal Health,
should be approved, it is, in particular, appropriate to
require further confirmatory information.
HAS ADOPTED THIS REGULATION:
(10) A
reasonable
period
should
be
allowed
to
elapse
before
approval in order to permit Member States and the
interested parties to prepare themselves to meet the
new requirements resulting from the approval.
Article 1
Approval of active substance
(11) Without
prejudice
to
the
obligations
defined
by
Regu
lation (EC) No 1107/2009 as a consequence of the
The active substance terbuthylazine, as specified in Annex I, is
approval, taking into account the specific situation
approved subject to the conditions laid down in that Annex.
created by the transition from Directive 91/414/EEC to
Regulation (EC) No 1107/2009 the following should,
however, apply. Member States should be allowed a
Article 2
period of six months after approval to review authori
sations of plant protection products containing terbuthy
Re-evaluation of plant protection products
lazine. Member States should, as appropriate, vary,
1. Member
States
shall
in
accordance
with
Regulation
(EC)
replace or withdraw existing authorisations. By way of
No 1107/2009, where necessary, amend or withdraw existing
derogation from the above deadline, a longer period
authorisations for plant protection products containing terbu
should be provided for the submission and assessment
thylazine as an active substance by 30 June 2012.
of the update of the complete Annex III dossier, as set
out in Directive 91/414/EEC, of each plant protection
product for each intended use in accordance with the
uniform principles.
By that date they shall in particular verify that the conditions in
Annex I to this Regulation are met, with the exception of those
identified in Part B of the column on specific provisions of that
(12) The
experience
gained
from
inclusions
in
Annex
I
to
Annex, and that the holder of the authorisation has, or has
Directive 91/414/EEC of active substances assessed in
access to, a dossier satisfying the requirements of Annex II to
the framework of Commission Regulation (EEC) No
Directive 91/414/EEC in accordance with the conditions of
3600/92 of 11 December 1992 laying down the
Article 13(1) to (4) of that Directive and Article 62 of Regu
detailed rules for the implementation of the first stage
lation (EC) No 1107/2009.
of the programme of work referred to in Article 8(2) of
Council Directive 91/414/EEC concerning the placing of
plant protection products on the market ( 1 ) has shown
that difficulties can arise in interpreting the duties of
2. By way of derogation from paragraph 1, for each auth
holders of existing authorisations in relation to access
orised plant protection product containing terbuthylazine as
to data. In order to avoid further difficulties it therefore
either the only active substance or as one of several active
appears necessary to clarify the duties of the Member
substances all of which were listed in the Annex to Imple
States, especially the duty to verify that the holder of
menting Regulation (EU) No 540/2011 by 31 December
an authorisation demonstrates access to a dossier
2011 at the latest, Member States shall re-evaluate the
satisfying the requirements of Annex II to that Directive.
product in accordance with the uniform principles, as referred
However, this clarification does not impose any new
to in Article 29(6) of Regulation (EC) No 1107/2009, on the
obligations on Member States or holders of authori
basis of a dossier satisfying the requirements of Annex III to
sations compared to the directives which have been
Directive 91/414/EEC and taking into account Part B of the
adopted until now amending Annex I to that Directive
column on specific provisions of Annex I to this Regulation.
or the Regulations approving active substances.
On the basis of that evaluation, they shall determine whether
the product satisfies the conditions set out in Article 29(1) of
(13) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
Regulation (EC) No 1107/2009. Following that determination
1107/2009 the Annex to Commission Implementing
Member States shall:
Regulation (EU) No 540/2011 ( 2 ) should be amended
accordingly.
(a) in the case of a product containing terbuthylazine as the
( 1 ) OJ L 366, 15.12.1992, p. 10.
only active substance, where necessary, amend or withdraw
( 2 ) OJ L 153, 11.6.2011, p. 1.
the authorisation by 31 December 2015 at the latest; or

---

L 209/20
EN
Official Journal of the European Union
17.8.2011
(b) in the case of a product containing terbuthylazine as one of
Article 4
several active substances, where necessary, amend or
withdraw the authorisation by 31 December 2015 or by
Amendments to Decision 2008/934/EC
the date fixed for such an amendment or withdrawal in the
The line concerning terbuthylazine in the Annex to Decision
respective act or acts which added the relevant substance or
2008/934/EC is deleted.
substances to Annex I to Directive 91/414/EEC or approved
that substance or substances, whichever is the latest.
Article 5
Article 3
Entry into force and date of application
Amendments to Implementing Regulation (EU) No
This Regulation shall enter into force on the 20th day following
540/2011
its publication in the Official Journal of the European Union.
The Annex to Implementing Regulation (EU) No 540/2011 is
amended in accordance with Annex II to this Regulation.
It shall apply from 1 January 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 August 2011.
For the Commission
The President
José Manuel BARROSO

---

17.8.2011 Off
ANNEX I
Common name,
identification numbers
IUPAC name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Terbuthylazine
N2-tert-butyl-6-chloro-
≥ 950 g/kg
1 January 2012 31
December
2021 PART
A
N4-ethyl-1,3,5-triazine-
EN
CAS No 5915-41-3
2,4-diamine
Impurities:
Only uses as herbicide may be authorised.

CIPAC No 234
Propazine not more
PART B
than 10 g/kg
For the implementation of the uniform principles, as referred to in Article 29(6) of
Atrazine not more
Regulation (EC) No 1107/2009, the conclusions of the review report on terbuthy
than 1 g/kg
lazine, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken
Simazine not more
into account.
than 30 g/kg
In this overall assessment Member States shall pay particular attention to:
(a) the protection of groundwater, when the active substance is applied in regions with
vulnerable soil and/or climatic conditions;
icial
(b) the risk to mammals and earthworms.
Jour
Conditions of use shall include risk mitigation measures and the obligation to carry
nal
out monitoring programmes to verify potential groundwater contamination in
of
vulnerable zones, where appropriate.
the
The applicant shall submit confirmatory information as regards:
European
(1) the specification of the technical material, as commercially manufactured including
information on the relevance of the impurities;
(2) the equivalence between the specifications of the technical material, as
Union
commercially manufactured, and the specifications of the test material used in
the toxicity studies;
(3) groundwater exposure assessment for the unidentified metabolites LM1, LM2, LM3,
LM4, LM5 and LM6;
(4) the relevance of the metabolites MT1 (N-tert-butyl-6-chloro-1,3,5-triazine-2,4-
diamine), MT 13 (4-(tert-butylamino)-6-(ethylamino)-1,3,5-triazin-2-ol or 6-
hydroxy-N2-ethyl-N4-tert-butyl-1,3,5-triazine-2,4-diamine), MT14 (4-amino-6-
(tert-butylamino)-1,3,5-triazin-2-ol or N-tert-butyl-6-hydroxy-1,3,5-triazine-2,4-
diamine), and of the unidentified metabolites LM1, LM2, LM3, LM4, LM5 and
LM6 with respect to cancer, if terbuthylazine is classified under Regulation (EC)
No 1272/2008 as ‘suspected of causing cancer’.
The applicant shall submit to the Commission, the Member States and the Authority
the information set out in points (1) and (2) by 30 June 2012, the information set out
in point (3) by 30 June 2013 and the information set out in point (4) within six
months from the notification of the classification decision concerning that substance.
L
209/21
(1 ) Further details on identity and specification of active substance are provided in the review report.

---

L 209/22
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Number
Common name,
EN
identification numbers
IUPAC name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions

‘16 Terbuthylazine
N2-tert-butyl-6-
≥ 950 g/kg
1 January 2012 31
December
2021 PART
A
chloro-N4-ethyl-1,3,5-
CAS No 5915-41-3
triazine-2,4-diamine
Impurities:
Only uses as herbicide may be authorised.
CIPAC No 234
Propazine not more than
PART B
10 g/kg
For the implementation of the uniform principles, as referred to in
Atrazine not more than
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the
1 g/kg
review report on terbuthylazine, and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the Food Chain and
Off
Simazine not more than
Animal Health on 17 June 2011 shall be taken into account.
icial
30 g/kg
In this overall assessment Member States shall pay particular attention to:
Jour
(a) the protection of groundwater, when the active substance is applied in
nal
regions with vulnerable soil and/or climatic conditions;
of
the
(b) the risk to mammals and earthworms.
European
Conditions of use shall include risk mitigation measures and the obligation to
carry out monitoring programmes to verify potential groundwater contami
nation in vulnerable zones, where appropriate.
Union
The applicant shall submit confirmatory information as regards:
(1) the specification of the technical material, as commercially manufactured,
by appropriate analytical data, including information on the relevance of
the impurities;
(2) the equivalence between the specifications of the technical material, as
commercially manufactured, and the specifications of the test material
used in the toxicity studies;
(3) groundwater exposure assessment for the unidentified metabolites LM1,
LM2, LM3, LM4, LM5 and LM6;
(4) the relevance of the metabolites MT1 (N-tert-butyl-6-chloro-1,3,5-
triazine-2,4-diamine), MT 13 (4-(tert-butylamino)-6-(ethylamino)-1,3,5-
triazin-2-ol or 6-hydroxy-N2-ethyl-N4-tert-butyl-1,3,5-triazine-2,4-
diamine), MT14 (4-amino-6-(tert-butylamino)-1,3,5-triazin-2-ol or N-
tert-butyl-6-hydroxy-1,3,5-triazine-2,4-diamine), and of the unidentified
17.8.2011
metabolites LM1, LM2, LM3, LM4, LM5 and LM6 with respect to
cancer, if terbuthylazine is classified under Regulation (EC) No
1272/2008 as “suspected of causing cancer”.

---

17.8.2011 Off
Number
Common name,
identification numbers
IUPAC name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
The applicant shall submit to the Commission, the Member States and the
Authority the information set out in points (1) and (2) by 30 June 2012, the
information set out in point (3) by 30 June 2013 and the information set out
in point (4) within six months from the notification of the classification
decision concerning that substance.’
EN

(*) Further details on identity and specification of active substance are provided in the review report.
icial
Jour
nal
of
the
European
Union
L
209/23

---