HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 109/14
EN
Official Journal of the European Union
19.4.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 355/2013
of 18 April 2013
approving the active substance maltodextrin, 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,
Standing Committee on the Food Chain and Animal
Health and the draft assessment report was finalised on
Having regard to the Treaty on the Functioning of the European
15 March 2013 in the format of the Commission review
Union,
report for maltodextrin.
(5)
It has appeared from the various examinations made that
Having regard to Regulation (EC) No 1107/2009 of the
plant protection products containing maltodextrin may
European Parliament and of the Council of 21 October 2009
be expected to satisfy, in general, the requirements laid
concerning the placing of plant protection products on the
down in Article 5(1)(a) and (b) and Article 5(3) of
market and repealing Council Directives 79/117/EEC and
Directive 91/414/EEC, in particular with regard to the
91/414/EEC ( 1 ), and in particular Article 13(2) and Article 78(2)
uses which were examined and detailed in the
thereof,
Commission review report. It is therefore appropriate
to approve maltodextrin.
Whereas:
(6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
1107/2009 in conjunction with Article 6 thereof and in
1107/2009, Council Directive 91/414/EEC (
the light of current scientific and technical knowledge, it

2 ) is to apply,
with respect to the procedure and the conditions for
is, however, necessary to include certain conditions and
approval, to active substances for which a decision has
restrictions.
been adopted in accordance with Article 6(3) of that
Directive before 14 June 2011. For maltodextrin 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
2008/20/EC (
new requirements resulting from the approval.

3 ).
(8) Without
prejudice
to
the
obligations
provided
for
in
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
Regulation (EC) No 1107/2009 as a consequence of
the United Kingdom received on 8 October 2008 an
approval, taking into account the specific situation
application from Biological Crop Protection Ltd for the
created by the transition from Directive 91/414/EEC to
inclusion of the active substance maltodextrin in Annex I
Regulation (EC) No 1107/2009, the following should,
to Directive 91/414/EEC. Decision 2008/20/EC
however, apply. Member States should be allowed a
confirmed that the dossier was ‘complete’ in the sense
period of six months after approval to review authori
that it could be considered as satisfying, in principle, the
sations of plant protection products containing maltod
data and information requirements of Annexes II and III
extrin. Member States should, as appropriate, vary,
to Directive 91/414/EEC.
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 update of the
animal health and the environment have been assessed,
complete Annex III dossier, as set out in Directive
in accordance with the provisions of Article 6(2) and (4)
91/414/EEC, of each plant protection product for each
of Directive 91/414/EEC, for the uses proposed by the
intended use in accordance with the uniform principles.
applicant (now Certis Europe B.V.). The designated
rapporteur Member State submitted a draft assessment
(9) The
experience
gained
from
inclusions
in
Annex
I
to
report on 29 November 2011.
Directive 91/414/EEC of active substances assessed in
the framework of Commission Regulation (EEC) No
3600/92 of 11 December 1992 laying down the
(4) The
draft
assessment
report
was
reviewed
by
the
Member
detailed rules for the implementation of the first stage
States and the European Food Safety Authority (here
of the programme of work referred to in Article 8(2) of
inafter ‘the Authority’). The Authority presented to the
Council Directive 91/414/EEC concerning the placing of
Commission its conclusion on the review of the pesticide
plant protection products on the market (
risk assessment of the active substance maltodextrin (

5 ) has shown

4 )
that difficulties can arise in interpreting the duties of
on 3 December 2012. The draft assessment report and
holders of existing authorisations in relation to access
the conclusion of the Authority were reviewed by the
to data. In order to avoid further difficulties it therefore
Member States and the Commission within the
appears necessary to clarify the duties of the Member
States, especially the duty to verify that the holder of
( 1 ) OJ L 309, 24.11.2009, p. 1.
an authorisation demonstrates access to a dossier
( 2 ) OJ L 230, 19.8.1991, p. 1.
satisfying the requirements of Annex II to that Directive.
( 3 ) OJ L 1, 4.1.2008, p. 5.
( 4 ) EFSA Journal 2013; 11(1):3007. Available online: www.efsa.europa.
eu
( 5 ) OJ L 366, 15.12.1992, p. 10.

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EN
19.4.2013 Official
Journal
of
the
European
Union L
109/15
However, this clarification does not impose any new
2. By way of derogation from paragraph 1, for each auth
obligations on Member States or holders of authori
orised plant protection product containing maltodextrin as
sations compared to the Directives which have been
either the only active substance or as one of several active
adopted until now amending Annex I to that Directive
substances, all of which were listed in the Annex to Imple
or the Regulations approving active substances.
menting Regulation (EU) No 540/2011 by 30 September
2013 at the latest, Member States shall re-evaluate the
product in accordance with the uniform principles, as referred
(10) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
1107/2009, the Annex to Commission Implementing
to in Article 29(6) of Regulation (EC) No 1107/2009, on the
Regulation (EU) No 540/2011 of 25 May 2011 imple
basis of a dossier satisfying the requirements of Annex III to
menting Regulation (EC) No 1107/2009 of the European
Directive 91/414/EEC and taking into account the column on
Parliament and of the Council as regards the list of
specific provisions of Annex I to this Regulation. On the basis
approved active substances
(
of that evaluation, they shall determine whether the product

1 ) should be amended
accordingly.
satisfies the conditions set out in Article 29(1) of Regulation

(EC) No 1107/2009.
(11) The
measures
provided
for
in
this
Regulation
are
in
Following that determination Member States shall:
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(a) in the case of a product containing maltodextrin as the only
active substance, where necessary, amend or withdraw the
authorisation by 31 March 2015 at the latest; or
HAS ADOPTED THIS REGULATION:
(b) in the case of a product containing maltodextrin as one of
Article 1
several active substances, where necessary, amend or
withdraw the authorisation by 31 March 2015 or by the
Approval of active substance
date fixed for such an amendment or withdrawal in the
The active substance maltodextrin, as specified in Annex I, is
respective act or acts which added the relevant substance
approved subject to the conditions laid down in that Annex.
or substances to Annex I to Directive 91/414/EEC or
approved that substance or 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
No 1107/2009, where necessary, amend or withdraw existing
540/2011
authorisations for plant protection products containing maltod
The Annex to Implementing Regulation (EU) No 540/2011 is
extrin as an active substance by 31 March 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 October 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 April 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 153, 11.6.2011, p. 1.

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L 109/16
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval
Expiration of
approval
Specific provisions
Maltodextrin
None allocated
≥ 910 g/kg 1
October
30 September For the implementation of the uniform principles as referred to in Article 29(6) of
2013
2023
Regulation (EC) No 1107/2009, the conclusions of the review report on maltod
EN
CAS No 9050-36-6
extrin, and in particular Appendices I and II thereof, as finalised in the Standing

CIPAC No 801
Committee on the Food Chain and Animal Health on 15 March 2013 shall be
taken into account.
In this overall assessment Member States shall pay particular attention to:
(a) the potential increased growth of fungi and possible presence of mycotoxins
on the surface of treated fruits;
(b) the potential risk to honeybees and non-target arthropods.
Conditions of use shall include risk mitigation measures, where appropriate.
Off
icial
(1 ) Further details on identity and specification of active substance are provided in the review report.
Jour
nal
of
the
European
Union
19.4.2013

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19.4.2013 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
(*) Date
of
approval Expiration
of
approval Specific
provisions
EN
‘44 Maltodextrin
None allocated
≥ 910 g/kg 1
October
2013 30
September
2023
For the implementation of the uniform principles as

referred to in Article 29(6) of Regulation (EC) No
CAS No 9050-36-6
1107/2009, the conclusions of the review report on
maltodextrin, and in particular Appendices I and II
CIPAC No 801
thereof, as finalised in the Standing Committee on the
Food Chain and Animal Health on 15 March 2013 shall
be taken into account.
In this overall assessment Member States shall pay
particular attention to:
(a) the potential increased growth of fungi and possible
presence of mycotoxins on the surface of treated
icial
fruits;
Jour
(b) the potential risk to honeybees and non-target arth
nal
ropods.
of
Conditions of use shall include risk mitigation measures,
the
where appropriate.’
European
(*) Further details on identity and specification of active substance are provided in the review report.
Union
L
109/17

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