HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 171/2
EN
Official Journal of the European Union
30.6.2012
COMMISSION IMPLEMENTING REGULATION (EU) No 578/2012
of 29 June 2012
concerning the non approval of the active substance diphenylamine, 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
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) The
application
was
submitted
to
Ireland,
which
had
been designated rapporteur Member State by Regulation
(EC) No 1490/2002. The time period for the accelerated
Having regard to the Treaty on the Functioning of the European
procedure was respected. The specification of the active
Union,
substance and the supported uses are the same as were
the subject of Decision 2009/859/EC. That application
also complies with the remaining substantive and
Having regard to Regulation (EC) No 1107/2009 of the
procedural requirements of Article 15 of Regulation
European Parliament and of the Council of 21 October 2009
(EC) No 33/2008.
concerning the placing of plant protection products on the
market and repealing Council Directives 79/117/EEC and
91/414/EEC ( 1 ), and in particular Article 13(2) thereof,
(5)
Ireland evaluated the additional data submitted by the
applicant and prepared an additional report. It
communicated that report to the European Food Safety
Whereas:
Authority (hereinafter ‘the Authority’) and to the
Commission on 3 December 2010.
(1) In
accordance
with
Article
80(1)(c)
of
Regulation
(EC)
No
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
with respect to the procedure and the conditions for
(6) The
Authority
communicated
the
additional
report
to
the
approval, to active substances for which completeness
other Member States and the applicant for comments
has been established in accordance with Article 16 of
and forwarded the comments it had received to the
Commission Regulation (EC) No 33/2008 of 17 January
Commission. In accordance with Article 20(1) of Regu
2008 laying down detailed rules for the application of
lation (EC) No 33/2008 and at the request of the
Council Directive 91/414/EEC as regards a regular and an
Commission, the Authority presented its conclusion on
accelerated procedure for the assessment of active
the risk assessment of diphenylamine to the Commission
substances which were part of the programme of work
on 5 December 2011 ( 7 ). The draft assessment report, the
referred to in Article 8(2) of that Directive but have not
additional report and the conclusion of the Authority
been included into its Annex I (
were reviewed by the Member States and the

3 ). Diphenylamine is an
active substance for which completeness has been estab
Commission within the Standing Committee on the
lished in accordance with that Regulation.
Food Chain and Animal Health and finalised on 1 June
2012 in the format of the Commission review report for
diphenylamine.
(2) Commission
Regulations
(EC)
No
451/2000
( 4 ) and
1490/2002 ( 5 ) lay down the detailed rules for the imple
mentation of the second and third stages of the
(7)
The additional data and information provided by the
programme of work referred to in Article 8(2) of
applicant did not permit to eliminate the specific
Directive 91/414/EEC and establish a list of active
concerns that led to the non-inclusion. In particular, it
substances to be assessed, with a view to their possible
was not possible to perform a reliable consumer
inclusion in Annex I to Directive 91/414/EEC. That list
exposure assessment because information concerning
included diphenylamine. By Commission Decision
residues in raw and processed apples was missing and
2009/859/EC (
because the presence of nitrosamines in apples could not

6 ) it was decided not to include dipheny
lamine in Annex I to Directive 91/414/EEC.
be excluded. Specifically, three metabolites could not be
identified and, consequently, their toxicological properties
could not be assessed. Furthermore, the processing study
(3) In
agreement
with
the
original
notifier,
another
person
submitted by the applicant was not representative of the
(hereinafter 'the applicant') submitted a new application
standard hydrolytic conditions and did not allow to
pursuant to Article 6(2) of Directive 91/414/EEC
identify breakdown and reaction products including the
requesting the accelerated procedure to be applied, as
three unknown metabolites. Finally, the additional
provided for in Articles 14 to 19 of Commission Regu
evidence submitted on nitrosamines was inconclusive as
lation (EC) No 33/2008.
the analytical method was not validated and had an
insufficient resolution and a lack of selectivity.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 7 ) European Food Safety Authority; Conclusion on the peer review of
( 3 ) OJ L 15, 18.1.2008, p. 5.
the pesticide risk assessment of the active substance diphenylamine.
( 4 ) OJ L 55, 29.2.2000, p. 25.
EFSA Journal 2012; 10(1):2486 [59 pp.]. doi:10.2903/
( 5 ) OJ L 224, 21.8.2002, p. 23.
j.efsa.2012.2486. Available online: www.efsa.europa.eu/efsajournal.
( 6 ) OJ L 314, 1.12.2009, p. 79.
htm

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EN
30.6.2012 Official
Journal
of
the
European
Union L
171/3
(8) The
Commission
invited
the
applicant
to
submit
its (13) The
measures
provided
for
in
this
Regulation
are
in
comments on the conclusion of the Authority.
accordance with the opinion of the Standing
Furthermore, in accordance with Article 21(1) of Regu
Committee on the Food Chain and Animal Health,
lation (EC) No 33/2008, the Commission invited the
applicant to submit comments on the draft review
report. The applicant submitted its comments, which
HAS ADOPTED THIS REGULATION:
have been carefully examined.
(9) However,
despite
the
arguments
put
forward
by
the
Article 1
applicant, the concerns referred to in recital 7 could
not be eliminated. Consequently, it has not been demon
Non approval of active substance
strated that it may be expected that, under the proposed
The active substance diphenylamine is not approved.
conditions of use, plant protection products containing
diphenylamine satisfy in general the requirements laid
down in Article 5(1)(a) and (b) of Directive 91/414/EEC.
Article 2
(10) Diphenylamine should therefore not be approved
Repeal
pursuant to Article 13(2) of Regulation (EC) No
Decision 2009/859/EC is repealed.
1107/2009.
(11) In
the
interest
of
clarity,
Decision
2009/859/EC
should
Article 3
be repealed.
Entry into force
(12) This
Regulation
does
not
prejudice
the
submission
of
a
This Regulation shall enter into force on the twentieth day
further application for diphenylamine pursuant to
following that of its publication in the Official Journal of the
Article 7 of Regulation (EC) No 1107/2009.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 June 2012.
For the Commission
The President
José Manuel BARROSO

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