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26.4.2012 Official
Journal
of
the
European
Union L
114/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) No 359/2012
of 25 April 2012
approving the active substance metam, 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,
included metam. By Council Decision 2009/562/EC of
13 July 2009 concerning the non-inclusion of metam
in Annex I to Directive 91/414/EEC and the withdrawal
Having regard to the Treaty on the Functioning of the European
of authorisations for plant protection products
Union,
containing that substance ( 6 ) it was decided not to
include metam in Annex I to Directive 91/414/EEC.
Having regard to Regulation (EC) No 1107/2009 of the
European Parliament and of the Council of 21 October 2009
(3) Pursuant
to
Article
6(2)
of
Directive
91/414/EEC
the
concerning the placing of plant protection products on the
original notifier (hereinafter ‘the applicant’) submitted a
market and repealing Council Directives 79/117/EEC and
new application requesting the accelerated procedure to
91/414/EEC ( 1 ), and in particular Article 13(2) and Article 78(2)
be applied, as provided for in Articles 14 to 19 of Regu
thereof,
lation (EC) No 33/2008.
Whereas:
(4) The
application
was
submitted
to
Belgium,
which
had
been designated rapporteur Member State by Regulation
(EC) No 1490/2002. The time period for the accelerated
(1) In
accordance
with
Article
80(1)(c)
of
Regulation
(EC)
No
procedure was respected. The specification of the active
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply
substance and the supported uses are the same as those
with respect to the procedure and the conditions for
that were the subject of Decision 2009/562/EC. That
approval to active substances for which completeness
application also complies with the remaining substantive
has been established in accordance with Article 16 of
and procedural requirements of Article 15 of Regulation
Commission Regulation (EC) No 33/2008 of 17 January
(EC) No 33/2008.
2008 laying down detailed rules for the application of
Council Directive 91/414/EEC as regards a regular and an
accelerated procedure for the assessment of active
(5) Belgium
evaluated
the
additional
data
submitted
by
the
substances which were part of the programme of work
applicant and prepared an additional report. It
referred to in Article 8(2) of that Directive but have not
communicated that report to the European Food Safety
been included into its Annex I ( 3 ). Metam is an active
Authority (hereinafter ‘the Authority’) and to the
substance for which completeness has been established
Commission on 31 August 2010.
in accordance with that Regulation.
(6) The
Authority
communicated
the
additional
report
to
the
(2) Commission
Regulations
(EC)
No
451/2000
( 4 ) and (EC)
other Member States and the applicant for comments
No 1490/2002 ( 5 ) lay down the detailed rules for the
and forwarded the comments it had received to the
implementation of the second and third stages of the
Commission. In accordance with Article 20(1) of Regu
programme of work referred to in Article 8(2) of
lation (EC) No 33/2008 and at the request of the
Directive 91/414/EEC and establish lists of active
Commission, the Authority presented its conclusion on
substances to be assessed, with a view to their possible
metam to the Commission on 8 August 2011 ( 7 ). The
inclusion in Annex I to Directive 91/414/EEC. These lists
draft assessment report, the additional report and the
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 6 ) OJ L 196, 28.7.2009, p. 22.
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 7 ) European Food Safety Authority; Conclusion on the peer review of the
( 3 ) OJ L 15, 18.1.2008, p. 5.
pesticide risk assessment of the active substance metam. EFSA Journal
( 4 ) OJ L 55, 29.2.2000, p. 25.
2011;9(9):2334.[97 pp.] doi:10.2903/j.efsa.2011.2334. Available
( 5 ) OJ L 224, 21.8.2002, p. 23.
online: www.efsa.europa.eu/efsajournal.htm

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L 114/2
EN
Official Journal of the European Union
26.4.2012
conclusion of the Authority were reviewed by the
into account for the calculation of that period. Hence,
Member States and the Commission within the
such a period of grace should expire at the latest by
Standing Committee on the Food Chain and Animal
31 December 2014.
Health and finalised on 9 March 2012 in the format of
the Commission review report for metam.
(16) The
experience
gained
from
inclusions
in
Annex
I
to
Directive 91/414/EEC of active substances assessed in
(7) The
additional
report
by
the
rapporteur
Member
State
the framework of Commission Regulation (EEC) No
and the new conclusions by the Authority concentrate
3600/92 of 11 December 1992 laying down the
on the concerns that led to the non-inclusion. Those
detailed rules for the implementation of the first stage
concerns were in particular that it was not possible to
of the programme of work referred to in Article 8(2) of
demonstrate the acceptability of consumer exposure and
Council Directive 91/414/EEC concerning the placing of
lack of data with respect to the behaviour in the
plant protection products on the market ( 1 ) has shown
environment of the impurity N,N-dimethylthiourea
that difficulties can arise in interpreting the duties of
(DMTU).
holders of existing authorisations in relation to access
to data. In order to avoid further difficulties it therefore
(8) The
new
information
submitted
by
the
applicant
shows
appears necessary to clarify the duties of the Member
that the exposure of consumers may be considered
States, especially the duty to verify that the holder of
acceptable and the behaviour of DMTU in the
an authorisation demonstrates access to a dossier
environment will not result in unacceptable effects.
satisfying the requirements of Annex II to that Directive.
However, this clarification does not impose any new
(9) Consequently,
the
additional
information
provided
by
the
obligations on Member States or holders of authori
applicant permits to eliminate the specific concerns that
sations compared to the directives which have been
led to the non-inclusion.
adopted until now amending Annex I to that Directive
or to the Regulations approving active substances.
(10) It has appeared from the various examinations made that
plant protection products containing metam may be
(17) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
expected to satisfy, in general, the requirements laid
1107/2009 the Annex to Commission Implementing
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
Regulation (EU) No 540/2011 of 25 May 2011 imple
in particular as regards the uses which were examined
menting Regulation (EC) No 1107/2009 of the European
and detailed in the Commission review report. It is
Parliament and of the Council as regards the list of
therefore appropriate to approve metam in accordance
approved active substances
( 2 ) should be amended
with Regulation (EC) No 1107/2009.
accordingly.
(11) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
1107/2009 in conjunction with Article 6 thereof and in
(18) In
the
interest
of
clarity,
Decision
2009/562/EC
should
the light of current scientific and technical knowledge, it
be repealed.
is, however, necessary to include certain conditions and
restrictions.
(19) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
(12) Without
prejudice
to
the
conclusion
that
metam
should
Committee on the Food Chain and Animal Health,
be approved, it is, in particular, appropriate to require
further confirmatory information.
HAS ADOPTED THIS REGULATION:
(13) A
reasonable
period
should
be
allowed
to
elapse
before
Article 1
approval in order to permit Member States and the
interested parties to prepare themselves to meet the
Approval of active substance
new requirements resulting from the approval.
The active substance metam, as specified in Annex I, is
approved subject to the conditions laid down in that Annex.
(14) Without
prejudice
to
the
obligations
defined
by
Regu
lation (EC) No 1107/2009 as a consequence of the
approval, taking into account the specific situation
Article 2
created by the transition from Directive 91/414/EEC to
Re-evaluation of plant protection products
Regulation (EC) No 1107/2009 the following should,
however, apply. Member States should be allowed a
1. Member
States
shall
in
accordance
with
Regulation
(EC)
period after approval to review authorisations of plant
No 1107/2009, where necessary, amend or withdraw existing
protection products containing metam which have been
authorisations for plant protection products containing metam
maintained for certain uses in accordance with Article 3
as an active substance by 31 December 2014.
of Decision 2009/562/EC. For the calculation of that
period that provision is to be taken into account.
By that date they shall in particular verify that the conditions in
Member States should, as appropriate, vary, replace or
Annex I to this Regulation are met, with the exception of those
withdraw existing authorisations.
identified in Part B of the column on specific provisions of that
Annex, and that the holder of the authorisation has, or has
(15) For
plant
protection
products
containing
metam,
where
access to, a dossier satisfying the requirements of Annex II to
Member States grant any period of grace in accordance
with Article 46 of Regulation (EC) No 1107/2009,
( 1 ) OJ L 366, 15.12.1992, p. 10.
Article 4 of Decision 2009/562/EC should be taken
( 2 ) OJ L 153, 11.6.2011, p. 1.

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EN
26.4.2012 Official
Journal
of
the
European
Union L
114/3
Directive 91/414/EEC in accordance with the conditions
Article 3
of Article 13(1) to (4) of that Directive and Article 62 of
Regulation (EC) No 1107/2009.
Grace period
Where Member States withdraw or amend an existing authori
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
sation in accordance with Article 2(1), any grace period granted
orised plant protection product containing metam as either the
by Member States in accordance with Article 46 of Regulation
only active substance or as one of several active substances, all
(EC) No 1107/2009 shall be as short as possible and shall
of which were listed in the Annex to Implementing Regulation
expire by 31 December 2014 at the latest.
(EU) No 540/2011, by 30 June 2012 Member States shall re-
evaluate the product in accordance with the uniform principles,
as referred to in Article 29(6) of Regulation (EC) No
Article 4
1107/2009, on the basis of a dossier satisfying the requirements
Amendments to Implementing Regulation (EU)
of Annex III to Directive 91/414/EEC and taking into account
No 540/2011
Part B of the column on specific provisions of Annex I to this
Regulation. On the basis of that evaluation, they shall determine
The Annex to Implementing Regulation (EU) No 540/2011 is
whether the product satisfies the conditions set out in
amended in accordance with Annex II to this Regulation.
Article 29(1) of Regulation (EC) No 1107/2009.
Article 5
Following that determination Member States shall:
Repeal
(a) in the case of a product containing metam as the only
Decision 2009/562/EC is repealed.
active substance, where necessary, amend or withdraw the
authorisation by 30 June 2016;
Article 6
(b) in the case of a product containing metam as one of several
Entry into force and date of application
active substances, where necessary, amend or withdraw the
authorisation by 30 June 2016 or by the date fixed for such
This Regulation shall enter into force on the twentieth day
an amendment or withdrawal in the respective act or acts
following that of its publication in the Official Journal of the
which added the relevant substance or substances to Annex
European Union.
I to Directive 91/414/EEC or approved that substance or
substances, whichever is the latest.
It shall apply from 1 July 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 April 2012.
For the Commission
The President
José Manuel BARROSO

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L 114/4
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval
Expiration of
approval
Specific provisions
Metam
Methyldithiocarbamic
≥ 965 g/kg
1 July 2012 30
June
2022 PART
A
acid
EN
CAS No 144-54-7
Expressed as metam-sodium on
Only uses as nematicide, fungicide, herbicide and insecticide may be authorised for

a dry weight basis
application as soil fumigant prior to planting, limited to one application every third
CIPAC No 20
≥ 990 g/kg
year on the same field.
Expressed as metam-potassium
The application may be authorised in open field by soil injection or drip irrigation, and
on a dry weight basis
in greenhouse by drip irrigation only. The use of gas-tight plastic film for drip irri
gation shall be prescribed.
Relevant impurities:
methylisothiocyanate (MITC)
The maximum application rate shall be 153 kg/ha (corresponding to 86,3 kg/ha of
MITC) in case of open field applications.
— max. 12 g/kg on dry weight
Off
basis (metam-sodium),
Authorisations shall be limited to professional users.
icial
— max. 0,42 g/kg on dry
PART B
Jour
weight basis (metam-
potassium).
For the implementation of the uniform principles as referred to in Article 29(6) of
nal
N,N’-dimethylthiourea (DMTU)
Regulation (EC) No 1107/2009, the conclusions of the review report on metam, and in
of
particular Appendices I and II thereof, as finalised in the Standing Committee on the
the
— max. 23 g/kg on a dry
Food Chain and Animal Health on 9 March 2012, shall be taken into account.
European
weight basis (metam-
sodium),
In this overall assessment Member States:
— max. 6 g/kg on a dry
(a) shall pay particular attention to the protection of operators and shall ensure that
weight basis (metam-potass
Union
the conditions of use include risk mitigation measures such as application of
ium).
adequate personal protective equipment and a limitation in the daily work rate;
(b) shall pay particular attention to the protection of workers and shall ensure that the
conditions of use include risk mitigation measures, such as use of adequate
personal protective equipment, re-entry period and limitation in the daily work
rate;
(c) shall pay particular attention to the protection of bystanders and residents and shall
ensure that the conditions of use include risk mitigation measures, such as an
appropriate buffer zone during and until 24 hours after the application from the
perimeter of the application area to any occupied residences and areas used by the
general public with obligation to use warning signs and ground markers;
(d) shall pay particular attention to the protection of groundwater, when the active
substance is applied in regions with vulnerable soil and/or climatic conditions and
shall ensure that the conditions of use include risk mitigation measures, such as
appropriate buffer zone;
26.4.2012
(e) shall pay particular attention to the risk to non-target organisms and shall ensure
that conditions of use shall include risk mitigation measures, where appropriate.

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26.4.2012 Off
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval
Expiration of
approval
Specific provisions
The applicant shall submit confirmatory information on methyl isothiocyanate as
regards:
(1) the assessment of the long-range atmospheric transport potential and related envi
ronmental risks;
EN

(2) the potential groundwater contamination.
The applicant shall submit to the Commission, the Member States and the Authority
such information by 31 May 2014.
(1 ) Further details on identity and specification of active substance are provided in the review report.
icial
Jour
nal
of
the
European
Union
L
114/5

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L 114/6
ANNEX II
In Part B of the Annex to Implementing Regulation No (EU) 540/2011, the following entry is added:
No
Common Name,
Expiration of
Identification Numbers
IUPAC Name Purity
(1 )
Date of
approval
approval
Specific provisions
EN

‘22 Metam
Methyldithiocarbamic ≥ 965 g/kg
1 July 2012 30
June
2022 PART
A
acid
CAS No 144-54-7
Expressed as metam-sodium on a
Only uses as nematicide, fungicide, herbicide and insecticide may be authorised for
dry weight basis
application as soil fumigant prior to planting, limited to one application every third
CIPAC No 20
year on the same field.
≥ 990 g/kg
The application may be authorised in open field by soil injection or drip irrigation,
Expressed as metam-potassium on
and in greenhouse by drip irrigation only. The use of gas-tight plastic film for drip
a dry weight basis
irrigation shall be prescribed.
Relevant impurities:
The maximum application rate shall be 153 kg/ha (corresponding to 86,3 kg/ha of
Off
MITC) in case of open field applications.
icial
methylisothiocyanate (MITC)
Authorisations shall be limited to professional users.
Jour
— max. 12 g/kg on dry weight
basis (metam-sodium),
PART B
nal
of
— max. 0,42 g/kg on dry weight
For the implementation of the uniform principles as referred to in Article 29(6) of
the
basis (metam-potassium).
Regulation (EC) No 1107/2009, the conclusions of the review report on metam,
and in particular Appendices I and II thereof, as finalised in the Standing
European
N,N’-dimethylthiourea (DMTU)
Committee on the Food Chain and Animal Health on 9 March 2012, shall be
taken into account.
— max. 23 g/kg on a dry weight
basis (metam-sodium),
In this overall assessment Member States:
Union
— max. 6 g/kg on a dry weight
(a) shall pay particular attention to the protection of operators and shall ensure
basis (metam-potassium).
that the conditions of use include risk mitigation measures such as application
of adequate personal protective equipment and a limitation in the daily work
rate;
(b) shall pay particular attention to the protection of workers and shall ensure that
the conditions of use include risk mitigation measures, such as use of adequate
personal protective equipment, re-entry period and limitation in the daily work
rate;
(c) shall pay particular attention to the protection of bystanders and residents and
shall ensure that the conditions of use include risk mitigation measures, such as
an appropriate buffer zone during and until 24 hours after the application from
the perimeter of the application area to any occupied residences and areas used
by the general public with obligation to use warning signs and ground markers;
(d) shall pay particular attention to the protection of groundwater, when the active
26.4.2012
substance is applied in regions with vulnerable soil and/or climatic conditions
and shall ensure that the conditions of use include risk mitigation measures,
such as appropriate buffer zone;

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26.4.2012 Off
No
Common Name,
Expiration of
Identification Numbers
IUPAC Name Purity
(1 )
Date of
approval
approval
Specific provisions
(e) shall pay particular attention to the risk to non-target organisms and shall
ensure that conditions of use shall include risk mitigation measures, where
appropriate.
The applicant shall submit confirmatory information on methyl isothiocyanate as
EN
regards:

(1) the assessment of the long-range atmospheric transport potential and related
environmental risks;
(2) the potential groundwater contamination.
The applicant shall submit to the Commission, the Member States and the
Authority such information by 31 May 2014.’
(1 ) Further details on identity and specification of active substance are provided in the review report.
icial
Jour
nal
of
the
European
Union
L
114/7

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