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EN
Official Journal of the European Union
1.2.2014
COMMISSION IMPLEMENTING REGULATION (EU) No 92/2014
of 31 January 2014
approving zineb as an existing active substance for use in biocidal products for product-type 21
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5)
It appears from that report that biocidal products used
for product-type 21 and containing zineb may be
Having regard to the Treaty on the Functioning of the European
expected to satisfy the requirements laid down in
Union,
Article 5 of Directive 98/8/EC, provided that the
conditions specified in the Annex to this Regulation are
Having regard to Regulation (EU) No 528/2012 of the
satisfied. It is therefore appropriate to approve zineb for
European Parliament and of the Council of 22 May 2012
use in biocidal products for product-type 21.
concerning the making available on the market and use of
biocidal products ( 1 ), and in particular the third subparagraph
of Article 89(1) thereof,
(6) Since
the
evaluation
did
not
address
nanomaterials,
the
approval should not cover such materials pursuant to
Whereas:
Article 4(4) of Regulation (EU) No 528/2012.
(1) Commission
Regulation
(EC)
No
1451/2007
( 2 ) estab
(7) A
reasonable
period
should
be
allowed
to
elapse
before
lishes a list of active substances to be assessed, with a
an active substance is approved, in order to permit
view to their possible inclusion in Annex I, IA or IB to
Member States, interested parties, and the Commission
Directive 98/8/EC of the European Parliament and of the
where appropriate, to prepare themselves to meet the
Council ( 3 ). That list includes zineb.
new requirements entailed.
(2) Zineb
has
been
evaluated
in
accordance
with
Article
11(2)
of Directive 98/8/EC for use in product-type 21, anti
(8) The
measures
provided
for
in
this
Regulation
are
in
fouling products, as defined in Annex V to that Directive,
accordance with the opinion of the Standing
which corresponds to product-type 21 as defined in
Committee on Biocidal Products,
Annex V to Regulation (EU) No 528/2012.
HAS ADOPTED THIS REGULATION:
(3) Ireland
was
designated
as
rapporteur
Member
State
and
submitted the competent authority report, together with
Article 1
a recommendation, to the Commission on 29 March
2011 in accordance with Article 14(4) and (6) of Regu
Zineb shall be approved as an active substance for use in
lation (EC) No 1451/2007.
biocidal products for product-type 21, subject to the specifi
cations and conditions set out in the Annex.
(4) The
competent
authority
report
was
reviewed
by
the
Member States and the Commission. In accordance
Article 2
with Article 15(4) of Regulation (EC) No 1451/2007,
the findings of the review were incorporated, within
This Regulation shall enter into force on the twentieth day
the Standing Committee on Biocidal Products on
following that of its publication in the Official Journal of the
13 December 2013, in an assessment report.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 31 January 2014.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 167, 27.6.2012, p. 1.
( 2 ) Commission Regulation (EC) No 1451/2007 of 4 December 2007
on the second phase of the 10-year work programme referred to in
Article 16(2) of Directive 98/8/EC of the European Parliament and
of the Council concerning the placing of biocidal products on the
market (OJ L 325, 11.12.2007, p. 3).
( 3 ) Directive 98/8/EC of the European Parliament and of the Council of
16 February 1998 concerning the placing of biocidal products on
the market (OJ L 123, 24.4.1998, p. 1).

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1.2.2014 Off
ANNEX
IUPAC Name
Minimum degree of
Common Name
purity of the active
Date of approval Expiry
date
of
approval Product
type Specific
conditions
(2 )
substance (1 )
Identification Numbers
EN

Zineb IUPAC
Name:
940 g/kg 1
January
2016 31
December
2025 21 The
product
assessment
shall
pay
particular
attention
to
the
exposures, the risks and the efficacy linked to any uses covered by
an application for authorisation, but not addressed in the Union level
Zinc ethylenebis(dithioc
risk assessment of the active substance.
arbamate) (polymeric)
Persons making products containing zineb available on the market
EC No: 235-180-1
for non-professional users shall make sure that the products are
supplied with appropriate gloves.
CAS No: 12122-67-7
icial
Authorisations are subject to the following conditions:
Jour
nal
(1) For industrial or professional users, safe operational procedures
and appropriate organisational measures shall be established.
of
Where exposure cannot be reduced to an acceptable level by
the
other means, products shall be used with appropriate personal
European
protective equipment.
(2) Labels and, where provided, instructions for use shall indicate
Union
that children shall be kept away until treated surfaces are dry.
(3) Labels and, where provided, safety data sheets of products auth
orised shall indicate that application, maintenance and repair
activities shall be conducted within a contained area, on imper
meable hard standing with bunding or on soil covered with an
impermeable material to prevent losses and minimise emissions
to the environment, and that any losses or waste containing
zineb shall be collected for reuse or disposal.
(4) For products that may lead to residues in food or feed, the need
to set new or to amend existing maximum residue levels (MRLs)
in accordance with Regulation (EC) No 470/2009 of the
European Parliament and of the Council (3 ) or Regulation (EC)
No 396/2005 of the European Parliament and of the Council (4 )
shall be verified, and any appropriate risk mitigation measures
L
shall be taken to ensure that the applicable MRLs are not
32/17
exceeded.

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L 32/18
Minimum degree of
Common Name
IUPAC Name
Identification Numbers
purity of the active
Date of approval Expiry
date
of
approval Product
type Specific
conditions
(2 )
substance (1 )
Where a treated article has been treated with or intentionally incor
porates zineb, and where necessary due to the possibility of skin
contact as well as the release of zineb under normal conditions of
use, the person responsible for placing the treated article on the
EN
market shall ensure that the label provides information on the risk

of skin sensitisation, as well as the information referred to in the
second subparagraph of Article 58(3) of Regulation (EU) No
528/2012.
(1 ) The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012. The active substance in the product placed on
the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.
(2 ) For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/
biocides/index.htm
(3 ) Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal
origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152,
Off
16.6.2009, p. 11).
(4 ) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC
icial
(OJ L 70, 16.3.2005, p. 1).
Jour
nal
of
the
European
Union
1.2.2014

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Document Outline

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