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27.11.2012 Official
Journal
of
the
European
Union L
327/31
COMMISSION DIRECTIVE 2012/42/EU
of 26 November 2012
amending Directive 98/8/EC of the European Parliament and of the Council to include hydrogen
cyanide as an active substance in Annex I thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(6) Not
all
potential
uses
have
been
evaluated
at
Union
level.
It is therefore appropriate to require that Member States
assess those uses or exposure scenarios and those risks to
Having regard to the Treaty on the Functioning of the European
human populations and to environmental compartments
Union,
that have not been representatively addressed in the
Union level risk assessment and, when granting
Having regard to Directive 98/8/EC of the European Parliament
product authorisations, ensure that appropriate
and of the Council of 16 February 1998 concerning the placing
measures are taken or specific conditions imposed in
of biocidal products on the market ( 1 ), and in particular the
order to reduce the identified risks to acceptable levels.
second subparagraph of Article 16(2) thereof,
(7) In
view
of
the
highly
toxic
and
flammable
properties
of
Whereas:
the active substance and the assumptions made during
the risk assessment, it is appropriate to require that
products are only authorised for use by professionals
(1) Commission
Regulation
(EC)
No
1451/2007 of
4 December 2007 on the second phase of the 10-year
adequately trained to use them and that safe operational
work programme referred to in Article 16(2) of Directive
procedures during fumigation and venting are established
98/8/EC of the European Parliament and of the Council
for operators and bystanders, including the following
concerning the placing of biocidal products on the
requirements: products shall be used with adequate
market (
personal protective equipment including, where appro

2 ) establishes a list of active substances to be
assessed, with a view to their possible inclusion in
priate, self-contained breathing apparatus and gas-tight
Annex I, IA or IB to Directive 98/8/EC. That list
clothing; re-entry into fumigated spaces shall be
includes hydrogen cyanide.
prohibited until the air concentration has reached safe

levels for operators and bystanders by ventilation;
exposure during and after ventilation shall be prevented
(2) Pursuant
to
Regulation
(EC)
No
1451/2007,
hydrogen
from exceeding safe levels for operators and bystanders
cyanide has been evaluated in accordance with
by the establishment of a supervised exclusion zone;
Article 11(2) of Directive 98/8/EC for use in the
prior to fumigation, any food and any porous material
following product types, as defined in Annex V to that
with a potential to absorb the active substance, except
Directive: product type 8, wood preservatives, product
wood intended to be treated, shall either be removed
type 14, rodenticides, and product type 18, insecticides,
from the space to be fumigated or protected from
acaricides and products to control other arthropods.
absorption by adequate means, and the space to be
fumigated shall be protected against accidental ignition.
(3) The
Czech
Republic
was
designated
as
Rapporteur
Member State and submitted three competent authority
(8) The
provisions
of
this
Directive
should
be
applied
simul
reports, including recommendations, to the Commission
taneously in all Member States in order to ensure equal
on 24 January 2008 in accordance with Article 14(4)
treatment on the Union market of biocidal products of
and (6) of Regulation (EC) No 1451/2007.
product types 8, 14 and 18 containing the active
substance hydrogen cyanide and also to facilitate the
(4) The
competent
authority
reports
were
reviewed
by
the
proper operation of the biocidal products market in
Member States and the Commission. In accordance with
general.
Article 15(4) of Regulation (EC) No 1451/2007, the
findings of the review were incorporated, within the
Standing Committee on Biocidal Products on 25 May
(9) A
reasonable
period
should
be
allowed
to
elapse
before
2012, in three assessment reports.
an active substance is included in Annex I to Directive
98/8/EC, in order to permit Member States and interested
parties to prepare themselves to meet the new
(5) It
appears
from
the
evaluations
that
biocidal
products
requirements entailed and to ensure that applicants
used as wood preservatives, rodenticides, insecticides,
who have prepared dossiers can benefit fully from the
acaricides and products to control other arthropods
10-year period of data protection, which, in accordance
and containing hydrogen cyanide may be expected to
with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from
satisfy the requirements laid down in Article 5 of
the date of inclusion.
Directive 98/8/EC. It is therefore appropriate to include
hydrogen cyanide in Annex I to that Directive.
(10) After
inclusion,
Member States should
be allowed
a
( 1 ) OJ L 123, 24.4.1998, p. 1.
reasonable period to implement Article 16(3) of
( 2 ) OJ L 325, 11.12.2007, p. 3.
Directive 98/8/EC.

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L 327/32
EN
Official Journal of the European Union
27.11.2012
(11) Directive
98/8/EC
should
therefore
be
amended
accord
They shall apply those provisions from 1 October 2014.
ingly.
When Member States adopt those provisions, they shall contain
(12) In
accordance
with
the
Joint
Political
Declaration
of
a reference to this Directive or be accompanied by such a
Member States and the Commission on explanatory
reference on the occasion of their official publication. Member
documents of 28 September 2011 ( 1 ), Member States
States shall determine how such reference is to be made.
have undertaken to accompany, in justified cases, the
notification of their transposition measures with one or
2. Member
States
shall
communicate
to
the
Commission
the
more documents explaining the relationship between the
text of the main provisions of national law which they adopt in
components of a directive and the corresponding parts of
the field covered by this Directive.
national transposition instruments.
Article 3
(13) The
measures provided for in this Directive are in
accordance with the opinion of the Standing
This Directive shall enter into force on the twentieth day
Committee on Biocidal Products,
following that of its publication in the Official Journal of the
European Union.
HAS ADOPTED THIS DIRECTIVE:
Article 4
Article 1
This Directive is addressed to the Member States.
Annex I to Directive 98/8/EC is amended in accordance with
the Annex to this Directive.
Done at Brussels, 26 November 2012.
Article 2
For the Commission
1. Member
States
shall
adopt
and
publish,
by
30
September
2013 at the latest, the laws, regulations and administrative
The President
provisions necessary to comply with this Directive.
José Manuel BARROSO
( 1 ) OJ C 369, 17.12.2011, p. 14.

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27.11.2012 Off
ANNEX
In Annex I to Directive 98/8/EC, the following entry is added:
Minimum
Deadline for compliance with
purity of the
Article 16(3) (except for
active
products containing more
EN
than one active substance, for

No
Common
IUPAC Name
substance in
Name
Identification Numbers
the biocidal
Date of inclusion which the deadline to comply Expiry date of inclusion Product type Specific
provisions
(*)
product as
with Article 16(3) shall be the
placed on the
one set out in the last of the
market
inclusion decisions relating to
its active substances)
‘60 hydrogen hydrogen cyanide
976 g/kg 1
October
2014 30
September
2016 30
September
2024 8,
14
and When assessing the application for authorisation of a
cyanide
18
product in accordance with Article 5 and Annex VI,
EC No: 200-821-6
Member States shall assess, where relevant for the particular
product, those uses or exposure scenarios and those risks to
CAS No: 74-90-8
human populations and to environmental compartments
that have not been representatively addressed in the
icial
Union level risk assessment.
Jour
Member States shall ensure that authorisations of products
for use as a fumigant are subject to the following
nal
conditions:
of
the
(1) product shall only be supplied to and used by profes
sionals adequately trained to use them;
European
(2) safe operational procedures during fumigation and
venting shall be established for operators and
bystanders;
Union
(3) products shall be used with adequate personal protective
equipment including, where appropriate, self-contained
breathing apparatus and gas-tight clothing;
(4) re-entry into fumigated spaces shall be prohibited until
the air concentration has reached safe levels for
operators and bystanders by ventilation;
(5) exposure during and after ventilation shall be prevented
from exceeding safe levels for operators and bystanders
by the establishment of a supervised exclusion zone;
(6) prior to fumigation, any food and any porous material
with a potential to absorb the active substance, except
wood intended to be treated, shall either be removed
from the space to be fumigated or protected from
absorption by adequate means, and the space to be
L
fumigated shall be protected against accidental ignition.’
327/33
(*) For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm

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Document Outline

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