HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 124/36
EN
Official Journal of the European Union
11.5.2012
DIRECTIVES
COMMISSION DIRECTIVE 2012/16/EU
of 10 May 2012
amending Directive 98/8/EC of the European Parliament and of the Council to include hydrochloric
acid as an active substance in Annex I thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
and other biocidal products, in accordance with the said
product-type 2, and containing hydrochloric acid may be
expected to satisfy the requirements laid down in
Having regard to the Treaty on the Functioning of the European
Article 5 of Directive 98/8/EC. It is therefore appropriate
Union,
to include hydrochloric acid in Annex I to that Directive.
Having regard to Directive 98/8/EC of the European Parliament
(6) Not
all
potential
uses
have
been
evaluated
at
Union
level.
and of the Council of 16 February 1998 concerning the placing
It is therefore appropriate that Member States assess
of biocidal products on the market ( 1 ), and in particular the
those uses or exposure scenarios and those risks to
second subparagraph of Article 16(2) thereof,
human populations and to environmental compartments
that have not been representatively addressed in the
Whereas:
Union level risk assessment and, when granting
product authorisations, ensure that appropriate
measures are taken or specific conditions imposed in
(1) Commission
Regulation
(EC)
No
1451/2007 of
order to reduce the identified risks to acceptable levels.
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
(7)
In view of the corrosivity of the substance as well as the
concerning the placing of biocidal products on the
possible measures identified to mitigate the related risk, it
market (
is appropriate to require that exposure during non-

2 ) establishes a list of active substances to be
assessed, with a view to their possible inclusion in
professional use is minimised through the design of the
Annex I, IA or IB to Directive 98/8/EC. That list
packaging, unless it can be demonstrated in the appli
includes hydrochloric acid.
cation for product authorisation that risks for human
health can be reduced to acceptable levels by other
means.
(2) Pursuant
to
Regulation
(EC)
No
1451/2007,
hydrochloric
acid has been evaluated in accordance with Article 11(2)
of Directive 98/8/EC for use in product-type 2, private
(8)
The provisions of this Directive should be applied at the
area and public health area disinfectants and other
same time in all Member States in order to ensure equal
biocidal products, as defined in Annex V to that
treatment on the Union market of biocidal products
Directive.
containing the active substance hydrochloric acid and
also to facilitate the proper operation of the biocidal
products market in general.
(3) Latvia
was
designated
as
rapporteur
Member
State
and
submitted the competent authority report, together with
a recommendation, to the Commission on
(9) A
reasonable
period
should
be
allowed
to
elapse
before
16 October 2009 in accordance with Article 14(4) and
an active substance is included in Annex I to Directive
(6) of Regulation (EC) No 1451/2007.
98/8/EC, in order to permit Member States and interested
parties to prepare themselves to meet the new
requirements entailed and to ensure that applicants
(4) The
competent
authority
report
was
reviewed
by
the
who have prepared dossiers can benefit fully from the
Member States and the Commission. In accordance
10-year period of data protection, which, in accordance
with Article 15(4) of Regulation (EC) No 1451/2007,
with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from
the findings of the review were incorporated, within
the date of inclusion.
the Standing Committee on Biocidal Products on
9 December 2011, in an assessment report.
(10) After
inclusion,
Member States should
be allowed
a
reasonable period to implement Article 16(3) of
(5) It
appears
from
the
evaluations
that
biocidal
products
Directive 98/8/EC.
used as private area and public health area disinfectants
( 1 ) OJ L 123, 24.4.1998, p. 1.
(11) Directive
98/8/EC
should
therefore
be
amended
accord
( 2 ) OJ L 325, 11.12.2007, p. 3.
ingly.

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EN
11.5.2012 Official
Journal
of
the
European
Union L
124/37
(12) The
measures provided for in this Directive are in
reference on the occasion of their official publication. Member
accordance with the opinion of the Standing
States shall determine how such reference is to be made.
Committee on Biocidal Products,
2. Member
States
shall
communicate
to
the
Commission
the
text of the main provisions of national law which they adopt in
HAS ADOPTED THIS DIRECTIVE:
the field covered by this Directive.
Article 1
Article 3
Annex I to Directive 98/8/EC is amended in accordance with
This Directive shall enter into force on the twentieth day
the Annex to this Directive.
following that of its publication in the Official Journal of the
European Union.
Article 2
Article 4
1. Member
States
shall
adopt
and
publish,
by
30
April
2013
This Directive is addressed to the Member States.
at the latest, the laws, regulations and administrative provisions
necessary to comply with this Directive.
Done at Brussels, 10 May 2012.
They shall apply those provisions from 1 May 2014.
For the Commission
When Member States adopt those provisions, they shall contain
The President
a reference to this Directive or be accompanied by such a
José Manuel BARROSO

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L 124/38
ANNEX
In Annex I to Directive 98/8/EC, the following entry is added:
Deadline for compliance
with Article 16(3) (except
Minimum purity
for products containing
EN
of the active
more than one active

substance, for which the
No Common
name
IUPAC name
substance in the
Date of
Expiry date of
Identification numbers
biocidal product
inclusion
deadline to comply with
inclusion
Product type Specific
provisions
(*)
as placed on the
Article 16(3) shall be the
market
one set out in the last of
the inclusion decisions
relating to its active
substances)
‘56 Hydrochloric Hydrochloric acid
999 g/kg 1
May
2014 30
April
2016 30
April
2024
2 When
assessing
the
application
for
authorisation
of
a
acid
product in accordance with Article 5 and Annex VI,
CAS No: not applicable
Member States shall assess, where relevant for the
Off
particular product, those uses or exposure scenarios
EC No: 231-595-7
icial
and those risks to human populations and to environ
mental compartments that have not been represen
Jour
tatively addressed in the Union level risk assessment.
nal
Member States shall ensure that authorisations of
of
products for non-professional use are subject to the
the
packaging being designed to minimise user exposure,
unless it can be demonstrated in the application for
European
product authorisation that risks for human health can
be reduced to acceptable levels by other means.’
Union
(*) 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
11.5.2012

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