HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"EN
25.10.2013 Official
Journal
of
the
European
Union L
283/25
COMMISSION IMPLEMENTING REGULATION (EU) No 1033/2013
of 24 October 2013
approving copper sulphate pentahydrate as an existing active substance for use in biocidal products
for product-type 2
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) France
was
designated
as
Rapporteur
Member
State
and
submitted the competent authority report, together with
a recommendation, to the Commission on 5 April 2011
in accordance with Article 14(4) and (6) of Regulation
Having regard to the Treaty on the Functioning of the European
(EC) No 1451/2007.
Union,
(5) The
competent
authority
report
was
reviewed
by
the
Having regard to Regulation (EU) No 528/2012 of the
Member States and the Commission. In accordance
European Parliament and of the Council of 22 May 2012
with Article 15(4) of Regulation (EC) No 1451/2007,
concerning the making available on the market and use of
the findings of the review were incorporated, within
biocidal products (
the Standing Committee on Biocidal Products on

1 ), and in particular the third subparagraph
of Article 89(1) thereof,
27 September 2013, in an assessment report.
(6)
It appears from that report that biocidal products used
Whereas:
for product-type 2 and containing copper sulphate
pentahydrate may be expected to satisfy the requirements
laid down in Article 5 of Directive 98/8/EC.
(1) Commission
Regulation
(EC)
No
1451/2007
( 2 ) estab
lishes a list of active substances to be assessed, with a
view to their possible inclusion in Annex I, IA or IB to
(7) It
is
therefore
appropriate
to
approve
copper
sulphate
for
Directive 98/8/EC of the European Parliament and of the
use in biocidal products for product-type 2.
Council ( 3 ). That list includes copper sulphate.
(8) Since
the
evaluation
did
not
address
nanomaterials,
the
(2) Copper
sulphate
has
been
evaluated
in
accordance
with
approval should not cover such materials pursuant to
Article 11(2) of Directive 98/8/EC for use in product-
Article 4(4) of Regulation (EU) No 528/2012.
type 2, private area and public health area disinfectants
and other biocidal products, as defined in Annex V to
that Directive, which corresponds to product-type 2 as
defined in Annex V to Regulation (EU) No 528/2012.
(9) A
reasonable
period
should
be
allowed
to
elapse
before
an active substance is approved, in order to permit
Member States, interested parties, and the Commission
where appropriate, to prepare themselves to meet the
(3)
The data submitted for the purpose of the evaluation
new requirements entailed.
allowed conclusions to be drawn only regarding a
certain form of copper sulphate, i.e. copper sulphate
pentahydrate CAS No 7758-99-8. The evaluation did
not allow conclusions to be drawn regarding any other
(10) The
measures
provided
for
in
this
Regulation
are
in
substance complying with the definition of copper
accordance with the opinion of the Standing
sulphate CAS 7758-99-7 in the abovementioned list of
Committee on Biocidal Products,
active substances in Regulation (EC) No 1451/2007.
Therefore, only copper sulphate pentahydrate should be
covered by the approval.
HAS ADOPTED THIS REGULATION:
( 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 1
Article 16(2) of Directive 98/8/EC of the European Parliament and
of the Council concerning the placing of biocidal products on the
Copper sulphate pentahydrate shall be approved as an active
market (OJ L 325, 11.12.2007, p. 3).
substance for use in biocidal products for product-type 2,
( 3 ) Directive 98/8/EC of the European Parliament and of the Council of
16 February 1998 concerning the placing of biocidal products on
subject to the specifications and conditions set out in the
the market (OJ L 123, 24.4.1998, p. 1).
Annex.

---

L 283/26
EN
Official Journal of the European Union
25.10.2013
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official
Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 24 October 2013.
For the Commission
The President
José Manuel BARROSO

---

25.10.2013 Off
ANNEX
Minimum degree of
Common Name
IUPAC Name
Identification Numbers
purity of the active
Date of approval
Expiry date of
substance (
approval
Product type Specific
conditions
(2 )
1 )
EN
Copper
IUPAC Name: copper sulphate pentahydrate
999 g/kg 1
July
2015 30
June
2025
2 The
product
assessment
shall
pay
particular
attention
to
the
sulphate
exposures, the risks and the efficacy linked to any uses
pentahydrate
covered by an application for authorisation, but not
EC No: 231-847-6 (3 )
addressed in the Union level risk assessment of the active
substance.
CAS No: 7758-99-8
Authorisations are subject to the following condition:
For industrial or professional users, safe operational
procedures and appropriate organisational measures shall
be established. Where exposure cannot be reduced to an
icial
acceptable level by other means, products shall be used
with appropriate personal protective equipment.
Jour
nal
(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
of
(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/
the
biocides/index.htm
(3 ) Only copper sulphate pentahydrate should be considered under this EC number
European
Union
L
283/27

---

Document Outline

• �

---