HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 125/4
EN
Official Journal of the European Union
7.5.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 414/2013
of 6 May 2013
specifying a procedure for the authorisation of same biocidal products in accordance with
Regulation (EU) No 528/2012 of the European Parliament and of the Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
is identical to another biocidal product or product family which
has been authorised or registered in accordance with Directive
98/8/EC of the European Parliament and of the Council (
Having regard to the Treaty on the Functioning of the European

2 ) or
Regulation (EU) No 528/2012, or for which an application for
Union,
such registration or authorisation has been submitted (the
‘related reference product’), with regards to all the latest
Having regard to Regulation (EU) No 528/2012 of the
information submitted in relation to the authorisation or regis
European Parliament and of the Council of 22 May 2012
tration, except information which can be the subject of an
concerning the making available on the market and use of
administrative change in accordance with Commission Imple
biocidal products ( 1 ), and in particular Article 17(7) thereof,
menting Regulation (EU) No 354/2013 of 18 April 2013 on
changes of biocidal products authorised in accordance with
Regulation (EU) No 528/2012 of the European Parliament
Whereas:
and of the Council ( 3 ).
(1) Regulation
(EU)
No
528/2012
specifies
procedures
for
applying for and granting authorisation of biocidal
Article 2
products.
Content of applications
By way of derogation from Article 20(1) of Regulation (EU)
(2) Where
applications
are
submitted
to
the
same
receiving
competent authority or to the Agency for two or more
No 528/2012 and the information requirements in Article 43(1)
authorisations of biocidal products with the same
thereof, an application for authorisation of a same product shall
properties, the authorisations may be granted based on
contain the following information:
one single product evaluation and, as the case may be,
comparative assessment. It is therefore appropriate to
provide for an adapted authorisation procedure for
(a) the authorisation number or, for not yet approved related
such cases.
reference products, the application number in the Register
for Biocidal Products of the related reference product;
(3) The
terms
and
conditions
relating
to
the
making
available on the market and use of a biocidal product
(b) an indication of the proposed differences between the same
should be based on the evaluation made of the product.
product and the related reference product, and evidence that
It is therefore appropriate to require that biocidal
the products are identical on all other aspects;
products authorised in accordance with this Regulation
are authorised on the same terms and conditions as the
evaluated biocidal products to which they refer, with the
(c) where required by Article 59(1) of Regulation (EU) No
exception of the details on which the products differ.
528/2012, letters of access to all the data supporting the
authorisation of the related reference product;
(4) Since
this
Regulation
specifies
a
procedure
provided
for
by Regulation (EU) No 528/2012, which applies from
1 September 2013, this Regulation should also apply
(d) a draft summary of the biocidal product characteristics for
from that date.
the same product.
(5) The
measures
provided
for
in
this
Regulation
are
in
Article 3
accordance with the opinion of the Standing
Committee on Biocidal Products,
Submission and validation of applications for national
authorisation
HAS ADOPTED THIS REGULATION:
1. Where
the
related
reference
product
has
been
authorised
by national authorisation or is the subject of an application for
such an authorisation, applications for authorisation of a same
Article 1
product shall be submitted in accordance with Article 29(1) of
Subject matter
Regulation (EU) No 528/2012 to the competent authority that
has granted or is requested to grant the national authorisation
This Regulation lays down the procedure applicable where an
of the related reference product.
authorisation is sought for a product (the ‘same product’) which
( 2 ) OJ L 123, 24.4.1998, p. 1.
( 1 ) OJ L 167, 27.6.2012, p. 1.
( 3 ) OJ L 109, 19.4.2013, p. 4.

---

EN
7.5.2013 Official
Journal
of
the
European
Union L
125/5
2. By way of derogation from paragraphs 2 and 4 of
whether to grant or refuse authorisation of a same product in
Article 29 of Regulation (EU) No 528/2012, the competent
accordance with Article 19 of that Regulation within 60 days
authority shall validate the application within 30 days of
from the validation of the application in accordance with
accepting it, provided that the information indicated in
Article 3, or, where applicable, from the subsequent date of
Article 2 has been submitted.
adoption of the corresponding decision concerning the related
reference product.
The validation shall include a check that the proposed
differences between the same product and the related
Article 6
reference product concern merely information which can be
the subject of an administrative change in accordance with
Evaluation and decision on applications for Union
Implementing Regulation (EU) No 354/2013.
authorisation
1. By way of derogation from Article 44(1), (2) and (3) of
Regulation (EU) No 528/2012 the Agency shall prepare and
Article 4
submit to the Commission an opinion on the application
within 30 days from the validation of the application in
Submission and validation of applications for Union
accordance with Article 4 of this Regulation, or, where appli
authorisation
cable, on the subsequent date of submission of an opinion on
1. Where
the
related
reference
product
has
been
authorised the related reference product in accordance with Article 44(3) of
by Union authorisation or is the subject of an application for
Regulation (EU) No 528/2012.
such an authorisation, applications for authorisation of a same
product shall be submitted to the Agency in accordance with
Article 43(1) of Regulation (EU) No 528/2012.
2. If the Agency recommends the authorisation of the
biocidal product, the opinion shall contain at least both the
following elements:
2. However,
the
application
shall
not
include
a
confirmation
that the biocidal product would have similar conditions of use
across the Union or a reference to an evaluating competent
(a) a statement on whether the conditions laid down in
authority.
Article 19 of Regulation (EU) No 528/2012 are fulfilled,
and a draft summary of biocidal products characteristics,
as referred to in Article 22(2) of that Regulation;
3. For the purposes of the application of this Article,
Article 43(2) of Regulation (EU) No 528/2012 shall be read
as requiring the Agency to inform the applicant only.
(b) where relevant, details of any terms and conditions which
should be imposed on the making available on the market
and use of the biocidal product.
4. By
way
of
derogation
from
the
first
and
second
subpara
graphs of Article 43(3) of Regulation (EU) No 528/2012, the
Agency shall validate the application within 30 days of
accepting it provided that the information indicated in
Article 7
Article 2 has been submitted.
Authorisations and changes of same products
1. A
same
product
shall
have
a
different
authorisation
number than that of the related reference product.
5. The validation shall include a check that the proposed
differences between the same product and the related
reference product concern merely information which can be
the subject of an administrative change in accordance with
On all other aspects, the content of the authorisation of a same
Implementing Regulation (EU) No 354/2013.
product shall be identical with that of the related reference
product except in terms of the information in respect of
which the products differ. The Register for Biocidal Products
6. For the purposes of the application of this Article, all
shall show a link between same products and related
references to the evaluating competent authority in the third
reference products.
subparagraph of Article 43(3) and in Article 43(4) and (5) of
Regulation (EU) No 528/2012 shall be read as referring to the
Agency.
2. Changes of a same product or of a related reference
product shall be notified or applied for in accordance with
Implementing Regulation (EU) No 354/2013 independently of
Article 5
each other.
Evaluation and decision on applications for national
authorisation
Authorisations of a same product or of a related reference
By way of derogation from Article 30 of Regulation (EU) No
product may be changed or cancelled independently of each
528/2012, the receiving competent authority shall decide
other.

---

L 125/6
EN
Official Journal of the European Union
7.5.2013
However, in the evaluation of a proposed change of a same
Article 8
product or of a related reference product, the receiving
competent authority or, where relevant, the Agency shall
This Regulation shall enter into force on the twentieth day
consider the appropriateness of cancelling or amending the
following that of its publication in the Official Journal of the
authorisation of other products to which the product is
European Union.
linked in the Register for Biocidal Products as referred to in
the second subparagraph of paragraph 1.
It shall apply from 1 September 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 6 May 2013.
For the Commission
The President
José Manuel BARROSO

---

Document Outline

• �

---