Proposal for a COUNCIL DECISION on the position to be adopted, on behalf of the European Union, in the EEA Joint Committee amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
Date: 2013-10-29
Institutions: European Commission
Subjects: EU control, European Economic Area, chemical product, market approval, marketing standard, revision of an agreement













EUR-Lex - 52013PC0738 - EN











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52013PC0738

Proposal for a COUNCIL DECISION on the position to be adopted, on behalf of the European Union, in the EEA Joint Committee amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement /* COM/2013/0738 final - 2013/0354 (NLE) */









EXPLANATORY MEMORANDUM
1.           CONTEXT OF THE PROPOSAL
In order to ensure the requisite legal
security and homogeneity of the Internal Market, the EEA Joint Committee is to
integrate all the relevant EU legislation into the EEA Agreement as soon as
possible after its adoption.
2.           RESULTS OF CONSULTATIONS
WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENTS
The EEA EFTA Member States welcome
Regulation (EU) No 528/2012 on Biocides. The EEA EFTA Member States would like
to be associated as closely as possible with the work of the European Chemicals
Agency in this regard and the EEA EFTA Member States will not only comply with
the Regulation, but would also like to contribute actively to the work foreseen
under Regulation 528/2012. The draft EEA Joint Committee Decision (annexed to
the proposed Council Decision) has been drafted with this in mind.
The Commission wishes to stress certain
features of the draft EEA Joint Committee Decision.
The entry into force of this Joint
Committee Decision in Liechtenstein will come later than the date of entry into
force in the other EFTA states. 
Liechtenstein has
an agreement with Switzerland on biocidal products. Based on this Agreement, Switzerland processes the Liechtenstein applications and Liechtenstein authorises (or prohibits) the
biocidal product in question. 
Switzerland will
align in the near future its legislation in this field to the new developments
in the EU (Regulation 528/2012) and in the light of this, the Agreement between
 Liechtenstein and Switzerland laying down the cooperation in the field of
authorisation procedures for biocidal products will be updated. 
This solution ensures a high level of
protection of both human and animal health and the environment, while
guaranteeing the proper functioning of the internal market, explicitly
mentioned as one of the objectives of the Regulation.
In this context, it has to be emphasised
that the suggested solution does not prohibit the placing on the market of
biocidal products and does not infringe any of the freedoms guaranteed by the
EEA Agreement, in particular not the free movement of goods. This also does not
result in any distortion of competition within the EEA.
Moreover, the EFTA side proposes
adaptations in particular in relation to the participation of the EFTA states
in the work of the coordination group under Article 35 of Regulation 528/2012
and the process of granting Union authorisations and corresponding decisions in
the EFTA states.
3.           LEGAL ELEMENTS OF THE
PROPOSAL
Regulation (EU) No 528/2012 of the
European Parliament and of the Council of 22 May 2012 concerning the
making available on the market and use of biocidal products is to be
incorporated into the EEA Agreement. 
The Commission submits the Draft Decision
of the EEA Joint Committee for adoption by the Council of the corresponding Union’s position. The Commission would hope to be able to present it in the EEA Joint
Committee at the earliest possible opportunity.
2013/0354 (NLE)
Proposal for a
COUNCIL DECISION
on the position to be adopted, on behalf of
the European Union,
in the EEA Joint Committee amending Annex II (Technical regulations, standards,
testing and certification) to the EEA Agreement
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the
Functioning of the European Union, and in particular Article 114 in conjunction with Article 218(9) thereof,
Having regard to Council Regulation (EC) No
2894/94 of 28 November 1994 concerning arrangements for implementing the
Agreement on the European Economic Area[1],
and in particular Article 1(3) thereof,
Having regard to the proposal from the
European Commission,
Whereas:
(1)       The Agreement on the
European Economic Area[2]
(“the EEA Agreement”) entered into force on 1 January 1994.
(2)       Pursuant to Article 98 of
the EEA Agreement, the EEA Joint Committee may decide to amend, inter alia, Annex
II thereto.
(3)       Annex II to the EEA
Agreement contains specific provisions on technical regulations, standards,
testing and certification.
(4)       Regulation (EU)
No 528/2012 of the European Parliament and of the Council of 22 May
2012 concerning the making available on the market and use of biocidal products
is to be incorporated into the EEA Agreement.
(5)       Regulation (EU)
No 528/2012 repeals, with effect from 1 September 2013, Directive 98/8/EC
of the European Parliament and of the Council[3]
which is incorporated into the EEA Agreement and which is consequently to be
repealed under the EEA Agreement with effect from 1 September 2013.
(6)       Annex II to the EEA
Agreement should therefore be amended accordingly.
(7)       The position of the Union in the EEA Joint Committee should be based on the attached draft Decision,
HAS ADOPTED THIS DECISION: 
Article 1
The position to be adopted, on behalf of
the European Union, in the EEA Joint Committee on the proposed amendment to Annex
II to the EEA Agreement shall be based on the draft Decision of the
EEA Joint Committee attached to this Decision.
Article 2
This Decision shall enter into force on the
day of its adoption.
Done at Brussels,
                                                                       For
the Council
                                                                       The
President
ANNEX 
Draft
DECISION
OF THE EEA JOINT COMMITTEE 
No
of
amending
Annex II (Technical regulations, standards, testing and certification) to the
EEA Agreement
THE EEA JOINT COMMITTEE,
Having regard to the Agreement on the
European Economic Area (“the EEA Agreement”), and in particular Article 98
thereof,
Whereas:
(1)                   
Regulation (EU) No 528/2012 of the European
Parliament and of the Council of 22 May 2012 concerning the making
available on the market and use of biocidal products[4] is to be incorporated into the
EEA Agreement.
(2)                   
Regulation (EU) No 528/2012 repeals, with
effect from 1 September 2013, Directive 98/8/EC of the European Parliament and
of the Council[5]
which is incorporated into the EEA Agreement and which is consequently to be
repealed under the EEA Agreement with effect from 1 September 2013.
(3)                   
Annex II to the EEA Agreement should therefore
be amended accordingly,
HAS ADOPTED THIS DECISION:
Article 1
The text of point 12n (Directive 98/8/EC of
the European Parliament and of the Council) of Chapter XV of Annex II shall be
replaced by the following with effect from 1 September 2013:
‘32012 R 0528: Regulation (EU)
No 528/2012 of the European Parliament and of the Council of 22 May
2012 concerning the making available on the market and use of biocidal products
(OJ L 167, 27.6.2012, p. 1).
The provisions of the Regulation shall, for
the purpose of this Agreement, be read with the following adaptations:
(a)          The EFTA States shall participate
in the work of the European Chemicals Agency, hereinafter referred to as ‘the
Agency’, as set up by European Parliament and Council Regulation (EC) No
1907/2006. 
(b)          Notwithstanding the provisions of
Protocol 1 to the Agreement, the term ‘Member State(s)’ contained in the
Regulation shall be understood to include, in addition to its meaning in the
Regulation, the EFTA States. 
(c)          As regards the EFTA States, the
Agency shall, as and when appropriate, assist the EFTA Surveillance Authority
or the Standing Committee, as the case may be, in the performance of their
respective tasks.
(d)          The following paragraph shall be
added in Article 35:
“4.     The EFTA States shall be entitled to
participate fully in the work of the coordination group and shall within it
have the same rights and obligations as EU Member States, except the right to
vote. The rules of procedures of the coordination Group shall give full effect
to the EFTA States’ participation.” 
(e)          The following subparagraph shall
be added in Article 44(5):
“When the Commission grants a Union
authorisation or decides that a Union authorisation has not been granted, the
EFTA States will simultaneously and within 30 days of the Commission act take
corresponding decisions. The EEA Joint Committee shall be informed and shall
periodically publish lists of such decisions in the EEA Supplement to the Official
Journal.”
(f)           The following paragraph shall be
added in Article 48:
“4.     If the Commission cancels or amends a
Union authorisation, the EFTA States    shall cancel or amend the corresponding
decision.”
(g)          The following subparagraph shall
be added in Article 49:
“If the Commission cancels a Union
authorisation, the EFTA States shall cancel the corresponding decision.”
(h)          The following paragraph shall be
added in Article 50:
“4.     If the Commission amends a Union
authorisation, the EFTA states shall amend   the corresponding decision.”
(i)           The following paragraph shall be
added in Article 75:
“5.     The EFTA States shall be entitled to
participate fully in the work of the  Biocidal Products Committee and shall
within it have the same rights and obligations as EU Member States, except the
right to vote.”
(j)           The following paragraph shall be
added in Article 78:
“3.     The EFTA States shall, as from the
entry into force of this Decision participate in the financing of the Agency.
For this purpose the procedures laid down in Article 82(1)(a) and Protocol 32
of the Agreement shall apply mutatis mutandis.”
(k)          Should any disagreement between
the Contracting Parties arise as to the administration of these provisions,
Part VII of the Agreement shall apply mutatis mutandis.’
Article 2
The texts of Regulation (EU)
No 528/2012 in the Icelandic and Norwegian languages, to be published in
the EEA Supplement to the Official Journal of the European Union, shall
be authentic.
Article 3
This Decision shall enter into force on ,
provided that all the notifications under Article 103(1) of the EEA Agreement
have been made*.
For Liechtenstein, this Decision shall
enter into force on the same day or on the day of entry into force of the
Agreement between Liechtenstein and Switzerland laying down the cooperation in
the field of authorisation procedures for biocidal products according to
Regulation (EU) No 528/2012, whichever is the later.
Article 4
This Decision shall be published in the EEA
Section of, and in the EEA Supplement to, the Official Journal of the
European Union.
Done at Brussels, .
            For
the EEA Joint Committee
            The
President
            
            
            
            The Secretaries
            to the EEA Joint Committee
[1]               OJ L 305, 30.11.1994, p. 6.
[2]               OJ L 1, 3.1.1994, p. 3. 
[3]               OJ L 123, 24.4.1998, p. 1.
[4]               OJ L 167, 27.6.2012, p. 1.
[5]               OJ L 123, 24.4.1998, p. 1.
*              [No constitutional
requirements indicated.] [Constitutional requirements indicated.]