# EUR-Lex - 52015PC0167 - EN

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# 52015PC0167

**Proposal for a COUNCIL DECISION on the position to be adopted, on behalf of the European Union, in the EEA Joint Committee concerning an amendment to Annex II (Technical regulations, standards, testing and certification) of the EEA Agreement (Novel foods) /* COM/2015/0167 final - 2015/0086 (NLE) */**

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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 draft Decision of the EEA Joint
Committee (annexed to the proposed Council Decision) aims to amend Annex II to
the EEA Agreement in order to incorporate the following in the EEA Agreement,
and more concretly:

(1) 
Regulation (EC) No 258/97 of the European
Parliament and of the Council of 27 January 1997 concerning novel foods and
novel food ingredients[1].

(2) 
Commission Regulation (EC) No 1852/2001 of 20
September 2001 laying down detailed rules for making certain information
available to the public and for the protection of information submitted
pursuant to European Parliament and Council Regulation (EC) No 258/97[2].

(3) 
Commission Recommendation 97/618/EC of 29 July 1997
concerning the scientific aspects and the presentation of information necessary
to support applications for the placing on the market of novel foods and novel
food ingredients and the preparation of initial assessment reports under
Regulation (EC) No 258/97 of the European Parliament and of the Council[3].

(4) 
Article 38 of Regulation (EC) No 1829/2003 of
the European Parliament and of the Council of 22 September 2003 on genetically
modified food and feed[4]
amends Regulation (EC) No 258/97.

The EEA EFTA side is proposing notably an
adaptation to Article 7 of Regulation (EC) No 258/97. The proposed text states
that when the Commission takes authorization decisions under that Article, the
EFTA States will simultaneously and within 30 days take corresponding decisions.

Annex II to the EEA agreement should
therefore be amended accordingly.

3.           LEGAL ELEMENTS OF THE
PROPOSAL

Article 1(3) of Council
Regulation (EC) No 2894/94 concerning arrangements for implementing the EEA
Agreement provides that the Council establishes the position to be adopted on
the Union’s behalf on such Decisions, on a proposal from the Commission.

The Commission submits the
Draft Decision of the EEA Joint Committee for adoption by the Council as the
Union’s position. The Commission would hope to be able to present it in the EEA
Joint Committee at the earliest possible opportunity.

2015/0086 (NLE)

Proposal for a

COUNCIL DECISION

on the position to be adopted, on behalf
of the European Union, in the EEA Joint Committee concerning an amendment to Annex
II (Technical regulations, standards, testing and certification) of the EEA
Agreement
(Novel foods)

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[5],
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[6]
('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 to the EEA Agreement.

(3)       Annex II to the EEA
Agreement contains specific provisions and arrangements concerning technical
regulations, standards, testing and certification.

(4)       Regulation (EC) No 258/97
of the European Parliament and of the Council[7]
is to be incorporated into the Agreement.

(5)       Commission Regulation (EC)
No 1852/2001 of 20 September 2001[8]
is to be incorporated into the Agreement.

(6)       Commission Recommendation
97/618/EC of 29 July 1997[9]
is to be incorporated into the Agreement.

(7)       Article 38 of Regulation
(EC) No 1829/2003 of the European Parliament and of the Council[10] amends Regulation (EC)
No 258/97 and is to be incorporated into the Agreement.

(8)       Annex II to the EEA
Agreement should therefore be amended accordingly.

(9)       The position of the Union
within the EEA Joint Committee should therefore be based on the attached draft
Decision.

HAS ADOPTED THIS DECISION:

Article 1

The position to be adopted, on behalf of
the European Union, within the EEA Joint Committee on the proposed amendment to
Annex II (Technical regulations, standards, testing and certification) 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
date of its adoption.

Done at Brussels,

For
the Council

The
President

[1]               OJ L 43, 14.2.1997, p. 1.

[2]               OJ L 253, 21.9.2001, p. 17.

[3]               OJ L 253, 16.9.1997, p. 1.

[4]               OJ L 268, 18.10.2003, p. 1

[5]               OJ L 305, 30.11.1994, p. 6.

[6]               OJ L 1, 3.1.1994, p. 3.

[7]               Regulation (EC) No 258/97 of the European Parliament
and of the Council of 27 January 1997 concerning novel foods and novel food
ingredients, OJ L 43, 14.2.1997, p. 1.

[8]               Commission Regulation (EC) No 1852/2001 of 20
September 2001 laying down detailed rules for making certain information
available to the public and for the protection of information submitted
pursuant to European Parliament and Council Regulation (EC) No 258/97, OJ L
253, 21.9.2001, p. 17.

[9]               Commission Recommendation 97/618/EC of 29 July 1997
concerning the scientific aspects and the presentation of information necessary
to support applications for the placing on the market of novel foods and novel
food ingredients and the preparation of initial assessment reports under
Regulation (EC) No 258/97 of the European Parliament and of the Council, OJ L
253, 16.9.1997, p. 1.

[10]             Regulation (EC) No 1829/2003 of the European Parliament
and of the Council of 22 September 2003 on genetically modified food and feed,
OJ L 268, 18.10.2003, p. 1

ANNEX
DECISION OF THE EEA JOINT COMMITTEE 
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 (EC) No 258/97 of the European
Parliament and of the Council of 27 January 1997 concerning novel foods and
novel food ingredients[1]
is to be incorporated into the Agreement.

(2) 
Commission Regulation (EC) No 1852/2001 of 20
September 2001 laying down detailed rules for making certain information
available to the public and for the protection of information submitted
pursuant to European Parliament and Council Regulation (EC) No 258/97[2] is to be incorporated
into the Agreement.

(3) 
Commission Recommendation 97/618/EC of 29 July
1997 concerning the scientific aspects and the presentation of information
necessary to support applications for the placing on the market of novel foods
and novel food ingredients and the preparation of initial assessment reports
under Regulation (EC) No 258/97 of the European Parliament and of the Council[3] is to be incorporated
into the Agreement.

(4) 
Article 38 of Regulation (EC) No 1829/2003 of
the European Parliament and of the Council of 22 September 2003 on genetically
modified food and feed[4]
amends Regulation (EC) No 258/97 and is to be incorporated into the Agreement.

(5) 
This Decision concerns legislation regarding
foodstuffs. Legislation regarding foodstuffs shall not apply to Liechtenstein
as long as the application of the Agreement between the European Community and
the Swiss Confederation on trade in agricultural products is extended to
Liechtenstein, as specified in the introduction to Chapter XII of Annex II to
the EEA Agreement. This Decision is therefore not to apply to Liechtenstein.

(6) 
Annex II to the EEA Agreement should therefore
be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

Chapter XII of Annex II to the EEA
Agreement shall be amended as follows:

1.           The following is added after
point 97 (Regulation (EU) No 1169/2011 of the European Parliament and of the
Council):

‘98.   31997 R 0258: Regulation (EC) No
258/97 of the European Parliament and of the Council of 27 January 1997
concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1),
as amended by:

– 
32003 R 1829:
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of
22 September 2003 (OJ L 268, 18.10.2003, p. 1),

– 
32008 R 1332:
Regulation (EC) No 1332/2008 of the European Parliament and of the Council of
16 December 2008 (OJ L 354, 31.12.2008, p. 7).

The provisions of the
Regulation shall, for the purpose of this Agreement, be read with the following
adaptations:

Article 7 shall be read with the following
adaptations:

“When
the Commission takes authorization decisions, the EFTA States will
simultaneously and within 30 days of the Community Decision, 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.

Should
any disagreement between the contracting parties arise to the administration of
these provisions, Part VII of the Agreement shall apply mutatis mutandis.”

99.    32001 R 1852: Commission
Regulation (EC) No 1852/2001 of 20 September 2001 laying down detailed rules
for making certain information available to the public and for the protection
of information submitted pursuant to European Parliament and Council Regulation
(EC) No 258/97 (OJ L 253, 21.9.2001, p. 17).’

2.           Under the heading ‘ACTS OF
WHICH THE EFTA STATES AND THE EFTA SURVEILLANCE AUTHORITY SHALL TAKE DUE
ACCOUNT’ the following point is added after point 16 (Commission
Recommendation 2013/647/EU):

‘17.   31997 H 0618: Commission
Recommendation 97/618/EC of 29 July 1997 concerning the scientific aspects and
the presentation of information necessary to support applications for the
placing on the market of novel foods and novel food ingredients and the
preparation of initial assessment reports under Regulation (EC) No 258/97 of
the European Parliament and of the Council (OJ L 253, 16.9.1997, p. 1).’

Article 2

The texts of Regulations (EC) No 258/97,
(EC) No 1852/2001 and (EC) No 1829/2003 and Recommendation 97/618/EC, 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 Agreement have been made to the EEA Joint Committee*.

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 43, 14.2.1997, p. 1.

[2]               OJ L 253, 21.9.2001, p. 17.

[3]               OJ L 253, 16.9.1997, p. 1.

[4]               OJ L 268, 18.10.2003, p. 1

- [No constitutional requirements indicated.] [Constitutional
requirements indicated.]