Common Position (EC) No 6/2008 of 10 March 2008 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to the adoption of a Regulation of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings (Text with EEA relevance)
Date: 2008-03-10
Institutions: Council of the European Union
Subjects: approximation of laws, consumer protection, enzyme, flavouring, food additive, food safety, foodstuffs legislation, public health

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III

(Preparatory Acts)

COUNCIL

COMMON POSITION (EC) No 6/2008

adopted by the Council on 10 March 2008

with a view to adopting Regulation (EC) No …/2008 of the European Parliament and of the Council
of … establishing a common authorisation procedure for food additives, food enzymes and food
flavourings

(Text with EEA relevance)

(2008/C 111 E/01)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

(4)

Having regard to the Treaty establishing the European Com-
munity, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the Opinion of the European Economic and
Social Committee (1),

Acting in accordance with the procedure
Article 251 of the Treaty (2),

laid down in

Council

Regulation

83/417/EEC,

Regulation (EC) No …/2008 of the European Parliament
and of the Council of … on food additives (3), Regulation
(EC) No …/2008 of the European Parliament and of the
Council of … on food enzymes and amending Council
Directive
(EC)
No 1493/1999, Directive 2000/13/EC, Council Directive
2001/112/EC and Regulation (EC) No 258/97 (4) and
Regulation (EC) No …/2008 of the European Parliament
and of the Council of … on flavourings and certain
food ingredients with flavouring properties for use in
and on foods and amending Council Regulations (EEC)
No 1576/89 and (EEC) No 1601/91, Regulation (EC)
No 2232/96 and Directive 2000/13/EC (5)
lay down
harmonised criteria and requirements concerning the
assessment and authorisation of these substances.

Whereas:

(1)

(2)

(3)

The free movement of safe and wholesome food is an
essential aspect of the internal market and contributes
significantly to the health and well-being of citizens, and
to their social and economic interests.

A high level of protection of human life and health
should be assured in the pursuit of Community policies.

In order to protect human health, the safety of additives,
enzymes and flavourings for use in foodstuffs for human
consumption must be assessed before they are placed on
the Community market.

(5)

(6)

It is envisaged,
in particular, that food additives, food
enzymes and food flavourings, to the extent that the
safety of food flavourings must be assessed in accordance
with Regulation (EC) No …/2008 (*), must not be placed
on the market or used in foodstuffs for human consump-
tion, in accordance with the conditions laid down in each
sectoral food law, unless they are included on a Com-
munity list of authorised substances.

In this context,
it appears appropriate to establish for
these three categories of substances a common Com-
munity assessment and authorisation procedure that is
effective, time-limited and transparent, so as to facilitate
their free movement within the Community market.

(1) OJ C 168, 20.7.2007, p. 34.
(2) Opinion of the European Parliament of 10 July 2007 (not yet published
in the Official Journal), Council Common Position of 10 March 2008,
Position of the European Parliament of … (not yet published in the
Official Journal) and Council Decision of …

(3) See page 10 of this Official Journal.
(4) See page 32 of this Official Journal.
(5) See page 46 of this Official Journal.
(*) See footnote 5.

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This common procedure must be founded on the princi-
ples of good administration and legal certainty and must
be implemented in compliance with those principles.

(13)

In order to ensure that both business operators in the
sectors concerned and the public are kept informed of
the authorisations in force,
the authorised substances
should be included on a Community list created, main-
tained and published by the Commission.

(7)

(8)

(9)

This Regulation will thus complete the regulatory frame-
work concerning the authorisation of the substances by
laying down the various stages of
the procedure, the
deadlines for those stages, the role of the parties involved
and the principles that apply. Nevertheless,
for some
is necessary to take the
aspects of
the procedure,
food law into
specific characteristics of each sectoral
consideration.

it

The deadlines laid down in the procedure take into
account the time needed to consider the different criteria
set in each sectoral law, as well as allowing adequate time
for consultation when preparing the draft measures. In
particular, the nine-months deadline for the Commission
to present a draft regulation updating the Community list
should not preclude the possibility of this being done
within a shorter period.

(10) Upon receipt of an application the Commission should
initiate the procedure and where necessary seek the
opinion of the European Food Safety Authority (herein-
after referred to as ‘the Authority’) established by Regu-
lation (EC) No 178/2002 of the European Parliament and
of the Council of 28 January 2002 laying down the
general principles and requirements of food law, estab-
lishing the European Food Safety Authority and laying
down procedures in matters of food safety (6) as soon as
possible after the validity and applicability of the applica-
tion have been assessed.

(11)

In accordance with the framework for risk assessment in
matters of
food safety established by Regulation (EC)
No 178/2002, the authorisation to place substances on
the market must be preceded by a scientific assessment,
of the highest possible standard, of the risks that they
pose to human health. This assessment, which must be
the Authority,
carried out under the responsibility of
must be followed by a risk management decision taken
by the Commission under a regulatory procedure that
ensures close cooperation between the Commission and
the Member States.

(14) Networking between the Authority and the Member
States' organisations operating in the fields within the
Authority's mission is one of the basic principles of the
Authority's operation. In consequence,
in preparing its
opinion, the Authority may use the network made avail-
able to it by Article 36 of Regulation (EC) No 178/2002
and by Commission Regulation (EC) No 2230/2004 (7).

(15)

The common authorisation procedure for the substances
must fulfil transparency and public information require-
ments while guaranteeing the right of applicants to
preserve the confidentiality of certain information.

(16)

(17)

(18)

Protecting the confidentiality of certain aspects of an
application should be maintained as a consideration in
order to protect the competitive position of an applicant.
safety of
However,
a
substance,
toxicological
studies, other safety studies and raw data as such, should
under no circumstances be confidential.

information relating to the
limited to,
including, but not

Pursuant to Regulation (EC) No 178/2002, Regulation
(EC) No 1049/2001 of the European Parliament and of
the Council of 30 May 2001 regarding public access to
European Parliament, Council and Commission docu-
ments (8) applies to documents held by the Authority.

Regulation (EC) No 178/2002 establishes procedures for
taking emergency measures in relation to foodstuffs of
Community origin or imported from third countries. It
authorises the Commission to adopt such measures in
situations where foodstuffs are likely to constitute a
serious risk to human health, animal health or the envir-
onment and where such risk cannot be contained satis-
factorily by measures taken by the Member State(s)
concerned.

(12)

It is recognised that, in some cases, scientific risk assess-
ment alone cannot provide all the information on which
a risk management decision should be based, and that
other legitimate factors relevant
to the matter under
consideration may be taken into account, including soci-
etal, economic,
traditional, ethical and environmental
factors and the feasibility of controls.

(6) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission

Regulation (EC) No 575/2006 (OJ L 100, 8.4.2006, p. 3).

(19)

In the interests of efficiency and legislative simplification,
there should be a medium-term examination of the ques-
tion whether to extend the scope of the common proce-
dure to other legislation in the area of food.

(7) Regulation (EC) No 2230/2004 of 23 December 2004 laying down
detailed rules for the implementation of European Parliament and
Council Regulation (EC) No 178/2002 with regard to the network of
organisations operating in the fields within the European Food Safety
Authority's mission (OJ L 379, 24.12.2004, p. 64).

(8) OJ L 145, 31.5.2001, p. 43.

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(20)

(21)

(22)

Since the objectives of
this Regulation cannot be
sufficiently achieved by the Member States on account of
differences between national laws and provisions and can
the
therefore be better achieved at Community level,
Community may adopt measures, in accordance with the
principle of subsidiarity as set out in Article 5 of the
Treaty.
In accordance with the principle of propor-
tionality, as set out in that Article, this Regulation does
not go beyond what is necessary in order to achieve
those objectives.

The measures necessary for the implementation of this
adopted in accordance with
Regulation should be
Council Decision 1999/468/EC of 28 June 1999 laying
down the procedures for the exercise of implementing
powers conferred on the Commission (9).

In particular the Commission should be empowered to
update the Community lists. Since those measures are of
general scope and are designed to amend non-essential
elements of
inter alia by
supplementing it with new non-essential elements, they
must be adopted in accordance with the regulatory
procedure with scrutiny provided for in Article 5a of
Decision 1999/468/EC.

each sectoral

food law,

(23) On grounds of efficiency, the normal time-limits for the
regulatory procedure with scrutiny should be curtailed
for the addition of substances to the Community lists
and for adding, removing or changing conditions, specifi-
cations or restrictions associated with the presence of a
substance on the Community lists.

(24) When, on imperative grounds of urgency, the normal
time-limits for the regulatory procedure with scrutiny
cannot be complied with, the Commission should be
able to apply the urgency procedure provided for in
Article 5a(6) of Decision 1999/468/EC for the removal
of a substance from the Community lists and for adding,
specifications or
removing or
restrictions associated with the presence of a substance
on the Community lists,

changing conditions,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PRINCIPLES

Article 1

Subject matter and scope

1.
This Regulation lays down a common assessment and
authorisation procedure (hereinafter referred to as the ‘common
procedure’) for food additives, food enzymes, food flavourings

(9) OJ L 184, 17.7.1999, p. 23. Decision as amended by Council Decision

2006/512/EC (OJ L 200, 22.7.2006, p. 11).

and source materials of food flavourings and of food ingredients
with flavouring properties used or intended for use in or on
foodstuffs (hereinafter referred to as the ‘substances’), which
facilitates the free movement of these substances within the
Community. This Regulation shall not apply to smoke flavour-
ings falling within the scope of Regulation (EC) No 2065/2003
of the European Parliament and of the Council of 10 November
2003 on smoke flavourings used or intended for use in or on
foods (10).

The common procedure shall

2.
lay down the procedural
arrangements for updating the lists of substances the marketing
of which is authorised in the Community pursuant to Regu-
lation (EC) No …/2008 (*), Regulation (EC) No …/2008 (**)
and Regulation (EC) No …/2008 (***) (hereinafter referred to as
the ‘sectoral food laws’).

The criteria according to which substances can be included
3.
on the Community list provided for in Article 2, the content of
the regulation referred to in Article 7 and, where applicable, the
transitional provisions concerning ongoing procedures are laid
down in each sectoral food law.

Article 2

Community list of substances

1.
Under each sectoral food law, substances that have been
authorised to be placed on the Community market shall be
included on a list the content of which is determined by the
said law (hereinafter referred to as the ‘Community list’). The
Community list shall be updated by the Commission. It shall be
published in the Official Journal of the European Union.

2.

‘Updating the Community list’ means:

(a) adding a substance to the Community list;

(b) removing a substance from the Community list;

(c) adding, removing or changing conditions, specifications or
restrictions associated with the presence of a substance on
the Community list.

CHAPTER II

COMMON PROCEDURE

Article 3

Main stages of the common procedure

1.
The common procedure for updating the Community list
may be started either on the initiative of the Commission or
following an application. Applications may be made by a
Member State or by an interested party, who may represent
in accordance with the conditions
several
provided for by the implementing measures referred to in
Article 9(1)(a) (hereinafter referred to as the ‘applicant’). Applica-
tions shall be sent to the Commission.

interested parties,

(10) OJ L 309, 26.11.2003, p. 1.
(*) See page 10 of this Official Journal.
(**) See page 32 of this Official Journal.
(***) See page 46 of this Official Journal.

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2.
The Commission shall seek the opinion of the European
Food Safety Authority (hereinafter referred to as the ‘Authority’),
to be given in accordance with Article 5.

However, for the updates referred to in Article 2(2)(b) and (c),
the Commission shall not be required to seek the opinion of the
Authority if the updates in question are not liable to have an
effect on human health.

The common procedure shall end with the adoption by
in

3.
the Commission of a regulation implementing the update,
accordance with Article 7.

4.
By way of derogation from paragraph 3, the Commission
may end the common procedure and decide not to proceed
with a planned update, at any stage of the procedure, if it judges
that such an update is not justified. Where applicable, it shall
take account of the opinion of the Authority, the views of
Member States, any relevant provisions of Community law and
any other
to the matter under
consideration.

legitimate factors relevant

In such cases, where applicable, the Commission shall inform
the applicant and the Member States directly, indicating in its
letter the reasons for not considering the update justified.

Article 4

Initiating the procedure

On receipt of an application to update the Community

1.
list, the Commission:

(a) shall acknowledge receipt of the application in writing to

the applicant within 14 working days of receiving it;

(b) where applicable, shall as soon as possible notify the
its opinion in
the application and request

Authority of
accordance with Article 3(2).

The application shall be made available to the Member States by
the Commission.

2. Where it starts the procedure on its own initiative, the
Commission shall inform the Member States and, where applic-
able, request the opinion of the Authority.

Article 5

Opinion of the Authority

The Authority shall give its opinion within six months of

1.
receipt of a valid application.

The Authority shall forward its opinion to the Commis-

2.
sion, the Member States and, where applicable, the applicant.

Article 6

Additional information concerning risk assessment

1.
tional

In duly justified cases where the Authority requests addi-
information from applicants, the period referred to in

Article 5(1) may be extended. After consulting the applicant, the
Authority shall lay down a period within which this information
can be provided and shall inform the Commission of the addi-
tional period needed. If the Commission does not object within
eight working days of being informed by the Authority, the
period referred to in Article 5(1) shall be automatically extended
by the additional period. The Commission shall
inform the
Member States of the extension.

2.
If the additional information is not sent to the Authority
within the additional period referred to in paragraph 1, the
Authority shall finalise its opinion on the basis of the informa-
tion already provided.

3. Where applicants submit additional information on their
own initiative, they shall send it to the Authority and to the
Commission. In such cases, the Authority shall give its opinion
within the original period without prejudice to Article 10.

The additional information shall be made available to the

4.
Member States and the Commission by the Authority.

Article 7

Updating the Community list

1. Within nine months of the Authority giving its opinion,
the Commission shall submit to the Committee referred to in
Article 14(1) a draft regulation updating the Community list,
taking account of the opinion of the Authority, any relevant
provisions of Community law and any other legitimate factors
relevant to the matter under consideration.

In those cases where an opinion of the Authority has not been
requested, the nine-month period shall start from the date the
Commission receives a valid application.

2. Where the draft regulation is not in accordance with the
opinion of
the Authority, the Commission shall provide an
explanation of the reasons for the differences.

3.
The measures, designed to amend non-essential elements
of each sectoral food law, relating to the removal of a substance
from the Community list, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in
Article 14(3).

On grounds of efficiency, the measures designed to amend
4.
non-essential elements of each sectoral food law,
inter alia by
supplementing it, relating to the addition of a substance to the
Community list and for adding, removing or changing condi-
tions, specifications or restrictions associated with the presence
of the substance on the Community list, shall be adopted in
accordance with the regulatory procedure with scrutiny referred
to in Article 14(4).

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5.
On imperative grounds of urgency, the Commission may
use the urgency procedure referred to in Article 14(5) for the
removal of a substance from the Community list and for
removing or changing conditions, specifications or
adding,
restrictions associated with the presence of a substance on the
Community list.

request,
if the nature of the matter in question so justifies,
without prejudice to Article 6(1) and Article 8(1). In such cases
the Commission shall, where appropriate, inform the applicant
and the Member States of the extension and the reasons for it.

Article 8

Additional information concerning risk management

information
1. Where the Commission requests additional
from applicants on matters concerning risk management,
it
shall determine, together with the applicant, a period within
which that information can be provided.
In such cases, the
period referred to in Article 7 may be extended accordingly. The
Commission shall inform the Member States of the extension
and shall make the additional
information available to the
Member States once it has been provided.

2.
If the additional information is not sent within the addi-
tional period referred to in paragraph 1, the Commission shall
act on the basis of the information already provided.

CHAPTER III

MISCELLANEOUS PROVISIONS

Article 9

Implementing measures

1.
In accordance with the regulatory procedure referred to in
Article 14(2), within a period of no longer than 24 months
from the adoption of each sectoral food law, the implementing
measures for this Regulation shall be adopted by the Commis-
sion, and shall concern in particular:

(a)

the content, drafting and presentation of the application
referred to in Article 4(1);

(b) the arrangements for checking the validity of applications;

(c)

the type of
opinion of the Authority referred to in Article 5.

information that must be included in the

2. With a view to the adoption of
the implementing
measures referred to in paragraph 1(a), the Commission shall
consult the Authority, which, within six months of the date of
entry into force of each sectoral food law, shall present it with a
proposal concerning the data required for risk assessment of the
substances concerned.

Article 10

Extension of time periods

In exceptional
referred to in
Article 5(1) and Article 7 may be extended by the Commission
on its own initiative or, where applicable, at the Authority's

circumstances,

the periods

Article 11

Transparency

The Authority shall ensure the transparency of its activities in
accordance with Article 38 of Regulation (EC) No 178/2002. In
particular,
it shall make its opinions public without delay. It
shall also make public any request for its opinion as well as any
extension of period pursuant to Article 6(1).

Article 12

Confidentiality

1.
Among the information provided by applicants, confiden-
tial treatment may be given to information the disclosure of
which might significantly harm their competitive position.

Information relating to the following shall not, in any circum-
stances, be regarded as confidential:

(a)

the name and address of the applicant;

(b) the name and a clear description of the substance;

(c)

the justification for the use of the substance in or on specific
foodstuffs or food categories;

(d) information that is relevant to the assessment of the safety

of the substance;

(e) where applicable, the analysis method(s).

2.
For the purposes of implementing paragraph 1, applicants
shall indicate which of the information provided they wish to be
treated as confidential. Verifiable justification must be given in
such cases.

The Commission shall decide after consulting with the
3.
applicants which information can remain confidential and shall
notify applicants and the Member States accordingly.

After being made aware of the Commission's position,
4.
applicants shall have three weeks in which to withdraw their
application so as to preserve the confidentiality of the informa-
tion provided. Confidentiality shall be preserved until
this
period expires.

5.
The Commission, the Authority and the Member States
shall, in accordance with Regulation (EC) No 1049/2001, take
the necessary measures to ensure appropriate confidentiality of
the information received by them under this Regulation, except
for information which must be made public if circumstances so
require in order to protect human health, animal health or the
environment.

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6.
If an applicant withdraws, or has withdrawn, its applica-
tion, the Commission, the Authority and the Member States
shall not disclose confidential information, including informa-
tion the confidentiality of which is the subject of disagreement
between the Commission and the applicant.

7.
The implementation of paragraphs 1 to 6 shall not affect
the circulation of information between the Commission, the
Authority and the Member States.

Article 13

Emergencies

In the event of an emergency concerning a substance on the
Community list, particularly in the light of an opinion of the
Authority, measures shall be adopted in accordance with the
procedures referred to in Articles 53 and 54 of Regulation (EC)
No 178/2002.

Article 14

Committee

1.
The Commission shall be assisted by the Standing
Committee on the Food Chain and Animal Health established
by Article 58 of Regulation (EC) No 178/2002.

2. Where reference is made to this paragraph, Articles 5
and 7 of Decision 1999/468/EC shall apply, having regard to
the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.

3. Where reference is made to this paragraph, Article 5a(1)
to (4) and Article 7 of Decision 1999/468/EC shall apply,
having regard to the provisions of Article 8 thereof.

4. Where reference is made to this paragraph, Article 5a(1)
to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.

The time-limits laid down in Article 5a(3)(c) and (4)(b) and (e)
of Decision 1999/468/EC shall be 2 months, 2 months and
4 months respectively.

5. Where reference is made to this paragraph, Article 5a(1),
(2), (4) and (6) and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.

Article 15

Competent authorities of the Member States

Not later than six months after the entry into force of each
sectoral food law, Member States shall forward to the Commis-
sion and to the Authority, in relation to each sectoral food law,
the name and address of the national competent authority for
the purposes of the common procedure, as well as a contact
point therein.

CHAPTER IV

FINAL PROVISION

Article 16

Entry into force

This Regulation shall enter into force on the twentieth day
following its publication in the Official Journal of the European
Union.

For each sectoral food law, it shall apply from the date of appli-
cation of the measures referred to in Article 9(1).

Article 9 shall apply from … (*).

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, …

For the European Parliament

The President

For the Council

The President

(*) Date of entry into force of this Regulation.

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STATEMENT OF THE COUNCIL'S REASONS

I.

INTRODUCTION

On 28 July 2006, the Commission adopted the proposal for a Regulation establishing a common
authorisation procedure for food additives, food enzymes and food flavourings (1). The proposal is based
on Article 95 of the Treaty establishing the European Community.

The European Parliament adopted its Opinion at first reading on 10 July 2007 (2).

Following the European Parliament's first reading Opinion, the Commission submitted an amended
proposal on 24 October 2007 (3).

On 10 March 2008, the Council adopted its Common Position in accordance with Article 251(2) of the
Treaty.

In carrying out its work, the Council also took account of the opinion of the European Economic and
Social Committee adopted on 25 April 2007 (4).

II. OBJECTIVE

The aim of the proposed Regulation, as part of four proposals designed to overhaul the Community's
rules on food improvement agents, is to ensure the proper functioning of the internal market, including
fair practices in food trade, while also guaranteeing a high level of protection of human health, of
consumer interests and of the environment, by introducing a harmonised Community approval proce-
dure for food additives, flavourings and enzymes.

The common authorisation procedure should be centralised, effective, expedient and transparent, and
based on risk assessment carried out by the European Food Safety Authority (EFSA) and on a risk
management system in which the Commission takes action within the framework of a regulatory
committee procedure (comitology).

It assigns to the Commission the task of creating, maintaining and updating a general positive list for
each category of substances concerned. The inclusion of a substance on one of these lists means that its
use is authorised in general for all operators in the Community.

III. ANALYSIS OF THE COMMON POSITION

1. Introductory remarks

The Common Position reflects the result of the examination of the Commission's proposal by the
Council. The Council introduced several changes in the text, some of them inspired by the amend-
ments proposed by the European Parliament.

The Commission has accepted the Common Position agreed by the Council.

2. The amendments of the European Parliament

In its Plenary vote on 10 July 2007, the European Parliament adopted 31 amendments to the
proposal.

The Council incorporated, in full or in principle, 11 amendments in its Common Position.

(1) COM(2006) 425 final.
(2) Doc. 11639/07 CODEC 775.
(3) COM(2007) 672 final.
(4) OJ C 168, 20.7.2007, p. 34.

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Amendments accepted in the Common Position

— Introduction of the regulatory comitology procedure with scrutiny (in line with amendments 34, 35, 36,

37)

The Council introduced the regulatory procedure with scrutiny. The Council also introduced the
urgency procedure (Article 14(5)) for removal of substances from the list of authorised substances
and for adding, changing or removing conditions for their use in order to protect human health.
The efficiency procedure was also introduced (Article 14(4)) for adding a substance to the Com-
munity list and for adding, removing or changing conditions, specifications or restrictions asso-
ciated with the presence of the substance on the Community list.

— Smoke flavourings

The Council clarified that the authorization for smoke flavourings is excluded from the scope of
the proposal (in line with amendment 12).

— Protection of the environment

The Council referred to the fact that risk management would also need to take into account other
legitimate factors, such as environment, which was introduced in Recital 12 (in line with amend-
ment 6).

— Confidentiality

The Council clarified which aspects of the application can be kept confidential to protect compe-
titiveness (in line with amendment 8).

— Information to Member States

The Council agreed that information on the stages of the procedure should be provided also to
Member States (in line with amendments 27, 28, 32).

In addition, the substance of amendment 25 is reflected in Article 6(3), which mentions the prin-
ciple of exceptional extension of deadlines pursuant to Article 10.

Amendments not introduced

The Council was not able to introduce all the amendments, either on account of rules on legal
drafting (amendment 31) or for other specific reasons as outlined below:

— Issues already regulated in Regulation (EC) No 178/2002 on general principles and requirements of food

law (1), which do not need to be addressed in this Regulation (amendments 3, 5, 9, 10, 23)

The requirement to have an independent risk assessment (amendment 5 — recital 10) is already
provided for in Article 22(2) of Regulation (EC) No 178/2002.

Amendment 3 (new recital) was not accepted as transparency in the production and handling of
food is of a general nature. Under Regulation (EC) No 178/2002 the primary responsibility for
food safety rests with food business operators. The latters' responsibility is reinforced though
legislation imposing the Hazard Analysis Critical Control Point System (HACCP) principle and
good hygiene practice provided for in other Community legislation.

— Consultation of stakeholders by the Commission (amendments 9, 10 — recitals 19 and 21)

is
provided for in Article 9 of the Regulation (EC) No 178/2002 as well as in other documents of a
general nature, such as the Commission White Paper on European governance and the Commis-
sion's Communication on general principles and minimum standards for consultation of inter-
ested parties. Similarly, the provision that EFSA should publish its opinions without delay is
provided for in Article 38 of that Regulation, thus amendment 23 (Article 5(2)) is not necessary.

(1) JO L 31, 1.2.2002, p. 1.

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— Criteria for authorisation (amendment 4 — new recital)

The general criteria for authorisation of substances are laid down in the legislation for each sector
and they have to be respected. Therefore, the Council did not consider repetition necessary.

— Reference to consumer protection and public health (amendment 11 — Article 1)

This proposal deals with procedural arrangements for updating the lists of authorised substances.
The reference that the Regulations aim at human health, consumer interests, including fair prac-
tices in food trade, taking into account, where appropriate, the protection of the environment, is
set out in the proposed Regulations for each sector.

— Protection of data (amendments 14, 33 — Article 2(1a), 12(6a))

A 5-year period of data protection and, as a result, preferential authorisation of the substance
during this time for the company that provided the data would change the present system in the
field of food law, notably for food additives, which is generally applied internationally. A provi-
sion on the protection of data in this legislative act would complicate administrative procedures,
and thus is not in line with the objective of simplification of the regulatory framework. Therefore,
the Council does not consider these amendments acceptable.

— Deadline for an EFSA opinion (amendment 22 — Article 5(1))

for an EFSA opinion from
The Council did not agree with extension of
6 to 9 months as proposed in amendment 22. The set periods are further clarified in
Recital 8a(new) of the Common Position. It should be noted that time limits are also important
from the industry's point of view.

the time limit

— Extension of
Article 6(1))

the 6 months deadline when additional

information is needed (amendment 24 —

The Council considers that this deadline should be extended only in justified cases.

Other amendments that have not been introduced include amendments 1, 2, 19, 21 and 30.

IV. Conclusions

The Council believes that the Common Position represents a balance of concerns and interests that
would respect the objectives of the Regulation. It looks forward to constructive discussions with the
European Parliament with a view to the early adoption of the Regulation, ensuring a high level of
human health and consumer protection.