Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (Text with EEA relevance)
Date: 2008-12-16
Institutions: Council of the European Union, European Parliament
Subjects: enzyme, flavouring, food safety, foodstuff, market approval

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I

(Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory)

REGULATIONS

REGULATION (EC) No 1331/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 16 December 2008

establishing a common authorisation procedure for food additives, food enzymes and food flavourings

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,

(4)

Having regard to the Treaty establishing the European Commu-
nity, 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 laid down in Article 251
of the Treaty (2),

(5)

Whereas:

(1)

(2)

(3)

The free movement of safe and wholesome food is an
essential aspect of the internal market and contributes sig-
nificantly 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.

(1) OJ C 168, 20.7.2007, p. 34.
(2) Opinion of the European Parliament of 10 July 2007 (OJ C 175 E,
10.7.2008, p. 134), Council Common Position of 10 March 2008
(OJ C 111 E, 6.5.2008, p. 1), Position of the European Parliament of
8 July 2008 (not yet published in the Official Journal) and Council
Decision of 18 November 2008.

Regulation (EC) No 1333/2008 of the European Parlia-
ment and of the Council of 16 December 2008 on food
additives (3), Regulation (EC) No 1332/2008 of the Euro-
pean Parliament and of the Council of 16 December 2008
on food enzymes (4) and Regulation (EC) No 1334/2008
of
the Council of
16 December 2008 on flavourings and certain food ingre-
dients with flavouring properties for use in and on foods (5)
(hereinafter referred to as the sectoral food laws) lay down
harmonised criteria and requirements concerning the
assessment and authorisation of these substances.

the European Parliament and of

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 1334/2008 [on flavourings and certain
food ingredients with flavouring properties for use in and
on foods], must not be placed on the market or used in
foodstuffs for human consumption, in accordance with the
conditions laid down in each sectoral food law, unless they
are included on a Community list of authorised substances.

(6)

(7)

Ensuring transparency in the production and handling of
food is absolutely crucial in order to maintain consumer
confidence.

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

(3) See page 16 of this Official Journal.
(4) See page 7 of this Official Journal.
(5) See page 34 of this Official Journal.

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(8)

(9)

(10)

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

(14)

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 consider-
ation may be taken into account, including societal, eco-
nomic, traditional, ethical and environmental factors and
the feasibility of controls.

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 dead-
lines for those stages, the role of the parties involved and
the principles that apply. Nevertheless, for some aspects of
the procedure, it is necessary to take the specific character-
istics of each sectoral food law into consideration.

(15)

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

The deadlines laid down in the procedure take into account
the time needed to consider the different criteria set in each
sectoral food law, as well as allowing adequate time for
consultation when preparing the draft measures. In par-
ticular, 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.

(16) Where appropriate and under certain circumstances, the
specific sectoral food law may provide for protection of
scientific data and other information submitted by the
applicant for a certain period of time. In this case, the sec-
toral food law should lay down the conditions under which
these data may not be used for the benefit of another
applicant.

(11) Upon receipt of an application the Commission should ini-
tiate the procedure and where necessary seek the opinion
of the European Food Safety Authority (hereinafter referred
to as the Authority) established by Regulation (EC)
No 178/2002 of the European Parliament and of the Coun-
cil of 28 January 2002 laying down the general principles
and requirements of food law, establishing the European
Food Safety Authority and laying down procedures in mat-
ters of food safety (1) as soon as possible after the validity
and applicability of the application have been assessed.

(12)

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 an independent scientific
assessment, of the highest possible standard, of the risks
that they pose to human health. This assessment, which
must be carried out under the responsibility of the Author-
ity, 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.

(13)

The authorisation to place substances on the market should
be granted pursuant to this Regulation provided that the
criteria for authorisation laid down under the sectoral food
laws are satisfied.

(17) 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 available to it by
Article 36 of Regulation (EC) No 178/2002 and by Com-
mission Regulation (EC) No 2230/2004 (2).

(18)

(19)

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

Protecting the confidentiality of certain aspects of an appli-
cation should be maintained as a consideration in order to
protect the competitive position of an applicant. However,
information relating to the safety of a substance, includ-
ing, but not limited to, toxicological studies, other safety
studies and raw data as such, should under no circum-
stances be confidential.

(20)

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 Euro-
pean Parliament, Council and Commission documents (3)
applies to documents held by the Authority.

(2) 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).

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

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

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(21)

(22)

(23)

(24)

(25)

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 situ-
ations where foodstuffs are likely to constitute a serious
risk to human health, animal health or the environment
and where such risk cannot be contained satisfactorily by
measures taken by the Member State(s) concerned.

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.

Since the objectives of this Regulation cannot be suffi-
ciently achieved by the Member States on account of dif-
ferences between national laws and provisions and can
therefore be better achieved at Community level, the Com-
munity may adopt measures, in accordance with the prin-
ciple of subsidiarity as set out in Article 5 of the Treaty. In
accordance with the principle of proportionality, 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
Regulation should be adopted in accordance with Council
Decision 1999/468/EC of 28 June 1999 laying down the
procedures for the exercise of implementing powers con-
ferred on the Commission (1).

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 ele-
ments of each sectoral food law, inter alia, by supplement-
ing 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.

(26) 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, specifications or
restrictions associated with the presence of a substance on
the Community lists.

(27) 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, removing or
changing conditions, specifications or restrictions associ-
ated with the presence of a substance on the Community
lists,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PRINCIPLES

Article 1

Subject matter and scope

This Regulation lays down a common procedure for the
1.
assessment and authorisation (hereinafter referred to as the com-
mon procedure) of food additives, food enzymes, food flavour-
ings 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
contributes to the free movement of food within the Community
and to a high level of protection of human health and to a high
level of consumer protection, including the protection of con-
sumer interests. 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 (2).

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 Regulation
(EC) No 1333/2008 [on food additives], Regulation (EC)
No 1332/2008 [on food enzymes] and Regulation (EC)
No 1334/2008 [on flavourings and certain food ingredients with
flavouring properties for use in and on foods] (hereinafter referred
to as the sectoral food laws).

3.
The criteria according to which substances can be included
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 Commu-
nity 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;

(1) OJ L 184, 17.7.1999, p. 23.

(2) OJ L 309, 26.11.2003, p. 1.

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(b)

removing a substance from the Community list;

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

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

2. Where it starts the procedure on its own initiative, the Com-
mission shall inform the Member States and, where applicable,
request the opinion of the Authority.

CHAPTER II

COMMON PROCEDURE

Article 5

Opinion of the Authority

Article 3

Main stages of the common procedure

The Authority shall give its opinion within nine months of

1.
receipt of a valid application.

1.
The common procedure for updating the Community list
may be started either on the initiative of the Commission or fol-
lowing an application. Applications may be made by a Member
State or by an interested party, who may represent several inter-
ested parties, in accordance with the conditions provided for by
the implementing measures referred to in Article 9(1)(a) (herein-
after referred to as the applicant). Applications shall be sent to the
Commission.

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 Authority shall forward its opinion to the Commission,

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

Article 6

Additional information concerning risk assessment

In duly justified cases where the Authority requests addi-
1.
tional 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.

3.
The common procedure shall end with the adoption by the
Commission of a regulation implementing the update, in accor-
dance with Article 7.

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.

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
legitimate factors relevant to the matter under consideration.

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 list,

1.
the Commission:

(a)

shall acknowledge receipt of the application in writing to the
applicant within 14 working days of receiving it;

3. Where applicants submit additional information on their
own initiative, they shall send it to the Authority and to the Com-
mission. 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, tak-
ing account of the opinion of the Authority, any relevant provi-
sions 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.

(b) where applicable, shall as soon as possible notify the Author-
ity of the application and request its opinion in accordance
with Article 3(2).

In the Regulation updating the Community list, the consid-

2.
erations on which it is based shall be explained.

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3. Where the draft regulation is not in accordance with the
opinion of the Authority, the Commission shall explain the rea-
sons for its decision.

The measures, designed to amend non-essential elements of
4.
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).

5.
On grounds of efficiency, the measures designed to amend
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 conditions,
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).

6.
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 adding,
removing or changing conditions, specifications or restrictions
associated with the presence of a substance on the Community
list.

Article 8

Additional information concerning risk management

1. Where the Commission requests additional
information
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 mea-
sures for this Regulation shall be adopted by the Commission, 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 information that must be included in the opinion
of the Authority referred to in Article 5.

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

the periods

In exceptional circumstances,
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 request,
if the nature of the matter in question so justifies, without preju-
dice to Article 6(1) and Article 8(1). In such cases the Commis-
sion shall, where appropriate,
inform the applicant and the
Member States of the extension and the reasons for it.

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 exten-
sion of period pursuant to Article 6(1).

Article 12

Confidentiality

Among the information provided by applicants, confiden-
1.
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.

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

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

4.
After being made aware of the Commission’s position,
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.

If an applicant withdraws, or has withdrawn, its application,
6.
the Commission, the Authority and the Member States shall not
disclose confidential information, including information the con-
fidentiality 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 Com-
munity list, particularly in the light of an opinion of the Author-
ity, measures shall be adopted in accordance with the procedures
referred to in Articles 53 and 54 of Regulation (EC) No 178/2002.

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 two months, two months and
four 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 sec-
toral food law, Member States shall forward to the Commission
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

Article 14

Committee

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

This Regulation shall enter into force on the 20th 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 20 January 2009.

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

Done at Strasbourg, 16 December 2008.

For the European Parliament
The President
H.-G. PÖTTERING

For the Council
The President
B. LE MAIRE