# EUR-Lex - 52013PC0894 - EN

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# 52013PC0894

**Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on novel foods /* COM/2013/0894 final - 2013/0435 (COD) */**

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EXPLANATORY MEMORANDUM

1.           CONTEXT OF THE PROPOSAL

·        Grounds for and objectives of the proposal

This proposal aims to ensure food safety, to protect
public health and secure the functioning of the internal market for food, while
supporting innovation for the food sector.

It aims to streamline the authorisation procedure,
to improve its efficiency and transparency. It clarifies the definition of a
novel food, including new technologies which have an impact on food.

It introduces a faster and more proportionate safety
assessment for traditional foods from third countries having a history of safe
food use.

The general criteria for the Novel Food
definition remain unchanged: novel foods are foods and food ingredients which
were not consumed in the EU to a significant degree before the entry into force
(15 May 1997) of the current Novel Food Regulation.

·        General context

On 14 January 2008, the Commission adopted a
proposal for a Regulation of the European Parliament and of the Council on Novel
Food[1].

The legislative discussions under the Ordinary
legislative procedure mainly focused on the provisions applicable to
nanomaterials, the cloning of animals for food production, traditional foods
from third countries, the criteria to be examined for the risk assessment and risk
management and to the procedure for the authorisation of novel foods in
accordance with the Treaty on the Functioning of the European Union (Lisbon
Treaty).

The discussions reached a stalemate on a
limited number of issues (in particular those linked to cloning of animals). The
Conciliation Committee did not reach a final agreement at its last meeting on
28 March 2011 and the proposal was not adopted by the Union legislator.

The Commission considers that issues related to
cloning of farm animals should be addressed in a separate proposal, based on an
impact assessment.

This proposal is therefore limited to the
safety of novel food and is based on the overall agreement achieved in
Conciliation.

·        Current
legislation

Authorisation and use of novel foods and food ingredients have been
harmonised in the European Union since 1997 when Regulation (EC) No 258/97 on Novel
Food and novel food ingredients[2]
was adopted. The current legislation consists of the Novel Food Regulation and
one Commission Regulation:

– 
Regulation (EC) No 258/97 of the European
Parliament and of the Council concerning novel foods and novel food ingredients
lays down the general principles for authorisation of novel foods and food
ingredients in the European Union.

– 
Commission Regulation (EC) No 1852/2001 lays
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[3].

Currently, an application for a pre-market authorisation
is first assessed by a Member State food assessment body. The initial
assessment report is circulated for comments and objections to all Member
States by the Commission. If no reasoned safety objections are presented, the
novel food may be placed on the market. If reasoned safety objections are
presented, an authorisation decision is required by the Commission. This in
most cases includes an additional assessment which is carried out by the
European Food Safety Authority (EFSA).

The authorisation under current rules is granted
to the applicant (individual authorisation). In addition, another applicant may
notify to the Commission the placing on the market of a food that is
substantially equivalent to the authorised food. This notification has to be
substantiated by scientific evidence showing the substantial equivalence of the
notified food to the authorised food. These rules have allowed for placing on
the market various foods such as Baobab dried fruit pulp, Chia seeds, fish (Sardinops
sagax) peptide product or synthetic vitamin K2.

·       Consistency with the other policies and objectives of the
Union

The proposal brings together and updates the
provisions of the above mentioned texts which will be repealed at the time of
entry into application of the new legislation.

The proposal pursues the objectives of the
Communication on Smart Regulation in the European Union[4] and of the Europe 2020
Strategy[5].
The emphasis is on simplifying and streamlining the regulatory process, thus
reducing the administrative burden and improving the competitiveness of the
European food industry, while ensuring the safety of food, maintaining a high
level of public health protection and taking global aspects into consideration.

2.           RESULTS OF CONSULTATIONS
WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENT

·        Consultation of interested parties

Stakeholders from food industry, consumers,
third countries and national authorities and international organisations have
been consulted both before and after the adoption of Commission proposal of
January 2008. Commission representatives also participated at several meetings
or seminars organised by stakeholders and dedicated to specific issues (e.g.
traditional food from third countries, assessment and authorisation procedure,
nanotechnologies) and bilateral meetings with interested parties.

During the first and second reading and the
Conciliation procedure on the 2008 legislative proposal, stakeholders also
expressed their positions.

·        Impact assessment

The Commission carried out an Impact Assessment
in 2007. For each of the measures of the 2008 proposal, several options were
examined with regard to their economic, social and environmental impact on the
various stakeholders and Member States. It is available at      
http://ec.europa.eu/food/food/biotechnology/novelfood/initiatives_en.htm.
Regarding the current proposal, the 2008 impact assessment is still valid, as
the rationale for an in-depth revision of the current legislation (the length
and cost of the current authorisation procedure, the need for a centralised
risk assessment and risk management and for an adjusted procedure for the
placing on the EU market of traditional foods from third countries) is unchanged.

The main changes compared to the 2008 proposal
are primarily those introduced during the Ordinary legislative procedure whose
impact is unchanged as they only clarify the purpose of the measures.

As regards a possible exclusion of micro-enterprises
from the scope, it appears that such an exemption would not be compatible with
the overall objective of ensuring the safety of the novel foods which are put
on the EU market.

3.           LEGAL ELEMENTS OF THE
PROPOSAL

·        Legal basis

Legal basis of this
proposal is Article 114 of the Treaty on the Functioning of the European Union.

·        Subsidiarity
principle

The proposal has to comply with the subsidiarity principle since it
does not fall under the exclusive competence of the Union.

The objectives of the proposal cannot be
sufficiently achieved by the Member States for the following reasons:

– 
Individual action by Member States could lead to
different levels of food safety and protection of human health and confuse
consumers. Repealing the Novel Food Regulation would do away with harmonised
food safety rules and would endanger the free movement of food in the EU.

– 
Effective functioning of the internal market in
relation to novel foods while protecting the health and the interest of the
European consumers can best be met by action at EU level.

The proposal therefore complies with the
subsidiarity principle.

·        Proportionality principle

The proposal complies with the proportionality
principle for the following reasons:

– 
The proposal harmonises the regulatory framework
for novel food authorisation and thus contributes to the functioning of the
food market in the EU.

– 
The proposed measures are sufficient in terms of
reaching the objectives of ensuring food safety and securing the functioning of
the internal market for food while reducing the administrative burden.

4.           BUDGETARY IMPLICATION

The financial and budgetary impact of the
proposal is indicated in the legislative financial statement attached to this
proposal.

5.           choice of
instruments

The proposed
instrument is Regulation.

Other means
would not be adequate for the following reasons:

– 
The area of novel foods is fully harmonised in
the EU. Non-legislative action based, for example, on a code of good practice
or guidelines could not give sufficient protection and would lack legal
certainty.

– 
The safe use of novel foods depends on
pre-market safety evaluations and often on permitted conditions of use of these
substances, therefore recommendations or self-regulations would not guarantee
the protection of consumer's health.

6.           OTHER ISSUES

·        Simplification

The proposal provides for the simplification of
legislation and administrative procedures for public authorities and private
parties as compared to the legislation in place:

– 
There is only one centralised procedure for the
assessment and authorisation of novel foods. The wording of the proposal has
been up-dated and clarified.

– 
National administrative procedures and duplication
of work are removed.

– 
The authorisation procedure is streamlined,
increasing its efficiency and reducing the administrative burden in particular
for private parties.

– 
A simplified procedure for the placing on the
market of the traditional foods from third countries is introduced.

·        Cost for business, in particular
SMEs

The proposed measures will reduce
administrative burden and the length and cost of the authorisation procedure
for the food industry (18 months instead of 3 years in average currently).
Generic authorisation will avoid the re-submission of new applications by other
companies for the same novel food and are expected to benefit in particular
SMEs. However, in order to maintain an incentive for developing really
innovative food products, a "data protection" regime with the
granting of an applicant linked authorisation for a maximum of 5 years is
introduced. The measures will also facilitate EU market access for traditional
foods from third countries by setting up a simplified and more proportionate
procedure.

·        European
Economic Area

The proposed act
concerns an European Economic Area (EEA) matter and therefore extends to the
EEA.

·        Detailed
explanation of the proposal

Chapter I – Subject matter, scope and
definitions

Novel foods shall be subject to safety
evaluation and authorisation via a fully harmonised procedure. The definitions
are clarified and updated. It may be determined with the examination procedure
if a food falls within the scope of the Regulation.

Nanomaterials which are intended for food uses
and covered by the definition of "engineered nanomaterials", as laid
down in Regulation (EU) n°1169/2011 on Food Information to Consumers, shall be
assessed and authorised under this Regulation before being placed on the EU
market.

Chapter II – Requirements for placing
novel foods on the market within the Union

All novel foods and their use in food have to
comply with the following criteria: they should not present a danger to human
health and their use should not mislead the consumer.

For every authorised novel food,
specifications, labelling requirements, conditions of use and, where appropriate,
a requirement of post-market monitoring may be laid down.

The current system of individual authorisations
is replaced by generic authorisations. The so called current "simplified
procedure" based on substantial equivalence, which aims to extend an
individual authorisation to another company for the same novel food, is removed
since authorisations become directly generic.

Already authorised novel foods shall continue
to be marketed and will be included in the Union list of novel foods.

Chapter III – Authorisation procedure
for a novel food

In line with the decision to switch to a
centralised EU-level procedure and to separate risk management and risk
assessment, all applications for the authorisation of novel foods shall be
submitted to the Commission. The Commission may then request a scientific
opinion on risk assessment from the European Food Safety Authority (EFSA).

The inclusion of a novel food in the Union list
of novel foods will be considered by the Commission on the basis of the opinion
from EFSA. The Commission will be assisted by the Standing Committee on the
Food Chain and Animal Health (SCOFCAH).

For traditional foods from third countries, a
safety assessment and a risk management, based on a history of safe food use, is
introduced. If a history of safe food use in a third country for at least 25
years has been demonstrated by the applicant, and if the Member States or EFSA do not present reasoned safety objections based on scientific evidence, the food
may be included in the Union list.

However, in case reasoned safety objections are
presented, an EFSA assessment followed by an EU authorisation procedure,
similar to the standard authorisation procedure but with shorter deadlines, is
required.

This procedure provides for a more proportionate
risk assessment and risk management of traditional foods from third countries and
allows for a quicker placing on the EU market for a range of products from
primary production without compromising food safety.

Chapter IV – Additional
procedural rules and other requirements

The information provided by the applicant
should be kept confidential where the disclosure of such information might
significantly harm their competitive position.

Chapter V – Data
protection

By way of derogation from the generic authorisation
in order to support innovation in the EU food industry and only in duly
justified cases, individual authorisations with data protection may be granted
for a maximum period of five years.

Chapter VI – Penalties
and committee procedure

The Member States shall lay down rules on
penalties applicable to infringements of the provisions of the proposed Regulation.

Implementation of the measures proposed in this
Regulation will mainly be adopted by the Commission in accordance with the examination
procedure laid down in Article 5 of Regulation (EU) n°182/2011. This consists
of including the conditions of use and labelling of a novel food as well as
laying down specifications and, where appropriate post-market monitoring
requirements.

Chapter VII –
Transitional and final provisions

Transitional measures are necessary to ensure a
smooth transition with on-going applications and notifications, pending the
entry into application of this legislation. Furthermore, due to clarification
of the definition of the novel food laid down in this Regulation and to enhance
legal certainty, a food that was legally placed on the market prior to the
application of this Regulation, should be allowed to be continued to be
marketed until the risk assessment and authorisation procedures have been
concluded.

2013/0435 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

on novel foods

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the
Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the
European Commission,

After transmission of the draft legislative
act to the national Parliaments,

Having regard to the opinion of the European
Economic and Social Committee[6],

Acting in accordance with the ordinary
legislative procedure[7],

Whereas:

(1)       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,
as well as benefitting their social and economic interests.
Differences between national laws concerning the safety assessment and
authorisation of novel foods may hinder the free movement of such food, thereby
creating unfair conditions of competition.

(2)       A high level of protection
of human health and of consumers’ interests and the effective functioning of
the internal market should be assured in the pursuit of Union food policies,
whilst ensuring transparency.

(3)       The Union's rules on novel
foods were established by Regulation (EC) No 258/97 of the European Parliament
and of the Council[8]
and by Commission Regulation (EC) No 1852/2001[9].
Those rules need to be updated to simplify the current authorisation procedures
and to take account of recent developments in Union law. For the sake of
clarity of Union legislation, Regulations (EC) No 258/97 and (EC) No 1852/2001 should
be repealed and Regulation (EC) No 258/97 should be replaced by this
Regulation.

(4)       Foods which are intended
to be used for technological purposes and genetically modified food should not
fall within the scope of this Regulation as they are already covered by other
Union rules. Therefore, genetically modified food falling within the scope
of Regulation (EC) No 1829/2003 of the European Parliament and of the Council[10], enzymes falling
within the scope of Regulation (EC) No 1332/2008 of the European
Parliament and of the Council[11],
food used solely as additives falling within the scope of Regulation (EC) No
1333/2008 of the European Parliament and of the Council[12], flavourings falling
within the scope of Regulation (EC) No 1334/2008 of the European
Parliament and of the Council[13]
and extraction solvents falling within the scope of Directive 2009/32/EC of the
European Parliament and of the Council[14]
should be excluded from the scope of this Regulation.

(5)       The existing categories of
novel food laid down in Article 1 of Regulation (EC) No 258/97 should be
clarified and updated by replacing the existing categories with a reference to
the general definition of food provided for in Article 2 of Regulation (EC) No
178/2002 of the European Parliament and of the Council[15].

(6)       In order to ensure
continuity with the rules laid down in Regulation (EC) No 258/97, the absence
of a use for human consumption to a significant degree within the Union before
the date of entry into force of that Regulation, namely 15 May 1997, should be maintained
as a criterion for a food to be considered as a novel food. A use within the
Union should also refer to a use in the Member States irrespective of the
date of accession of the various Member States to the Union.

(7)       Emerging technologies in food
production processes may have an impact on food and thereby on food safety.
Therefore, it should also be clarified that a food should be considered as a
novel food where a production process which was not previously used for food
production in the Union is applied to that food or when foods contain or
consist of engineered nanomaterials, as defined in Article 2(2)(t) of
Regulation (EU) No 1169/2011 of the European Parliament and of the Council[16].

(8)       Vitamins, minerals and
other substances intended to be used in food supplements or to be added to food
including infant formula and follow-on formulae, processed cereal-based food
and baby food for infants and young children, food for special medical
purposes, and total diet replacement for weight control are subject to the
rules provided for in Directive 2002/46/EC of the European Parliament and of
the Council[17],
in Regulation (EC) No 1925/2006 of the European Parliament and of the Council[18] and in Regulation (EU)
No 609/2013 of the European Parliament and of the Council[19]. Those substances should
also be assessed in accordance with the rules laid down in this Regulation when
they fall within the definition of novel food laid down in this Regulation.

(9)       When there is a
significant change in the production process of a substance that has been used
in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation
(EU) No 609/2013, or a change in particle size of such a substance, for example
through nanotechnology, it may have an impact on food and thereby on food
safety. Therefore, that substance should be considered a novel food under this
Regulation and should be re-evaluated first in accordance with this Regulation
and subsequently in accordance with the relevant specific legislation.

(10)     If, prior to 15 May 1997, a
food was used exclusively as, or in, a food supplement, as defined in point (a)
of Article 2 of Directive 2002/46/EC, it should be allowed to be placed on the
market within the Union after that date for the same use without being
considered a novel food for the purposes of this Regulation. However, that use
as, or in, a food supplement should not be taken into account for the
assessment of whether the food was used for human consumption to a significant
degree within the Union before 15 May 1997. Therefore, uses of the food
concerned other than in, or as, a food supplement should be subject to this
Regulation.

(11)     The placing on the market within
the Union of traditional foods from third countries should be facilitated, where
the history of safe food use in a third country has been demonstrated. Those foods
should have been consumed in a third country for at least 25 years as a part of
the customary diet within a large part of the population of the country. The
history of safe food use should not include non-food uses or uses not related
to normal diets.

(12)     It should be clarified that
foods from third countries which are regarded as novel foods in the Union should
only be considered as traditional foods from third countries when they are
derived from primary production as defined in Article 3 of Regulation (EC)
No 178/2002, regardless of whether or not they are processed or
unprocessed foods. Therefore, where a new production process has been applied
to this food or where the food contains or consists of "engineered
nanomaterials" as defined in Article 2(2)(t) of Regulation (EU) No
1169/2011, the food should not be considered to be traditional.

(13)     Food products produced from
food ingredients that do not fall within the scope of this Regulation, in
particular by changing the ingredients of the food, their composition or
amount, should not be considered as novel foods. However, modifications of a
food ingredient, such as selective extracts or the use of other parts of a
plant, that have so far not been used for human consumption to a significant
degree within the Union, should fall within the scope of this Regulation.

(14)     Directive 2001/83/EC of the European Parliament and of the Council[20] applies where a
product, taking into account all its characteristics, may fall both within the
definition of "medicinal product" as laid down in Article 1(2) of that
Directive and within the definition of a product covered by this Regulation. In
that respect, where a Member State establishes in accordance with Directive
2001/83/EC that a product is a medicinal product, it may restrict the placing
on the market of that product in accordance with Union law. Moreover, medicinal
products are excluded from the definition of food as laid down in Article 2 of
Regulation (EC) No 178/2002 and should therefore not fall within the scope
of this Regulation.

(15)     Implementing powers should
be conferred to the Commission to decide whether a particular food falls within
the definition of a novel food and is thereby subject to rules on novel food
laid down in this Regulation.

(16)     The determination of
whether a food was used for human consumption to a significant degree within
the Union before 15 May 1997 should be based on information submitted by
food business operators and, where appropriate, supported by other information
available in the Member States. Food business operators should consult Member
States if they are unsure of the status of the food they intend to place on the
market. When there is no information or insufficient information available on
human consumption before 15 May 1997, a simple and transparent procedure, involving
the Commission, the Member States and food business operators, should be
established for collecting such information. Implementing powers should be
conferred on the Commission to specify the procedural steps of such
consultation process.

(17)     Novel foods should be authorised
and used only if they fulfil the criteria laid down in this Regulation. Novel
foods should be safe and their use should not mislead the consumer. Therefore,
where a novel food is intended to replace another food, it should not differ
from that food in a way that would be nutritionally less advantageous for the
consumer.

(18)     Novel foods should not be
placed on the market or used in food for human consumption unless they are
included in a Union list of novel foods authorised to be placed on the market
within the Union (‘the Union list’). Therefore, it is appropriate to establish,
by means of an implementing act, a Union list of novel foods by entering novel
foods already authorised or notified in accordance with Article 4, 5 or 7 of
Regulation (EC) No 258/97 in the Union list, including any existing authorisation
conditions. As those novel foods have already been evaluated for their safety,
have been legally produced and marketed in the Union and have not given rise to
health concerns in the past, the advisory procedure should be used for the
initial establishment of the Union list.

(19)     It is appropriate to authorise
a novel food by updating the Union list subject to the criteria and the
procedures laid down in this Regulation. A procedure that is efficient,
time-limited and transparent should be put in place. As regards traditional
foods from third countries having a history of safe use it is appropriate to
provide for a faster and simplified procedure to update the Union list if no
reasoned safety objections are expressed. As the updating of the Union list
implies the application of criteria laid down in this Regulation, implementing
powers should be conferred on the Commission in that respect.

(20)     Criteria for the evaluation
of the safety risks arising from novel foods should also be laid down. In order
to ensure the harmonised scientific assessment of novel foods, such assessments
should be carried out by the European Food Safety Authority ("EFSA").

(21)     As regards the possible use
of nanomaterials for food use, EFSA considered in its opinion of 6 April 2011[21] on Guidance on the
risk assessment of the application of nanoscience and nanotechnologies in the
food and feed chain that limited information is available in relation to aspects
of nanotoxicokinetics and toxicology of engineered nanomaterials and that
existing toxicity testing methods may need methodological modifications. In
order to better assess the safety of nanomaterials for food use, the Commission
is developing test methods which take into account specific characteristics of
engineered nanomaterials.

(22)     When a novel food is authorised
and included in the Union list, the Commission should have the power to
introduce post‑market monitoring requirements to monitor the use of the
authorised novel food to ensure that the use is within safe limits as
established in the safety assessment by EFSA.

(23)     Under specific
circumstances, in order to stimulate research and development within the
agri-food industry, and thus innovation, it is appropriate to protect the
investment made by innovators in gathering the information and data provided in
support of an application for a novel food made in accordance with this
Regulation. The newly developed scientific evidence and
proprietary data provided in support of an application for inclusion of a novel
food in the Union list should be protected. Those data and information should,
for a limited period of time, not be used to the benefit of a subsequent
applicant, without the agreement of the prior applicant. The protection of
scientific data provided by one applicant should not prevent other applicants
from seeking the inclusion in the Union list on the basis of their own
scientific data or by referring to the protected data with the agreement of the
prior applicant. However, the overall five year period of data protection which
has been granted to the prior applicant should not be extended due to the
granting of data protection to subsequent applicants.

(24)     Novel foods are subject to
the general labelling requirements laid down in Regulation (EU) No 1169/2011 of
the European Parliament and of the Council on the provision of food information
to consumers and other relevant labelling requirements in Union food law. In
certain cases it may be necessary to provide for additional labelling
information, in particular regarding the description of the food, its source or
its conditions of use to ensure that consumers are sufficiently informed of the
nature of the novel food.

(25)     For those applications which
have been submitted under Regulation (EC) No 258/97 before the date of
application of this Regulation risk assessment and authorisation procedures should
be concluded in accordance with this Regulation. Furthermore, due to
clarification of the definition of novel food laid down in this Regulation and
to enhance legal certainty, a food that was legally placed on the market at the
date of application of this Regulation, should in principle be allowed to be
placed on the market until the risk assessment and authorisation procedures
have been concluded. Therefore, transitional rules should be laid down to
ensure a smooth transition to the rules of this Regulation.

(26)     The Member States should
lay down rules on penalties applicable to infringements of the provisions of
this Regulation and should take all measures necessary to ensure that they are
implemented. Those penalties should be effective, proportionate and dissuasive.

(27)     In order to ensure uniform
conditions for the implementation of this Regulation with regard to updating
the Union list concerning the adding of a traditional food from a third country
where no reasoned safety objections have been expressed, implementing powers
should be conferred on the Commission.

(28)     The implementing powers relating
to the definition of ‘novel food’, the consultation process for determination
of novel food status, other updates of the Union list, the drafting and
presentation of applications or notifications for the inclusion of foods in the
Union list, the arrangements for checking the validity of applications or
notifications, confidentiality treatment and transitional provisions, should be exercised in
accordance with Regulation (EU) No 182/2011 of the European Parliament and of
the Council[22].

(29)     Since the objective of this
Regulation, namely laying down rules for the placing of novel foods on the
market within the Union, cannot be sufficiently achieved by the Member States but
can rather be better achieved at Union level, the Union may adopt measures, in accordance
with the principle of subsidiarity as set out in Article 5 of the Treaty on European
Union. 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 that objective,

HAVE ADOPTED THIS REGULATION:

Chapter I 
Subject matter, scope and definitions

Article 1
Subject matter and scope

1.           This Regulation lays down rules
for the placing of novel foods on the market within the Union in order to
ensure the effective functioning of the internal market while providing a high
level of protection of human health and consumer interests.

2.           This Regulation shall not apply
to:

(a)     genetically modified foods falling
within the scope of Regulation (EC) No 1829/2003;

(b)     foods when and in so far as they are
used as:

(i)      food enzymes falling within the scope
of Regulation (EC) No 1332/2008;

(ii)     food additives falling within the
scope of Regulation (EC) No 1333/2008;

(iii)    food flavourings falling within the
scope of Regulation (EC) No 1334/2008;

(iv)    extraction solvents used or intended
to be used in the production of foodstuffs or food ingredients and falling
within the scope of Directive 2009/32/EC;

(c)     food falling within the scope of Council
Directive XXX/XX/EU on [on the placing on the market of food from animal clones].

Article 2
Definitions

1.           For the purposes of this
Regulation, the definitions laid down in Articles 2 and 3 of Regulation (EC)
No 178/2002 shall apply.

2.           The
following definitions shall also apply:

(a)     "novel
food" means all food that was not used for human consumption to a
significant degree within the Union before 15 May 1997 irrespective of the date
of accession of the various Member States to the Union and includes in
particular:

(i)      food to which a new production
process not used for food production within the Union before 15 May 1997
is applied, where that production process gives rise to significant changes in
the composition or structure of the food which affect its nutritional value, the
way it is metabolised or the level of undesirable substances;

(ii)     food containing or consisting of "engineered
nanomaterials" as defined in Article 2(2)(t) of Regulation (EU) No
1169/2011;

(iii)    vitamins, minerals and other
substances used in accordance with Directive 2002/46/EC, Regulation (EC) No
1925/2006 or Regulation (EU) No 609/2013, where:

– 
a new production process has been applied as
referred to in point (i) of this paragraph; or

– 
such substances contain or consist of
"engineered nanomaterials" as defined in Article 2(2)t of Regulation
(EU) No 1169/2011;

(iv)    food used exclusively in food
supplements within the Union before 15 May 1997, where it is intended to
be used in foods other than food supplements as defined in point (a) of Article
2 of Directive 2002/46/EC;

(b)     "traditional food from a third
country" means novel food, other than the novel food as referred to
in point (a)(i) to (iii), which is derived from primary production, with a
history of safe food use in a third country;

(c)     "history of safe food use in a
third country" means that the safety of the food in question has been
confirmed with compositional data and from experience of continued use for at
least 25 years in the customary diet of a large part of the population of a third
country, prior to a notification referred to in Article 13;

(d)     "the applicant" means the
Member State, the third country or the interested party, who may represent
several interested parties, who has submitted an application in accordance with
Article 9 or 15 or a notification in accordance with Article 13 to the
Commission;

(e)     "valid application" and
“valid notification” mean an application or a notification which falls in the
scope of this Regulation and contains the information required for risk
assessment and authorisation procedure.

Article 3
Implementing power concerning the definition of novel food in Article 2(2)(a)

In order to ensure the uniform
implementation of this Regulation, the Commission may decide, by means of
implementing acts, whether or not a particular food falls within the definition
of novel food, as laid down in Article 2(2)(a).

Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 27(3).

Article 4
Procedure for determination of novel food status

1.           Food business operators shall
verify whether or not the food which they intend to place on the market within
the Union falls within the scope of this Regulation.

2.           Food business operators shall
consult a Member State where they are unsure whether or not a food which they
intend to place on the market within the Union falls within the scope of this
Regulation. In that case, food business operators shall provide the necessary
information to the Member State on request to enable it to determine in particular
the extent to which the food in question was used for human consumption within
the Union before 15 May 1997.

3.           The Commission may, by means of
implementing acts, specify the procedural steps of the consultation process provided
for in paragraph 2.

Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 27(3).

Chapter II
Requirements for placing novel foods
on the market within the Union

Article 5
Union list of novel foods

1.           The Commission shall establish
and update a Union list of novel foods authorised to be placed on the market
within the Union in accordance with Articles 6, 7 and 8 ("the Union
list").

2.           Only novel foods authorised and
included in the Union list may be placed on the market within the Union as such and used in or on foods under the conditions of use specified therein.

Article 6
General conditions for inclusion of
novel foods in the Union list

The Commission shall only authorise and
include a novel food in the Union list if it complies with the following
conditions:

(a)          it does not, on the basis of the
scientific evidence available, pose a safety risk to human health;

(b)          its use does not mislead the
consumer;

(c)          where it is intended to replace
another food, it does not differ from that food in such a way that its normal
consumption would be nutritionally disadvantageous for the consumer.

Article 7
Initial establishment of the Union list

No later than ...[23] the Commission shall,
by means of an implementing act, establish the Union list by entering novel
foods authorised or notified under Articles 4, 5 or 7 of Regulation (EC) N° 258/97
in the Union list, including any existing authorisation conditions.

That implementing act shall be adopted in
accordance with the advisory procedure referred to in Article 27(2).

Article 8
Contents of the Union list

1.           The Commission shall authorise a
novel food and update the Union list in accordance with the rules laid down in:

(a)     Articles 9, 10 and 11 and, where
applicable, in accordance with Article 25 or

(b)     Articles 13 to 18.

2.           The authorisation of a novel food
and updating of the Union list provided for in paragraph 1 shall consist of one
of the following:

(a)     adding a novel food to the Union list;

(b)     removing a novel food from the Union
list;

(c)     adding, removing or changing the conditions,
specifications or restrictions associated with the inclusion of a novel food on
the Union list.

3.           The
entry for a novel food in the Union list provided for in paragraph 2 shall
include where relevant:

(a)     a
specification of the novel food;

(b)     the conditions
under which the novel food may be used, in order to avoid, in particular, possible
adverse effects on particular groups of the population, the exceeding of
maximum intake levels and risks in case of excessive consumption;

(c)     additional specific labelling
requirements to inform the final consumer of any specific characteristic or
food property, such as the composition, nutritional value or nutritional effects
and intended use of the food, which renders a novel food no longer equivalent
to an existing food or of implications for the health of specific groups of the
population;

(d)     a post-market monitoring requirement
in accordance with Article 23.

Chapter III
Authorisation procedure for a novel food

Section I
General rules

Article 9
The procedure for authorising the placing on the market within the Union of a novel food and updating the Union list

1.           The procedure for authorising the
placing on the market within the Union of a novel food and updating of the Union
list provided for in Article 8 shall start either on the Commission's
initiative or following an application to the Commission by an applicant.

The application shall include:

(a)     the name and description of the novel
food;

(b)     the composition of the novel food;

(c)     scientific evidence demonstrating that
the novel food does not pose a safety risk to human health;

(d)     where applicable, a proposal for the
conditions of use and a proposal for specific labelling requirements which do
not mislead the consumer.

2.           The Commission may request EFSA
to render its opinion if the update is liable to have an effect on human health.

3.           The procedure for authorising the
placing on the market within the Union of a novel food and updating the Union list as provided for in Article 8 shall end with the adoption of an implementing act
in accordance with Article 11.

4.           By way of derogation from
paragraph 3, the Commission may end the authorisation procedure and decide not
to proceed with an update, at any stage of the procedure, where it considers
that such an update is not justified.

Where applicable, it shall take account of the
views of Member States, the EFSA's opinion and any other legitimate factors
relevant to the update under consideration.

In such cases, the Commission shall inform the
applicant and all Member States directly, indicating the reasons for not considering
the update justified.

5.           The applicant may withdraw its
application referred to in paragraph 1 at any time before the adoption of
EFSA's opinion referred to in paragraph 2, thereby terminating the procedure
for authorising a novel food and updating the Union list.

Article 10
Opinion of EFSA

1.           Where the Commission requests an
opinion from EFSA, it shall forward the valid application to EFSA. EFSA shall adopt
its opinion within nine months from the date of receipt of a valid application.

In assessing the safety of novel foods, EFSA
shall, where appropriate, consider the following:

(a)     whether the novel food concerned is as
safe as food from a comparable food category already existing on the market
within the Union;

(b)     whether the composition of the novel
food and the conditions of its use do not pose a safety risk to human health in
the Union.

2.           EFSA shall forward its opinion to
the Commission, the Member States and, where applicable, to the applicant.

3.           In duly justified cases, where EFSA
requests additional information from the applicant, the period of nine months
provided for in paragraph 1 may be extended.

After consulting the applicant, EFSA shall specify
a period within which that additional information may be provided and shall
inform the Commission of the additional period required.

Where the Commission does not object within
eight working days of being informed by EFSA, the period of nine months
provided for in paragraph 1 shall be automatically extended by that additional
period. The Commission shall inform the Member States of that extension.

4.           Where the additional information
referred to in paragraph 3 is not sent to EFSA within the additional period
referred to in that paragraph, it shall finalise its opinion on the basis of
the information already provided to it.

5.           Where applicants submit
additional information on their own initiative, they shall send it to the
Commission and to EFSA.

In such cases, EFSA shall give its opinion
within the period of nine months provided for in paragraph 1.

6.           EFSA shall make the additional
information referred to in paragraph 3 available to the Commission and to the
Member States.

Article 11
Authorisation of a novel food and updating the Union list

1.           Within nine months from the date
of publication of EFSA's opinion, the Commission shall submit to the committee
referred to in Article 27(1) a draft implementing act updating the Union list
taking account of:

(a)     the conditions provided for in Article
6 where applicable;

(b)     any relevant provisions of Union law;

(c)     the EFSA's opinion;

(d)     any other legitimate factors relevant
to the application under consideration.

That implementing act shall be adopted in accordance
with the examination procedure referred to in Article 27(3).

2.           Where the Commission has not
requested an opinion from EFSA in accordance with Article 9(2), the nine-month
period provided for in paragraph 1 shall start from the date on which the Commission
received a valid application in accordance with Article 9(1).

Article 12
Implementing power concerning administrative and scientific requirements for
applications

By ...[24]
at the latest, the Commission shall adopt implementing acts concerning:

(a)          the contents, drafting and
presentation of the application referred to in Article 9(1);

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

(c)          the type of information required
to be included in the opinion of EFSA referred to in Article 10.

Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 27(3).

Section II 
Specific rules for traditional foods from third countries

Article 13
Notification of traditional foods from third countries

An applicant, who intends to place on the
market within the Union a traditional food from a third country, shall notify that
intention to the Commission.

The notification shall include the
following information:

(a)          the name and a description of the
traditional food;

(b)          its composition;

(c)          its country of origin;

(d)          documented data demonstrating the
history of safe food use in a third country;

(e)          where applicable, the conditions
of use and specific labelling requirements, which do not mislead the consumer.

Article 14
Procedure for traditional foods from third countries

1.           The Commission shall forward the
valid notification provided for in Article 13 without delay to the Member
States and to EFSA.

2.           Within four months from the date
on which the valid notification is forwarded by the Commission in accordance
with paragraph 1, a Member State or EFSA may submit to the Commission reasoned
safety objections, based on scientific evidence, to the placing on the market within
the Union of the traditional food concerned.

3.           The Commission shall inform the
Member States, EFSA and the applicant of the outcome of the procedure referred
to in paragraph 2.

4.           Where no reasoned safety objections
are made in accordance with paragraph 2 within the time-limit laid down in that
paragraph, the Commission shall authorise the placing on the market within the
Union of the traditional food concerned and update without delay the Union
list.

5.           Where reasoned safety objections,
based on scientific evidence, are submitted to the Commission in accordance
with paragraph 2, the Commission shall not authorise the placing on the market
of the traditional food concerned nor update the Union list.

In that case, the applicant may submit an
application to the Commission in accordance with Article 15.

Article 15
Application for a traditional food from a third country

The application provided for in Article 14(5)
shall include in addition to the information already provided in accordance
with Article 13, documented data relating to the reasoned safety objections
submitted in accordance with Article 14(5).

The Commission shall forward the valid
application without undue delay to EFSA and make it available to the Member
States.

Article 16
Opinion of EFSA on a traditional food from a third country

1.           EFSA shall adopt its opinion
within six months from the date of receipt of a valid application.

2.           In assessing the safety of a
traditional food from a third country, EFSA shall consider the following
matters:

(a)     whether the history of safe food use
in a third country is substantiated by reliable data submitted by the applicant
in accordance with Articles 13 and 15;

(b)     whether the composition of the food
and the conditions of its use, do not pose a safety risk to human health in the
Union.

3.           EFSA shall forward its opinion to
the Commission, the Member States and the applicant.

4.           In duly justified cases, where
EFSA requests additional information from the applicant, the period of six
months provided for in paragraph 1 may be extended.

After consulting the applicant, EFSA shall specify
a period within which that additional information may be provided and shall
inform the Commission of the additional period needed.

Where the Commission does not object within
eight working days of being informed by EFSA, the period of six months provided
for in paragraph 1 shall be automatically extended by that additional period.
The Commission shall inform the Member States of that extension.

5.           Where the additional information
referred to in paragraph 4 is not sent to EFSA within the additional period
referred to in that paragraph, it shall finalise its opinion on the basis of
the information already provided to it.

6.           Where applicants submit
additional information on their own initiative, they shall send it to the
Commission and to EFSA.

In such cases, EFSA shall give its opinion
within the period of six months provided for in paragraph 1.

7.           EFSA shall make the additional information
available to the Commission and to the Member States.

Article 17
Authorisation of a traditional food from a third country and update of the
Union list

1.           Within three months of the date
of publication of EFSA's opinion, the Commission shall submit to the Committee
referred to in Article 27(1) a draft implementing act to authorise the placing on
the market within the Union of the traditional food from a third country and to
update the Union list, taking into account the following:

(a)     the conditions provided for in Article
6 where applicable;

(b)     any relevant provisions of Union law;

(c)     the EFSA's opinion;

(d)     any other legitimate factors relevant
to the application under consideration.

That implementing act shall be adopted in
accordance with the examination procedure referred to in Article 27(3).

2.           By way of derogation from
paragraph 1, the Commission may end the authorisation procedure and decide not
to proceed with an update, at any stage of the procedure, where it considers
that such an update is not justified.

Where applicable, it shall take account of the
views of Member States, the EFSA's opinion and any other legitimate factors
relevant to the update under consideration.

In such cases, the Commission shall inform the
applicant and all Member States directly, indicating the reasons for not
considering the update justified.

3.           The applicant may withdraw its
application referred to in Article 15 at any time before the adoption of EFSA's
opinion referred to in Article 16, thereby terminating the procedure for authorising
a traditional food from a third country and updating the Union list.

Article 18
Updates to the Union list as regards authorised traditional foods from third
countries

For removing a traditional food from a third
country from the Union list or for adding, removing or changing conditions,
specifications or restrictions associated with the inclusion of a traditional
food from a third country on the Union list, Articles 9 to 12 apply.

Article 19
Implementing power concerning administrative and scientific requirements
concerning traditional foods from third countries

By ...[25]
the Commission shall adopt implementing acts concerning:

(a)          the contents, drafting and
presentation of the notification provided for in Article 13 and of the
application provided for in Article 14(5);

(b)          the arrangements for checking the
validity of those notifications and applications;

(c)          the procedural steps for the
exchange of information with the Member States and with EFSA for submitting reasoned
safety objections as referred to in Article 14(2), (4) and (5);

(d)          the type of information required
to be included in the opinion of EFSA referred to in Article 16.

Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 27(3).

Chapter IV
Additional procedural rules and other requirements

Article 20
Additional information concerning risk management

1.           Where the Commission
requests additional information from an applicant on matters concerning risk
management, it shall determine, together with the applicant, the period within
which that information must be provided.

In such cases, the time period provided for in
Article 11(1) or (2) or in Article 17(1) may be extended accordingly. The
Commission shall inform the Member States of that extension and shall make the
additional information available to the Member States once it has been received.

2.           Where the additional information referred
to in paragraph 1 is not received within the extended period referred to in that
paragraph, the Commission shall act on the basis of the information already
provided.

Article 21
Extension of time periods

In exceptional circumstances, the
Commission may extend the time periods provided for in Articles 10(1), 11(1)
or (2), 16(1) and 17(1) on its own initiative or, where applicable, at EFSA's
request, where the nature of the matter in question so justifies.

In such cases the Commission shall inform
the Member States and the applicant of the extension and the reasons for it.

Article 22
Confidentiality of the application for updating of the Union list

1.           Applicants may request confidential
treatment of certain information submitted under this Regulation where
disclosure of such information may significantly harm their competitive
position.

2.           For the purposes of paragraph 1,
applicants shall indicate which of the information provided they wish to be treated
as confidential and provide all the necessary information to substantiate their
request for confidentiality. Verifiable justification shall be given in such
cases.

3.           After being informed of the
Commission’s position on the request, applicants may withdraw their application
within three weeks so as to preserve the confidentiality of the information provided.

Confidentiality shall be preserved until that
period expires.

4.           After expiry of the time period
referred to in paragraph 3, the Commission may decide after consulting with the
applicants which information may remain confidential and, in the case a
decision has been taken, shall notify the Member States and the applicants
accordingly.

However, confidentiality shall not apply to the
following information:

(a)     the name and address of the applicant;

(b)     the name and description of the novel
food;

(c)     the proposed use of the novel food;

(d)     a summary of the studies submitted by
the applicant;

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

5.           The Commission, the Member States
and EFSA shall take the necessary measures to ensure appropriate
confidentiality of the information received by them under this Regulation in
accordance with paragraph 4, except for information which is required to be
made public in order to protect human health.

6.           Where an applicant withdraws, or
has withdrawn, its application, the Commission, the Member States and EFSA
shall not disclose confidential information, including information the
confidentiality of which is the subject of disagreement between the Commission
and the applicant.

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

8.           The Commission may, by means of
implementing acts, adopt detailed rules on the implementation of paragraphs 1
to 6.

Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 27(3).

Article 23
Post-market monitoring

1.           The Commission may, for food
safety reasons and taking into account the opinion of EFSA, impose a
requirement for post-market monitoring of a novel food to ensure that the use
of the authorised novel food is within safe limits.

2.           The food business operators shall
forthwith inform the Commission of:

(a)     any new scientific or technical
information which might influence the evaluation of the safety in use of the
novel food;

(b)     any prohibition or restriction imposed
by any third country in which the novel food is placed on the market.

Chapter V
Data protection

Article 24 
Authorisation procedure in case of data protection

1.           On request by the applicant,
supported by appropriate and verifiable information included in the application
provided for in Article 9(1), newly developed scientific evidence or scientific
data supporting the application may not be used for the benefit of a subsequent
application during a period of five years from the date of the authorisation
and the inclusion of the novel food in the Union list without the agreement of
the prior applicant.

2.           That data protection shall be
granted where the following conditions are met:

(a)     the newly developed scientific
evidence or scientific data was designated as proprietary by the prior applicant
at the time the first application was made;

(b)     the prior applicant had exclusive
right of reference to the proprietary scientific evidence or scientific data at
the time the first application was made and

(c)     the novel food could not have been
authorised without the submission of the proprietary scientific evidence or
scientific data by the prior applicant.

However, the prior applicant may agree with a
subsequent applicant that such scientific evidence and scientific data may be
used.

3.           Paragraphs 1 and 2 shall not
apply to notifications and applications concerning the placing on the market
within the Union of traditional foods from third countries.

Article 25 
Authorisation of a novel food and inclusion in the Union list based on
protected proprietary scientific evidence or scientific data

1.           Where a novel food is authorised
and included in the Union list based on proprietary scientific evidence or scientific
data that are granted data protection as provided for in Article 24(1), the
entry of a novel food in the Union list shall indicate, in addition to the
information referred to in Article 8(3):

(a)     the date of entry of the novel food in
the Union list;

(b)     the fact that that entry is based on
proprietary scientific evidence and scientific data protected in accordance
with Article 24;

(c)     the name and address of the applicant;

(d)     the fact that the novel food is
authorised for placing on the market within the Union only by the applicant
specified in point (c) during the period of data protection, unless a subsequent
applicant obtains authorisation for the novel food without reference to the
proprietary scientific evidence or scientific data designated as such by the
prior applicant or with the agreement of the prior applicant;

(e)     the end date of the data protection
provided for in Article 24.

2.           Scientific evidence or scientific
data protected in accordance with Article 24 or for which the protection period
under that Article has expired shall not be protected again.

Chapter VI
Penalties and committee procedure

Article 26 
Penalties

Member States shall lay down the rules on
penalties applicable to infringements of the provisions of this Regulation and
shall take all measures necessary to ensure that they are implemented. The
penalties provided for must be effective, proportionate and dissuasive. Member
States shall notify those provisions to the Commission by ...[26] at the latest and
shall notify it without delay of any subsequent amendment affecting them.

Article 27 
Committee procedure

1.           The Commission shall be assisted
by the Standing Committee on the Food Chain and Animal Health established by
Article 58(1) of Regulation (EC) No 178/2002. That committee shall be the committee
within the meaning of Regulation (EU) No 182/2011.

2.           Where reference is made to this
paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

Where the opinion of the committee is to be
obtained by written procedure, that procedure shall be terminated without
result when, within the time-limit for delivery of the opinion, the chair of
the committee so decides or a simple majority of committee members so request.

3.           Where reference is made to this
paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Where the opinion of the committee is to be
obtained by written procedure, that procedure shall be terminated without
result when, within the time-limit for delivery of the opinion, the chair of
the committee so decides or a simple majority of committee members so request.

Chapter VII
Transitional and final provisions

Article 28 
Repeal

Regulation
(EC) No 258/97 and Regulation (EC) No 1852/2001 are hereby repealed.

Article 29 
Transitional measures

1.           Any request for placing a novel
food on the market within the Union submitted to a Member State in accordance
with Article 4 of Regulation (EC) No 258/97 and for which the final decision
has not been taken before ...[27]
shall be considered as an application under this Regulation.

2.           Foods
which are lawfully placed on the market at the date of entry into force of this
Regulation and which fall within the definition of novel foods laid down in
this Regulation may continue to be placed on the market subject to the
following conditions:

(a)     An application for authorisation of a
novel food in accordance with Article 9(1) or a notification or application for
authorisation of a traditional food from a third country in accordance with
Articles 13 and 15 shall be submitted by [date of application of implementing
rules according to Article 12(a) or 19(a) + 24 months] at the latest. That
application or notification shall be forwarded by the Commission to the Member
States and EFSA.

(b)     If no reasoned safety objections are
made by a Member State or EFSA within four months from the date of receipt of the
application or of the notification referred to in point (a), the food may
continue to be placed on the market until a final decision on the application or
notification has been taken in accordance with Article 11, 14 or 17.

(c)     If reasoned safety objections are made
by a Member State or EFSA, the Commission shall take an interim decision on the
placing on the market of the food within the Union within four months of the
date of receipt of such objections.

3.           The Commission may, by means of
implementing acts, adopt transitional measures for the application of
paragraphs 1 and 2. Those implementing acts shall be adopted in accordance with
the examination procedure referred to in Article 27(3).

Article 30
Entry into force

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

It shall apply from ...[28].

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

Done at Brussels,

For the European Parliament                        For
the Council

The President                                                 The
President

LEGISLATIVE FINANCIAL STATEMENT

1.           FRAMEWORK OF THE
PROPOSAL/INITIATIVE

1.1.    Title of the proposal/initiative

1.2.    Policy
area(s) concerned in the ABM/ABB structure

1.3.    Nature
of the proposal/initiative

1.4.    Objective(s)

1.5.    Grounds
for the proposal/initiative

1.6.    Duration
and financial impact

1.7.    Management
method(s) envisaged

2.           MANAGEMENT MEASURES

2.1.    Monitoring
and reporting rules

2.2.    Management
and control system

2.3.    Measures
to prevent fraud and irregularities

3.           ESTIMATED FINANCIAL
IMPACT OF THE PROPOSAL/INITIATIVE

3.1.    Heading(s)
of the multiannual financial framework and expenditure budget line(s) affected

3.2.    Estimated
impact on expenditure

3.2.1. Summary of
estimated impact on expenditure

3.2.2. Estimated impact
on operational appropriations

3.2.3. Estimated impact
on appropriations of an administrative nature

3.2.4. Compatibility
with the current multiannual financial framework

3.2.5. Third-party
participation in financing

3.3.    Estimated impact on revenue

LEGISLATIVE FINANCIAL STATEMENT

1.           FRAMEWORK OF THE
PROPOSAL/INITIATIVE

1.1.        Title of the
proposal/initiative

Proposal for a Regulation of the European Parliament and of the
Council on novel foods

1.2.        Policy area(s) concerned
in the ABM/ABB structure[29]

Novel Food and Food Safety

1.3.        Nature of the
proposal/initiative

 ̈ The
proposal/initiative relates to a new action

 ̈ The
proposal/initiative relates to a new action following a pilot
project/preparatory action[30]

 ̈ The proposal/initiative relates to the
extension of an existing action

X The proposal/initiative relates to an
action redirected towards a new action[31]

1.4.        Objectives

1.4.1.     The Commission’s
multiannual strategic objective(s) targeted by the proposal/initiative

In the field of novel foods, the proposals aim

(1) to ensure a high level of public health and the good
functioning of the internal market,

(2) to facilitate market access for traditional foods from third
countries which have a long history of safe food use,

(3) to promote innovation for the food sector.

1.4.2.     Specific objective(s) and
ABM/ABB activity(ies) concerned

Specific objective 1: Simplification of
legislation and of administrative procedures for public authorities and food
business operators through streamlined and fully centralised authorisation
procedure.

ABM/ABB activity(ies) concerned

Health within the heading 3 Security and Citizenship.

1.4.3.     Expected result(s) and
impact

Specify the effects
which the proposal/initiative should have on the beneficiaries/groups targeted.

On food business operators: the
authorisation procedure is streamlined and fully centralised with deadlines for
each step of the procedure. The administrative burden is reduced (removal of
current double risk assessment). Time and related costs for getting a Novel
Food authorisation are reduced.

Individual authorisations are becoming generic which facilitates
market access in particular for SMEs. The introduction of the "data
protection" regime stimulates innovation in the food sector.

On operators from third countries:
Better EU market access for traditional foods from third countries through
simplified procedure (notification).

On EU consumers: a high level of public
health is ensured by a systematic centralised risk assessment by EFSA followed
by an EU authorisation decision.

On Member State authorities: The
workload for ensuring the national assessment is removed.

1.4.4.     Indicators of results and
impact

Specify the indicators for monitoring
implementation of the proposal/initiative.

- The average length for applicants to get an authorisation
decision.

- Number of notifications agreed per year for traditional foods from
third countries.

- Number and ratio of authorisations with data protection regime
granted to innovative foods per year.

1.5.        Grounds for the
proposal/initiative

1.5.1.     Requirement(s) to be met in
the short or long term

The existing regulatory framework is being criticised for being
particularly burdensome, lengthy and costly to get a Novel Food authorisation.
As a consequence most EU food businesses do not want to develop and put on the
market new foods or food ingredients which would fall under the Novel Food
scope, in particular SMEs.

At international level, the EU is much criticized at WTO level by third
countries which consider that the Novel Food authorisation is a barrier to
trade and prevents EU market access to foods which have a long history of safe
food use in their country of origin.

The present revision aims to address these weaknesses of current EU
legislation and to put in place a streamlined and adapted regulatory framework,
thus ensuring a high level of public health.

1.5.2.     Added value of EU
involvement

The proposed revision of the existing Regulation concerning novel
foods can only be achieved at Union level. The proposal is based on Article 114
of the Treaty on the Functioning of the European Union (TFEU).

1.5.3.     Lessons learned from
similar experiences in the past

The removal of the national assessment has already been achieved for
other food ingredients (additives, flavourings and enzymes) under Regulation
(EC) N° 1331/2008 establishing a common authorisation procedure. The Novel Food
authorisation procedure is similar.

1.5.4.     Coherence and possible
synergy with other relevant instruments

The Novel Food Regulation addresses mainly the authorisation
procedure to ensure that novel foods are safe. The requirements of the food law
also apply to novel foods.

1.6.        Duration and financial
impact

 ̈ Proposal/initiative of limited
duration

– 
Proposal/initiative in effect from [DD/MM]YYYY
to [DD/MM]YYYY

– 
Financial impact from YYYY to YYYY

X Proposal/initiative
of unlimited duration

– 
Implementation with a start-up period from end
2014 to end 2016, followed by full-scale operation.

1.7.        Management mode(s)
envisaged[32]

X Centralised direct management by the
Commission.

X Centralised indirect management with the
delegation of implementation tasks to:

– 
 ̈         executive agencies

– 
X          bodies
set up by the Communities[33]

– 
 ̈         national public-sector bodies/bodies with public-service
mission

– 
 ̈         persons entrusted with the implementation of specific
actions pursuant to Title V of the Treaty on European Union and identified in
the relevant basic act within the meaning of Article 49 of the Financial
Regulation

 ̈ Shared management with the Member States

 ̈ Decentralised management with third countries

 ̈ Joint management with international organisations (to be specified)

If more than one
management mode is indicated, please provide details in the
"Comments" section.

Comments

The
Commission intends to ensure the services concerned via centralised direct
management with the EFSA in charge of the scientific risk assessment.

2.           MANAGEMENT MEASURES

2.1.        Monitoring and reporting
rules

Specify frequency
and conditions.

The Novel Food expert working group composed of Member State experts
and the SCOFCAH committee (Member State Authorities) provide regular platforms
to discuss issues related to the implementation of the new regulatory
framework.

Five years after entry into force, the Commission should report to
the European Parliament and to the Council about the implementation of the new
Regulation including on indicators and results. The report should address the
impact of the new rules in particular on the simplified procedure for
traditional foods from third countries.

2.2.        Management and control
system

2.2.1.     Risk(s) identified

It is the responsibility of food business operators to check if
their products need a Novel Food authorisation to be put on the EU market.

The main risk for food safety is that foods which are novel may be
on the EU market without a Novel Food Authorisation and therefore illegal.

2.2.2.     Control method(s) envisaged

Member States shall establish annual official control plans for all
types of foods which are submitted to Commission for authorisation.

Regular meetings with stakeholders and Member States will be
organised to ensure that the EU Regulation is respected.

2.3.        Measures to prevent fraud
and irregularities

Specify existing or
envisaged prevention and protection measures.

In addition to the application of all regulatory control mechanisms,
DG Health and Consumers will devise an anti-fraud strategy in line with the
Commission's new anti-fraud strategy (CAFS) adopted on 24 June 2011 in order to
ensure inter alia that its internal anti-fraud related controls are
fully aligned with the CASF and that the fraud risk management approach is
geared to identify fraud risk areas and adequate responses. Where necessary,
networking groups and adequate IT tools dedicated to analysing fraud cases
related to the financing implementing activities of the Novel Food Regulation
will be set up; In particular a series of measures will be put in place such
as:

- decisions, agreements and contracts resulting from the financing
implementing activities of the Novel Food regulation will expressly entitle the
Commission, including OLAF and the Court of Auditors to conduct audits, on the
spot checks and inspections;

- during the evaluation phase of a call for proposals/tenders, the
proposers and tenderers are checked against the published exclusion criteria
based on declarations and the Early Warning System (EWS);

- the rules governing the eligibility of costs will be simplified in
accordance with the provisions of the financial Regulation;

- regular training on issues related to fraud and irregularities is
given to all staff involved in contract management as well as to auditors and
controllers who verify the beneficiaries' declarations on the spot.

3.           ESTIMATED FINANCIAL
IMPACT OF THE PROPOSAL/INITIATIVE

3.1.        Heading(s) of the
multiannual financial framework and expenditure budget line(s) affected

– 
Existing expenditure budget lines

In order of multiannual financial framework
headings and budget lines.

No new resources will be needed. Operational
resources which are necessary for implementation of this initiative will be
covered by redeployment within the contribution granted to EFSA during the
annual budgetary procedure, in accordance with the financial programming set by
the Communication from the Commission to the European Parliament and the
Council (reference COM (2013) 519 final).

Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution

Number [Description: EFSA] || Diff./non-diff. ([34]) || from EFTA[35] countries || from candidate countries[36] || from third countries || within the meaning of Article 18(1)(aa) of the Financial Regulation

3 || 17.03.11. || Diff/non-diff. || YES/NO || YES/NO || YES/NO || YES/NO

3.2.        Estimated impact on
expenditure

3.2.1.     Summary of estimated impact
on expenditure (in current prices)

EUR million (to 3 decimal places)

Heading of multiannual financial framework: || Number 3 || Security and Citizenship

DG SANCO || || || Year 2014 || Year 2015 || Year 2016 || Year 2017 || Year 2018 || 2019 et sq years || TOTAL

Ÿ Operational appropriations || || || || || || || ||

Number of budget line: 17.03.11 || Commitments || (1) || 0 || 0 || 0 || 0 0 || 0 || 0 || 0 || 0

Payments || (2) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

|| || || || || || || || || ||

|| || || || || || || || ||

Appropriations of an administrative nature financed  from the envelope for specific programmes[37] || || || || || || || ||

Number of budget line: || || (3) || || || || || || || ||

TOTAL appropriations for DG SANCO || Commitments || =1+1a +3 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

Payments || =2+2a +3 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

Ÿ TOTAL operational appropriations || Commitments || (4) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

Payments || (5) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

Ÿ TOTAL appropriations of an administrative nature financed from the envelope for specific programmes || (6) || || || || || || || ||

TOTAL appropriations under HEADING 3 of the multiannual financial framework || Commitments || =4+ 6 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

Payments || =5+ 6 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

If more
than one heading is affected by the proposal / initiative:

Ÿ TOTAL operational appropriations || Commitments || (4) || || || || || || || || 0

Payments || (5) || || || || || || || || 0

Ÿ TOTAL appropriations of an administrative nature financed from the envelope for specific programmes || (6) || || || || || || || ||

TOTAL appropriations under HEADINGS 1 to 4 of the multiannual financial framework (Reference amount) || Commitments || =4+ 6 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

Payments || =5+ 6 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

Heading of multiannual financial framework: || 5 || " Administrative expenditure "

EUR million (to 3 decimal places)

|| || || Year 2014 || Year 2015 || Year 2016 || Year 2017 || Year 2018 || 2019 et sq years || TOTAL

DG SANCO ||

Ÿ Human resources || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

Ÿ Other administrative expenditure || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

TOTAL DG SANCO || Appropriations || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

TOTAL appropriations under HEADING 5 of the multiannual financial framework || (Total commitments = Total payments) || || || || || || || ||

EUR
million (to 3 decimal places)

|| || || Year 2014 || Year 2015 || Year 2016 || Year 2017 || Year 2018 || 2019 et sq years || TOTAL

TOTAL appropriations under HEADINGS 1 to 5 of the multiannual financial framework || Commitments || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

Payments || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.2.2.     Estimated impact on
operational appropriations

– 
 ̈      The proposal/initiative does not require the use of
operational appropriations

– 
X       The
proposal/initiative requires the use of operational appropriations, as
explained below:

Commitment appropriations in EUR million (to 3 decimal
places)

Indicate objectives and outputs ò || || || Year 2014 || Year 2015 || Year 2016 || Year 2017 || Year 2018 || 2019 et sq years || TOTAL

OUTPUTS

Type of output || Average cost of the output || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Total num­ber of out­puts || Total cost

SPECIFIC OBJECTIVE No 1 || Simplification of legislation and of administrative procedures for public authorities and food business operators through streamlined and fully centralised authorisation procedure.

- Output || Technical and scientific opinions and advice and scientific guidelines || || || 0 || || 0 || || 0 || || 0 || || 0 || || 0 || || 0 || || 0

Sub-total for specific objective N°1 || || 0 || || 0 || || 0 || || 0 || || 0 || || 0 || || 0 || || 0

Total costs || || 0 || || 0 || || 0 || || 0 || || 0 || || 0 || || 0 || || 0

3.2.3.     Estimated impact on
appropriations of an administrative nature

3.2.3.1.  Summary

– 
X       The
proposal/initiative does not require the use of administrative appropriations

– 
 ̈      The proposal/initiative requires the use of administrative
appropriations, as explained below:

EUR million (to 3
decimal places)

|| Year 2014 || Year 2015 || Year 2016 || Year 2017 || Year 2018 || 2019 et sq years || TOTAL

HEADING 5 of the multiannual financial framework || || || || || || || ||

Human resources || || || || || || || ||

Other administrative expenditure || || || || || || || ||

Subtotal HEADING 5 of the multiannual financial framework || || || || || || || ||

Outside HEADING 5[38] of the multiannual financial framework || || || || || || || ||

Human resources || || || || || || || ||

Other expenditure of an administrative nature || || || || || || || ||

Subtotal outside HEADING 5 of the multiannual financial framework || || || || || || || ||

TOTAL || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

Additional
administrative costs will be covered through re-allocation within Commission
services (DG SANCO).

3.2.3.2.  Estimated requirements of
human resources

– 
X       The proposal/initiative does not require
the use of human resources

– 
 ̈      The proposal/initiative requires the use of human resources,
as explained below:

Estimate to be expressed in full amounts
(or at most to one decimal place)

|| Year 2014 || Year 2015 || Year 2016 || Year 2017 || Year 2018 || Year 2019 || Year >2019

Ÿ Establishment plan posts (officials and temporary agents)

17 01 01 01 (Headquarters and Commission’s Representation Offices) || 0 || 0 || 1 || 1 || 1 || 0 || 0

XX 01 01 02 (Delegations) || || || || || || ||

XX 01 05 01 (Indirect research) || || || || || || ||

10 01 05 01 (Direct research) || || || || || || ||

Ÿ External personnel (in Full Time Equivalent unit: FTE)[39]

XX 01 02 01 (CA, INT, SNE from the "global envelope") || || || || || || ||

XX 01 02 02 (CA, INT, JED, LA and SNE in the delegations) || || || || || || ||

XX 01 04 yy [40] || - at Headquarters[41] || || || || || || ||

- in delegations || || || || || || ||

XX 01 05 02 (CA, INT, SNE - Indirect research) || || || || || || ||

10 01 05 02 (CA, INT, SNE - Direct research) || || || || || || ||

Other budget lines (specify) || || || || || || ||

TOTAL || || || || || || ||

The human
resources required will be met by staff from DG Health and Consumers who are already
assigned to the management of the action and who will be redeployed within the DG,
together if necessary with any additional allocation which may be granted to
the managing DG under the annual allocation procedure and in the light of budgetary
constraints.

Description of tasks
to be carried out:

Officials and temporary agents || To transform existing individual authorisation decisions and notifications (around 100) into a consolidated Union list with harmonised specifications and conditions of use (2016-2017). To manage in parallel pending applications under current provisions and applications under new provisions (transitional period).

External personnel ||

3.2.4.     Compatibility with the
current multiannual financial framework

– 
X       Proposal/initiative
is compatible with the new multiannual financial framework 2014-2020.

– 
 ̈      Proposal/initiative will entail reprogramming of the relevant
heading in the multiannual financial framework.

Explain what reprogramming is required,
specifying the budget lines concerned and the corresponding amounts.

– 
 ̈      Proposal/initiative requires application of the flexibility
instrument or revision of the multiannual financial framework[42].

Explain what is required, specifying the
headings and budget lines concerned and the corresponding amounts.

3.2.5.     Third-party contributions

– 
X       The
proposal/initiative does not provide for co-financing by third parties

– 
The proposal/initiative provides for the
co-financing estimated below:

Appropriations
in EUR million (to 3 decimal places)

|| Year N || Year N+1 || Year N+2 || Year N+3 || ... enter as many years as necessary to show the duration of the impact (see point 1.6) || Total

Specify the co-financing body || || || || || || || ||

TOTAL appropriations cofinanced || || || || || || || ||

3.3.        Estimated impact on
revenue

– 
X       Proposal/initiative
has no financial impact on revenue.

– 
 ̈      Proposal/initiative has the following financial impact:

– 
1.       on own resources

– 
2.       on miscellaneous revenue

EUR
million (to 3 decimal places)

Budget revenue line: || Appropriations available for the ongoing budget year || Impact of the proposal/initiative[43]

2014 || 2015 || 2016 || 2017 || Subsequent years

Article ............. || || 0 || 0 || 0 || 0 || 0 || 0 || 0

For miscellaneous
assigned revenue, specify the budget expenditure line(s) affected.

Specify the method for
calculating the impact on revenue.

ANNEX to the NOVEL FOOD LEGISLATIVE FINANCIAL STATEMENT

(Information received from EFSA)

1.         Number and cost of human
resources considered necessary

 ̈      The proposal/initiative does not require the use of human resources

ü      The proposal/initiative requires the use of human
resources, described as follows:

EUR million (to 3
decimal places)

EFSA || Year 2014 || Year 2015 || Year 2016 || Year 2017 || Year 2018 || Year 2019 || Year 2020 || Total (Sum 2014-2020)

FTE || Appropriations || FTE || Appropriations || FTE || Appropriations || FTE || Appropriations || FTE || Appropriations || FTE || Appropriations || FTE || Appropriations || FTE || Appropriations

Staff || AD || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

AST || || || || || || || || || || || || || || || ||

2.         Cost of other expenditure
of an administrative nature

 ̈      The proposal/initiative does not
require the use of any appropriation of an administrative nature

ü      The proposal/initiative requires the
use of appropriations of an administrative nature, described as follows:

EUR
million (to 3 decimal places)

EFSA || Year 2014 || Year 2015 || Year 2016 || Year 2017 || Year 2018 || Year 2019 || Year 2020 || TOTAL (Sum 2014-2020)

Contractual agents || 0,052 || 0,052 || 0,260 || 0,260 || 0,260 || 0,260 || 0,260 || 1,404

Scientific Meetings || || || || 0.169 || 0.169 || 0.169 || 0.169 || 0.676

Scientific Cooperation || || || || 0.150 || 0.150 || 0.150 || 0.150 || 0.600

Staff Missions || 0.010 || 0.010 || 0.010 || 0.010 || 0.010 || 0.010 || 0.010 || 0.070

Total[44] || 0,062 || 0,062 || 0,270 || 0,589 || 0,589 || 0,589 || 0,589 || 2,750

3.           Methods of calculation used
to estimate costs

General considerations

Regulation (EC) No 258/97 of January 1997 lays
down detailed rules for the authorisation of novel foods and novel food
ingredients. These rules include an initial safety assessment by a Member
State. If concerns from other Member States with respect to this assessment are
raised, EFSA is asked to perform an additional risk assessment. At present
around 2/3 of all novel food applications in Europe are subject to this further
assessment by EFSA.

The revised novel food legislation foresees
amongst other that all novel food applications are to undergo a centralised
risk assessment by EFSA and that a simplified notification procedure for
traditional foods from third countries with the involvement of EFSA is
established in order to allow easier market access for these types of products.

It is expected that EFSA will receive around
15 applications for Novel Food per year. Also, the transfer from a
partially decentralised to a fully centralised procedure alone will result in
an increase in workload for EFSA.

It is also expected that EFSA will receive
per year around 10 notifications for traditional foods from third countries
with a high peak to be expected immediately after the date of application of
the Regulation. This is expected to be driven by botanicals used in traditional
Chinese and Ayurvedic medicine which currently cannot enter the market because
of their Novel Food status.

EFSA will also be requested to revise the
scientific guidelines for the risk assessment of Novel Food as well as to
develop technical guidance and tools to assist food business operators
(EU and 3rd country operators) for submitting an application or a notification.

Currently, the workload under the existing
Novel Food Regulation (around 8 applications per year) is covered by 2 FTE (1.5
scientists, 0.5 administrative support) and EFSA’s risk assessment can rely on
preparatory work performed by Member States.

The data provided under points 1 and 2 of this
Annex provides for the needs of EFSA on the basis of the increased workload
compared to the current legal framework.

EFSA will need to carry out administrative tasks
to support the increased workload, including organisation of meetings, document
management, and procurement as well as organisation of missions and additional
financial transactions. EFSA will absorb those needs by internal
redeployment of resources and by further gains of efficiency in the provision
of administrative and support services.

[1]               COM(2007) 872 final.

[2]               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).

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

[4]               COM(2010) 543 final.

[5]               COM(2010) 2020 final.

[6]               OJ C [...], [...], p. [...].

[7]               OJ C [...], [...], p. [...].

[8]               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).

[9]               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).

[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).

[11]             Regulation (EC) No 1332/2008 of the European Parliament
and of the Council of 16 December 2008 on food enzymes (OJ L 354,
31.12.2008, p. 7).

[12]             Regulation (EC) No 1333/2008 of the European Parliament
and of the Council of 16 December 2008 on food additives (OJ L 354,
31.12.2008, p. 16).

[13]             Regulation (EC) No 1334 /2008 of the European
Parliament and of the Council of 16 December 2008 on flavourings and
certain food ingredients with flavouring properties for use in and on foods (OJ
L 354, 31.12.2008, p. 34).

[14]             Directive 2009/32/EC of the European Parliament and of
the Council of 23 April 2009 on the approximation of the laws of the Member
States on extraction solvents used in the production of foodstuffs and food
ingredients (recast) (OJ L 141, 6.6.2009, p. 3).

[15]             Regulation (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, establishing the European Food Safety Authority and
laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

[16]             Regulation (EU) No 1169/2011 of the European Parliament
and of the Council of 25 October 2011 on the provision of food information to
consumers, amending Regulation (EC) No 1924/2006 and (EC) No 1925/2006 of the
European Parliament and of the Council, and repealing Commission Directive
87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC,
Directive 2000/13/EC of the European Parliament and of the Council, Commission
Directive 2002/67/EC and 2008/5/EC and Commission Regulation (EC No 608/2004
(OJ L 304, 22.11.2011, p. 18).

[17]             Directive 2002/46/EC of the
European Parliament and of the Council of 10 June 2002 on the approximation of
the laws of the Member States relating to food supplements (OJ L 183,
12.7.2002, p. 51).

[18]             Regulation (EC) No 1925/2006 of the European Parliament
and of the Council of 20 December 2006 on the addition of vitamins and minerals
and of certain other substances to foods (OJ L 404, 30.12.2006, p. 26).

[19]             Regulation (EU) No 609/2013 of
the European Parliament and of the Council of 12 June 2013 on food intended for
infants and young children, food for special medical purposes, and total diet
replacement for weight control and repealing Council Directive 92/52/EEC, Commission
Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive
2009/39/EC of the European Parliament and of the Council and Commission
Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).

[20]             Directive 2001/83/EC of the European Parliament and of
the Council of 6 November 2001 on the Community code relating to medicinal
products for human use (OJ L 311, 28.11.2001, p. 67).

[21]             EFSA Journal 2011;9(5):2140.

[22]             Regulation (EU) No 182/2011 of the European Parliament
and of the Council of 16 February 2011 laying down the rules and general
principles concerning mechanisms for control by Member States of the
Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

[23]             Publications Office: please insert date: 24 months
after the entry into force of this Regulation.

[24]             Publications Office: please insert date: 24 months
after the date of entry into force of this Regulation.

[25]             Publications Office: please insert date: 24 months
after the date of entry into force of this Regulation.

[26]             Publications Office: please insert date: 24 months
after the date of entry into force of this Regulation.

[27]             Publications Office: please insert date: 24 months
after the date of entry into force of this Regulation.

[28]             Publications Office: please insert date: 24 months
after the date of entry into force of this Regulation.

[29]             ABM: Activity-Based Management – ABB: Activity-Based
Budgeting.

[30]             As referred to in Article 49(6)(a) or (b) of the
Financial Regulation.

[31]             The applications currently sent to the Member States
will be sent to the Commission and the risk assessment currently managed by the
Member States will be performed by EFSA (fully centralised procedure).

[32]             Details of management modes and references to the
Financial Regulation may be found on the BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html

[33]             As referred to in Article 185 of the Financial
Regulation.

[34]             Diff. = Differentiated appropriations / Non-diff. =
Non-Differentiated Appropriations.

[35]             EFTA: European Free Trade Association.

[36]             Candidate countries and, where applicable, potential
candidate countries from the Western Balkans.

[37]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.

[38]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.

[39]             CA= Contract Agent; INT= agency staff ("Intérimaire");
JED= "Jeune Expert en Délégation" (Young Experts in
Delegations); LA= Local Agent; SNE= Seconded National Expert.

[40]             Under the ceiling for external personnel from
operational appropriations (former "BA" lines).

[41]             Essentially for Structural Funds, European Agricultural
Fund for Rural Development (EAFRD) and European Fisheries Fund (EFF).

[42]             See points 19 and 24 of the Inter-institutional
Agreement.

[43]             As regards traditional own resources (customs duties,
sugar levies), the amounts indicated must be net amounts, i.e. gross amounts
after deduction of 25% for collection costs.

[44]             The required financial resources will be met by the
budget already allocated to EFSA and will be redeployed within EFSA, together,
if necessary, with any additional allocation which may be granted to EFSA under
the annual allocation procedure and in the light of budgetary constraints.