Proposal for a Regulation of the European Parliament and of the Council on novel foods and amending Regulation (EC) No XXX/XXXX [common procedure]

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1. Tekst

Delegations may find in the Annex the text of the above proposal as it results from the meeting of

the Working Party on Foodstuffs of 19 November 2008, with new wording suggested by

the Presidency.

Additions to the Commission's proposal (doc. 5431/08) are indicated in bold, while deletions are

indicated in strikethrough. The Presidency's additions to the previous document (15068/08) are

indicated in bold and underlined, whilst deletions are indicated in bold strikethrough .

The updated positions of the delegations are indicated in footnotes.

The Commission and DELETED maintain their general scrutiny reservations, while DK and MT

maintain their parliamentary scrutiny reservations.

________________

ANNEX

Proposal for a Regulation of the European Parliament and of the Council

on novel foods and amending Regulation (EC) No XXX/XXXX [common procedure]

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95

thereof,

Having regard to the proposal from the Commission ,

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

Acting in accordance with the procedure laid down in Article 251 of the Treaty ,

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 to their social

and economic interests. Differences between national laws, regulations and administrative

provisions concerning the safety assessment and authorisation of novel foods may hinder their

free movement, thereby creating unfair competition conditions.

(2) A high level of protection of human health protection should be assured in the pursuit of Community policies.

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

2 OJ C [...],[...], p. [...]. 3

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

(3) Community rules on novel foods were established by Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and

novel food ingredients and by 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 . For the sake of clarity, Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001 should be repealed. Recommendation

97/618/EC should become, therefore, obsolete as regards novel foods. Regulation (EC) No 258/97 should be replaced by this Regulation. The present Regulation should include

measures currently governed by Regulation (EC) No 1852/2001.

(4) In order to ensure continuity with Regulation (EC) No 258/97, the absence of a use for human consumption to a significant degree within the Community before the date of application of

Regulation (EC) No 258/97, namely 15 May 1997, should be kept as criteria for a food to be

considered as novel. A use within the Community refers to a use in the Member States

independently of the date of their accession to the European Union.

(5) The rules with regard to food law in 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 apply. The existing definition of novel food should be clarified and updated by replacing the existing categories, with a reference to the general

definition of food in Regulation (EC) No 178/2002.

OJ L 43, 14.2.1997, p. 1. Regulation as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1). 5

OJ L 253, 21.9.2001, p. 17. 6

OJ L 253, 16.9. 1997, p. 1.

7 OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 575/2006 (OJ L 100, 8.4.2006, p. 3).

(6) It should also be clarified that a food should be considered as novel when it is applied a production technology which was not previously used for food production. In particular,

emerging technologies in breeding and food production processes, which have an impact on

food and thus might have an impact on food safety, should be covered by this Regulation.

Novel food should therefore include foods derived from plants and animals, produced by non-

traditional breeding techniques, and foods modified by new production processes, such as

nanotechnology and nanoscience, which might have an impact on food. Food derived from

new plant varieties, or animal breeds produced by traditional breeding techniques, should not

be considered as novel foods.

(6a) However, in the light of the opinion of the European Group on Ethics in Science and

New technologies issued on 16 January 2008 and of the opinion of the European Food

Safety Authority adopted on 15 July 2008, cloning techniques of animals, such as the

somatic nuclear cell transfer technique, have specific characteristics that imply that this

Regulation cannot manage all the issues of cloning. Therefore, food produced from

cloned animals obtained by using a cloning technique, and from their offspring should 9 10

be excluded from the scope of this Regulation when a specific legislation is adopted.

DELETED: offsprings should be considered in the scope of this regulation, pending a specific legislation

Cion/DELETED: offsprings should be excluded from the scope of this regulation.

DELETED: only the first generation of offsprings should be examinated specifically. DELETED: no position yet 9

Cion: scrutiny reservation on this recital 10

DELETED: reservation, as they consider that this recital is not enough to express their wish

to exclude cloned animals from the scope of this regulation and to submit them to another piece of legislation. DELETED would add provisions in the body of the text underlining the provisional nature of the inclusion of cloned animals in this Regulation.

DELETED: proposed to keep food safety aspects related with cloned animals under the scope of this regulation while other aspects might be dealt with by other legislation.

DELETED: considering this suggestion favourably. DELETED: opposed.

DELETED: would like a ban of foods from cloned animals and their offsprings.

(7) If necessary, Implementing measures should be adopted to provide for criteria in order to facilitate the assessment of whether a food has been used for human consumption to a

significant degree within the Community before 15 May 1997. If a food has been used

exclusively as or in a food supplement, as defined in 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 , prior to that date 15 May 1997, it can be placed on the market after that date for the same use without being considered as a novel

food. However, that use as or in a food supplement should not be taken into account for the

assessment whether it has been used for human consumption to a significant degree within the

Community before 15 May 1997. Therefore, other uses of the food concerned, e.g. other than

food supplement uses, have to be authorised in accordance with this Regulation.

(8) The reformulation of food products produced from existing food ingredients available on the Community market, in particular by changing the composition or amounts of those food

ingredients, should not be considered as novel food. Food products produced from food

ingredients that do not fall within the scope of the Regulation, in particular by changing

the ingredients of the food, the composition or amounts of those food ingredients, should

not be considered as novel food. However, modifications of a food ingredient, e. g.

selective extracts or the use of other parts of a plant, that have so far not been used for

human consumption within the Community, should still fall within the scope of the

Regulation.

11 OJ L 183, 12.7.2002, p. 51. Directive as amended by Commission Directive 2006/37/EC (OJ L 94, 1.4.2006, p. 32).

(8a) The provisions of Directive 2001/83/EC on the Community code relating to medicinal

products for human use should apply where, taking into account all its characteristics, a product may fall within the definition of "medicinal product" and within the

definition of a product covered by other Community legislation. In this respect, a

Member State may, if it establishes in accordance with Directive 2001/83/EC that a

product is a medicinal product, restrict the placing on the market of such product in

accordance with Community law. Moreover, medicinal products are excluded from the

definition of food as established by Article 2 of Regulation (EC) No 178/2002 and should

not be subject to this Regulation.

(9) Novel foods authorised under the Regulation (EC) No 258/97 should maintain their novel food status but authorisation should be required for any new uses of such foods.

12 OJ L 311, 28.11.2001, p. 67. 13

Cion: reservation on this recital.

(10) Foods which are intended for technological uses or which are genetically modified should not

fall within the scope of this Regulation . Therefore, food used solely as additives falling within the scope of Regulation (EC) No XX/XXX of the European Parliament and of the

Council of [..] , flavourings falling within the scope of Regulation (EC) No XX/XXX of the 16

European Parliament and of the Council of [..] , extraction solvents falling within the scope of Council Directive 88/344/EEC of 13 June 1988 on the approximation of the laws of the

Member States on extraction solvents used in the production of foodstuffs and food

ingredients , enzymes falling within the scope of Regulation (EC) No XX/XXX of the 18

European Parliament and of the Council of [..] and genetically modified food falling within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of

22 September 2003 on genetically modified food and feed should be excluded from the scope of this Regulation.

DELETED: suggested to add at the end of the first sentence: ", as long as these foods are covered by a safety evaluation or approval according to other Community legislation."

OJ C [...],[...], p. [...]. 16

OJ C [...], [...], p. [...]. 17

OJ L 157, 24.6.1988, p. 28. Directive as last amended by Regulation (EC) No 1882/2003. 18

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

19 OJ L 268, 18.10.2003, p. 1. Regulation as amended by Commission Regulation (EC) No 1981/2006 (OJ L 368, 23.12.2006, p. 99).

(11) The use of vitamins and minerals is governed by specific sectoral food laws. The vitamins and

minerals falling within the scope of Council Directive 89/398/EEC of 3 May 1989 on the

approximation of the laws of the Member States relating to foodstuffs intended for particular

nutritional uses , Directive 2002/46/EC and 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 should therefore be excluded from the scope of this Regulation. However, these specific legislations do not deal with the cases where

authorised vitamins and mineral substances are obtained by production methods or

using new sources that were not taken into account when they were authorised.

Therefore, pending the amendments of the specific sectoral law legislations, those

vitamins and mineral substances should not be excluded from the scope of this

Regulation when the production methods or new sources give rise to significant changes

in the composition or structure which affects the nutritional value, metabolism or level

of undesirable substances.

(12) Novel foods, other than vitamins and minerals, intended for particular nutritional uses, for food fortification or as food supplements, should be assessed in conformity with the safety

criteria and requirements applicable to all novel foods this Regulation. At the same time they

should remain subject to the rules provided for in Directive 89/398/EEC and in the specific

Directives referred to in Article 4(1) thereof and in Annex I thereof, in Directive 2002/46/EC

and in Regulation (EC) No 1925/2006.

(13) Whether a food was used for human consumption to a significant degree 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. Where the

Commission does nit have information when there is not sufficient information on

human consumption before 15 May 1997 available, a simple and transparent procedure,

involving the Commission, the Member States and any parties concerned, should be

established for collecting that information.

20 OJ L 186, 30.6.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003. 21

OJ L 404, 30.12.2006, p. 26.

(14) Novel foods should be placed on the Community market only if they are safe and do not

mislead the consumer. In addition, where the novel food is intended to replace another

food, they it should not differ from that food that they are to replace in a way that would

be nutritionally disadvantageous for the consumer.

(15) It is necessary to apply a harmonised centralised procedure for safety assessment and

authorisation that is efficient, time-limited and transparent. With a view to further

harmonising different authorisation procedures of food, the safety assessment of novel foods

and their inclusion in the Community list should be carried out in accordance with the

procedure laid down in Regulation (EC) No [..] of the European Parliament and of the

Council of [date] establishing a common authorisation procedure for the food additives, food

enzymes and food flavourings , which should be applicable whenever it is not specifically derogated by the present Regulation. The authorisation of a novel food should also take

into account other factors relevant to the matter under consideration including, ethical,

environmental and animal welfare factors.

(16) Criteria for the evaluation of the potential risks arising from novel foods should also be laid

down. In order to ensure a harmonised scientific assessment of novel foods, such assessments

should be carried out by the European Food Safety Authority ("the Authority").

(17) In order to simplify procedures, applicants should be allowed to present a single application

for foods regulated under different sectoral food laws. Regulation EC No [common

procedure] should therefore be amended accordingly.

OJ L [...],[...], p. [...].

(17a) As regards the safety assessment and management of traditional food from third countries, their history of safe food use in the third country of origin should be taken into account. The

history of safe food use should not include non-food uses or uses not related to normal diets.

If Member States, taking into account the opinion of the Authority, and the Authority have not presented any reasoned, evidence-based safety objections, based on scientific

evidence, for example information on adverse health effects, it should be permissible to place

the food on the Community market under conditions that correspond to those for which

the history of safe food use has been demonstrated after notification of the intention to do

so. The food should also be included in a list of traditional foods from third countries.

(18) Where appropriate and based on the conclusions of the safety assessment, post-market

monitoring requirements for the use of novel foods for human consumption should be

introduced.

(19) The inclusion of a novel food in the Community list of novel foods or in the list of

traditional foods from third countries should be without prejudice to the possibility of

evaluating the effects of the overall consumption of a substance which is added to, or used for

the manufacture of that food, or of a comparable product in accordance with Article 8 of

Regulation (EC) No 1925/2006.

(20) Under specific circumstances in order to stimulate research and development within the agri-

food industry, and thus innovation, the newly developed scientific evidence and proprietary

data provided in support of an application for inclusion of a novel food in the Community list

should not be used to the benefit of another applicant during a limited period of time, without

the agreement of the first applicant. The protection of scientific data provided by one

applicant should not prevent other applicants from seeking the inclusion in the Community

list of novel foods on the basis of their own scientific data.

Moved from recital 23. 24

DELETED: reservation, linked with the reservation on Article 8.

(21) Novel foods are subject to the general labelling requirements laid down in Directive

2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the

approximation of the laws of the Member States relating to labelling, presentation and

advertising of foodstuffs and, where necessary, to the nutritional labelling requirements laid down in Council Directive 90/496/EEC of 24 of September 1990 on nutrition

labelling for foodstuffs. In certain cases it might be necessary to provide for additional

labelling information, in particular regarding the description of the food, its source or its

conditions of use. Therefore, the inclusion of a novel food in the Community list or in the list

of traditional foods from third countries may impose specific conditions of use or labelling

obligations, which may inter alia relate to any specific characteristic or food property,

such as composition, nutritional value or nutritional effects and intended use of the food,

or to ethical considerations or implications for the health of specific groups of the

population.

(22) Regulation (EC) No 1924/2006 of the European Parliament and of the Council of

20 December 2006 on nutrition and health claims made on foods harmonises the provisions in the Member States which relate to nutrition and health claims. Therefore, claims regarding

novel foods should only be made in accordance with that Regulation.

(23) [....]

(24) The European Group on Ethics in Science and New Technologies established by Commission

Decision of 16 December 1997 may be consulted, where appropriate, with a view to obtaining advice on ethical issues regarding the placing on the market of novel foods.

OJ L 109, 6.5.2000, p. 29. Directive as last amended by Commission Directive 2006/142/EC (OJ L 368, 23.12.2006, p. 110). 26

OJ L 404, 30.12.2006, p. 9. Corrected version (OJ L 12, 18.1.2007, p. 3). 27 Moved to recital 17a. 28

SEC (97) 2404.

(25) Novel foods placed on the Community market under Regulation (EC) No 258/97 should

continue to be placed on the market. Novel foods authorised in accordance with Regulation

(EC) No 258/97 should be included in the Community list of novel foods established by this

Regulation. In addition, applications submitted under Regulation (EC) No 258/97 before the

date of application of this Regulation should be transformed as an application under this

Regulation and for which a final decision has not been take before the date of application of

the present Regulation, should be considered as applications under this Regulation. where the

initial assessment report provided for under Article 6(3) of Regulation (EC) No 258/97

has not yet been forwarded to the Commission, as well as in all cases where an

additional assessment report is required in accordance with Article 6(3) or (4) of

Regulation (EC) No 258/97. Other pending requests submitted under Article 4 of

Regulation (EC) No 258/97 before the date of application of this Regulation should be

processed under the provisions of Regulation (EC) No 258/97.

(26) Since the objectives of the action to be taken cannot be achieved by the Member States and

can therefore be better achieved at Community level, the Community may adopt measures, in

accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In

accordance with the principle of proportionality, as set out in that Article, this Regulation

does not go beyond what is necessary in order to achieve those objectives.

(27) The Member States should lay down the rules on penalties applicable to infringements of the

provisions of this Regulation and should take all measures necessary to ensure that they are

implemented. The penalties provided for must be effective, proportionate and dissuasive.

(28) The measures necessary for the implementation of this Regulation should be adopted in

accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures

for the exercise of implementing powers conferred on the Commission .

29 OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11). Consolidated version (OJ C 255, 21.10.2006, p. 4).

(29) In particular, power should be conferred on the Commission to establish the criteria under

which foods may be considered as having been used for human consumption to a significant

degree within the Community before 15 May 1997. Since those measures are of general scope

and are designed to supplement this Regulation by the addition of new non-essential elements,

they must be adopted in accordance with the regulatory procedure with scrutiny provided for

in Article 5a of Decision 1999/468/EC.

(30) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April

2004 on official controls performed to ensure the verification of compliance with feed and

food law, animal health and animal welfare rules lays down general rules for the performance of official controls to verify compliance with food law. Therefore, the Member

States are to carry out official controls in accordance with Regulation (EC) No 882/2004, in

order to enforce compliance with the present Regulation. Requirements on the hygiene of

the foods as laid down in Regulation (EC) No 852/2004 of the European Parliament and

of the Council on 29 April 2004 on the hygiene on foodstuffs apply.

OJ L 165, 30.4.2004, p. 1. Corrected version (OJ L 191, 28.5.2004, p. 1). Regulation as last amended by Council Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1). 31

OJ L 139, 30.4.2004, p.1.

HAVE ADOPTED THIS REGULATION:

Chapter I

Introductory provisions

Article 1

Subject matter

This Regulation lays down harmonised rules for the placing of novel foods on the market in the

Community with a view to ensuring a high level of protection of human health and consumers'

protection interests, whilst ensuring the effective functioning of the internal market.

Article 2

Scope

1.

This Regulation shall apply to the placing of novel foods on the market in the Community.
2.

This Regulation shall not apply to:

(a) foods when and insofar as they are used as:

(i) food additives falling within the scope of Regulation (EC) No [on food additives]; (ii) food flavourings falling within the scope of Regulation (EC) No [on food

flavourings] ;

DELETED: suggested to add at the end "taking into account, where appropriate, the protection of the environment".

DELETED: would like to add: "If a food flavouring mentioned in Article 8(1)(a), (b) and (c) of the Regulation on food flavourings is produced from a novel food, the novel food shall be covered by this Regulation;"

(iii) extraction solvents used in the production of foodstuffs and falling within the

scope of Council Directive 88/344/EEC;

(iv) food enzymes falling within scope of Regulation (EC) No [on food enzymes];

(v) vitamins and minerals falling within the scope of Directive 89/398/EEC, Directive 2002/46/EC or Regulation (EC) No 1925/2006, except for vitamin and mineral

substances already approved which are obtained by production methods or

using new sources that were not taken into account when they were

authorized under respective sectoral food laws specific legislations, where

these production methods or new sources give rise to significant changes

referred to in article 3 (2)(a)(iv).

(b) foods falling within the scope of Regulation (EC) 1829/2003.

3.

Where necessary, it may be determined in accordance with the procedure referred to in Article 14(2) whether a type of food falls within the scope of this Regulation.

Article 3

Definitions

1.

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

Cion: reservation.

2.

The following definitions shall also apply :

(a) "novel food" means food that has not been used for human consumption to a significant degree within the Community before 15 May 1997, including :

(i) food of plant or animal origin, when to the plant and animal is applied a non traditional breeding technique not used for food production within the

Community before 15 May 1997; and

(ii) food of plant origin, when to the plant is applied a non-traditional breeding

technique not used for food production within the Community before

15 May 1997, where that production process gives rise to significant changes

in the composition or structure of the food which affect its nutritional value,

metabolism or level of undesirable substances; and

(iii) food to which is applied a new production process, such as nanotechnology and

nanoscience , not used within the Community before 15 May 1997, where that 37

production process gives rise to significant changes in the composition or structure of the food which affect its nutritional value, metabolism or level of

undesirable substances.

This paragraph was rearranged following the DELETED proposal, supported by other delegations. 35

Cion/DELETED: reservation 36

DELETED: food produced using nanotechnology and nanoscience should be submitted to evaluation/authorisation in all cases, and not only in cases where there are significant changes.

DELETED: scrutiny reservation on the concept of "significant change".

The use of a food exclusively as or in a food supplement shall not be sufficient to show whether it has been used for human consumption to a significant degree

within the Community before 15 May 1997. Food ingredients used exclusively

in food supplements within the Community before 15 May 1997 shall require

authorisation according to this Regulation if they are to be used in foods

other than food supplements. However, if a food has been used exclusively as

or in a food supplement prior that date, it can be placed on the Community market

after that date for the same use without being considered as novel food.

Further criteria for assessing if a food has been used for human consumption to a

significant degree, within the Community before 15 May 1997, which are

designed to amend non-essential elements of this Regulation, inter alia by

supplementing it, may shall be adopted in accordance with the regulatory

procedure with scrutiny referred to in Article 14(3), before the date of

application of this Regulation.

(b) "traditional food from a third country" means novel food with a history of food use in a third country, meaning that the food in question has been and continues to be part of

the normal diet for at least one generation 25 years in a large part of the population of

the country ;

(c) "history of safe food use" means that the safety of the food in question is confirmed with compositional data and from experience of use and continued use in the normal

diet of a large part of the population of a country.

If appropriate, the Commission may adopt further criteria to clarify the definitions

under points (a)(i), (a)(ii), a(iii) and (b), which are designed to amend non-essential

elements of this Regulation, inter alia by supplementing it, in accordance with the

regulatory procedure with scrutiny referred to in Article 14(3).

Cion: reservation. 39

DELETED: wish to limit the definition to fruits and vegetables; the definition should not be

too broad..

DELETED: scrutiny reservation on the concepts of "normal diet", "large part of population".

41 42

Article 4 Procedure for determination of novel food status

1.

The Commission may collect information from the Member States and/or from food business operators to determine to what extent a food has been used for human

consumption within the Community before 15 May 1997. Food business operators shall provide information concerning the status of foods they

intend to place on the Community market with respect to the scope of this Regulation.

43 44

They shall submit this information to the competent authority for novel foods as defined in Article 15 of Regulation No [common procedure], in order to allow it to verify

the status of the food. they intend to place on the market.

1a. Where necessary, the competent authority may consult other competent authorities and

the Commission concerning the extent to which a food has been used for human

consumption within the Community before 15 May 1997.

The Commission shall summarize the information collected from the consultation.

The result of the consultation shall be communicated to the competent authorities by the Commission.

1b. In cases where a food business operator provides evidence to the Commission

concerning the extent to which a food has been used for human consumption before 15

May 1997 to a significant degree within the Community, the Commission may ask the

concerned Member States to confirm this information.

DELETEDscrutiny reservation. 42

DELETED: need for more transparency; asked for a reference to the novel foods catalogue. 43

DELETED: proposed to add "if necessary". 44

DELETED: proposed to add "relevant". 45

DELETED needs for coordination of the consultation and publication of the results. 46

DELETED: asked for the recuperation of this paragraph.

1c. Where necessary, it may be determined in accordance with the procedure referred to in 47

Article 14(2) whether a type of food falls within the scope of this Regulation.

2.

Implementing measures for the application of paragraph 1 and 1a which are designed to amend non-essential elements of this Regulation, inter alia by supplementing it, may be

adopted in accordance with the regulatory procedure with scrutiny referred to in Article

14(32).

Chapter II

Requirements for placing novel foods on the market

Article 5

Community list Lists of novel foods

1.

The Commission shall maintain a Community list of authorised novel foods, other than traditional foods from third countries referred to under Article 8 (3a) (hereinafter "the

Community list"), which will be published in accordance with Article 2(1) of Regulation

(EC) No [common procedure].

1a. The Commission shall establish and maintain a list of traditional foods from third

countries, as referred to in Article 8(3a) of this Regulation, which shall be published in

the C series of the Official Journal of the European Union.

2.

Only novel foods, included in the Community list or in the list of traditional foods from third countries referred to under Article 8 (3a) may be placed on the market.

DELETED: prefer "product".

Article 5a

Prohibition of non-compliant novel foods

No person shall place on the market a novel food if its use does not comply with this

Regulation.

Article 6

General conditions for inclusion of novel foods in the Community lists

A novel food may be included in the lists only if it meets the following conditions:

(a) it does not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer under normal consumption conditions;

(b) it does not mislead the consumer, by the way it is presented or by its intended use,;

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

consumer.

(d)

DELETED: asked for the insertion under point d) of "Authorisation of a novel food should

only be granted in accordance with the ethical advice pursuant to Article 11a, where appropriate."

DELETED: asked for a point d) "it is ethically acceptable".

Article 7

Content of the Community list

1.

The Community list shall be updated in accordance with the procedure laid down in 49

Regulation (EC) No [common procedure] and, where applicable, in accordance with Article 12.

2.

The entry of a novel food, other than traditional food from third country referred to in Article 8(4), in the Community list shall include a specification of the food, and, where

appropriate, specify the conditions of use, additional specific labelling requirements to inform the final consumer and/or a post-market monitoring requirement and, where

applicable, information specified in Article 12(3).

3.

By way of derogation from the third paragraph of Article 7 of Regulation (EC) No [common procedure], the updating of the Community list with a novel food, other than traditional food

from third countries, shall be decided in accordance with the regulatory procedure referred to

in Article 14(2) in cases where newly developed scientific evidence and proprietary data are

protected in accordance with Article 12.

In the cases referred to in the first subparagraph the entry of novel food in the Community list

shall indicate, in addition to the information referred to in paragraph 2:

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

(b) the fact that the entry is based on newly developed scientific evidence and/or proprietary data protected in accordance with Article 12;

DELETED: the validation of an application if the application meets the definition of novel

food.

DELETED: it should be specified in which cases additional labelling is needed (requirements mentioned in Article 8 of Reg. 258/97);

4.

Before the expiry of the period referred to in Article 12, the Community list shall be updated to amend non-essential elements of this Regulation in accordance with the regulatory

procedure with scrutiny referred to in Article 14(3) laid down in Regulation (EC) No

[common procedure] so that, provided that the authorised food still meets the condition laid

down in this Regulation, the specific indications referred to in paragraph 3, second

subparagraph of this Article, are no longer included.

51 52

Article 8 Traditional food from a third country

1.

A food business operator By way of derogation from the procedure laid down in article 7(1) of this Regulation, an interested party, intending to place a traditional food from a

third country on the market in the Community, as referred to in Article 3(1) of Regulation

(EC) No [common procedure], who intends to place on the Community market a

traditional food from a third country whose history of safe food use can be

demonstrated, shall notify it to the Commission. indicating the name of the food, its

composition, and country of origin.

The notification shall include :

(a) the name of the food, (b) its composition,

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

(e) where applicable, the conditions of use and specific labelling requirements, (f) a summary of the content of the notification.

DELETED: reservation; would like to apply the common authorisation procedure to

traditional food from third countries, in a simplified form, that would take into account that there is a history of safe food use.

DELETED: reservation; prefers the Cion proposal. Cion: scrutiny reservation.

The notification shall be made be accompanied by documented data demonstrating the

history of safe food use in the third country in accordance with the implementing rules

referred to in paragraph 6 of this Article.

2.

The Commission shall forward the notification including the demonstration of history of safe food use referred to in paragraph 1 without delay to the Member States and the European

Food Safety Authority (hereinafter referred to as the Authority).

2a. The Authority shall give its opinion within four months of receipt of a valid notification.

The Authority shall forward its opinion to the Commission, the Member States and the

interested party.

3.

Within four two months from the date on which the notification provided for in paragraph 2 is forwarded by the Commission, a the Authority gives its opinion, Member States and/or the

Authority shall may inform the Commission of any that they have reasoned, evidence-based

based scientific evidence, safety objections they may have to the placing on the market of the

traditional food concerned, taking into account the opinion of the Authority

In that case, the food shall not be placed on the market in the Community and Articles 5 to 7 shall apply. The notification as referred to in paragraph 1 shall be considered as an

application referred to in Article 3(1) of the Regulation XX/XXX [common procedure].

The Commission shall inform the interested food business operator concerned

accordingly within five months from the date of the notification in accordance with

paragraph 1.

3a. If no reasoned, evidence-based safety objections, based on scientific evidence, have been

raised and no information thereof has been communicated to the food business operator

concerned interested party in accordance with paragraph 3, the traditional food may be

placed on the Community market, in the Community under conditions that correspond to

those for which the history of safe food use has been demonstrated, after five seven

months from the date of the notification in accordance with paragraph 1 and will be included

on the list of traditional foods from third countries. The list shall include a detailed

description of the food, conditions of use and additional specific labelling requirements,

where appropriate.

3b. If objections are raised, the Commission shall inform without delay the interested party of

the safety objections invoked and invite it to provide complementary elements. Those

complementary elements shall be submitted by the interested party to the Commission

which shall forward them without delay to the Member States. Within two months from

the date on which the complementary elements were forwarded by the Commission,

Member States shall inform the Commission if they maintain their objections.

If no objection is maintained by Member States, the traditional food may be placed on

the Community market under the conditions for which the history of safe use has been

demonstrated, within three months from the date of the transmission of the

complementary elements, and will be included on the list of traditional foods from third

countries referred to in paragraph 3a.

3c. If objections are maintained by Member States, it shall be decided in accordance with the procedure referred to in Article 14(3) [comitology with scrutiny] whether the

traditional food may be placed on the Community market under the conditions for

which the history of safe use has been demonstrated and included on the list of

traditional foods from third countries referred to in paragraph 3a.

Moved from original paragraph (4).

4.

At any stage of the procedure laid down in paragraph 2 to paragraph 3c, the interested party may withdraw its notification.

If no complementary elements as referred to in paragraph 3b are provided by the

interested party within two months from the date of invitation to do so by the

Commission, the notification shall be considered withdrawn.

[5. The Commission shall, in accordance with paragraph 3a, publish each year a summary of notifications in the C series of the Official Journal of the European Union a list of

traditional foods from third countries that may be placed on the market in the

Community in accordance with paragraph 4 on a dedicated page of the Commission's

website.]

6.

Detailed rules for the implementation of this Article, which are designed to amend non essential elements of this Regulation, inter alia by supplementing it, may shall be adopted in

accordance with the regulatory procedure with scrutiny referred to in Article 14(3), before

the date of application of this Regulation .

Article 9

Technical guidance

Notwithstanding the provisions of Article 9 (1)(a) of Regulation [common procedure] and

before the date of application of this Regulation the Commission shall, where appropriate, in close cooperation with the Authority, make available technical guidance and tools to assist food

business operators and especially small and medium-sized enterprises or other interested parties

in preparing and submitting applications and notifications under this Regulation.

Cion: scrutiny reservation.

Article 10

Opinion of the Authority

In assessing the safety of novel foods, the Authority shall in particular and where appropriate:

(a) compare, where appropriate, if the food is as safe as food from a comparable food category already existing on the market in the Community or as the food that the novel food is intended

to replace;

(b) take into account for traditional food from a third country, the history of safe food use.

Article 11

Special obligations on the food business operators

1.

The Commission may impose for food safety reasons and following the opinion of the Authority, a requirement for post-market monitoring. The food business operators placing the

food in the Community market shall be responsible for the implementation of the post-

marketing requirements specified in the entry of the food concerned in the Community list of

novel foods or the list of traditional foods from third countries.

2.

The producer 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 the competent authority of any third country in which the novel food is placed on the market.

Article 11a

Committee on Ethics and new Technologies

Where appropriate, on ethical questions relating to science and new technologies of major

ethical importance , the Commission, on its own initiative or at the request of a Member 57

State, may consult the European Group on Ethics and new Technologies , with a view to obtaining its opinion on ethical issues.

The Commission shall make this opinion available to the public.

Cion/DELETED: reservation on this article.

56 See OJ L 127, 20.5.2005, p.17. 57

Established by Commission Decision of 16 December 1997, SEC(97) 2404.

Chapter III

General provisions

Article 12

Authorisation procedure in cases of data protection

1.

On request by the applicant, supported by appropriate and verifiable information included in the application dossier, proprietary newly developed scientific evidence and/or scientific data

to support the application may not be used for the benefit of another application during a

period of five years from the date of the inclusion of the novel food in the Community list

without the agreement of the applicant, where:

(a) newly developed scientific evidence and/or scientific data has been designated as

proprietary by the applicant at the time the first application was made; and

(b) the applicant had exclusive right of reference to the proprietary scientific data at the

time the first application was made; and

proprietary scientific data by the applicant.

1a. The Commission shall determine, in consultation with the applicant, which information

should be granted the protection referred to in paragraph 1 and shall inform the

applicant, the Authority and the Member States of its decision.

Cion: scrutiny reservation

2.

By way of derogation from Article 7(5) of Regulation (EC) No [common procedure], the updating of the Community list with a novel food, other than traditional food from third

countries, shall be decided in accordance with the regulatory procedure referred to in

Article 14(2) of this Regulation in cases where proprietary newly developed scientific

evidence and proprietary data are protected in accordance with this Article. In this case,

the authorisation shall be granted for the period specified in the first paragraph.

3.

In the cases referred to in the second paragraph the entry of a novel food in the Community list shall indicate, in addition to the information referred to in Article 7(2)

of this Regulation:

(a) the date of entry of the novel food in the Community list; (b) the fact that the entry is based on proprietary newly developed scientific evidence

and/or proprietary scientific data protected in accordance with this Article;

(d) the fact that the novel food is restricted for placing on the market by the applicant

specified in point (c) unless a subsequent applicant obtains authorisation for the

food without reference to that proprietary data.

4.

Before the expiry of the period referred to in paragraph 1, the Community list shall be updated to amend non-essential elements of this Regulation in accordance with the

regulatory procedure with scrutiny referred to in Article 14(3) of this Regulation so that,

provided that the authorised food still meets the condition laid down in this Regulation,

the specific indications referred to in paragraph 3, of this Article, are no longer

included.

Article 12a (new)

Information of the public

The Commission shall make available to the public :

(a) the Community list specified in paragraph 1 of Article 5 and the list of traditional foods

from third countries specified in paragraph 1a of Article 5, on a single dedicated page of

the Commission website ;

(b) the summaries of the applications and notifications submitted under this Regulation.

Implementing measures for the application of this Article, including arrangements for

making public the outcome of the consultations under point (c), may be adopted in

accordance with the regulatory procedure referred to in Article 14(2).

Chapter III

General provisions

Article 13

Penalties

The Member States shall lay down the rules on penalties applicable to infringements of the

provision 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. The

Member States shall notify those provisions to the Commission by [...] at the latest and shall notify

it without delay of any subsequent amendment affecting them.

Article 14

Committee

1.

The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, set up by Article 58 of Regulation (EC) No 178/2002, hereinafter referred to as

"the Committee".

2.

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

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

3.

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

Article 15

Review

No later than [1 January 2015] and in the light of experience gained, the Commission shall forward

to the European Parliament and to the Council a report on the implementation of this Regulation

and in particular of Article 8 and Article 12, accompanied, where appropriate, by any proposals.

The report and any proposal shall be made accessible to the public.

Chapter IV

Transitional and final provisions

Article 16

Repeal

Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001 shall be repealed

with effect from the date of application of this Regulation, except with respect to pending

requests which according to Article 18(1) are to be processed under Regulation (EC)

No 258/97.

Article 17

Establishment of the Community list

Within 24 six months from the date of entry into force of this Regulation [date] at the latest the Commission shall establish the Community list by entering novel foods authorised and/or notified

under Articles 4, 5 and 7 of Regulation (EC) No 258/97 in this the Community list, including any

existing authorisation conditions, as appropriate.

Article 18

Transitional measures

1.

Any request for placing a novel food on the market submitted to a Member State under Article 4 of Regulation (EC) No 258/97 and for which a final decision has not been taken

before the date of application of this Regulation shall be transformed considered as to an

application under this Regulation where an initial assessment report provided for under

Article 6(3) of Regulation (EC) No 258/97 has not yet been forwarded to the

Commission, as well as in cases where the additional assessment report is required in

accordance with Article 6(3) or (4) of Regulation (EC) No 258/97. Other pending

requests submitted under Article 4 of Regulation (EC) No 258/97 before the date of

application of this Regulation shall be processed under the provisions of Regulation

(EC) No 258/97.

2.

Any appropriate transitional measures for the application of paragraph 1, which are designed to amend non-essential elements of this Regulation, inter alia by supplementing it, shall be

adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).

Article 19

Amendments to Regulation (EC) o [common procedure]

Regulation (EC) No [common procedure] is amended as follows:

(1) The title is replaced by the following:

"Regulation (EC) No XXX/XXXX of the European Parliament and of the Council of [date] establishing a common authorisation procedure for food additives, food enzymes, food

flavourings and novel foods"

(2) Recitals are replaced by the following:

(3) In order to protect human health, the safety of additives, enzymes, flavourings and novel foods for use in foodstuffs for human consumption must be assessed before

they are placed on the Community market.

(4) Regulation (EC) No .../... of the European Parliament and of the Council of ... on 60

food additives , Regulation (EC) No .../... of the European Parliament and of the ** 61

Council of ... on food enzymes , Regulation (EC) No .../... of the European ***

Parliament and of the Council of ... on flavourings and certain food ingredients 62

with flavouring properties for use in and on foods and Regulation (EC) No .../... 63

on novel foods (hereinafter referred to as the "sectoral food laws") lay down harmonised criteria and requirements concerning the assessment and

authorisation of these substances and products.

Pending the adoption of Regulation (EC) No [common procedure]. *

OJ: Please fill in the number and the date of document 16675/07. 60

OJ: Please fill in the relevant OJ reference. **

OJ: Please fill in the number and the date of document 16676/07. 61

OJ: Please fill in the relevant OJ reference. ***

OJ: Please fill in the number and the date of document 16677/07.

62 OJ: Please fill in the relevant OJ reference. 63

OJ: Please fill in the relevant OJ reference.

(5) It is envisaged, in particular, that food additives, food enzymes, novel foods and

food flavourings, to the extent that the safety of food flavourings must be assessed

in accordance with Regulation (EC) No .../... [on flavourings and certain food ingredients with flavouring properties for use in and on food], must not be placed

on the market or used in foodstuffs for human consumption, in accordance with

the conditions laid down in each sectoral food law, unless they are included on a

Community list of authorised substances or Community list of authorised novel

foods.

(7) In this context, it appears appropriate to establish for these four categories of

substances or products a common Community assessment and authorisation

procedure, that is effective, time-limited and transparent, so as to facilitate their

free movement within the Community market.

(2)(3) In Article 1, paragraph 1, first sub-paragraph is replaced by the following:

"1 This Regulation lays down a common procedure for the assessment and authorisation procedure (hereinafter referred to as the "common procedure") of food additives, food

enzymes, food flavourings and source materials of food flavourings and of food ingredients

with flavouring properties used or intended for use in or on foodstuffs and novel foods

(hereinafter referred to as the "substances or products") which contributes to the free

movement of food within the Community and to a high level of protection of human

health and to a high level of consumer protection, including the protection of consumer

interests. This Regulation shall not apply to smoke flavourings falling within the scope of

Regulation (EC) No 2065/2003 of the European Parliament and of the Council of

10 November 2003 on smoke flavourings used or intended for use in or on foods ."

*

OJ: Please fill in the number of document 16677/07. 64

OJ L 309, 26.11.2003, p. 1.

(3) (4) In Article 1, paragraph 2 is replaced by the following:

"2. The common procedure shall lay down the procedural arrangements for updating the lists of

substances and products the marketing of which is authorised in the Community pursuant to

Regulation (EC) No .../2008 [on food additives], Regulation (EC) No .../2008 [on food

enzymes] and Regulation (EC) No .../2008 [on flavourings and certain food ingredients with

flavouring properties for use in and on foods] and Regulation (EC) No .../2008 [on novel foods] (hereinafter referred to as the "sectoral food laws")."

(4) (5)In Recitals 9, 12, 13, 15, 18, 19, 26 and 27 and in Article 1 paragraph 3, Article 2

paragraphs 1 and 2, Article 7 paragraph 4, 5 and 6, Article 9 paragraph 2, Article 12

paragraph 1 and Article 13 the word 'substance' or 'substances' is replaced by 'substance or

product' or 'substances or products'.

(5) (6)The title of Article 2 is replaced by the following:

"Community list of substances or products"

(6) (7) In Article 4 the following paragraph 3 is added:

3.

A single application relating to a substance or product may be made to update the different Community lists regulated under the different sectoral food laws in so far as

the application complies with the requirements of each of the sectoral food laws."

(7) (8)The following sentence is added at the beginning of Article 6, paragraph 1:

"In the case of scientific grounds for safety concerns, additional information concerning risk assessment, shall be identified and requested from the applicant."

OJ: Please fill in the relevant numbers for each of these documents.

Article 20

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 24 six months after the date of publication of this Regulation [date].

However, Article 17 shall apply from the date of the entry into force of this Regulation.

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

Cion: scrutiny reservation.

2. Originele weergave

Open document als PDF

3. Meer informatie

verder

Proposal for a Regulation of the European Parliament and of the Council on novel foods and amending Regulation (EC) No XXX/XXXX [common procedure] - Hoofdinhoud

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publicatiedatum	25-11-2008
kenmerk	16300/08