1997R0258 — EN — 18.04.2004 — 002.001 — 1
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►B REGULATION(EC)No258/97OFTHEEUROPEANPARLIAMENTANDOFTHECOUNCIL
of27January1997
concerningnovelfoodsandnovelfoodingredients
(OJ L 43, 14.2.1997, p. 1)
Amended by:
Official Journal
No page date
►M1Regulation (EC) No 1829/2003 of the European Parliament and of the
Council of 22 September 2003L 268 1 18.10.2003
►M2Regulation (EC) No 1882/2003 of the European Parliament and of the
Council of 29 September 2003L 284 1 31.10.2003
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REGULATION (EC) No 258/97 OF THE EUROPEAN PARLIA-
MENTANDOFTHECOUNCIL
of27January1997
concerningnovelfoodsandnovelfoodingredients
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and
inparticular Article 100a thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the Economic and Social
Committee (2),
Acting in accordance with the procedure laid down in Article 189b of
the Treaty (3) in the light of the joint text approved by the Conciliation
Committee on9 December 1996,
(1)Whereas differences between national laws relating to novelfoods or food ingredients may hinder the free movement offoodstuffs; whereas they may create conditions of unfair compe-tition, thereby directly affecting the functioning of the internalmarket;
(2)Whereas, inorder to protect public health, it is n ecessary toensure that novel foods and novel food ingredients are subjectto a single safety assessment through a Community procedurebefore they are placed onthe market withinthe Commun ity;
whereas in the case of novel foods and novel food ingredients
which are substantially equivalent to existing foods or foodingredients a simplified procedure should be provided for;
(3)Whereas food additives, flavourings for use in foodstuffs andextraction solvents are covered by other Community legislationand should therefore be excluded from the scope of this Regula-tion;
(4)Whereas appropriate arrangements should be made for theplacing on the market of novel foods and novel food ingredientsderived from plant varieties subject to Council Directive 70/457/EEC of 29 September 1970 onthe commoncatalogue of vari-eties of agricultural plant species (
4) and Council Directive 70/
458/EEC of 29 September 1970 onthe marketin g of vegetable
seed(5);
(5)Whereas risks to the environment may be associated with novel
foods or novel food ingredients which contain or consist ofgenetically modified organisms; whereas Council Directive 90/
220/EEC of 23 April 1990 onthe deliberate release in to the
environment of genetically modified organisms (
6) stipulates
that, for such products, an environmental risk assessment mustalways be undertaken to ensure environmental safety; whereas,in order to establish a unified Community system for assessment
of such products, provisionmust be made un der this Regulation1997R0258 — EN — 18.04.2004 — 002.001 — 2
(1) OJ No C 190, 29. 7. 1992, p. 3
and OJ No C 16, 19. 1. 1994, p. 10.
(2) OJ No C 108, 19. 4. 1993, p. 8.
(3) Opinion of the European Parliament of 27 October 1993 (OJ No C 315, 22.
11. 1993, p. 139). Council Common Position of 23 October 1995 (OJ No C
320, 30. 11. 1995, p. 1) and Decision of the European Parliament of 12
March 1996 (OJ No C 96, 1. 4. 1996, p. 26). Decisionof the Coun cil of
19 December 1996 and Decision of the European Parliament of 16 January
1997.
(4) OJ No L 225, 12. 10. 1970, p. 1. Directive as last amended by Directive 90/
654/EEC (OJ No L 353, 17. 12. 1990, p. 48).
(5) OJ No L 225, 12. 10. 1970, p. 7. Directive as last amended by Directive 90/
654/EEC (OJ No L 353, 17. 12. 1990, p. 48).
(6) OJ No L 117, 8. 5. 1990, p. 15. Directive as last amended by Directive 94/
15/EC (OJ No L 103, 22. 4. 1994, p. 20).
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for a specific environmental risk assessment, which in accor-
dance with the procedure provided for in Article 10 ofDirective 90/220/EEC must be similar to that laid downinthat
Directive, but must also include the assessment of the suitability
of the product to be used as a food or food ingredient;
(6)Whereas the Scientific Committee for Food set up by Decision74/234/EEC (
1) should be consulted on any question relating to
this Regulationwhich may have aneffect onpublic health;
(7)Whereas Council Directive 89/397/EEC of 14 June 1989 on theofficial control of foodstuffs(
2) and Council Directive 93/99/
EEC of 29 October 1993 onthe subject of addition al measures
concerning the official control of foodstuffs(3) apply to novel
foods or food ingredients;
(8)Whereas, without prejudice to the other requirements in Commu-nity legislation relating to the labelling of foodstuffs, additionalspecific requirements on labelling should be laid down; whereasthese requirements must be subject to precise provisions in order
to ensure that the necessary information is available to the
consumer; whereas defined population groups associated withwell established practices regarding food should be informedwhen the presence in a novel food of material which is notpresent in the existing equivalent foodstuff gives rise to ethical
concerns as regards those groups; whereas foods and food ingre-
dients which contain genetically modified organisms and whichare placed onthe market must be safe for humanhealth; whereasthis assurance is provided for through compliance with theauthorization procedure contained in Directive 90/220/EEC and/or by the single assessment procedure laid down in this Regula-
tion; whereas insofar as an organism is defined by Community
law, with respect to labelling, information to the consumer onthe presence of an organism which has been genetically modi-fied constitutes an additional requirement applicable to thefoods and food ingredients referred to in this Regulation;
(9)Whereas, in respect of foods and food ingredients which are
intended to be placed on the market to be supplied to the final
consumer, and which may contain both genetically modifiedand conventional produce, and without prejudice to the otherlabelling requirements of this Regulation, information for theconsumer on the possibility that genetically modified organismsmay be present in the foods and food ingredients concerned is
deemed — by way of exception, in particular as regards bulk
consignments — to fulfil the requirements of Article 8;
(10)Whereas nothing shall prevent a supplier from informing theconsumer on the labelling of a food or food ingredient that theproduct in question is not a novel food within the meaning ofthis Regulation or that the techniques used to obtain novel foods
indicated in Article 1 (2) were not used in the production of that
food or food ingredient;
(11)Whereas, under this Regulation, provision should be made for aprocedure instituting close cooperation between Member Statesand the Commission within the Standing Committee on Food-stuffs set up by Decision69/414/EEC (
4);
(12)Whereas amodus vivendi betweenthe EuropeanParliamen t, the
Council and the Commission concerning the implementing
measures for acts adopted inaccordan ce with the procedure laid
downinArticle 189b of the Treaty was con cluded on20December 1994 (
5),1997R0258 — EN — 18.04.2004 — 002.001 — 3
(1) OJ No L 136, 20. 5. 1974, p. 1.
(2) OJ No L 186, 30. 6. 1989, p. 23. Directive as last amended by Directive 93/
99/EEC (OJ No L 290, 24. 11. 1993, p. 14).
(3) OJ No L 290, 24. 11. 1993, p. 14.
(4) OJ No L 291, 19. 11. 1969, p. 9.
(5) OJ No C 102, 4. 4. 1996, p. 1.
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HAVE ADOPTED THIS REGULATION:
Article 1
1. This Regulation concerns the placing on the market within the
Community of novel foods or novel food ingredients.
2. This Regulationshall apply to the placin g onthe market within
the Community of foods and food ingredients which have not hithertobeen used for human consumption to a significant degree within theCommunity and which fall under the following categories:
(c) foods and food ingredients with a new or intentionally modified
primary molecular structure;
(d) foods and food ingredients consisting of or isolated from micro-
organisms, fungi or algae;
(e) foods and food ingredients consisting of or isolated from plants and
food ingredients isolated from animals, except for foods and food
ingredients obtained by traditional propagating or breeding prac-tices and having a history of safe food use;
(f) foods and food ingredients to which has been applied a production
process not currently used, where that process gives rise to signifi-cant changes in the composition or structure of the foods or foodingredients which affect their nutritional value, metabolism or levelof undesirable substances.
3. Where necessary, it may be determined in accordance with the
procedure laid downinArticle 13 whether a type of food or food
ingredient falls within the scope of paragraph 2 of this Article.
Article 2
1. This Regulationshall n ot apply to:
(a) food additives falling within the scope of Council Directive 89/107/
EEC of 21 December 1988 onthe approximationof the laws of the
Member States concerning food additives authorized for use infoodstuffs intended for human consumption (
1);
(b) flavourings for use in foodstuffs, falling within the scope of
Council Directive 88/388/EEC of 22 June 1988 on the approxima-tion of the laws of the Member States relating to flavourings foruse infoodstuffs an d to source materials for their production(
2);
(c) extraction solvents used in the production of foodstuffs, falling
within the scope of Council Directive 88/344/EEC of 13 June1988 onthe approximationof the laws of the Member States onextraction solvents used in the production of foodstuffs and foodingredients (
3).
2. The exclusions from the scope of this Regulation referred to in
paragraph 1, indents (a) to (c) shall only apply for so long as the safetylevels laid downinDirectives 89/107/EEC, 88/388/EEC an d 88/344/EEC correspond to the safety level of this Regulation.
3. With due regard for Article 11 the Commissionshall en sure that
the safety levels laid downinthe above Directives, as well as inthe
implementing measures for these Directives and this Regulation, corre-spond to the safety level of this Regulation.1997R0258 — EN — 18.04.2004 — 002.001 — 4
(1) OJ No L 40, 11. 2. 1989, p. 27. Directive as last amended by Directive 94/
34/EC (OJ No L 237, 10. 9. 1994, p. 1).
(2) OJ No L 184, 15. 7. 1988, p. 61. Directive as last amended by Directive 91/
71/EEC (OJ No L 42, 15. 2. 1991, p. 25).
(3) OJ No L 157, 24. 6. 1988, p. 28. Directive as last amended by Directive 92/
115/EEC (OJ No L 409, 31. 12. 1992, p. 31).▼M1
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Article 3
1. Foods and food ingredients falling within the scope of this Regu-
lationmust n ot:
— present a danger for the consumer,
— mislead the consumer,
— differ from foods or food ingredients which they are intended to
replace to such an extent that their normal consumption would benutritionally disadvantageous for the consumer.
2. For the purpose of placing the foods and food ingredients falling
withinthe scope of this Regulationonthe market withinthe Commu-
nity, the procedures laid down in Articles 4, 6, 7 and 8 shall apply onthe basis of the criteria defined in paragraph 1 of this Article and theother relevant factors referred to in those Articles.
4. By way of derogationfrom paragraph 2, the procedure referred toin Article 5 shall apply to foods or food ingredients referred to inArticle 1(2)(d) and (e) which, on the basis of the scientific evidence
available and generally recognised or on the basis of an opinion deliv-
ered by one of the competent bodies referred to in Article 4(3), aresubstantially equivalent to existing foods or food ingredients as regardstheir composition, nutritional value, metabolism, intended use and thelevel of undesirable substances contained therein.
Where necessary, it may be determined in accordance with the proce-
dure laid down in Article 13 whether a type of food or food ingredientfalls under this paragraph.
Article 4
1. The person responsible for placing on the Community market
(hereinafter ‘the applicant’) shall submit a request to the Member Stateinwhich the product is to be placed onthe market for the first time. Atthe same time, he shall forward a copy of the request to the Commis-
sion.
2. An initial assessment as provided for in Article 6 shall be carried
out.
Following the procedure referred to in Article 6 (4), the Member State
referred to in paragraph 1 shall inform the applicant without delay:
— that he may place the food or food ingredient on the market, where
the additional assessment referred to in Article 6 (3) is not required,and that no reasoned objection has been presented in accordance
with Article 6 (4), or
— that, inaccordan ce with Article 7, anauthorizationdecisionis
required.
3. Each Member State shall notify to the Commission the name and
address of the food assessment bodies responsible in its territory forpreparing the initial assessment reports referred to in Article 6 (2).
4. Before the date of entry into force of this Regulation, the
Commission shall publish recommendations concerning the scientificaspects of:
— the information necessary to support an application and the presen-
tation of such information,
— the preparation of the initial assessment reports provided for in
Article 6.
5. Any detailed rules for implementing this Article shall be adopted
inaccordan ce with the procedure laid downinArticle 13.1997R0258 — EN — 18.04.2004 — 002.001 — 5
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Article 5
In the case of the foods or food ingredients referred to in Article 3 (4),
the applicant shall notify the Commission of the placing on the market
when he does so. Such notification shall be accompanied by the rele-vant details provided for in Article 3 (4). The Commission shallforward to Member States a copy of that notification within 60 daysand, at the request of a Member State, a copy of the said relevant
details. The Commissionshall publish each year a summary of those
notifications in the ‘C’ series of the Official Journal of the European
Communities .
With respect to labelling, the provisions of Article 8 shall apply.
Article 6
1. The request referred to in Article 4 (1) shall contain the necessary
information, including a copy of the studies which have been carriedout and any other material which is available to demonstrate that thefood or food ingredient complies with the criteria laid down in Article3 (1), as well as an appropriate proposal for the presentation and label-
ling, in accordance with the requirements of Article 8, of the food or
food ingredient. In addition, the request shall be accompanied by asummary of the dossier.
2. Uponreceipt of the request, the Member State referred to in
Article 4 (1) shall ensure that an initial assessment is carried out. To
that end, it shall notify the Commission of the name of the competentfood assessment body responsible for preparing the initial assessmentreport, or ask the Commission to arrange with another Member Statefor one of the competent food assessment bodies referred to in Article4 (3) to prepare such a report.
The Commissionshall forward to the Member States without delay a
copy of the summary provided by the applicant and the name of thecompetent body responsible for carrying out the initial assessment.
3. The initial assessment report shall be drawn up within a period of
three months from receipt of a request meeting the conditions laid
down in paragraph 1, in accordance with the recommendations referredto in Article 4 (4), and shall decide whether or not the food or foodingredient requires additional assessment in accordance with Article 7.
4. The Member State concerned shall without delay forward the
report of the competent food assessment body to the Commission,
which shall forward it to the other Member States. Withina period of60 days from the date of circulationof the report by the Commission , aMember State or the Commission may make comments or present areasoned objection to the marketing of the food or food ingredient
concerned. The comments or objections may also concern the presenta-
tion or labelling of the food or food ingredient.
Comments or objections shall be forwarded to the Commission, which
shall circulate them to Member States withinthe period of 60 daysreferred to inthe first subparagraph.
The applicant shall, where a Member State so requests, provide a copy
of any pertinent information appearing in the request.
Article 7
1. Where an additional assessment is required in accordance with
Article 6 (3) or anobjectionis raised inaccordan ce with Article 6
(4), anauthorizationdecisionshall be takeninaccordan ce with theprocedure laid downinArticle 13.
2. The decision shall define the scope of the authorization and shall
establish, where appropriate:
— the conditions of use of the food or food ingredient,
— the designation of the food or food ingredient, and its specification,— specific labelling requirements as referred to in Article 8.1997R0258 — EN — 18.04.2004 — 002.001 — 6
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3. The Commission shall without delay inform the applicant of the
decision taken. Decisions shall be published in the Official Journal of
the European Communities .
Article 8
1. Without prejudice to the other requirements of Community law
concerning the labelling of foodstuffs, the following additional specificlabelling requirements shall apply to foodstuffs in order to ensure that
the final consumer is informed of:
(a) any characteristic or food property such as:
— composition,
— nutritional value or nutritional effects,— intended use of the food,
which renders a novel food or food ingredient no longer equivalent
to an existing food or food ingredient.
A novel food or food ingredient shall be deemed to be no longer
equivalent for the purpose of this Article if scientific assessment,
based upon an appropriate analysis of existing data, can demon-
strate that the characteristics assessed are different in comparisonwith a conventional food or food ingredient, having regard to theaccepted limits of natural variations for such characteristics.
In this case, the labelling must indicate the characteristics or prop-
erties modified, together with the method by which thatcharacteristic or property was obtained;
(b) the presence in the novel food or food ingredient of material which
is not present in an existing equivalent foodstuff and which mayhave implications for the health of certain sections of the popula-
tion;
(c) the presence in the novel food or food ingredient of material which
is not present in an existing equivalent foodstuff and which gives
rise to ethical concerns.
2. In the absence of an existing equivalent food or food ingredient,
appropriate provisions shall be adopted where necessary in order toensure that consumers are adequately informed of the nature of thefood or food ingredient.
3. Any detailed rules for implementing this Article shall be adopted
inaccordan ce with the procedure laid downinArticle 13.
Article 10
Detailed rules for the protectionof the in formationprovided by the
applicant shall be adopted in accordance with the procedure laid downinArticle 13.
Article 11
The Scientific Committee for Food shall be consulted on any matter
falling within the scope of this Regulation likely to have an effect onpublic health.
Article 12
1. Where a Member State, as a result of new information or a reas-
sessment of existing information, has detailed grounds for consideringthat the use of a food or a food ingredient complying with this Regula-tion endangers human health or the environment, that Member State1997R0258 — EN — 18.04.2004 — 002.001 — 7
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may either temporarily restrict or suspend the trade in and use of the
food or food ingredient in question in its territory. It shall immediatelyinform the other Member States and the Commission thereof, giving
the grounds for its decision.
2. The Commission shall examine the grounds referred to in para-
graph 1 as soon as possible within the Standing Committee forFoodstuffs; it shall take the appropriate measures inaccordan ce withthe procedure laid downinArticle 13. The Member State which tookthe decision referred to in paragraph 1 may maintain it until the
measures have entered into force.
Article 13
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 (
1), hereinafter referred to as ‘the Committee’.
2. Where reference is made to this Article, Articles 5 and 7 of Deci-
sion1999/468/EC (2) shall apply, having regard to the provisions of
Article 8 thereof.
The period laid downinArticle 5(6) of Decision1999/468/EC shall be
set at three months.
3. The Committee shall adopt its rules of procedure.
Article 14
1. No later than five years from the date of entry into force of this
Regulation and in the light of experience gained, the Commission shallforward to the European Parliament and to the Council a report on theimplementation of this Regulation accompanied, where appropriate, byany suitable proposal.
2. Notwithstanding the review provided for in paragraph 1, the
Commission shall monitor the application of this Regulation and its
impact on health, consumer protection, consumer information and thefunctioning of the internal market and, if necessary, will bring forwardproposals at the earliest possible date.
Article 15
This Regulation shall enter into force 90 days following its publication
intheOfficial Journal of the European Communities .
This Regulation shall be binding in its entirety and directly applicable
inall Member States.1997R0258 — EN — 18.04.2004 — 002.001 — 8
(1) OJ L 31, 1.2.2002, p. 1.
(2) Council Decision 1999/468/EC of 28 June 1999 laying down the procedures
for the exercise of implementing powers conferred on the Commission (OJ
L 184, 17.7.1999, p. 23).▼M2
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