Commission Regulation (EC) No 1565/2000 of 18 July 2000 laying down the measures necessary for the adoption of an evaluation programme in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council (Text with EEA relevance)
Date: 2000-07-18
Institutions: European Commission
Subjects: disclosure of information, flavouring, foodstuff, marketing, public health

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COMMISSION REGULATION (EC) No 1565/2000

of 18 July 2000

laying down the measures necessary for the adoption of an evaluation programme in application of
Regulation (EC) No 2232/96 of the European Parliament and of the Council

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

European Commission (SCF) and the Joint FAO/WHO
Expert Committee on Food Additives (JECFA).

Having regard to the Treaty establishing the European
Community,

Having regard to Regulation (EC) No 2232/96 of the European
Parliament and of the Council of 28 October 1996 laying
down a Community procedure for flavouring substances used
or intended for use in or on foodstuffs (1) and in particular
Article 4 thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

Commission Decision 1999/217/EC (2)
a
register of flavouring substances used in or on foodstuffs
drawn up in application of Regulation (EC) No 2232/96.

adopted

Regulation (EC) No 2232/96 lays down in its Annex the
general criteria for the use of flavouring substances. It
in particular, that they present no risk to the
covers,
health of the consumer and that their use does not
mislead the consumer.

to check that

In order
the flavouring substances
contained in the register comply with the general use
criteria, Article 4(1) of Regulation (EC) No 2232/96
provides that a programme for the evaluation of these
flavouring substances is to be carried out. According to
Article 4(3) substances have to be deleted from the
register, where, following evaluation, it is clear that they
do not comply with the general use criteria.

As the first step of
the evaluation programme the
substances of the register should receive FL-numbers
according to their chemical characteristics and should be
distributed in groups of structurally related compounds
which are expected to show some metabolic and biolog-
ical behaviour in common.

In the light of the large number of flavouring substances
in the register and the deadline set by the Regulation by
which a list of authorised flavouring substances shall be
adopted, the evaluation programme should not waste
scientific resources and, therefore, make use of safety
assessments already performed by the Committee of
Experts on Flavouring Substances of
the Council of
Europe (CEFS), the Scientific Committee on Food of the

(1) OJ L 299, 23.11.1996, p. 1.
(2) OJ L 84, 27.3.1999, p. 1.

(6)

(7)

(8)

(9)

flavourings considered acceptable at

The Scientific Committee on Food has been consulted,
addressing especially the question whether results of
evaluations of other
scientific committees can be
accepted. In its conclusion expressed on 2 December
1999, the SCF was of the opinion that, subject to certain
exceptions,
the
current estimated intake by JECFA comply with the
general use criteria and could be included in the list of
authorised substances without undergoing a separate
SCF evaluation for the time being. Likewise, the SCF
concluded that flavourings previously evaluated by the
SCF and CEFS as being safe, need not be re-evaluated as
the criteria previously used are stringent enough to
consider the substances to be safe in current use.

The Scientific Committee on Food further considered
that for the remaining flavouring substances, unneces-
sary duplication of work could be avoided by dividing
different groups of substances between JECFA and the
SCF for evaluation.

Article 4(2) of Regulation (EC) No 2232/96 provides
that the person responsible for placing the substances on
the market shall
forward the data necessary for the
evaluation to the Commission. Information about the
substances on purity, chemical specification, natural
occurrence in food, total amount added to foods and
results of toxicological and metabolic studies are consid-
ered to be essential for the evaluation. In order to enable
a constant evaluation over the whole period the infor-
mation should be presented as soon as possible and be
available well in advance of the evaluation of a particular
substance. The information should be updated as soon
as new data are available.

If the data provided on chemical identity of a substance
and the amount added to foods or the toxicological and
metabolic studies on a substance or on closely related
substances appear to be insufficient, further data may be
requested. Following the initial exposure assessment
which should be based on the total amounts added to
foods more refined usage data might become necessary
for the evaluation of certain substances.

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(10)

In order to enable the completion of the evaluation
programme within five years, deadlines for the submis-
sion of information have to be set as well as minimal
numbers of substances to be evaluated within a given
time period.

(11) Where the necessary information is not provided, so
that the evaluation of a flavouring substance cannot be
undertaken, that substance may not be included in the
definitive list of
flavouring substances referred to in
Article 5 of Regulation (EC) No 2232/96.

(12)

(13)

(14)

(15)

The register contains about 2 800 substances. Following
the opinion of the SCF, it can be concluded that about
800 substances need not be re-evaluated for the time
being. Based on the assumption that JECFA would eval-
uate a considerable number of substances during the
next five years, about 1 000 to 1 250 remain for evalu-
ation by the SCF.
In order to make the evaluation
process as efficient as possible a group-based approach
should be followed, i.e. substances which are expected to
show some metabolic and biological behaviour
in
common should be evaluated together.

By Commission Decision 94/652/EC (1), as last amended
by Decision 1999/634/EC (2), the task 1.1 on ‘chemically
defined flavouring substances’ has been defined to be
undertaken within the framework of scientific coopera-
tion by Member States in the examination of questions
relating to food (SCOOP). This task has built up the
Flavis database which compiles information for the
scientific evaluation of flavouring substances. The infor-
mation provided by the person responsible for placing
the substance on the market should be added to the
database and be critically reviewed in order to establish
if it is sufficiently complete for evaluation.

In accordance with the opinion of the SCF, the evalu-
ation of the substances by the SCF should follow the
procedure applied by JECFA, which is the most updated
and systematic procedure presently applied. After
approval by the SCF, results of future evaluations of
the register performed by
flavouring substances of
JECFA should also be accepted.

The JECFA procedure is a stepwise approach that inte-
grates information on intake from current uses, struc-
ture-activity relationships, metabolism and toxicity. In
addition, information on purity and chemical specifica-
tion is assessed. One of the key elements in the proce-
dure is the subdivision of flavourings into three struc-
tural classes for which human exposure thresholds that

(1) OJ L 253, 29.9.1994, p. 29.
(2) OJ L 249, 22.9.1999, p. 32.

are not considered to present a safety concern have been
specified. Toxicological and metabolic studies performed
within a group of chemically related substances can be
used to draw conclusions about possible toxicological
effects of substances not studied or studied but not
intensively.

(16) A substance should be re-evaluated if, in the light of new
data on toxicological effects or on human intake, doubt
arises on the validity of
the already performed and
accepted evaluation.

(17)

1999/217/EC

Commission Decision

By
certain
flavouring substances received first priority in the evalu-
ation programme since concerns about the safety of the
health of consumers were expressed by some Member
States. The programme should then proceed group-wise
giving priority to those groups of substances for which
most information is available. However, higher priorities
for certain substances may be requested in the future.

(18)

The measures provided for in this Regulation are in
accordance with the opinion of the Standing Committee
on Foodstuffs,

HAS ADOPTED THIS REGULATION:

Article 1

the

first

step in the

establishment of

evaluation
The
programme shall be the attribution of FL-numbers, as defined
in the Flavis database system, to each flavouring substance of
the register and subdivision of all substances into groups of
related substances according to the list of groups as laid down
in Annex I to this Regulation. This stage shall be completed
within three months of the adoption of this Regulation by the
Member States participating in SCOOP task 1.1, established by
Decision 94/652/EC.

Article 2

Substances that are contained in the register and have

1.
already been classified

— by the SCF in Category 1 (substances considered safe in

use) (3), or

— by the CEFS in Category A (substances which may be used

in foodstuffs) (4), or

— by JECFA so as to present no safety concern at current
levels of intake with the exception of substances which
have been accepted on the sole basis that their estimated
intake is lower than the threshold of concern of 1,5 µg per
person per day, as laid down in the reports of the 46th,
49th, 51st and 53rd JECFA meetings (5),

(3) Annex 6 to the minutes of

the 98th meeting of

the Scientific

Committee on Food, 21 and 22 September 1995.

(4) Flavouring substances and natural

flavourings, Volume I,
Chemically-defined flavouring substances, Fourth Edition. Council of
in the social and public health field, Stras-
Europe, Partial agreement
bourg, 1992,
including its subsequent loose-leaf modifications until
year 1999.

sources of

(5) Evaluation of certain food additives and contaminants. 46th Report
of the Joint FAO/WHO Expert Committee on Food Additives, WHO
Technical report, series 868, Geneva 1997.
Evaluation of certain food additives and contaminants. 49th Report
of the Joint FAO/WHO Expert Committee on Food Additives, WHO
Technical Report, series 884, Geneva 1999.
51st Report of
Additives, WHO Technical Report, series to be published.
53rd Report of
Additives, WHO Technical Report series to be published.

the Joint FAO/WHO Expert Committee on Food

the Joint FAO/WHO Expert Committee on Food

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need not be re-evaluated within the present evaluation
programme,

— if information on purity and chemical specification of the
substance as outlined in Annex II is provided, and

— unless the SCF receives new information which might

change the results of the evaluations.

Substances that are contained in the register and will be

2.
classified in the future

— by JECFA so as to present no safety concern at current

levels of intake

will be considered by the SCF, who may then decide that no
further evaluation is necessary.

3.
In the event that the SCF decides that further evaluation
of a substance referred to in paragraph 1 or 2 is necessary, the
person responsible for placing a substance of the register on
the market shall provide the information laid down in Article
3(1).

Article 3

The person responsible for placing on the market a
1.
substance contained in the register which is not covered by
Article 2(1) has to provide the following information within 12
months of the adoption of this Regulation in order to enable
the evaluation of a substance:

— purity and chemical specification of

the substance as

outlined in Annex II,

— natural occurrence in foodstuffs,

— total amount of the substance which is added to foods in

the Community,

— normal and maximum use levels of the substance in food

categories as outlined in Annex III,

if available,

— all relevant

toxicological and metabolic studies on the

substance or on closely related substances.

This information has to be transmitted in a standardised
format, as outlined in Annex IV.

2.
If the information referred to in paragraph 1 does not
become available for a particular substance within 12 months
of the adoption of this Regulation, the person responsible for
placing it on the market shall inform the Commission, within
this period, of the date on which he can fulfil his obligation
under paragraph 1 either for individual substances or for
groups of substances as laid down in Annex I.

3.
In the light of the information received according to
paragraphs 1 and 2, the Commission may establish different
deadlines from that proposed under paragraph 2, for individual
substances or groups of substances as laid down in Annex I, in
order to allow the smooth running of the evaluation process.

market within deadlines which are consistent with the overall
deadline of the programme. In particular, for certain substances
it might become necessary to submit
information on the
normal and maximum use levels in food categories as outlined
in Annex III.

5. Where the information specified in paragraph 1, or addi-
tional information specified in paragraph 4, is not provided,
the substance may not be evaluated.

6.
The information specified in paragraph 1 shall be
updated, including for those substances already evaluated, by
the person responsible for placing the respective substance(s)
on the market as soon as new data become available.

Information which has already been provided shall be

7.
made available to Member States.

Article 4

At
1.
provided that
additional
within the specified deadlines.

least 200 substances per year shall be evaluated
the information specified in Article 3(1), or
is supplied

information specified in Article 3(4),

2. Within the SCOOP task 1.1, established by Decision 94/
652/EC, participating Member States shall:

— incorporate the information of each substance given
according to Article 3(1) and (4) into the Flavis database,

— check if the information is sufficiently complete for evalu-
ation and inform the Commission if this is not the case,

— prepare data sheets which collate and summarise the infor-

mation and which contain a pre-evaluation, and

— present these data sheets to the SCF.

The SCOOP task shall be organised so as to meet the require-
ment of paragraph 1.

3.
On basis of the data sheets referred to in paragraph 2 the
SCF will evaluate the substances for their compliance with the
general use criteria. The SCF shall check the information for its
completeness and shall inform the Commission if this is not
the case. If necessary, measures to restrict the levels of use can
be proposed. The evaluation procedure applied shall follow the
procedure applied by JECFA, as far as considered appropriate
by the SCF.

4.
The Commission or a Member State may request the
re-evaluation of a substance already accepted as complying
with the general use criteria, if new data that may lead to a
different result become available.

Article 5

The Commission may request additional

4.
information
considered to be relevant for the evaluation of a particular
substance from the person responsible for placing it on the

1.
Substances in the register that bear the remark ‘2’ or ‘3’ in
the ‘Comments’ column of Decision 1999/217/EC, shall be
evaluated first.

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2. Without prejudice to paragraph 1, those groups of substances as laid down in Annex I, for which the
information as referred to in Article 3(1) is most complete, shall receive priority for evaluation.

By way of derogation from paragraph 2, the Commission or a Member State may request priority for

3.
the evaluation of (a) particular substance(s) or (a) group(s) of substances.

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

Article 6

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

Done at Brussels, 18 July 2000.

For the Commission

David BYRNE

Member of the Commission

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ANNEX I

CHEMICAL GROUPS FOR FLAVOURING SUBSTANCES (1)

1. Straight-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing saturated alcohols
and acetals containing saturated aldehydes. No aromatic or heteroaromatic moiety as a component of an ester or
acetal.

2. Branched-chain primary aliphatic alcohols/aldehydes/acids, acetal and esters with esters containing branched-chain
alcohols and acetals containing branched-chain aldehydes. No aromatic or heteroaromatic moiety as a component of
an ester or acetal.

3. α, β-unsaturated (alkene or alkyne) straight-chain and branched-chain aliphatic primary alcohols/aldehydes/acids,
acetals and esters with esters containing α, β-unsaturated alcohol and acetal containing α, β-unsaturated alcohols or
aldehydes. No aromatic or heteroaromatic moiety as a component of an ester or acetal.

4. Non-conjugated and accumulated unsaturated straight-chain and branched-chain aliphatic primary alcohols/alde-
hydes/acids, acetals and esters with esters containing unsaturated alcohols and acetals containing unsaturated alcohols
or aldehydes. No aromatic or heteroaromatic moiety as a component of an ester or acetal.

5. Saturated and unsaturated aliphatic secondary alcohols/ketones/ketals/esters with esters containing secondary alco-

hols. No aromatic or heteroaromatic moiety as a component of an ester or ketal.

6. Aliphatic, alicyclic and aromatic saturated and unsaturated tertiary alcohols and esters with esters containing tertiary

alcohols. Esters may contain any acid component.

7. Primary alicyclic saturated and unsaturated alcohols/aldehydes/acids/acetals/esters with esters containing alicyclic

alcohols. Esters/acetals may contain aliphatic acyclic or alicylic acids or alcohol component.

8. Secondary alicyclic saturated and unsaturated alcohols/ketones/ketals/esters with ketals containing alicyclic alcohols
or ketones and esters containing secondary alicyclic alcohols. Esters may contain aliphatic acyclic or alicyclic acid
component.

9. Primary aliphatic saturated or unsaturated alcohols/aldehydes/acids/acetals/esters with a second primary, secondary or

tertiary oxygenated functional group including aliphatic lactones.

10. Secondary aliphatic saturated or unsaturated alcohols/ketones/ketals/esters with a second secondary or tertiary

oxygenated functional group.

11. Alicyclic and aromatic lactones.

12. Maltol derivatives and ketodioxane derivatives.

13. Furanones and tetrahydrofurfuryl derivatives.

14. Furfuryl and furan derivatives with and without additional side-chain substituents and heteroatoms.

15. Phenyl ethyl alcohols, phenylacetic acids, related esters, phenoxyacetic acids and related esters.

16. Aliphatic and alicyclic ethers.

17. Propenylhydroxybenzenes.

18. Allylhydroxybenzenes.

19. Capsaicin related substances and related amides.

20. Aliphatic and aromatic mono- and di- thiols and mono-, di-, tri-, and polysulfides with or without additional

oxygenated functional groups.

21. Aromatic ketones, secondary alcohols and related esters.

22. Aryl-substituted primary alcohol/aldehyde/acid/ester/acetal derivatives,

including unsaturated ones.

(1) These chemically based groups are expected to show some metabolic and biological behaviours in common.

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23. Benzyl alcohols/aldehydes/acids/esters/acetals. Benzyl and benzoate esters included. May also contain aliphatic acyclic

or alicyclic ester or acetal component.

24. Pyrazine derivatives.

25. Phenol derivatives containing ring-alkyl, ring-alkoxy, and side-chains with an oxygenated functional group.

26. Aromatic ethers including anisole derivatives.

27. Anthranilate derivatives.

28. Pyridine, pyrrole, and quinoline derivatives.

29. Thiazoles, thiophene, thiazoline and thienyl derivatives.

30. Miscellaneous substances.

31. Aliphatic and aromatic hydrocarbons.

32. Epoxides.

33. Aliphatic and aromatic amines.

34. Amino acids.

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CHEMICAL SPECIFICATIONS TO BE PROVIDED FOR FLAVOURING SUBSTANCES

ANNEX II

— chemical name as used in the register of Decision 1999/217/EC,

— IUPAC name,

if different from chemical name as used in the register,

— synonyms,

— CAS-, E-, EINECS-, FL-, CoE- and FEMA numbers,

if available,

— chemical and structural formula, molecular weight,

— physical form/odour,

— solubility,

— solubility in ethanol,

— identity test (infra red-, nuclear magnetic resonance- and/or mass spectrum),

— minimum assay value,

— impurities,

— physical parameters related to purity (justification is required if information is not provided):

— boiling point (for liquids),
— melting point (for solids),
— refractive index (for liquids),
— specific gravity (for liquids),

— stability and decomposition products,

if relevant,

— interaction with food components,

if relevant,

— any other relevant information.

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ANNEX III

FOOD CATEGORIES

Dairy products, excluding products of category 2.

Fats and oils, and fat emulsions (type water-in-oil).

Edible ices,

including sherbet and sorbet.

1.

2.

3.

4.

Processed fruits and vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes), and nuts
and seeds.
Fruit.

4.1.
4.2. Vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes), and nuts and seeds.

5.

6.

7.

8.

9.

10.

11.

12.

13.

Confectionery.

Cereals and cereal products, including flours and starches from roots and tubers, pulses and legumes, excluding
bakery.

Bakery wares.

Meat and meat products,

including poultry and game.

Fish and fish products,

including molluscs, crustaceans and echinoderms (MCE).

Eggs and egg products.

Sweeteners,

including honey.

Salts, spices, soups, sauces, salads, protein products, etc.

Foodstuffs intended for particular nutritional uses.

Beverages, excluding dairy products.

14.
14.1. Non-alcoholic (‘soft’) beverages.
14.2. Alcoholic beverages,

including alcohol-free and low-alcoholic counterparts.

15.

16.

Ready-to-eat savouries.

Composite foods (e.g. casseroles, meat pies, mincemeat), foods that could not be placed in categories 1 to 15.

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ANNEX IV

FORMAT FOR THE TRANSMISSION OF INFORMATION ON FLAVOURING SUBSTANCES

1. The information as specified in Article 3(1) first to fourth indents as well as summaries of information requested by
the fifth indent have to be provided in a standard electronic format, the ‘Input form for the Flavis database’ (IF-FL). The
summaries of information requested by the fifth indent should contain the main findings of the referred study to allow
conclusions on the metabolic and toxicological effects of the substances. The IF-FL can be downloaded from the
following internet site or ordered from the coordinating institute of the SCOOP task 1.1 which address is given below.

http://www.flavis.net

2. The information has to be provided in English. To identify a substance the name in the column headed ‘Name’ of the
English version of the register of Decision 1999/217/EC has to be used. If already available, the FL-number has to be
given in addition.

3.

(a) The completed IF-FL has to be sent to the coordinating institute of the SCOOP task 1.1

by e-mail to the address (input@flavis.net) given on the abovementioned internet site or
by post to the address below (recommended for substances in part 4 of the register);

(b) three separately bound copies of the information as specified in Article 3(1), fifth indent have to be provided in
paper format. Each copy needs to be clearly identified with the English ‘Name’ of the substance and the chemical
grouping (as listed in Annex I) to which it relates. If already available, the FL-number has to be given in addition.
The copies have to be sent to the coordinating institute of SCOOP task 1.1:

Danish Veterinary and Food Administration
Institute of Food Safety and Toxicology
Flavis
Mørkhøi Bygade 19
DK-2860 Søborg