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,
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) Commission Decision 1999/217/EC(2) adopted a register of flavouring substances used in or on foodstuffs drawn up in application of Regulation (EC) No 2232/96.
(2) Regulation (EC) No 2232/96 lays down in its Annex the general criteria for the use of flavouring substances. It covers, in particular, that they present no risk to the health of the consumer and that their use does not mislead the consumer.
(3) In order to check that 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.
(4) 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 biological behaviour in common.
(5) 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 European Commission (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
(6) 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, flavourings considered acceptable at 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.
(7) The Scientific Committee on Food further considered that for the remaining flavouring substances, unnecessary duplication of work could be avoided by dividing different groups of substances between JECFA and the SCF for evaluation.
(8) 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 considered to be essential for the evaluation. In order to enable a constant evaluation over the whole period the information 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.
(9) 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.
(10) In order to enable the completion of the evaluation programme within five years, deadlines for the submission 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) The register contains about 2800 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 evaluate a considerable number of substances during the next five years, about 1000 to 1250 remain for evaluation 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.
(13) By Commission Decision 94/652/EC(3), as last amended by Decision 1999/634/EC(4), the task 1.1 on "chemically defined flavouring substances" has been defined to be undertaken within the framework of scientific cooperation 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 information 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.
(14) In accordance with the opinion of the SCF, the evaluation 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 flavouring substances of the register performed by JECFA should also be accepted.
(15) The JECFA procedure is a stepwise approach that integrates information on intake from current uses, structure-activity relationships, metabolism and toxicity. In addition, information on purity and chemical specification is assessed. One of the key elements in the procedure is the subdivision of flavourings into three structural classes for which human exposure thresholds that 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) By Commission Decision 1999/217/EC certain flavouring substances received first priority in the evaluation 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 the evaluation 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
1. Substances that are contained in the register and have already been classified
- by the SCF in Category 1 (substances considered safe in use)(5), or
- by the CEFS in Category A (substances which may be used in foodstuffs)(6), 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(7),
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.
2. Substances that are contained in the register and will be 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
1. The person responsible for placing on the market a 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.
4. The Commission may request additional information considered to be relevant for the evaluation of a particular substance from the person responsible for placing it on the 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 additional 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.
7. Information which has already been provided shall be made available to Member States.
Article 4
1. At least 200 substances per year shall be evaluated provided that the information specified in Article 3(1), or additional information specified in Article 3(4), is supplied within the specified deadlines.
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 evaluation and inform the Commission if this is not the case,
- prepare data sheets which collate and summarise the information 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 requirement 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
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.
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.
3. By way of derogation from paragraph 2, the Commission or a Member State may request priority for the evaluation of (a) particular substance(s) or (a) group(s) of substances.
Article 6
This Regulation shall enter into force on the seventh day following its publication in the Official Journal of the European Communities.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 July 2000.