Explanatory Memorandum to COM(2007)671 - Flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1576/89, Council Regulation (EEC) No 1601/91, Regulation (EC) No 2232/96 and Directive 2000/13/EC (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)

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I. PROCEDURE

1. On 28th July 2006, the Commission adopted the proposal for a European Parliament and Council Regulation on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1576/89, Council Regulation (EEC) No 1601/91, Regulation (EC) No 2232/96 and Directive 2000/13/EC [Document (COM (2006)0427 final)] as part of a package of four proposals on food improvement agents. The proposal was submitted to the Council and the European Parliament on 28th July 2006.

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2. The Economic and Social Committee adopted its opinion on 25th April 2007


3. The general approach agreed in the Council at the EPSCO meeting on 31st May 2007 on the other text of the package does not apply to the text on flavourings.

4. The European Parliament has given in first reading a favourable opinion on the proposal on 9 July 2007.

5. The present proposal amends the original proposal [COM (2006)0427 – 2006/0147(COD)] so as to take into account the amendments of the European Parliament that were accepted by the Commission.

6. With regard to the original proposal, the European Parliament adopted 43 amendments. Commissioner Kyprianou had indicated to the plenary meeting on 9 July 2007 that the Commission could accept many of the amendments, wholly or in part, and subject to rewording. From the adopted amendments the following cannot be accepted by the Commission 2, 11, 13, 16, 17, 19, 20, 21, 23, 26, 31 (second part), 32, 37, 40, 43, 44, 46, 49, 52.

7. The amendments in the revised proposal are in bold and underlined . A number of amendments have been reformulated so as to ensure consistency of the terminology used throughout the proposal and the other proposals of the package, or to bring the text in line with the approach of the Council where similar amendments have been proposed.

8. The numbering of the Articles has been adapted to take into account a number of amendments.

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II. OBJECTIVES OF THE PROPOSAL


9. The proposed Regulation aims at replacing current Council Directive 88/388/EEC in order to take into account technological and scientific developments in the area of flavourings and the developments of the food legislation in the European Community.

The main objectives are:

to clarify the scope of legislation on flavourings;

to modernise and adapt the existing legislation on flavourings to technological and scientific developments;

to establish clear evaluation and authorisation procedures;

to better inform the consumer about the use of natural flavourings;

to adapt to the requirements of Regulation (EC) N° 882/2004 on official controls performed to ensure the verification with feed and food law, animal health and animal welfare rules.

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III. OVERVIEW OF THE AMENDMENTS OF THE EUROPEAN PARLIAMENT


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10. Technical/editorial amendments


Amendments 4, 5, 6, 7, 8, 9, 12, 15, 27, 28, 29, 30, 31 (first part), 35, 36, 39, 41, 42, 45 aim to improve the proposal from a technical and editorial point of view and have been taken over by the Commission, in some cases subject to some editorial changes.

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11. Legal basis


Article 37 is deleted as legal basis for the Regulation. The same reasoning as for enzymes applies for which the Parliament voted in favour of this deletion, because the agricultural aspects of the proposal (amendments to vertical agricultural texts) are only secondary objectives of the proposed Regulation.

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12. Comitology


Since the package was adopted around the time that Decision 2006/512/EC amending Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission was adopted, the Commission proposal referred to the normal regulatory procedure. Therefore the alignment of the amended proposal with Decision 2006/512/EC is generally endorsed by the Commission.

The amendments 11, 23 and 32 concern the introduction of the regulatory procedure with scrutiny. The decisions referred to in these amendments will not add new elements to the Regulation, scrutiny is therefore not required.

Amendment 16 removes the possibility to decide (with the assistance of the Standing Committee) to which category a flavouring belongs and is therefore not acceptable, as the Commission is of the opinion that such a decision may be needed.

Amendments 24, 33 and 34 are partially accepted, the urgency procedure should however be allowed in case there is a risk for the safety of the consumer.

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13. Definitions (Article 3)


Amendment 14 defines that food ingredients with flavouring properties contribute significantly to the presence of the substances in Annex III part B. In practice, this may be the case, however, such a concept does not belong to the legal text and is already mentioned in recital 5.

Amendment 13 changes de term ' other flavouring' to 'flavourings not elsewhere specified' . Even though both terms have the same meaning the first is preferred.

Amendment 49 restricts the production of 'flavouring substances' to appropriate ‘natural’ processes or chemical synthesis. There may however be other ways to produce flavouring substances e.g. extraction from smoke condensates or from thermal process flavourings. The amendment is therefore not acceptable.

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14. Prohibition of non-compliant flavourings


This amendment is introduced in order to bring the text in line with the amended proposals on food additives and food enzymes. The proposed text clarifies that a flavouring or a food in which a flavouring is used should not be placed on the market, if the flavouring or its use does not comply with the proposed Regulation. This clarification is introduced in the amended proposal with the inclusion of Article 5.

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15. General conditions of use


The Commission proposal sets general conditions of use of flavourings or food ingredients with flavouring properties. They must be safe and their use must not mislead the consumer. In recital 6 a clarification is introduced explaining what is meant by misleading the consumer (amendment 1 ).

Amendment 19 requires that the use of flavourings must have advantages and benefits for the consumer and amendment 20 requires that there should be a technological need. These amendments are not needed as technological need and benefit for the consumer are implicit in the definition of flavourings

Amendment 2 and 17 require the authorisation of flavourings to be based on the precautionary principle. The precautionary principle and the conditions for its application are already laid down in the General Food Law (Regulation (EC) No 178/2002) and it should not be repeated in the proposed Regulation on flavourings.

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16. Presence of certain substances


Amendment 46 concerns the maximum limits for substances of toxicological concern in Annex III Part B. These maximum limits would not apply to compound foods to which no flavourings have been added and the only food ingredients with flavouring properties added are spices and herbs. This is unacceptable as a safety concern is not excluded.

Amendments 21 and 40 introduce a blank Annex III Part B, and only when there is a justified scientific concern, maximum levels could be included by comitology. This amendment is not in line with recent scientific opinions which confirm the need for maximum limits as proposed in Annex III Part B.

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17. Relation with Regulation 1829/2003 on GM food and feed (Article 12)


Flavourings or source materials which fall within the scope of Regulation (EC) No 1829/2003 will be subject to that Regulation with regard to the safety assessment of the genetic modification, while the other aspects of safety, the consideration of the other criteria and the final authorisation will, where appropriate, be dealt with under the flavourings Regulation. The two evaluations and authorisations can run in parallel.

Amendments 41 and 42 clarify that the two procedures may run simultaneously in accordance with good administrative practice. The proposed clarification is endorsed by the Commission subject to some drafting changes in order to make the provision compatible with Regulation 1829/2003.

Amendments 52 introduces a definition of the term "produced by GMO's" . If such a definition is needed it should be covered by Regulation (EC) No 1829/2003.

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18. Labelling


Amendment 29 concerns the labelling of natural flavourings, were the 90 % rules is replaced by 95 % when referring to a natural source. The proposed change is acceptable as it corresponds better to consumer expectations and will have limited impact on current practices.

Amendment 26 requires that for trade between food business operators, an address in the EU should be provided. This is not accepted as it could lead to barriers to trade with third countries.

A description of smoke flavourings such as 'smoked salmon flavour' (amendment 37 ) is not acceptable as this could be misleading for the consumer; in practice the flavouring could be a mixture of smoke flavouring with salmon flavouring.

Labelling of flavourings obtained from GMO's should be covered by Regulation 1829/2003 and not by this Regulation (amendment 38 ).

Finally the Commission can not accept amendment 43 as it is a basic principle of the proposal to name the source of the natural flavouring to ensure correct consumer information.

In its original proposal the Commission aligned furthermore the labelling provisions of flavourings with those additives and enzymes. The European Parliament made a number of amendments to the latter proposals to ensure a new presentation and simplification of the labelling provisions for additives and enzymes sold from business to business or to the final consumer. The Commission has therefore taken on board the spirit of these amendments also in this amended proposal on flavourings.

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19. Reporting by food business operators


Amendment 31 is partly accepted, as a producer or user of a flavouring substance should inform the Commission immediately of any new scientific or technical information which might affect the assessment of the safety of the flavouring substance. An addition that it concerns information which is known and accessible to him is not acceptable as this restricts the responsibility of the producer

The second part of Amendment 31 , which lays down what information should be requested is not acceptable as it restricts the Commission proposal and pre-empts the contents of the implementation measure.

20. Pursuant to Article 250 i of the EC-Treaty, the Commission amends it proposals in accordance with the lines set out above.