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Document 52006SC1042

Commission staff working document - Annex to the proposal for a Regulation of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods amending Council Regulation (EEC) No 1576/89, Council Regulation (EEC) No 1601/91, Regulation (EC) No 2232/96 and Directive 2000/13/EC - Impact assessment {COM(2006) 427 final } {SEC(2006)1043}

/* SEC/2006/1042 */

52006SC1042

Commission staff working document - Annex to the proposal for a Regulation of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods amending Council Regulation (EEC) No 1576/89, Council Regulation (EEC) No 1601/91, Regulation (EC) No 2232/96 and Directive 2000/13/EC - Impact assessment {COM(2006) 427 final } {SEC(2006)1043} /* SEC/2006/1042 */


[pic] | COMMISSION OF THE EUROPEAN COMMUNITIES |

Brussels, 28.7.2006

SEC(2006) 1042

COMMISSION STAFF WORKING DOCUMENT

Annex to the proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on flavourings and certain food ingredients with flavouring properties for use in and on foods amending Council Regulation (EEC) No 1576/89, Council Regulation (EEC) No 1601/91, Regulation (EC) No 2232/96 and Directive 2000/13/EC IMPACT ASSESSMENT {COM(2006) 427 final }{SEC(2006)1043}

1. INTRODUCTION

Most of the Flavourings are naturally present in foodstuffs or are formed during the normal preparation of food. Flavourings are used in or on foodstuffs to impart odour and/or taste. They can be added as individual chemically defined substances or as complex mixtures of substances.

Since ancient times flavouring components have been extracted from their natural sources for use as balsams, in pharmaceuticals, perfumery and for flavouring food. Isolation of single flavouring substances from natural sources as well as their synthetic production started in the middle of the 19th century. Since then the number of isolated, identified and synthesised substances has grown rapidly.

At the same time a flavour & fragrance industry developed. The EU countries have acquired a leadership position in the market.

Figure 1 : Overview of the estimated market share for the flavour industry.

The market of flavouring substances is dominated by multinational companies; 65 % of the market belongs to 10 companies.

The total value of the market was estimated in the year 2000 at about 10 billion euro. In Europe, 10,000 – 13,000 persons are employed in the sector.

The flavourings industry is a very dynamic part of the food industry. It closely follows and contributes to fulfil consumer demands for healthier, more natural and more convenient foods.

Research and development of new technologies, new flavourings and new applications in foods are therefore essential. About 10 % of the turnover of the major flavour producers is used for this purpose.

The major efforts go to the development of new flavouring substances and of systems for targeted release of flavourings (various encapsulation technologies).

The innovations can only be accepted if the human health and the interests of the consumers continue to be ensured. A legal framework has therefore been developed: Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foods and to source materials for their production.

2. PROBLEM IDENTIFICATION

Council Directive 88/388/EEC establishes the general principles applicable to flavourings for use in foods:

- it provides definitions for flavourings, flavouring substances, flavouring preparations, process flavourings and smoke flavourings;

- it restricts the addition and the presence of certain toxicologically relevant substances in flavourings and/or foods to which flavourings and food ingredients with flavouring properties have been added;

- it provides rules for the labelling of flavourings which are intended for sale as such to food manufacturers;

- it provides rules for the labelling of flavourings which are intended for sale as such to final consumers.

- it requests the adoption of more specific provisions on flavouring sources, flavouring substances, process flavourings, smoke flavourings, production methods as well as on additives, solvents and processing aids used for flavourings, methods of analysis and sampling as well as purity and microbiological criteria.

As a consequence of the last indent, the following legislation has been adopted or proposed:

1. A procedure for the establishment of a positive list of flavouring substances for use in and on foods has been adopted as European Parliament and Council Regulation (EC) No 2232/96[1].

2. Regulation (EC) N° 2065/2003 of the European Parliament and Council Regulation of 10 November on smoke flavourings used or intended for use in or on foods[2].

3. Directive 2003/114/EC of the European Parliament and of the Council of 22 December 2003 amending Directive 95/2/EC on food additives other than colours and sweeteners.[3].

The White Paper of food safety (COM/99/0719 final), specifies the following in relation to flavourings (chapter 5. 77):

“Specific action concerning flavourings has so far concentrated on chemically defined substances. More work is needed to reflect innovation in this field and new insight in toxicological effects of substances naturally present in flavourings.”

In discussions following up the White Paper it was concluded that Council Directive 88/388/EEC needs to be substantially amended on order to:

- clarify its scope;

- allow for future technological developments;

- better inform the consumer about the use of flavourings.

Additional modifications are needed to:

- take into account scientific advice on substances of toxicological concern;

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

- to formalise the role of the European Food Safety Authority (EFSA) for the risk assessment of flavourings.

2.1. The scope of Directive 88/388/EEC

Article 1 of Directive 88/388/EEC restricts its scope to flavourings. However, through Article 4 (c), maximum levels for certain undesirable substances are established in foods which contain flavourings and food ingredients with flavouring properties.

Due to this lack of consistency, Member States apply these maximum levels differently: some apply them to foods which contain only flavourings; others apply them to foods that contain both flavourings and food ingredients with flavouring properties.

2.2. Technological developments

Flavourings are defined as flavouring substances, flavouring preparations, process flavourings and smoke flavourings. At the moment, new technologies are being developed to produce flavourings which do not fall under these definitions.

Examples are flavourings, which are obtained by heating oil or fat for a very short period to a temperature of 800°C, resulting in “grill” flavourings.

Industry should be able to develop and market new categories of flavourings, whilst the safety of the consumer can be guaranteed.

2.3. Information to the consumer

2.3.1. Rules for labelling

Different labelling rules exist for

- flavourings sold as such to food manufacturers,

- flavourings sold as such to final consumers and

- flavourings present in compound foods intended for final consumers.

Labelling of flavourings sold as such to food manufacturers and tot the final consumer is covered by Directive 88/388/EEC.

Labelling of flavourings sold as such to final consumers should and labelling of flavourings added to food should be covered by Directive 2000/13/EC on labelling.

2.3.2. Use of the term natural identical

Directive 88/388/EEC defines three categories of flavouring substances:

- obtained by appropriate physical processes from material of vegetable animal origin (natural);

- chemically synthesized but (natural identical);

- chemically synthesised but not chemically identical to a substances naturally present in material of vegetable origin (artificial).

In order to make the distinction between natural identical and artificial flavouring substances, reference lists are needed. These lists need to be regularly updated for example when a chemically synthesized substance has been identified in a natural product. At the moment there is no official EU list of artificial substance. A reference list is maintained by the International Organisation of the Flavour Industry (IOFI).

Data on the natural occurrence of flavouring substances in foodstuffs was provided for those substances that were registered in accordance with Regulation 2232/96/EC. This information was not introduced in the register adopted by Commission Decision 1999/217 EC and last amended by Commission Decision 2005/389/EC, but is for all the substances still available in the FLAVIS database. About 450 of the 2628 registered substances are classified as artificial.

The term “natural identical” is considered confusing by the consumer. The use of the word natural should therefore be restricted to flavourings which are exclusively obtained from natural sources.

For toxicologists there is no reason to expect a difference in toxicity between natural, natural identical and artificial flavouring substances. They all need to be evaluated according the same procedure independent of the way they are produced.

Council Regulation (EEC) N° 1576/89 on spirit drinks and Council Regulation (EEC) N° 1601/91 on aromatized wines, wine-based products and wine-product cocktails, do not allow the use of artificial flavouring substances in certain products.

In addition vertical provisions exist in some Member States:

( In France only natural and natural identical flavouring substances are allowed in the following foodstuffs: Yoghurts and Fermented milk (Décret n°88-1203), Cheese (new Décret in preparation), Flavoured milk (Décret du 25/03/1924), (Margarines Décret n°88-1205), Vinegar (Décret n°88-1207), Mustard (Décret n°2000-658), Cider (Décret n°87-599 and Décret n°86-208)

( In Belgium only natural and natural identical flavouring substances are allowed in Yoghurts and Fermented milk. There are no specific provisions for other foodstuffs.

( In Germany there are guidelines which do not allow the use of artificial flavouring substances in nearly all foodstuffs. Exceptions are: certain backery wares, some deserts and certain lemonades. In addition, artificial substances that are allowed must be evaluated as an additive. At the moment 15 such flavourings have been allowed.

2.3.3. Reference to the natural flavouring source

The use of the term natural may be used only if component is exclusively obtained from natural flavouring substances or flavouring preparations. There is no obligation to inform the consumers about the source of the natural flavouring. This can be confusing for example if lemonade would be made with natural flavourings obtained from lemon grass or natural vanilla obtained from wood lignin and not from vanilla pods.

It is therefore important for the consumers that they are correctly informed about the source of the natural flavouring added to their foods. This is not foreseen in Directive 88/388/EEC.

The obligation to mention the source of the natural flavouring was considered positive in the consumer magazines Test-Achats (Belgium), Altro Consumo (Italy), Proteste (Portugal) and Compra Maestra (Spain), (issues of July 2004).

2.3.4. Use of smoke flavourings

The original purpose of smoking was to preserve food. Smoking is now primarily used to achieve the characteristic taste and appearance and to a minor degree to obtain preservation. Smoky taste can however also be added to food by using smoke flavourings. Consumers should therefore be informed if the smoky taste of food is due to the addition of smoke flavourings.

2.4. Scientific advice

2.4.1. Substances of toxicological concern

The annex to Directive 88/388/EEC lists substances of toxicological concern with maximum levels allowed in food. These substances occur naturally in flavourings sources or in plants traditionally used as food ingredient with flavouring properties, e.g. common herbs, spices or vegetables such as rosemary, basil, cinnamon, fennel and others.

Scientific opinions on the substances of toxicological concern have been adopted, by the Scientific Committee on Food (SCF) and/or by the European Food Safety Authority (EFSA). Since 1999, 22 individual substances have been evaluated.

The Annex should be adapted to take into account these recent scientific opinions.

2.4.2. Process flavourings

Process flavourings are a category of flavourings that are obtained by heating a mixture of ingredients, of which one contains nitrogen and another is a reducing sugar.

The Committee of Experts on Flavouring Substances of the Council of Europe has proposed conditions for production of such flavourings and maximum levels for certain undesirable substances they may contain.

In order to ensure the safety of process flavourings, these conditions for production and maximum levels the undesirable substances should be introduced into the legislation.

2.5. Control capacity of the Member States

The Annex II of Directive 88/388/EEC lays down limits for the substances of toxicological concern for food and beverages in general with exception for certain specific food categories in which higher amounts are allowed.

These provisions are however to general to assure efficient control and do not allow for risk based controls as requested by Regulation (EC) No 882/2004.

2.6. Collaboration with EFSA

The adoption of Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority (EFSA) and laying down procedures in matters of food safety[4], makes it necessary to formalise the role of EFSA for the risk assessment of flavourings, and to lay down provisions for the collaboration between EFSA, Member States and the Commission.

3. POLICY OBJECTIVES

The policy objectives to be met are:

- the protection of human health and consumers’ interests;

- to create a clear framework that allows for innovation and enables new technological developments.

To this end specific objectives will be:

- to allow for more efficient risk based controls;

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

- to take into account scientific advice on the safety of substances;

- to clarify the scope of the Directive;

- to lay specific provisions for use and authorisation of flavourings;

- to provide provisions for collaboration with EFSA.

As a consequence these objectives will contribute to the strategic objectives of the Commission as set out in the Lisbon Strategy, the Commission five year plan and the Commissions White paper of Food Safety published in 2000.

This new proposal will help the European industry to maintain and solidify its leading position in the area of flavourings.

4. CONSULTATION WITH MEMBER STATES AND STAKEHOLDERS

The opinion of Member States and stakeholders has been assessed through consultations at different working groups (see below) and during bilateral contacts were working documents were discussed.

In addition a questionnaires were circulated to question the different stakeholders.

4.1. Clarification of the scope

Impact of the clarification of the scope to flavourings, food ingredients with flavouring properties and the foods containing flavourings and food ingredients with flavouring properties:

Member States | + |

Consumer Organisations | ++ |

Manufacturer of flavourings | + |

User of flavourings | + |

Trade association | + |

There is general agreement that the discrepancies between Member states will be avoided.

4.2. Definitions of flavourings

4.2.1. Restriction of the use of the term natural

How is the impact of the new definition for flavouring substances which no longer makes a distinction between natural identical and artificial flavouring substances considered:

Member States | Favourable/Unfavourable |

Consumer Organisations | Favourable/Unfavourable |

Manufacturer of flavourings | Favourable/Unfavourable |

User of flavourings | Neutral/Unfavourable |

Trade association | Neutral/Unfavourable |

There is no unanimity between Member States, between consumer organisations and within the flavouring industry. The users as well as the trade organisations are rather unfavourable to this proposal.

The arguments in favour are: it avoids confusion (for consumers it is difficult to understand the difference between natural and natural identical), it reserves the term natural to products that really are natural; there is no toxicological basis to maintain this difference and maintaining this difference is an extra administrative burden. The correct implementation of the use of the term “natural identical” can lead to difficult discussions on purity and the correct identification of the substances (existence of isomers and enantiomeres will have to be considered). The deletion of this term will simplify legislation.

The arguments not in favour relate especially to the fact that vertical legislation which does not allow artificial flavouring in certain food categories will need to be amended. Some consumer organisations are of the opinion that natural identical flavouring substances would be safer than substances which have not been found in nature.

4.2.2. Introduction of the category “Other flavourings”

Will the new category “Other flavourings” have an impact on development of new flavourings?

Member States | Favourable/Neutral |

Consumer Organisations | Favourable/Neutral |

Manufacturer of flavourings | Favourable/Neutral |

User of flavourings | Neutral |

Trade association | Favourable/Neutral |

Companies that are developing new flavourings are in favour of such a category as it gives them the opportunity to develop new flavourings that are not covered by the other definitions.

Consumer organisations are in favour because it creates more transparency and it assures safety protection.

4.3. New provisions for labelling

4.3.1. Labelling costs

Costs related to changes of the labelling requirements.

Member States | Limited |

Consumer Organisations | NA |

Manufacturer of flavourings | Limited |

User of flavourings | Limited |

Trade association | Limited |

The possible impact of the new provisions is considered limited. It is furthermore suggested that the introduction of a transitional period can limit possible costs.

4.3.2. Consumer information

Will the changes of the labelling requirements improve consumer information?

Member States | ++ |

Consumer Organisations | ++ |

Manufacturer of flavourings | +/- |

User of flavourings | +/- |

Trade association | - |

Members States as well as the Consumer organisation are of the opinion that the proposal will lead to better information for the consumer about the nature of the flavourings used.

The food industry and especially the trade association are less enthusiastic or are even against the new provisions for labelling.

4.4. Maximum levels for substances of toxicological concern

Would the changes in annex II, in which maximum levels for substances of toxicological concern are proposed only for food categories which contribute the most to their intake, result in a more effective and targeted control?

Member States | + |

Consumer Organisations | ++ |

Manufacturer of flavourings | ++ |

User of flavourings | ++ |

Trade association | ++ |

There is agreement that the deletion of the maximum levels in food and beverages in general will result in a more targeted control.

4.5. Monitoring of intake

Would the monitoring of the intake of the substances listed in annex II, have additional budgetary consequences for the Public Authorities? This question is only applicable to the Member States.

Most of the Member states replied that this monitoring will have substantial additional budgetary consequences.

5. POLICY OPTIONS

The following policy options have been considered by the Commission:

5.1. No action

No action would mean that Directive 88/388/EEC remains in place. The Directive was published in June 1988 and was completed with provisions for labelling of flavouring intended for sale to the final consumer in January 1991.

No further amendments to this directive have since been introduced. The provisions in the Directive are 14 to 17 years old.

5.2. Non legislative action

Guidelines for the safe use of flavourings could be elaborated in combination with self controlling actions by the food industry. Such guidelines do not exist yet.

5.3. Deregulation of flavouring legislation

Specific flavouring legislation could be revoked as the Regulation (EC) 178/2002 lays down that food shall not be placed on the market unless it is unsafe.

5.4. Amending Council Directive 88/388/EEC

The following amendments are needed:

- Definitions;

- scope of the Directive;

- maximum levels for substances of toxicological concern and use of flavouring sources of toxicological concern;

- provisions for labelling;

- provisions for applications evaluation and authorisation;

- provisions for monitoring of intake.

5.5. Proposal for a new Regulation.

Since a substantial amount of amendments to Council Directive 88/388/EEC is needed to take into account different problems it is in the interest of clarity and efficiency that a new Regulation of the European Parliament and Council could be proposed to replace Directive 88/388/EEC.

The Regulation would:

- Clarify the scope;

- create opportunity for continuing technological developments;

- bring labelling more in line with consumer expectations;

- allow for risk based controls;

- lay down procedures for application, evaluation by EFSA and authorisation of the Community;

- take into account scientific opinions.

6. IMPACT ASSESSMENT

The impacts expected on the different option concern Economic and Social aspects. Environmental impacts are not expected from the different options considered.

6.1. No action

6.1.1. Economic impact

The economic situation will become negative:

( New technological developments are not encouraged because there are now specific provisions for the authorisation of flavourings. It is unclear wether the safety of a newly developed flavourings will need to be evaluated are not.

( Lack of Clear provisions that take into account the latest scientific and technological developments could lead to in trade barriers with third countries.

6.1.2. Social impact

The health of the consumers is not well protected because:

( Maximum levels of substances of toxicological concern do not take into account the latest scientific opinions.

( Maximum levels of substances of toxicological concern in food and beverages in general do not allow for a risk based control.

The consumers request for more informative labelling is not fulfilled.

6.2. Non legislative action

6.2.1. Economic impact

At the moment we are in a situation where there is legislation on flavourings. Guidelines can not overrule existing legislation. This could lead to contradictory and confusing situation for the industry with as a consequence negative economic impact.

6.2.2. Social impact

Guidelines could be in contradiction with existing legislation and are therefore not the most efficient way to protect the health of the consumer.

An unclear legal situation will result in loss of consumer confidence in the use of flavourings.

6.3. Deregulation of flavouring legislation

6.3.1. Economic impact

This could lead to the situation that each Member State makes its own rules. Since the risks perception could be different between the Member States this would result in ineffective functioning of the internal market.

6.3.2. Social impact

Differences in approach between Member States for safety assessment will lead to a confusing situation for the consumers, with different levels of protection and a loss of confidence in certain Member States and in the internal market.

6.4. Amending Council Directive 88/388/EEC

6.4.1. Economic impact

The introduction of the necessary amendments in the actual Directive would have a beneficial economic impact as explained in 6.5.

Changes to the annexes and II and other provisions for the protection of public health would still need to be introduced via co-decision. A more efficient authorisation procedure is however needed for the management of a positive list containing about 2600 flavouring substances to be used in and on food.

The amount of changes necessary could lead to unclear legislation.

6.4.2. Social impact

Positive impacts on public health are expected due to a comprehensive system for safety evaluation of flavourings, to the adaptation of maximum levels of substances of toxicological concern to the latest scientific opinion and by allowing controls of those substances to foods of highest risk.

6.5. Proposal for a new Regulation

6.5.1. Economic impact

6.5.1.1. Impact on administrative requirements imposed on business

The elimination of the distinction between Natural Identical and Artificial flavouring substances, both chemically synthesized, will result in less administrative requirements by harmonising the provisions in all Member States. In order to use a chemically synthesized flavouring substance in certain food categories, producers will no longer have to assure that the substances is identical to a substance found in nature.

Additional efforts will be needed to comply with the changes proposed for the labelling of flavourings. These will however be temporarily, until the labels have been brought in line with the new requirements. Moreover, the efforts are limited compared to the additional transparency acquired and judged positive by the consumer.

In order to limit efforts and costs involved, a transitional period for adaptation to new labelling requirements will be proposed.

6.5.1.2. Impact on innovation and research

The specific provisions for use and authorisation of flavourings clarify when the safety of flavouring needs to be evaluated. Certain flavourings are by definition exempt of evaluation. This will allow industry to more correctly estimate the development costs of new flavourings.

The proposal also specifies what kind of preparations can be accepted in order to allow labelling as natural. This is important for the further development and production of new natural flavourings. Natural flavourings can more easily be developed.

The introduction of the category “other flavouring” is considered positive for innovation and research. If new categories of flavourings are developed, they can be authorised as long as their safety has been evaluated.

6.5.1.3. Impact on households

The consumer will be better informed about the nature of the flavourings present in the food he buys.

It is not expected that the proposed Regulation will affect the prices of foodstuffs.

6.5.1.4. Impact on third countries and international relations

This proposal will further harmonise the legislation on flavourings and will create a uniform market within the EU and predictability to importers.

The new provisions in the proposal are furthermore expected not to have an impact on third countries and international relations.

The harmonisation of the legislation on flavourings will place the European Union in a better position when negotiating with third countries about the introduction of flavourings in the Codex Alimentarius system.

6.5.1.5. Impact on public Authorities

The controls by the Member States will be more efficient as they will focus on foodstuffs who contribute the most to the intake of substances of toxicological concern listed in Annex II and no longer to foodstuffs and beverages in general.

National legislation will have to be adapted in those countries where certain food categories exist to which only natural or natural identical flavouring substances may be added. This simplification will however lead to less administrative requirements because the distinction between natural identical and artificial flavouring substances is no longer maintained. Their will be no need to elaborate and update lists with chemically synthesized substances of which identical substances have been found in nature.

Member States are concerned that for the monitoring of intake of the substances listed in annex II and substances for which restrictions of use are laid down, extra resources will be needed. This is however essential to assure that the regulation will be effective in protecting the health of the consumers.

Members States did not provide us with information about resources needed. The impact for the specific monitoring of intake of flavourings can significantly be reduced by organising this monitoring together with the monitoring of intake of additives that is already requested by EU legislation. It is therefore foreseen that the Commission may adopt a common methodology.

6.5.2. Social Impact

Positive impacts on public health are expected due to a comprehensive system of safety evaluation of flavourings at Community level.

Control of the limits for substances of toxicological concern will focus on foods of highest risk resulting in a more efficient protection of the health of the consumers.

The conclusions of the monitoring of intake can be used to adapt legislation when it would appear that the intake is of safety concern.

7. CONCLUSION

There is a need to substantially amend the Council Directive 88/388/EEC. The scope of the Directive must be clarified; scientific opinions and technological developments must be taken into account; consumers need better information about the use of flavourings in the foodstuffs; Members States must used their control capacities more efficient; provisions for collaboration with the European Food Safety Authority must be established.

In the interest of clarity and efficiency the best option is to replace the current Directive by a new Regulation of the European Parliament and the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods and by a separate regulation which sets up common procedures for food additives, food enzymes and food flavourings.

The present proposal has been elaborated following consultation with Member States and stakeholders. It seeks a more efficient legislation that insures effective functioning of the internal market wile providing a basis for a high level of protection of the consumers’ health and interests. Safety can assessed be appropriately and if needed measures can easily be proposed

The proposal offers a framework for industry in which it can continue to develop new flavourings and new applications in order to respond to the increasing consumer demands. This framework will allow the European industry to maintain and solidify its leadin position in the Global market.

A point of discussion in the proposal concerns the deletion of the distinction between natural identical and artificial flavouring substances. The consultation shows that within each group of stakeholders (Member States, flavour manufacturers, food industry and consumer organisations) there is a wide divergence of views. In some Member States, there is legislation which does not allow the use of artificial flavouring substances in certain food categories. These Member States raise this point as a problem. However, this legislation can be adapted.

The Commission proposes this deletion because both categories are produced by chemical synthesis and are subject to the same safety evaluation. In addition, consumers find the term “Natural Identical” confusing. Furthermore, the use of this distinction leads to an extra burden for Member States, who will have to assure the correct implementation and for the Commission to hold two separate lists that will need regularly updating.

Some hesitations exist within the food industry in relation to some additional administrative requirements to comply with to the changes proposed in the labelling of the flavourings. These will however be limited in time, until the new provisions will be implemented. A transitional period for adaptation to new labelling is proposed in order to limit efforts and costs involved.

The proposal will allow Member States to save resources by organising more risk based controls, wile at the same time offering more safety to the consumer.

Extra resources will be needed by the Member States for the monitoring of the intake of the same substances. This monitoring is however essential in order to assure that the Regulation offers sufficient protection of the consumer or on the contrary does not lead to overregulation there where problems do not exist.

8. OVERVIEW CONSULTATION

CONSULTATION WITH THE STAKEHOLDERS ON FLAVOURINGS

Stakeholder organisations involved :

BEUC (The European Consumers’ Organisation)

CAOBISCO (Association of the Chocolate, Biscuit and Confectionery Industries of the EU)

CEPS (Comité Vins, Confédération Européenne des Producteurs de Spiritueux)

CIAA (Confederation of the food and drink industries of the EU)

EACGI (European Association of the Chewing Gum Industry)

EDA (European Dairy Association)

EFFA (European Flavour and Fragrance Association)

EHGA (European Herb Grower Association)

EHIA (European Herbal Infusion Association)

ESA (European Spice Association)

FIC Europe (European Condiment Association)

SFMA (Smoke Flavourings Manufacturers Association)

In Flavouring Working Group Meetings Member States experts and the abovementioned stakeholder organisations had the opportunity to present their position on amendments to Council Directive 88/388/EEC:

- 07 October 1997

- 02 June 1998

- 05 July 1999

- 15 October 1999

- 26 January 2000

- 28 June 2000

- 28 November 2000

- 20 March 2001

- 03 July 2001

- 19 March 2002

Following these discussions, in the interest of clarity and efficiency and because of the substantial amount of amendments needed, a working document was proposed to replace Directive 88/388/EEC by a new Regulation of the European Parliament and Council.

This document was discussed at following Flavouring Working Group meetings with Member State experts and stake holders:

- 29 November 2002

- 09 December 2002

- 27 January 2003

- 12 July 2004

- 01 March 2005

[1] OJ L 299, 23.11.1996, p. 1

[2] OJ L 309, 26.11.2003, p. 1

[3] OJ L 024 , 29.1.2004, p. 58

[4] OJ L 31, 1.2.2002, p. 1

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