# C_2004117EN.01000101.xml

| 30.4.2004 | EN | Official Journal of the European Union | C 117/1 |
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30.4.2004

EN

Official Journal of the European Union

C 117/1

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408TH PLENARY SESSION, 28 AND 29 APRIL 2004

408TH PLENARY SESSION, 28 AND 29 APRIL 2004

Opinion of the European Economic and Social Committee on the ‘proposal for a Regulation of the European Parliament and of the Council on materials and articles intended to come into contact with food’

(COM(2003) 689 final – 2003/0272 COD)

(2004/C 117/01)

On 28 November 2003, the Council decided to consult the European Economic and Social Committee, under Articles 53 and 54 of the Treaty establishing the European Community, on the ‘Proposal for a Regulation of the European Parliament and of the Council on materials and articles intended to come into contact with food’ (COM(2003) 689 final – 2003/0272 COD).

The Section for Agriculture, Rural Development and the Environment, which was responsible for preparing the Committee's work on this subject, adopted its opinion on 5 April 2004. The rapporteur was Ms Sharma.

At its 408th plenary session of 28 and 29 April 2004 (meeting of 28 April 2004), the European Economic and Social Committee adopted the following opinion by 84 votes to 2.

1.   Introduction

| 1.1 | Directive 89/109/EEC provided the basis for the assurance of a high level of protection of human health and of consumers' interests in relation to materials and articles intended to come into contact with food whilst ensuring the effective functioning of the internal market. |
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1.1

Directive 89/109/EEC provided the basis for the assurance of a high level of protection of human health and of consumers' interests in relation to materials and articles intended to come into contact with food whilst ensuring the effective functioning of the internal market.

| 1.2 | Technological progress have produced materials to maintain or improve the condition of the food and prolong its shelf life – ‘active’ materials. Other new packaging applications known as ‘intelligent’ food contact materials and articles are used to give information about the condition of the food. |
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1.2

Technological progress have produced materials to maintain or improve the condition of the food and prolong its shelf life – ‘active’ materials. Other new packaging applications known as ‘intelligent’ food contact materials and articles are used to give information about the condition of the food.

| 1.3 | It is currently unclear under Directive 89/109/EEC, if ‘active’ or ‘intelligent’ types of packaging are covered by national or Community legislation. The new proposal clarifies that these two types of food contact materials and articles are covered by the Regulation and sets basic rules for their use. It also foresees the possibility of drafting specific implementing measures for them. |
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1.3

It is currently unclear under Directive 89/109/EEC, if ‘active’ or ‘intelligent’ types of packaging are covered by national or Community legislation. The new proposal clarifies that these two types of food contact materials and articles are covered by the Regulation and sets basic rules for their use. It also foresees the possibility of drafting specific implementing measures for them.

| 1.4 | The evaluation of substances is currently carried out by the Scientific Committee on Food (SCF). It is however necessary, for reasons of transparency, to establish more detailed procedures for the safety assessment and authorisation of substances used for the manufacture of food contact materials. |
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1.4

The evaluation of substances is currently carried out by the Scientific Committee on Food (SCF). It is however necessary, for reasons of transparency, to establish more detailed procedures for the safety assessment and authorisation of substances used for the manufacture of food contact materials.

| 1.5 | Food contact materials and articles need to be traceable at all stages of manufacture, processing and distribution and general rules of traceability for food contact materials, in line with similar traceability provisions for food and feed established in Article 18 of Regulation (EC) No. 178/2002. |
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1.5

Food contact materials and articles need to be traceable at all stages of manufacture, processing and distribution and general rules of traceability for food contact materials, in line with similar traceability provisions for food and feed established in Article 18 of Regulation (EC) No. 178/2002.

| 1.6 | Some additional provisions of labelling are proposed to better inform the consumers and the users of the food contact materials. |
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1.6

Some additional provisions of labelling are proposed to better inform the consumers and the users of the food contact materials.

2.   Gist of the Commission proposal

| 2.1 | The Commission document proposes to replace the existing framework directive on packaging legislation and additionally consider regulation for the traceability of active and intelligent packaging. |
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2.1

The Commission document proposes to replace the existing framework directive on packaging legislation and additionally consider regulation for the traceability of active and intelligent packaging.

| 2.2 | Active and intelligent packaging can be summarised simplistically in two main forms: Absorbers – packaging which removes excesses ( for example oxygen absorbing materials) or Releasers – packaging which has a slow release mechanism of preservatives or flavourings into the food contents. In all cases, it is important to highlight that the packaging and either the absorbers or release ingredients must comply with both food and labelling EU legislation and therefore be safe for food. As such the Proposal must be in line with Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. |
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2.2

Active and intelligent packaging can be summarised simplistically in two main forms: Absorbers – packaging which removes excesses ( for example oxygen absorbing materials) or Releasers – packaging which has a slow release mechanism of preservatives or flavourings into the food contents. In all cases, it is important to highlight that the packaging and either the absorbers or release ingredients must comply with both food and labelling EU legislation and therefore be safe for food. As such the Proposal must be in line with Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.

| 2.3 | The present proposal aims at modifying Directive 89/109/EEC to take into account the issues mentioned above. It also integrates for reasons of simplicity the symbol which should accompany food contact materials and articles determined in Directive 80/590/EEC. The proposed Regulation will therefore replace and repeal Directives 89/109/EEC and 80/590/EEC. |
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2.3

The present proposal aims at modifying Directive 89/109/EEC to take into account the issues mentioned above. It also integrates for reasons of simplicity the symbol which should accompany food contact materials and articles determined in Directive 80/590/EEC. The proposed Regulation will therefore replace and repeal Directives 89/109/EEC and 80/590/EEC.

| 2.4 | The Council Directive 89/109/EEC on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (Framework Directive) establishes the general principles applicable to all food contact materials including principles of ‘inertness’ of the materials and ‘purity of the food, together with lists of authorised substances used in the manufacture of food contact materials to the exclusion of all others (positive lists) and the groups of materials and articles to be regulated by implementing measures (specific directives), including the evaluation of substances by the Scientific Committee on Food (SCF) and the opinion of the Standing Committee on Foodstuffs. |
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2.4

The Council Directive 89/109/EEC on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (Framework Directive) establishes the general principles applicable to all food contact materials including principles of ‘inertness’ of the materials and ‘purity of the food, together with lists of authorised substances used in the manufacture of food contact materials to the exclusion of all others (positive lists) and the groups of materials and articles to be regulated by implementing measures (specific directives), including the evaluation of substances by the Scientific Committee on Food (SCF) and the opinion of the Standing Committee on Foodstuffs.

| 2.5 | The overall policy objective in terms of expected impacts is:






  — | To secure a high level of protection of human health and the interests of the consumer. |
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2.5

The overall policy objective in terms of expected impacts is:

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To secure a high level of protection of human health and the interests of the consumer.

| — | To ensure the free movement of materials and articles intended to come into contact with food. |
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To ensure the free movement of materials and articles intended to come into contact with food.

| — | To take into account important technological developments in the area of food packaging. |
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To take into account important technological developments in the area of food packaging.

| — | To ensure better traceability as well as labelling of materials and articles intended to come into contact with food. |
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To ensure better traceability as well as labelling of materials and articles intended to come into contact with food.

| — | To improve the transparency of the authorisation process by specifying the various phases of the procedure. |
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To improve the transparency of the authorisation process by specifying the various phases of the procedure.

| — | To give the possibility to the Commission to adopt for the implementing measures not only directives, but also decisions and regulations, as the latter are more appropriate for provisions, such as positive lists. |
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To give the possibility to the Commission to adopt for the implementing measures not only directives, but also decisions and regulations, as the latter are more appropriate for provisions, such as positive lists.

| — | To ensure better enforceability of the rules through the establishment of Community and national Reference Laboratories. |
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To ensure better enforceability of the rules through the establishment of Community and national Reference Laboratories.

3.   General comments

| 3.1 | The provisions on active and intelligent food contact materials and articles are general and establish the regulatory status of these packaging applications in the Community to the benefit of the concerned industry, the consumers and the Member States. |
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3.1

The provisions on active and intelligent food contact materials and articles are general and establish the regulatory status of these packaging applications in the Community to the benefit of the concerned industry, the consumers and the Member States.

| 3.2 | The additional labelling requirements will ensure a more informed use of the food contact materials and articles by the purchaser and the final consumer. |
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3.2

The additional labelling requirements will ensure a more informed use of the food contact materials and articles by the purchaser and the final consumer.

| 3.3 | Improving traceability of food contact materials will be beneficial for the consumer in case of a problem, and will allow a more limited withdrawal of deficient products by the companies. |
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3.3

Improving traceability of food contact materials will be beneficial for the consumer in case of a problem, and will allow a more limited withdrawal of deficient products by the companies.

| 3.4 | The basic approach suggested to reach the above-mentioned objectives is to improve and harmonise Community legislation on materials and articled intended to come into contact with food by introducing the proposed rules. |
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3.4

The basic approach suggested to reach the above-mentioned objectives is to improve and harmonise Community legislation on materials and articled intended to come into contact with food by introducing the proposed rules.

| 3.5 | In terms of respecting the subsidiarity and proportionality principles the Framework Directive 89/109/EEC was adopted on the grounds that differences between national laws of the Member States impended the free movement of these materials and articles. Directive 89/109/EEC approximated those laws to achieve the free movement of food contact materials and articles whilst protecting consumer's health and interests. This Directive also established a list of materials and articles to be covered by specific directives. This approach was successful and should be continued. |
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3.5

In terms of respecting the subsidiarity and proportionality principles the Framework Directive 89/109/EEC was adopted on the grounds that differences between national laws of the Member States impended the free movement of these materials and articles. Directive 89/109/EEC approximated those laws to achieve the free movement of food contact materials and articles whilst protecting consumer's health and interests. This Directive also established a list of materials and articles to be covered by specific directives. This approach was successful and should be continued.

| 3.6 | The adoption of a Regulation instead of a Directive is justified by the technical nature of the act and will lead to the direct application of the proposed rules throughout the Community. This is important in the perspective of an enlarged Community that will soon comprise 25 Member States and that will certainly benefit from homogenous and directly applicable rules throughout its territory. |
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3.6

The adoption of a Regulation instead of a Directive is justified by the technical nature of the act and will lead to the direct application of the proposed rules throughout the Community. This is important in the perspective of an enlarged Community that will soon comprise 25 Member States and that will certainly benefit from homogenous and directly applicable rules throughout its territory.

| 3.7 | Community authorisation for the substances used in the manufacture of food contact materials is already foreseen in Directive 89/109/EEC. Thus, no new obligations arise for business from the provisions on the authorisation procedure. |
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3.7

Community authorisation for the substances used in the manufacture of food contact materials is already foreseen in Directive 89/109/EEC. Thus, no new obligations arise for business from the provisions on the authorisation procedure.

| 3.8 | The Commission's Proposal contains the following general obligations for applicants: |
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3.8

The Commission's Proposal contains the following general obligations for applicants:

| 3.8.1 | To send the application for the authorisation of a substance to the national competent authority of a Member State, in first place. |
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3.8.1

To send the application for the authorisation of a substance to the national competent authority of a Member State, in first place.

| 3.8.2 | To inform the Authority about new information which may influence the evaluation of the safety in the use of an authorised substance. |
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3.8.2

To inform the Authority about new information which may influence the evaluation of the safety in the use of an authorised substance.

| 3.9 | The general obligations for business operators responsible for the manufacture, processing, importation, or distribution of food contact materials, include the following: |
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3.9

The general obligations for business operators responsible for the manufacture, processing, importation, or distribution of food contact materials, include the following:

| 3.9.1 | To label all materials and articles that are intended to come into contact with food, including those for which this use is obvious by their nature and which were so far excluded from this obligation by Directive 89/109/EEC. |
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3.9.1

To label all materials and articles that are intended to come into contact with food, including those for which this use is obvious by their nature and which were so far excluded from this obligation by Directive 89/109/EEC.

| 3.9.2 | To instruct on the permitted uses of active and intelligent materials and articles, in order to enable the users of those materials and articles to comply with relevant legislation applicable to food. |
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3.9.2

To instruct on the permitted uses of active and intelligent materials and articles, in order to enable the users of those materials and articles to comply with relevant legislation applicable to food.

| 3.10 | Business operators are obliged: |
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3.10

Business operators are obliged:

| 3.10.1 | To comply with the conditions of use and restrictions attached to the authorisation of substances for manufacturing food contact materials. |
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3.10.1

To comply with the conditions of use and restrictions attached to the authorisation of substances for manufacturing food contact materials.

| 3.10.2 | To have in place systems to identify the suppliers to their businesses of materials and articles and where appropriate the substances and products used for their manufacture. On request, they should be able to make this information available to the competent authorities. |
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3.10.2

To have in place systems to identify the suppliers to their businesses of materials and articles and where appropriate the substances and products used for their manufacture. On request, they should be able to make this information available to the competent authorities.

| 3.10.3 | To identify to whom their products have been supplied and, upon request, to make this information available to the competent authorities. |
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3.10.3

To identify to whom their products have been supplied and, upon request, to make this information available to the competent authorities.

| 3.10.4 | To adequately label or identify the materials and articles placed on the market in the Community to allow their traceability. |
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3.10.4

To adequately label or identify the materials and articles placed on the market in the Community to allow their traceability.

4.   Specific comments

| 4.1 | The EESC supports the Commission document COM(2003) 689 and praises the Commission for its continued consultation with trade associations and consumer representative organisations in reaching its final document. The Committee also welcomes the introduction of the positive list. |
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4.1

The EESC supports the Commission document COM(2003) 689 and praises the Commission for its continued consultation with trade associations and consumer representative organisations in reaching its final document. The Committee also welcomes the introduction of the positive list.

| 4.2 | The EESC notes that the Commission has identified problematic issues (contained within this document for reference) and is aware that there will not be an extended assessment of the proposal. However, the EESC additionally would request the Commission to consider that the current proposal lacks clarity in the initial paragraphs on three main issues:






  i. | The document proposes to replace the existing framework directive on packaging legislation and additionally consider regulation for the traceability of active and intelligent packaging. The EESC understands that further examination of plastic packaging will also be under review in the near future. |
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4.2

The EESC notes that the Commission has identified problematic issues (contained within this document for reference) and is aware that there will not be an extended assessment of the proposal. However, the EESC additionally would request the Commission to consider that the current proposal lacks clarity in the initial paragraphs on three main issues:

i.

The document proposes to replace the existing framework directive on packaging legislation and additionally consider regulation for the traceability of active and intelligent packaging. The EESC understands that further examination of plastic packaging will also be under review in the near future.

| ii. | A clear definition of active and intelligent packaging and how they work. Although consultations with consumer groups have taken place, clear simple definitions and consumer education leaflets would be valuable to remove ignorance and fear. |
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ii.

A clear definition of active and intelligent packaging and how they work. Although consultations with consumer groups have taken place, clear simple definitions and consumer education leaflets would be valuable to remove ignorance and fear.

| iii. | Clarity that in all cases, the packaging and either the absorbers or release ingredients must comply with EU legislation on food safety and food labelling. All migrating ingredients to and from the packaging must be listed on the ingredients label and be food safe. |
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iii.

Clarity that in all cases, the packaging and either the absorbers or release ingredients must comply with EU legislation on food safety and food labelling. All migrating ingredients to and from the packaging must be listed on the ingredients label and be food safe.

| 4.3 | The implications of additional regulation and procedures for small and medium sized enterprises (SMEs) in the food manufacturing and packaging industries will impose additional auditing procedures on food manufactures and reflective costs for packaging manufactures, many of which are difficult to absorb for smaller companies. |
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4.3

The implications of additional regulation and procedures for small and medium sized enterprises (SMEs) in the food manufacturing and packaging industries will impose additional auditing procedures on food manufactures and reflective costs for packaging manufactures, many of which are difficult to absorb for smaller companies.

| 4.4 | The implications of the new authorisation procedures for materials and designs in an industry not traditionally accustomed to such regulation, in particular time scales, security of design and the restrictive procedures may lead to reduced innovation and competitiveness in the industry. Tight checks on imported products must be made to retain a productive and competitive global industry. |
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4.4

The implications of the new authorisation procedures for materials and designs in an industry not traditionally accustomed to such regulation, in particular time scales, security of design and the restrictive procedures may lead to reduced innovation and competitiveness in the industry. Tight checks on imported products must be made to retain a productive and competitive global industry.

| 4.5 | The EESC understands that it is the Commission's intention to reduce onerous auditing procedures, requiring only a ’Certificate of Conformity‘ or ’Compliance Approval Certificate‘ to be issued ’one–step before and one–step after‘ in the supply chain. However, in the Commission document this is open to misinterpretation with the use of the words ’whereby at least‘. Guidelines to assist the food industry, with reference to the correct checks required, should be laid down by the Commission together with clear information to assist them, enforcement officers, and Member States on the specific provision for traceability to prevent any extension of requirement or due diligence, in reviewing the correct information from packaging manufacturers throughout the supply chain. This should be done in an assistive manner, rather than further regulation imposed on an already heavily regulated industry. |
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4.5

The EESC understands that it is the Commission's intention to reduce onerous auditing procedures, requiring only a ’Certificate of Conformity‘ or ’Compliance Approval Certificate‘ to be issued ’one–step before and one–step after‘ in the supply chain. However, in the Commission document this is open to misinterpretation with the use of the words ’whereby at least‘. Guidelines to assist the food industry, with reference to the correct checks required, should be laid down by the Commission together with clear information to assist them, enforcement officers, and Member States on the specific provision for traceability to prevent any extension of requirement or due diligence, in reviewing the correct information from packaging manufacturers throughout the supply chain. This should be done in an assistive manner, rather than further regulation imposed on an already heavily regulated industry.

| 4.6 | The EESC would request the Commission to consider some additional funding to support both a public and industry campaign. The public awareness campaign is to educate consumers and the users of the food contact materials on the additional provisions of labelling, and how to dispose of the packaging with environmental consideration. An awareness raising campaign for the food industry and consumers should be supported by Member States and Regional Development Agencies The EESC raises concerns in relation to the correct labelling of active and intelligent materials and articles, with provisions to rule out that such systems may mislead the consumers in relation to the quality or condition of the food. In no case may the use of active packaging mask natural spoilage. The EESC would additionally request the Commission to conduct trials on the nutritional value of product contained in active packaging verses unpackaged product, so that the consumer can be can have an informed choice. Currently consumers are unaware whether active package retains or depletes nutritional content. The EESC understands that comprehensive labelling for active and intelligent packaging is currently under consideration and believe that product testing for nutritional risk or benefit should be carried out in conjunction with the new legislation. |
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4.6

The EESC would request the Commission to consider some additional funding to support both a public and industry campaign. The public awareness campaign is to educate consumers and the users of the food contact materials on the additional provisions of labelling, and how to dispose of the packaging with environmental consideration. An awareness raising campaign for the food industry and consumers should be supported by Member States and Regional Development Agencies The EESC raises concerns in relation to the correct labelling of active and intelligent materials and articles, with provisions to rule out that such systems may mislead the consumers in relation to the quality or condition of the food. In no case may the use of active packaging mask natural spoilage. The EESC would additionally request the Commission to conduct trials on the nutritional value of product contained in active packaging verses unpackaged product, so that the consumer can be can have an informed choice. Currently consumers are unaware whether active package retains or depletes nutritional content. The EESC understands that comprehensive labelling for active and intelligent packaging is currently under consideration and believe that product testing for nutritional risk or benefit should be carried out in conjunction with the new legislation.

| 4.7 | Whilst the EESC accepts that the packaging is subject to current food legislation, it highlights that this must be legible, clear and understandable. However, further clarity on labelling is required immediately. It must not be open to misinterpretation or false claims. Whilst not directly related to this Commission document, the EESC would wish to highlight the need for further labelling on plastic packaging to prevent misuse, particularly on heating when in contact with food and fats. This consideration could be made with the additional labelling legislation and the review of plastic packaging and labelling regulations. |
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4.7

Whilst the EESC accepts that the packaging is subject to current food legislation, it highlights that this must be legible, clear and understandable. However, further clarity on labelling is required immediately. It must not be open to misinterpretation or false claims. Whilst not directly related to this Commission document, the EESC would wish to highlight the need for further labelling on plastic packaging to prevent misuse, particularly on heating when in contact with food and fats. This consideration could be made with the additional labelling legislation and the review of plastic packaging and labelling regulations.

| 4.8 | Particular attentions should be paid to imported food products where the ’symbol‘ which should accompany food contact materials and articles should be determined as genuinely being used on authorised products. This responsibility has been designated to the importer, however complete traceability from a non-EU source may be more difficult to determine. This combined with foreign language labelling may lead to inferior products appearing in the EU, harming EU food and packaging manufacturers, and potentially health risks for the consumer. |
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4.8

Particular attentions should be paid to imported food products where the ’symbol‘ which should accompany food contact materials and articles should be determined as genuinely being used on authorised products. This responsibility has been designated to the importer, however complete traceability from a non-EU source may be more difficult to determine. This combined with foreign language labelling may lead to inferior products appearing in the EU, harming EU food and packaging manufacturers, and potentially health risks for the consumer.

| 4.9 | The EESC understands that a long lead time for both the food and packaging industries to allow for the use of packaging currently in stock will be made. This is essential to avoid environmental consequences and industry costs for packaging removal and destruction particularly for items, which cannot be recycled. |
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4.9

The EESC understands that a long lead time for both the food and packaging industries to allow for the use of packaging currently in stock will be made. This is essential to avoid environmental consequences and industry costs for packaging removal and destruction particularly for items, which cannot be recycled.

Brussels, 28 April 2004.

The President

of the European Economic and Social Committee

Roger BRIESCH

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