Explanatory Memorandum to COM(2003)689 - Materials and articles intended to come into contact with food - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2003)689 - Materials and articles intended to come into contact with food. |
|---|---|
| source | COM(2003)689  |
| date | 17-11-2003 |
Council Directive 89/109/EEC of 21 December 1988 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:
(a) The principles of 'inertness' of the materials and 'purity of the food', i.e.
- migration of substances from the material or article into the food shall not endanger human health,
- migration shall not bring an unacceptable change in the composition of the food or deteriorate its organoleptic characteristics.
(b) The principle of 'positive labelling', stating that materials and articles intended to come into contact with food must be accompanied by the words for food or by a symbol determined in Directive 80/590/EEC.
Directive 89/109/EEC also lays down:
(c) the principle of lists of authorised substances used in the manufacture of food contact materials to the exclusion of all others (positive lists);
(d) the groups of materials and articles to be regulated by implementing measures (specific directives);
(e) procedures and criteria to be followed in drafting and adopting the specific directives for the different groups of materials and articles, including the evaluation of substances by the Scientific Committee on Food (SCF) and the opinion of the Standing Committee on Foodstuffs.
Contents
- OBJECTIVES OF THE PROPOSAL
- 1. Legal instrument for implementing provisions
- 3. Authorisation procedure
- 4. Labelling
- 5. Traceability (Article 15)
- 6. Safeguard measures
- 7. Reference laboratories (Article 23)
- 8. New materials which may be regulated by specific measures
- IMPACT OF THE PROPOSAL ON THE ACCEDING COUNTRIES
Since the adoption of Council Directive 89/109/EEC a number of new issues have emerged that need to be considered in the existing legislation:
- important technological developments have occurred in the area of food packaging,
- traceability as well as labelling of materials and articles intended to come into contact with food need to be better ensured,
- the transparency of the authorisation process should be improved by specifying the various phases of the procedure,
- the Commission must be given the possibility to adopt for the implementing measures not only directives, but also decisions or regulations, as the latter are more appropriate for provisions such as positive lists,
- better enforceability of the rules must be ensured through the establishment of Community and national Reference Laboratories,
- the symbol which should accompany materials and articles suitable for food contact, and which has been determined in Directive 80/590/EEC, should be for reasons of simplicity included in this proposal. Directive 80/590/EEC should be consequently repealed.
To this end and in the interest of clarity and efficiency, a new Regulation is proposed which will repeal Directive 89/109/EEC. This new Regulation introduces the following main modifications.
A detailed examination of the provisions of the specific implementing directives adopted so far in the sector of food contact materials leads to the following conclusions:
- the specific directives are purely technical provisions, aimed at implementing the general principles laid down in the Framework Directive in accordance with previously established criteria and procedures;
- they require frequent technical amendments to adapt them to the rapid technological progress in the sector (new materials, analytical methods, technological processes, food conservation and processing techniques, etc.);
- they mostly contain simple, repetitive provisions consisting of additions or amendments to the lists of substances authorised for use (positive lists) or laying down the conditions for their use. These annual additions or amendments are always put forward after consulting the SCF.
For these reasons, it is more appropriate to draw up regulations than directives. In fact, so far the Member States have mostly reproduced verbatim the content and format of the Community directives. This situation will occur even more frequently in the near future, when amendments to existing directives or new directives on other groups of materials (paper and board, varnishes, elastomers) are prepared.
It should also be pointed out that the use of regulations as legal instruments for the implementing provisions will ensure uniform and timely application of the rules for the benefit both of the consumers and of the competitiveness of the industry. For implementing procedures, the proposed Regulation changes from the compulsory system of issuing directives to a more flexible one enabling a decision about the legal nature of the act to be adopted - directive, regulation or decision - according to the content. Replacing the term 'directive' by 'measure', as provided in Article 95 of the Treaty, would achieve such flexibility. This approach has also been requested by some Member States.
2. Active and intelligent food contact materials and articles ("active and intelligent materials and articles")
The main purpose of food packaging is to protect the food against physical, biological and chemical risks. Food packaging materials have traditionally been developed to avoid interactions with food and, in particular, to minimise the release of their components ("migration") into the food. Accordingly, current Community legislation asks for maximum inertness of the food contact materials and minimised food contamination. Packaging materials must not cause unacceptable changes in the composition of the food or in its organoleptic characteristics.
Active materials and articles are new concepts in packaging, designed to interact with food in order to maintain or improve the condition of the food during storing and prolong its shelf life. Such applications include oxygen scavengers, flavourings, preservative or antioxidant emitters, ethylene absorbers from fresh food, etc. Another innovative type of packaging called intelligent materials and articles are developed to provide information about the actual condition of the food.
The proposed Regulation provides the legal framework, which introduces the possibility to take into account these new technological solutions to food packaging and sets some basic requirements for their use.
- The proposal defines the active and intelligent materials and articles and specifies that the Regulation should apply to these materials and articles (Article 2).
- Article 2 of Directive 89/109/EEC states that materials and articles should not bring about unacceptable changes to the composition or deteriorate the organoleptic properties of the food. Active materials and articles, however, due to their intended use may change these properties of the food. Therefore, this Article has been modified to clarify that compositional and organoleptic changes brought to the food by active materials and articles are allowed provided these changes comply with any other Community legislation applicable to food (Article 4).
- Labelling requirements are proposed to inform the user of active materials and articles (food packers) about the interaction of these applications with the food in order to comply with any relevant food legislation (Article 12(1)(e)).
- Since active and intelligent materials and articles include sophisticated systems composed of different materials, such as plastic, paper, metal, adhesives etc, more detailed rules might be needed in specific measures. For this reason, these materials and articles are added to the list of materials to be regulated by specific measures (Annex I).
Directive 89/109/EEC lays down the principle of positive lists of authorised substances and the groups of materials and articles to be regulated by specific measures implementing the basic principles. It also sets the procedures and criteria to be followed in drafting and adopting the implementing measures, including the evaluation of substances by the SCF.
The proposed Regulation establishes more detailed procedures for the safety assessment and authorisation of substances to be used in the manufacture of food contact materials.
Where a positive list is drawn up, the procedure proposed in the draft Regulation (Articles 8-11) can be summarised as follows:
- those interested in placing a new substance for a food contact material on the market submit an application to the )national competent authority of a Member State;
- the national competent authority informs the European Food Safety Authority ("Authority") about the receipt of an application and makes available to the Authority the application and any supplementary information provided by the applicant;
- the Authority informs the Commission and the other Member States of the application and makes the application and any supplementary information submitted by the applicant available to them;
- the Authority expresses an opinion within a defined limited time, forwards it to the Commission, the Member States and the applicant, and makes it public after adoption;
- based on the opinion of the Authority, the Commission proposes a draft measure.
Confidentiality for sensitive data is provided if requested by the applicant, which is subject to the decision of the Commission (Article 18).
- Article 6 i of Directive 89/109/EEC states that materials and articles, which by their nature are obviously intended to come into contact with food, do not need to be labelled with the words for food use or the symbol. However, since there are also materials and articles of a shape or nature suggesting that they can be used for food contact, without being manufactured for this purpose, the proposed Regulation replaces Article 6 i of 89/109/EEC with the requirement that all materials or articles suitable for food contact should be labelled by the words 'suitable for food contact' or a symbol. For simplicity, this symbol, specified by Directive 80/590/EEC, should be integrated into the draft Regulation (Annex II) and Directive 80/590/EEC should be repealed.
- A labelling provision for active and intelligent materials and articles has been mentioned above (Article 12(1)(e)).
The provisions on traceability established in Article 18 of 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, do not apply to food contact materials and articles. It is, therefore, necessary to establish general requirements to ensure traceability of all materials and articles in contact or intended to come into contact with food at all stages.
In line with Regulation (EC) No 178/2002, this draft Regulation requires all food contact material businesses to have in place systems to identify at every given stage of production and trade, their supplier(s) and to whom materials and articles are supplied, whereby at least one step 'above' and one 'below' must be identifiable, unless specific provisions require further traceability. Importers are also concerned.
Additional provisions for specific groups of materials and articles may be adopted, if necessary, in specific measures.
Emergency measures for food are established in Articles 53 and 54 of Regulation (EC) No 178/2002. They are applicable also when serious risk to human health derives from migration of substances from food contact materials and articles into food. In addition to these emergency measures foreseen for food by Regulation (EC) No 178/2002, a safeguard clause specific to materials and articles as such is included in Article 16.
In order to ensure enforceability of the rules, it is proposed to establish a Community Reference Laboratory and national reference laboratories, in accordance with Regulation of the European Parliament and of the Council on official feed and food controls i.
Further to active and intelligent materials and articles, three more groups of materials, i.e. ion-exchange resins, adhesives, printing inks, are proposed to be added to the list of groups of materials, which may be regulated by specific measures (Annex I).
The proposed Regulation will have no specific impact on the acceding countries in particular, nor will it affect the enlargement of the Union in general.
The new provisions aim at introducing more clarity and transparency to the currently existing provisions as laid down in Directive 89/109/EEC. The core principles of Directive 89/109/EEC remain unchanged in this proposal. The new provisions are in line with Regulation (EC) No 178/2002 which is part of the acquis accepted by the acceding countries under the Accession Treaty.
Notably in relation to active and intelligent materials and articles the proposal simply establishes the legal frame for regulating these new types of packaging. The description of the authorisation procedure is introduced for reasons of transparency and does not change the current practice. Finally the traceability provisions are aligned with the requirements established by the above mentioned Regulation (EC) No 178/2002.
Practically all acceding countries have already transposed most of the acquis on food contact materials, including Directive 89/109/EEC or are in the process of doing so. They have been fully informed on the principles of the above-mentioned Regulation (EC) No 178/2002 which will be directly applicable upon accession. Further, in the context of the monitoring exercise of the Commission, DG SANCO is currently actively co-operating with these countries to assist them and to ensure their national texts are fully conform with EU law, including the acquis on food contact materials.
In view of the nature of the changes introduced in the proposal and of the maintaining of exactly the same policy as in the past the proposed Regulation should not have cause any specific problems of transposition or implementation in the acceding countries, as compared to the existing acquis.