REPORT on the proposal for a European Parliament and Council regulation on materials and articles intended to come into contact with food
(COM(2003) 689 – C5‑0549/2003 – 2003/0272(COD))

16 March 2004 - ***I

Committee on the Environment, Public Health and Consumer Policy
Rapporteur: Astrid Thors

PROCEDURAL PAGE

By letter of 17 November 2003 the Commission submitted to Parliament, pursuant to Articles 251(2) and 95 of the EC Treaty, the proposal for a European Parliament and Council regulation on materials and articles intended to come into contact with food (COM(2003) 689 – 2003/0272(COD)).

At the sitting of 20 November 2003 the President of Parliament announced that he had referred the proposal to the Committee on the Environment, Public Health and Consumer Policy as the committee responsible and the Committee on Agriculture and Rural Development, to the Committee on Industry, External Trade, Research and Energy and to the Committee on Legal Affairs and the Internal Market for their opinions (C5‑0549/2003).

The Committee on the Environment, Public Health and Consumer Policy appointed Astrid Thors rapporteur at its meeting of 27 November 2003.

The committee considered the Commission proposal and draft report at its meetings of 16 February and 15 March 2004.

At the last meeting it adopted the draft legislative resolution by 29 votes to 5, with 2 abstentions.

The following were present for the vote: Mauro Nobilia (chairman), Alexander de Roo, Guido Sacconi (vice-chairmen), Astrid Thors (rapporteur), Hans Blokland, John Bowis, Hiltrud Breyer, Raquel Cardoso, Chris Davies, Säid El Khadraoui, Karl-Heinz Florenz, Cristina García-Orcoyen Tormo, Martin Kastler, Hedwig Keppelhoff-Wiechert, Christa Klaß, Eija-Riitta Anneli Korhola, Hans Kronberger, Paul A.A.J.G. Lannoye, Peter Liese, Torben Lund, Rosemarie Müller, Riitta Myller, Ria G.H.C. Oomen-Ruijten, Dagmar Roth-Behrendt, Jacqueline Rousseaux, Yvonne Sandberg-Fries, Karin Scheele, Horst Schnellhardt, Inger Schörling, Jonas Sjöstedt, Renate Sommer, Bart Staes, Catherine Stihler, Nicole Thomas-Mauro, Peder Wachtmeister, Phillip Whitehead.

The opinion of the Committee on Industry, External Trade, Research and Energy is attached. The Committee on Agriculture and Rural Development decided on 25 November 2003 not to deliver an opinion. The Committee on Legal Affairs and the Internal Market decided on 8 March 2004 not to deliver an opinion.

The report was tabled on 16 March 2004.

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

on the proposal for a European Parliament and Council regulation on materials and articles intended to come into contact with food

(COM(2003) 689 – C5‑0549/2003 – 2003/0272(COD))

(Codecision procedure: first reading)

The European Parliament,

–   having regard to the Commission proposal to the European Parliament and the Council (COM(2003) 689)[1],

–   having regard to Articles 251(2) and 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C5‑0549/2003),

–   having regard to Rule 67 of its Rules of Procedure,

–   having regard to the report of the Committee on the Environment, Public Health and Consumer Policy and the opinion of the Committee on Industry, External Trade, Research and Energy (A5‑0147/2004),

1.   Approves the Commission proposal as amended;

2.   Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text;

3.   Instructs its President to forward its position to the Council and Commission.

Text proposed by the Commission	Amendments by Parliament
Amendment 1 Recital 7 a (new)
	(7a)   No chemical substance should be authorised under this Regulation unless it is considered authorised for use under the chemicals legislation.
Justification Chemical substances that are not authorised for use under the chemicals legislation should not be eligible for authorisation for use in food packaging.
Amendment 2 Recital 15
(15)   Traceability of materials and articles intended to come into contact with food should be ensured at all stages. Business operators should at least be able to identify the businesses from which and to which the materials and articles have been supplied.	(15)   Traceability of materials and articles intended to come into contact with food should be ensured at all stages. Business operators should at least be able to identify the businesses from which and to which the materials and articles have been supplied. As this could create trade barriers, particularly for producers from developing countries, the Commission should study the impact on such operators and, if trade barriers are created, adopt measures in accordance with Article 24a.
Justification The export of food is for some very poor countries the only way of participating in the global economy. Finding a supplier of packaging material that can guarantee the conformity with EC regulations might not always be possible and could lead to products from these countries disappearing from our markets. This would be counterproductive and against the sense of the Doha Development Agenda. Thus a solution for this problem must be found.
Amendment 3 Recital 18 a (new)
	(18a)   The use of recycled plastics as packaging materials might lead to problems with the declaration of conformity with national legislation in some Member States. This could lead to distortions of the common market. Therefore, the Commission is currently drafting a directive that will regulate this field. The draft directive should be published at the latest one year after the entry into force of this Regulation in order to clarify the legal situation.
Justification The European Parliament welcomes this initiative of the Commission as it supports on the one hand the use of recycled material, among which plastics, and considers on the other hand food safety as very important. To facilitate the situation for producers, the legal situation of recycled materials which come into contact with food should be clarified as soon as possible.
Amendment 4 Article 1, paragraph 2, point (c)
(c)   can reasonably be expected to be brought into contact with foods or to transfer their constituents to food.	(c)   can reasonably be expected to be brought into contact with foods or to transfer their constituents to food, under normally envisaged conditions of use.
Justification The original wording could allow the inclusion, within the regulation, of materials and articles not designed for food use and which might come into contact with food only by accident. The new wording makes it clear that only materials and articles intended for food contact are included.
Amendment 5 Article 4, paragraph 1
1.   Without prejudice to Article 3(a), active materials and articles may bring about changes in the composition or the organoleptic characteristics of the food only if the changes comply with the Community provisions or, in their absence, with the national provisions applicable to food.	1.   Without prejudice to Article 3(a), active materials and articles may bring about changes in the composition or the organoleptic characteristics of the food only if the changes comply with the Community provisions, such as Directive 89/107/EEC and related implementing measures, or, in their absence, with the national provisions applicable to food.
Justification Explicit reference should be made to Directive 89/107/EEC on food additives and related implementing measures.
Amendment 6 Article 4, paragraph 2
2.   Active materials and articles shall not bring about changes in the composition or the organoleptic characteristics of the food which could mislead the consumers.	2.   Active materials and articles shall not bring about changes in the composition or the organoleptic characteristics of the food which could mislead the consumers. Substances which mask the odour of food are not considered as active materials, and thus are not permitted.
Justification An active material after the definition in Article 2 (1) might be a substance which reacts with the products of decomposition in a package in a way that the odours of food going bad are masked but the process of the food going bad is not slowed. This should be prevented. The Commission text is ambiguous as it speaks only of the organoleptic characteristics of the food, whereas it is the atmosphere around the food that smells.
Amendment 7 Article 5, point (j)
(j)   additional provisions for ensuring traceability of materials and articles;	(j)   specific provisions for ensuring traceability of materials and articles;
Justification The use of the term “additional” implies that there may be more demanding requirements than contained in the framework regulation. The specific measures will contain guidelines for ensuring that the requirements of the framework regulation are met. These will differ according to the particular materials or articles and will be, therefore, “specific provisions” not "additional provisions”.
Amendment 8 Article 5, paragraph 1a (new)
	1a.   Measures favouring the use of recycled materials for the manufacturing of food contact materials and articles shall be carefully assessed on a case-by-case basis for their possible impact on food safety and consumer health.
Justification Measures to promote a specific percentage of recycled content for food packaging should take into account food safety.
Amendment 9 Article 9, paragraph 1, subparagraph 2
The Authority may extend the said period. In such a case it shall provide an explanation for the delay to the applicant, the Commission and the Member States.	The Authority may extend the said period by a maximum period of a further six months. In such a case it shall provide an explanation for the delay to the applicant, the Commission and the Member States.
Justification A time limit to any extension should be established to guarantee legal certainty. Article 9 paragraph 2 remains valid and gives the opportunity to ask for more information and subsequently prolong the period.
Amendment 10 Article 10, paragraph 1
1.   The Commission shall prepare, where appropriate, a draft of a specific measure to authorise the substance or substances evaluated by the Authority and specify or change the conditions of their use.	1.   The Community authorisation of a substance or substances shall take place in the form of the adoption of a specific measure. The Commission shall prepare, where appropriate, a draft of a specific measure, as referred to in Article 5, to authorise the substance or substances evaluated by the Authority and specify or change the conditions of their use.
Justification This amendment aims to clarify the authorisation procedure by stating explicitly that the authorisation of a substance takes place through an adoption of a specific measure.
Amendment 11 Article 10, paragraph 2
2.   The draft specific measure shall take into account the opinion of the Authority, relevant provisions of Community law and other legitimate factors relevant to the matter under consideration. Where the draft specific measure is not in accordance with the opinion of the Authority, the Commission shall provide an explanation for the reasons for the differences.	2.   The draft specific measure shall take into account the opinion of the Authority, relevant provisions of Community law and other legitimate factors relevant to the matter under consideration. Where the draft specific measure is not in accordance with the opinion of the Authority, the Commission shall provide an explanation for the reasons for the differences. If the Commission decides not to prepare a draft specific measure after a positive opinion by the Authority, it shall inform the applicant within seven days after the decision has been taken and provide the applicant with an explanation of the reasons for its decision.
Justification Legal certainty requires that all possible outcomes of the authorisation procedure are clearly covered. The applicant has a right to be informed without delay, if the Commission decides not to prepare a draft specific measure even if the opinion by the Authority is positive.
Amendment 12 Article 10, paragraph 3
3.   The specific measure referred to in paragraph 1 shall be adopted in accordance with the procedure referred to in Article 21(2).	3.   Community authorisation in the form of a specific measure, as referred to in paragraph 1, shall be adopted in accordance with the procedure referred to in Article 21(2).
Justification This amendment aims to make the wording more understandable and less bureaucratic.
Amendment 13 Article 11, paragraph 3
3.   On its own initiative or following a request from a Member State or the Commission, the Authority shall deliver an opinion on whether an authorisation is still in accordance with this Regulation, in accordance with the procedure laid down in Article 9, where applicable.	3.   On its own initiative or following a request from a Member State or the Commission, the Authority shall evaluate whether the opinion or the authorisation is still in accordance with this Regulation, in accordance with the procedure laid down in Article 9, where applicable. The applicant shall be given an opportunity to be heard in the re-assessment made by the Authority.
Justification As Member States and the Commission can initiate re-assessment of the authorisation, it is necessary to state that the applicant needs to be consulted, when the others have initiated the procedure. Should there be a European Code on Good Administration, many of these provisions would be unnecessary. Until then the specific legislation must be more detailed.
Amendment 14 Article 12, paragraph 1, point (d)
(d)   adequate labelling or identification to allow traceability of the material or article;	(d)   adequate labelling or identification to allow traceability of the material or article, as referred to in Article 15;
Justification The amendment makes clear that the details of traceability are dealt with in Article 15.
Amendment 15 Article 12, paragraph 1, point (e)
(e)   in the case of active materials and articles, instructions on the permitted use or uses to enable the users of these materials and articles to comply with any other relevant Community provisions or, in their absence, national provisions applicable to food.	(e)   in the case of active materials and articles, instructions on the permitted use or uses to enable the users of these materials and articles to comply with any other relevant Community provisions or, in their absence, national provisions applicable to food. Food packed in active or intelligent materials shall always comply with food legislation, including legislation on labelling.
Justification This amendment is to clarify that food and its labelling must always comply with relevant food legislation, even if it were packed in active or intelligent material.
Amendment 16 Article 12, paragraph 3a (new)
	3a.   The data referred to in paragraph 1 shall not, however, be obligatory for any articles which, because of their characteristics, are clearly designed to come into contact with food.
Justification This amendment seeks to bring the wording of this Regulation into line with that of Directive 89/109/EEC, which has proved its worth. Without this addition, every single item of articles such as domestic ware (e.g. every single glass used in hotel catering activities), which are sold unpackaged, would, in future, have to be marked (for example with the glass and fork icons depicted in Annex I). This rule is all the more sensible since, in future, provision is made for negative marking (e.g. for decorative items such as wall plates which, because of their elaborate decoration, are not appropriate for uses where they might come into contact with food). The argument that an additional symbol on articles imported into or manufactured in the EU would provide protection against illegal trade is unfounded. Anyone planning to trade illegally in products which, for example, do not meet EU heavy-metals thresholds, will not, in future, be deterred from such activities by the presence of a particular icon.
Amendment 17 Article 13, paragraph 1, subparagraph 2
Appropriate documentation shall be available to demonstrate such compliance. That documentation shall be made available to the competent authorities on demand.	Appropriate documentation shall be available to demonstrate such compliance. That documentation shall be made available to the competent authorities and to the public.
Justification In order to garantee full transparency and real availability of the documents, the public should also have an access to them.
Amendment 18 Article 14
Retail trade in materials and articles shall be prohibited if the information required under Article 12(1)(a) and (b) is not given in a language easily understood by purchasers. This provision shall not preclude such information appearing in several languages.	1.   Retail trade in materials and articles shall be prohibited if the information required under Article 12(1)(a), (b) and (e) is not given in a language easily understood by purchasers.
	2.   Within its own territory, the Member State in which the material or article is marketed may, in accordance with the rules of the Treaty, stipulate that those labelling particulars shall be given in one or more languages which it shall determine from among the official languages of the Community.
	3.   Paragraphs 1 and 2 shall not preclude the labelling particulars from being indicated in several languages.
Justification The original wording is ambiguous. The most practical solution is to have the same formulation as in the labelling directive 2000/13/EC.
Amendment 19 Article 15, paragraph 1
1.   The traceability of the materials and articles shall be established at all stages of manufacture, processing and distribution.	1.   The traceability of the materials and articles shall be established at all stages of manufacture, processing and distribution in order to facilitate the recall of any defective products which pose an identified health risk and to attribute responsibility.
Justification It must be made clear that traceability is not enshrined in the Regulation purely as a theoretical exercise. It is there to ensure that all affected materials or articles may be quickly removed from the market in the event of any possible risk to human health. Besides, the attribution of legal responsibility is facilitated by this rule.
Amendment 20 Article 15, paragraph 2
2.   Business operators shall have in place systems and procedures to allow the identification of the businesses from which and to which the materials or articles and, where appropriate, substances or products used in their manufacture have been supplied. That information shall be made available to the competent authorities on demand.	2.   With due regard to technological feasibility, business operators shall have in place systems and procedures to allow the identification of the businesses from which and to which the materials or articles and, where appropriate, substances or products covered by this Regulation used in their manufacture have been supplied. That information shall be made available to the competent authorities on demand.
Justification The systems should not be designed in a disproportionately complicated manner so that small and medium-sized undertakings, too, may be put in a position where they may guarantee the traceability of the materials used. This amendment seeks to ensure traceability throughout the packaging chain from the manufacturer of primary materials, such as glass, plastic film and paper, to packer-fillers and retail premises. Business operators should expect traceability to be in place for supplies of materials and articles already covered by this Regulation, e.g. board and plastic film supplies to a package manufacturer. However, it would not be practicable, or indeed necessary on public health grounds, to extend traceability to raw materials such as silica and trees which are not covered by this Regulation, i.e. which are not, in themselves, food contact materials and articles. Manufacturers of primary materials will be able to refer to guidelines included in the specific measures designed to ensure product recall where defective raw materials have been used. Tracing those raw materials might have relevance for commercial reasons but would not make a positive contribution to public health.
Amendment 21 Article 16, paragraph 1
1.   When a Member State, as a result of new information or a reassessment of existing information made since one of the specific measures referred to in Article 5 was adopted, has detailed grounds for concluding that the use of a material or article endangers human health, although it complies with the relevant specific measures, it may temporarily suspend or restrict application of the provisions in question within its territory.	1.   When a Member State, as a result of new information or a reassessment of existing information has detailed grounds for concluding that the use of a material or article endangers human health, although it complies with the relevant specific measures, it may temporarily suspend or restrict application of the provisions in question within its territory.
Justification The reference to a specific measure is not necessary.
Amendment 22 Article 16, paragraph 4
4.   The Member State referred to in paragraph 1 may retain the suspension or restriction until the amendments referred to in paragraph 3 have been adopted.	4.   The Member State referred to in paragraph 1 may retain the suspension or restriction until the amendments referred to in paragraph 3 have been adopted, or the Commission has declined to adopt such amendments.
Justification Without this addition to the text, there would be nothing to stop a Member State retaining its suspension or restriction on a particular material or article indefinitely, even if the Commission had rejected the human health argument used by the Member State.
Amendment 23 Article 17, paragraph 2
2.   The Authority shall apply the principles of Regulation (EC) No 1049/2001 of the European Parliament and of the Council mutatis mutandis when handling applications for access to documents held by the Authority.	2.   The Authority shall apply Regulation (EC) No 1049/2001 of the European Parliament and of the Council when handling applications for access to documents held by the Authority.
Justification The provisions of Regulation (EC) No 1049/2001 should directly apply to the EFSA.
Amendment 24 Article 18, paragraph 3
3.   The Commission shall determine, after consultation with the applicant, which information should be kept confidential and shall inform the applicant and the Authority of its decision.	3.   The Authority or the Commission shall determine, after consultation with the applicant, which information should be kept confidential and shall inform the applicant of their respective decisions.
Justification The Authority and the Commission should take a decision on the confidentiality of those documents they have received during the authorisation procedure, after consultation with the applicant.
Amendment 25 Article 22, paragraph 1
1.   Member States shall ensure that inspections and other control measures, as appropriate, are carried out to ensure compliance with this Regulation.	1.   Member States shall carry out official controls in order to enforce compliance with this Regulation in accordance with relevant provisions of Community law relating to official food and feed controls.
Justification It should be made explicit that food, feed and materials which come into contact with food and the rules on enforcement are complementary. This amendment seeks to reflect more effectively other relevant measures, in particular Article 17 of Council Regulation (EC) No 178/2002 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.
Amendment 26 Article 24 a (new)
	Article 24a
	Support for developing countries
	The following measures may be adopted for ensuring that developing countries are able to comply with the provisions of this Regulation:
	(a)   a phased introduction of the requirements for labelling and traceability for the products that are exported to the Community;
	(b)   assistance on the establishment of systems to establish traceability, if necessary by Community experts;
	(c)   the promotion of twin projects between a developing country and a Member State;
	(d)   the development of guidelines to assist organisms from developing countries applying for import authorisations for the products exported to the Community;
	(e)   the sending of Community experts to developing countries so as to assist in the setting up of traceability schemes;
Justification The text of this amendment is analogue to the Commission draft of the Regulation on official feed and food controls[2]. In both cases, market access of developing countries might be hindered by the new rules and this must be prevented.

• [1] Not yet published in OJ.
• [2] COM (2003) 52.

EXPLANATORY STATEMENT

Background

The European Commission’s proposal aims at updating the rules on materials which come into contact with food currently set by Directive 89/109/EEC, and it replaces that directive.

The main changes proposed in the regulation are:

-   The possibility to use regulations and not only directives as legal instruments for the implementing provisions (measures on a specific group of materials and articles such as plastics) and

-   The new provisions for the so-called “active and intelligent” packaging.

Changes are also suggested to the provisions concerning the procedure for the authorisation of substances, the traceability of food contact materials, some additional labelling requirements and finally a clarification that the declaration of compliance should be supported by appropriate documentation which should be made available to the competent authorities on demand.

Naturally the proposal now takes into account the role of the European Food Safety Authority, EFSA.

As this Parliament has made huge and successful efforts in the field of food safety, and many principles on good and transparent administration have been established, the intention of your rapporteur is to align the draft legislation with the other pieces; especially the EFSA regulation and the recently adopted rules on smoke flavourings. The intention is also to make it crystal clear that the Regulation on Access to documents; 1049/2001 is applied as such in these matters.

The draft regulation is really a framework regulation that sets out the rules by which packages and materials should be covered, the safety standards to be achieved and the procedure for the authorisation both of materials and methods.

In the view of your rapporteur this approach is correct, as the rules on the content of materials naturally need to be specified both according to the material but also according to the food stuff that is to be wrapped into the package. The often-used example is that of plastics and fish. The risk of migration of substances is much bigger in the field of fat fish in contact with plastics, compared to other materials.

“Active” and “intelligent” packaging

Packaging in general is used to protect food from light, micro-organisms and air. Effective packaging can help maintain the taste and freshness of food and prolong its shelf life.

Intelligent packaging is used to monitor the food and give information on its quality. Intelligent packaging can change colour to let the customer know how fresh the food is and show if the food has been spoiled because of a change in temperature during storage or a leak in the packaging.

Active packaging is developed to interact with the food to improve quality, safety and keep the food fresh for longer time. Active packaging is used for example to remove detrimental gases like oxygen from the food or add flavourings or preservatives to the food.

Fresh foods sometimes produce gas or moisture inside the packaging as they age naturally. This can encourage micro-organisms to grow. For example, oxygen can cause bread and pizza crusts to grow mould. It also causes vegetable oils to go rancid and makes other foods lose their flavour. Some types of active packaging contain oxygen scavengers who absorb the gas the food releases. It cuts down the risk of food poisoning and it also helps the food keep its flavour for longer.

The existing legislation is to some extent not clear on the new packaging methods, because even if an active packaging is safe it is not always clear if it can be marketed, since it does change the condition of the food.

The proposed Regulation aims at clarifying the legal situation for “active” and "intelligent" packaging in Europe and sets some basic requirements for their use. Active components in food packaging will be allowed as long as they comply with other EU legislation on food safety and do not mislead the consumer. Labelling will inform users about the nature of the active packaging. More specific rules on “active and intelligent” packaging will be adopted later, if necessary.

Labelling

Labelling requirements for food contact materials and articles already exist in the present directive. Currently, food contact materials which are obviously intended to come into contact with food (e.g. spoons, plates etc.) do not need to be labelled as such. The proposed Regulation requires all empty materials and articles suitable for food contact to be labelled ‘suitable for food contact” or to carry the special food contact symbol. Additionally, the proposal incorporates the symbol established in Directive 80/590/EEC.

Authorisation of substances

Operators who wish to have a substance approved for use in food contact materials and introduced in a positive list must submit an application to a national authority, which will send it to the European Food Safety Authority (EFSA).

EFSA will consider the application, carry out a safety assessment and express an opinion on the safety of the substance. Taking EFSA's opinion into account the Commission would draft a measure to authorise the substances favourably evaluated by the EFSA and to specify the conditions of use. The procedure is similar to the current one (except from the first step; the application today is submitted directly to the EFSA and the Commission and not to the Member States); but similar to that one adopted in the rules on smoke flavourings.

Your rapporteur is suggesting some amendments to these rules, as she finds that the rules are not taking into account all the different possibilities in the decision making. The applicants must also better know the reasons for the different decisions than suggested by the Commission.

Public access and confidentiality

Two new provisions set the right of public access to information and the terms of confidentiality of data. Your rapporteur stresses that the rules in this Regulation must be in strict accordance with the European Parliament and Council Regulation EC (No) 1049/2001 regarding public access to European Parliament, Council and Commission documents; not only mutatis mutandis as the Commission proposed. Some amendments are also made to stress that the general principle of access for the public to the documents. This provides opportunities for public scrutiny of decisions made, which enhances good administration.

The drafting of the report; access to preparatory documents

During the preparation of this draft report, the Commission has been very transparent. Your rapporteur, shadowrapporteurs, draftsmen for opinion and the Parliament’s administration have had access to the preparatory documents, including the input by stakeholders and submissions during the consultation. This information is very valuable to avoid misunderstandings and to give a level playing field for all legislators. The Commission has indeed been very helpful and this example set now needs to be followed.

Your rapporteur in the discussions with the Commission also raised the question of application on these rules in the new Member States. According to oral information given by the Commission, no derogation has been given to the acceding countries. Therefore, no difficulties should be encountered.

OPINION OF THE COMMITTEE ON INDUSTRY, EXTERNAL TRADE, RESEARCH AND ENERGY

24 February 2004

for the Committee on the Environment, Public Health and Consumer Policy

on the proposal for a European Parliament and Council regulation on materials and articles intended to come into contact with food.

(COM(2003) 689 – C5‑0549/2003 – 2003/0272(COD))

Draftswoman: Dorette Corbey

PROCEDURE

The Committee on Industry, External Trade, Research and Energy appointed Dorette Corbey draftswoman at its meeting of 2 December 2003.

It considered the draft opinion at its meetings of 27 January and 24 February 2004.

At the last meeting it adopted the following amendments unanimously.

The following were present for the vote: Luis Berenguer Fuster (chairman), Peter Michael Mombaur (vice-chairman), Dorette Corbey (draftswoman), Gordon J. Adam (for Gary Titley), María del Pilar Ayuso González (for Jaime Valdivielso de Cué), Ward Beysen (for Marco Cappato), Guido Bodrato, David Robert Bowe (for Norbert Glante), Giles Bryan Chichester, Nicholas Clegg, Concepció Ferrer, Francesco Fiori (for Umberto Scapagnini), Jacqueline Foster (for Sir Robert Atkins), Cristina García-Orcoyen Tormo (for Angelika Niebler), Neena Gill (for Myrsini Zorba), Michel Hansenne, Hedwig Keppelhoff-Wiechert (for Werner Langen pursuant to Rule 153(2)), Dimitrios Koulourianos (for Konstantinos Alyssandrakis), Helmut Kuhne (for Massimo Carraro), Rolf Linkohr, Caroline Lucas, Erika Mann, Marjo Matikainen-Kallström, Eryl Margaret McNally, Ana Miranda de Lage, Giuseppe Nisticò (for W.G. van Velzen), Reino Paasilinna, Paolo Pastorelli, Samuli Pohjamo (for Willy C.E.H. De Clercq), Godelieve Quisthoudt-Rowohl, Bernhard Rapkay (for Harlem Désir), Imelda Mary Read, Mechtild Rothe, Christian Foldberg Rovsing, Paul Rübig, Herman Schmid (for Marianne Eriksson pursuant to Rule 153(2)), Konrad K. Schwaiger, Esko Olavi Seppänen, Alejo Vidal-Quadras Roca and Olga Zrihen Zaari.

SHORT JUSTIFICATION

With the creation of the Common European Market it became necessary to harmonise regulations governing standards in the food industry to facilitate the selling of products in different EC countries. A first wave of legislation has been drafted around 1980. In a second wave, a framework directive governing materials and articles intended to come into contact with food was adopted in 1989. In the following years, a number of daughter directives have been adopted, e.g. one relating to plastics materials intended to come into contact with food, one on epoxy derivatives, etc. In recent years, the emphasis has been on food safety and consumer protection.

Now, the Commission states that latest developments make it necessary to adapt the legislation in this area to the results of the latest innovations. Active and intelligent food contact materials and articles are such a development. Active materials are designed to interact with food in order to maintain or improve the condition during storing and prolong the life. Substances e.g. prevent oxidation, preserve the food or absorb ethylene. Intelligent materials are designed to provide information about the condition of the food. A possible development would be a substance in the packaging that changes colour if milk goes sour or if the food goes bad, another option would be a colour spot that shows if the storage temperature has been kept all the time.

Other changes in the draft legislation are rules for traceability and a better enforceability through the establishment of Community and national Reference Laboratories.

The Commission states that in the past, Member States have simply taken over the text of the directive and reproduced it verbatim into national law. Thus the Commission proposes now a Regulation instead of a Directive. Given the technical nature of the legislation, the rapporteur supports this proposal.

Some questions - and answers:

-   What will happen to the daughter directives?
They will remain valid. The Commission plans to draft a "super"-directive on plastics though to facilitate the existing legislative jungle.

-   How far will the traceability go?
A producer will have to be able to name the source of all used materials for all products which leave his house. But this refers to the material he purchases, not the first source. Traceability will be important in case of a recall. If the lot that has to be recalled can be narrowed, the economical damage can be minimised and effectiveness can be optimised. Questions have been asked concerning the need to document back until the tree from which paper has been made - this will not be the case. The original producer will have to certify the conformity of material with the EC legislation. However, it seems unnecessary to label each substance according to its origin. A production number that enables the producer to identify the lot and then link this to the origin of all materials is sufficient.

-   Will there be problems for trading partners?
For importers of food products made in third countries, not much will change. They will need to know the origin of the product. But certainly, this will have an impact on producers in third countries, and for producers in LDCs this might have a negative impact. They will have to document the source and aim of all materials and products - something they do not do at this stage. They will have to ask their suppliers to certify the conformity of materials with EC legislation. This could be a new barrier for the access to EU markets - and might be harmful to the weakest trading partners. In any case, the Commission should take all possible measures to assist third countries to comply with EU laws.

-   Are active and intelligent materials sufficiently regulated?
The requirements for these materials are as a start the same as for all materials: they should not endanger human health. Article 4 then sets some extra conditions, namely that changes in the composition of organoleptic characteristics of food must comply with EC or national provisions and shall not mislead the consumer. The same goes for the information the intelligent materials give. It must be prevented that consumers are deceived by such materials - this should be forbidden. Modern technologies should only be used for the benefit of the consumers.

AMENDMENTS

The Committee on Industry, External Trade, Research and Energy calls on the Committee on the Environment, Public Health and Consumer Policy, as the committee responsible, to incorporate the following amendments in its report:

Text proposed by the Commission[1]	Amendments by Parliament
Amendment 1 Recital 15
(15)   Traceability of materials and articles intended to come into contact with food should be ensured at all stages. Business operators should at least be able to identify the businesses from which and to which the materials and articles have been supplied.	(15)   Traceability of materials and articles intended to come into contact with food should be ensured at all stages. Business operators should at least be able to identify the businesses from which and to which the materials and articles have been supplied. As this could create trade barriers, particularly for producers from developing countries, the Commission should study the impact on such operators and, if trade barriers are created, adopt measures in accordance with Article 24a (new).
Justification The export of food is for some very poor countries the only way of participating in the global economy. Finding a supplier of packaging material that can guarantee the conformity with EC regulations might not always be possible and could lead to products from these countries disappearing from our markets. This would be counterproductive and against the sense of the Doha Development Agenda. Thus a solution for this problem must be found.
Amendment 2 Recital 18 a (new)
	(18a)   The use of recycled plastics as packaging materials might lead to problems with the declaration of conformity with national legislation in some Member States. This could lead to distortions of the common market. Therefore, the Commission is currently drafting a directive that will regulate this field. The draft directive shall be published at the latest one year after this regulation enters into force in order to clarify the legal situation.
Justification The European Parliament welcomes this initiative of the Commission as it supports on the one hand the use of recycled material, among which plastics, and considers on the other hand food safety as very important. To facilitate the situation for producers, the legal situation of recycled materials which come into contact with food should be clarified as soon as possible.
Amendment 3 Article 4, paragraph 2
2.   Active materials and articles shall not bring about changes in the composition or the organoleptic characteristics of the food which could mislead the consumers.	2.   Active materials and articles shall not bring about changes in the composition or the organoleptic characteristics of the food which could mislead the consumers. Substances which mask the odour of food are not considered as active materials, and thus are not permitted.
Justification An active material after the definition in Article 2 (1) might be a substance which reacts with the products of decomposition in a package in a way that the odours of food going bad are masked but the process of the food going bad is not slowed. This should be prevented. The Commission text is ambiguous as it speaks only of the organoleptic characteristics of the food, whereas it is the atmosphere around the food that smells.
Amendment 4 Article 9, paragraph 1, subparagraph 2
The Authority may extend the said period. In such a case it shall provide an explanation for the delay to the applicant, the Commission and the Member States.	The Authority may extend the said period for a maximum of a further six months. In such a case it shall provide an explanation for the delay to the applicant, the Commission and the Member States.
Justification A producer or importer needs to have legal certainty that a decision will be taken within a certain time frame. Article 9 paragraph 2 remains valid and gives the opportunity to ask for more information and subsequently prolong the period.
Amendment 5 Article 15, paragraph 1
1.   The traceability of the materials and articles shall be established at all stages of manufacture, processing and distribution.	1.   The traceability of the materials and articles shall be established at all stages of manufacture, processing and distribution in order to facilitate recall of defective product and attribute responsibility.
Justification According to the European Commission, the main reason for the demand for traceability is to facilitate the removal from the market of faulty goods - recall faster and only the lots which are really affected. Besides, the attribution of legal responsibility is facilitated by this rule.
Amendment 6 Article 15, paragraph 3
3.   The materials and articles which are placed on the market in the Community shall be adequately labelled or identified to facilitate their traceability through relevant documentation or information.	3.   The materials and articles which are placed on the market in the Community shall be identifiable by an appropriate system which allows their traceability through relevant documentation or information.
Justification It does not make sense to ask each piece of packaging to be labelled in order to be traceable. Food and drink manufacturers normally use a label which enables them to identify a production lot. For each lot they have information on the source of all ingredients and packaging. This should be sufficient. The original text could mean that e.g. for a lollipop the stick would have to be labelled according to its origin and the plastic foil surrounding the sweet would also have to be labelled to show its origin. The label which explains the food content would then have to be added. This seems to be exaggerated.
Amendment 7 Article 24 a (new)
	Article 24a
	Support for developing countries
	The following measures may be adopted for ensuring that developing countries are able to comply with the provisions of this Regulation:
	(a)   a phased introduction of the requirements for labelling and traceability for the products that are exported to the Community;
	(b)   assistance on the establishment of systems to establish traceability, if necessary by Community experts;
	(c)   the promotion of twin projects between a developing country and a Member State;
	(d)   the development of guidelines to assist organisms from developing countries applying for import authorisations for the products exported to the Community;
	(e)   the sending of Community experts to developing countries so as to assist in the setting up of traceability schemes;
Justification The text of this amendment is analogue to the Commission draft of the Regulation on official feed and food controls[2]. In both cases, market access of developing countries might be hindered by the new rules and this must be prevented.

• [1] Not yet published in OJ.
• [2] COM (2003) 52.