Tag Archives: Food packaging

Active and intelligent materials and articles

Active and intelligent materials and articles

Outline of the Community (European Union) legislation about Active and intelligent materials and articles

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Contamination and environmental factors

Active and intelligent materials and articles

Document or Iniciative

Commission Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food.

Summary

This Regulation establishes specific requirements for the marketing of active * and intelligent * materials and articles intended to come into contact with food. It supplements the general principles defined in Regulation (EC) No 1935/2004 and describes the procedure for the authorisation of substances at Community level.

Scope

This Regulation shall apply to active or intelligent materials and articles which are placed on the Community market.

Requirements for active and intelligent materials and articles

Active and intelligent materials and articles:

  • must be suitable and effective for the intended purpose of use;
  • must not release to food any components * in sufficient quantity as to endanger human health or to bring about an unacceptable change in the composition or organoleptic characteristics of food;
  • must not mislead consumers through their labelling, presentation or advertising material.

These specific requirements are without prejudice to Community or national provisions applicable to materials and articles to which active or intelligent components are added or into which they are incorporated.

Composition

Only substances which are included in the Community list of authorised substances may be used in components of active and intelligent materials and articles.

However, the following substances may be used in components of active and intelligent materials and articles without being included in the Community list:

  • released active substances, added or incorporated by techniques such as grafting or immobilisation which are used in full compliance with the relevant Community and national provisions (for example, legislation on food additives and food enzymes);
  • substances used in the components which are not in direct contact with food or the environment surrounding the food; and if they are not “mutagenic”, “carcinogenic”, or “toxic to reproduction” or substances produced deliberately in a particle size that exhibits chemical and physical properties that significantly differ from those at a larger scale.

Applications for authorisation of substances constituting the components of active and intelligent materials and articles

Applications for authorisation of substances constituting the components of active and intelligent materials and articles are to be made to the competent authorities of a Member State accompanied by a technical dossier containing the information described in the guide to safety assessment prepared by the European Food Safety Authority.

The Member State sends the application to the Authority which is responsible for assessing whether the substance meets the above conditions.

Community list of authorised substances

In order to be included in the Community list, substances constituting the components of active and intelligent materials and articles must meet the requirements that apply to the said products (see above).

The Commission shall adopt the Community list after the Authority has delivered its opinion on all substances for which a valid application for market authorisation has been submitted.

The Community list shall specify:

  • the identity of the substance(s);
  • the function of the substance(s);
  • the reference number;
  • if necessary, the conditions of use of the substance(s) or component.

Labelling

Active and intelligent materials and articles:

  • in contact with food are to be labelled appropriately to allow the consumer to identify the non-edible parts. In this case the words “DO NOT EAT” must be added to the label as well as (if possible) the symbol reproduced in Annex I;
  • labelled so that it is clear that they are active and/or intelligent.

Released active substances are considered as ingredients and are to be labelled pursuant to the general rules for the labelling of foodstuffs.

Application

The provisions relating to the composition of active and intelligent materials and articles apply from the date at which the Community list of substances that may be used in the composition of the said materials and articles enters into force.

The provisions on labelling apply from 19 December 2009.

Key terms of the Act
  • Active materials and articles: materials and articles intended to extend the shelf-life or to maintain or improve the condition of packaged food. They are designed to deliberately incorporate components that would release substances into or onto the packaged food or the environment surrounding the food.
  • Intelligent materials and articles: materials and articles which monitor the condition of packaged food or the environment surrounding the food.
  • A component: an individual substance or a combination of individual substances which cause the active and/or intelligent function of a material or article, including the products of an in situ reaction of those substances; it does not include the passive parts, such as the material they are added to or incorporated into.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 450/2009

19.6.2009

OJ L 135 of 30.5.2009

Plastic materials and articles

Plastic materials and articles

Outline of the Community (European Union) legislation about Plastic materials and articles

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Contamination and environmental factors

Plastic materials and articles

Document or Iniciative

Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food.

Summary

This Regulation establishes specific requirements applicable to the manufacture and marketing of plastic materials and articles intended to come into contact with food. These requirements supplement the general provisions laid down in Regulation (EC) No 1935/2004 on materials and articles used for the packaging of food.

Materials

This Regulation applies to plastic materials and articles intended to come into contact with food. These materials and articles and parts thereof may be composed:

  • exclusively of plastics;
  • of several layers of plastics; or
  • of plastics combined with other materials.

This Regulation does not apply to ion exchange resins, rubber, or silicones.

The provisions on printing inks, adhesives or coatings supplement the requirements laid down in this Regulation.

Placing on the market

Plastic materials and articles intended to come into contact with food must comply with:

  • the requirements for use, labelling and traceability set out in Regulation (EC) No 1935/2004;
  • the good manufacturing practice defined in Regulation (EC) No 2023/2006;
  • the compositional and declaration requirements set out in this Regulation.

Authorised substances

Only the substances included in the list set out in Annex I may be intentionally used in the manufacture of plastic materials and articles. The list includes:

  • monomers;
  • additives (excluding colorants);
  • polymer production aids (excluding solvents); and
  • macromolecules obtained from microbial fermentation.

By way of derogation, substances not included on this list may be authorised under certain conditions.

Requirements on substances

This Regulation lays down the conditions of use for authorised substances (see Annex II) and migration limits (see Annex I). These migration limits correspond to the maximum amount of substances that materials and articles may transfer to food. They are expressed in mg of substance per kg of food (mg/kg).

All plastic materials and articles must comply with specific migration limits and overall migration limits.

The composition of each plastic layer constituting a material or article must comply with this Regulation. However, a layer which is not in direct contact with food may:

  • not comply with the restrictions and specifications of this Regulation (except for vinyl chloride monomer as provided in Annex I);
  • be manufactured with substances not included on the list of authorised substances (these substances must nevertheless not be mutagenic, carcinogenic or toxic to reproduction, or be in nanoform).

Declaration of compliance

The manufacturer shall draw up a written declaration containing the information set out in Annex IV. The information provided shall identify the materials, articles and products from intermediate stages of their manufacturing as well as the substances themselves. This declaration shall be renewed when substantial changes in the composition or production occur.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EU) No 10/2011

4.2.2011

OJ L 12, 15.1.2011

The successive amendments and corrections to Regulation (EC) No 10/2011 have been incorporated into the original text. This consolidated version  is of documentary value only.

Materials and articles which come into contact with foodstuffs

Materials and articles which come into contact with foodstuffs

Outline of the Community (European Union) legislation about Materials and articles which come into contact with foodstuffs

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Contamination and environmental factors

Materials and articles which come into contact with foodstuffs

Document or Iniciative

Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC [See amending acts].

Summary

This Regulation aims at guaranteeing a high level of protection of human health and the interests of consumers with regard to the placing on the Community market of materials and articles intended to come into contact with food either directly or indirectly.

Scope

This Regulation covers all materials and articles that are intended to come into contact with food: all types of packaging, bottles (plastic and glass), cutlery, and even adhesives and inks for printing labels.

The Regulation also introduces specific provisions concerning “active”
* and “intelligent”
*
packaging which extends the shelf-life of food or which reacts when food has gone off (packaging which changes colour, for example).

The Regulation does not cover:

  • materials and articles which are supplied as antiques;
  • covering or coating materials, such as materials which cover cheese rinds, prepared meat products or fruit;
  • fixed water supply equipment.

Requirements for materials and articles

Materials and articles which come into contact with food shall be produced in line with good manufacturing practice. They must under no circumstances transfer substances to the food with which they are in contact in quantities likely to:

  • endanger human health;
  • bring about an unacceptable change in the composition of the food; or
  • bring about a deterioration in the organoleptic characteristics thereof.

If “active” materials and articles change the composition or organoleptic characteristics of food, they must comply with Directive 89/107/EEC on additives and/or any national rules.

The labelling, advertising and presentation of a material or article shall not mislead consumers under any circumstances.

Specific measures for groups of materials and articles

Annex I of this Regulation identifies 17 groups of materials and articles for which specific measures may be adopted:

  • intelligent materials and articles;
  • adhesives;
  • ceramics;
  • cork;
  • rubbers;
  • glass;
  • ion-exchange resins;
  • metals and alloys;
  • paper and cardboard;
  • plastic materials;
  • printing inks;
  • regenerated cellulose;
  • silicones;
  • textiles;
  • varnishing and coatings;
  • waxes;
  • wood.

These specific measures may include:

  • the list of substances authorised for use in the manufacture of materials and articles that are intended to come into contact with food;
  • criteria of purity;
  • specific conditions of use;
  • limits on the migration of certain constituents into or on to food;
  • provisions aimed at protecting human health or ensuring compliance with requirements for materials and articles that are intended to come into contact with food;
  • basic rules for checking compliance with the provisions above;
  • rules concerning the collection of samples;
  • provisions for ensuring traceability;
  • additional provisions of labelling for active and intelligent materials and articles;
  • provisions concerning the establishment of a Community Register of authorised substances, processes, materials or articles;
  • specific procedural rules for the authorisation of a substance, process, material or article.

In the absence of specific measures, Member States may maintain or adopt national provisions.

Authorisation of substances

Applications for authorisation of a new substance for the manufacture of materials or articles intended to come into contact with food shall be made to the competent authority of the Member State where the substance is to be placed on the market. Applications shall then be sent to the European Food Safety Authority which is responsible for evaluating the toxicity of substances in order to avoid any risk to consumers.

Traceability

This Regulation also establishes the requirements to be met regarding the traceability of food contact materials from production to sale.

The labelling or documentation accompanying materials and articles placed on the market in the Community should guarantee the traceability of the said materials and articles. This facilitates control, the recall of defective products, consumer information and the attribution of responsibility.

Labelling

The nature of materials and articles intended to come into contact with food is to be described on their labelling. Materials and articles which are not clearly intended to contain or to package food must bear the words “For food contact” or the symbol given in Annex II (the symbol represents a glass and a fork).

Context

Earlier legislation on materials in contact with foodstuffs protected the health of consumers by ensuring that no material or article in contact with foodstuffs could bring about chemical reactions which would change the composition or organoleptic properties of these foodstuffs (taste, appearance, texture or even smell).

This Regulation repeals this legislation in order to allow the introduction of “active” and “intelligent” packaging. It also repeals Directive 80/590/EEC determining the symbol that may accompany materials and articles intended to come into contact with foodstuffs and incorporates the symbol in Annex II (see the above explanation on labelling).

Key terms of the Act
  • Materials and articles intended to come into contact with food: materials and articles that are intended to extend the shelf-life or to maintain or improve the condition of packaged food. They are designed to deliberately incorporate components that would release or absorb substances into or from the packaged food or the environment surrounding the food.
  • Intelligent materials and articles intended to come into contact with food: materials and articles which monitor the condition of packaged food or the environment surrounding the food.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1935/2004

3.12.2004

OJ L 338 of 13.11.2004


Amending act(s)
Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 596/2009

7.8.2009

OJ L 188 of 18.7.2009