Tag Archives: Materials in contact with food

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

Good manufacturing practice for materials and articles intended to come into contact with food

Good manufacturing practice for materials and articles intended to come into contact with food

Outline of the Community (European Union) legislation about Good manufacturing practice for materials and articles intended to come into contact with food

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

Good manufacturing practice for materials and articles intended to come into contact with food

Document or Iniciative

Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food.

Summary

This Regulation establishes “good manufacturing practice *” for materials and articles intended to come into contact with food.

“Good practice” harmonises manufacturing procedures in the European Union for the aforementioned materials at all stages of production, from manufacture to distribution.

Manufacturers must establish a quality assurance system and a quality control system (see below) following the detailed manufacturing regulations, for example the processes involving printing inks.

Materials in contact with food include objects such as containers and packaging, but also all materials in contact with foodstuffs, such as paper and cardboard or those which could possibly transfer their constituents to food, for example inks and adhesives.

Annex 1 to Regulation (EC) No 1935/2004 includes a list of the materials covered by this Regulation: active and intelligent objects, adhesives, ceramics, cork, rubbers, glass, ion-exchange resins, metals and alloys, paper and cardboard, plastics, printing inks, regenerated cellulose, silicones, textiles, varnishes and coatings, waxes and wood.

Quality assurance system and quality control system

This Regulation includes an obligation for manufacturers to implement a quality assurance system (taking account of the personnel required to put the system in place and the size of the business), as well as a quality control system. The latter provides for measures to be taken should a business fail to comply with good manufacturing practice.

In addition, manufacturers shall create and maintain documentation regarding the specifications, manufacturing formulae and product processing which are important for the compliance and safety of the finished article, as well as those related to the various manufacturing operations. They are required to make the documentation available to the competent authorities at their request.

Key terms of the Act
  • ‘good manufacturing practice (GMP)’ means those aspects of quality assurance which ensure that materials and articles are consistently produced and controlled to ensure conformity with the rules applicable to them and with the quality standards appropriate to their intended use by not endangering human health or causing an unacceptable change in the composition of the food or causing a deterioration in the organoleptic characteristics thereof.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 2023/2006

18.1.2007

OJ L 384 of 29.12.2006

AMENDMENTS TO THE ANNEXES

Annex – Detailed rules on good manufacturing practice
Regulation (EC) No 282/2008 [Official Journal L 86 of 28.3.2008].