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Summaries of EU Legislation

Plastic materials and articles

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Plastic materials and articles

Plastic materials and articles coming into contact with foodstuffs may transfer toxic substances which present a risk to human health. All such substances are controlled at Community level by means of maximum limits on their migration to food, and are subject to very specific conditions of use, in the general interest of food safety.

ACT

Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs [See amending acts].

SUMMARY

Scope

The Directive applies to plastic materials and articles intended to come into contact with foodstuffs. Such materials and articles, and parts thereof, may be composed either of plastic material only or of several layers of plastic material or of different types of materials.

It excludes:

  • varnished or unvarnished regenerated cellulose film;
  • elastomers and natural and synthetic rubber;
  • paper and paperboard, whether modified or not by the addition of plastics;
  • surface coatings obtained from waxes;
  • ion-exchange resins;
  • silicones;
  • materials and articles composed of two or more layers, of which at least one does not consist of plastics.

Approved substances

Approved substances are:

  • Monomers and other starting substances which may be used in the manufacture of plastic materials and articles (Annex II);
  • Additives which may be used in the manufacture of plastic materials and articles (Annex III). At the moment a new additive can always be included in the list after evaluation and authorisation by the European Food Safety Authority (EFSA).

These lists set out the specific conditions of use of the substances in question and the maximum limits of specific migration * to foodstuffs (expressed in mg/kg). These limits are expressed in mg/dm2 of the packaging surface area in the case of:

  • containers with a capacity of less than 500 millilitres or more than 10 litres;
  • sheet, film or similar materials.

The total amount of substances transferred from plastic articles to foodstuffs must not exceed 60 mg/kg, or 10 mg/dm2 of the surface area of the material or article in the case of:

  • containers or similar objects with a capacity of less than 500 millilitres or more than 10 litres;
  • containers for which it is impracticable to estimate the surface area in contact with foodstuffs.

Background

Directive 2002/72/EC is part of the legislative framework covered by Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food. Following adoption of the present Directive, Directive 90/128/EEC (as amended) has been repealed.

Key terms used in the act

  • Overall migration limit. This limit is a measure of the inertness of the material which prevents an unacceptable change in the composition of the foodstuffs.
  • Specific migration limit (SML). Specific migration limits are set for substances in respect of which the toxicological data make it necessary.

References

Act

Entry into force

Deadline for transposition in the Member States

Official Journal

Directive 2002/72/EC

4.9.2002

-

OJ L 220 of 15.8.2002

Amending act(s)

Entry into force

Deadline for transposition in the Member States

Official Journal

Directive 2004/19/EC

31.3.2004

1.9.2005

OJ L 71 of 10.3.2004

Directive 2005/79/EC

8.12.2005

19.11.2006

OJ L 302 of 19.11.2005

Directive 2007/19/EC

20.4.2007

1.4.2008

OJ L 91 of 31.3.2007

Directive 2008/39/EC

27.3.2008

7.3.2009

OJ L 63 of 7.3.2008

The successive amendments and corrigenda to Directive 2002/72/EC have been incorporated into the basic text.

AMENDMENT OF ANNEXES

Annex I – Further provisions applicable when checking compliance with the migration limits Directive 2005/79/EC [Official Journal L 302 of 19.11.2005];

Directive 2007/19/EC [Official Journal L 91 of 31.3.2007];

Directive 2008/39/EC [Official Journal L 63 of 7.3.2008].

Annex II – List of monomers and other starting substances which may be used in the manufacture of plastic materials and articles Directive 2004/19/EC [Official Journal L 71 of 10.3.2004];

Directive 2005/79/EC [Official Journal L 302 of 19.11.2005];

Directive 2007/19/EC [Official Journal L 91 of 31.3.2007];

Directive 2008/39/EC [Official Journal L 63 of 7.3.2008];

Regulation (EC) No 975/2009 [Official Journal JO L 274 of 20.10.2009].

Annex III – Incomplete list of additives which may be used in the manufacture of plastic materials and articles Directive 2004/1/EC [Official Journal L 7 of 13.1.2004];

Directive 2004/19/EC [Official Journal L 71 of 10.3.2004];

Directive 2005/79/EC [Official Journal L 302 of 19.11.2005];

Directive 2007/19/EC [Official Journal L 91 of 31.3.2007];

Directive 2008/39/EC [Official Journal L 63 of 7.3.2008];

Regulation (EC) No 975/2009 [Official Journal JO L 274 of 20.10.2009].

Annex IV – Products obtained by means of bacterial fermentation Directive 2004/19/EC [Official Journal L 71 of 10.3.2004].

Annex IVa – Lipophilic substances to which the FRF applies Directive 2007/19/EC [Official Journal L 91 of 31.3.2007];

Directive 2008/39/EC [Official Journal L 63 of 7.3.2008];

Regulation (EC) No 975/2009 [Official Journal JO L 274 of 20.10.2009].

Annex V – Specifications Directive 2004/19/EC [Official Journal L 71 of 10.3.2004];

Directive 2007/19/EC [Official Journal L 91 of 31.3.20];

Regulation (EC) No 975/2009 [Official Journal JO L 274 of 20.10.2009].

Annex VI – Notes related to the column “restrictions and/or specifications" Directive 2004/19/EC [Official Journal L 71 of 10.3.2004];

Directive 2005/79/EC [Official Journal L 302 of 19.11.2005];

Directive 2007/19/EC [Official Journal L 91 of 31.3.2007];

Regulation (EC) No 975/2009 [Official Journal JO L 274 of 20.10.2009].

Annex VIa – Declaration of conformity Directive 2007/19/EC [Official Journal L 91 of 31.3.2007].

RELATED ACTS

Council Directive 85/572/EEC of 19 December 1985 laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs [Official Journal L 372 of 31.12.1985];

Council Directive 82/711/EEC of 18 October 1982 laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs [Official Journal L 297 of 23.10.1982; corrigendum L 332 of 27.11.1982].

Last updated: 19.11.2009

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