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Food Packaging [EU]

Good manufacturing practice 

From 1 August 2008, the manufacture of materials intended to come into contact with food must comply with the regulations on good manufacturing practice harmonised for the whole of the European Union (EU), so that these materials do not represent a danger for the consumer, nor change the composition of food nor the organoleptic characteristics thereof.

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.

“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

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.

Active” and “intelligent” packaging

This Regulation lays down a general framework for materials and articles that are intended to come into contact with food. All materials and articles used to package food must comply with the requirements of the Regulation. In order to take into account scientific progress, the new framework authorises the introduction of “active” and “intelligent” packaging which extends the shelf-life of food or provides information on its freshness (for example, intelligent packaging may change colour if food has gone off).

ACT

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;

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.

Trace ability

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).

Ceramics

Ceramics can transfer toxins (lead and cadmium) to foodstuffs with which they are in contact. Only ceramic objects intended to come into contact with foodstuffs must be accompanied by a written declaration from the manufacturer or seller stating that they do not exceed the maximum limits for the transfer of lead and cadmium.

Council Directive 84/500/EEC of 15 October 1984 on the approximation of the laws of the Member States relating to ceramic articles intended to come into contact with foodstuffs [See amending acts].

Ceramic objects used to contain foodstuffs may transfer lead and cadmium to these foodstuffs. These two metals are toxic and can constitute a risk to human health.

The Directive lays down maximum limits for the cadmium and lead transferred by ceramic objects to the foodstuffs with which they enter into contact.

Declaration of conformity

To be sold, these ceramics must be accompanied by a written declaration provided by the manufacturer or importer, guaranteeing that they do not exceed the maximum limits for lead and cadmium. The information required is described in Annex II (introduced by Directive 2005/31/EC).

The declaration was introduced to meet the requirements of Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food (Directive 84/500/EEC is a measure specific to the groups of materials and objects listed in Regulation (EC) No 1935/2004).

The maximum limits for lead and cadmium must be checked by means of a test and a method of analysis (Annex III, introduced by Directive 2005/31/EC).

These methods take into account the very latest scientific progress in methods of analysis for official tests of lead and cadmium in foodstuffs, in accordance with Directive 2001/22/EC (see the Associated Acts heading below).

Materials and articles containing vinyl chloride monomer

This Directive limits the presence and migration of vinyl chloride monomer in and from materials and articles intended to come into contact with foodstuffs.

Vinyl chloride monomer

Materials and articles which are intended to come into contact with foodstuffs may not transfer certain constituents to these materials and articles in quantities liable to endanger human health.

In order to guarantee that these foodstuffs contain no trace of vinyl chloride monomer detectable by a method by a general Community method of analysis, materials and articles intended to come into contact with foodstuffs must comply with this Directive. Thus materials and articles:

  • must not contain vinyl chloride monomer in quantities above one milligram per kilogram in the final product; and
  • must not transfer vinyl chloride monomer to foodstuffs in quantities above 0.01 mg/kg in the final product.

 

Commission Directive 80/766/EEC of 8 July 1980 laying down the Community method of analysis for the official control of the vinyl chloride monomer level in materials and articles which are intended to come into contact with foodstuffs [Official Journal L 213 of 16.8.1980].
This Directive lays down the Community method of analysis for the determination of the vinyl chloride monomer level in materials and articles which are intended to come into contact with foodstuffs. This method meets the criteria laid down in the annex to Directive 78/142/EEC.

Commission Directive 81/432/EEC of 29 April 1981 laying down the Community method of analysis for the official control of vinyl chloride released by materials and articles into foodstuffs [Official Journal L 167 of 24.6.1981].
This Directive lays down the Community method of analysis for determining the quantity of vinyl chloride released by materials and articles into foodstuffs.

Materials and articles in regenerated cellulose film

Materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs are regulated at European level by a specific Directive. This Directive lays down a definitive list of authorised substances as well as quantities not to be exceeded in order to protect consumers’ health.

Commission Directive 2007/42/EC of 29 June 2007 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs.

This Directive is a specific directive provided for by Regulation (EC) No 1935/2004 of 27 October 2004 on the approximation of Member States’ legislation concerning materials and articles intended to come into contact with food.

Scope

It applies to regenerated cellulose film which constitutes a finished product in itself, or forms part of a finished product containing other materials and which are intended to come into contact or are placed in contact with foodstuffs.

It does not apply to synthetic casings of regenerated cellulose.

Description

Regenerated cellulose film is defined as a thin sheet obtained from a refined cellulose derived from unrecycled wood or cotton. To meet technical requirements, suitable substances may be added either in the mass or on the surface. Regenerated cellulose film may be coated on one or both sides.

The regenerated cellulose films covered by this Directive belong to one of the following categories:

  • uncoated regenerated cellulose film;
  • coated regenerated cellulose film with coating derived from cellulose; or
  • coated regenerated cellulose film with coating consisting of plastics.

Authorised substances and restrictions

The Directive lays down a positive list of substances authorised in the manufacture of regenerated cellulose film with restrictions of use (see Annex II).

Regenerated cellulose films which are uncoated or coated with plastics may be manufactured with substances other than those specified in Annex II if they are employed as colouring matter or as adhesives, provided that there is no trace of migration of the substances into or onto foodstuffs.

Regenerated cellulose films which are coated with plastics shall comply with the provisions laid down by Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs.

Printed surfaces of regenerated cellulose film shall not come into contact with the foodstuffs.

Marketing and labelling

At the marketing stages other than the retail stages, materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs shall be accompanied by a written declaration in accordance with Regulation (EC) No 1935/2004. However, materials and articles which, by their nature, are clearly intended to come into contact with foodstuffs are not subject to this obligation.

Where special conditions of use are indicated, the material or article made of regenerated cellulose film shall be labelled accordingly.

Context

This Directive codifies and repeals Commission Directive 93/10/EEC of 15 March 1993 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs and its amendments.

Recycled plastic materials and articles

Recycled plastic materials and articles intended to come into contact with foods are regulated at European level by a specific Regulation. This Regulation establishes particular provisions which supplement the existing legislation on food packaging.

Commission Regulation (EC) No 282/2008 of 27 March 2008 on recycled plastic materials and articles intended to come into contact with foods and amending Regulation (EC) No 2023/2006.

This Regulation lays down specific measures for recycled plastic materials and articles, supplementing Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food.

Scope

This Regulation covers recycled plastic materials and articles which may come partially or totally into contact with food.

This Regulation does not apply to recycled plastic materials and articles:

  • made with monomers and substances derived from chemical depolymerization of plastic materials and articles;
  • made from unused production offcuts or process scraps;
  • in which the recycled plastic is used behind a plastic functional barrier *.

The materials and articles covered by this Regulation are subject to Directive 2002/72/EC on plastic materials intended for food packaging.

Requirements for recycled plastic materials and articles

The recycled plastic used for the manufacture of materials and articles covered by this Regulation must be obtained from an authorised recycling process. The said process is to be managed using a quality assurance system which complies with the rules laid down in the Annex of Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food.

Conditions for the authorisation of recycling processes

Authorisation may be granted if recycling processes comply with the following conditions:

  • the quality of plastic input must be characterised and controlled;
  • the plastic input must originate from plastic materials and articles that have been manufactured in accordance with Community legislation on plastic food contact materials and articles;
  • the recycling process must be able to guarantee that there can be no contamination or that it is reduced to a concentration that does not pose a risk to human health;
  • the conditions of use of recycled plastic must guarantee that the final materials and articles do not release into food components in a quantity likely to endanger human health or to bring about an unacceptable change in the composition of the food, or to bring about a deterioration in the organoleptic characteristics thereof.

Applications for authorisation of recycling processes

Applications for authorisation for a recycling process are to be made to the competent authority of a Member State accompanied by a technical dossier containing the information described in the guidelines for the safety assessment of a recycling process prepared by the European Food Safety Authority.

The Member State sends the application to the Authority which is responsible for assessing whether the said process meets the above conditions. Following a transitory phase, the Authority will have a period of six months from receipt of the application to give its opinion.

The Commission shall take into account the opinion of the Authority and adopt a Decision that it will send to the applicant. In this Decision, it will grant or refuse authorisation of the recycling process.

Community register

The Commission shall maintain a register of authorised recycling processes. The register shall be made available to the public.

Official control

Recycling plants and converters shall be subject to official controls. These controls aim at verifying that the recycling processes correspond to the processes for which authorisation was granted and that the quality assurance system is in place.

The authorisation holder shall notify the competent authority in the Member State about the recycling or manufacturing site in which the authorised recycling process is being applied. Member States shall send this information to the Commission who will keep updated a register of recycling sites in the Community and third countries.

Labelling of recycled plastic materials and articles

Voluntary self-declaration of the recycled content in recycled plastic materials and articles shall follow the rules laid down in ISO 14021:1999 or equivalent.

Declaration of compliance and record keeping

In addition to the conditions laid down by Directive 2002/72/EC, the declaration of compliance of recycled plastic materials and articles shall certify that the recycled plastic used comes from an authorised recycling process and shall bear the EC register number corresponding to the recycling process.

In addition to the conditions laid down by Directive 2002/72/EC, the declaration of compliance for recycled plastic materials shall certify that:

  • the recycling process has been authorised. A precise indication of the EC register number for the process;
  • the plastic input, the recycling process and the recycled plastic meet the specifications for which the authorisation has been granted;
  • a quality assurance system is in place.

Restriction of epoxy derivatives in food packaging

Some epoxy derivatives (plastics) in contact with food are toxic. European legislation has prohibited two substances (BFGD * and NOGE *) in materials and articles intended to come into contact with food. The use of BADGE and its derivatives has been authorised but with maximum limits.

Commission Regulation (EC) No 1895/2005 of 18 November 2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food.

Authorisation of BADGE

Following the opinion issued by the European Food Safety Authority (EFSA), the European Commission permits the use of the substance known as BADGE * in materials and articles * used in packaging or other articles intended to come into contact with food, including active and intelligent packaging.

The specific migration limit for this substance is:

  • 9 mg/kg in food or food simulants;
  • 9 mg/6dm2 for containers with a capacity of less than 500 ml or more than 10 litres, but also for sheet and film.

(See also “Provisional arrangements” below.)

In addition, materials and articles containing BADGE must be accompanied by a written declaration stating that they comply with the rules. This compulsory declaration will be required as of 1 January 2007.

Prohibition of BFDGE * and NOGE

Two other substances used in manufacturing packaging or other items in contact with food have been prohibited: BFDGE and NOGE.

NOGE and BFDGE had been prohibited since 31 December 2004, in accordance with Directive 2002/16/EC, now repealed. The current Regulation maintains this ban, applicable as of 1 January 2005. However, the Regulation permits the exhaustion of existing stocks of these products (see “Provisional arrangements” below).

Exceptions for large containers

Large containers (capacity greater than 10 000 litres) may continue to use BADGE, NOGE and BFDGE in their special surface coatings without having to comply with limits for migration (or transfer of significant levels of these substances to the products in contact). The level of migration for this type of container is negligible, according to the Regulation.

Provisional arrangements

BADGE, NOGE and BFDGE placed on the market before 1 March 2003 may continue to be marketed, provided the date of filling appears on them.

Background

Materials and articles containing BADGE, BFDGE and NOGE may transfer significant levels of these substances to foodstuffs (migration), particularly when used as additives, which may pose a risk to human health.

The use and/or presence of BADGE had been prohibited as of 31 December 2005 by Directive 2002/16/EC, but Regulation (EC) No 1895/2005, which repeals it, once again permits the use of this group of substances. After analysing the toxicological data transmitted for this group of substances, the European Food Safety Authority (EFSA) concluded that they do not raise concerns about carcinogenicity and genotoxicity in vivo.

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