Food contact suitability is governed by European regulation which harmonizes, in the member states of the European Union, the requirements applicable to materials and articles intended to come into contact with food. A framework regulation sets out the general requirements for all materials and articles (Regulation (EC) No. 1935/2004). Specific measures are defined for each category of materials in the form of specific regulations directly applicable in the member states, or specific directives which must be transposed into national regulatory texts.

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Understanding regulations

Subject to regulations on Food Contact Materials

The following materials and articles:

  • packaging and containers,
  • containers and kitchen utensils,
  • materials, machines and equipment used in the production, storage or transportation of foodstuffs,
  • nipples and pacifiers.

The foodstuffs concerned are food and beverages:

  • in both finished and intermediate product states,
  • intended for human consumption.

Not covered by Food Contact Materials regulations

  • edible coating materials;
  • fixed public or private drinking water distribution installations.

Specific regulations or directives have already been published, defining inertia criteria for some of the 17 categories of materials and articles defined in Annex I of Regulation (EC) No 1935/2004.

European regulations governing the health safety of materials and articles in contact with foodstuffs are the responsibility of the Directorate General for Health and Food Safety (DG SANTE) within the European Commission. This Directorate General's remit also extends to food safety.

The food contact suitability of materials is governed by Regulation EC No. 1935/2004.

What's in Regulation (EC) n°1935/2004

Specific regulations or directives describe inertia criteria for certain materials (plastics, ceramics, regenerated cellulose film and partially for rubbers, monomers for epoxy varnishes, active and intelligent materials) as well as conformity control procedures.

What regulations are applicable by material?

Specific regulations or directives contain inertia criteria that depend on the nature of the materials. For certain materials (e.g. plastics), there are lists of substances authorized in the European Union, which are supplemented by lists of substances authorized at national level. Any substance used to manufacture a material or object intended to come into contact with food must undergo a risk assessment. Authorization of a substance is granted by Directorate General for Health and Food Safety, following favorable opinions issued by scientific bodies such as the European Food Safety Authority (EFSA) and, in the past, the Scientific Committee for Food. These opinions are published on the Internet. Where there is no specific requirement for a material, the principle of inertia set out in the framework regulation (Regulation (EC) No 1935/2004) still applies. It is up to the operator responsible for placing the material on the market to demonstrate compliance with these principles.

 

In the absence of a specific regulation or directive for a category of material or article and in accordance with Article 6 of Regulation (EC) No 1935/2004, existing national provisions apply, which is the case in France for several materials.

What regulations apply by material?

In addition, France has extended the scope of this regulation to materials and articles intended to come into contact with animal feed. Decrees n°2007/766 and n°2008/1469 complete or specify the European Union's regulatory provisions.

Decree n°2007/766 of 10/05/2007

Decree n°2008/1469 of 30/12/2008

Applicable regulations by material

The following requirements defined in Regulation (EC) No 1935/2004 apply to all categories of materials and articles intended to come into contact with foodstuffs:

  • Risk assessment for any new substance used to manufacture materials and articles;
  • Manufacture of materials and articles according to good practices;
  • Obligation to provide written declarations of compliance to purchasers of finished materials and articles;
  • Traceability of finished materials and articles;
  • Labeling of finished materials and articles;

In the absence of harmonized regulations applicable in the EU and subject to compliance with the principle of mutual recognition, wood and articles made of wood are covered by French regulations.

In accordance with the decree of November 15, 1945 (arrêté du 15/11/1945), certain types of wood used in measuring instruments are authorized for contact with all foodstuffs (oak, hornbeam, chestnut, ash, locust) or only solid foodstuffs (walnut, beech, elm, poplar). In 1980, this decree was extended to include containers for storing and preserving beverages and foodstuffs. The finished products concerned are packaging (crates, pallet boxes, boxes, hampers, baskets, candy boxes, skewers, ice-cream sticks), kitchen utensils (bowls, trays, cutting boards, cutlery, dishes, salad bowls) and equipment and worktops for the food industry or catering.

Other wood species traditionally used in France and Europe have been allowed in contact with all foodstuffs since 2012 (fir, spruce, Douglas fir, maritime pine, Scots pine, poplar, beech, plane, aspen, alder, olive, birch). Only wood species in contact with fruit and vegetables can be treated with a temporary antifungal agent.

If finished wood products are varnished, lacquered, painted, glued, printed or coated, the recommendations published by the DGCCRF can be used to check compliance with Article 3 of Regulation (EC) No 1935/2004 (Compliance of composition, overall migration limit, specific migration limits as indicated in DGCCRF Information Note No 2012-93).

Arrêté du 15/11/1945

Rubbers are polymers of natural or synthetic origin that possess a high degree of elastic elongation. They are made up of carbonaceous macromolecules, generally obtained by vulcanization. According to European Union guidelines published on February 21, 2014, thermoplastic elastomers are not considered rubbers and are covered by Regulation (EU) No 10/2011.

In the absence of harmonized regulations in the EU and subject to compliance with the principle of mutual recognition, rubbers and rubber articles intended to come into contact with foodstuffs must comply, since July 1, 2021, with the Decree of August 5, 2020 (arrêté français du 05/08/2020), which provides for compliance with composition criteria (Positive list of substances, residual quantities of substances) and overall and specific migration limits. The Decree  authorizes the use of constituents (monomers, starting substances, modifying agents, etc.) intended for use in the manufacture of rubber materials and articles from other European Union member states, Turkey or other contracting parties of the European Economic Area, provided they have been assessed according to the rules of EFSA or a competent scientific body. This Decree replaces and repeals the Deree of 9 November 1994 and its amendments (Decree of 9/08/2005 and Decree of 19/12/2006) relating to rubber materials and articles in contact with foodstuffs, products and beverages.

The end products concerned are household items (pressure cooker gaskets, jar seals, stopper gaskets, gloves, bottle nipples, pacifiers, ...) or food industry equipment (hoses, conveyor belts, valve elements, gaskets, gloves, ...). Nipples and pacifiers made of rubber elastomers are subject to the requirements of directive No 93/11/EEC, which has been transposed into the Decree of August 5, 2020 (Migration limits for nitrosamines and N-nitrosatable substances in reconstituted saliva).

Arrêté du 5 août 2020

Directive n°93/11/EEC

"Traditional" ceramics are obtained by high-temperature solidification of a plastic wet paste. It is a mixture of inorganic materials, generally with a high clay or silicate content, to which small quantities of organic matter may be added. Ceramic articles are first formed, and the resulting shape is permanently fixed by firing. They can be vitrified, glazed and/or decorated.

Ceramics intended to come into contact with foodstuffs must comply with directive No 84/500/EEC transposed in France in the Decree of November 7, 1985, which stipulates compliance with migration limits for lead and cadmium. Directive No 2005/31/CE transposed in the Decree of 05/23/2006 requires the provision of a written declaration of compliance up to the retail sale stage, excluding delivery to the final consumer. The recommendations published by the DGCCRF on its website also require compliance with migration limits for aluminum, cobalt and arsenic.

Directive n°84/500/EEC

Directive n°2005/31/CE

Arrêté du 7 novembre 1985

Arrêté du 23/05/2006

According to European Union legislation, a plastic is a polymer to which additives or other substances may have been added, and which is capable of serving as the main structural component of final materials and objects. The materials and objects concerned can be:

  • composed exclusively of plastic, which may be printed and/or coated;
  • consisting of several layers of plastic joined together with glue or by any other means, and which may be printed and/or coated;
  • plastic layers of multi-layer multi-material materials and articles;
  • plastic layers or coatings forming seals for capsules and closures.

Plastic materials and plastic articles must comply with Regulation (EU) No. 10/2011, which provides for compliance with composition criteria (List of authorized substances, provisional list of substances, purity criteria, residual substance levels, categories of substances with derogation, categories of substances assessed by operators) and overall and specific migration limits. The end products concerned are rigid or flexible, single-material or complex packaging (films, sheets, containers, cans, trays, caps, closures...), cookware and household appliances (boxes, dishes, cutlery, parts of household appliances, worktops, gloves...) and food industry and catering equipment (Machine parts such as gaskets and hoses, worktops, gloves and protective equipment...).

Lots of melamine or polyamide cookware imported into the European Union from China and Hong Kong must be accompanied by a written declaration of compliance and the results of analyses for migration of primary aromatic amines and formaldehyde in accordance with Regulation (EC) No. 284/2011.

Recycled plastics intended for contact with foodstuffs, must be derived from an authorized process in accordance with regulation (EU) No. 20222/2016.

Regulation (EU) n°10/2011

Regulation (EC) n°282/2008 (repealed in 2022)

Regulation (EU) n°2022/2016

Regulation (EC) n°284/2011

According to Regulation (EC) No. 1935/2004, active materials and articles are intended to extend the shelf life or maintain or improve the condition of packaged foodstuffs. They are deliberately designed with constituents that release or absorb substances into the packaged foodstuffs or the food environment. Intelligent materials and objects control the condition of packaged foodstuffs or the food environment.

According to Article 6 of Regulation (EC) No. 1935/2004, the action of active and intelligent materials and articles must not mislead consumers. Where necessary, appropriate labeling must alert consumers to the non-edible nature of active or intelligent systems. In addition, released active components must be authorized by EU legislation applicable to foodstuffs, following the good practices prescribed by the latter.

In addition to being effective and suitable for their intended uses, active and intelligent substances must be risk-assessed (EFSA Guidelines of 21/07/2009) and authorized in accordance with the provisions laid down in Regulation (EC) No 450/2009. Migration of authorized active components must not be included in overall migration results, and must not render foodstuffs non-compliant with current regulations.

The applications of active and intelligent materials are highly varied:

  • By limiting exudates, blotting pads are active materials that improve the preservation of fresh meat and fresh fish packed in trays;
  • By trapping water, moisture-absorbing bags are active materials that improve the shelf life of dry products by extending the minimum durability date (MDD);
  • By reducing the oxidation of foodstuffs, oxygen-absorbing bags are active materials that slow down the degradation of foodstuffs;
  • By limiting microbial growth, packaging that releases antimicrobial substances are active materials that extend the use-by date (UBD) of foodstuffs;
  • Changing color according to temperatures in the supply chain, freshness chip labels are intelligent materials that inform professionals and consumers of possible breaks in the cold chain;
  • By communicating information via radio waves, RFID (Radio Frequency Identification) chips are intelligent materials that can provide supply chain information and enable traceability of reusable plastic bins in the food industry.

Regulation (EC) n°450/2009

EFSA guidelines of 21/07/2009

Ionizing radiation treatment is a technology used to cross-link certain plastics or to remove microbial contamination from materials or articles intended for contact with foodstuffs, or from foodstuffs already packaged. These treatments induce chemical reactions in the materials, and the substances thus produced are liable to migrate into foodstuffs and present risks to human health. Moreover, the organoleptic properties of foodstuffs can be altered even at low concentrations.

In the absence of harmonized regulations applicable in the EU and subject to compliance with the principle of mutual recognition, materials subject to treatment by ionizing radiation intended to come into contact with foodstuffs are covered by French regulations (Articles 4 and 5 of Decree No 92/631 of 8/07/1992). In accordance with the Decree of August 12, 1986 (arrêté du 12 août 1986), modified by the Decree of June 23, 2006 (arrêté du 23 juin 2006), companies manufacturing or importing materials or articles intended to come into contact with foodstuffs and treated with ionizing radiation at doses exceeding 10 kGy must submit an authorization application to the DGCCRF, which requires an opinion from ANSES. For the ANSES risk assessment, a dossier is sent by the petitioner with the data required by the AFFSA guidelines of February 6, 2006.

Ionizing radiation treatments of materials and articles at doses below 10 KGy must be declared to the DGCCRF but are not subject to the requirement to apply for authorization with risk assessment by ANSES.

Arrêté du 12 août 1986

Arrêté du 23 juin 2006

AFFSA guidelines February 6, 2006  

In the absence of harmonized regulations applicable to metals and alloys in the EU, and subject to compliance with the principle of mutual recognition, certain metals and alloys are covered by French regulations:

Stainless steel

Uncoated stainless steels and articles made exclusively of stainless steel must comply with the Decree of January 13, 1976 (Arrêté du 13/01/1976), which lays down criteria for chemical composition but does not provide criteria in terms of release limits. The end products concerned are mainly cooking utensils or materials and equipment used in the production, processing, storage or transport of foodstuffs. When treatments are applied, the recommendations published by the DGCCRF on its website can be used to check compliance with Article 3 of Regulation (EC) No 1935/2004 (Test specifications in Annex II and specific release limits (SRLs) in Annex I of FCM sheet No.1 (V02 - 01/04/2017) "Suitability for food contact of metals and alloys intended to come into contact with foodstuffs". The main examples of use of the various families of stainless steels are specified in Appendix B of standard NF A 36-711.

Arrêté du 13/01/1976

Aluminum

Uncoated aluminum and aluminum alloys and articles made exclusively of aluminum or aluminum alloy must comply with the Decree of August 27, 1987 (Arrêté du 27/08/1987), which lays down chemical composition criteria but does not lay down criteria in terms of release limits. The end products concerned are packaging (appertized cans, beverage cans, capsules, aerosols, lids, foil, cups, trays, tubes, staples) or reusable articles (household items, household appliances, food industry equipment). When organic coatings are applied to aluminum or its alloys, the recommendations published by the DGCCRF on its website can be used to check compliance with Article 3 of Regulation (EC) No. 1935/2004 (Conformity of composition, overall migration limit, specific migration limits as indicated in FCM sheet No.1 (V02 - 01/04/2017) "Suitability for food contact of metals and alloys intended to come into contact with foodstuffs".

Arrêté du 27/08/1987

Tin

Objects made of tin or tin alloy or coated with tin or tin alloy or partially tinned must have a purity in compliance with the Decree of 28/06/1912 (Arrêté du 28/06/1912) modified by the Decree of 5/07/1956 and comply with the requirements of Decree n°76-492 of 28/05/1976. The items concerned are measuring instruments, pottery, dishes, plates and other culinary utensils, metal packaging as well as food industry equipment which, however, are not covered by Decree n°76-492 of 28/05/1976.

Arrêté du 28/06/1912

Décret n°76-492

Regenerated cellulose film is a thin sheet obtained from refined cellulose derived from non-recycled wood or cotton. For technological purposes, suitable substances can be added in the mass or on the surface. Regenerated cellulose films can be coated on one or both sides. They can be uncoated or coated with a cellulose-derived or plastic-based coating.

Regenerated cellulose films intended to come into contact with foodstuffs which, on their own, constitute a finished product or part of a finished product comprising other materials, must comply with Directive No. 2007/42/EC and the Decree of November 4, 1993 (Arrêté du 04/11/1993), modified by the Decree of October 21, 2004 (Arrêté du 21/10/2004). These regulations do not apply to synthetic casings made from regenerated cellulose. It provides for compliance with compositional criteria (positive list of authorized substances) and restrictions on use (Specific Migration Limits, Maximum Quantities of Substances in the Material and other restrictions).

Directive no. 2007/42/EC

Arrêté du 4 novembre 1993

Arrêté du 21 octobre 2004

In the food industries or catering, cleaning and disinfection operations are necessary to eliminate soiling as well as contamination of microbiological and chemical origin. As a result, equipment surfaces may show traces of residues following the use of cleaning products. These chemical residues can contaminate foodstuffs and present risks to human health.

In France, substances used to formulate cleaning products are subject to regulations that apply without prejudice to existing provisions for materials and objects that are either covered by specific harmonized measures, or by French national measures.

Decree No. 73-138 of February 12, 1973 applies the law of August 1, 1905 on fraud and falsification to processes and products used for cleaning materials and objects intended to come into contact with foodstuffs, products and beverages for human or animal consumption. Article 11 of this Decree requires that the constituents of cleaning products be included in a positive list established by Decree. The Decree of September 8, 1999 (Arrêté du 08/09/1999) establishes the list of authorized constituents in cleaning products for materials and articles intended to come into contact with foodstuffs.

For applications for authorization to use substances in cleaning products, the DGCCRF instruction of August 27, 1986 sets out the procedures for compiling dossiers and the type of information required. In addition, ANSES issued recommendations on the data to be provided for risk assessment in its opinion of August 2, 2007 (Saisine n°2007-SA-0028).

Cleaning products are essentially detergents or disinfectants. Substances permitted in cleaning products include acids, bases, surfactants, biocides, mineral salts, sequestrants, defoaming agents, solvents, thickeners, enzymes, aromatics and colorants matérials

Decree No 73-138 of February 12, 1973

Decree of September 8, 1999

Silicones, or polysiloxanes, are inorganic compounds formed from a silicon-oxygen chain in which groups attach to silicon atoms. Organopolysiloxanes have methyl groups, carbon chains or other radicals attached to the silicon atom. Silicones can be in liquid, resin or elastomer form, depending on their physical properties (viscosity, cross-linking rate, mechanical properties).

In the absence of harmonized regulations applicable in the EU and subject to compliance with the principle of mutual recognition, silicones intended to come into contact with foodstuffs are covered by French regulations. Silicones and silicone articles of the organopolysiloxane type intended to come into contact with foodstuffs must comply with the decree of November 25, 1992 (Arrêté du 25/11/1992), which provides for compliance with composition criteria (Positive list of substances, residual quantities of substances) and overall and specific migration limits.

The end products concerned are household articles (gaskets, molds, linings for household articles, baby bottle nipples, pacifiers, etc.) or food industry equipment (pipes, valve components, gaskets, etc.).

Arrêté du 25 novembre 1992

BADGE (bisphenol A diglycidyl ether), used for epoxy varnish synthesis, is the reaction product of bisphenol A and epichlorohydrin. The resulting varnishes contain linear or cyclic oligomers, reaction products and impurities of the starting substances. Used to coat metal packaging for beverages and canned foods, these varnishes can react with foodstuffs to form BADGE reaction products such as BADGE.HCl, BADGE.H2O and BADGE.HCl.H2O.

Following a health crisis in the 90s, the European Union regulated the use of BADGE and the appearance of epoxy derivatives linked to the contact of varnishes with foodstuffs (Regulation (EC) No. 1895/2005). It also banned the use of BFDGE and NOGE in the manufacture of varnishes intended to come into contact with foodstuffs.

Following a second health crisis, since 01/01/2015 France has suspended the import and placing on the market, free of charge or for a fee, of any packaging, container or utensil containing bisphenol A and intended to come into direct contact with foodstuffs (Law no. 2010-729 of 06/30/2010 amended by Law no. 2012-1442 of 12/24/2012). This suspension does not apply to industrial materials and equipment used in the production, processing, storage or transport of foodstuffs, such as fixed or mobile tanks, reservoirs and cisterns, silos, tubing and pipes, industrial production tools such as chocolate molds integrally integrated with mass production equipment, industrial systems integrally incorporating pastry sleeves and used by agri-food companies...). It does, however, apply to utensils and containers such as molds, tubs and pastry cases intended for sale to consumers or for sale in mixed consumer/professional channels such as pastry shops, restaurants or others.

Regulation (CE) No.1895/2005

Law No.2010-729 of 30/06/2010 modified by the Law No. 2012-1442 of 24/12/2012