Food Contact Material Compliance - An Overview

July 2023

Background

The food industry must comply with all legal and regulatory requirements (national and international) related to the safe production of food. Although these requirements vary in different parts of the world, they are fundamentally the same in terms of their basic intentions about protecting the consumer from harm.

The international symbol for ‘food safe’ material is a wine glass and a fork symbol. The symbol indicates that ‘the material used in the product is considered safe for food contact’ and relates to food and water containers, packaging materials, cutlery, for example.

Legislation

A cornerstone of food safety is the requirement that all materials and articles intended to come into contact with food, such as packaging and containers, food processing equipment (at kitchen and manufacturing level), utensils, cutlery and dishes must be food-contact compliant. These materials can include plastics, rubber, paper and metal.

European legislation for food contact materials (FCM) also covers materials that contact water intended for human consumption, e.g., bottles, but excludes fixed public or private water supply equipment.

National Regulations

In the UK, national regulations (Food contact materials regulations | Food Standards Agency) provide requirements for materials and articles that are likely to come into contact with foods or have chemical migration of FCM to food, for example packaging including materials such as printing inks, adhesive labels and also items such as lunchboxes and cutlery.

The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 amended the National Regulations 2012 and retained the EU FCM legislation.

EU Framework

General requirements for all food contact materials are laid down in Framework Regulation EC 1935/2004. Good Manufacturing Practice (GMP) for materials and articles intended to come in contact with food is described in Regulation EC 2023/2006. There are also EU regulations for specific materials: ceramics, regenerated cellulose film, plastics, recycled plastics and active and intelligent materials. In addition, some directives cover single substances or groups of substances used in the manufacture of food contact materials.

Food contact materials must not transfer their components into the foods in unacceptable quantities (migration). This relies on ensuring that during contact there is no migration of unsafe levels of chemical substances from the material to the food. They should also not change the composition of the food in an unacceptable way or have adverse effects on the taste and/or odour of foods.

For Europe, food contact material requirements are summarised by the European Food Safety Authority (EFSA) EU legislation on food contact materials, and detailed in the following EC Regulations:

 

As part of a European network, the European Commission’s Joint Research Centre operates a European Union Reference Laboratory for FCM that provides scientific support to EU policies on food safety through information about research and analysis on food contact materials.

USA

Food contact compliance is covered under the Food and Drink Administration (FDA’s) CFR Title 21: https://www.fda.gov/medical-devices/medical-device-databases/code-federal-regulations-title-21-food-and-drugs#:~:text=The%20Code%20of%20Federal%20Regulations,the%20Food%20and%20Drug%20Administration.

It is important to note that FDA food contact compliance alone is not sufficient in the EU. Products must be EU compliant and may additionally be FDA compliant.

Guidance

EFSA is a European agency funded by the European Union that operates independently of the European legislative and executive institutions (Commission, Council, Parliament) and EU Member States. Established in 2002 it is a source of scientific advice and communication on risks associated with the food chain. The agency was legally established by the EU under the General Food Law – Regulation 178/2002.

EFSA's Role

EFSA adopts and publishes scientific opinions and provides scientific advice for risk managers on the safety of substances used or intended to be used to manufacture materials which come into contact with food as well as the safety of related processes (e.g., recycling of plastics). This guidance is available via the following links:

 

Activities

The general task of evaluating substances intended for use in food contact materials, as well as additional risk assessments in relation to food contact materials, are carried out by the Panel on FCM, Enzymes and Processing Aids (CEP). Their work is based on reviewing scientific information and data submitted by applicants. EFSA has published guidance for the submission of applications for the safety evaluation of substances intended to be used in food contact materials. The Authority has also developed specific guidance for submission of applications related to active and intelligent packaging and processes for recycling plastic used in food contact materials.

The CEP Panel also responds to ad-hoc requests from the European Commission to review certain food contact materials in the light of new scientific information and/or changing conditions and/or use.

 

Plasticisers

EFSA are currently working closely with the European Chemicals Agency (ECHA) to facilitate the implementation of the EC’s Chemicals Strategy for Sustainability, e.g. ‘One-Substance, One-Assessment’ approach. In May 2022, they published an opinion on the identification and prioritisation of plasticiser substances, such as phthalates and structurally similar substances, in food contact materials for reassessment and a protocol for assessing exposure.

 

Silver compounds as biocides

In March 2021, ECHA and EFSA published a joint document to compare the evaluations performed on silver compounds used as biocidal active substances in food contact materials.

The document provides:

  1. An overview of the assessments carried out on these substances according to their respective legislative framework (Biocidal Product Regulation (EU) No 528/2012; Regulation (EC) No1935/2004
  2. The joint ECHA/EFSA conclusions regarding the alignment of their scientific evaluation, taking account of their respective regulatory framework.

 

The European Hygienic Design Engineering Group (EHEDG) comprises a network of more than 1,300 food safety professionals working in companies, institutes, or as individuals, representing:

  • manufacturers of food and equipment used in the production of food, pharmaceuticals and cosmetics.
  • companies supplying engineering services
  • scientific and research organisations
  • health authorities and associations,

with a mission to influence trends in the food industry and build strong relationships. EHEDG publish useful guidance documents related to materials used in the construction of food processing equipment:

  • Guideline 8: Hygienic Design Principles (free to download)
  • Guideline 32: Materials of construction for equipment in contact with food (available for purchase).

A full list of EHEDG Guidelines: https://www.ehedg.org/guidelines-working-groups/guidelines/guidelines/

Food Safety Standard Requirements

In addition to food safety regulations, companies in the food industry often operate in accordance with different sets of voluntary food safety standards. These include Global Food Safety Initiative (GFSI) approved schemes such as:

 

  • IFS https://www.ifs-certification.com/index.php/en/download-standards?item=4128  (available to download)
    •  2.2.3.5 Conduct a hazard analysis for each step: A hazard analysis shall be conducted for all possible and reasonably expected physical, chemical (including radiological and allergens) and biological hazards. The analysis shall also include hazards linked to materials in contact with food, packaging materials and hazards related to the work environment. The hazard analysis shall consider the likely occurrence of hazards and the severity of their adverse health effects. Consideration shall be given to the specific control measures that shall be applied to control each hazard.
    • 4.17.2 For all equipment and utensils with direct food contact, a certificate of conformity shall be in place, which confirms compliance with legal requirements. In case no specific legal requirements are in place, evidence shall be available, such as:
  • certificate of conformity
  • technical specifications
  • manufacturer’s self-declaration to demonstrate that they are suitable for the intended use.
  • SQF https://www.sqfi.com/resource-center/sqf-code-edition-9-downloads/ (available to download)
    • 2.3.2.5 Verification of packaging materials shall include:
      • Certification that all packaging that comes into direct contact with food meets either regulatory acceptance or approval criteria.
      • Documentation shall either be in the form of a declaration of continued guarantee of

compliance, a certificate of conformance, or a certificate from the applicable regulatory agency.

  • In the absence of a certificate of conformance, certificate of analysis, or letter of guarantee, tests, and analyses to confirm the absence of potential chemical migration from the packaging to the food contents shall be conducted and records maintained.
Migration testing and Declarations of Compliance - for plastics in contact with food (courtesy of Vikan)

Manufacturers of plastic equipment and packaging have a legal obligation to provide information on its suitability in contact with food to the end user.

European Food Contact Compliance

To secure food contact compliance in Europe, plastic equipment and packaging must comply with the requirements of (EU) 10/2011 https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32011R0010. This regulation, and its Annexes, are regularly updated with new substances, or substance specific restriction limits.

Plastic equipment and packaging intended for food contact must undergo rigorous migration testing performed by an independent, accredited test laboratory. The materials are tested for different time and temperature conditions and food types (e.g., acidic, aqueous, fatty), and the testing results are documented in an official Migration Test Certificate. Manufacturers of plastic equipment and packaging have a legal obligation to use the information in the certificate to produce a Declaration of Compliance (DoC) which adheres to the appropriate regulatory requirements.

The DoC is a requirement in Article 16 of the EU food contact material Framework Regulation (EC) 1935/2004, and more details are set out in Annex IV of the Plastics Regulation (EU) 10/2011. The requirement extends all the way from the plastic chemical supplier to any intermediate plastic supplier (suppliers of plastic granules and masterbatch for example), to the supplier of the finished plastic article, the retailer, and finally to the end-user. This entire chain relies on clear communication from one step to another, and all documentation must be exchanged, one step back and one step forward.

Based on the information gathered, DoCs are issued for finished articles, and must detail how the plastic material was tested and whether there are any restrictions for its use. Regulatory authorities, as well as food safety auditors, may wish to check a company’s DoCs and are entitled to do so at any time.

A DoC is legally required to provide specific information, as laid out in Annex IV of (EU) 10/2011. These are:

  1. The identity and address of the business operator issuing the declaration of compliance. This lists the official name and address of the company issuing the DoC.
  2. The identity (official name) and address of the business operator which manufacturers or imports the plastic material or article. If the same company is issuing the DoC and manufacturing/importing the product, points 1 and 2 can be combined.
  3. The identity of the plastic material or article (trade name and material types) to clarify which product(s) are covered, so they should be specifically identifiable by an item number for example. Regarding the materials used, it is important to declare the type of polymer used in the material. Other materials, such as adhesives, coatings or inks, should also be listed. N.B. European Union Guidance on Regulation (EU) No 10/2011 states that ‘Several materials with different composition leading to significant differences in reportable substances cannot be covered by one DoC’.
  4. The date of the declaration, which should be reviewed, and document records updated regularly.
  5. Confirmation that the plastic material or article complies with relevant requirements of Regulation (EC) 1935/2004 (Article 3, 11(5), 15 and 17) and Regulation (EU) 10/2011. This confirms that the plastic article is manufactured using only monomers, other substances and additives listed and authorised under (EU) 10/2011. The DoC should also mention that the article complies with the overall migration limit (OML). Details about the test conditions, such as any food simulants used and the OM test number according to Annex V to (EU) 10/2011 can be included. Part of complying with (EU) 10/2011 is that a company’s manufacturing processes must comply with GMP as set out in Regulation (EC) 2023/2006 which should be mentioned, if appropriate.
  6. Information on substances with restrictions in Annex I or II of (EU) 10/2011. This provides the identity of any substances with specific migration limits (SML) in Annex I and II of (EU) 10/2011, or information about the presence of any such substances. There should also be confirmation that the substances featuring SMLs do not migrate above the migration limit, if used under the specified conditions.
  7. Information on dual use additives as listed in the European legislation on additives or flavourings (Regulation (EC) No 1333/2008 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32008R1333 , Regulation (EC) No 1334/2008 https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A32008R1334). This provides the identity of any dual-use additives (additives or flavourings that can be used in plastics as well as in food) or information about their presence.
  8. Specifications on the use of the material or article, such as:
    1. type or types of food with which it is intended to be put in contact. It is important to know which kind (aqueous, acidic, alcoholic, fatty and/or dry) of food the plastic product is intended for use with. Only products that have been tested in the food simulants (10% ethanol, 3% acetic acid and olive oil) are suitable for use in contact with all food types hence one should be aware of any restrictions in food types.
    2. time and temperature of treatment and storage in contact with the food. Consider how long can you use the product in contact with food and at which temperatures - information crucial for the safety of food products.
    3. ratio of food contact surface area to volume used to establish the compliance of the material or article. This is technical information from the test laboratory about the ratio of food contact surface area to volume that has been used to determine the compliance of the product; often specified in dm2/ml.
  9. When a functional barrier is used in a multi-layer material or article, the confirmation that the material or article complies with the requirements of Article 13(2), (3) and (4) or Article 14(2) and (3) of the Plastics Regulation (EU) 10/2011. This point is only relevant for multi-layer articles that feature a functional barrier. This point confirms that the non-authorised additives behind the functional barrier are not mutagenic, carcinogenic or toxic for human reproduction, and are not in nano-form. It also confirms that the non-authorised substances comply with the detection limit of 0.01 mg/kg.

If these information requirements are not complied with, one risks receiving a non-conformity from the authority in question.

FDA Food Contact Compliance

In addition to EU compliance, the materials intended for food contact can additionally comply with the US FDA CFR article 21. This compliance is described in the ‘FDA Compliance’ section with reference to the relevant sections in this set of requirements.

It should be noted that within Europe, compliance with FDA requirements alone is not sufficient. In USA there is no requirement for migration testing of the finished article, instead the plastic material itself is considered safe, based on testing or is designated as exempt from testing.

CE versus UKCA marking.

The letters ’CE’ (Conformité Européenne, meaning European conformity) signify conformity with European Economic Area (EEA) standards.

The UKCA mark is used for products being placed on the market in Great Britain (England, Scotland and Wales). It will replace ’CE’ marking for manufactured products placed on the GB market from the beginning of 2025.

 

 

 

 

BSI video https://www.youtube.com/watch?v=Sz-t-DjenSg

Summary of Changes (courtesy of Eric Partington, Nickel Institute, EHEDG UK:IE Chair)

Contrary to popular belief, the CE mark on a piece of food-processing equipment is not an indication of its quality or that it has been manufactured in the EU.  It is a guarantee from the equipment manufacturer, wherever in the world, that the item meets all the regulations applicable to it, in the country in which it is to be used. In the EU these include not only the obvious electrical and noise regulations, but also Framework Regulation EC 1935/2004, which controls the materials that will be in contact with a food product, and Machinery Directive 2006/42 EC, which requires food processing equipment to be hygienically designed. Only manufacturers who can provide proof of compliance with all the applicable legislation are allowed to attach the CE mark to their product.

 

Since UK has left the EU, the requirements of the Framework Regulation have been embodied in UK Statutory Instrument 2619 and those of the Machinery Directive in Statutory Instrument 1597. As the CE mark is gradually being replaced by the UKCA mark, it is advisable when considering the purchase of a piece of food processing equipment, to ask the manufacturer to confirm all the legislation it complies with, including that related to food contact compliance.

Institute of Food Science & Technology has authorised the publication of this Information Statement on Food Contact Material Compliance.

This Information Statement has been prepad by Debra Smith and peer-reviewed and approved by the IFST Scientific Committee. This Information Statement is dated July 2023. 

The Institute takes every possible care in compiling, preparing and issuing the information contained in IFST Information Statements, but can accept no liability whatsoever in connection with them. Nothing in them should be construed as absolving anyone from complying with legal requirements. They are provided for general information and guidance and to express expert professional interpretation and opinion, on important food-related issues.

Information Statement