# ☰ SAFETY OF FOOD CONTACT MATERIALS ☰

📚Total number of documents: 20

## 🙋Foreword

The food safety of materials in contact with food is a long-standing concern that dates back to the use of lead for soldering cans in the 19th century. The first harmonized regulations were introduced in Europe in 1976. The materials and uses have evolved a lot since then. PVC has disappeared and has been replaced by PET for bottle use, LDPE for cling film, etc. Recycled materials, active and intelligent packaging have been authorized. The demand for recycled materials, biosourced, biodegradable polymer and additives has skyrocketed. Some materials (paper, cardboard, adhesives, printing ink, etc.) are still not regulated at the European level.

This section lists the applicable and relevant guidance to manage the safety of the main groups of materials in contact with food (as enforced by the EU regulation). The documents are presented for RISK MANAGEMENT and NOT for RISK ASSESSMENT. Only the document about Non-Intentionally Added Substances (NIAS) recommends best practices for RISK ASSESSMENT.

📖LEGAL DOCUMENTS

Reference regulations for the EU and the US can be accessed on official websites (please note that only the texts published on Official Journals and on Code of Federal Rules have legal binding)

📖OTHER PUBLIC SOURCES

Some important materials (paper and board, rubbers) are not still covered by specific measures and guidance. Resolutions of Council of Europe (CoE) and recommendations from member states provide intermediate information. The situation of non-harmonized food contact materials has been reviewed by JRC and the European Parliament, based on the European Implementation Assessment's report.

📖ASSOCIATIONS

Consumer and industry associations (EuPia, Feica...) may provide also valuable information. Among them, the Food Packaging Forum provides a wealth of information, trends and news. As a reader, we encourage you to engage a dialogue with all stakeholders and to read the scientific literature.

## FUNCTIONAL BARRIERS | 🔥🚧

Functional barriers 🚧 are thought as a possible solution for the use of non-evaluated substances and consequently of non recycled materials (plastics, paper, board). It is 🔥 topic with strong industrial demand.

📚documents: 1 |📌plastic materials, paper & board, printing inks, adhesives, functional barriers, NIAS, metals, all materials | 🔝

 📙Functional barriers against mineral oil from paper and cardboard packaging materials | 📄8 pages | 🏫DLG, 🇩🇪 | 🔉English | 🔖Mineral oil components from paper and cardboard packaging materials have moved more strongly into the focus of surveillance authorities in recent years. Attention centres on saturated and unsaturated hydrocarbons that are designated MOSH and MOAH. The unsaturated substances (MOAH) are appraised as having mutagenic and carcinogenic potential. The aim is to reduce migration of such substances from the packaging to the foods as far as possible. In response to the question of how the transfer of mineral oil components from cardboard packagings to foods can be minimised, the German Federal Institute for Risk Assessment (BfR) points out that the transfer of mineral oil components is influenced not only by their content level in the packaging material, but also by the storage conditions and the nature of the food. “It can be prevented by using virgin fibre-based board and printing inks free of mineral oils, as well as by integrating functional barriers in the packaging structure. Here not only the direct food packaging must be taken into account, but also the possibility of migration from secondary packagings”. According to the third draft.of the Mineral Oil Regulation, specific migration limits of 2 mg/kg for MOSH and 0.5 mg/kg for MOAH are planned. Functional barriers are not all equally effective. Inner packagings made of paper or polyolefins delay migration (lag time), but do not prevent it.

## PLASTIC MATERIALS | ♳♴♵♶♷♸♹

Functional barriers 🚧 are thought as a possible solution for the use of non-evaluated substances and consequently of non recycled materials (plastics, paper, board). It is 🔥 topic with string industrial demand.

📚documents: 6 | 📌functional barriers, NIAS, printing inks, adhesives, all materials | 🔝

## PRINTING INKS | ✒️🖨️

There is no harmonized regulation for printing inks. Recommendations and good manufacturing practices have been stated by the European Printing Ink Association (EuPIA). The early guide produced by the Nordic Council is included.

📚documents: 5 | 📌plastic materials, paper & board, adhesives, functional barriers, NIAS, metals, all materials | 🔝

## ADHESIVES & SEALANTS | ♹🎰

There is no harmonized regulation for glues, adhesives and sealants used in food packaging. Recommendations and good manufacturing practices have been stated by the industry association of adhesive and sealant industry (FEICA).

📚documents: 3 | 📌plastic materials, paper & board, functional barriers, NIAS, metals, all materials | 🔝

## PAPER & BOARD MATERIALS | 🌳📰

The European assaciation of paper industry (CEPI) uses the following arguments not to promote specific migration limits already set for plastics, printing inks, adhesives:

• "[Paper & board] has low consumer exposure due to the low proportion of all direct contact food packaging, where the main application is contact with dry food."
• "It has a completely different manufacturing process compared to plastics."
• "Its predominant base polymer is cellulose whose monomer, ß-glucose, has no known adverse health issues."
• "Standard migration test methods used for plastics are not easily applicable or not appropriate for control."

🙋With the phase-out of single-use plastics and the generalization of recycled materials for primary and secondary packaging, these justifications are becoming more and more disputable. In particular, the application of specific rules of the 17 groups of materials is not consistent with the risk of cross-mass transfer between materials (cellulosic or not, recycled or not, ternary/secondary and primary layers) and with the risk of delayed food contamination. The guidelines of the Nordic Council predate the mineral oil crisis and, without being obsolete, does not adequately address the risk of contamination for dry food and cross-contamination.

📚documents: 2 | 📌plastic materials, printing inks, adhesives, functional barriers, NIAS, metals, all materials | 🔝

📘Industry Guideline for the Compliance of Paper & Board Materials and Articles for Food Contact
| 📄36 pages | 🏢CEPI, 🇧🇪 | 🔉English | ⬆️➡️

🔖

#### Objective

This document is aimed at manufacturers of paper and board materials and articles intended for food contact and is designed to provide guidance for establishing compliance with Regulation (EC) No 1935/2004. Whilst it provides a methodology for the demonstration of the suitability of materials and articles for a variety of food contact applications, in itself it has no legal force. Its use is voluntary and it should be noted that other compliance mechanisms exist which may be used separately or in conjunction with this Guideline.
It is the intention that the contents of this document are not fixed and will be updated in accordance with evolving best practice and knowledge of food safety.

#### Field of application

Paper and board materials and articles are manufactured from cellulose-based natural fibres both bleached and unbleached, from primary and recycled sources. In addition paper and board may contain functional additives and synthetic fibres and also other treatment agents and polymeric binders for organic and inorganic pigments.
This Guideline applies to materials and articles constituted of paper and board (excluding non-wovens as defined by ISO 9092) which may comprise one or more layers of fibre and which in their finished state:
• are intended to be brought into contact with food, or
• are already in contact with food and were intended for that purpose, or
• can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use.
The two principal operations in the manufacture of paper and board materials and articles for food contact are normally papermaking and conversion. Most of the specific requirements given in this Guideline will apply at the papermaking stage and will be applicable to paper and board at the completion of that operation.Some requirements are relevant to the converting operation.
Paper and board includes mineral coated papers, and the components including polymeric binders in the coating formula are covered by the requirements of this Guideline.
This Guideline may also be applied to paper and board as it is used in other coated and laminated materials, including combinations with plastics, aluminium, and waxes. Specific sections of this Guideline deal with multi-material multi-layer materials involving combinations of paper and board and plastics, filtering and baking applications, and packaging not actually in food contact.
📔Paper and Board Food Contact < Materials and Articles for Food Contact
| 📄52 pages | 🏛️Norden, Copenhagen, 🇩🇰 | 🔉English | ⬅️⬆️

🔖This document is elaborated for, manufacturers, other business operators and interested parties in the production chain. The document should ensure that the end-product does not constitute a risk to health and by all other means are produced in accordance with Article 3 of Regulation (EC) No 1935/2004. This document may also provide a help to national enforcement authorities and laboratories. As long as it is not transposed into national legislation in the Nordic Countries, the fulfilment of the requirements in this document is not mandatory. The basis for this document is the Council of Europe Resolution on Paper and Board Materials and Articles intended to come into contact with foodstuffs AP (2002) 1. However, legislative, scientific and technological development has been considered after the publication of CoE resolution as well as other development followed in the EU/EEA-area and elsewhere.
Requirements in this document on Good Manufacturing Practice (GMP), compliance declarations, documentation, traceability, active and intelligent materials and articles and functional barriers are harmonized with Regulation (EC) No 1935/2004, and existing measures given under the power of this regulation. According to this document substances used in the production of paper and board used for all food contact applications should have been evaluated by EFSA, BfR or FDA. Specifications and conditions of use must be respected.Substances may be used as long as they are evaluated for use in food contact materials or as direct food additives. However, special attention should be paid to Food Consumption Factors e.g. for infants and small children.
This document applies to materials and articles constituted of paper and board which may comprise one or more layer(s) of fibres and are intended to come into contact with or are placed in contact with foodstuffs. Any layer which is composed of paper and board must fulfil the requirements of this document, unless separated from the foodstuffs by a functional barrier.
The fibres of paper and board produced of Nordic tree types, as well as tree types from other parts of the world, are not necessarily toxicologically evaluated, but are in this context generally regarded as safe. Paper and board are manufactured from cellulose-based natural fibres from bleached and unbleached fibre material, including recycled fibres. In addition paper and board may contain several monomer or polymeric additives.
Detailed requirements to compliance declarations and documentation are essential elements in this document, specifying in detail what information shall be kept for inspection by national authorities and what information shall be provided in compliance declarations to the downstream user as a minimum. Requirements on compliance declarations are based on Directive 84/500/EEC including later amendments and Directive 2002/72/EC and amendments. Both are Directives operationalising the obligation in Article 16 of Regulation (EC) No 1935/2004 of issuing compliance declarations.
Specific restrictions are given on finished materials. For virgin fibres tests has to be carried out on heavy metals and PCP. More tests have to be carried out on products made from recycled fibres, dependent on which types of food the materials are intended for contact with. Until new biological tests have been fully accepted and validated for paper the specific requirements for recycled fibres in this document has to be checked for to ensure safe products.
Foods have been classified into three types, taking into account the nature of the food and the potential for migration in contact with paper and board. The classification laid down in EU Directive 85/572/EEC should be used to determine the food type for individual foodstuffs except where Chapter 6.4 indicates otherwise.
No specific process technologies in connection to the production of recycled fibres is required, only that end product testing is carried out, and restrictions given in relevant tables is respected. However, a short description from the producer of paper and board on which type of process technologies is used shall be included in the documentation.

## METALS & ALLOYS | 🥫

Metals can be released into foods and the risk needs to be minimized with a proper choice of materials, control of impurities and coating

📚documents: 1 | 📌plastic materials, paper & board, functional barriers, all materials | 🔝

 📔Food contact materials - metals and alloys | 📄66 pages | 🏛️Norden, Copenhagen, 🇩🇰 | 🔉English | 🔖Metals and alloys are widely applied as food contact materials, e.g. as process equipment in the food industry and as household utensils. Therefore, they are a potential source of food contamination. Migration of substances from food contact materials to food must not occur in amounts that endanger human health. Relevant for food contact materials made from metals and alloys are the migration (release) of metals, both the main components and foreseen impurities. In-house control based on a declaration of compliance, DoC, and supporting documentation at the producers and importers are important prerequisites to limit this contamination and to ensure compliance with the legislation. This is considered a general part of quality assurance, even though the European legislation does not specifically require a DoC for metals and alloys used as food contact materials. This Nordic guideline gives a short overview of toxicology, analytical feasibility, legislation and guideline values for release of metals from food contact materials. Therefore, the guideline will be a useful tool for industry and official food inspectors. The guideline is based on the work done by the Council of Europe, risk assessments from the European Food Safety Authority, EFSA, and by the WHO/FAO Joint Expert Committee on Food Additives, JECFA. Additional sources of information on metals in food are the plastic food contact material (EU regulation 10/2011) and the contaminants legislation (EU regulation 1881/2006).

## NON-INTENTIONALLY ADDED SUBSTANCES (NIAS) | ❓☝️

The concept of NIAS is evolving progressively from substances "not declared" to "unknown migrating substance" or "substance with unknown origin". The complications with NIAS are numerous. Their presence may be certain, but their amount highly random due to the random occurrence and extent of impurities, cross-contamination, reactions of degradation/aging... Absolute identification and quantification requires standards, migration above the limits of detection. Hazard requires the substance to have been evaluated. These conditions are rarely met. As a rule of thumb, it is easier to avoid NIAS when the source is identified, whereas to determine whether the risk may be acceptable.

Several computational approaches have be developed to accelerate the identification of NIAS, the evaluation of risks/hazards based on hypothetical but reasonable chemical structures, the hierarchization of avoiding strategies. The generation of recycled materials makes the use of NIAS and undesirable substance management concepts indispensable. This field has evolved with new practices and tools (chemometrics, structure-activity relationships, molecular modeling of migration).

📚documents: 1 | 📌plastic materials, paper & board, printing inks, adhesives, functional barriers, all materials | 🔝

📓Guidance on Best Practices on the Risk Assessment of Non-Intentionally Added Substances (NIAS) on Food Contact Materials and Articles
| 📄72 pages | 🏛️Norden, Copenhagen, 🇩🇰 | 🔉English |

🔖

#### Conclusions

The risk assessment of FCMs strongly depends on a proper exposure assessment. This is probably the most critical piece of information as the source to which exposure to NIAS occurs is an uncertain step in the risk assessment process. It should be noted, however, that this is an uncertainty which is not specific for FCM. Accurate exposure information is difficult to obtain for most risk assessments due to a lack of data on the full production process and the different non-FCM sources of the NIAS.
A risk assessment is typically only performed on NIAS that exceed 10 μg/kg food. This is a regulatory defined LOD which is not based on analytical or toxicological facts. It finds limited use for the risk assessment of NIAS since many NIAS exceed this threshold making risk assessment difficult if not impossible and, on the other hand, a lower concentration of NIAS does not guarantee the absence of concern. A better and more realistic approach is to move to exposure driven risk assessment.
Combination toxicity where two or more substances are present below the LOI but which may have the same target organ or mechanism or mode of action, is in principle, not covered by the NIAS screening approaches. According to two literature studies (EU-SCENIHR, 2012; Boobis et al., 2011) and a publication by Leeman et al. (2013), the health relevance of possible cumulative effects at low (TTC) dose levels is considered to be so low that a need for a correction factor to cover possible cumulative effects is very low to absent. However, for endocrine active substances and genotoxic substances, possible cumulative effects at low dose cannot be excluded (Leeman et al., 2013). The latter can be covered by performing in-vitro bioassays on these end points.
Risk assessment of NIAS should ascertain that these do not contain a potential for genotoxicity. For nonidentified NIAS, it is not possible to determine whether these have a structural alert for genotoxicity. The alternative approach is to perform a genotoxicity in-vitro assay. However, the sensitivity of the applied assay has to be validated towards known FCM related genotoxic substances (e.g. certain primary aromatic amines) and be related to the FCM under investigation. Some promising in-vitro bioassays are in development that will inform about the mechanism of action of substances (EFSA, 2011). Therefore, genotoxicity testing according to the current acceptable state-of-the-art is being advised.
Although some limitations are described, it should be noted that the risk assessment strategy for unidentified NIAS as described in this report is currently the only approach available for unknown chemicals. The approach should therefore be considered to be state-of-the-art until new and/or more sensitive methods become available. However, since no alternative is available to evaluate these unidentifiable substances, the best one can do today is that described in this guidance. Although some limitations are described, it should be noted that the risk assessment strategy for unidentified NIAS as described in this report is currently the only approach available for unknown chemicals. The approach should therefore be considered to be state-of-the-art until new and/or more sensitive methods become available. However, since no alternative is available to evaluate these unidentifiable substances, the best one can do today is that described in this guidance.

## ALL MATERIALS TOGETHER | 🥤🍿🥫🇫🇷

The guide from ACTIA (national federation of food technology institutes in France) is the only guide that deliberately takes the part of the food and not a specific material.

Migration phenomena are reviewed in this reference document.

📚documents: 1 | 📌plastic materials, paper & board,printing inks, adhesives, functional barriers, NIAS, metals | 🔝

 📙Functional barriers against mineral oil from paper and cardboard packaging materials | 📄66 pages | 🏫ACTIA/PROPACK FOOD, 🇫🇷 | 🔉French | 🔖Modern food packaging is made of different materials combined in parallel (laminated, glued, coated or lacquered) or placed side by side for all or part of the shelf life of the food. Few guides deal with materials or their use in combination. The result is a vision that privileges the material to the detriment of the food. The opposite point of view (defending the food) is at the heart of preventive food safety management methods such as HACCP, ISO 22000 and their variants. The ACTIA guide (in French, not translated) tries to bring this global vision by starting from the phenomena (migration) and by looking at the means of action to minimize the effects according to the European and national (here France) obligations. The point of view addressed in the guide represents the point of view of the food industry, which is the marketer, and therefore responsible vis-à-vis the law. There is no consensus among the materials industry and processors, who invoke limited liability. The complex material flows of packaging materials subject to hazards, recycling cycles and varied supplies greatly complicate the demonstration of compliance. The management of traceability, the implementation of quality assurance procedures and crisis management procedures are essential. .

## ✔️Disclaimer

The opinions expressed in the documents or in the introductive sections are those of the authors and not those of the institutions or authorities. The guides have been written in a variety of contexts, at different times and according to disparate logics. The material guides are most often intended for producers and processors of materials. The authorities' guides are aimed at the applicability of the law and the ability to enforce it. The guides supported by the agro-food sector develop an overall vision and the need for quality management procedures. It is the responsibility of the reader to make the synthesis for his own case. Despite the quality of the documents presented cannot serve as the only source of information within the company.

Introductive sections were written by INRAE\Olivier Vitrac. The presented 🔖abstracts were extracted from the documents using the executive summary (preferred), the introduction (the text is truncated) or the conclusions (the text is truncated).

The content of the documents are made available unmodified through the platform for educational and training purposes.

 PROJECT FITNess - funded by the European Union's ERASMUS programme (contract 2017-1-FR01-KA202-037441) Food packaging open courseware for higher education and staff of companies Partners: Croatia (UZAG-PBF), France (ACTIA, LNE, AGROPARISTECH/INRA, AGROSUP DIJON), Germany (TUM), Portugal (UCP), Spain (CSIC) - Report issues

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