03.02.2016 - FOODBOARD™, Barriers
Here you will find explanations of terms frequently used in connection with migration and unintended substances as well as information on central authorities and important regulations on the subject of food contact materials.
By migration is meant the transition of substances between the packaging and its contents (food). In the process the food can be affected through the air (migration by gas-phase) or through direct contact (e.g. fibre-to-fibre migration). Various factors influence the migration such as the storage temperature, storage time or contact time, composition of the food and the type of packaging. The following types of migration are differentiated:
— Penetration migration: migration of substances from the packaging into the food and vice versa.
— Set-off migration: migration of substances from a printed surface to the food contact side (reverse side) through contact in the pack or angle of roll.
— Migration through the air: migration from the evaporation of volatile substances when heating (e.g. cooking, baking or steaming chilled and frozen products in their original packaging), during storage and through transition in the gaseous phase.
— Distillation migration: migration through steam distillation, for example, during cooking, baking or sterilisation process.
One possible source of the migration of unintended substances is cross-contamination. During storage and transportation, migration of unintended substances can occur from the environment and from secondary or corrugated board packaging to packed food. MOAH analyses of many different foodstuffs from the supermarket shelf packed in virgin fibre or recycled fibre based folding cartons provide evidence of significant cross-contamination from the environment as well as from secondary or corrugated board packaging. It is therefore impossible to prevent mineral oil migration by using standard folding cartons or standard plastic packaging. Only a functional barrier between the food and the environment represents an effective solution.
Test procedures for measuring migration
Four types of migration analysis are to be distinguished:
— Chemical analysis: The volume of migrated substances can be directly determined on the food or else simulants are used. These show comparable or stricter characteristics than the packed food. Testing for migrated substances is carried out under precisely defined conditions such as the room temperature and humidity as well as a defined exposure time.
— Sensory analysis: The packaging is tested for migrating substances which can affect the taste or smell of the food. In this process, samples taken from production with test simulants (often chocolate) are enclosed for a certain period of time in a clean glass with neutral odour. Then the sample is checked and evaluated by trained personnel for changes in taste and/or smell.
— Global migration analysis: This analysis is non-specific and gives an overall value, usually in mg/dm².
— Specific migration analysis: Substance-specific limits are given with respect to 1 kg of food. Specific migration values are usually justified for toxicological reasons. Adherence to migration limits in food is monitored under extreme conditions with respect to duration and temperature.
ADI (Acceptable daily intake)
The ADI value gives the quantity of a substance which can be absorbed daily over an entire lifetime without any expectation of danger to health. ADI is given in milligrams per kilogram of body weight and day (mg/kg body weight * d; d=day) or abbreviated as mg/kg body weight, and it is calculated using a safety factor.
NIAS (Not Intentionally Added Sustances)
NIAS are substances which have no function and which are therefore unintended. They are caused by natural background levels (substances of natural origin that can be detected every-
where in nature), accumulations (e.g. phthalates), contaminants in raw material or by-products and reaction products.
Mineral oils are complex mixtures consisting of Mineral Oil Saturated Hydrocarbons (MOSH) and to a lesser extent of Mineral Oil Aromatic Hydrocarbons (MOAH). The main sources of mineral oils in food are additives, processing aids, lubricants and migration from packaging as well as environmental influences. MOSH accumulate in the human body and MOAH are considered to be mutagenic, potentially carcinogenic and possibly estrogenic. According to the latest draft of the mineral oil regulation from BMEL, MOAH may only migrate from food commodities to food to a very limited extent.
Phthalates are plasticisers which are mainly used in plastics to make them flexible and pliable. They were also used earlier as additives in printing inks and dispersion adhesives. The occurrence of phthalates in food is not only due to direct contact with packaging materials but can also originate in the food production process. Phthalates are considered to be ubiquitous due to their many areas of application and the very high production volumes. They are under suspicion of causing hormonal effects. A limit can be found in the plastics directive and in recommendation XXXVI. It is better still to shield these harmful substances originating from plastics completely from food through the use of functional barriers.
DIPN is used as a solvent for dyes in carbonless paper and cannot be completely removed in the fibre preparation process. According to current knowledge, DIPN does not give rise to any specific health concerns but in the opinion of experts, the content of DIPN should be kept as low as possible in line with the general minimisation imperative.
Bisphenol A is used to produce the plastic, polycarbonate, but also for the production of thermal paper on which sales receipts, tickets or parking receipts are printed. The many scientific studies of the effect of bisphenol A come to contradictory results. In high doses bisphenol A is suspected of affecting the hormone balance. The latest comprehensive reassessment by EFSA was published in January 2015. There the authority comes to the conclusion that bisphenol A does not represent a health hazard to consumers of any age at the present levels of consumer exposure. Nevertheless bispenol A may not be used for food packaging in France.
Benzophenone is a photoinitiator which is used to support the UV curing of industrial paints and coatings and which protects printed inks from fading. Its effect on health is normally critically regarded. Benzophenone is suspected of having an estrogenic effect on the hormone balance in high doses.
oil regulation -
|Estrogenic effects||Plastics regulation;|
|Solvent||Carbonless paper||No harmful effects|
in food packaging
since January 2015
|Estrogenic effects||SML (specific|
BMEL (german Federal Ministry for Food and Agriculture)
The Federal Ministry for Food and Agriculture is a supreme federal authority of the Federal Republic of Germany. BMEL‘s primary sphere of responsibility is food safety, economically viable farming and ecologically and socially intact rural areas. BMEL is working on two statutory regulations to control the problem of the migration of mineral oil from packaging to food: the printing ink regulation and the mineral oil regulation.
BLE (German Federal Office for Agriculture and Food)
The Federal Office for Agriculture and Food is a central implementation authority with diverse assignments in the fields of agriculture, food and consumer protection and it operates under the aegis of the BMEL. In the final report of its project to support the decision-making process from 2012, “Extent of migration of printing ink components from packaging materials into foodstuffs”, the BLE regards a functional barrier as “indispensable” in order to protect food from unintended substances, and it recommends such a barrier specifically to the BMEL.
BLL (German Federation for Food Law and Food Science)
The German Federation for Food Law and Food Science is an association of the German food industry. In the interplay between the law, politics, science and business, it is considered to be a competent and recognised partner for the wide-ranging subject area of “food law and food science”.
BfR (German Federal Institute for Risk Assessment)
The Federal Institute for Risk Assessment is an institution under the aegis of the BMEL and serves to strengthen consumer health protection in Germany and abroad. Its tasks comprise the evaluation of existing and identification of new health risks, drawing up recommendations on ways to contain risks
and the communication of this process. The BfR published three analytical measuring methods to reliably detect mineral oil compounds in September 2011.
Council of Europe
The Council of Europe is a pan-European, international organisation with 47 member countries. Institutionally, it is not connected to the European Union and is not to be confused with the European Council (the body comprising heads of state and governments) or the Council of the European Union (Council of Ministers). The Council of Europe is a forum for debate on general European questions; it concludes intergovernmental agreements with binding force under international law with the aim of promoting economic and social progress. The Council of Europe is working on a technical guideline for paper and cartonboard with regard to mineral oil migration. In the first draft, the migration thresholds for MOSH and MOAH correspond to the third draft of the German mineral oil regulation. Cross-contamination is also explicitly addressed in the guideline, and a functional barrier is recommended.
DG Sante (directorate general for health and safety)
DG SANTE, until 2014 DG SANCO, is the European Commission‘s directorate general for health and consumers. The directorate
general was set up to improve the health and safety of European citizens and to strengthen consumer confidence. It is charged with keeping legal regulations governing health and consumer protection up to date.
EFSA (european food safety authority)
The European Food Safety Authority is an agency of the European Union which supplies information on existing and emerging risks in connection with the food chain and offers scientific advice on them. The authority‘s work covers all issues which have a direct or indirect effect on food safety.
Third draft of the mineral oil regulation
On July 24, 2014, the German Federal Ministry for Food and Agriculture (BMEL) presented a new draft of its planned regulation, “22nd Amended Ordinance regarding the Commodities Regulation” (Mineral Oil Regulation), and in the process refers to food contact materials, which have been produced using recovered paper. With this draft, the authority is now focussing on the mineral oil contents in the food contact materials themselves and on the migration from such materials to the food. The changes to the Regulation of food contact materials have a transitional period of 24 months after the date the regulations are finally approved by the authorities. The maximum levels permitted in the food contact materials themselves is 24 mg/kg MOSH and 6 mg/kg MOAH. If these values are exceeded, the food contact material may still be put into circulation if the maximum permitted migration value of 2 mg/kg MOSH and 0.5 mg/kg MOAH from the food contact material to the food itself is not exceeded. Indirect migration from the secondary packaging is included in the limits shown. The distributor of the product must ensure compliance with the relevant migration limit values. The distributor has to create appropriate documentation to demonstrate compliance – for instance through the evidence of a functional barrier in the food contact material. In the case of frozen food, table salt or dry food with short-term contact, the authority sees no migration risk from recycled cartonboard, although compliance documents are still needed. For MOAH in particular, the authority is aiming to largely avoid migration to food. The limits set in this regard are linked to the authority‘s current analytical capability and are still significantly above the desired level of 0.15 mg/kg MOAH migration from food contact materials (detection limit).
Regulation (EC) No. 1935/2004
This is a regulation issued by the European Parliament and the Council on October 27, 2004 governing materials and articles intended to come into contact with food.
— The regulation lays down the conditions for when materials and articles may come into contact with food as finished products.
— The regulation stipulates that materials and articles “[…] shall be manufactured in compliance with good manufacturing
practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could endanger human health”. (Art. 3 Sec. 1a)
— “The principle underlying this Regulation is that any material or article intended to come into contact directly or indirectly with food must be sufficiently inert to preclude substances from being transferred to food in quantities large enough to endanger human health or to bring about an unacceptable change in the composition of the food or a deterioration in its organoleptic properties.”
— The traceability of materials and articles intended to come into contact with food “shall be ensured at all stages in order to facilitate control, the recall of defective products, consumer information and the attribution of responsibility.” (Art. 17 Sec. 1)
Regulation (EC) no. 2023/2006
This regulation specifies that an appropriate quality assurance and monitoring system must be implemented and documented for the production of materials and articles for the food industry.
Recommendation XXXVI contains a list of raw materials which may be used for the production of paper and cartonboard in contact with food. There are usage restrictions (max. limits), purity criteria for the raw materials, limit values for the finished product and a few migration limits.
Declaration of Conformitiy
The Declaration of Conformity is a written confirmation that materials and articles for which individual measures are prescribed in Art. 5 of 1935/2004/EC, meet current specifications. Suitable documentation giving evidence that the specifications are being met, must be made available to the responsible authorities on request (SD, Supporting Documents). The Declaration of Conformity must be drafted by each company for its stage of the
Plastics regulation (EC) No. 10/2011
This defines testing specifications, test simulants and limit values for global migration (total amount of migrating substances) for plastics. Furthermore, it comprises a list of over 300 monomers and other raw materials which may be used for the production of plastics as well as an incomplete directory with over 500 substances. These lists contain usage restrictions and SML.
ECMA GMP GUIDE (ECMA GOOD MANUFACTURING PRACTICE GUIDE), 2011
The ECMA GMP is an information and management tool with methods that can be adopted by converters. To a large extent this GMP is based on the GMPs published by BPIF Cartons, the Carton Makers division of the British Printing Federation, by the German Fachverband Faltschachtel Industrie (FFI), and on the publications by the French Club MCAS (Matériaux pour contact alimentaire et santé), and the Italian Assografici GIFASP contribution in the EU CAST project. This guide assures the converter of producing packaging that, under specified and controlled circumstances, will not give rise to non-compliant migration, organoleptic changes or contamination. Relevant control points should ensure, among other things, the traceability of the materials used and the manufactured products.
NGO’s and consumer magazines
foodwatch is an independent Non-Profit-Organisation which deals with the rights of consumers and the quality of food. The declared aim of the organisation according to its statutes is to “advise and inform consumers in the area of agricultural and food production, the retail trade and the sale of consumer goods as well as the provision of services”. At the end of October 2015, foodwatch published a detailed test report on the subject of “mineral oil in food”. Germany, France and the Netherlands were selected as test markets, and the focus was on dry, long-lasting food such as rice, noodles and cornflakes. foodwatch is demanding protective functional barriers for food packaging and is calling for European authorities to act.
ÖKO-TEST is a German consumer magazine which tests products and services for consumers. The subject of mineral oil migration is repeatedly taken up by ÖKO-TEST (September 2010 “Black on Rice” / February 2012 “Red for Green” / November 2014 “Horror of Food”). Most recently in September 2015, the contents of chocolate muesli were examined, and unintended substances such as pesticides and mineral oils were identified. Cross-contamination is confirmed in the article as the source of mineral oil migration.
Stiftung Warentest is a German consumer organisation which was set up in 1964 on a vote passed by the German Bundestag. Complying with its official mandate, Stiftung Warentest examines and compares products and services from different suppliers in order to offer consumers independent, objective support. In November 2012, Stiftung Warentest published the results of its examination of chocolates in advent calendars in which traces of mineral oil and related substances were found. Traces of mineral oils were also found in tea in October 2014 and in chocolates in December 2014.