At J.S. Hamilton, we conduct various tests for plastic packaging and materials:
- Overall and Specific Migration into all food simulants
- Specific migration of:
- Primary Aromatic Amines (PAAs) and Annex II Metals,
- Plasticizers, antioxidants, monomers and other additives acc. EU 10/2011 Annex I and Swiss Ordinance,
- Non-Intentionally Added Substances (NIAS) Screenings by methods: GC-MS/FID, LC-QToF-MS, Headspace-GC/MS
- Bisphenols A, B, S, F and epoxy resin derivatives BADGE, BFDGE and NOGE in coated materials, plastics and adhesives,
- Mineral oils (MOSH/POSH & MOAH),
- Isocyanates and azo-dyes,
- Set-off effect of printing inks and specific migration UV-initiators, acrylates, BHT, PAAs, etc.,
- Sensory analysis acc. DIN 10955, EN 1230-1/-2,
- Colorfastness acc. EN 646, DIN 53160-1 / -2,
- Barrier properties against gases: oxygen (OTR), water (VWTR), CO2TR.
The most comprehensive specific EU measure is Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food. It sets out rules on the composition of plastic FCMs, and establishes a Union List of substances that are permitted for use in the manufacture of plastic FCMs. The Regulation also specifies restrictions on the use of these substances and sets out rules to determine the compliance of plastic materials and articles.
OVERALL & SPECIFIC MIGRATION
Food packaging can be a source of chemical food contaminants.
The chemicals transfer from FCMs into food is called migration. The extent to which migration occurs depends on various factors: the physico-chemical properties of the migrant, of the packaging material, and the food (e.g. fat content, acidity), temperature, storage time, size of the packaging in proportion to the foodstuff volume (smaller size packaging has a larger surface to volume ratio).
| Food simulants acc. (EU) 10/2011 |
| A – Ethanol 10% (hydrophilic food) |
| B – Acetic acid 3% (hydrophilic food pH<4.5) |
| C – Ethanol 20% (alcoholic more lipophilic food) |
| D1 – Ethanol 50% (lipophilic/alcoholic food; oil in water emulsion), milk products |
| D2 – Vegetable oil; (lipophilic food; surface free fats) or alternative D2 food simulants Ethanol 95%, isooctane |
| E – Poly (2,6-diphenyl-p-phenylene oxide) (dry food), Tenax®, MPPO |
The types of chemicals that can migrate from packaging into food are highly diverse and depend on the type of packaging material. For inert materials (stainless steel, ceramic, glass), only chemicals from the inside surface, directly in contact with the foodstuff, can migrate. Chemical diffusion from within the packaging material or from the outside (printing inks, adhesives) is not possible.
Non-inert materials, like paper and board or plastics, can be a direct source of migrants. Chemicals may also migrate from the outside through the packaging. An example are printing inks compounds that may migrate through paper into dry foods.
A special case of migration is SET-OFF migration, when outside layer of a food packaging (printed) can transfer chemicals to the inside, direct food contact layer when both layers are in direct contact with each other. Set-off migration occurs when printed film foil is stored in rolls, or when paper cups are stacked into each other.
The most comprehensive description and detailed migration testing rules is given by Plastic Regulation EU 10/2011. Safety assessment mechanism of plastic materials is based on use of migration limits. These limits specify the maximum amount of substances allowed to migrate to food.
For the substances on the Union list the Regulation sets out Specific Migration Limits (SML). These are established by EFSA on the basis of toxicity data of each specific substance. To ensure the overall quality of the plastic, the overall migration to a food of all substances together may not exceed the Overall Migration Limit (OML) of 60mg/kg food, or 10 mg/dm2 of the contact material.
Although migration testing in the food prevails, migration is usually tested using ‘food simulants’. These simulants are representative for a food category, e.g. Acetic acid 3 % is assigned for acidic foods, 50% Ethanol for milk and dairy products. Food simulants are used as substitutes for food due to the simplification of chemical analysis. Chemical detection and quantification requires specific analytical methods for each chemical of interest, specially developed for each food and food simulant type.
The migration testing is done under standardized time/temperature conditions, representative for a certain food use, and covers the maximum shelf life of packed food and special thermal treatment conditions.
To ensure the safety, quality and compliance of plastic materials, adequate data on the composition of (intermediate) materials has to be communicated via the manufacturing chain, up to but not including the retail stage. For this purpose a Declaration of Compliance (DoC) needs to be provided. The DoC is based on supporting documentation which documents the reasoning on the safety of a plastic food contact material, and which must be provided to enforcement Authorities on their request. The supporting documentation also provides an important link to the manufacturer’s responsibility under GMP (Regulation (EC) No 2023/2006).
NON-INTENTIONALLY ADDED SUBSTANCES
During the life cycle of food contact materials, unexpected and potentially harmful substances may migrate from packaging materials to food products. The term NIAS was introduced for plastic FCMs in the legal context (EU) 10/2011. However, NIAS are not limited to plastics but also occur in all other non-plastic FCMs. Article 3(9) of EU 10/2011 defines NIAS as an impurity in the substances used or a reaction intermediate formed during the production process or decomposition or reaction product. Thus NIAS have various sources, it may be side products, breakdown products, and contaminants. Side products are often formed during the production of starting substances and all further manufacturing stages. Polymers, fibers as well as additives (e.g., antioxidants, UV-stabilizers) are often degraded during manufacture and use, thus leading to various different breakdown products. Starting substances often contain impurities or environmental contaminants which may remain in the final FCM. Processing and especially recycling can also introduce many different contaminants in FCMs. Typical recycling-related NIAS are mineral oil hydrocarbons (MOHs), bisphenols, phthalates, and photoinitiators in recycled paper or flavor compounds, oligomers, and additives in recycled plastics.
According to the legislation, NIAS have to be assessed using scientifically recognized principles of risk assessment. Non-Intentionally Added Substances have to comply with the general safety requirements of Article 3 of Regulation (EC)1935/2004 and are subject to a risk assessment by the business operator in accordance with Article 19 of Regulation EU 10/2011.
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