Tagi Oferty: Packaging Testing

Consultancy Services

J.S. HAMILTON POLAND IS:

  • a leading laboratory in testing of packaging for food, cosmetics and pharmaceuticals in Central & Eastern Europe,
  • an independent research center offering knowledge and experience as well as a wide range of analytical methods,
  • a reliable Partner of Food, Packaging, Plastics Processing and Paper Industry,
  • expert team ensuring impartial assessment of the Quality, Compliance and Safety of Products.

We support our Partners’ business growth and development, confirm their credibility, responsibility & innovation.

J.S. Hamilton Poland Sp. z o.o. is a laboratory that comprehensively combines consultancy services with comprehensive analytical research. Our experts team ensures an independent assessment of the quality of products.  The central laboratory in Gdynia and a network of specialized local laboratories have been offering a wide range of accredited physic-chemical, microbiological and sensory analyzes since 1949.

J.S Hamilton’s experts advise the appropriate and optimized configuration of testing plan in order to ensure compliance with the relevant national and European safety regulations, as well as with specific requirements of  clients, organizations, Brand Owners and retailers.

We offer the following consultancy services:

  • documents review and verification,
  • set-up of optimized testing plans for compliance assessment,
  • compliance assessment based on EU 10/2011, Swiss Ordinance, BfR Recommendations and relevant, Industry Guidance (EuPIA, CEPI, FCA, FEICA, JRC, EFSA, EDQM)
  • toxicological risk assessment – e.g., by TTC-concept method,
  • drafts of DoC (Declaration of Compliance) for final FCMs,
  • trainings.

Food comes into contact with many materials and articles during production, processing, storage, preparation and serving, before its eventual consumption. Such materials and articles are called Food Contact Materials (FCMs). Food contact materials are either intended to be brought into contact with food, are already in contact with food, or can reasonably be brought into contact with food or transfer their constituents to the food under normal or foreseeable use. This includes direct or indirect contact.

Food contact materials (FCMs) are widely used in everyday life in the form of food packaging, dishes and utensils, tableware, food containers, etc. When put into contact with food, the different materials may behave differently and transfer their components to the food. If transferred in large quantities, many chemicals might endanger human health, or change the food itself. Therefore, food contact materials are subject to legally binding rules at EU level, currently laid down in Regulation (EC)1935/2004, which aims at ensuring FCM safety but also the effective functioning of the internal market in FCMs raw materials and final products. The purpose of this framework legislation for FCMs is to ensure the effective functioning of the internal market for materials and articles intended to come into contact with food and secure a high level of protection of human health, as well as the interests of consumers.

(EC)1935/2004 provides general requirements that all FCMs must be manufactured in accordance with good manufacturing practice (GMP) so that they are safe and do not change the properties of food in unacceptable ways. As the general requirements for all FCMs set out under Article 3 are linked to the general obligations on GMP, separate rules on GMP are laid down in Commission Regulation (EC)2023/2006. It also specifies other rules, including those on labelling and on compliance documentation and traceability, and lays down the risk assessment process involving EFSA as part of the authorization process for substances.

 

The following are examples of key legislation currently binding in Europe:

EU FCMs requirements overview
 

General Regulations on FCM
Regulation EC 1935/2004 (on materials and articles intended to come into contact with food)
Regulation EC 2023/2006 (on Good Manufacturing Practices)
 

Specific Materials
Ceramics Directive 84/500/EEC
Epoxy Resins Regulation (EC) 1895/2005
Regenerated Cellulose Film Directive 2007/42/EC
Recycled Plastics Materials Regulation (EC) 282/2008
Active and Intelligent Packaging Regulation (EC) 450/2009
Plastics Regulation (EU) 10/2011
 

Specific Regulations
Regulation (EU) 321/2011 (restricting the use of bisphenol A in polycarbonate infant feeding bottles)
Regulation (EU) 284/2011 (import procedures for polyamide and melamine plastic kitchenware from China and Hong Kong)
Regulation (EC) 1895/2005 (restricting the use of certain epoxy resins)
Directive 93/11/EEC (regulating the release of N-nitrosamines and N-nitrosatable substances from rubber teats and soothers)

 

The declaration of compliance (DoC) is a document that contains basic information about FCMs as required by applicable laws. The DoC should contain information about the following:

  • who manufactured or imported the materials or articles or the raw materials intended for their manufacture,
  • what they are,
  • date of the declaration,
  • confirmation that the materials or articles meet relevant requirements laid down in Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food and in any specific measures,
  • information about the compliance of substances used that are subject to any restrictions and/or specifications that will allow the downstream businesses ensure compliance with those restrictions,
  • information about the compliance of substances subject to a restriction in food, about the level of their specific migration and, where appropriate, purity criteria to enable the user of these materials or articles to comply with the law,
  • specifications on the use of the material or article, such as:
  • type or types of food it is intended to be put in contact with,
  • time and temperature of treatment and storage in contact with the food,
  • ratio of food-contact surface area to volume used to establish the compliance of the material or article,
  • confirmation that the material or article complies with any rules on functional barriers when one is incorporated into the material or article.

 

Plastics packaging and materials

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.

Has this article been interesting to you? Contact us for more detail – or schedule tests for your plastic packaging and contact materials.