SGS Helps Manufacturers Comply with EU Regulations Concerning NIAS in Food Contact Materials

SGS assists manufacturers of food contact materials comply with European regulations on non-intentionally added substances.
( | Press Release | 2018-06-11 16:56:46 )
Non-intentionally added substances (NIAS) are currently a hot topic for manufacturers of food contact materials (FCM). NIAS, unlike intentionally added substances, are found in products without the knowledge of the manufacturer, making it difficult to ensure legal compliance.

NIAS can originate from several different sources, such as:
• Impurities coming from the starting materials
• Degradation reactions of the polymer itself and of additives
• Contaminants originating from recycled materials of FCMs

FCMs can be manufactured by using different adhesives and polymers, which can be coated by varnishes and printing inks. In some instances, high temperatures and high irritation energies occur and expose degradation of the polymer to low molecular weight compounds, such as alcohols, aldehydes, ketones and acids. For instance, within the thermal degradation of polyethylene terephthalate (PET), formaldehyde and acetaldehyde is formed. Acetaldehyde will affect the quality of mineral water in terms of both odor and taste. In addition, antioxidants, such as Irgafos 168, Irganox 1010 or tris(nonylphenyl)phosphite (TNNP) are added to the polymer to protect it from heat and oxygen ageing during their own degradation. Printing inks contain azo dyes and form, under certain conditions, primary aromatic amines - compounds that may have adverse effects on consumer health.

The complete list of possible NIAS in packaging materials is seemingly endless, and yet, manufacturers have a legal obligation to ensure consumers are protected from the harmful effects of NIAS. In Europe, this is enshrined in:

• Regulation (EC) No 1935/2004 – general requirements for FCM concerning the release of constituents into food. Quantities should not:
o Endanger human health
o Bring about an unacceptable change in the composition of the food
o Bring about a deterioration in the organoleptic characteristics of the food at any stage of the manufacturing process
• Regulation EU 2023/2006 – Good Manufacturing Practice (GMP) for materials and articles intended to come in contact with food includes a general framework to ensure the safety of the end product is not compromised
• Regulation EU 10/2011 – defines NIAS in terms of definition and legal requirements: “Non-intentionally added substance’ means an impurity in the substances used or a reaction intermediate formed during the production process or a decomposition or reaction product.

EU 10/2011 also notes NIAS in FCM are subject to a risk assessment. For manufacturers, the problem is toxicological data is not always available for every substance.

One approach to overcoming this problem is to apply the threshold of toxicological concern (TTC), based on the Cramer rules, and recommendations of the European Food Safety Authority. TTC estimates the theoretical toxicity in accordance with the chemical structure. Compounds are classified according to EFSA as follows, with the accepted TTC value presented as μg/kg body weight per day:
• Carcinogens:
o Genotoxicity Alert - 0.0025
• Non-carcinogens:
o Neurotoxicity Alert - 0.3
o Cramer Class II and III substances - 1.5
o Cramer Class I – 30

SGS offers a range of services to help manufacturers and suppliers of FCM ensure their products comply with relevant regulations required by target markets around the world. To deal with the special challenges associated with NIAS, SGS has developed a special analytical approach to help ensure stakeholders achieve compliance with EU rules.

SGS Food Contact Materials Services
SGS technicians provide expertise and the full range of tests associated with materials and articles in contact with food. They work to ensure that your products meet the appropriate regulations for food contact materials and pave the way for compliance with regulations enforced around the world. Learn more about SGS’s Food Contact Material Services (

For further information, please contact:
Dr. Anja Eichler
Customer Service Consultant CRS NonFood - Hardlines
Tel: +49 6128 744 172

About SGS
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 95,000 employees, SGS operates a network of over 2,400 offices and laboratories around the world.

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Ben Christie

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