Besides the substances with a specified technical role in the manufacturing (IAS = intentionally added substances), manufacturers must identify and evaluate non-intentionally added substances (NIAS), currently a hot topic in the FCM industry.
What are NIAS?
FCMs often contain a panel of NIAS. These can originate from several different sources, such as impurities in the starting materials, the products of chemical reactions, and degradation products created during the manufacturing process. There is a seemingly endless list of NIAS originating from different packaging materials – major representatives are shown in Table 1.
Table 1: Representatives of NIAS and their origins.
|Alcohols, Aldehydes, Ketones, Acids||Oxidation products generated during the extrusion process|
||Degradation products of polyethylene terephthalate (PET) due to thermo-mechanical and thermo-oxidative conditions|
|Limonene||Impurity of post-consumer PET recyclate|
|Primary aromatic amines||
|Nonylphenol, Octyphenol||Degradation of antioxidant tris(nonylphenyl)phosphite (TNNP) used for instance in material polyvinyl chloride (PVC)|
||Degradation of antioxidant, e.g. Irgafos 168 , Irganox 1010|
According to EU Regulations (EC) No 1935/2004, EU 2023/2006 and No 10/2011, manufacturers of FCMs are obliged to ensure NIAS safety.
General requirements for FCMs are set out in Regulation (EC) No 1935/2004, which addresses the release of constituents into food and requires that quantities do not:
- Endanger human health
- Bring about an unacceptable change in the composition of the food
- Bring about a deterioration in the organoleptic characteristics of the food
In this context, Regulation EU 2023/2006 on Good Manufacturing Practice (GMP) for materials and articles intended to come in contact with food lays down a general framework to ensure that at no stage of the manufacturing process is the safety of the end product compromised.
EU Regulation No 10/2011 deals with materials made of plastics and is the first Regulation introducing NIAS in terms of the definition and the legal requirements. In article 3 of Regulation No 10/2011, NIAS are defined as:
“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.”
In the scope of Article 19 of Regulation EU 10/2011, NIAS are subject to a risk assessment.
To assess risk, it is important to understand what makes a substance, or poison, a risk to human health. The father of toxicology, Paracelsus, stated:
“Poison is in everything, and no thing is without poison. The dosage makes it either a poison or a remedy.”
In essence, all substances have the potential to harm humans if exposure is at a sufficient level.
For FCM, the problem is the toxicological data for some substances is not available. One way to overcome this, is to apply the threshold of toxicological concern (TTC) based on the Cramer rules (Cramer et al. 1978) and recommendations of the European Food Safety Authority (EFSA, 2012, 2016). TTC estimates the theoretical toxicity in accordance with the chemical structure. Compounds are classified according to EFSA as follows (Table 2):
Table 2. Overview of human exposure threshold values based on chemical structure.
|TTC value (μg/kg body weight per day)|
|Cramer Class II and III substances||1.5|
|Cramer Class I||30|
SGS Solutions: Identification and evaluation of NIAS in FCMs
SGS offers a range of services to help manufacturers and suppliers of FCMs ensure their products comply with the regulations required by target markets around the world.
Since there are specific challenges associated with the testing for NIAS, SGS experts support manufacturers and suppliers by using state-of-the-art testing facilities and high-level technical know-how in the analysis and evaluation of NIAS originating from FCMs as follows (Scheme 1):
Scheme 1: Services of SGS concerning NIAS.
Within this approach, SGS helps manufacturers and suppliers of FCMs to achieve compliance with EU regulations.
For further information, please contact:
Dr. Anja Eichler
Consumer and Retail
Customer Service Consultant CRS NonFood - Hardlines
SGS INSTITUT FRESENIUS GmbH
t: +49 6128 744 172