Continuous research about purity and migration reveal doubts about chemicals in plastics for packaging and pharma.
- Human health and safety is a high focus area for global food producers and medical companies.
- Even the smallest concentrations of doubtful substances may be critical.
- More knowledge about health impact of chemicals are developed which may lead to new restrictions.
Food contact materials are regulated in EU No. 10/2011. This gives instructions to allowed monomers and additives. It also deals with the topic of Non Intentionally Added Substances
(NIAS) in plastics and states that all substances >10ppb shall be identified and accounted for.
During the last 25 years, several cases of questionable chemicals and NIAS have been published as illustrated in the above figure.
Regulation (EU) No. 10/2011 gives a clear definition for NIAS as any impurity in approved substances:
- Reaction intermediates formed during the production process
- Decomposition products
- Reaction products
The production of food contact materials (FCM) can never be free of NIAS. FCM are also often complex, e.g. multilayer, combinations of different materials with the use of adhesives and inks.
During our research project, “Chemicals in Packaging”, we have analysed NIAS in a wide range of plastics packaging. In most cases the results are very positive but some need deeper investigations.
Norner has high focus on these matters and provide support to customers and projects like:
- Analysis of additives and NIAS in plastics and packaging
- Migration testing and analysis
- Long term stability studies
- Investigation of contaminants
- Raw material consistency
- Resin change procedures
- Advisory by our experts in packaging, plastics, REACH and food or pharma regulations
We also continuously keep track of >500 plastic additives and their status in EU 10/2011, FDA and REACH.
Our liability services cover:
- Industry experts in polymers and additives
- Understanding the regulations
- Quantitative analysis of organic additives by GC or LC
- Quantitative analysis of inorganic additives by SEM/EDS
- Analysis of NIAS in polymers and packaging
- Migration analysis (EU/FDA)
- Food (EU/FDA), Reach and Pharma advisory
- Physical testing of the effect of additives
- Ageing / compatibility testing
- Compounding and extrusion