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		Abstract
	
	
Food Contact Materials (FCMs) are produced and marketed worldwide global value in excess of 400.20 billion dollars. All FCMs have to be safe and guarantee the safety and security of food in contact with them. Specific regulations, which establish the rules for all materials, exist in different regions, which implies that the same material has to comply with different limits depending on the region in which it is distributed and marketed. This paper reviews differences and similarities between the FDA, EU, MERCOSUR, India, China, Japan and Thailand. Various areas essential for a risk assessment are compared. Requirements for testing substances or materials is an area where there are divergencies or commonalities. Harmonization of regulations and procedures is needed, as humans are the same, independently of where they live, and the substances released by the FCMs are the same. The same protocols and procedures are not applied worldwide, but the results are essential for the risk assessment of FCMs. Examining the approaches of different regions showed that there is room for harmonization in many areas, to obtain a more harmonized risk assessment and facilitate subsequent risk management. This review establishes the main areas of risk assessment of FCMs, compares the main regulations in different regions and discusses the essential areas that influence their global risk assessment and provides a guide to help to the development of the relevant research field and industry. Some examples and proposals for the main areas for harmonising risk assessment globally, are given.
			
							Read the full paper
					
	
This work was commissionned by the Packaging Materials Task Force

		One pager
	
				
				
				


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                    [post_title] => An Overview of Approaches for Analysing NIAS from different FCMs
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                    [post_content] => 

		
		Packaging Materials Task Force
		
	

		
		SMART PACKAGING
		
	
	
There are numerous approaches and methodologies for assessing the identity and quantities of non-intentionally added substances (NIAS) in food contact materials (FCMs). They can give different results and it can be difficult to make meaningful comparisons. The initial approach was to attempt to prepare a prescriptive methodology but as this proved impossible; this paper develops guidelines that need to be taken into consideration when assessing NIAS. Different approaches to analysing NIAS in FCMs are reviewed and compared. The approaches for preparing the sample for analysis, recommended procedures for screening, identification, and quantification of NIAS as well as the reporting requirements are outlined. Different analytical equipment and procedures are compared. Limitations of today's capabilities are raised along with some research needs.
	
Link to download the full-text
			Keywords
							Expand
		
Food contact materials; NIAS; chromatographic methods; food packaging; migration; non-intentionally added substances; plastics


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                    [post_content] => 

		
		Process-Related Compounds and Natural Toxins Task Force
		
	

		FOOD RELATED CONTAMINANTS
	
	
Mineral Oil Hydrocarbons may unintentionally contaminate food through different routes across food chains and the lifecycle of food contact materials.
Gaps in the knowledge about mineral oil hydrocarbons (MON) still exist despite the recent advances in the research field.
A workshop to identify those gaps was organized by the European Branch of the International Life Science Institute.
Some of these were identified to be:

the lack of validated and standardized analytical methods for relevant food matrices, and
gaps in assessing the risk for consumers' health.

The consensus is that the lack of standardized, validated analytical methods able to assure good inter-laboratory reproducibility is the main gap underlining most of the existing difficulties to understand MOH.
In order to conduct adequate substance identification and quantification for input into risk assessment, the need for confirmatory methods that provide a detailed characterization of the unresolved complex mixtures needs to be solved.
The limited number of surveys covering a wide range of foods and enough samples to detect major sources of contamination other than packaging in paperboard also hinders reliable exposure estimation.
				

		Decision tree to identify auxilary methods. (Adapted from Bratinova & Hoekstra, 2019)
	
			
 Industry sectors represented in the workshop
 
Food & Drink
Mineral Oil/Waxes
Testing Laboratories
Analytical Instruments
Food Contact Materials
Cosmetics
Petroleum
		
	
Read the full-text article here
			Scientific abstract 
							Expand
		Background

In recent years there have been significant advancements in the understanding of mineral oil hydrocarbons (MOH) in foods and their potential risk to health. However, important gaps in knowledge remain, such as the lack of validated and standardized analytical methods for relevant food matrices and gaps in assessing the risk for consumers' health.
Scope & approach

A workshop was organized by the European Branch of the International Life Science Institute to identify knowledge gaps in analytical methods, assessment of exposure, hazard characterisation, and risk assessment of MOH. This work captures the outcome of the workshop and builds upon it by combining the perspectives of the participants with an updated review of the literature to provide a roadmap for future management of the topic.
Key findings and conclusions

Most participants to the workshop agreed that the key issue underlying many of the knowledge gaps in the field of MOH risk analysis and management is the lack of standardized, validated analytical methods able to assure good inter-laboratory reproducibility and to enable understanding of MOH occurrence in foods. It has been demonstrated that method EN 16995 used for MOH determination in vegetable oils and fats is not reliable below 10 mg/kg of food. There is also a need for confirmatory methods that provide a detailed characterization of the unresolved complex mixture observed from one-dimensional chromatographic methods. This is required to enable adequate substance identification and quantification for input into risk assessment. A major gap in the exposure estimation is the limited number of surveys covering a wide range of foods and enough samples to detect major sources of contamination other than packaging in paperboard. Data on concentration of MOH fractions in human body needed to determine internal exposure estimates is scarce. Data relating concentration in tissues with personal data, lifestyle, food intake and the use of cosmetics are needed to clarify the complex system of distribution of MOSH in the body and to possibly establish relationship between external and internal exposure. Additional toxicological studies to better characterize the hazards of relevant MOH are required for a better human health risk assessment.
			Keywords
							Expand
		
Mineral oil hydrocarbon, Risk assessment, Exposure assessment, Food contaminant, MOSH, MOAH
					Number of participants in the workshop
		61
					from Academica, Public organisations, and Industry.
					EN 16995 used for MOH determination in vegetable oils and fats is not reliable below
		10
					mg/kg of food.
					Main indetified gaps in the knowledge of Mineral Oil Hydrocarbons
		8
	
To enable human risk assessment, the performance of toxicological studies on the relevant MOH mixtures and possibly their components is required.
	
This work was conducted in collaboration with the Packaging Materials Task Force.


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                    [post_title] => Value and limitation of in vitro bioassays to support the application of the threshold of toxicological concern to prioritise unidentified chemicals in food contact materials
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		Abstract
	
	
Food Contact Materials (FCMs) are produced and marketed worldwide global value in excess of 400.20 billion dollars. All FCMs have to be safe and guarantee the safety and security of food in contact with them. Specific regulations, which establish the rules for all materials, exist in different regions, which implies that the same material has to comply with different limits depending on the region in which it is distributed and marketed. This paper reviews differences and similarities between the FDA, EU, MERCOSUR, India, China, Japan and Thailand. Various areas essential for a risk assessment are compared. Requirements for testing substances or materials is an area where there are divergencies or commonalities. Harmonization of regulations and procedures is needed, as humans are the same, independently of where they live, and the substances released by the FCMs are the same. The same protocols and procedures are not applied worldwide, but the results are essential for the risk assessment of FCMs. Examining the approaches of different regions showed that there is room for harmonization in many areas, to obtain a more harmonized risk assessment and facilitate subsequent risk management. This review establishes the main areas of risk assessment of FCMs, compares the main regulations in different regions and discusses the essential areas that influence their global risk assessment and provides a guide to help to the development of the relevant research field and industry. Some examples and proposals for the main areas for harmonising risk assessment globally, are given.
			
							Read the full paper
					
	
This work was commissionned by the Packaging Materials Task Force

		One pager
	
				
				
				


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