The hazard would be given by toxicological profile and exposure is from the quantity subjected to.
In today’s (Thursday) webinar on “Risk assessment in the supply chain“ Monika Tönnießen gave an overview about regulatory requirements and what to consider in risk assessment.
She said that product placed on the market must be safe and not exceed migration restrictions, adding that it is a very important topic for customers.
Hazard risk and exposure count
Tönnießen cited the example of sugar as a hazard being low as it can be easily eaten without problems but if the exposure is high because you eat a lot of sweets, then you can end with high risk of illnesses such as diabetes.
The roles in different parts of the supply chain for raw material suppliers, adhesive producers, packaging producers, fillers of the packed food and consumers were identified.
“The material flow is from left to right but the information flow is in both directions because the better information in the chain the better the risk assessment in the supply chain,” she said.
Tönnießen said risk assessment formed different evaluations of raw materials, adhesive, migratable substances and the final adhesive in the end packaging.
She said the firm gives a questionnaire to their suppliers to get the required information.
This includes listing all substances that may migrate, any nanoparticles and if the substances are listed in food contact legislation.
“If it is not sufficient we need to go to an analytical assessment to manage the risk to see if the raw material is suitable for use in food packaging. If the information is still not sufficient it must be rejected for use as a food contact adhesive,” she said.
Tönnießen said people often ask if there is no European Union (EU) legislation for food contact, how the firm assess risk and is it necessary to do so.
She said that while in the EU there is no specific legislation on adhesives in food contact, there is applicable legislation.
Safe food packaging has to protect foodstuff against impact from outside, she said, citing article 14 of European Commission regulation 178-2002 stating that “food shall not be placed on market if it is unsafe”.
EC Framework 1935/2004 and good manufacturing practice EC 2023/2006 also apply for adhesives.
Adhesive producer angle
Tönnießen said as an adhesive producer they must check the formulation to see if it has suitable raw material for the intended application.
She said the firm looks at what is coming out from formulations such as migratable substances and the overall migration limit. If there non-intentionally added substances (NIAS) and ones that might change the organoleptic characteristics of food.
“Is the information sufficient about the formulation? If yes it is suitable for a food packaging adhesive and we can go further. If it is not sufficient we must overcome questions by analytical assessment and go on or if risk is not manageable and the formulation contains substances not suitable for food contact it must be rejected for this application.”
Substances that may migrate are listed in EU legislation 10/2011 or the firm checks BfR or FDA recommendations.
The packaging producers’ role includes checking that the adhesive is technically suitable depending on the final food packaging (paper, board, foil) and packaging components (printing inks).
Whether the barrier between adhesive and food packaging is a total barrier (e.g. glass) or functional barrier (e.g. plastic) influences the need for migration modelling to check specific migration limits (SML) of substances.