Migration Studies for Regulatory Submissions

We can help you with notifications for a wide range of new food contact substances. Our experts are on hand to explain the process and the support we offer.

In many jurisdictions around the globe the Food Contact legislation contains lists of approved substances which have been positively evaluated by the regulatory authorities. These are often referred to as positive lists. The process for adding a new substance to a positive list varies in detail between regulatory authorities, however, in general it comprises a migration study, a toxicology study and a notification or dossier containing all the required information.

Food Contact TestingSmithers Pira can help you with notifications of:
  • A broad range of new food contact substances including polymers, additives, papermaking chemicals, can coating chemicals and colorants to the FDA.
  • Monomers and additives to the European Food Safety Authority (EFSA) for inclusion in the EU legislation on plastics in contact with food.
  • Active and intelligent ingredients to EFSA for inclusion in the EU legislation on active and intelligent packaging according to EC Regulation 450/2009.
  • Papermaking chemicals to the German national authorities.
  • Colorants to the French national authority.

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Find out more about notifications for new food contact substances

The migration study gives the level of consumer exposure and can be completed by calculation, mathematical modelling or actual migration experiments. Which is the most cost effective depends on the resulting level of consumer exposure. Calculation always gives the highest, actual experiments the lowest, and modelling falls between these two. Smithers Pira carries out many migration studies per annum and will recommend the most cost effective route, and test protocols where applicable, for your substance and application.

The toxicology study shows that your substance is safe at the level of consumer exposure found in the migration study. Experimental toxicological requirements, and hence costs, increase with the level of consumer exposure. For this reason it is sometimes beneficial to carry out a migration study to give the lowest, and most realistic, estimate of exposure and minimise the toxicological requirements. Smithers Pira does not perform experimental toxicology, however, we can manage the studies on your behalf saving you time.

The dossier or notification contains the results of migration and toxicology studies, physiochemical data on the substance, details of the manufacturing process and a reasoned case for why the regulator should consider the substance to be safe in its proposed application. Smithers Pira can prepare and submit dossiers on your behalf or just write up the migration and toxicology studies in the required formats to enable you to complete the dossier and submit it yourself.

Technical dossiers of a different sort are also required for approval of recycling processes in the EU and Smithers Pira can help you with the part that involves determination of the decontamination efficiency of the recycling process, often referred to as challenge testing since it involves "challenging" the process with a plastic deliberately contaminated with surrogate contaminants. We can also help you carry out challenge testing of processes according to FDA guidelines.