EU Dossiers

We can help you with notifications for a wide range of new food contact substances. Our experts are on hand to explain what's required, recommend the most cost effective route and test protocols where applicable for your substance and application.

In Europe there is harmonised food contact legislation for plastics and regenerated cellulose films which incorporates positive lists of substances approved by EFSA. Additionally, a positive list is being developed for active and intelligent packaging. Positively listed substances are approved with restrictions where the available toxicology indicates there is the need to limit consumer exposure. In all cases positive listing requires the submission of a Technical Dossier to EFSA. This dossier contains details of the food contact substance and its manufacture, the food contact application, migration and associated toxicology studies and a reasoned argument for why the substance is safe in the proposed application.

Full support with  EU dossiers 

Smithers Pira will help you every step of the way:

  • Initial advice and guidance on the requirements for your products
  • Assistance with the required studies
  • Full preparation and submission of of dossiers on your behalf
  • Alternatively we can write up the migration and toxicology studies in the required formats to enable you to complete the dossier and submit it yourself.
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Understand more about Migration studies

The migration study is carried out under worst foreseeable conditions of use. Testing is therefore carried out on samples which are the thickest and contain the highest concentration of the new substance expected in actual usage. Test conditions need to reflect the highest temperatures of contact with, and longest times of exposure to, food. Impurities need to be considered as well as the substance itself. However, it is not always necessary to carry out actual migration testing. Sometimes a calculation of 100% migration or mathematical modelling will be sufficient, and these two approaches can save significant sums of money compared to actual migration testing. However, both mathematical approaches predict higher levels of migration than those found by testing, so testing is the most cost effective approach if it minimises the amount of experimental toxicology required.  In some situations migration testing can be replaced by hydrolysis studies using simulated gastro-intestinal fluids, a particularly effective approach if hydrolysis produces substances that have already been evaluated, thereby avoiding new toxicological studies.

How we can help: 
Smithers Pira carries out many such migration studies per annum and will recommend the most cost effective route, and test protocols where applicable, for your substance and application.
Contact our featured expert to find out more.

The amount of migration found is used to estimate consumer exposure. In the EU this is done quite crudely by assuming that the migration is equal to exposure. This consumer exposure is important because it sets the amount of toxicological testing that needs to be carried out to show that the substance is safe in its intended application. As the exposure increases so does the amount of experimental toxicology required and the associated cost. 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.

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How we can help: 
Smithers Pira does not perform experimental toxicology, however, we can manage the studies on your behalf saving you time.