FAQ about

Food & Food Contact Materials

Challenges you might face...and where our team can help!

knoell Food and Food Contact Materials

If your substance of great interest is not listed on any positive list and it is possible to carry out a self-risk assessment. What is needed in terms of toxicological data / information? When is it possible to involve Quantitative Structure-Activity Relationship (QSAR) and when the Threshold of Toxicological Concern (TTC) approach? Our toxicologists will support to determine the self-derived Specific Migration Limit (SML) and help with establishing the safety level of your substance of interest.


Your substance is listed under the Generally Regarded As Safe (GRAS) programme with the United States (US) Food and Drug Administration (FDA), but you intend to use it as a Food Contact Substance (FCS) with a new use in making food contact materials (FCM). Should you consider a Food Contact Substance Notification (FCN) with US FDA? If so, when exactly?

Your customer is asking you to provide a Declaration of Compliance (DoC) document for food packaging in Canada. What should you do? Do you need to obtain for a Letter of No-Objection (LONO) from Health Canada? If so, which LONO, Category 1 or 2? 

Your substance of interest is not listed in MERCOSUR (= Mercado Común del Sur) in the GMC Resolution No. 39/19 (plastic materials and polymeric coatings in contact with food), which covers your intended use. What to do? Under which conditions is it possible to perform a self-risk assessment of your substance and not apply for an authorisation?  


Your substance of interest is listed in a positive list in Belgium allowed to be used in manufacturing rubber for food contact materials, but is not listed in your own country (EU Member State) of interest. Do you need a new application in your own country?

Is your facility used for the manufacturing of FCM compliant with Good Manufacturing Practice (GMP) Regulation in the European Union (EU) No. 2023/2006? If not, do you need an external audit to be carried out at your facility, helping on having a GMP compliance certificate issued?

What to do after Brexit if your substance is listed in Annex I of Regulation (EU) No. 10/2011?  Do you need a new application in UK? If so, when exactly?

You have a substance and intend to use it in manufacturing of a printing ink for indirect food contact in Switzerland. Can you apply for a listing in Appendix 10, List B, of the Swiss Ordinance 817.023.21? If so, under which conditions?

You have identified analytically that a number of different Non-Intentionally Added Substances (NIAS) migrate from a plastic Food Contact Material into food/food simulant, considering the intended conditions of use. What to do next, and how to comply with the risk assessment requirements indicated in Art. 19 of the Regulation (EU) No. 10/2011 ?

You have developed a Novel Food and you want to obtain authorisation for the EU market in accordance with the new Novel Food Regulation (EU) No. 2015/2283. Which are the steps that need to be undertaken in this process, and what data requirements are applicable for such a Novel Food application in the EU?

Your company has developed a new antioxidant and you need to have an authorisation in the EU for this particular food improvement agent under the Regulation (EC) No. 1333/2008. What are the data requirements and the steps to be taken to obtain such an EU authorisation for this new food additive ?


Your substance is listed in Table A.2 of the Chinese Standard GB 9685-2016, but has not been approved to be listed in Table A.1, which covers your use of interest. When is it possible to cross-reference and under which conditions? Do you need to submit a new application to the National Health Committee (NHC) of China to extend the use or not?

Your substance is a pigment added to an already listed base resin, intended to be used in the manufacturing of Utensils, Containers and Packaging (UCPs) in Japan. Do you need to apply for an authorisation at the Ministry of Health, Labor and Welfare (MHLW) in Japan for such a pigment to get it listed, too? Under which circumstances is such an application not required?