FAQ: Regulation (EU) No. 10/2011 - migration testing of TPS

At the end of March, our digital event took place, on Regulation (EU) No. 10/2011, focusing on a recommended course of action for migration testing of TPS. During the web seminar, as well as in the follow-up, our TPE experts were asked the following questions:

 

New regulations are introduced on a regular basis. Do you share these updates with your customers? 

KRAIBURG TPE is constantly monitoring the updates on the most relevant regulations internally as well as with the help of a professional service provider. Confirmation letters are up to date and reflect the latest amendment of regulations. Customers are welcome to request a current statement on the product purchased.



Which one is the relevant FDA chapter for your migration testing of TPS?  

In every statement on FDA food conformity issued by KRAIBURG TPE, relevant parts and sections of Code of Federal Regulations (CFR) 21 that apply to the product are mentioned. Various articles from the 21 CFR are important and it always depends on the constitution of product. Examples that apply are part 177.1520, 177.1640, 177.1810, 177.1820. 177.2600 is usually used for testing vulcanized elastomeres (rubbers). Generally, TPEs can be tested with 177.2600, however, this is not recommended as the test methods are not suitable and will (in most cases) lead to inconclusive and/or negative test results. 



How about food compliance for Mercosur?

Mercosur compliance is available upon request and will be issued individually.



Do you have experience on 1245/2020, and is this covered by EU 10/2011 for plastic materials?

Regulation (EU) Nr. 1245/2020 is the most recent amendment to Regulation (EU) Nr. 10/2011. It adds new or corrects existing entries to food contact materials and food contact substances to the original text of Regulation (EU) No. 10/2011. With our food contact statements KRAIBURG TPE covers the changes made by Regulation (EU) No. 1245/2020 as long as the statement explicitly gives a validity date later than 22 September 2022.



What should be considered when commissioning migration testing? 

The test conditions should correspond to the final application and be defined before the material selection. Good coordination can reduce the cost of testing and possibly prevent retesting. KRAIBURG TPE will be happy to assist you in selecting the test conditions.  

Will the Guideline be publicly available?

The Guideline is intended to enable laboratories in particular to select material-specific test conditions. For current projects in which material from KRAIBURG TPE is used, KRAIBURG TPE will make the Guideline available to the test laboratories involved. It will be published at a later date. 

What distinguishes the compounds of the "Controlled Migration" series compared to commercially available compounds?

The compounds of this series have been specially developed for contact with fatty foods; a whole series of applications have already been successfully implemented. Meeting food conformity requirements in the EU, the USA and China with one material is a special feature. Another special feature is the formulation conformity of our compounds for FDA CFR 21, which means that no additional migration tests are required. 

Can KRAIBURG TPE provide global migration values or can tests be carried out? 

KRAIBURGT TPE has carried out a large number of tests on sample sheets over the last few years. These results are available and show a very low migration level. KRAIBURG TPE works with trusted laboratories during development to assess compound migration.