To mark the end of our blog series that highlighted the changes made to EU No. 10/2011, Eric Andrews, our Technical Services Manager, will discuss the changes made to Annex V.
This portion outlines the EU’s general approach to migration testing of additives from plastic materials and articles over the course of four chapters which include:
This chapter briefly describes the process for testing materials and articles that actually have or currently contain food using analytical methodology defined in Article 11 of Regulation (EC) No 882/2004. The goal of this brief chapter in Annex V is to standardize testing of food-contact products that are removed from the shelf and tested after the manufacturer’s prescribed shelf life or as a way of conducting a final check of the FCM before it hits the retail market.
This is similar to the FDA Guidance for Premarket Submissions, which describes temperature and time conditions of use as well as food simulants to be used as surrogates for real food in all theoretical categories of application.
Also, similar to the FDA, sponsors are encouraged to conduct migration testing under the worst foreseeable conditions, erring conservatively in declaring conclusions about the testing and a product’s suitability for its intended use.
Materials and articles intended for contact with all types of food shall be tested with certain food simulants defined in the tables included in the chapter, while materials and articles intended only for specific types of foods shall be tested with the food simulants indicated for the food types in Annex III of the regulation.
Regarding the tables, there are numerous tiers for contact temperature and time which must be considered when outlining a migration test – both of which are conservative by design: e.g.: if the intended use is at or greater than 40 degrees C but not exceeding 70 degrees C, then testing must be conducted at 70 degrees C, flat for the entirety of the study.
Similar to the FDA, the regulation describes accelerated testing for applications involving contact times greater than 30 days. Mathematical extrapolation guidance is provided according to an equation and its terms in this section. Ten days is the minimum length of time to elapse in order to calculate results for contact times greater than that.
Repeat use articles are mentioned with two major stipulations: migration testing be conducted on the same article three individual times in succession with fresh portions of simulant for each test, and that while only the third test in succession shall be used to declare compliance of the repeat use article, any applicable specific migration limits found in Annex I must be obeyed.
Chapter 2 ends with a subsection devoted to the definition of screening alternatives to the premier verification methodology by migration testing.
There are several alternatives including migration modelling which are all considered to be more severe than verification migration testing and are typically designed for situations in which it is impossible to utilize food or food simulant in conjunction with a quantification method.
This chapter continues with conceptualizing overall migration (OM) testing. Beyond the aforementioned specific migration (SM) testing and limits of particular components of FCM, the overall migration limit – the sum of the migration of all (non-volatile) components – must be obeyed. OM testing is a tiered system wherein the more intense testing allows for comment on all others below it: OM6 and OM7 both cover conditions of OM1-5, for example.
OM testing as stated above can be used as a tool to adjust for specific migration testing in situations where it is challenging to test accurately or if the assumption of OML = 10 mg per 1 dm2 is to be logically contested.
Chapter 4 incorporates correction factors that can be seen as the equivalent to US FDA “reduction factors,” in specific situations, including more conservative rules for products intended to come into contact with food for infants and children, and for substances that are lipophilic intended to come into contact with fatty food, but which will not be consumed at a rate setup for lipophobic substances.
Finally, food simulants and specific correction factors are commented on which need manual adjustments based on specific situations.
All in all, this is a great crossover between the US and EU in terms of how these parameters are designed. Migration testing on the whole is relatively universal in how it’s based on internationally-accepted scientific principles.
The changes to Annex V within the amendment to EU 10/2011 are many, but relatively subtle.
Many of the OM tests have been tweaked to better reflect real world applications in terms of exposure time, temperature settings and food simulant types.
These are referenceable by the sponsor in situations where OM testing is to be performed and it’s highly recommended that one consult the synopsis of these changes before proceeding with testing.
The changes mentioned are nicely packaged together on page 14 of 17 of the amendment document.
Besides OM testing, repeat use article testing is elaborated on in how the triplicate testing is conducted.
In the previous iteration, emphasis wasn’t placed fundamentally on the requirement for migration test one to result in the greatest “amount” of migration than subsequent tests two and three.
So, while it hasn’t changed that compliance of the material is based on the third migration test performed, the stability of the material will be considered insufficient if there is an increase in migration from the first test to the second or from the second test to the third. Effectively there are two requirements now, to include a caveat that migration must always be decreasing in repeat use scenarios.
Thank you to those who have followed us through these posts and if you’re interested in learning more about how our team at CSS can help manage these changes for your business, contact Kelly Schaefer.