Regulatory Declarations For Detectable Polymer Compounds And Masterbatches
SCOPIC detectable masterbatches and compounds are commonly used to manufacture polymer components that are utilised on or in the vicinity of food processing equipment. Some of these components are designed to have varying degrees of direct food contact, whilst others are designed with no direct food contact in mind at all. Regardless of the final application, the fact that detectable polymers are used in and around food processing equipment means that the regulations relating to how the components behave when in contact with food are a key consideration.
The end-user of the final article, into which SCOPIC technology is incorporated, must ensure compliance with all applicable regulatory requirements, including application(?) limitations and migration testing, to allow use in the specific end-use conditions. However, this process can be made much easier and the masterbatch, compound or additive used with much more confidence if it is supported by a sound regulatory declaration, under a defined set of conditions.
Whilst understanding that not every material, application and operating condition can necessarily be accounted for, Radical Materials wanted to ensure that solutions offered were backed by such sound declarations in two very different areas:
EU – Common masterbatches/additives have been tested (at higher concentrations than the guidelines for normal usage) and compliance reported for migration limits of relevant substances according to EU 10/2011, under specific conditions listed in the respective declarations. All materials offered, comply with the requirements of the Framework Regulation: Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food, as amended.
USA – Rather than relying upon generic statements, it was again decided to provide a worst-case and more meaningful approach by performing actual migration testing on the range of detectable additives utilised in SCOPIC solutions. Again, specific conditions of testing are described in the full reports, but results indicated that, under these conditions, all additives would meet the regulatory requirements for 21 CFR 170.39 ‘Threshold of regulation’ for substances used in food-contact articles.
All statements and conditions are available on request and help support the final product’s regulatory assessment.
If you’d like to learn more about how SCOPIC can help you solve your X-ray and metal detectable challenges, contact us to talk to one of our experts.