Meaning
A legislative clause defines the conditions under which non-listed plastic layers can be used behind a functional barrier in food-contact materials. Under the provisions of regulation eu 10 2011 article 13, unlisted substances may be utilized if their migration into food remains below the established threshold of safety.
Compliance Requirements
The rule prohibits the use of mutagenic or carcinogenic substances in these non-contact layers. When operating under regulation eu 10 2011 article 13, processors must ensure that the multi-layer structure prevents any detectable migration of these hazardous substances into the foodstuff. This requirement is intended to protect consumers while allowing the use of recycled materials in the core of the packaging sheet.
Analytical Testing
Moulders must perform migration studies or use mathematical modeling to prove compliance with this clause. To satisfy the demands of regulation eu 10 2011 article 13, the migration of non-listed substances must not exceed 0.01 milligrams per kilogram of food or food simulant. This low concentration requires highly sensitive analytical techniques such as gas or liquid chromatography paired with mass spectrometry.
Industrial Compliance
Quality assurance departments must maintain detailed documentation of the barrier’s effectiveness. Complying with regulation eu 10 2011 article 13 requires a complete declaration of compliance that can be audited by food safety authorities.
