Colour pigments, separating agents and additives: The interaction between foodstuffs and foreign substances carries certain risks. In order to minimise these risks and prevent any possible contamination, the European Commission introduced a new regulation in January 2011 on materials and matter made from plastic (regulation 10/2011).
EU regulation no. 10/2011 (PIM)
There are 885 source materials listed on the current Union list of monomers and additives authorised by the EU. Only these materials can be used for manufacturing of plastic products and materials. In order to minimise migration of materials and objects to foodstuffs, every manufacturer of plastic materials that may come into contact with foodstuffs must provide a declaration of conformity for their product. For a product to obtain this declaration, the material must undergo tests on migration values carried out by an independent institute. The object of the regulation is to control contact between plastics and foodstuffs and the traceability of the materials used, specifically addressed in EC regulation no. 2023/2006 (GMP): A material or object must be traceable throughout all possible manufacturing, processing and distribution stages, and at least to one upstream and one downstream stage.
When testing migration rates, a distinction is made between the OML (overall migration limit) and SML (specific migration limit). The OML is the highest quantity of a material or object authorised to be released into foodstuffs. The SML is the highest quantity of a specific substance authorised to be transferred into foodstuffs.
EU Regulation no. 10/2011 is an individual measure from EC framework regulation no. 1935/2004
Traceability via a 5-digit batch number on the delivery note
Quality systems, quality control systems and documentation are regulated under EC regulation no. 2023/2006, also known as the Good Manufacturing Practise regulation (GMP)
Wefapress tests migration using a testing sheet, as the specific application (e.g. contact medium, contact time and contact temperature) is not known. As Wefapress has no access to this information, we are not able to provide a final, conclusive assessment of migration values for components. The plant manufacturer or operator is responsible for providing this.
Wefapress play it safe
Wefapress already consider the EU requirements essential. The majority of our materials made from polyethylene (PE-UHMW and PE-HMW) meet EU regulation no. 1935/2004 and EU/10/2011. These products carry the Wefapress FSP (Food Secure Product) label. In addition to offering a range of tested materials, Wefapress is happy to test new materials in collaboration with our customers - even for small orders.
Material types that conform to EC regulation no. 1935/2004 and have been tested in accordance with EU regulation 10/2011: