Whether in contact with food, in medical technology and pharmacy, for personal care products, toys or household goods, if plastics are used there are lots of legislations, specifications, regulations and limit values to be adhered. Hardly any set of rules is as comprehensive as the EU Plastics Directive. The requirements to be complied with have been extensively documented in numerous amending directives, positive lists for additives and monomers, specified limit values for individual substances and details on the scope of declarations of conformity. For seal materials, these include the fact “... that under normal, foreseeable use conditions, no components migrate from the seal material to food in amounts which are suitable for posing a risk to human health ...”. Furthermore, it must not be possible “... that an unacceptable alteration in the composition of food is achieved ...”, nor may the organoleptic properties – odor, taste, appearance – be impaired. What has been defined so comprehensively for seal materials applies for all items made of plastic which come into contact with food. As these plasticizing additives can be eluted by grease or liquids from plastics which are PVC-based and contain phthalates or other plasticizers, limit values were defined at an early stage in order to protect consumers. Initially, the EU handled this migration problem in the form of the framework regulation 1935/2004, followed by the 4th amendment directive to the 2007/19/EC Plastics Directive and finally, the so-called Super-Regulation and the Plastics Implementation Measure or PIM. In the form of stringent regulations with regard to the migration limits to be maintained – global and specific migration – traceability, declarations of conformity and realistic migration tests.
Whether storage containers, chopping boards, plates, mixing bowls, knife handles or drinking cups – if an item manufactured from plastic comes into contact with food in any way, the manufacturer need to be aware of and adhere to these legislations, specifications, regulations and limit values. Ideally relying on a partner availing of extensive knowledge of this material. Such as Actega DS, a specialist in the manufacture of TPE plastic granulates certified for applications which come into contact with food, for example. With an innovative range of TPE materials, the company relies on freedom from PVC, sustainable production, resource and energy efficiency and of course adherence to all provisions and limit values specified by the EU or the FDA.
And this also applies for the high demands applicable to medical grade materials for use in medical technology, pharmaceuticals and personal care. On the one hand, it concerns tested bio-compatibility and physiological safety in accordance with ISO 10993 and USP Class IV, whereby not only compliance with technical requirements is examined but also how compatible the material is with the human organism. In accordance with the Medical Products Directive MDD 93/42 EEC, this biological test is always necessary when the patient comes into direct contact with the material/product. Furthermore, the raw materials must be conformant with the FDA and free of heavy metals. They should not contain silicone, latex or phthalates. Chemical and media resistance represent further features. Finally sterilizability of materials is another must in the medical environment.
With a wide range of TPE-materials Actega DS offers suitable solutions for the food and beverage industry, medical technology, pharmacy, personal care and consumer products.