Regulation EU 10-2011 for Plastics Intended to come into Contact with Food

Regulation EU 10/2011 is in force within the EU, applying rules for plastic materials and articles intended to come into contact with food

The European Regulation (EU) no 10/2011 has replaced Directive 2002/72/EC and its amendments, the vinyl chloride monomer Directive and the specific directives for migration testing.

The (EU) no 10/2011 is a specific measure for plastic food contact materials as mentioned in the European Framework Regulation EU 1935/2004.

The regulation applies to

  • Materials and articles and parts thereof consisting exclusively of plastics
  • Plastic multi-layer materials and articles held together by adhesives
  • These materials can be printed or covered by a coating
  • Plastic layers or plastic coatings, forming gaskets in caps and closures
  • Plastic layers in multi-material multi-layer materials and articles 

The regulation covers

  • Compositional requirements; only substances that are authorised may be intentionally used in the manufacture of plastic materials and articles and are listed in the so called “Union list”.
  • Specific provisions for plastic multi-layer materials and articles and for multi-material multilayers.
  • The set-up of a Declaration of Compliance (DoC) which need to be available at all market stages other than the retail stage. Supporting documents needs to demonstrate the statements of compliance to authorities.
  • Provision of specific rules for overall and specific migration testing and information on simulants and conditions to be used in the testing programs.
  • Assessment of NIAS (Non Intentionally Added Substances) and their risk, by the manufacturer of plastic food contact materials and articles.

Notwithstanding the comprehensive rules as stipulated in the regulation of many companies, it is still a challenge for companies developing and manufacturing plastic food contact materials to demonstrate compliance with this regulation. For each stakeholder in the supply chain of the manufacturing of plastic food contact materials it is important to know - and understand - their obligations and to be able to demonstrate compliance.

Intertek regulatory experts and chemist possess broad knowledge and experience within setting up compliance programs according to the rules of the (EU) no 10/2011. Our services include setting up compliance programs, suppliers document assessment, migration testing, mathematical modelling, NIAS studies, notification of new substances and support with setting up Declaration of Compliance, plus more.

Please contact one of our experts with your expectations and requests in regard to the European Regulation ( EU) no 10/2011.

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