Commission Regulation (EU) 2023/1627

Annex I of Regulation (EU) No 2023/1627 concerning the authorisation of the substance bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (FCM no 1079) has been amended by Commission Regulation (EU) No 10/2011 published in the European Union countries.

Regulation (EU) 10/2011 is about plastic materials and articles intended to come into contact with food. This regulation establishes specific requirements for the manufacture and marketing of the following types of plastic materials and articles:

• Materials intended to come into contact with food
• Materials already in contact with food
• Materials that can reasonably be expected to come into contact with food

Regulation (EU) 10/2011 applies to materials and substances placed on the European Union market that fall into the following categories:

• Materials, articles and parts thereof consisting solely of plastics
• Plastic multilayer materials and articles held together by adhesives or other means
• The above mentioned printed or coated materials and substances
• Plastic layers or plastic coatings that form seals on covers and locks (these together with covers and locks form a set of two or more layers of different types)
• Multi-material multilayer materials and plastic layers in materials

This regulation does not apply to the following materials and substances placed on the European Union market and intended to be covered by other special measures:

• Ion exchange resins
• Rubber
• Silicones

This regulation does not affect European Union or national provisions applying to printing inks, adhesives or coatings.

For the purposes of regulation (EU) 10/2011, the following definitions apply:

• Plastic materials and substances refer to the materials and substances described above and plastic sheets.
• Plastic refers to polymer to which additives or other substances may have been added, which can serve as the main structural component of final materials and substances.
• Polymer means any macromolecular substance obtained from:
  • A polymerization process such as polyaddition or polycondensation or any other similar process of monomers and other starting materials
  • Chemical modification of natural or synthetic macromolecules
  • Microbial fermentation
• Multilayer plastic refers to a material or substance composed of two or more layers of plastic.
• Multilayer material means a material or substance consisting of two or more layers of different types of materials, at least one of which is a plastic layer.
• Monomer or other starting material means a substance that undergoes any polymerization process to produce a polymer, or a natural or synthetic macromolecular substance used in the production of modified macromolecules, or a substance used to modify existing natural or synthetic macromolecules.
• Additive means a substance intentionally added to plastics during the processing of the plastic or to achieve a physical or chemical effect in the final material or substance (intended to be present in the final material or substance)
• Polymer production aid means any substance used to provide a suitable environment for the production of polymers or plastics. It may be present in the final material or substances but is not intended to be present and has no physical or chemical effect on the final material or substance.

Commission regulation (EU) 2023/1627 added the following entry in numerical order in Annex I to regulation (EU) 10/2011:

• FCM article no: 1079
• CAS no: 84731-70-4
• Substance name: bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate (DEHCH)
• Use as additive or polymer production aid: yes
• Monomer or other starter obtained from microbial fermentation ​​Use as a substance or macromolecule: no
• FRF applicable: no
• Specific migration limit valid for the substance: 0,05
• Limitations and specifications: To be used only as an additive at up to 2 percent w/w in poly(vinyl chloride) (PVC) foods intended to come into contact with foods identified as food simulants A or B in Table 25 of Annex III at room temperature or below.

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