European Testing standard

European Council issued the standard named Resolution Res AP 2004(4). This standard contains a list of substances that can be used in the rubber. The list is not a positive list of authorized substances, but it can be used to lean on when assessing the precautions to be taken when the substances are used. All food contact materials and articles made of rubber must observe the standard limit.

EU testing:
Rubber AP (2004)4
  • Overall migration
  • Overall migration in rectified olive oil or substitute of rectified olive oil
  • Overall migration in MPPO
  • Nitrosamine and nitrosatable substances content (only for rubber teats)
  • Specific migration of Nitrosamine and nitrosatable substances in 3 % acetic acid
  • Specific migration of aromatic amine
LFGB ( Germany), besides above EU testing request, the following additional testing will be required.
  • Overall migration in MPPO
  • Nitrosamine and nitrosatable substances content (for others)
  • Specific migration of Nitrosamine and nitrosatable substances
  • Specific migration of aromatic amine
  • Sensory test
  • Specific migration of formaldehyde
  • Specific migration of (Zn, Pb, Al)

DGCCRF(France)Besides above EU testing request, the following additional testing will be required.
  • Overall migration in MPPO
  • Specific migration of aromatic amine
  • Volatile organic matter(VOM)
  • Extractable formaldehyde
  • Extractable hexamethylenetetramine
  • Peroxide value
  • Migration of (Ba, Cu, Al, Zn)
  • Pb, Cd, Sb, Hg, As content
  • Total BPA
Italy Testing, besides above EU testing request, the following additional testing will be required.
  • Overall migration in MPPO
  • Nitrosamine and nitrosatable substances content (only for rubber teats)
  • Specific migration of Nitrosamine and nitrosatable substances in 3 % acetic acid (for non-teats)
  • Specific migration of aromatic amine
  • Color migration

The USA Testing standard

In the US, the materials used for food packaging are regarded as indirect additives, and incorporated in the food additives safety regulation system. US FDA 21 CFR is the main regulation for rubber materials. The testing is as below.

Rubber (177.2600)
  • water extractives (water-soluble food or liquid milk)
  • n-hexane extractives (fatty food only)

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