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March 2019 Regulatory Update

EU Approves Amendment to Food Contact Plastic Regulation


On January 10, 2019, the European Commission (EC) published the Regulation (EU) 2019/37 to amend Regulation (EU) No. 10/2011 regarding plastic materials and articles intended to come into contact with foodstuffs.

Under the amendment, 3 new substances are approved and may be used in the manufacturing of food contact materials.

  • Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) (CAS 147398-31-0)
  • Dimethyl carbonate (CAS 616-38-6)
  • Isobutane (CAS 75-28-5)

In addition, other changes included:

  • Modifying the specific migration limits and
  • Modifying the usage condition of specific listed substances
  • Clarifying the selection criterion of food simulants condition for overall migration:
  Updated Regulation (EU) 10/2011 Current Regulation (EU) 10/2011
Food simulant to be used for food type Food simulant D1 for aqueous and alcoholic food and milk products with a pH ≥ 4.5 Food simulant D1 for aqueous and alcoholic food and milk products
Food simulant D1 and simulant B for aqueous and alcoholic food and milk products with a pH < 4.5 Food simulant D1 and simulant B for aqueous, acidic and alcoholic food and milk products

The amendment came into force on January 31, 2019.


View the complete regulatory update
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