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Publication 12th Amendment

Publication Commission Regulation (EU) 2019/37

On 11 January the 12th amendment was published on EU 10/2011 as “Commission Regulation (EU) 2019/37 of 10 January 2019 amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food”.

This amendment contains a number of modifications/additions to Annex 1 (table 1, 2, 3 and 4) and Annex 3 (table 3).

Modifications/additions to Annex 1:

  • New substances added to table 1: FCM 1059, 1067 and 1069
  • Modifications to table 1:
    • FCM 467: SML of 0,05 mg/kg is replaced by group restriction (number 35) van 0,05 mg/kg, expressed as crotonic
      acid
    • FCM 744: QMA (0,05 mg/6dm2 in table 4) replaced by group restriction (number 35) van 0,05 mg/kg, expressed as crotonic acid
    • FCM 1066: adjustment contains a typographical error in the English version:
      – new name: 1,2,3,4-tetrahydronaphthalene-2,6-dicarboxylic acid, dimethyl ester
    • FCM 1068: correction regarding the use (columns 5 and 6)
      – old: considered as additive or polymer production aid
      – new: considered as a starting material or monomer
  • Modification to table 2: New group restriction – Group 35: substances 467, 744 and 1059
  • Modification to table 3: New note – Note 27: substance 27
  • Modification to table 4: Restriction of FCM 744 modified from QMA to SML(T)

Modifications to Annex 3:

  • Modification table 3: Row 3 and 4 have been modified
    • Row 3
      – old: D1: all aqueous and alcoholic foods and milk products
      – new: D1: all aqueous and alcoholic foods and milk products with a pH ≥ 4,5
    • Row 4
      – old: B, D1: all aqueous, acidic and alcoholic foods and milk products
      – new: B, D1: all aqueous and alcoholic foods and milk products with a pH < 4,5

This amendment shall enter into force on the twentieth day following that of its publication: 31 January 2019
Link to EUR-lex: Click here

This amendment will be incorporated into FOCOS® as soon as possible.

For any further questions, please contact us!