Plastics in food contact: published the 16th amendment of Reg. 10/2011

Important new updates for the regulatory framework of plastic materials and articles intended to come into contact with food.

In fact, Commission Regulation (EU) 2023/1442 "amending Annex I to Regulation (EU) No. 10/2011 on plastic materials and articles intended to come into contact with foodstuffs, as regards changes in substance authorizations and the addition of new substances" has been published

Several changes were introduced

Two entries have been deleted from Annex I of Regulation 10/2011, specifically.

Item 96: Flour and wood fibers, untreated
Item 121: Salicylic acid

Reduction of the Specific Migration Limit (SML) for some compounds.

Item 157: Dibutyl phthalate (DBT) from 0.3 mg/Kg to 0.12 mg/Kg
Item 159: Benzyl butyl phthalate (BBP) 30 mg/Kg to 6 mg/Kg
Item 283: Bis (2-ethylhexyl) phthalate (DEHP) 1.5 mg/Kg to 0.6 mg/Kg

Additional changes:

Entry 728: Phthalic acid, diesters with C8-C10 branched primary saturated alcohols with more than 60 percent C9 has been revised both in terms of substance name and as restrictions and specifications.
Entry 1007: Diethyl[[3,5-bis(1,1-dimethylethyl)- 4-hydroxyphenyl] methyl]phosphonate sees a revision in the scope of restrictions and specifications with inclusion of the possibility of use up to 0.2 percent (w/w) also in poly(ethylene 2,5-furandicarboxylate) (PEF)
Entries 1059: Poly[(R)- 3-hydroxybutyrate-co-(R)- 3-hydroxyhexanoate) ("PHBH") and 1076: Triphenyl ester of phosphoric acid polymerized with C10-16 alkyl esters of alpha-hydroxyhydroxypoly [oxy(methyl-1,2-ethanediol)]are amended in the text of the respective restrictions and specifications

The entries for the substances listed below have been inserted, each with additional information and possible reference in group restrictions and/or notes on verification of compliance:

Entry 1078: tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
Entry 1080: (triethanolamine-perchlorate, sodium salt), dimer
Heading 1081: N, N-bis(2-hydroxyethyl) stearylamine partially esterified with saturated C16/C18 fatty acids
Heading 1082: Phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate
Entry 1083: Benzophenon-3,3',4,4'- tetracarboxylic dianhydride ("BTDA")

It is noted that the note on verification of compliance (30) was introduced to supplement Table 3 of Annex I of Reg. 10/2011 for Item 1081

Changes to group restrictions

Group restriction (26), covering entries 728 and 729 sees a lowering in the specific migration limit from 9 mg/Kg to 1.8 mg/Kg

Group restriction (32) now also includes entries 1078 and 1085, with specific indication for entry 1085: "Diisobutyl phthalate, MCA substance No. 1085, with the synonyms 1,2-bis(2-methylpropyl) benzene-1,2-dicarboxylate or "DIBP" and CAS No. 84-69-5 is not among the substances authorized in Table 1. It may, however, be present in conjunction with other phthalates as a result of its use as a polymerization auxiliary substance, and is included in the group restrictions with MCA Assignment No. 1085."

Three new group restrictions are also introduced, specifically:

Group restriction (36) related to entries 157; 159; 283 (also amended as individual entries) and 1085 (mentioned as a note in the amendment to group restriction (32))
Group restriction (37) related to entries 793: triethanolamine and 1080, the latter introduced in this amendment
Group restriction (37) relating to items 822: Perchloric acid, salts (perchlorate) and 1080, the latter introduced in this amendment

The LabAnalysis Group Laboratories, thanks to the expertise gained over the years and the availability of state-of-the-art instrumentation, are at your disposal to monitor the status of compliance with respect to the various new features introduced by these new Regulations.

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