Quinolizidine Alkaloids in Lupins
ContaminantsQuinolizidine alkaloids are secondary metabolic products that serve plants as defense and protection against herbivores....
Commission Regulation (EU) 2023/1442 of 11 July 2023 is amending the Annex I to Regulation (EU) No 10/2011 on food contact materials.
Plastic materials and objects that are intended to come into contact with food must comply with strict safety requirements within European countries, described in Regulation (EU) No 10/2011. This regulation has been amended on July 11th, 2023 for the 16th time!
The amendment applies to the Annex I of the regulation which contains specifications as to which substances may be used to produce plastics coming into contact with food and it sets migration limits and restriction of use.
This new modification came into force on August 1, 2023. Among other measures, the regulation adds new substances to the positive list in Annex I and removes wood flour and salicylic acid from Annex I. The regulation also modified some migration limits, such as for certain Phthalates Plasticizers.
What are the Main Amendments?
The List of Positive of Annex I includes 3 New Substances:
- Tris(2-ethylhexyl)benzene-1,2,4-tricarboxylate (3319-3-1-1)
- (Triethanolamine perchlorate, Sodium salt) Dimer (156157-97-0)
- Benzophenone-3,3′,4,4′-tetracarboxylic dianhydride (BTDA, 2421-2-8-5)
Updating the Usage Restrictions for:
| DESIGNATION | UPDATE |
| 1007 Diethyl[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate -(PEF) | Expansion of the existing approval for PET to include the production of Polyethylene-2,5-furandicarboxylate |
| 1059 Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) | Precision of the maximum allowable usage temperature referring to Annex V Number 2.1.4 Letter d. |
| 1076 Phosphorsäure, Triphenylester, Polymer with Alpha-hydroomega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10–16 Alkylester | Addition of the usage restriction: (b) as an additive with a mass fraction of up to 0.025% in Acrylonitrile-Butadiene-Styrene (ABS) materials for use at a maximum of room temperature. |
New Migration Limits for Phthalates-plasticizers:
| DESIGNATION | NEW LIMIT | PREVIOUS LIMIT |
| Butylphthalate (DBP) | SML = 0.12 mg/kgGroup Restriction: 32 and 36 | SML = 0.3 mg/kgGroup Restriction: 32 |
| Benzyl Butyl Phthalate (BBP) | SML = 6 mg/kgGroup Restriction: 32 and 36 | SML = 30 mg/kgGroup Restriction: 32 |
| Bis(2-ethylhexyl)phthalate (DEHP) | SML = 0.6 mg/kgGroup Restriction: 32 and 36 | SML = 1.5 mg/kgGroup Restriction: 32 |
| Diisononyl Phthalate (DINP) | Group Restriction: 26SML(T) = 1.8 mg/kg (DINP + DIDP), 32 | Group Restriction: 26SML(T) = 9 mg/kg (DINP + DIDP), 32 |
New Groups Restrictions, SML(T)
Summed limits for various substances grouped together represent SML(T) limits. Companies can apply them in addition to specific migration limits (SML) for individual compounds.
- PHTHALATES:
Number 36 (FCM 157, 159, 283, 1085) = 0.6 mg/kg.
Sum of DBP, DIBP, BBP, and phthalic acid, DEHP.
- TRIETHANOLAMINE:
Number 37 (FCM 793, 1080) = 0.05 mg/kg.
Calculated as the sum of triethanolamine and the hydrochloride adduct, calculated as triethanolamine.
- PERCHLORATE:
Nr. 38 (FCM 822, 1080) = 0,0002 mg/kg.
Calculated as perchlorate.