New Amendment to Commission Regulation (EU) No 10/2011

Table 1 – Entries Removed from Annex I of the Regulation

Removed Food Contact Material or Article

Reason for Removal

FCM No 96 – Wood flour and fibers, untreated

Wood cannot be considered inert due to the many low molecular weight substances it contains.

FCM No 121 – Salicylic acid

Salicylic acid was determined to be a "high priority" substance in the European Food Safety Authority's scientific opinion published in 2020. No specific use or user was reported in the European Commission's stakeholder consultation.

Table 2 – Entries Revised in Annex I of the Regulation (Phthalates)

Revised Food Contact Material or Article

Details on the Revision

FCM 157 – Phthalic acid, dibutyl ester (DBP)

Authorised as an additive for use in plasticisers and technical support agents in plastic FCMs, subject to specific restrictions of use and migration limits.

SML = 0.3 mg/kg changed to 0.12 mg/kg
SML(T) groups 32 and 36 (new)

FCM 159  – Phthalic acid, benzyl butyl ester (BBP)

Authorised as an additive for use in plasticisers and technical support agents in plastic FCMs, subject to specific restrictions of use and migration limits.

SML = 30 mg/kg changed to 6.0 mg/kg
SML(T) groups 32 and 36 (new)

FCM 283  – Phthalic acid, bis(2-ethylhexyl) ester (DEHP)

Authorised as an additive for use in plasticisers and technical support agents in plastic FCMs, subject to specific restrictions of use and migration limits.

SML = 1.5 mg/kg changed to 0.6 mg/kg
SML(T) groups 32 and 36 (new)

FCM 728  – Phthalic acid, diesters with primary, saturated C8-C10 branched alcohols, more than 60% C9 (DINP)

Authorised as an additive for use in plasticisers and technical support agents in plastic FCMs, subject to specific restrictions of use and migration limits.

New SML(T) 1,8 mg/kg in group 26

Not to be used in combination with FCM substances 157, 159, 283, or 1085 (DIBP)*

FCM 729  – Phthalic acid, diesters with primary, saturated C8-C10 branched alcohols, more than 60% C9 (DIDP)

Authorised as an additive for use in plasticisers and technical support agents in plastic FCMs, subject to specific restrictions of use and migration limits.

New SML(T) 1,8 mg/kg in group 26

Not to be used in combination with FCM substances 157, 159, 283, or 1085 (DIBP)*

Table 3 – Additional Entries Revised in Annex I of the Regulation

Revised Food Contact Material or Article

Details on the Revision

FCM 793 – Triethanolamine

Removal of individual SML and reference to new SML(T) group 37.

FCM 822 – Perchloricacid, salts(perchlorate)

Removal of individual SML and reference to new SML(T) group 38.

FCM 1007 – Diethyl[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl] phosphonate

Addition of authorisation of use up to 0.2% in poly(ethylene 2,5-furandicarboxylate) (PEF)

FCM 1059 – poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) (PHBH)

Addition of production method (i.e., macromolecule obtained from microbial fermentation).

Addition of temperature conditions (see 2.1.4(d) of Annex V).

FCM 1076 – Phosphorous acid, triphenyl ester, polymer with alpha-hydro-omegahydroxypoly[oxy(methyl-1,2-ethanediyl)], C10–16 alkyl esters

Addition of authorisation of use up to 0.025% in acrylonitrile-butadienestyrene (ABS) at room temperature and below.

SML = 0.05 mg/kg (no change)

Table 4 – Entries Added to Annex I of the Regulation

Added Food Contact Material or Article

Details on the Addition

FCM 1078 – tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate ester

Only to be used as plasticiser to manufacture soft poly(vinyl chloride) (PVC).

Not to be used in contact with foods intended for infants.

SML = 1 mg/kg food
SML(T) group 32

FCM 1080 – (triethanolamine-perchlorate, sodium salt) dimer

Only to be used in rigid poly(vinyl chloride) in contact with water and acidic aqueous foods.

New SML(T) groups 37 and 38

Same group as FCM 793 and FCM 822, as (triethanolamine-perchlorate, sodium salt) dimer fully dissociates into triethanolamine and perchlorate.

FCM 1081 – N,N-bis(2-

hydroxyethyl)stearylaminepartially esterified with saturated C16/C18 fatty acids

Only to be used in all plastic polymers with dry foods at room temperature.

SML(T) group 7

Note 30: There is a risk that migration limits may be exceeded; migration increases with the thickness of the plastic in which the substance is contained, and with a decreasing polarity of the polymer and a decreasing degree of esterification of the substance itself.

FCM 1082 – Phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate

Only to be used up to 0.35% (w/w) to manufacture polymethylmethacrylate.

SML = 0.05 mg/kg food (as sum of mono-, di-and triesters of phosphoric acid and the mono-, di-, tri-and tetraesters of diphosphoric acid)

FCM 1083 – Benzophenone3,3',4,4'-tetracarboxylicdianhydride('BTDA')

Only to be used up to 0.35% (w/w) as a comonomer in the production of polyimides for use in contact with foods for which only simulants B and/or D2 are laid down in Table 2 of Annex III at temperatures up to 250°C.

SML = 0.05 mg/kg food