EU Amends Regulation (EU) No 10/2011 on Authorized Plastic FCMs and Use Requirements Thereof

1

tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate

Only to be used as plasticiser to manufacture soft poly (vinyl chloride); Not to be used in contact with foods intended for infants

2

Triethanolamine-perchlorate, sodium salt) dimer

Only to be used in rigid poly (vinyl chloride) in contact with foods included in the food category with reference number 01.01.A in table 2 of Annex III

3

N, N-bis(2-hydroxyethyl)stearylamine partially esterified with saturated C16/C18 fatty acids

Only to be used at up to 2 % (w/w) in plastic materials and articles intended for the packaging by food business operators of dry foods for which simulant E is assigned in table 2 of Annex III

4

Phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate

• Only to be used at up to 0,35 % (w/w) to manufacture polymethylmethacrylate.

• SML expressed as the sum of the mono-, di- and triesters of phosphoric acid and the mono-, di-, tri- and tetraesters of diphosphoric acid

5

Benzophenone-3,3',4,4'-tetracarboxylic dianhydride (BTDA)

Only to be used at up to 43 % (w/w) as a co-monomer 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

1

Phthalic acid, dibutyl ester (DBP)

• Specific migration limit (SML) (mg/kg): changed from 0.3 to 0.12

• Newly subject to group restriction No. 36 with detailed specifications

2

Phthalic acid, benzyl butyl ester (BBP)

• SML (mg/kg): changed from 30.0 to 6.0

• Newly subject to group restriction No. 36 with detailed specifications

3

Phthalic acid, bis(2-ethylhexyl) ester (DEHP)

• SML (mg/kg): changed from 1.5 to 0.6

• Newly subject to group restriction No. 36 with detailed specifications

4

Phthalic acid, diesters with primary, saturated C 8-C 10 branched alcohols, more than 60 % C 9 (DINP)

• Not to be used in combination with FCM substances 157, 159, 283, or 1085

• With amendment to the specification of involved group restriction No. 26 and 32

5

Triethanolamine

• SML for this substance deleted

• The substance in group restriction No. 37 newly included

6

Perchloric acid, salts (perchlorate)

• SML for this substance deleted

• The substance in group restriction No. 38 newly included

7

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

Expanded use scope to manufacture poly(ethylene 2,5-furandicarboxylate) (PEF)

8

Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) (PHBH)

Addition of a restriction about temperature condition for use

9

Phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters

Expanded use scope of this substance as an additive in manufacturing acrylonitrile-butadiene-styrene (ABS) materials

1

Group restriction No. 7

N, N-bis(2-hydroxyethyl)stearylamine partially esterified with saturated C16/C18 fatty acids (FCM No 1081) is newly included in the group

2

Group restriction No.26 (DINP & DIDP)

SML (T) is changed from 9 mg/kg to 1.8 mg/kg, expressed as the sum of the substances

3

Group restriction No. 32

“Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate ester” and “1,2-bis(2-methylpropyl) benzene-1,2-dicarboxylate” are added in the group with revised group restriction

4

Group restriction No. 36, 37 and 38

Newly added with corresponding specifications