EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2019/6074 Rev. 3 
(POOL/E2/2019/6074/6074R3 -EN.docx) 
D084605/02  
[…](2022) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION REGULATION  
amending Annex I to Regulation (EU) No 10/2011 on plastic materials and articles 
intended to come into contact with food as regards changes to substance authorisations 
and the addition of new substances    
EN 1  EN ANNEX  
Annex I to Regulation (EU) No 10/2011 is amended as follows:   
(1) point 1, Table 1 is amended as follows:  
(a) entry 96 on wood flour and fibers, untreated, and entry 121 on salicylic acid  are 
deleted ; 
(b) entry 157 on phthalic acid, dibutyl ester  is replaced by the following:  
“157  74880  000008
4-74-2 phthalic acid, 
dibutyl ester  
(‘DBP’)  yes no  no 0,12 (32) 
(36) Only to be used as:  
(a) plasticiser in 
repeated use materials 
and articles contacting 
non-fatty foods;  
(b) technical support 
agent in polyolefins in 
concentrations up to 
0,05 % (w/w) in the 
final product.  (7)” 
(c) entry 159 on phthalic acid, benzyl butyl ester is replaced by the following:  
“159  74560  000008
5-68-7 phthalic acid, 
benzyl butyl 
ester  (‘BBP’)  yes no no 6 (32) 
(36) Only to be used as:  
(a) plasticiser in repeated 
use materials and articles;  
(b) plasticiser in single -use 
materials and articles 
contacting non -fatty foods 
except for infant formula 
and follow -on formula (*); 
(c) technical support agent 
in concentrations up to 0,1 
% (w/w) in the final product.  (7)
” 
(d) entry 283 on phthalic acid,  bis(2 -ethylhexyl) ester is replaced by the following:  
“283  74640  000011
7-81-7 phthalic acid, 
bis(2 -
ethylhexyl) 
ester  
(‘DEHP’)  yes no no 0,6 (32) 
(36) Only to be used as:  
(a) plasticiser in 
repeated use materials 
and articles contacting 
non-fatty foods;  
(b) technical support 
agent in 
concentrations up to 
0,1 % (w/w) in the 
final product.  (7)” 
 
            ”  
EN 2  EN (e) entry 728 on phthalic acid, diesters with primary, saturated C 8-C10 branched 
alcohols, more than 60 % C 9 is replaced by the following:  
“728  75100  006851
5-48-0 
002855
3-12-0 phthalic acid, 
diesters with 
primary, 
saturated C 8 -
C 10 
branched 
alcohols, 
more than 60 
% C 9  
(‘DINP’)  yes no no  (26) 
(32) Only to be used as:  
(a) plasticiser in repeated 
use materials and 
articles;  
(b) plasticiser in single -
use materials and articles 
contacting non -fatty 
foods except for infant 
formula and follow -on 
formula  (*)  
(c) technical support 
agent in concentrations 
up to 0,1 % (w/w) in the 
final product.  
Not to be used in 
combination with FCM 
substances 157, 1 59, 
283, or 1085 . (7)” 
(f) entry 793 on triethanolamine is replaced by the following:  
“793  94000  000010
2-71-6 triethanolami
ne yes no no  (37)
”   
(g) entry 822 on perchloric acid, salts (perchlorate) is replaced by the following:   
“822 71983  14797 -
73-0 Perchloric 
acid, salts 
(perchlorate)  yes no no  (38)
”   
(h) entry 1007  on diethyl[[3,5 -bis(1,1 -dimethylethyl) -4-
hydroxyphenyl]methyl]phosphonate  is replaced by the following:  
“1007   976-
56-7 diethyl[[3,5 -
bis(1,1 -
dimethylethyl) -
4-
hydroxyphenyl]
methyl]phospho
nate no yes no   Only to be used up to 0,2 
% (w/w) based on the final 
polymer weight in the 
polymerisation process to 
manufacture poly(ethylene 
terephthalate) (PET) and 
poly(ethylene  
2,5-furandicarboxylate) 
(PEF)  ” 
 (i) entry 1059  on poly((R) -3-hydroxybutyrate -co-(R)-3-hydroxyhexanoate ) is 
replaced by the following:  
“1059   147398
-31-0 Poly((R) -3-
hydroxybutyratno yes no  (35) The substance is a 
macromolecule obtained (23
)”  
EN 3  EN  
(j) entry 1076  on Phosphorous acid, triphenyl ester, polymer with alpha -hydro -
omega -hydroxypoly[oxy(methyl -1,2-ethanediyl)], C10 -16 alkyl ester  is 
replaced by the following : 
“1076   122793
7-46-3 Phosphorous 
acid, triphenyl 
ester,  
polymer with 
alpha -hydro -
omega - 
hydroxypoly[ox
y(methyl -1,2- 
ethanediyl)], 
C10-16 alkyl 
ester s yes no no 0,05  To be used  only:  
a) as an additive at up to 
0,2 % w/w in high impact 
polystyrene materials and 
articles intended for 
contact with  food at room 
temperature and below, 
including hot -fill and/or 
heating up to 100 °C for up 
to 2 hours. It shall not be 
used in contact with  
foods for which simulant C 
and/or D1 is assigned in 
Annex III.  
b) as an additive at up  to 
0.025% w/w in 
acrylonitril e-butadiene -
styrene (ABS) materials for 
use at room temperature 
and below ”  
 
(k) the following entries are inserted  at the end of Table 1  in numerical order:  
“1078   3319 -
31-1 tris(2 -
ethylhexyl) 
benzene -1,2,4 -
tricarboxylate  yes no no 1 (32) Only to be used  as 
plasticiser  to manufacture 
soft poly(vinyl chloride )  
Not to be used in contact 
with foods intended for 
infants  (*)  
1080   156157
-97-0 (triethanolamin
e-perchlorate, yes no no  (37) 
(38) Only to be used in  rigid 
poly(vinyl chloride) in  e-co-(R)-3-
hydroxyhexano
ate) (‘PHBH’)   from microbial 
fermentation.  
Only to be used at 
temperature conditions not 
exceeding the conditions 
defined in point 2.1.4(d) of 
Annex V. The migration of 
all oligomers with a 
molecular weight below 1 
000 Da shall not exceed 
5,0 mg/kg food.   
EN 4  EN sodium salt) 
dimer  contact with foods included 
in the food category with 
reference number 01.01.A 
in table 2 of Annex III   
1081   - N, N -bis(2 -
hydroxyethyl)st
earylamine 
partially 
esterified with 
saturated 
C16/C18 fatty 
acids  yes no no  (7) 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 . (30
) 
1082   52628 -
03-2 Phosphoric 
acid, mixed 
esters with 2 -
hydroxyethyl 
methacrylate  no ye
s no 0.05  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  
1083   2421 -
28-5 Benzophenone -
3,3’,4, 4’-
tetracarboxylic 
dianhydride  
(‘BTDA’)  no ye
s no 0.05  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. ”  
 “(*) Infant , infant  formula and follow -on formula as defined in Article 2(2) of 
Regulation (EU) No 609/2013  of the European Parliament and of the Council 
of 12 June 2013 on food intended for infants and young children, food for 
special medical purposes, and total diet replacement for weight control and 
repealing Council Directive 92/52/EEC, Commission Directive s 96/8/EC, 
1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the 
European Parliament and of the Council and Commission Regulations (EC) No 
41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35). ” 
(2) in point 2, table 2 is amended as follows : 
(a) entry 7 is replaced by the following:  
“7 19 
20 
1081  1,2 expressed as tertiary amine ” 
 (b) entry 26 is replaced by the following:  
“26 728 1,8 expressed as the sum of the substances”   
EN 5  EN 729 
(c) entry 32 is replaced by the following:  
“32 8 
72 
73 
138 
140 
157 
159 
207 
242 
283 
532 
670 
728 
729 
775 
783 
797 
798 
810 
815 
1078  
1085 *  60 expressed as the sum of the substances (plasticisers)  
 
* Diisobutyl phthalate , FCM No 1085, with synonyms 1,2 -bis(2 -
methylpropyl) benzene -1,2-dicarboxylate or ‘DIBP’ and CAS number 84 -69-5 
is not  listed as an authorised substance in Table 1 . However, it may co -occur 
with other phthalates  as a consequence of its use as an aid to polymerisation  
and is included in group restrictions with the assignment FCM No 1085. ” 
(d) the following entries are added:  
“36 157 
159 
283 
1085 * 0,6 sum of phthalic acid, dibutyl ester (DBP), diisobutyl phthalate  (DIBP ), 
phthalic acid, benzyl butyl ester (BBP) and phthalic acid, bis(2 -ethylhexyl) 
ester (DEHP) expressed as DEHP equivalents using the following equation: 
DBP*5 + DIBP* 4 + BBP*0,1 + DEHP*1 . 
* See remark on FCM No 1085 in row 32  
37 793 
1080  0,05 expressed as the sum of triethanolamine and the hydrochloride adduct 
expressed as triethanolamine  
38 822 
1080  0,002  expressed as perchlorate  – note 4 of table 3 applies”  
(3) in point 3, table 3 , the following entry is added:  
“(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 ”