COMMI SSION REGUL ATION (EU) 2023/1442 
of 11 July 2023
amending Annex I to Regulation (EU) No 10/2011 on plast ic mater ials and articles intended to come 
into cont act with food, as regards changes to subst ance author isations and addition of new 
subst ances 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng regar d to Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 
mater ials and articles intende d to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (1), 
and in particular Article 5(1), second subparagraph, points (a), (d), (e), (h), and (i), Article 11(3) and Article 12(6) thereof,
Whereas:
(1) Commission Regulation (EU) No 10/2011 (2)lays down specific rules as regards plastic mater ials and articles 
intended to come into contact with food. In particular , Annex I to Regulation (EU) No 10/2011 establishes a Union 
list of author ised substances that may be intentionall y used in the manufacture of plastic mat erials and articles 
intended to come into contact with food.
(2) Since the last amendment to Regulation (EU) No 10/2011, the European Food Safe ty Auth ority (‘the Auth ority’) has 
published further scientific opinions on new substances that may be used in food contact mat erials (‘FCM’) as well as 
on the use of already author ised substances. In addition, certain ambiguities related to the application of that 
Regulation were identif ied. In order to ensure that Regulation (EU) No 10/2011 takes into account scientifi c and 
technical progress, in particular the most recent findings of the Author ity, and in order to remo ve any doubt as 
regards its correct application, that Regulation should be amended.
(3) The substance ‘wood flour and fibers, untreat ed’ (FCM No 96, ‘wood’) is presently author ised as an additive in plastic 
food contact mater ials on the basis of an evaluation by the Scientific Committ ee on Food whic h concluded that 
wood flour and fibres are an iner t mater ial. Howe ver, in its opinion (3)of November 2019 the Author ity could not 
validate the grounds for that conclusion. It state d that wood cannot be considered iner t per se, due to the man y low 
molecular weight substances it contains. Moreover , the opinion indicate s no conditions under whic h the use of 
wood in plastics may be considered safe, and notes that due to the chemical diffe rences in the compo sition of plant 
mater ials the safety of migrants from these mat erials must be evaluated on a case-by- case basis, consider ing beyond 
species also origin, processing, treatment for compatib ilisation with the host polymer and assessment of the low 
molecular weight constituents migrat e into food. As the present author isation of wood does not take into account 
those aspects and thus cannot suffic iently account for the safe use of that substance in plastic, and the Author ity did 
not provid e for other restr ictions that would never theless ensure the safe use of this substance in plastic, the 
author isation should be revok ed.
(1)OJ L 338, 13.11.2004, p. 4.
(2)Commission Regulation (EU) No 10/2011 of 14 Januar y 2011 on plastic mat erials and articles intended to come into contact with 
food (OJ L 12, 15.1.2011, p. 1).
(3)EFSA Journal 2019;17(11):5902 .EN Offi cial Jour nal of the European Union 12.7.2023 L 177/45  (4) Following a request by the Commission, the Author ity adopt ed on 29 Apr il 2020 a scientifi c opinion (4)reviewing 
the 451 substances listed in Annex I to Regulation (EU) No 10/2011, for which no specifi c migration limit (‘SML ’) is 
set pursuant to Article 11(1) of that Regulation. It considered that 284 of those substances needed to be re-evaluate d 
in order to deter mine whether a specific migration limit is required and classifie d them in three priority groups. 
Three substances were placed into the ‘high priority group’ . Of these three substances, styrene (FCM No 193) is 
known to be widely used and is already subject to a re-evaluation, while on the substance laur ic acid, vinyl ester 
(FCM No 436) a user provi ded the Author ity with additional data whic h showed its re-evaluation would be of a 
lower priority. However , no user of the third substance, salicylic acid (FCM No 121), contact ed either the 
Commission or the Author ity after it was placed in the high priority list and after the Commission services 
consulte d the stak eholders over a potential revocation of its author isation. The Author ity however cannot evaluate 
the use of a substance without a kno wn user as it is to take account of the intended conditions of use of the mate rial 
or article in which the substance would be used, and only a user can provide such information. Moreo ver, if 
provid ed, such information would to a large extent determi ne the scope of any future author isation whic h would be 
likely more limite d than the present wide author isation. Consequently , as no specific use or user of salicylic acid is 
known, and given the uncer tainty over the conditions of use under whic h the use of this substance would compl y 
with Regulation (EC) No 1935/2004, it is appropr iate to revok e the present author isation of salicylic acid.
(5) Based on opinions of the Author ity adopt ed in 2005 (5), five substances from a group commonly kno wn as 
‘phthalates’, namely FCM No 157 (‘DBP’), FCM No 159 (‘BBP’), FCM No 283 (‘DEHP’), FCM No 728 (‘DINP’) and 
FCM No 729 (‘DIDP’), are author ised as additives for use as plasticisers and technical suppor t agents in plastic FCM, 
subject to specifi c restr ictions of use and migration limits.
(6) Following an opinion in 2017 by the European Chemicals Agency (‘EC HA’) on restr iction proposals for some of 
these phthalat es(6), the Commission requested the Auth ority to re-assess the risk to public health from phthalat es 
that are author ised to be used in plastic FCM. The Author ity consequently adopt ed a scientifi c opinion on 
18 September 2019 (7), confir ming the individual TDIs set out in its 2005 opinions for all five phthalates but only 
on a temporar y basis (t-TDI), because of a number of limitations and uncer tainties related to the assessment, which 
should be addressed in the future.
(7) Based on a common mechanism of action underlying the reproductive effects of DBP , BBP and DEHP , the Author ity 
also established a new group t-TDI, taking into account their relative potencies. The Author ity further considered it 
appropr iate to include DINP in the group t-TDI as a conser vative approach based on its transient effects on foetal 
testoste rone levels, whilst accounting for the higher poten cy of DINP on the liver . The author ity set the group t-TDI 
for DBP , BBP, DEHP and DINP at 50 micrograms per kilogram of bodyweight (μg/kg bw) expressed as DEHP 
equivalent strength. The Authority did not include DIDP in the group t-TDI and set an individual t-TDI of 150 μg/kg 
bw based on effects on the liver , consist ent with its findings from 2005.
(8) In order to further character ise the risk, the Auth ority carried out a dietar y exposure assessment as part of the same 
opinion. Whilst it was unable to specifi cally deter mine the contr ibution from plastic FCM, it estimated dietar y 
exposure for all five phthalat es, which represent the worst-case estimate s of exposure from FCM sources. Based on 
an aggregat ed dietar y exposure assessment for DBP , BBP, DEHP and DINP , it concluded that dietar y exposure 
contr ibut es up to 14 % of the group t-TDI of 50 μg/kg bw for the average consumer and up to 23 % of the group 
t-TDI for high consumers. The estimat es for DIDP indicate that dietar y exposure is far below the t-TDI of 150 μg/kg 
bw for both average and high consumers.
(4)EFSA Journal 2020;18(6):6124 .
(5)EFSA Journal 2005; 3(9) :242 ; EFSA Journal 2005; 3(9):241 ; EFSA Journal 2005; 3(9):243 ; EFSA Journal 2005; 3(9):244, 1-18 ; EFSA 
Journal 2005; 3(9):245 .
(6)ECHA Committee for Risk Assessment (RAC) and Committee for Socioeconomic Analysis (SEA C) Opinion on an Annex XV dossier 
proposing restr ictions on four phthalates (DEHP , BBP, DBP , DIBP); ECH A/RA C/RES-O-0000001412-86-140/F and ECH A/SEA C/RES- 
O-0000001412-86-154/F respectively . Available online https://echa.europa.eu/documents/10162/a265bf86-5fbd-496b-87b4- 
63ff238de2f7 .
(7)EFSA Journal 2019;17(12):5838 .EN Offi cial Jour nal of the European Union L 177/46 12.7.2023  (9) Additionally , the Auth ority considered consumers’ exposure to other phthalat es, notably to 1,2-bis(2-methylprop yl) 
benzene-1,2-dicarbo xylat e (diisobutyl phthalat e or ‘DIBP’; FCM No 1085; CAS number 84-69-5), whic h is not 
author ised as an additive for plastic FCM, but may be present in smaller amounts therein as an impurity or as a 
consequence of its use as a technical suppor t agent in the manuf actur ing process of certain types of plastic. The 
Authority noted that DIBP substantially adds to the overall exposure and risk to consumers from phthalat es and 
that such exposure together with its potency with regar d to reproductive effects should also be take n into account 
by the risk manag er. The Auth ority further noted that consumers’ exposure to phthalates arises from sources other 
than the diet. Signif icant contr ibution to tota l phthalate exposure comes from their presence in consumer articles 
and constr uction mater ials and subsequent dermal contact with them, as well as from inhalation of air and dust in 
the indoor environment.
(10) In order to take into account the group t-TDI for DBP , BBP and DEHP and the Author ity’s considerations as regar ds 
DIBP , and, in particular , to ensure that exposure to these phthalates from plastic FCM does not exceed the group 
t-TDI, a new total specific migration limit (SML(T)) should be established. However , for the sake of clarity and 
simplification, in particular in establishing compl iance or when carrying out official controls in cases where one of 
these phthalates has been used alone, individual SMLs should be maintained for the author ised phthalat es in 
addition to the SML(T)s.
(11) Although the Author ity also included DINP in the group t-TDI, an SML(T) was previously established for DINP 
together with DIDP because they are mixtures that overlap chemically and could not be distinguished analytically in 
the case of co-occur rence. Although there have been advances in analytical methods since the establishment of that 
SML(T), further validation work is still required before DINP and DIDP can be routinely differ entiated by compet ent 
author ities when under taking official controls. It is theref ore appropr iate to maintain a separate SML(T) for the sum 
of DINP and DIDP and to prohibit the use of DINP together with DBP , BBP and DEHP as well as with DIBP where that 
may be used as a technical suppor t agent, in order to avoid any poten tial co-exposure from the same plastic FCM.
(12) Taking into account that the aggregat ed exposure from both FCMs and sources other than FCMs is expecte d to be in 
the order of the t-TDI, and that accumulation may occur in the food manufact uring chain due to migration from 
food processing equipment as well as from food packa ging, and taking into account the significant level of 
uncer tainty regar ding the present exposure estimat es, it is appropr iate to account for the exposure by means of an 
allocation factor of 20 % for DBP , BBP, DEHP and DINP in plastic FCM. Taking into account the need to also 
maintain the SML(T) for DINP and DIDP , it is appropr iate to use that allocation factor for all five phthalat es when 
setting the SML(T) and the individual SMLs.
(13) The substance diethyl[[3,5-bis(1,1-dimet hyleth yl)-4-h ydro xyphenyl] methyl] phosphonate (FCM No 1007) is 
presently author ised for use up to 0,2 % (w/w) based on the final polymer weight in the polymer isation process to 
manufact ure poly(eth ylene terephthalate) (‘PET’). Follo wing an application for the exte nsion of use of this substance, 
on 26 Januar y 2022 , the Authority adopt ed a favourable scientific opinion (8)on its use up to 0,1 % w/w based on 
the final polymer weight in the polymer isation process to manufact ure poly(eth ylene 2,5-furandicarbo xylate) (‘PEF’). 
The Author ity concluded that, when used in this amount, migration of the substance was not detected due to its 
incor poration in the polyest er chain. Because of that incor poration, there is also no reason to assume that, when 
used in PEF at a use level of 0,2 % w/w , migration of the substance would be substantially higher . As the safe use of 
the substance thus stems from its full incor poration into the polymer , and for the sake of consistency and 
simplicity , it is appropr iate to extend the existing author isation for the use level of this substance in PET at 0,2 % 
w/w also to the manuf acture of PEF.
(8)doi: 10.2903/j.efsa.2022.7172EN Offi cial Jour nal of the European Union 12.7.2023 L 177/47  (14) Commission Regulation (EU) 2019/1338 (9)author ised the substance Poly((R)-3-h ydro xybutyrate-co- (R)- 
3-hydro xyhexanoat e) (‘PHBH’, FCM No 1059). Howe ver, it appears the specifi cation of the permitted use of that 
substance requires clarification. On the one hand, since PHBH is a macromolecule obtained from microbial 
fermentation and Regulation (EU) No 10/2011 requires that it is specifi ed that a macromolecule is obtained from 
such fermentation, the reference to this production method should be added to the specifi cation of PHBH. In 
addition, the author isation allows for a shor t heating up phase, without specifying a maximum temperature. This 
absence of a maximum temperature could allow for heating at temperatures beyond those foreseen in the opinion 
of the Author ity on whic h basis the substance was author ised, which refers to ‘hot-f ill’ conditions, defined by 
Regulation (EU) No 10/2011 as a temperature not exceed ing 100 °C at the moment of filling. In addition, the 
opinion indicates that a plastic manuf actured with the substance has a melting point in the rang e of 120–150 °C. 
Moreover , absence of a maximum temperature implies that it is not clear which testing conditions should be used to 
verify compl iance with Regulation (EU) No 10/2011 as regards the specifi cation concer ning the ‘shor t heating up 
phase’. The specifi cation should theref ore be clarified by indicating a condition of use as that does not exceed the 
temperature conditions foreseen in the opinion.
(15) The Author ity adop ted a favour able scientific opinion (10)on the use of the substance ‘phosphorous acid, triphen yl 
ester, polymer with alpha-h ydro-omega-h ydro xypoly[o xy(methy l-1,2-ethanediyl)], C10–16 alkyl esters’ (FCM 
No 1076) as an additive at up to 0,025 % w/w in acrylonitr ile-butadiene-styrene (ABS) copolymers. The Author ity 
concluded that the use of the substance is not of safet y concer n for the consumer if it is used as an additive at up to 
0,025 % w/w in ABS mate rials and articles for sing le and repeate d use in contact with aqueous, acidic, alcoholic and 
oil-in-water emulsion foods, for long-t erm storage at room temperature and below , and if its migration does not 
exceed 0,05 mg/kg food. As the migration tests were carried out in order to cover uses in contact with all types of 
foods, it is appropr iate to author ise the use of this additive in the manufacture of ABS mate rials and articles in 
contact with all foods for all uses at room temperature and below and to set out a migration limit in accordance 
with the opinion of the Author ity.
(16) On 19 Sept ember 2019 , the Author ity adopt ed a favour able scientific opinion (11)on the use of the substance tris 
(2-ethylh exyl) benzene-1,2,4-tr icarbo xylat e ester (FCM No 1078, CAS number 3319-31-1), as an additive 
(plasticiser) in poly(vin yl chlor ide) (‘PVC’) FCM. In that opinion, the Author ity concluded that overall the use of FCM 
No 1078 does not raise a safety concer n when used in the manuf acture of soft PVC. Theref ore it is appropr iate to 
author ise this substance according ly. However , the conclusion of the Author ity is conditional to the migration of 
the substance not excee ding 5 mg/kg food. In addition, the Auth ority indicated that due to the additional 
contr ibution from other sources that may add to the exposure from plastic FCMs, the application of an allocation 
factor should be considered. In view of the absence of directly measured exposure data for this substance for the 
overall population from all sources, it is appropr iate to apply an allocation factor of 20 % until appropr iate 
scientific data is provided. Moreover , in its opinion, the Author ity stated that its evaluation does not cover the use 
of this substance in contact with ‘infant foods’. Theref ore, it has not been demonstrate d that the use of this 
substance in contact with ‘infant foods ’ would meet the requirements of Article 3 of Regulation (EC) 
No 1935/2004. Theref ore, the author isation of this substance should be subject to a limit on its migration of 
1 mg/kg food and a restr iction that prevents its in contact with foods intended for infants. For the sake of clarity 
and consistency with similar restr ictions, it is appropr iate to refer to the definition of ‘infa nt’ laid down in 
Article 2(2)(a) of Regulation (EU) No 609/2013 of the European Parliament and of the Council (12).
(9)Commission Regulation (EU) 2019/1338 of 8 August 2019 amending Regulation (EU) No 10/2011 on plastic mat erials and articles 
inten ded to come into contact with food (OJ L 209, 9.8.2019, p. 5).
(10)EFSA Journal 2021;19(8):6786.
(11)EFSA Journal 2019; 17(10):5864 ; the Authority refers in its opinion to ‘trimellitic acid, tris(2-eth ylhexyl) ester ’, whereas this 
Regulation refers to its IUPAC name ‘tris(2-ethylhexyl) benzene-1,2,4-tr icarbo xylate’ .
(12)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 Directives 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).EN Offi cial Jour nal of the European Union L 177/48 12.7.2023  (17) Further more, since group restr iction 32 in table 2 of Annex I to Regulation (EU) No 10/2011 sets out a SML(T)s for 
plasticisers and that the substance FCM No 1078 is also a plasticiser , it is appropr iate to apply this group restr iction 
also to that substance. In addition, to clear any doubt over the nature of this group restr iction, it is appropr iate to 
indicate that it concer ns plasticisers.
(18) Following an application for author isation of the use of the substance (triethanolamine-perc hlorate, sodium salt) 
dimer (FCM No 1080), as an additive in rigid PVC for repeated use bottles intended for contact with water , the 
Authority adopt ed on 29 Apr il 2020 a favourable scientifi c opinion (13)on that use. The Auth ority concluded that 
its use would be safe if in contact with water and acidic aqueous foods, such as fruit juices, as, in both water and 
acidic aqueous foods, the substance (triethanolamine-perc hlorate, sodium salt) dimer fully dissociates into 
triethanolamine and perchlor ate. Those two substances are already included in the Union list of author ised 
substances, triethanolamine as FCM No 793 with a migration limit of 0,05 mg/kg, and perchlorat e as FCM No 822 
with a migration limit of 0,002 mg/kg. The Author ity concluded that those limits should also apply to FCM 
No 1080 because, if the substance is used in plastic in contact with water and acidic aqueous foods, its safet y is fully 
controlled by the migration limits established for those two substances due to its dissociation. The Author ity 
further more confir med that the migration of FCM No 822 should be expressed as perchlor ate(14). It is theref ore 
appropr iate to establish two group restr ictions in table 2 of Annex I to Regulation (EU) No 10/2011, encom passing 
the FCM substance No 1080 together with FCM substance No 793 in one group, and with FCM substance No 822 
expressed as perch lorate in the other group. It is theref ore appropr iate to amend substances FCM No 793 and 822 
according ly, and to include the substance (triethanolamine-perc hlorate, sodium salt) dimer (FCM No 1080) as an 
additive in the Union list of author ised substances, with the restr iction that it should only be used in contact with 
foods included in the food catego ry with reference number 01.01.A in table 2 of Annex III whic h represents water 
and the acidic aqueous foods considered by the Author ity.
(19) Following an application for the author isation of the use of the substance N, N-bis(2-hy droxyet hyl)st earylamine 
partially esterified with saturated C16/C18 fatty acids (FCM No 1081), as an additive, in plastic FCM in contact with 
dry foods, acidic foods and alcoholic beverages with storage up to six months at ambient temperature, the Authority 
adopt ed a partially favourable scientific opinion (15)on that use. As part of its evaluation, the Author ity considered 
the migration data provided by the applicant for testing for storage conditions abov e six months at room 
temperature and below . The Author ity concluded that N,N-bis(2-hydr oxyethyl)st earylamine is not a safety concer n 
for the consumer when used at up to 2 % (w/w) in all polymers intended for contact only with dry foods, provid ed 
that the migration of the sum of N,N-bis(2-h ydro xyethyl)st earylamine and its mono- and di-ester , calculat ed as N,N- 
bis(2-hydr oxyethyl)st earylamine, does not exceed, the SML(T) for FCM substances No 19 and 20, in whic h according 
to the Auth ority the migration of the mono- and di-ester of N,N-bis(2-hydro xyeth yl)st earylamine was also to be 
included. Theref ore, it is appropr iate to author ise the use of this substance at up to 2 % (w/w) for manuf actur ing 
plastic FCM intended to be in contact only with dry foods at room temperature, and it should be included in the 
group restr iction laid down for the substances with FCM No 19 and 20.
(20) However , the Author ity also considered that the data provided did not enable the safety assessment of the substance 
with FCM No 1081 when in contact with acidic foods and alcoholic beverage s, and indicated that migration would 
be high in particular in contact with fatty foods. Theref ore, it is appropr iate to mitigat e the foreseeable risk that 
consumers would use a plastic containing this substance in contact with foods other than dry foods. To that 
purpose, this substance should only be used in applications for use by food business operat ors to packag e food. In 
addition, the Author ity noted that migration may increase with a lower degree of esterification and may excee d 
migration limits in case of a higher thickness of the plastic mater ial in whic h it is applied, and that also other 
parameter s, such as the polar ity of the polymer , could be relevant. Theref ore, it is appropr iate to indicate in a note 
on the verification of compliance that there is a risk that migration limits may be exceeded based on the thickness 
of the mater ial, the polar ity of the polymer and the degree of esterification of the substance itself.
(13)EFSA Journal 2020;18(5):6046 .
(14)Scientif ic panel on FCM, Enzymes, and processing aids (CEP ), Minutes of the 19th meeting of the working group on FCM 2018-2021 , 
30 September 2020, point 7(1).
(15)EFSA Journal 2020;18(3):6047.EN Offi cial Jour nal of the European Union 12.7.2023 L 177/49  (21) The Auth ority adopt ed a favourable scientific opinion (16)on the use of the substance phosphor ic acid, mixed esters 
with 2-hydro xyethyl methacr ylate (FCM No 1082) in polymethylmethacr ylate- based compo sites intende d for 
repeated contact with all food types. The Authority concluded that the substance is not a safety concer n for the 
consumer if used as a co-monomer at up to 0,35 % w/w , and provid ed that its migration does not exce ed 
0,05 mg/kg food expressed as the sum of the mono-, di- and triesters of phosphor ic acid and the mono-, di-, tri- 
and tetraeste rs of diphosphor ic acid. Although the Authority refer red to the use of this substance in ‘com posites’, 
that term may cover also mater ials whic h are not polymers and, theref ore, whic h are not plastic within the meaning 
of Regulation (EU) No 10/2011. Consequently it is appropr iate to author ise the use of this starting substance in the 
manufact ure of polymethylmethacr ylate up to 0,35 % w/w and to lay down a migration limit according to the 
opinion of the Auth ority.
(22) The Author ity adopt ed a favourable scientifi c opinion (17)on the use of the starting substance 
benzophenone-3,3',4,4'-te tracarbo xylic dianh ydride (‘BTD A’) (FCM No 1083). The Author ity concluded that the use 
of the substance BTD A is not a safety concer n for the consumer if it is applied at up to 43 % as a co-monomer in the 
production of polyimides for repeate d use contact with acidic and fatty foods at temperatures up to 250 °C, provided 
that the migration of BTD A does not exce ed 0,05 mg/kg. As the specifi c migration tests on which basis the Authority 
concluded favour ably on the use of this substance were carried out under repeated use conditions with acetic acid 
(simulant B) and olive oil (simulant D2), and the Authority obser ved that it would not raise a concer n even if used 
in non-repeated use applications, it is appropr iate to author ise the use of this starting substance for the use in the 
manufact ure of polyimides at up to 43 % w/w polymer in contact with foods for whic h only simulants B and/or D2 
are laid down in table 2 of Annex III to Regulation (EU) No 10/2011 at temperatures up to 250 °C, and if this use is 
subject to a migration limit of 0,05 mg/kg food.
(23) In order to allow operators to adapt to the changes to certain existing author isations set out in this Regulation, it is 
appropr iate to provide that plastic mater ials and articles compl ying with Regulation (EU) No 10/2011, as applicable 
before the date of the entr y into force of this Regulation, are allowed to be first placed on the mark et for a transition 
period of 18 months after the entr y into force of this Regulation and remain on the mark et until the exhaustion of 
stoc ks. Howe ver, the production of final plastic mat erials and articles typically involves the supply of several 
products and substances from interm ediate manufactur ing stages by other operators. For the sake of consumer 
safety , the transition to full compl iance with this Regulation should be achi eved as efficiently as possible, and with 
minimum dela y. Theref ore, operat ors manuf actur ing intermediat e products and substances that do not yet compl y 
with this Regulation, should be required to inform the users of these products already within nine months followi ng 
the entr y into force of this Regulation that these products, as provided, cannot be used to manufa cture plastic 
mater ials and articles to be placed on the mark et after the transition period of 18 months ends.
(24) This Regulation revok es the author isations for the substances ‘wood flour and fibers, untreat ed’ (FCM No 96) and 
salicylic acid (FCM No 121) because it cannot be established that those author isations, as they currently stand, are in 
accordance with Regulation (EU) No 1935/2004 given that information about specifi c substances or specifi c uses of 
those substances would be required to ensure that those author isations do not go beyond what is safe. Howe ver, in 
order to ensure a smooth transition to pote ntial more limite d author isations in case operat ors that have been 
manufact uring or using these substances before the entr y into force of this Regulation consider that some specific 
uses comply with Regulation (EU) No 1935/2004, it is appropr iate to allow the placing on the mark et of plastic 
mater ials and articles manuf actured with those substances provided that an application for author isation of those 
specifi c uses is submitted within a propor tionate period after the entr y into force of this Regulation. With regards to 
untreate d wood flour and fibres, since the Auth ority in its opinion on wood considered that wood like mate rials 
need to be evaluated on a case-by- case basis, specifi c to the species, such an application should be specific to a 
certain wood species.
(16)EFSA Journal 2020;18(5):6120.
(17)EFSA Journal 2020;18(7):6183.EN Offi cial Jour nal of the European Union L 177/50 12.7.2023  (25) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
Article 1
Amendments to Annex I to Regulation (EU) No 10/2011
Annex I to Regulation (EU) No 10/2011 is amended in accordance with the Annex to this Regulation.
Article 2
Transitional measures
1. Plastic mater ials and articles complying with Regulation (EU) No 10/2011 as applicable before the entr y into force of 
this Regulation, whic h were first placed on the mark et before 1 Febr uary 2025 may remain on the market until the 
exhaustion of stoc ks.
2. In case a product from an interm ediat e stage of the manuf actur ing of plastic mater ials and articles or a substance 
intended for the manuf actur ing of such a product, mate rial or article, which compl ies with Regulation (EU) No 10/2011 as 
applicable before the entr y into force of this Regulation and which is first placed on the mark et after 1 May 2024 does not 
compl y with this Regulation, the declaration of compl iance available for that substance or product shall indicate that it does 
not compl y with the present rules, and that it can only be used in the manuf acture of plastic mate rials and articles to be 
placed on the market before 1 Febr uary 2025 .
3. Plastic mate rials and articles manufactured with salicylic acid (FCM No 121) or manuf actured with untreated wood 
flour or fibre s from a specific wood species may continue to be first placed on the market after 1 Febr uary 2025 provided 
that the follo wing conditions are fulfilled:
(a) an application for the author isation of that substance or of that untreat ed wood flour or fibre from a specific wood 
species has been submitted to the compet ent author ity in accordance with Article 9 of Regulation (EC) No 1935/2004 
before 1 August 2024 ;
(b) the use of that substance or of that untreated flour or fibre from a specifi c wood species to manuf acture a plastic 
mater ial and article, and the use thereof, is limited to the intended conditions of use descr ibed in the application;
(c) the information provided to the Authority in accordance with Article 9(1)(b) of Regulation (EC) No 1935/2004 
includes a statement that the application is an application in accordance with this paragraph; and
(d) the Author ity has considered the application valid.
4. Plastic mater ials and articles manufactured with the substance or the untreat ed wood flour or fibre subject to an 
application may then continue to be used until the applicant withdraws its application or until the Commission adopts a 
decision granting or refusing the author isation for the use of that substance or wood flour or fibre pursuant to 
Article 11(1) of Regulation (EC) No 1935/2004.EN Offi cial Jour nal of the European Union 12.7.2023 L 177/51  Article 3
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 11 July 2023 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 177/52 12.7.2023  ANNEX 
Annex I to Regulation (EU) No 10/2011 is amended as follows :
(1) point 1, Table 1 is amended as follows:
(a) entr y 96 on wood flour and fibers, untreate d, and entr y 121 on salicylic acid are deleted;
(b) entr y 157 on phthalic acid, dibutyl ester is replaced by the followi ng:
‘157 74880 000008 -
4-74-2phthalic acid, 
dibutyl ester 
(‘DBP’)yes no no 0,12 (32)
(36)Only to be used as:
(a) plasticiser in re­
peated use mater ials 
and articles contact ­
ing non-fatty foods;
(b) technical suppor t 
agent in poly olefins 
in concentrations up 
to 0,05 % (w/w) in the 
final product.(7)’
(c) entr y 159 on phthalic acid, benzyl butyl ester is replaced by the followi ng:
‘159 74560 000008 -
5-68-7phthalic acid, 
benzyl butyl 
ester (‘BBP’)yes no no 6 (32)
(36)Only to be used as:
(a) plasticiser in re­
peated use mater ials 
and articles;
(b) plasticiser in sing le- 
use mat erials and ar­
ticles contacting 
non-fatty foods ex­
cept for infant formu­
la and follo w-on for­
mula (*);
(c) technical suppor t 
agent in concentra ­
tions up to 0,1 % 
(w/w) in the final pro­
duct.(7)’EN Offi cial Jour nal of the European Union 12.7.2023 L 177/53  (d) entr y 283 on phthalic acid, bis(2-eth ylhexyl) ester is replaced by the followi ng:
‘283 74640 000011 -
7-81-7phthalic acid, 
bis 
(2-ethyl -
hexyl) ester 
(‘DEHP’)yes no no 0,6 (32)
(36)Only to be used as:
(a) plasticiser in re­
peated use mater ials 
and articles contact ­
ing non-fatty foods;
(b) technical suppor t 
agent in concentra ­
tions up to 0,1 % 
(w/w) in the final pro­
duct.(7)’
(e) entr y 728 on phthalic acid, diest ers with primar y, saturated C8-C10 branch ed alcohols, more than 60 % C9 is 
replaced by the followi ng:
‘728 75100 006851 -
5-48-0 -
002855 -
3-12-0phthalic acid, 
diesters with 
primar y, 
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 re­
peated use mater ials 
and articles;
(b) plasticiser in sing le- 
use mat erials and ar­
ticles contacting 
non-fatty foods ex­
cept for infant formu­
la and follo w-on for­
mula (*)
(c) technical suppor t 
agent in concentra ­
tions up to 0,1 % 
(w/w) in the final pro­
duct.
Not to be used in 
combination with FCM 
substances 157, 159, 
283, or 1085.(7)’
(f) entr y 793 on triethanolamine is replaced by the followi ng:
‘793 94000 000010 -
2-71-6triethanola -
mineyes no no (37)’
(g) entr y 822 on perc hlor ic acid, salts (perchlorat e) is replaced by the following:
‘822 71983 14797-7 -
3-0Perchlori c 
acid, salts 
(perchlor ate)yes no no (38)’EN Offi cial Jour nal of the European Union L 177/54 12.7.2023  (h) entr y 1007 on diethyl[[3,5-bis(1,1-dimeth ylethy l)-4-hy droxyphenyl] methyl]phosphonat e is replaced by the 
follo wing:
‘1007 976-56-7 diethyl[ [3,5-bis 
(1,1-dimethy le-
thyl )- 
4-hydro xyphe -
nyl] methyl] 
phosphonateno yes no Only to be used up to 
0,2 % (w/w) based on the 
final polymer weight in 
the polymer isation 
process to manuf acture 
poly(eth ylene 
terephthalate) (PET) and 
poly(eth ylene 
2,5-furandicarbo xylat e) 
(PEF)’
(i) entr y 1059 on poly((R)-3-hydr oxybutyrate-co- (R)-3-hydro xyhexanoate) is replaced by the follo wing:
‘1059 147398- -
31-0Poly((R)- 
3-hydro xybuty -
rate-co-(R)- 
3-hydro xyhex -
anoat e) (‘PHBH’)no yes no (35) The substance is a 
macromolecule obtained 
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.(23)’
(j) entr y 1076 on Phosphorous acid, triphen yl ester, polymer with alpha-hydro-ome ga-h ydro xypoly[o xy 
(meth yl-1,2-ethanediyl)], C10-16 alkyl ester is replaced by the follo wing:
‘1076 122793 -
7-46-3Phosphorous 
acid, triphenyl 
ester, polymer 
with alpha- 
hydro-omega- 
hydroxypoly[o xy 
(methyl- 1,2-etha -
nediyl)], C10-16 
alkyl estersyes no no 0,05 To be used only:
a)as an additive at up to 
0,2 % w/w in high im­
pact polystyrene mate ­
rials and articles in­
tended for contact 
with food at room tem­
perature and below , in­
cluding 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 an­
d/or D1 is assigned in 
Annex III.EN Offi cial Jour nal of the European Union 12.7.2023 L 177/55  b)as an additive at up to 
0,025 % w/w in acry­
lonitr ile-butadiene- 
styrene (ABS) mater i­
als for use at room tem­
perature and below’
(k) the follo wing entr ies are inser ted at the end of Table 1 in numer ical order :
‘1078 3319-3 -
1-1tris(2-ethylhexyl) 
benze -
ne-1,2,4-tr icar-
boxylateyes no no 1 (32) Only to be used as 
plasticiser to manuf acture 
soft poly(vin yl chlor ide)
Not to be used in contact 
with foods intende d for 
infants (*)
1080 156157 -
-97-0(triethanolamine- 
perch lorate, 
sodium salt) 
dimeryes no no (37)
(38)Only to be used in rigid poly 
(vinyl chlor ide) in contact 
with foods included in the 
food categor y with 
referen ce number 01.01.A 
in table 2 of Annex III
1081 - N, N-bis 
(2-hydro xyethyl) 
stear ylamine 
partially 
esterified with 
satura -
ted C16/C18 fatty 
acidsyes no no (7) Only to be used at up to 2 % 
(w/w) in plastic mater ials 
and articles intended for the 
packag ing by food business 
operat ors of dry foods for 
which simulant E is assigned 
in table 2 of Annex III.(30)
1082 52628- -
03-2Phosphor ic acid, 
mixe d esters with 
2-hydro xyethyl 
methacr ylateno yes no 0,05 Only to be used at up to 
0,35 % (w/w) to 
manufact ure 
polymethy lmethacr ylate.
SML expressed as the sum of 
the mono-, di- and triesters 
of phosphor ic acid and the 
mono-, di-, tri- and 
tetraesters of diphosphor ic 
acidEN Offi cial Jour nal of the European Union L 177/56 12.7.2023  1083 2421-2 -
8-5Benzophe -
none-3,3',4,4'- 
tetracarbo xylic 
dianh ydride 
(‘BTD A’)no yes 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 follo w-on formula as defin ed 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 Directives 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) entr y 7 is replaced by the followi ng:
‘7 19
20
10811,2 expressed as tertiary amine’
(b) entr y 26 is replaced by the following:
‘26 728
7291,8 expressed as the sum of the substances’
(c) entr y 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 synon yms 1,2-bis(2-meth ylprop yl) 
benzene-1,2-dicarbo xylat e or ‘DIBP’ and CAS number 84-69-5 is not listed as 
an author ised substance in Table 1. However , it may co-occur with other 
phthalat es as a consequence of its use as an aid to polymer isation and is 
included in group restr ictions with the assignment FCM No 1085.’EN Offi cial Jour nal of the European Union 12.7.2023 L 177/57  (d) the follo wing entr ies are added:
‘36 157
159
283
1085*0,6 sum of phthalic acid, dibutyl ester (DBP), diisobutyl phthalat e (DIBP), phthalic acid, 
benzyl butyl ester (BBP) and phthalic acid, bis(2-eth ylhexyl) 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
10800,05 expressed as the sum of triethanolamine and the hydrochlori de adduct expressed 
as triethanolamine
38 822
10800,002 expressed as perchlor ate – note 4 of table 3 applies ’
(3) in point 3, Table 3, the follo wing entr y is added:
‘(30) There is a risk that migration limits may be exceed ed; migration increases with the 
thickness of the plastic in whic h the substance is contained, and with a decreasing 
polar ity of the polymer and a decreasing degree of esterification of the substance 
itself’EN Offi cial Jour nal of the European Union L 177/58 12.7.2023