EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
PLAN/2019/6074 Rev3  
(POOL/E2/2019/6074/6074R3 -EN.docx)   
D084605/02  
[…](2022) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
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 addition of new substances  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
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 addition of new substances  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the 
Council of 27 October 2004 on materials and articles intended to come into contact with food 
and repealing Directives 80/590/EEC and 89/109/EEC1, 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 10/20112 lays down specific rules as regards plastic 
materials and articles intended to come into contact with food. In particular, Annex I  
to Regula tion (EU) No 10/2011 establishes a Union list of authorised substances  that 
may be intentionally used in the manufacture of plastic materials and articles  intended 
to come into contact with food .  
(2) Since the last amendment to Regulation  (EU) No 10/2011 , the European Food Safety 
Authority (‘the Authority’) has published further scientific opinions on new substances 
that may be used in food contact materials (‘FCM’) as well as on the use of already 
authorised substances. In addition, certain ambiguities related to the application of that 
Regulation were identified. In order to ensure that Regulation (EU) No 10/2011 takes 
into account scientific and technical progress , in particular the most recent findings of 
the Authority , and in order to remove any doubt  as regards its correct application, that 
Regulation should be amended.  
(3) The substance ‘ wood flour and fibe rs, untreated’ (FCM No 96, ‘wood’ ) is presently 
authorised as an additive in plastic food contact materials on the basis of an evaluation  
by the Scien tific Committee on Food which concluded that  wood flour and fibres are 
an inert material. However, in its opinion3  of November 2019 the Authority could not 
validate the  grounds  for that conclusion . It stated that wood cannot be considered inert 
per se , due to the many low molecular weight substances it contains . Moreover, t he 
opinion indicates no conditions under which the use of wood in plastics may be 
considered safe , and notes  that due to the chemical differences in the composition of 
plant materials  the safety of migrants from these materials must be evaluated on a 
case-by-case basis, considering beyond species also origin, processing, treatment for 
                                                 
1 OJ L 338, 13.11.2004, p. 4.  
2 Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials 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 2  EN compatibilisation with the host polymer and assessment of the low molecul ar weight 
constituents migrate  into food. As  the present  authorisation of wood  does not take  into 
account th ose aspects and  thus cannot sufficiently account for the safe use of  that 
substance  in plastic , and  the Authority did not provide for other restrictions that would 
nevertheless ensure the safe use of this substance  in plastic , the authorisation should be 
revoked . 
(4) Following a request by the Commission , the Authority adopted on 29 April 2020 a 
scientific opinion4 review ing the 451 substances lis ted in Annex I to Regulation (EU) 
No 10/2011 , for which no specific migration limit  (‘SML ’) is set pursuant to Article 
11(1) of that Regulation . It considered that 284 of those substances  needed to be re -
evaluated  in order to determine whether a specific m igration limit is required  and 
classified them in three priority group s. 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  lauric 
acid, vinyl ester (FCM No 436)  a user provided the A uthority with additional data 
which showed its re -evaluation would be of a lower priority.  However , no user of the 
third substance, salicylic acid (FCM No 121),  contacted either the Commission or the 
Authority  after it was placed in the high priority list  and after the Commission services 
consulted the stakeholders over a potential  revocation of its authorisation . The 
Authority  however cann ot evaluate the use of a substance without a known user as it is 
to take account of the intended conditions of use of the material or article in which the 
substance would be used , and  only a user can provide  such information.  Moreover, if 
provided , such in formation would to a large extent determine the scope of any future 
authorisation which would be likely more limited than the present wide authorisation.  
Consequently, as no specific use or user of salicylic acid is known, and  given the 
uncertainty over the conditions of use under which the use of this  substance  would 
comply  with Regulation (EC) No 1935/2004 , it is appropriate to revoke the present 
authorisation  of salicylic acid . 
(5) Based on opinion s of the Authority adopted in 200 55, five substances  from a group 
commonly known 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 authorised as additives for use as plasticisers and technical support agen ts in 
plastic FCM, subject to specific restrictions of use and migration limits.  
(6) Following an opinion in 2017 by the European Chemicals Agency (‘ECHA’) on 
restriction proposals for some of these phthalates6, the Commission requested the 
Authority to re -assess the risk to public health from phthalates that are authorised to be 
used in plastic FCM. The Authority consequently adopted a scientific opinion on 18 
September 20197, confirming the individual TDIs set out in its 2005 opinion s for all 
five phthalates  but only on a temporary basis ( t-TDI), because of a number of 
                                                 
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 Socio -economic Analysis (SEAC) 
Opinion on an Annex XV dossier proposing restrictions on four phthalates (DEHP, BBP, DBP, DIBP); 
ECHA/RAC/RES -O-0000001412 -86-140/F and ECHA/SEAC/RES -O-00000 01412 -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 3  EN limitations and uncertainties related to the assessment, which should be addressed in 
the future.   
(7) Based on a common mechanism of action underlying the repro ductive  effects of DBP, 
BBP and DEHP , the Authority also established a new group t-TDI, taking into account 
their relative potencies. The Authority further considered it appropriate to include 
DINP in the group t-TDI as a conservative approach based on its transient effects on 
foetal testost erone levels, whilst accounting for the higher potency of DINP on the 
liver. The authority 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 i nclude DIDP in the group t-TDI and set an individual 
t-TDI of 150 µg/kg bw based on effects on the liver, consistent with its findings from 
2005.  
(8) In order to further characterise the risk, the Authority carried out a dietary exposure 
assessment as part of the same opinion. Whilst it was unable to specifically determine 
the contribution from plastic FCM, it estimated dietary exposure for all five phthalates, 
which represent the worst -case estimates of exposure from FCM sources. Based on an 
aggregated dietary  exposure assessment for DBP, BBP, DEHP and DINP, it concluded 
that dietary exposure contributes 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 
estimates for DIDP indicate that dietary exposure is far below the t-TDI of 150 µg/kg 
bw for both average and high consumers.  
(9) Additionally, the Authority considered consumers’ exposure to other phthalates, 
notably to 1,2-bis(2 -methylpropyl) benzene -1,2-dicarboxylate (diisobutyl phthalate  or 
‘DIBP’; FCM No 1085; CAS number 84 -69-5), which is not authorised 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 support agent in the manufacturing process of 
certain types of plastic . The Authority noted that DIBP substantially adds to the 
overall exposure and risk to consumers from phthalates and that such exposure 
together with its potency with regard to reproductive effects should also be taken into 
account by the risk manager. The Authority further noted that consumers’ exposure to 
phthalates arises from sources other than the diet. Significant contribution to total 
phthalate exposure comes from their presence in consumer articles and construction 
materials 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 
Authority’s considerations  as regards DIBP , and, in particular, to e nsure 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 compliance or when carrying 
out official controls in cases where one of these phthalates has been used alone, 
individual SMLs should be maintained for the authorised phthalates in addition to the 
SML(T)s.  
(11) Although the Authority 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 -
occurrence. 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 differentiated by competent authorities when undertaking  
EN 4  EN official controls. It is therefore appropriate to maintain a separate SML(T) for the sum 
of D INP 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 support agent, in 
order to avoid any potential co -exposure from the same plastic FCM.  
(12) Taking into account that the aggre gated exposure  from both FCMs and sources other 
than FCMs  is expected to be  in the order of the t-TDI, and that  accumulation may 
occur in the food manufacturing chain due to migration from  food processing 
equipment as well as  from food packaging , and takin g into account th e significant 
level of uncertainty regarding the present  exposure  estimates , it is appropriate 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 appropriate to use that allocation factor for all five 
phthalates when setting the SML(T) and the individual SMLs.  
(13) The substance diethyl[[3,5 -bis(1,1 -dimethylethyl) -4-hydroxyphenyl]methyl] 
phosphonate (FCM No 1007)  is presently authorised for use up to 0,2 % (w/w) based 
on the final polymer weight in the polymerisation process to manufacture 
poly(ethylene terephthalate) ( ‘PET’). Following an application for the extension of use 
of this substance, on 26 January 2022, the Authority adopted a favourable scientific 
opinion8 on its use up to 0,1 % w/w based on the final polymer weight in the 
polymerisation process to manufacture  poly(ethylene 2,5 -furandicarboxylate) ( ‘PEF’). 
The Authority concluded that, w hen used in this amount , migration of the substance 
was not detected due to its incorporation in the polyester chain. Because of that 
incorporation , there is also no reason to assume that , when used in PEF at a use level 
of 0,2 % w/w, migration of the substan ce would  be substantially higher . As the safe 
use of the substance thus stems from its full incorporation into the polymer, and for the 
sake of consistency and simplicity, it is appropriate to extend the existing authorisation 
for the use  level of this sub stance in PET  at 0.2 % w/w  also to the manufacture of PEF .  
(14) Commission Regulation (EU) 2019/13389 authorised the substance Poly((R) -3-
hydroxybutyrate -co-(R)-3-hydroxyhexanoate) (‘PHB H’, FCM No 1059).  However, it 
appears the specification of the permitted use of th at 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 specified that  a 
macromolecule is obtained from such fermentation , the refe rence to this production 
method should be added  to the specification of PHBH . In addition , the authorisation 
allows for a short heating up phase, without specifying  a maximum temperature . This 
absence of a maximum temperature could allow for heating  at temperature s beyond 
those foreseen in the opinion  of the Authority on which basis the substance was  
authorised , which refers to ‘hot -fill’ conditions , defined  by Regulation  (EU) No 
10/2011  as a temperature not exceeding 100 °C at the moment of filling. In addition , 
the opinion indicates that a plastic manufactured with the substance has a melting 
point in the range of 120 –150°C . Moreover,  absence of a maximum temperature 
implies that it is not clear which testing conditions should be used to verify 
complian ce with Regulation  (EU) No 10/2011 as regards the specification concerning 
the ‘short heating up phase ’. The specification  should therefore be clarified by 
                                                 
8 doi: 10.2903/j.efsa.2022.7172  
9 Commission Regulation (EU) 2019/1338 of 8 August 2019 amending Regulation (EU) No 10/2011 on 
plastic materials and articles intended to come into contact with food ( OJ L 209, 9.8.2019, p. 5 ).  
EN 5  EN indicating a condition of use as  that does not exceed the temperature conditions 
foreseen in the opi nion.  
(15) The Authority adopted a favourable scientific opinion10 on the use of the substance  
‘phosphorous acid, triphenyl ester, polymer with alpha -hydro -omega -
hydroxypoly[oxy(methyl -1,2-ethanediyl)], C10 –16 alkyl esters’ (FCM No 1076) as an 
additive at up to  0.025% w/w in acrylonitrile -butadiene -styrene (ABS) copolymers.  
The Authority concluded that the use of the substance is not of safety concern for the 
consumer if it is used as an additive at up to 0.025% w/w in ABS materials and articles 
for single and repeated use in contact with aqueous, acidic, alcoholic and oil -in-water 
emulsion foods , for long -term 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 appropriate to authorise the 
use of this additive in the manufacture of ABS materials 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 Authority.  
(16) On 19 September 2019 , the Authority adopted a favourable scientific opinion11 on the 
use of the substance tris(2 -ethylhexyl) benzene -1,2,4 -tricarboxylate ester (FCM No 
1078,  CAS number 3319 -31-1), as an additive (pl asticiser) in poly(vinyl chloride) 
(‘PVC’) FCM . In that opinion, the Authority co ncluded that overall the use of FCM 
No 1078 does not raise a safety concern when used in the manufacture of soft PVC. 
Therefore it is appropriate to authorise this substance a ccordingly. However, the 
conclusion of the Authority is conditional to the  migration  of the substance not 
exceed ing 5 mg/kg food.  In addition , the Authority indicated that due to the additional 
contribution 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 appropriate to apply an allocation factor of 20% until appropriate 
scientific data is provided. Moreover, in its opinion, the Authority state d that its 
evaluation does not cover the use of this substance  in contact with ‘infant foods ’. 
Therefore, it has not been demonstrated that the use of th is substance in contact with 
‘infant foods ’ would meet the requirements of Article 3 of Regulation (EC) No 
1935/2004. Therefore, the authorisation of this substance should be  subject to  a limit  
on its migration  of 1 mg/kg food  and a restriction  that prevent s its in contact with  
foods intended for infants . For the sake of clarity and consistency with similar 
restrictions, it is appropriate to refer to the definition of ‘ infant ’ laid down in Article 
2(2)(a) of Regulation (EU) No 609/2013  of the European Parliament and of the 
Council12.  
(17) Furthermore, since g roup restriction 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 
                                                 
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 -
ethylhexyl) ester’, whereas this Regulation re fers to its IUPAC name ‘tris(2 -ethylhexyl) benzene -1,2,4 -
tricarboxylate’.   
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 t otal 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) N o 41/2009 and (EC) No 953/2009 (OJ L 181, 
29.6.2013, p. 35).   
EN 6  EN also a plasticiser, it is appropriate to apply this group restriction also to that substance. 
In addition, to clear any  doubt over the nature of this group restriction , it is appropriate 
to indicate that it concerns plasticiser s. 
(18) Following an application for authorisation of the use of the substance 
(triethanolamine -perchlorate, sodium salt) dimer (FCM No 1080),  as an additive in 
rigid PVC for repeated use bottles intended for contact with water, t he Authority 
adopted on 29 Apri l 2020  a favourable scientific opinion13 on that use. The Authority 
concluded that it s 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 -perchlorate, sodium salt) dimer fully dissociates into triethanolamine 
and perchlorate . Those two substances are already included i n the Union list of 
authorised substances , triethanolamine as FCM No 793 with a migration limit of 0,05 
mg/kg , and p erchlorate  as FCM No 822 with a migration limit of 0,002 mg/kg.  The 
Authority concluded that th ose 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 
safety i s fully  controlled by the migration limits established for thos e two substances  
due to its dissociation . The Authority furthermore confirmed that the migration of 
FCM No 822 should be expressed as perchlorate14. It is therefore appropriate to 
establish two group restrictions in table 2 of Annex I to Regulation  (EU) No 10/2011 , 
encompassing the FCM substance No 1080  together with FCM substance No 793 in 
one group, and with FCM substance No 822 expressed as perchlorate in the other 
group . It is therefore appropriate to amend substance s FCM No 793 and 822 
accordingly , and to include the substance (triethanolamine -perchlorate, sodium salt) 
dimer (FCM No 1080) as an additive in the Union list of authorised substances, with 
the restriction that it should only be used in contact with  foods  included in the food 
category with reference number 01.01.A in table 2 of Annex III  which represents 
water and the acidic aqueous foods  considered by the Authority . 
(19) Following an application for the authorisation of the use of the substance N, N -bis(2 -
hydroxyethyl)stearylamine 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 ambien t temperature, t he 
Authority adopted a partially favourable scientific opinion15 on th at use. As part of its 
evaluation, t he Authority considered  the migration data provided  by the applicant for 
testing for storage conditions above six months at room temperature and below. The 
Authority concluded that N,N -bis(2 -hydroxyethyl)stearylamine  is not a safety concern 
for the consumer when used at up to 2% (w/w) in all polymers  intended for contact  
only with dry foods , provided  that the migrati on of the sum of N,N -bis(2 -
hydroxyethyl)stearylamine and its mono - and di -ester, calculated as N,N -bis(2 -
hydroxyethyl) stearyl amine , does not exceed , the SML(T) for FCM substances No 19 
and 20, in which  according to the Authority  the migration of the mono - and di -ester of 
N,N-bis(2 -hydroxyethyl)stearylamine was also to be included . Therefore , it is  
appropriate to authorise the use of this substance at up to 2% (w/w) for manufacturing  
plastic FCM intended to be in contact only with dry foods  at room temperature, and it 
                                                 
13 EFSA Journal 2020;18(5):6046 . 
14 Scientific 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):604 7.  
EN 7  EN should be included in the group restriction  laid down for  the substance s with FCM No  
19 and 20 .  
(20) However, the Authority also considered that the data provided did not enable the 
safety assessment of the substance with FCM No 10 81 when in contact with acidic 
foods and alcoholic beverages, and  indicated that migration would  be high in 
particular in contact with fatty foods. Therefore, it is appropriate to mitigate 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 operators to package food.  In addition, 
the Authority noted that migration may increase with a lower degree of esterification 
and may exceed migration limits in case of a higher thickness of the plastic material in 
which it is applied , and that also other parameters , such as the polarity of the polymer , 
could be relevant . Therefore , it is appropriate to indicate in a  note on the verification 
of compliance that there is a risk that migration  limits  may be exceede d based on the 
thickness  of the material, the polarity of the polymer  and the  degree of  esterification  of 
the substance  itself . 
(21) The Authority adopt ed a favourable scientific opinion16 on the use of the substance 
phosphoric acid, mixed esters with 2 -hydroxyethyl methacrylate (FCM No 1082)  in 
polymethylmethacrylate -based composites intended for repeated contact with all food 
types.  The Authority conclud ed that th e substance is not a safety concern for the 
consumer if used as a co -monomer at up to 0.35% w/w, and provided that its 
migration does not exceed 0.05 mg/kg food expressed as the sum of the mono -, di- and 
triesters  of phosphoric acid and the mono -, di-, tri- and tetraesters of diphosphoric 
acid. Although  the Authority refer red to the use of this substance in ‘composites’ , that 
term may cover also materials which are not polymers and, therefore, which are not 
plastic  within the meaning of Regulation (EU) No 10/2011 . Consequently  it is 
appropriate to  authorise the use of this s tarting s ubstance  in the manufacture of  
polymethylmethacrylate  up to 0.35% w/w and to lay down a migration limit according 
to the opinion of the  Authority.   
(22) The Authority adopted a favourable scientific opinion17 on the use of the starting 
substance benzophenone -3,3’,4,4’ -tetracarboxylic dianhydride ( ‘BTDA ’) (FCM No 
1083).  The Authority concluded that the use of the substance BTDA is not a safety 
concern for the consumer if it is applied at up to 43% as a co -monomer in the 
production of polyimides for repeated use contact with acidic and fatty foods at 
temperatures up to 250°C , provided that the migration  of BTDA does not exceed 0.05 
mg/kg . As the specific migration tests on which basis the Authority concluded 
favourably 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 observed 
that it woul d not raise a concern even if used in non -repeated use applications , it is 
appropriate to authorise the use of this starting substance  for the use in  the 
manufacture of  polyimides at up to 43% w/w polymer  in contact with  foods for which 
only simulants B an d/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.  
                                                 
16 EFSA Journ al 2020;18(5):612 0. 
17 EFSA Journal 2020;18(7):6183 .  
EN 8  EN (23) In order to allow operators to adapt to  the changes to certain existing authorisations set 
out in this Regulation, it is appropriate to provide that plastic materials and articles 
complying with Regulation (EU) No 10/2011, as applicable before the date of the 
entry into force of this Regulation , are allowed to be first placed on the market for a 
transition period of 18 months after the entry into force of this Regulation  and remain 
on the market until the exhaustion of stocks. However, the production of final plastic 
materials and articles typic ally involves the supply of several products  and substances  
from intermediate manufacturing stages by other operators. For the sake of consumer 
safety,  the transition to full co mpliance with this Regulation should be  achieved as 
efficiently as possible, and with minimum delay . Therefore , operators  manufacturing  
intermediate  products and substances  that do not yet comply with this Regulation,  
should  be required to inform the users of these products  already within nine months 
following the entry into force of  this Regulation that these products, as provided , 
canno t be used to manufacture plastic materials and articles to be placed on the market 
after the transition period of 18 months ends.   
(24) This Regulation revokes  the authorisation s for the substances ‘wood flour and fibe rs, 
untreated’  (FCM No 96) and salicylic acid (FCM No 121)  because it cannot be 
established that those authorisations, as they currently stand, are in accordance with 
Regulation (EU) No 1935/2004 given that information about specific sub stances or 
specific uses of those substances would be required to ensure that those authorisations 
do not go beyond what is safe . However , in order to ensure a smooth transition to 
potential more limited authorisations in case operators  that have been manu facturing 
or using these substances before the entry into force of this Regulation  consider that 
some specific uses comply with Regulation (EU) No 1935/2004 , it is appropriate to 
allow  the placing on the market of plastic materials and articles manufacture d with 
those substances  provided that an application for authorisation of those specific uses is 
submitted within a proportionate period after the entry into force of this Regulation. 
With regards to untreated wood flour and fibres, since  the Authority in its opinion on 
wood3 considered that  wood like materials need to be evaluated on a case -by-case 
basis, specific to the species , such an application should be specific to a certain wood 
species.   
(25) The measures  provided for in this Regulation are in accordance with the opinion of the  
Standing Committee on Plants, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Amendments to  Annex I to  Regulation (EU) No 10/2011  
Annex I to Regulation (EU) No 10/201 1 is amended in accordance with the Annex to this 
Regulation.  
Article 2 
Transition al measures   
1. Plastic materials and articles complying with Regulation (EU) No 10/2011 as 
applicable before the entry into force of this Regulation, which were first placed on  
the market before [enter date 18 months after the date of entry into force of this 
Regulation]  may remain  on the market until the exhaustion of stocks.    
EN 9  EN 2. In case a  product from an intermediate stage of the manufacturing of plastic materials 
and articles or a substance intended for the manufacturing of such a product, material 
or article, which complies with Regulation (EU) No 10/2011 as applicable before the 
entry i nto force of this Regulation and which is first placed on the market after [enter 
date 9 months after the date of entry into force of this Regulation]  does not comply 
with this Regulation , the declaration of compliance available for that substance or 
produ ct shall indicate that it does not comply  with the present rules, and that it can 
only be used in the manufacture of plastic materials and articles to be placed on the 
market before  [enter date 18 months after the date of entry into force of this 
Regulatio n].  
3. Plastic m aterial s and a rticles  manufactured with  salicylic acid (FCM No 121) or 
manufactured with untreated wood flour or fibres  from a  specific wood species  may 
continue to be first placed on the market  after [enter date 18 months after entry into 
force of this Regulation ] provided that the following conditions are fulfilled:  
(a) An application  for the authorisation of th at substance  or of that untreated wood 
flour or fibre from a specific wood species  has been submitted to the competent 
authority in accordance with Article  9 of Regulation (EC) No 1935/2004  
before  [enter date 12 months after entry into force of this Regulation ]; 
(b) the use of that substance or of that untre ated flour or fibre from a specific wood 
species to manufacture a plastic material and article, and the use thereof, is 
limited to the intended conditions of use described in th e application;  
(c) the information provided to the Authority in accordance with Art icle 9(1)(b) of 
Regulation (EC) No 1935/2004 include s a statement that the application is an 
application in accordance with this paragraph , and  
(d) The Authority has considered the application valid . 
4. Plastic materials and articles manufactured with t he substance or the untreated 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 authoris ation  for the use of that subs tance or wood flour or 
fibre pursuant to Article 11(1) of Regulation  (EC) No 1935/2004 .  
 
Article 3 
This Regulation shall enter into force on the twentieth day following 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,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN