COMMISSION REGUL ATION (EU) 2016/1416 
of 24 August 2016 
amending and correcting Regulation (EU) No 10/2011 on plastic mater ials and articles intended to 
come into contact with food 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d 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 
mate rials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (1), 
and in particular Article 5(1)(a), (c), (d), (e), (h), (i) and (j), Article 11(3) and Article 12(6) thereof, 
Whereas: 
(1)  Commission Regulation (EU) No 10/2011 (2) (‘the Regulation’) lays down specifi c rules as rega rds plastic 
mate rials and articles intended to come into contact with foods. In particular , it establishes a Union list of 
substances which may be used in the manuf acture of plastic food contact mate rials and articles. 
(2)  Since the Regulation's adop tion, the European Food Safety Author ity (‘the Author ity’) has published further 
repor ts on particular substances that may be used in food contact mate rials as well as on the permitted use of 
substances that have been author ised previously . In addition, certain textual errors and ambiguities were 
identified. In order to ensure that the Regulation reflects the most recent findings of the Auth ority and in order 
to remo ve any doubt as regar ds its correct application, the Regulation should be amended and corrected. 
(3)  The definition of ‘non-fat ty foods ’ in point (16) of Article 3 of the Regulation contains a reference to food 
simulants laid down in an annex to the Regulation. As the definition was intended to refer to food simulants 
listed in Table 2 of Annex III, the reference should be corrected according ly. 
(4)  Regulation (EU) No 10/2011 uses the term ‘hot-f ill’ in the context of setting restr ictions on the use of certain 
author ised monomers in mater ials and articles intended to act as a recep tacle for hot food. In order to clarify the 
scope of such restr ictions, it is appropr iate to provide a definit ion of the term specifying the temperatures at 
whic h such restr ictions apply . 
(5)  Article 6(3) of Regulation (EU) No 10/2011 establishes a derogat ion as regards the use of salts of specified metals 
derived from author ised acids, phenols or alcohols, even though these salts are not included in the Union list of 
author ised substances. As the conclusion of the Author ity on which the derogation is based was not specific to 
certain catego ries of salts (3), the qualification in point (a) of Article 6(3) that the derogat ion extends to ‘double 
salts and acid salts’ is superf luous. Since that qualification could be interpr eted as suppor ting an a contr ario inter ­
pretation according to whic h there could be categor ies of salts to which the definition does not apply , it should 
be clarified that the derogat ion applies to all salts of the listed metals, and the qualifi cation should be delet ed. 
(6)  Article 11(2) of the Regulation sets a generic specific migration limit for all substances for whic h no specifi c 
migration limit has been set. The absence of a prescr ibed limit for particular substances reflects the view that 
such specifi cation was not necessar y for the purposes of ensur ing compliance with the safety criteria laid down 
in Article 3 of Regulation (EC) No 1935/2004. As the migration levels from all substances are already subject to 
compl iance with an overall migration limit, the existence of a parallel gener ic specific limit is unnecessar y and 
gives rises to a duplication of migration testing and development of testing methods. In order to avoid the 
imposition of unnecessar ily burdensome testing oblig ations, the provision establishing gener ic specific migration 
limits should be delet ed. 25.8.2016 L 230/22 Official Jour nal of the European Union EN     
(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 2009; 7(10):1364. (7)  Pursuant to Article 13(3), and Annex I and Annex II to the Regulation, there are certain substances in respect of 
whic h it must not be possible to detect any level of migration. The prohibition is justif ied on the grounds that 
any degree of migration of such substances could pose a risk to health. As the presence of a particular substance 
can only be determined in so far as it reac hes a detectable threshold, its absence can also only be determined by 
reference to that threshold. As the rules governing the establishment and expression of detection thresholds are 
repeated throughout the Regulation, it is appropr iate to simplify the Regulation by deleting repetitions of those 
rules and by consolidating such rules within a sing le provision in the Regulation. 
(8)  As specific migration limits are expressed in mg/kg food, the same measurement unit should also be used for the 
verification of compl iance of a cap or closure, as a consistent approach avoids the poten tial for conf licting 
results. It is theref ore appropr iate to remo ve the option to express the migration from caps or closures 
in mg/dm2. 
(9)  Pursuant to Article 18(4) of the Regulation, the compl iance of mat erials and articles that were not yet in contact 
with food is to be verified in accordance with detailed rules laid down in Section 3.1 of Chapt er 3 of Annex V. 
As the provisions laid down in Sections 3.2, 3.3 and 3.4 of the same Chapt er may also be relevant to verification 
of compl iance, it is appropr iate to amend Article 18(4) so that it refers to the Chapt er 3 as a whole. 
(10)  Table 1 of Annex I to the Regulation contains the Union list of author ised substances which includes a reference 
to simulant D. Since the Regulation distinguishes between food simulants D1 and D2, the references to food 
simulant D should be replaced by more specific references to food simulant D1 or D2 for all substances. 
(11)  The substance silicon dioxide, silanated (food contact mater ial (‘FCM’) substance No 87) is currently author ised 
for use as an additive in all plastics. Also covered under FCM No 87 is a sub-cat egor y of this substance, synthetic 
amor phous silicon dioxide, silanat ed, which is produced using primar y particles in nanof orm. Under Article 9(2) 
of the Regulation, substances in nanof orm are only to be used if explicitly author ised and mentioned in the 
specifications in Annex I. Taking account of the available scientifi c information, and the absence of migration of 
primar y nanopar ticles of this synthetic form, the Auth ority has concluded that that synthetic amor phous silicon 
dioxide, silanat ed, produced from primar y particles in nanof orm does not raise a safety concer n when only 
aggrega tes larger than 100 nm and larger agglomerat es are present in the final mater ial (1). The Union list should 
theref ore be amended to add a specifi cation of substance FCM No 87 as rega rds the form in whic h it may be 
used in the final mater ial. 
(12) The Author ity has adopt ed a scientific opinion on the extension of the use of perf luorometh yl perf luoro viny ­
lether (MVE, FCM No 391) (2). According to that opinion the substance is not a safety concer n if used as 
a monomer for fluoro- and perf luoropolymers intende d for repeate d use applications, where the contact ratio is 
1 dm2 surface in contact with not less than 150 kg food such as in sealing and gaskets. It is theref ore appropr iate 
to add this application to the specif ications set out in relation to substance FCM No 391. 
(13)  The author isation of the substance ‘mixture of (35-45 % w/w) 1,6-diamino-2,2,4-tr imethyl hexane and (55-65 % 
w/w)1,6-diamino-2,4,4-tr imethylhexane’ (FCM No 641) refers in column 11 to note (10) in Table 3 of Annex I to 
the Regulation. Com pliance is theref ore verified by residual cont ent per food contact surface area (QMA) in case 
of reaction with food or simulant. Verification of compl iance by QMA is only appropr iate if a migration testing 
method is unavai lable or impractical. As adequate migration testing methods are available, and a specifi c 
migration limit has been specifi ed, the possibility to verify compl iance by residual content should be remo ved 
from the entr y for this substance in the Regulation. 
(14)  The author isation of the substance bis(methyl benzylidene)sorbitol (FCM No 752) refers in column 3 to four CAS 
numbers. These CAS numbers have been incor rectly separated in print. Theref ore the author isation of this 
substance should be correcte d by separating the CAS numbers correctly . 
(15)  The Authority adopt ed a scientifi c opinion concer ning substance FCM No 779 in 2007 (3). In its opinion the 
Author ity obser ved that analytical methods for the verification of compl iance to the migration limits are available 
and well descr ibed. Never theless, the present author isation of this substance contains a reference to note (1) of 
Table 3 of Annex I to the Regulation, which state s that, pending the availability of an analytical method, 
compl iance should be verified by residual cont ent per food contact surface area (QMA). Verification of 25.8.2016 L 230/23 Official Jour nal of the European Union EN     
(1)EFSA Journal 2014; 12(6):3712. 
(2)EFSA Journal 2015;13(7):4171. 
(3)EFSA Journal 2007, 555-563, 1-31, doi: 10.2903/j.efsa.2007.555. compl iance by QMA is only appropr iate if a migration testin g method is unavailable or impractical. Since the 
Author ity considers that analytical methods are available and well descr ibed, the reference to note (1) should be 
delet ed. The Author ity further notes in its opinion that a risk exists that migration levels in fatty foods may 
excee d the applicable migration limit, whic h was not refer red to in the present author isation. It is theref ore 
appropr iate to inser t a reference to note (2) of Table 3 of Annex I to the Regulation so as to ensure that this risk 
is considered as part of the verification of compl iance. 
(16)  At present, the substance with FCM No 974 is included in the Union list and may be used provided that the 
migration of its hydrolysis product 2,4-di-t ert-am ylphenol (CAS number 120-95-6), does not exceed 0,05 mg/kg. 
The migration of FCM No 974 is expressed as the sum of phosphite and phosphat e forms and the hydrolysis 
product 4-t-am ylphenol. The Author ity has adopt ed a scientifi c opinion according to which the migration limit 
applicable to this hydrolysis product could, without giving rise to health concer ns, be extended to 1 mg/kg food, 
provided that the migration from the product is added to the sum of the phosphite and phosphate forms and the 
hydrolysis product 4-t-am ylphenol, and that the sum of these four substances is subject to the existing 5 mg/kg 
specific migration limit for FCM No 974. The specifi cations of FCM No 974 should theref ore be amended 
according ly. 
(17)  The Author ity has adop ted a scientifi c opinion (1) on the use of the additive dodecanoic acid, 12-amino-, 
polymer with ethene, 2,5-furandione, α-hydr o-ω-hydro xypoly (oxy-1,2-ethanediyl) and 1-propene, FCM No 871. 
When used as an additive in poly olefi ns at levels of up to 20 weight % at ambient temperature or belo w in 
contact with dry foods as represente d by food simulant E, and when migration of the low molecular weight 
oligomer ic fraction less than 1 000 Da does not in total exce ed 50 μg/kg food, the use of this additive does not 
endange r human health. It is theref ore appropr iate to include this additive in the Union list and to author ise its 
use in accordance with those specifi cations. 
(18)  The Author ity has adopt ed a scientifi c opinion (2) on the use of the starting substance furan-2,5-dicarbo xylic acid 
(FCM No 1031). When used as a monomer in the production of polye thylene furanoat e (PEF) polymer this 
substance does not raise a safety concer n for the consumer when the migration of the substance itself does not 
excee d 5 mg/kg food, and when migration of the oligomers less than 1 000 Da does not exce ed 50 μg/kg food. 
It is theref ore appropr iate to include this starting substance in the Union list and to author ise its use in 
accordance with the specifi ed migration limits. 
(19)  The Authority has noted that PEF containing a substance with FCM No 1031 can safely be used in contact with 
non-alcoholic foods in accordance with its specifi ed migration limits. However when the compl iance of such 
a plastic is verified with food simulant D1 in accordance with the food simulant assignments in Table 2 of 
Annex III, there is a risk of interaction between this food simulant and the plastic. As this inter action would not 
occur in contact with the non-alcoholic foods for whic h this food simulant is assigned, the use of food 
simulant D1 for verification of compl iance would give unrealistic results in such cases. According to the 
Author ity, theref ore, when verifying whether the use of this substance compl ies with this Regulation, food 
simulant C should be used for non-alcoholic foods to which Table 2 of Annex III assigns food simulant D1. It is 
theref ore appropr iate to add a note on the verification of compliance to substance with FCM No 1031 to indicate 
that food simulant D1 should be substitut ed with food simulant C in case of testing. 
(20)  The Author ity has adopt ed a scientific opinion (3) on the use of the starting substance 1,7-octadiene (FCM 
No 1034). When used as a crosslinking co-monomer in the manufacture of poly olefins for contact with any type 
of foods for long term storage at room temperature, including hot-fil l conditions, and the migration of the 
substance does not exceed 0,05 mg/kg food, the use of this substance does not endange r human health. It is 
theref ore appropr iate to include that additive in the Union list and to author ise its use in accordance with those 
specifications. 
(21)  The Authority has adopt ed a scientific opinion (4) on the use of the polymer production aid perf luoro{acetic acid, 
2-[(5-metho xy-1,3-dio xolan-4-yl)o xy]}, ammonium salt (FCM No 1045). When used as polymer production aid 
during the manufacture of fluoropolymers which are produced under high temperature conditions of at least 
370 C the use of this substance does not endanger human health. Theref ore, it should be added to the Union list 
and its use author ised subject to compl iance with those specifi cations. 25.8.2016 L 230/24 Official Jour nal of the European Union EN     
(1)EFSA Journal 2014;12(11):3909. 
(2)EFSA Journal 2014;12(10):3866. 
(3)EFSA Journal 2015;13(1):3979. 
(4)EFSA Journal 2014;12(6):3718. (22)  The Author ity has adopt ed a scientific opinion (1) on the use of the additive ethylen e glycol dipalmitate (FCM 
No 1048). The Author ity concluded that when the substance is produced using a fatty acid precursor conven ­
tionally obtained from edible fats or oils and the migration of ethylene glycol is limited by including it in the 
group SML(T) for ethylen e glycol, the use of this additive does not endanger human health. Theref ore, that 
additive should be included in the Union list subject to the requirement that it compl ies with those specifi cations. 
In particular , it should be added to the group to which the SML(T) applies and entr y (2) of Table 2 of Annex I to 
Regulation (EU) No 10/2011 should be amended according ly. 
(23)  The Author ity has adopt ed a scientifi c opinion (2) on the use of the additive zinc oxide, nanopar ticles, uncoat ed 
(FCM No 1050) and zinc oxide, nanopar ticles, coated with [3-(methacr yloxy)prop yl] trimetho xysilane (FCM 
No 1046). The Authority concluded that these additives do not migrate in nanof orm from poly olefi ns. In 
a further opinion the Authority extended this conclusion to the migration of zinc oxide nanopar ticles to unplas ­
ticised polymers (3). It theref ore stated that its safety evaluation focused on the migration of soluble ionic zinc, 
whic h should respect the specifi c migration limit for zinc specifi ed in Annex II to the Regulation. For the coated 
form of zinc oxide, nanopar ticles, the levels of migration of [3-(methacr yloxy)prop yl]tr imetho xysilane should 
remain within the existing specific migration limits for this substance, namely 0,05 mg/kg. Theref ore, the two 
additives should be included in the Union list. 
(24)  The Author ity has adop ted a scientifi c opinion (4) on the use of the additive N,N′-bis(2,2,6,6-tetrameth yl-4- 
piper idinyl) isophthalamide (FCM No 1051). The Auth ority concluded that when its migration does not exceed 
5 mg/kg food, the use of this additive does not endange r human health. Theref ore, it should be included in the 
Union list subject to a migration limit of 5 mg/kg food. 
(25)  The Auth ority has adopt ed a scientifi c opinion (5) on the use of the starting substance 2,4,8,10-t etrao xaspiro[5,5] 
undecane-3,9-diethanol,β3,β3,β9,β9-t etramethyl- (‘SPG’, FCM No 1052). The Author ity concluded that when this 
substance is used as a monomer in the production of polyes ters, when its migration does not exceed 5 mg/kg 
food, and when the migration of the oligomers of less than 1 000 Da does not exceed 50 μg/kg food (expressed 
as SPG), the use of this additive does not endanger human health. Theref ore, it should be included in the Union 
list and its use author ised subject to compl iance with those specifi cations. 
(26)  The author isation of the substances with FCM Nos 871, 1031 and 1052 provided for in this Regulation, requires 
that the migration of the low molecular weight oligomer ic fraction less than 1 000 Da shall not in total exceed 
a migration limit of 50 μg/kg food. Analytical methods to determine the migration of this oligomer ic fraction are 
compl ex. A descr iption of those methods is not necessar ily available to compet ent author ities. Without 
a descr iption it is not possible for the compe tent author ity to verify that the migration of oligomers from the 
mate rial or article compl ies with the migration limit for these oligomers. Theref ore, business operat ors placing on 
the market the final article or mat erial containing that substance should be required to provide a descr iption of 
the method and a calibration sam ple if required by the method. 
(27)  The Author ity has adopt ed a scientifi c opinion (6) on the use of the additive fatty acids, C16–18 saturated , 
hexaester s with dipentaer ythr itol (FCM No 1053). Since any content of lower esters (e.g. penta-, tetra-,) does not 
give rise to a safety concer n, the Author ity concluded that the use of fatty acids, C16–18 saturated , esters with 
dipentaer ythr itol does not endange r human health, provided that the substance is produced using a fatty acid 
precursor obtained from edible fats or oils. Theref ore, the additive fatty acids, C16–18 saturated, esters with 
dipentaer ythr itol should be included in the Union list without restr icting it to hexaester s, subject to the 
requirement that its fatty acid precursor is obtained from edible fats or oils. 
(28)  The Auth ority has adop ted a scientific opinion (7) on the safety of aluminium from dietar y intak e, which 
establishes a tolerable weekly intake of 1 mg aluminium per kg body weight per week . Applying the 
conven tional exposure assump tions for food contact mater ials, the migration limit would have to be set at 
8,6 mg/kg food. The opinion however notes that the current dietar y exposure of a signif icant part of the Union's 
population likely exceeds this level. Theref ore, it is appropr iate to limit the contr ibution from exposure by food 
contact mate rials to the overall exposure by applying an allocation factor of 10 % to the conventionally derived 
migration limit. Theref ore, a migration limit for aluminium of 1 mg/kg food is considered appropr iate for food 
contact mate rials. 25.8.2016 L 230/25 Official Jour nal of the European Union EN     
(1)EFSA Journal 2015;13(2):4019. 
(2)EFSA Journal 2015;13(4):4063. 
(3)EFSA Journal 2016;14(3):4408. 
(4)EFSA Journal 2014;12(10):3867. 
(5)EFSA Journal 2014;12(10):3863. 
(6)EFSA Journal 2015;13(2):4021. 
(7)EFSA Journal (2008) 754, 1-34. (29)  The Author ity has adopt ed a scientifi c opinion on dietar y reference values for zinc (1). This conf irms the opinion 
expressed by the Scientific Committ ee on Foods (SCF) in 2002 (2) which sets the tolerable upper level of zinc for 
adults to 25 mg per day. In Annex II to Regulation (EU) No 10/2011, the migration limit for zinc is set at 
25 mg/kg food. As dietar y exposure from other sources signif icantly contr ibut es to the total exposure, and 
according to the Author ity, the upper level could be excee ded in combination with the current migration limit. 
Theref ore to reduce the contr ibution from food contact mater ials to the total exposure to zinc, and taking into 
account that the tota l dietar y exposure to zinc is in the rang e of the upper limit but generally belo w, it is 
appropr iate to use an allocation factor of 20 % for the exposure from food contact mater ial. It is theref ore 
appropr iate to amend the migration limit specifi ed in Annex II to the Regulation to 5 mg/kg food. 
(30)  A sing le specification of the amount of saponifiable matte r in vegetable oil to be used for food simulant D2 is 
sufficient to specify that food simulant. Theref ore, any further specifi cations are not necessar y and the note belo w 
Table 1 of Annex III to the Regulation should be delet ed. 
(31)  The Regulation does not lay down specifi c migration testing provisions for fresh unpeeled fruits and vegetables as 
no food simulant has been assigned to these products. Possible health risks to consumers from migrating 
substances, including substances that should not be present to any exte nt can theref ore remain undetect ed. 
A food simulant should thus be assigned to those products in Table 2 of Annex III to Regulation (EU) 
No 10/2011. Those fruits and vege tables vary widely in proper ties, but are dry. Food simulant E is suitable for 
dry foods but may overestimat e the contact surface depending on size and shape of the fruits and vegeta bles. 
Moreo ver, fruits and vegetables may be peeled before consum ption remo ving part of the migrants. The overesti ­
mation should be addressed with a correction factor and the correction procedure should be set out in point 3 of 
Annex III to the Regulation. 
(32)  Only food simulant A is assigned for fresh vegetables that are peeled and/or cut. As such vegetables can be acidic, 
it is appropr iate that food simulant B is also specified for peeled and/or cut vegetables. Theref ore, that catego ry 
should be added to Table 2 of Annex III to the Regulation. 
(33)  Testing in several diffe rent food simulants provides no added value if it is scientificall y evident that one food 
simulant alwa ys yields the highest migration results for a specific substance or mat erial, and this food simulant 
can theref ore be considered as the most severe for such a substance or mate rial. Theref ore, a general derogation 
to the assignment of food simulants should be included in Annex III to the Regulation to allow the testing in 
only one food simulant if appropr iate scientific evidence is documente d showing that that food simulant is the 
most severe. 
(34)  Point 5 of Annex IV to the Regulation requires a written conf irmation that the requirements laid down in 
Regulation (EC) No 1935/2004 are met. However , most of the provisions set out in Regulation (EC) 
No 1935/2004 cannot directly apply to plastic mater ials or articles, or to the substances used to manufa cture 
those mater ials or articles. Theref ore the referen ce to Regulation (EC) No 1935/2004 should be made more 
specific by adding references to the provisions of that Regulation to whic h confir mation of compl iance is 
required. 
(35)  Substances found in food already in contact with a mater ial or article that is being tested for its compl iance, do 
not necessar ily originate from that mater ial or article, but may originate from other sources, including other food 
contact mate rials or articles with which the food has been in contact previously . Theref ore, the amount of 
a substance present in the food which does not originat e from the tested mater ial or article should not be take n 
into account to deter mine the compl iance with the Regulation. This correction should equally apply to all 
substances for which the Regulation sets a specific migration limit or for whic h no migration is permitted . While 
Section 1.4 of Chapt er 1 of Annex V to the Regulation already includes a requirement to take account of contam ­
ination from other sources, it is appropr iate, in the inter ests of legal certainty , to clarify that prior to compar ing 
tests results to the applicable specifi c migration limit, the test result should be corrected to take into account 
contamination from other sources. 
(36)  The migration testing conditions should alwa ys be at least as strict as the real conditions of use. Theref ore, the 
second paragraph of Section 2.1.3 of Chapt er 2 of Annex V to the Regulation should be amended to make it 
clear that the testing conditions cannot be adjusted to conditions that are less strict than the real conditions 
of use. 25.8.2016 L 230/26 Official Jour nal of the European Union EN     
(1)EFSA Journal 2014;12(10):3844. 
(2)SCF/CS/NUT/UPPLEV/62 Final, http://ec.europa.eu/f ood/fs/sc/scf/out177_en.pdf (37)  Business operat ors use food processing equipment that is capable of precisely controlling the time and 
temperature conditions at whic h the food and the equipment, or, if the food is already packa ged, its packag ing, 
are in contact, such as during past eurisation and sterilisation of the food. Such equipment must alwa ys be 
operat ed in accordance with good manufa ctur ing practice. Theref ore when using the exact worst foreseeable 
processing conditions applied in such equipment as testin g conditions for migration testing, this testin g will be 
representative for the actual migration, and will rule out possible adverse effects to human health. The 
standardised testing conditions set out in Table 1 and 2 of Annex V may signif icantly overestimat e migration, and 
consequently place an unreasonable burden on business operat ors. Theref ore it is appropr iate to amend the 
Regulation to allow the use of actual processing conditions used in such equipment as testing conditions for 
migration testing. 
(38)  Certain worst foreseeable conditions of use may occur in practice under which it is not technically feasible to use 
food simulant D2 for testing. Appropr iate altern ative food simulants and rules for verification of compl iance 
should be specif ied for such conditions. 
(39)  The title and titles of columns of Tables 1 and 2 of Section 2.1.3 of Chapt er 2 of Annex V to the Regulation do 
not clearly set out that the temperature specif ied for testing represents the temperature of the food simulant used 
during the test. Those tables should theref ore be amended to ensure correct application of the specif ied testing 
conditions. 
(40)  The temperature specifi ed for testin g above 175 °C is not representative for all foreseeable conditions to which 
food contact mater ials may be subjected . Theref ore, appropr iate rules for testing above 175 °C should be added 
to Table 2 of Section 2.1.3 of Chapt er 2 of Annex V to the Regulation. 
(41)  Section 2.1.4 of Annex V to the Regulation specifi es testing conditions for contact times beyond 30 days. Those 
conditions include a formula and provide specifi c conditions which can both be used to determine a testing 
temperature for testing at accelerated conditions. It however does not clarify that the formula should only be 
applied when the standardised testing conditions do not apply . This section also does not clearly specify test 
conditions for stora ge at frozen conditions or when an article or mat erial is initially filled under hot-fi ll 
conditions. This section should theref ore be amended to ensure the formula is only applied for conditions not 
specified by the standard conditions, and to clarify the test condition for hot-fi ll and frozen conditions. 
(42)  Section 2.1.6 of Annex V to Regulation (EU) No 10/2011 specifi es that when testing repeated use mater ials the 
migration limit should already be respected in the first migration test when testing the migration of substances 
for which the Regulation specifi es that the specifi c migration is set as non-detectable. This however should 
include all substances for whic h this is the case and theref ore also include those specif ied in Annex II to the 
Regulation. It is theref ore appropr iate to delet e the specific reference from the Regulation and to clarify that this 
rule applies to all substances for which the migration should be non-det ectable. 
(43)  If the migration beha viour of a mat erial or article is well established, a sing le test may suffice to screen its 
compl iance with the Regulation. Provided that a justif ication for such substitution on the basis of the known 
beha viour of the mate rial is documented, a series of tests representative for various time and temperature 
combinations that would foreseeably be used in the real use of a mater ial or article, can be substituted by a sing le 
test. Such a substitution may significantly reduce the testing burden, without compromising the high level of 
human health prote ction that this Regulation seeks to achi eve. Theref ore, it is appropr iate to provide for the 
possibility of applying a sing le screening test in appropr iate circumstances. 
(44)  Table 3 in Chapt er 3 of Annex V to the Regulation currently states that the standardised testing condition OM6 
represents the worst case conditions for food simulants A, B and C. However , it also represents the worst case 
conditions for food simulant D1, and this food simulant can also be used in this test. Theref ore, the Regulation 
should be corrected to include references to food simulant D1 in this conte xt. 
(45)  According to the text provided belo w Table 3 in Section 3.1 of Annex V to the Regulation, the standardised 
testing condition OM7 represents the worst case conditions for ‘fatty food simulants’. However , it only represents 
the worst case conditions for food simulant D2 and the Regulation should be clarified according ly. 25.8.2016 L 230/27 Official Jour nal of the European Union EN     (46)  It is not alwa ys technically feasible to test overall migration with food simulant D2. In Section 3.2 of Annex V, 
the Regulation only specifi es a substitute test for the standardised testing condition OM7. However substitute 
tests for conditions OM1 to OM6 should also be specifi ed to allow for overall migration testing when food 
simulant D2 cannot be used under these standardised testing conditions. Theref ore it is appropr iate to include 
appropr iate substitute tests in this section. 
(47)  It is not alwa ys technically feasible to test overall migration of repeate d use Articles in an oily medium using the 
same sample three times. Theref ore an altern ative testing approach should be specif ied. 
(48)  Regulation (EU) No 10/2011 does not specify a method for verifying compliance with the overall migration limit 
set out in Article 12 of the Regulation. However , the accuracy of the determi nation as to whether mat erials or 
articles compl y with the prescr ibed limit is dependent on the existence of an appropr iate verification method. It 
is theref ore appropr iate to include a reference to Regulation (EC) No 882/2004 (1) whic h specifies rules for the 
selection of appropr iate methods for the verification of compl iance. 
(49)  The Regulation does not clearly specify that the application of the Fat Consump tion Reduction Fact or (FRF) 
should not allow the specif ic migration of a sing le substance to exceed the overall migration limit. It is theref ore 
appropr iate to include such a prohibition in Section 4.1 of Chapt er 4 of Annex V to the Regulation. 
(50)  Regulation (EU) No 10/2011 should theref ore be amended according ly. 
(51)  In order to limit the administrative burden and to provide business operat ors with suffi cient time to adjust their 
practices to compl y with the requirements of this Regulation, transitional measures should be provided. 
(52)  The measures provided 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 
Regulation (EU) No 10/2011 is amended as follows:  
(1) Article 3 is amended as follows: 
(a)  point 16 is replaced by the following:  
‘(16) “non-fat ty food” means a food for which in migration testing only food simulants other than food 
simulants D1 or D2 are laid down in Table 2 of Annex III to this Regulation;’; 
(b)  point 18 is replaced by the following: 
‘(18) “specification” means compo sition of a substance, purity criteria for a substance, physico-chemical charac ­
teristics of a substance, details concer ning the manuf actur ing process of a substance or further information 
concer ning the expression of migration limits;’; 
(c)  a new point 19 is added:  
‘(19) “hot-fil l” means the filling of any article with a food with a temperature not excee ding 100 °C at the 
moment of filling, after whic h the food cools down to 50 °C or belo w within 60 minutes , or to 30 °C or 
belo w within 150 minutes.’; 25.8.2016 L 230/28 Official Jour nal of the European Union EN     
(1)Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 Apr il 2004 on official controls perfor med to ensure 
the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1). (2) in Article 6(3), point (a) is replaced by the following: 
‘(a)  all salts of aluminium, ammonium, barium, calcium, cobalt, copper , iron, lithium, magnesium, mang anese, 
potassium, sodium, and zinc of author ised acids, phenols or alcohols;’;  
(3) Article 11 is amended as follows: 
(a)  paragraph 2 is deleted; 
(b)  paragraph 3 is replaced by the following: 
‘3. By derog ation from paragraph 1, additives whic h are also author ised as food additives by Regulation (EC) 
No 1333/2008 or as flavourings by Regulation (EC) No 1334/2008 shall not migrat e into foods in quantities 
having a technical effect in the final foods and shall not: 
(a)  excee d the restr ictions provided for in Regulation (EC) No 1333/2008 or in Regulation (EC) No 1334/2008 
or in Annex I to this Regulation for foods for which their use is author ised as food additive or flavouring 
substances; or 
(b)  excee d the restr ictions set out in Annex I to this Regulation in foods for which their use is not author ised as 
food additive or flavouri ng substances.’; 
(c)  the following paragraph 4 is added: 
‘4. Where it is specifi ed that no migration of a particular substance is permitted , compliance shall be 
established using appropr iate migration test methods selected in accordance with Article 11 of Regulation (EC) 
No 882/2004 that can conf irm the absence of migration above a specifi ed limit of detection. 
For the purposes of the first subparagraph, unless specific detec tion limits have been set for particular 
substances or groups of substances, a detection limit of 0,01 mg/kg shall apply .’;  
(4) in Article 13, paragraph 3 is replaced by the following: 
‘3. Substances under paragraph 2(b) shall not migrat e into food or food simulant, in accordance with 
Article 11(4). The detec tion limit set out in the second subparagraph of Article 11(4) shall apply to groups of 
substances if they are structurally and toxicologically relat ed, including isomers or substances with the same relevant 
functional group, or to individual substances that are not relat ed, and shall include possible set-off transfer .’;  
(5) in Article 17(3), point (a) is replaced by the following: 
‘(a)  mg/kg using the actual content of the container for whic h the closure is intended applying the total contact 
surface of sealing article and sealed container if the intended use of the article is kno wn, while taking into 
account the provisions of paragraph 2;’;  
(6) Article 18 is amended as follows: 
(a)  paragraph 4 is replaced by the following: 
‘4. For mate rials and articles not yet in contact with food verification of compliance with the overall 
migration limit shall be carried out in food simulants as set out in Annex III in accordance with the rules set out 
in Chapt er 3 of Annex V.’; 
(b)  paragraph 7 is replaced by the following: 
‘7. Before compari ng specifi c and overall migration test results with the migration limits the correction 
factors set out in point 3 of Annex III and Chapt er 4 of Annex V shall be applied in accordance with the rules 
set out therein.’;  
(7) Annexes I, II, III, IV and V are amended in accordance with the Annex to this Regulation. 25.8.2016 L 230/29 Official Jour nal of the European Union EN     Article 2 
Plastic mater ials and articles compl ying with Regulation (EU) No 10/2011 as applicable before the entr y into force of 
this Regulation, may be placed on the market until 14 September 2017 and may remain on the mark et until exhaustion 
of stoc ks. 
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. 
The provisions on the specif ic migration limits for aluminium and for zinc set out in point 2(a) of the Annex and the 
assignments of food simulants in point 3(c) of the Annex shall apply from 14 Sept ember 2018. 
This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 24 August 2016. 
For the Commission 
The Presid ent 
Jean-Claude JUNCKER  25.8.2016 L 230/30 Official Jour nal of the European Union EN     ANNEX 
Annex es I, II, III, IV and V to Regulation (EU) No 10/2011 are amended as follows:  
(1) Annex I is amended as follows: 
(a)  in point 1, the paragraph referring to Column 8 of Table 1 is replaced by the following: 
‘Column 8 (SML [mg/kg]): the specifi c migration limit applicable for the substance. It is expressed in 
mg substance per kg food. It is marked as ND (“not-detec table”) if the substance is one in respect of which no 
migration is permitted, to be determined in accordance with Article 11(4).’; 
(b)  in point 1, the last paragraph before Table 1 is delet ed; 
(c)  in point 1, in column 10 of Table 1, in the entr ies for the substances with FCM substance Nos 72, 642, 672, 
776, 782, 923 and 974, the word ‘should’ is replaced by the word ‘shall’; 
(d)  in point 1, Table 1 is amended as follows: 
(i)  in column 10, in the entr ies for the substances with FCM substance Nos 93, 199, 262, 326, 637, 768, 803, 
810, 815, 819 and 884, the words ‘simulant D’ are replaced by the words ‘simulant D1 and/or D2’; 
(ii)  the entr ies concer ning substances with FCM substance Nos 87, 391, 641, 752, 779 and 974 are replaced 
by the following: 
‘87 86285  Silicon dioxide, 
silanat ed yes no no   For synthetic amor phous sili­
con dioxide, silanat ed: pri­
mar y particles of 1–100 nm 
whic h are aggreg ated to 
a size of 0,1–1 µm and may 
form agglomerat es within the 
size distr ibution of 0,3 µm to 
the mm size.’  
‘391 22932 0001187-93-5 perf luoromethyl 
perf luoro vinyl 
ether no yes no 0,05  Only to be used in: 
—  anti-stic k coatings; 
—fluoro- and perf luoropo ­
lymers intended for re­
peat ed use applications 
where the contact ratio is 
1 dm2 surface in contact 
with at least 150 kg 
food.’  
‘641 22331 0025513-64-8 mixture of (35- 
45 % w/w) 1,6- 
diamino-2,2,4- 
trimeth ylhexane 
and (55-65 % w/ 
w)1,6-diamino- 
2,4,4-tr imethyl ­
hexane no yes no 0,05’    25.8.2016 L 230/31 Official Jour nal of the European Union EN     ‘752 39890 0087826-41-3 
0069158-41- 4 
0054686-97-4 
0081541-12-0 bis(meth ylbenzy ­
lidene)sorbit ol yes no no’     
‘779 39815 0182121-12-6 9,9-bis(metho xy­
meth yl)fluorene yes no yes 0,05   (2)’ 
‘974 74050 939402-02-5 phosphorous 
acid, mixed 2,4- 
bis(1,1-dimeth yl­
prop yl)phen yl 
and 4-(1,1-di ­
meth ylprop yl) 
pheny l triester s yes no yes 5  SML expressed as the sum of 
the phosphite and phosphat e 
forms of the substance, 4- 
tert-am ylphenol and 2,4-di- 
tert-am ylphenol. 
The migration of 2,4-di-ter t- 
amylphenol shall not exce ed 
1 mg/kg food.’   
(iii)  the following entr ies are inser ted in numer ical order of the FCM substance numbers: 
‘871  0287916-86-3 dodecanoic acid, 
12-amino-, poly ­
mer with ethene, 
2,5-furandione, 
α-hydro-ω-hydro ­
xypoly (oxy-1,2- 
ethanediyl) and 
1-propene yes no no   Only to be used in poly ole­
fins at levels of up to 
20 weight %. These poly ole­
fins shall only be used in 
contact with foods for which 
Table 2 of Annex III assigns 
food simulant E, at ambient 
temperature or belo w, and 
when migration of the total 
oligomer ic fraction of less 
than 1 000 Da does not ex­
ceed 50 μg/kg food. (23)’ 
‘1031  3238-40-2 furan-2,5-dicar ­
boxylic acid no yes no 5  Only to be used as a mono ­
mer in the production of 
polye thylene furanoate. The 
migration of the oligomer ic 
fraction of less than 
1 000 Da shall not exce ed 
50 μg/kg food (expressed as 
furan-2,5-dicarbo xylic acid). (22) 
(23) 
1034  3710-30-3 1,7-octadiene no yes no 0,05  Only to be used as a cross ­
linking co-monomer in the 
manufa cture of poly olefi ns 
for contact with any type of 
foods for long term stora ge 
at room temperature, includ ­
ing when packag ed under 
hot-fill conditions.’  25.8.2016 L 230/32 Official Jour nal of the European Union EN     ‘1045  1190931-27-1 perf luoro{acetic 
acid, 2-[(5-meth ­
oxy-1,3-dio xo­
lan-4-yl)o xy]}, 
ammonium salt yes no no   Only to be used as a polymer 
production aid during the 
manufa cture of fluoropoly ­
mers under high temperature 
conditions of at least 370 °C.  
1046   zinc oxide, nano ­
particles, coated 
with [3-(metha ­
cryloxy)prop yl] 
trimetho xysilane 
(FCM No 788) yes no no   Only to be used in unplas ti­
cised polymers. 
The restr ictions and specifi ­
cations specified for FCM 
substance No 788 shall be 
respected .  
1048  624-03-3 ethylene glycol 
dipalmitate yes no no  (2) Only to be used when pro­
duced from a fatty acid pre­
cursor that is obtained from 
edible fats or oils.  
1050   zinc oxide,  
nanopar ticles, 
uncoat ed yes no no   Only to be used in unplas ti­
cised polymers.  
1051  42774-15-2 N,N′-bis(2,2,6,6- 
tetramethyl-4-pi ­
peridinyl) iso­
phthalamide yes no no 5    
1052  1455-42-1 2,4,8,10-t etrao x­
aspiro[5,5]unde ­
cane-3,9-dietha ­
nol,β3,β3,β9,β9- 
tetramethyl- 
(“SPG”) no yes no 5  Only to be used as a mono ­
mer in the production of 
polye sters. The migration of 
oligomers of less than 
1 000 Da shall not exce ed 
50 μg/kg food (expressed as 
SPG). (22) 
(23) 
1053   fatty acids, C16– 
18 saturated , es­
ters with dipen ­
taerythr itol yes no no   Only to be used when pro­
duced from a fatty acid pre­
cursor that is obtained from 
edible fats or oils’   
(e)  in point 2, in Table 2, the entr y concer ning the group restr iction with Group Restr iction No 2 is replaced by the 
following: 
‘2 89 
227 
263 
1048 30 expressed as ethyleneg lycol’  25.8.2016 L 230/33 Official Jour nal of the European Union EN     (f)  in point 3, in column 2 of Table 3, in the entr ies for Notes 4 and 5, the word ‘should’ is replaced by the word 
‘shall’; 
(g)  in point 3, in Table 3, the following entr ies are added: 
‘(22) When used in contact with non-alcoholic foods for whic h Table 2 of Annex III assigns food simu ­
lant D1, food simulant C shall be used for verification of compliance instead of food simulant D1; 
(23) When a final mater ial or article containing this substance is placed on the market, a well descr ibed 
method to determine whether the oligomer migration compl ies with the restr ictions specified in 
column 10 of Table 1 shall form part of the suppor ting documentation refer red to in Article 16. This 
method shall be suitable for use by a compet ent author ity to verify compl iance. If an adequat e method 
is publicly available, referen ce shall be made to that method. If the method requires a calibration sam ­
ple, a sufficient sam ple shall be supplied to the compet ent author ity on its request.’   
(2) Annex II is amended as follows: 
(a)  point 1 is replaced by the following: 
‘1.  Plastic mate rials and articles shall not release the following substances in quantities exceed ing the specifi c 
migration limits belo w: 
Aluminium = 1 mg/kg food or food simulant 
Barium = 1 mg/kg food or food simulant 
Cobalt = 0,05 mg/kg food or food simulant 
Copper = 5 mg/kg food or food simulant 
Iron = 48 mg/kg food or food simulant 
Lithium = 0,6 mg/kg food or food simulant 
Mangan ese = 0,6 mg/kg food or food simulant 
Zinc = 5 mg/kg food or food simulant.’; 
(b)  point 2 is replaced by the following: 
‘2.  Primar y aromatic amines which are not liste d in Table 1 of Annex I shall not migrat e or shall not other wise 
be released from plastic mater ials and articles into food or food simulant in accordance with Article 11(4). 
The detection limit referred to in the second subparagraph of Article 11(4) applies to the sum of primar y 
aromatic amines released.’;  
(3) Annex III is amended as follows: 
(a)  Table 1 ‘List of food simulants’ is replaced in its entirety by the following: 
‘Table 1 
List of food simulants 
Food simulant Abbreviation 
Ethanol 10 % (v/v) Food simulant A 
Acetic acid 3 % (w/v) Food simulant B 25.8.2016 L 230/34 Official Jour nal of the European Union EN     Food simulant Abbreviation 
Ethanol 20 % (v/v) Food simulant C 
Ethanol 50 % (v/v) Food simulant D1 
Any veget able oil containing less than 1 % unsaponifiable 
matt er Food simulant D2 
poly(2,6-diphen yl-p-phenyl ene oxide), particle size 60- 
80 mesh, pore size 200 nm Food simulant E’  
(b)  point 3, excl uding Table 2, is replaced by the following:  
‘3. Specif ic assignment of food simulants to foods for mig ration testin g of mater ials and articles not yet 
in cont act with food 
For testing migration from mate rials and articles not yet in contact with food the food simulants that 
corresponds to a certain food categor y shall be chosen according to Table 2 belo w. 
For testin g migration from mat erials and articles intended to come into contact with foods not listed in 
Table 2 belo w, or a combination of foods, the general food simulant assignments in point 2 shall be used for 
specific migration testing, and for overall migration testing the food simulant assignments in point 4 shall be 
applicable. 
Table 2 contains the following information: 
—  Column 1 (Reference number): contains the referen ce number of the food categor y 
—  Column 2 (Descr iption of food): contains a descr iption of the foods covered by the food catego ry 
—  Column 3 (Food simulants): contains sub-columns for each of the food simulants 
The food simulant for whic h a cross is contained in the respective sub-column of column 3 shall be used 
when testing migration of mater ials and articles not yet in contact with food. 
For food catego ries where in sub-column D2 or E the cross is followed by an oblique stroke and a figure, the 
migration test result shall be corrected by dividing the result by this figur e. The corrected test result shall 
then be compar ed to the migration limit to establish compliance. The test results for substances that shall 
not migrat e in detectable quantities shall not be corrected in this way. 
For food categor y 01.04 food simulant D2 shall be replaced by 95 % ethanol. 
For food categor ies where in sub-column B the cross is followed by (*) the testing in food simulant B can be 
omitt ed if the food has a pH of more than 4,5. 
For food cate gories where in sub-column D2 the cross is followed by (**) the testing in food simulant D2 can 
be omitted if it can be demonstrate d that there is no “fatty contact” with the plastic food contact mater ial.’; 25.8.2016 L 230/35 Official Jour nal of the European Union EN     (c)  Table 2 is amended as follows: 
(i)  the entr ies with reference numbers 04.01 and 04.04 are replaced by the following: 
‘04.01 Fruit, fresh or chilled:       
A.  unpeeled and uncut      X/10’ 
B.  peeled and/or cut X X (*)     
‘04.04 Vegetables, fresh or chilled:       
A.  unpeeled and uncut      X/10’ 
B.  peeled and/or cut X X (*)      
(ii)  in the entr y with reference number 04.05 is replaced by the following: 
‘04.05 Processed vegetables: 
A.  Dried or dehydrat ed vege tables whole, 
sliced or in the form of flour or powder .      X’ 
B.  (obsolete)       
C.Vegetables in the form of purée, pre­
serves, pastes or in its own juice (includ ­
ing pickle d and in brine).  X (*) X    
D.  Preser ved vegetables:        
I.  In an oily medium X    X   
II.  In an alcoholic medium    X    
(d)  the following point 5 is added:  
‘5. General derogation to the assignment of food simulants 
By derogation from the assignments of food simulants in points 2 to 4 of this Annex, where testing with 
several food simulants is required, a sing le food simulant shall be suffi cient if on the basis of evidence 
acquired using generally recognised scientific methods this food simulant is shown to be the most severe 
food simulant for the particular mater ial or article being tested under the applicable time and temperature 
conditions selecte d in accordance with Chapt ers 2 and 3 of Annex V. 
The scientifi c basis on which this derogation is used shall in such cases form part of the documentation 
required under Article 16 of this Regulation.’;  
(4) in Annex IV, point (5) is replaced by the following: 
‘(5)  conf irmation that the plastic mate rials or articles, products from interm ediate stages of manufact ure or the 
substances meet the relevant requirements laid down in this Regulation and in Article 3, 11(5), 15 and 17 of 
Regulation (EC) No 1935/2004;’; 25.8.2016 L 230/36 Official Jour nal of the European Union EN     (5) Annex V is amended as follows: 
(a)  Section 1.4 of Chapt er 1 is replaced by the following:  
‘1.4. Account of subst ances originating from other sources 
In case there is evidence linked to the food sample that a substance partially or wholly originates from 
a source or sources other than the mater ial or article for which the test is being carried out, the test 
results shall be corrected for the amount of that substance originating from the other source or sources 
before compari ng the test results to the applicable specific migration limit ’; 
(b)  in Section 2.1.3 of Chapt er 2, the text before Table 1 is replaced in its entirety by the following: 
‘The sam ple shall be placed in contact with the food simulant in a manner representing the worst of the 
foreseeable conditions of use as regar d contact time in Table 1 and as regar d contact temperature in Table 2. 
By way of derog ation to the conditions set out in Tables 1 and 2, the following rules apply: 
(i)  If it is found that carrying out the tests under the combination of contact conditions specifi ed in Tables 1 
and 2 causes physical or other changes in the test specimen whic h do not occur under worst foreseeable 
conditions of use of the mater ial or article under examination, the migration tests shall be carried out 
under the worst foreseeable conditions of use in which these physical or other change s do not take place; 
(ii)  if the mater ial or article during it intended use is subjected only to precisely controlled time and 
temperature conditions in food processing equipment, either as part of food packag ing or as part of the 
processing equipment itself, testing may be done using the worst foreseeable contact conditions that can 
occur during the processing of the food in that equipment ; 
(iii)  if the mat erial or article is intended to be emplo yed only for hot-fi ll conditions, only a 2-hour test at 70 °C 
shall be carried out. However , if the mate rial or article is intended to be used also for stora ge at room 
temperature or belo w, the test conditions set out in Tables 1 and 2 of this Section or in Section 2.1.4 of 
this Chapt er apply depending on the duration of storag e. 
If the testing conditions representative for the worst foreseeable conditions of intended use of the mat erial or 
article, are not technically feasible in food simulant D2, migration tests shall be done using ethanol 95 % and 
isooctane. In addition a migration test shall be done using food simulant E if the temperature under the worst 
foreseeable conditions of intended use exceed s 100 °C. The test that results in the highest specifi c migration 
shall be used to establish compl iance with this Regulation.’; 
(c)  in Table 1, the title of the table is replaced by the following: 
‘Selection of test time’; 
(d)  in Table 1, the title of column 2 is replaced by the following: 
‘Time to be selecte d for testing’ ; 
(e)  Table 2 is replaced by the following: 
‘Table 2 
Selection of test temperature 
Worst foreseeable contact temperature Contact temperature to be select ed for testing 
T ≤ 5 °C 5 °C 
5 °C < T ≤ 20 °C 20 °C 25.8.2016 L 230/37 Official Jour nal of the European Union EN     Worst foreseeable contact temperature Contact temperature to be select ed for testing 
20 °C < T ≤ 40 °C 40 °C 
40 °C < T ≤ 70 °C 70 °C 
70 °C < T ≤ 100 °C 100 °C or reflux temperature 
100 °C < T ≤ 121 °C 121 °C(*) 
121 °C < T ≤ 130 °C 130 °C(*) 
130 °C < T ≤ 150 °C 150 °C(*) 
150 °C < T < 175 °C 175 °C(*) 
175 °C < T ≤ 200 °C 200 °C(*) 
T > 200 °C 225 °C(*) 
(*)  This temperature shall be used only for food simulants D2 and E. For applications heated under pressure, migration testing 
under pressure at the relevant temperature may be perf ormed. For food simulants A, B, C or D1 the test may be replaced 
by a test at 100 °C or at reflux temperature for duration of four times the time selected according to the conditions in 
Table 1.’  
(f)  Section 2.1.4 of Chapt er 2 is replaced by the following: 
‘2.1.4. Specif ic conditions for contact times above 30 days at room temper ature and below 
For contact times above 30 days (long term ) at room temperature and belo w, the specimen shall be tested in 
accelerat ed test conditions at elevated temperature for a maximum of 10 days at 60 °C (*). 
(a)  Testing for 10 days at 20 °C shall cover all storag e times at frozen condition. This test can include the 
freezing and defrosting processes if labelling or other instr uctions ensure that 20 °C is not exceed ed and the 
total time above – 15 °C does not excee d 1 day in total during the foreseeable intended use of the mate rial 
or article. 
(b)  Testing for 10 days at 40 °C shall cover all storag e times at refrigerated and frozen conditions including hot- 
fill conditions and/or heating up to 70 °C ≤ T ≤ 100 °C for maximum t = 120/2^((T -70)/10) minutes . 
(c)  Testing for 10 days at 50 °C shall cover all storag e times of up to 6 months at room temperature, including 
hot-fill conditions and/or heating up to 70 °C ≤ T ≤ 100 °C for maximum t = 120/2^((T -70)/10) minute s. 
(d)  Testing for 10 days at 60 °C shall cover storage above 6 months at room temperature and belo w, including 
hot-fill conditions and/or heating up to 70 °C ≤ T ≤ 100 °C for maximum t = 120/2^((T -70)/10) minute s. 
(e)  For storage at room temperature the testing conditions can be reduced to 10 days at 40 °C if it is shown by 
scientific evidence that migration of the respective substance in the polymer has reach ed equilibration under 
this test condition. 25.8.2016 L 230/38 Official Jour nal of the European Union EN     (f)  For worst foreseeable conditions of intended use not covered by the test conditions set out in points (a) 
to (e), the testing time and temperature conditions shall be based on the following formula: 
t2 = t1 * Exp (9627 * (1/T2 – 1/T1)) 
t1 is the contact time 
t2 is the testing time 
T1 is the contact temperature in Kelvin. For room temperature storag e this is set at 298K (25 °C). For 
refrigerat ed conditions it is set at 278K (5 °C). For frozen storag e it is set at 258 K (– 15 °C). 
T2 is the testing temperature in Kelvin.  
(*)When testing at these accelerated test conditions the test specimen shall not undergo any physical or other 
chang es compar ed to the real conditions of use, including a phase transition of the mat erial.’; 
(g)  the first paragraph of Section 2.1.5 of Chapt er 2 is replaced by the following: 
‘If a mate rial or article is intended for differ ent applications covering diffe rent combinations of contact time and 
temperature the testin g shall be restr icted to the test conditions whic h are recognised to be the most severe on 
the basis of scientifi c evidence.’; 
(h)  in Section 2.1.6 of Chapt er 2, the third paragraph is replaced by the following: 
‘The mater ial or article shall respect the specifi c migration limit already in the first test for substances that are 
prohibit ed from migrating or from being released in detec table quantities under Article 11(4).’; 
(i)  the first paragraph of Section 2.2 of Chapt er 2 is replaced by the following: 
‘To screen if a mate rial or article compl ies with the migration limits any of the following approaches can be 
applied which are considered at least as severe as the verification method descr ibed in section 2.1.’; 
(j)  Section 2.2.3 of Chapt er 2 is replaced by the following: 
‘2.2.3. Mig ration modelling 
To screen for specific migration, the migration poten tial can be calculat ed based on the residual cont ent of the 
substance in the mate rial or article applying generally recognised diffusion models based on scientifi c evidence 
that are constr ucted in a way that must never underestimate real levels of migration.’; 
(k)  Section 2.2.4 of Chapt er 2 is replaced by the following: 
‘2.2.4. Food simulant substitutes 
To screen for specifi c migration, food simulants can be replaced by substitute food simulants if it is based on 
scientific evidence that the substitut e food simulants result in migration that is at least as severe as migration 
that would be obtained using the food simulants specifi ed in Section 2.1.2’; 
(l)  in Section 2.2 of Chapt er 2, the following paragraph 2.2.5 is added: 
‘2.2.5. Single test for successive combinations of time and temper ature 
If the mate rial or article is intended for a food contact application where it is successively subject to two or 
more time and temperature combinations, a sing le migration contact test time can be defined based on the 
highest contact test temperature from Section 2.1.3 and/or 2.1.4 by using the equation as descr ibed in point (f) 
of Section 2.1.4. The reasoning justifying that the resulting sing le test is at least as severe as the combined time 
and temperature combinations shall be documented in the suppor ting documentation provided for in 
Article 16.’; 25.8.2016 L 230/39 Official Jour nal of the European Union EN     (m)  Table 3 in Chapt er 3 is replaced by the following: 
‘Table 3 
Standardised conditions for testing the overall mig ration 
Column 1 Column 2 Column 3 
Test 
number Contact time in days [d] or hours [h] 
at contact temperature in [°C] for 
testing Intended food contact conditions 
OM1 10 d at 20 °C Any food contact at frozen and refrigerat ed conditions. 
OM2 10 d at 40 °C Any long term storag e at room temperature or belo w, includ ­
ing when packag ed under hot-fil l conditions, and/or heating 
up to a temperature T where 70 °C ≤ T ≤ 100 °C for a maxi ­
mum of t = 120/2^((T -70)/10) minute s. 
OM3 2 h at 70 °C Any food contact conditions that include hot-fill and/or heat ­
ing up to a temperature T where 70 °C ≤ T ≤ 100 °C for max ­
imum of t = 120/2^((T -70)/10) minute s, which are not fol­
lowed by long term room temperature or refrigerated storag e. 
OM4 1 h at 100 °C High temperature applications for all types of food at tem ­
perature up to 100 °C. 
OM5 2 h at 100 °C or at reflux or alter ­
natively 1 h at 121 °C High temperature applications up to 121 °C. 
OM6 4 h at 100 °C or at reflux Any food contact conditions at a temperature exceeding 
40 °C, and with foods for which point 4 of Annex III assigns 
simulants A, B, C or D1. 
OM7 2 h at 175 °C High temperature applications with fatty foods exceeding the 
conditions of OM5.’  
(n)  in Section 3.1 of Chapt er 3, the paragraphs belo w Table 3 are replaced by the following: 
‘Test OM7 also covers food contact conditions descr ibed for OM1, OM2, OM3, OM4 and OM5. It represents 
the worst case conditions for food simulant D2 in contact with non-poly olefins. In case it is technically not 
feasible to perform OM 7 with food simulant D2 the test can be replaced as set out in Section 3.2. 
Test OM6 covers also food contact conditions descr ibed for OM1, OM2, OM3, OM4 and OM5. It represents 
worst case conditions for food simulants A, B, C and D1 in contact with non-poly olefi ns. 
Test OM5 covers also food contact conditions descr ibed for OM1, OM2, OM3, and OM4. It represents the 
worst case conditions for all food simulants in contact with poly olefins. 
Test OM2 covers also food contact conditions descr ibed for OM1 and OM3.’; 25.8.2016 L 230/40 Official Jour nal of the European Union EN     (o)  Section 3.2 of Chapt er 3 is replaced by the following:  
‘3.2. Substitute overall mig ration tests for tests with food simulant D2 
If it is not technically feasible to perf orm one or more of the tests OM1 to OM6 in food simulant D2, 
migration tests shall be done using ethanol 95 % and isooctane. In addition a test shall be done using food 
simulant E in case the worst foreseeable conditions of use exce ed 100 °C. The test that results in the 
highest specifi c migration shall be used to establish compl iance with this Regulation. 
In case it is technically not feasible to perform OM7 with food simulant D2 the test can be replaced by 
either test OM8 or test OM9 as appropr iate given the intende d or foreseeable use. Both tests involve 
testing at two test conditions for which a new test sample shall be used for each test. The test condition 
that results in the highest overall migration shall be used to establish compl iance with this Regulation. 
Test 
number Test conditions Intended food contact conditions Covers the intended food 
contact conditions  
descr ibed in 
OM8 Food simulant E for 2 hours at 
175 °C and food simulant D2 
for 2 hours at 100 °C High temperature applications 
only OM1, OM3, OM4, OM5 
and OM6 
OM9 Food simulant E for 2 hours at 
175 °C and food simulant D2 
for 10 days at 40 °C High temperature applications 
including long term storag e at 
room temperature OM1, OM2, OM3, OM4, 
OM5 and OM6’  
(p)  Section 3.3 of Chapt er 3 is replaced by the following: 
‘3.3.  Verification of compliance 
3.3.1.  Singl e use articles and mater ials 
At the end of the prescr ibed contact time, to verify compl iance the overall migration is analysed in the 
food simulant using an analytical method in accordance with the requirements of Article 11 of 
Regulation (EC) No 882/2004. 
3.3.2.  Repeated use articles and mater ials 
The applicable overall migration test shall be carried out three times on a sing le sample using another 
portion of food simulant on each occasion. The migration shall be determined using an analytical 
method in accordance with the requirements of Article 11 of Regulation (EC) No 882/2004. The overall 
migration in the second test shall be lower than in the first test, and the overall migration in the third 
test shall be lower than in the second test. Com pliance with the overall migration limit shall be verified 
on the basis of the level of the overall migration found in the third test. 
If it is not technically feasible to test the same sample three times, such as when testing in oil, the overall 
migration test can be carried out by testing different samples for three diffe rent periods of time lasting 
one, two and three times the applicable contact test time. The difference between the third and the 
second test results shall be considered to represent the overall migration. Com pliance shall be verified on 
the basis of this differ ence, whic h shall not excee d the overall migration limit. In addition, it shall not be 
higher than the first result and the diffe rence between the second and the first test results. 
By derog ation from the first paragraph, if, on the basis of scientifi c evidence, it is established that for the 
mat erial or article being tested the overall migration does not increase in the second and third tests and 
if the overall migration limit is not exceed ed in the first test, the first test alone shall be sufficient.’; 25.8.2016 L 230/41 Official Jour nal of the European Union EN     (q)  the first paragraph of Section 3.4 of Chapt er 3 is replaced by the following: ‘To screen if a mater ial or article 
compl ies with the migration limits, any of the following approac hes can be applied which are considered at 
least as severe as the verification method descr ibed in Sections 3.1 and 3.2.’; 
(r)  Section 3.4.2 of Chapt er 3 is replaced by the following:  
‘3.4.2. Food simulant substitutes 
To screen for overall migration, food simulants can be replaced if based on scientific evidence the 
substitut e food simulants result in migration that is at least as severe as migration that would be 
obtained using the food simulants specifi ed in Annex III.’; 
(s)  in Section 4.1 of Chapt er 4, the fifth paragraph is replaced by the following: 
‘The specifi c migration in food or food simulant shall not exceed 60 mg/kg food before application of the FRF.’; 
(t)  in Section 4.1 of Chapt er 4, the following paragraph is added: 
‘When testing is perf ormed in food simulant D2 or E and when the test results are corrected in application of 
the correction factor laid down in Table 2 of Annex III this correction may be applied in combination with the 
FRF by multiplying both factors. The combined correction factor shall not exceed 5, unless the correction factor 
laid down in Table 2 of Annex III exceed s 5.’; 
(u)  Sections 4.2 and 4.3 of Chapt er 4 are delet ed.  25.8.2016 L 230/42 Official Jour nal of the European Union EN