EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2022/1435 CIS 
(POOL/E2/2022/1435/1435 -CIS 
ANNEX.docx) feedback  
[…](2024) XXX  draft  
ANNEXES 1 to 2  
 
ANNEXES  
to the  
COMMISSION REGULATION (EU) .../...  
amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come 
into contact with food and amending Regulation (EC) No 2023/2006 on good 
manufacturing practice for materials and articles intended to come into contact with 
food as reg ards recycled plastic and other matters related to quality control and 
manufacturing of plastic materials and articles intended to come into contact with food.   
Ref. Ares(2024)1923851 - 13/03/2024
 
EN 1  EN ANNEX I  
Annex es III to V to Regulation (EU) No 10/2011 are amended as follows:  
(1) In table 2 of Annex III, the descriptions and simulant assignments for cheeses with 
reference number 07.04 are replaced by the following : 
 
(1) (2) (3) 
Reference 
number  Description of food  Food simulants  
  A B C D1 D2 E 
‘07.04  Cheeses:        
 A. Whole cheese with inedible rind       X 
 B. Unripened soft cheese (fresh 
cheese), e.g. cottage cheese, quark, 
ricotta, cream cheese, fromage frais , 
and similar cheeses   X(*)   X   
 C. Sliced r ipened soft, firm or hard 
cheese  or whole with edible rind, 
e.g. gouda, cheddar , gruyère, 
parmesan , stilton,  tallegio, beaufort, 
tomino, brie, camembert , and 
similar cheeses      X/3  
 D. Processed cheese, e.g. wedges, 
spreads and slices      X/3  
 E. Brined or fresh cheese in a liquid 
medium e.g. feta and mozzarella:        
  I.  in an oily medium      X  
  II. in an aqueous medium   X(*)   X  ’ 
(2) Annex IV is amended as follows:  
(a) point 6 is replaced by the following:  
‘6.  adequate information relative to the substances used, including 
impurities in the substances used, reaction intermediate s formed during 
the production process , decomposition or reaction product s, in particular 
for which restrictions and/or specifications are set out in Annex es I and II 
to allow the downstream business operators to ensure compliance with 
the Regulation.   
EN 2  EN At intermediate stages, this information shall include the identification 
and amount of the substances referred to in first subparagraph  and 
present in the intermediate material,  
– that are subject to restrictions  and/or specifications  in Annex I 
and/or Anne x II, or  
– for which genotoxicity has not been ruled out, and which originate 
from an intentional use during a manufacturing stage of that 
intermediate material and which could be present in an amount that 
foreseeably gives rise to a n individual  migration into food from the 
final plastic material or article exceeding 0,00015 mg/kg food or 
food simulant;’;  
(b) in point 8, the following point is added:  
‘(iv) the maximum lifespan of the material or article based  on a report 
evaluating the maximum lifespan of the m aterial or article  taking into 
account the elements set out in Article 10 (3);’; 
(c) point s 10 and 11 are added :  
‘10. when the plastic material  is a batch of material intended for reprocessing :  
(a) the confirmation that it complies with Article 10(1)  of this 
Regulation  and that it has been collected  in accordance with point 
C of the Annex to Regulation (EC) No 2023/2006 ; and 
(b) as appropriate , a specification of its composition and instructions 
for reprocessing ; 
11. when the plastic material has been  manufactured with one or more 
substances included in the Union list of authorised substances in 
accordance with Article 5  of Regulation (EU) No 10/2011 that have been 
manufactured  from waste materials : 
(a) a confirmation that the level of individual conta minants is 
compliant with point ( 4) of Article 8 of this Regulation; and , 
(b) an indication of the total content of substances manufactured  from 
waste in the plastic material or article calculated as weight of 
substances manufactured  from waste per weight of the total 
material or article and expressed in percent .’ 
(3) Annex V is amended as follows : 
(c) The introductory part  on compliance testing preceding C hapter 1 is replaced by 
the following : 
‘ 
COMPLIANCE TESTING  
For testing compliance of migration from plastic food contact materials and 
articles, an analytical method in accordance with the requirements of Article 34 
of Regulation (EU) 2017/625  of the Europ ean Parliament and of the Council * 
shall be selected, applying the following specific performance criteria:  
– The calibration range of analytical methods shall be at least RL (relative 
lower calibration range threshold)  * LL (legal limit) to RU (relative upper  
EN 3  EN calibration range threshold)  * LL, using a minimum of 5 calibration 
points equally distributed in this range.  Unless otherwise specified in 
table 1 or 2 of Annex I for the substance of which the LL is being 
verified, R L shall be 0.2, and R U shall be 2 .  
The LL shall be LL=SML for the verification of compliance with a SML, 
unless the result of the migration test shall be divided by the correction 
factor used in the sub -columns for D2 and E in Table 2 of Annex III, or 
by the FRF in accordance with point 4.1 of this Annex. In this case the 
calibration range shall be adjusted upwards to compensate for this 
division, as follows:  
– LL = FRF *SML when only the FRF is applicable;  
– LL= C T2*SML where C T2=2, 3, 4, 5 or 10 as applicable given the 
figure indicated in Table 2 of Annex III, when the FRF is not 
applicable; or,  
– LL= FRF*C T2*SML if the FRF applies  and FRF*C T2 <5, CT2=2, 3, 
4, 5 or 10 ; or, 
– LL= 5*SML if the FRF applies  and FRF*C T2 ≥5, CT2=2, 3, 4, 5, or 
10; 
– The reproducibility coefficient o f variation CV R, which can be expressed 
in percentage if multiplied by 100, is used to calculate the relative 
standard measurement uncertainty. The formulas for calculating the CV R 
are as follows:  
CV R = 0.22  for m ≤ 0.12 * 10-6 kg /kg; and, 
CV R = 2(1-½log (m))/100 for  0.12 * 10-6 kg/kg < m < 0.138 kg/kg; 
Where m is the measured concentration of a substance that is to be 
evaluated against the legislative limit, and the uncertainty of the 
measured concentration of a substance, u(m), shall be determine d as 
follows: u( m) = CV R * m. 
– The compliance with the specific migration level shall then be evaluated 
by applying the following specific performance criteri um, where m is the 
measured concentration of a substance that is to be evaluated against the 
legislative limit : 
IF (m - LL)/[(u( m)] > 1.64   THEN  m > LL 
If m > LL  the measured concentration of a substance  shall be considered 
non compl iant. 
In addition, the rules in Ch apter 1 - 4 of this Annex shall apply.’  
(d) In Chapter 2 of Annex V , point 2.1.6 of  is replaced by the following:  
‘If the material or article is intended to come into repeated contact with foods, 
the migration test(s) shall be carried out three times on a singl e sample using 
another portion of food simulant on each occasion. Compliance of the material 
or article shall then be verified on the basis of the level of the migration found 
out in the course of the third test and on the basis of the stability of the mat erial 
or article . The specific migration found out during the second test shall not  
EN 4  EN exceed the level observed in the first test, and the specific migration in the third 
test shall not exceed the level observed during  the second test.   
To the purpose of the first paragraph, the sample shall be considered non -
compl iant if:  
m3 > SML, or,  
m1 < m2, or, 
m2 < m3, or, 
m1 < m3, 
where m 1, m 2, and m 3 are respectively the measured concentration during  
the first, the second and the third migration test  carried out in accordance 
with the first subparagraph . 
The compliance with the specific migration level shall be evaluated applying 
the following specific performance criteria : 
– IF (m3 - SML )/[(u( m3)] > 1.64   THEN  m3 > SML,  
– IF (m2 - m1)/[(u( m2) + u( m1)] > 1.64  THEN  m1 < m2 
– IF (m3 - m2)/[(u( m3) + u( m2)] > 1.64  THEN  m2 < m3 
– IF (m3 - m1)/[(u( m3) + u( m1)] > 1.64  THEN  m1 < m3 
where the uncertainty of the measured concentration of a substance, u( m), shall 
be determined as follows: u(m)= CV R * m. 
In case a measured concentration m < RL (relative lower calibration range 
threshold) * SML,  the measured concentration m shall be considered equal to 
RL * SML . This concentration shall be used for determining the corresponding 
uncertainty  of the measured concentration and the concentration R L * SML and 
the corresponding determined uncertainty shall be used for evaluating the 
compliance with the performance criteria  set out in this point .  
However, if there is scientific proof that the level of the migration decreases in 
the course of the second and third migration tests and if the migration limit is 
not exceeded during  the first migration test, the material or article is considered 
compliant  with the specific migration limit laid down in Regulation (EU) No 
10/2011.  
Irrespective of the above rules, a material or article shall never be considered to 
comply with this Regulation if in any of the migration tests a substance is 
detected that is prohibited from migrating or from being released in detectable 
quantities under Article 11(4) of this Regulation .’ 
(e) In Chapt er 2 of Annex V , point 2.1.7 of  is replaced by the following:  
‘At the end of the prescribed contact time, the specific migration is analysed in 
the food or food simulant using an analytical method in accordance with the 
applicable performance criteria laid  down in this Annex .’.  
(f) In Chapter 3 of Annex V , point 3.3.2 is replaced by the following:  
‘The applicable overall migration test shall be carried out three times on a 
single sample using a different portion of food simulant on each occasion. The 
migration shall be determined using an analytical method in accordance with  
EN 5  EN the requirements of Article 34 of Regulation (EU) 2017/625. Compliance with 
the overall migration limit shall be verified on the basi s of the level of the 
overall migration found during  the third test and on the basis of the stability of 
the material or article i.e.  the overall  migration during  the second test shall not 
exceed the level observed in the first test, and the overall  migrat ion in the 
course of the third test shall not exceed the level observed during  the second 
test. 
If it is not technically feasible to test the same sample three times, such as 
when testing in vegetable oil, the overall migration test can be carried out by 
testing different samples for three different periods of time lasting one, two and 
three times the applicable contact test time. The first migration, the difference 
between the second and the first migration and the difference between the third 
and the seco nd test results shall be considered to represent the three successive 
overall migrations.  
However, if there is scientific proof that the level of the migration decreases 
during  the second and third migration tests and if the migration limit is not 
exceede d in the course of the first migration test, t he material or article is 
considered compliant  with the specific migration limit.  
* Regulation (EU) 2017/625 of the European Parliament and of the Council 
of 15 March 2017 on official controls and other officia l activities 
performed to ensure the application of food and feed law, rules on animal 
health and welfare, plant health and plant protection products, amending 
Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, 
(EC) No 1107/2009, (EU) No 11 51/2012, (EU) No 652/2014, (EU) 
2016/429 and (EU) 2016/2031 of the European Parliament and of the 
Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and 
Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 
2008/120/EC, and re pealing Regulations (EC) No 854/2004 and (EC) No 
882/2004 of the European Parliament and of the Council, Council 
Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 
96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official 
Controls R egulation) (OJ L 95, 7.4.2017, p. 1, ELI: 
http://data.europa.eu/eli/reg/2017/625/oj) .’  
EN 6  EN ANNEX II  
The Annex to Regulation (EC) No 2023/2006 is amended as follows:  
(1) The title of section B and point 1 thereof are replaced by the following : 
‘B. Minimum requirements for a quality assurance system to be operated at 
recycling facilities , where recycled plastic i s manufactured in accordance with 
Regulation (EU) 2022/1616  
1. The quality assurance system implemented by the recycler must give adequate 
confidence in the ability  of all recycling operations taking place at the facility 
to ensure the recycled plastic meet s the requirements set out in  Regulation 
(EU) 2022/1616.’  
(2) In section B, t he following paragraph is added :  
‘3. The quality assurance system implemented by the recycler shall include 
specific operations in the recycling process, ‘Quality Assessment Stages’ , at 
which  the recycler shall assess the quality of each batch of  material directly 
originating from a manufacturing stage.   
This assessment shall  check  the quality of that material  by verifying : 
– Whether the  applicable critical limits referred to in point 2 , point (c) have 
been met at each unit operation  that is  part of the manufacturing stage;  
and, 
– whether the quality of the resulting material meets  pre-defined criteria , 
using the tests, protocols and eviden ce referred to in point 2 , point (e) 
applicable to th e manufacturing  stage.   
The assessment shall result in a decision on whether the quality of the batch is 
considered conform with Regulation (EU) 2022/1616 and suitable for further 
processing, whether its  quality requires correction before further processing or, 
whether the batch is to be discarded or used for non -food applications .’ 
(3) The following section  C is added : 
‘C. Reprocessing of plastics  falling within the scope of Regulation (EU) No 
10/2011  
1. Plastic offcuts, scraps, and similar by -products of plastic manufacturing 
processes and intended to be reprocessed in accordance with Article 
10(1) of Regulation (EU) No 10/2011 (‘materials intended for 
reprocessing’) shall be collected separately from was te as close as 
technical achieva ble to the point at which they are cut, scrapped  or 
otherwise produced  from a similar plastic manufacturing operation  
leading to offcuts and scraps and similar by -products of plastic . 
2. Materials intended for reprocessing s hall be collected either using a 
closed piping or belt system intended for that purpose  only, or in clean 
bins, bags, or other containers designated to this purpose and which can 
easily be recognised as being intended only for this purpose.  Those types 
of containers shall be closed as soon as they are fully filled . Up to the 
point of reinsertion in the plastic production process the applied 
containers shall be designed to prevent any contamination of the plastic 
material.   
EN 7  EN 3. Such bins, bags or containers m ay be transferred for reprocessing 
individually or be grouped  in secondary packaging. The resulting unit 
shall be considered as a batch of material intended for reprocessing. The 
definition of ‘batch’ in Article 2 , point (20) of Regulation (EU) 
2022/1616 s hall apply.  
4. At any stage of production or reprocessing operations, operators shall 
ensure that the quality assurance system prevents that materials intended 
for reprocessing are mixed with batches of plastic of another 
composition, other materials, or w ith waste materials. ’