EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10932/2021 ANNEX CIS 
(POOL/E2/2021/10932/10932 -EN 
ANNEX CIS.docx)  
[…](2021) XXX  draft  
ANNEXES 1 to 3  
 
ANNEXES  
to the  
COMMISSION REGULATION (EU) …/…  
on recycled plastic materials and articles intended to come into contact with foods    
   
EN 1  EN ANNEX  I 
Suitable Recycling  technologies  as referred to in Article 3(2)  
 
Table 1 contain s the following information:  
Column 1:  assignment number of the recycling  technology ; 
Column 2:  name of the recycling technology ;  
Column 3: types of polymer that the recycling technology allow to recycle ;  
Column 4 : short description of the recycling technology and reference to a detailed description in Table 3 ; 
Column  5: the type of input that the recycling  technology can decontaminate , where  
– PCW: ‘post-consumer waste ’ means  plastic waste collected in accordance with Article 6 ; 
– FG: ‘food -grade’ means plastic that was as primary material compliant with Regulation (EU) No 10/2011 ; 
– ‘Non -food PCW’ means packaging that was not used to package food and may not have been manufactured in full compliance 
with Regulation (EU) No 10/2011  and other post -consumer plastic materials which were not intended for contact with food ; 
–  ‘Non-food % ’ means the maximum amount of non -food PCW present in the input ;  
Column 6 : the type of output manufactured with the recycling technology ; 
Column 7 : if ‘yes’ is indicated in column 7, individual recycling processes shall be authorised in accordance with Article s 17 to 19; 
Column 8:  reference to table 4 on specifications and requirements applicable to the use of the technology in accordance with Article 4( 3) and (4);  
Column 9: derogation s from Article s 6 to 8  in accordance with Article 4(5) ;  
Column 10:  if ‘yes’ is indicated in column 10, the recycling technology shall only be used as part of a recycling scheme in accordance with Article 9  
 
 
 
  
EN 2  EN Table 1: List of suitable  recycling technologies  
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 
Recycling 
technolog
y number  Technolog
y name  Polymer 
type 
(detailed 
specification 
in Table 2)   Short 
description of 
the recycling 
technology  
(detailed 
specification in 
Table 3)  Specification 
of input  Specification of 
output  Subject to 
the 
authorisatio
n of 
individual 
processes   Specification
s and 
requirements 
(reference to 
table 4)  Derogation
s (reference 
to table 5)  Recyclin
g scheme 
applies  
1 Post-
consumer 
mechanical 
PET 
recycling  PET (2.1)  Mechanical 
recycling (3.1)  Only PET 
PCW 
containing 
maximum 5% 
materials and 
articles not 
used in contact 
with food.  Decontaminate
d PET; 
additional 
specifications 
may apply to 
output from 
individual 
processes   Yes - -   
EN 3  EN 2 Closed -
Loop 
Recycling  All polymer s 
manufacture
d as primary 
materials in 
compliance 
with 
Regulation 
(EU) No 
10/2011  Basic washing  
and 
microbiological 
decontaminatio
n during 
remoulding 
(3.2)  Chemically 
uncontaminate
d used 
materials and 
articles solely 
obtained from 
a closed loop; 
polymers not 
collected in 
mixed form, 
and/or from 
consumers  Materials and 
articles 
remoulded into 
the same 
materials and 
articles as those 
originating 
from the 
recycling 
scheme from 
which the 
plastic input 
was obtained   No 4.1  Yes 
   
EN 4  EN  
Table 2: Detailed specification of polymers  
Reference 
number  Acronym  Resin number 
and/or 
Recycling 
symbol , if 
any1  Detailed specification for the purpose s of this 
Regulation  
2.1 PET  1 Plastic consisting of at least 90% polyethylene 
terephthalate homopolymer made by the 
polycondensation of ethylene glycol and 
terephthalic acid or dimethyl terephthalate  
    
1: as defined in  Decision 97/129/EC , ASTM D7611 or GB/T 16288 -2008  
 
Table 3: Detailed description of the decontamination technology   
Reference 
number  Name Detailed description  
3.1 Mechanical 
recycling   A decontamination technology during which the polymeric 
chains that constitute the plastic are not intentionally changed 
and their molecular weight is not decreased, and during which 
either a vacuum or an inert gas mixture and heat is applied to 
remove incidental contamination  
3.2 Closed 
Loop A recycling technology  that recycles  plastic input only 
originating from the use or continued re -use of plastic materials  
EN 5  EN recycling  and articles in a food distribution chain , or catering services , 
based on a recycling scheme . Particular to this technology is that 
its input must originate from a product loop which is in a closed 
and controlled chain ensuring that only materials and articles 
which have been intended for food conta ct are used and any 
contamination can be ruled out. M aterials and articles  can 
therefore  not be provided to consumers for use outside the 
premises and/or control of the participating food business 
operators. The decontamination technology part of the recyc ling 
technology provides for microbiological decontamination  by 
high temperature  and basic cleaning  by means of surface 
washing.   
 
Table 4: specifications and  requirements applicable to the use of the technolog y in accordance with Article 4( 4)  
Reference 
number  Specifications / requirements  
4.1 (a) only plastic used  by consumers  within the premises or under control 
of food business operators participating in the recycling scheme  shall 
be part of that scheme ; 
(b) where materials are subject to re -use within the distribution chain , 
they shall be cleaned regularly and sufficiently to prevent the build -up 
of residues originating from food, usage and labelling;   
(c) the use, re -use, intermediate cleaning  in accordance with point (b) , and 
recycling  shall be implemented in  a way designed to prevent 
incidental contamination  of the plastic input that cannot be removed 
with surface washing ; 
(d) the document provided in accordance with article 9( 4) shall provide  
EN 6  EN explicit instructions and procedures to food business operators 
participating in the recycling scheme to prevent the introduction of 
external material and the incidental contamination ; 
(e) the plastic input and the recycled plastic shall at all times fully comply 
with Regulation (EU) No 10/2011; accumulation  of constituent s of the 
plastic material , present due to repeated recycling,  such as residues of 
additives, or degeneration products, shall be con sidered non -
intentionally added substances in accordance with Article 6(4)(a) of 
Regulation (EU) No 10/2011. Their presence s hall not exceed a level 
that is regarded unsafe in a risk assessment in accordance with  article 
19 of that Regulation . Where needed to ensure the quality of the 
recycled plastic materials and articles, new plastic manufactured in 
accordance with that Regul ation  shall be added ;  
(f) there is documented scientific evidence demonstrating that the plastic 
materials and articles recycled as part of the scheme do not pose a risk 
to human health due to:  
– accumulation of constituents of the plastic material, such as 
residues of additives, or degeneration products resulting from 
repeated recycling; or  
– the presence of common residues for other sources such as food, 
detergents and labelling  
 
Table 5: derogations  applicable to the use of the technology in accordance with Article 4(5)  
Reference 
number  Specifications / requirements  
   
EN 7  EN ANNEX II  
Template for the Compliance Monitoring Summary Sheet in accordance with Article 26 
of Regulation (EU) …/…  
Quality Assessment stages:  
For the purpose of the compliance monitoring summary sheet, a Quality Assessment 
(‘QA’) stage shall refer to a specific operation in the recycling process during which 
the quality assessment takes place of batches of material resulting from the 
manufacturi ng stage immediately prior to the QA stage.  
 
At a QA stage, one or more tests in accordance with point 2(e) of Annex B to 
Regulation (EC) No 2023/2006 shall be performed on the batch, and/or the production 
parameters used during that manufacturing stage f or the manufacturing of the batch 
shall be verified. The analysis and/or verification shall establish whether the assessed 
material meets the quality standards applied in the recycling process.  
 
There shall always be a QA stage where material enters the r ecycling process located 
at the facility, and where recycled plastic or plastic materials and articles leave the 
facility.  
 
At the QA stage, a record with the outcome of the QA shall be compiled and kept in 
the recording system.  
1. SECTION 1: IDENTIFICATI ON 
1.1 Identification of the recycling installation  
Installation name   
Applied recycling 
technology in accordance 
with Annex I   
EU Register number 
(recycling installation 
number, ‘RIN’)   
Facility Address   
Recycling Facility Number 
(‘RFN’)   
Contact details   
Position/Role of contact 
persons   
Relevant national register 
numbers, if any   
Notification date (Article 
25(1)(a))    
EN 8  EN 1.2. Identification of the recycler  
Company Name   
EU Register number 
(Recycler Operator 
Number, ‘RON’)   
Address of the head office   
Contact details   
Position/Role of main 
contact person   
Relevant national register 
numbers, if any   
Authorisation holder? 
(Yes/No/ Not applicable)   
1.3. Recycling process authorisation Decision  (if any)  
A: identification of the authorisation Decision for the process that the installation applies:  
EU Register number 
(Recycling Process 
Authorisation Number, 
‘RAN’)   
B: authorisation holder – the name of the authorisation holder and its address must be the 
same as on the authorisation Decision  
Name of authorisation 
holder   
Address   
Contact details   
Position/Role   
1.4. EFSA Documents  
EFSA Question number   
EFSA Publication date of 
the opinion   
EFSA Publication number 
(output number)   
Confidentiality Decision 
number   
Confidentiality Decision 
date  
1.5. Additional responsible person(s) for the operation of the recycling installation  
Name  Position/Role  contact details  
    
EN 9  EN 2. Section 2: Operation of the recycling installation  
2.1. Written Statements  
2.1.1  Recyclers’ statement explaining the production and quality of the recycled plastic  
2.1.2.  Recycler’s statement explaining correspondence to the authorised process  
This section is applicable only to authorised processes.  
 
2.2 Recycling operations at the recycling facility  
The following information shall be provided in this section:  
– A diagram of the main manufacturing stages that are part of the recycling process 
and which are located the recycling facility;  
– A table describing those manufacturing stages and the material streams connecting 
them located at the recycling facility and corresponding to that diagram.  
2.2.1.  Diagram of the main manufacturing stages located the recycling facility  
2.2.2.  Description of the main manufacturing stages located the rec ycling facility and the 
streams connecting them  
Stage 
Number  Name  Descripion  Average Processed 
Tonnage  
    
    
Stream 
Number  Name  Description  Average Stream size  
    
    
 
2.3. Internal Documents  
Provide a comprehensive list of documents relevant to the operation of the process 
and quality management and other administrative procedures related thereto, as well 
as documents related to the authorisation. The documents shall be numbered and 
these numbers shall be used in section 3 to refer to these docum ents. The recycler  
may apply its own numbering system.  
Document 
type Document 
Number  Related 
production 
stage  Title  Description  Date, version, 
author  
      
      
 
2.4. Batch definitions  
The following batches shall be defined in accordance with the table  below:  
– Entry Batch : the unprocessed plastic entering the recycling facility from suppliers;  
– Input Batch : input plastic processed at the facility entered at the decontamination 
stage;   
EN 10  EN – Output Batch : the recycled plastic resulting from the decontamination stage; and,  
– Exit Batch : the recycled plastic (or recycled plastic materials and articles) leaving 
the facility for further processing or use.  
– Any other intermediate batches corresponding to a QA check.  
Where either the entry or input batch is the same beca use no further QA checks take place, 
only the input batch shall be defined. The same approach shall be used for the output and exit 
batches. Where there are different types of entry and or exit batches, these shall be defined 
separately, and be given a mea ningful name.  
The QA shall be numbered in the same way is in the site diagram (section 2.2.1)  
 
Batch type  Internal  
Batch name  Stream/QA 
No. Definition/Description  Typical 
size range  Traceability rule  
      
      
 
2.5. Process diagram of the decontamination installation  
Add a piping and instrumentation diagram in accordance with section 4.4 of ISO 
10628 -1:2014, taking account of ISO 10628 -2. 
 
2.6. Control of critical decontamination operations  
The table below shall include a reference to step s, stages, or operations that EFSA 
identified as critical, a control criterion for each critical parameter, the involved 
control instruments, and the description of corrective actions in case the control 
criterion fails. Further information of the evaluati on of complex control rules shall be 
added if relevant.  
Critical 
operation (and 
ref to EFSA 
opinion)  Control 
criterion  Measuring or 
Control  
Instrument 
(reference to 
2.5) Short description of corrective 
actions if control rule is not met  SOP* code  
     
     
* SOP: Standard Operating Procedure  
2.6.1.  Further information on complex control rules, where relevant  
 
2.7. Relevant SOP for Operation  
The table below shall provide a reference to each SOP used for the operation of the 
installation, provide a short description thereof, and indicate the location where it is 
carried out.  
SOP code  Short description  Location)  
   
  
EN 11  EN 3. Section 3: Quality Assessment  
3.1. Internal Process QA  
Each QA stage shall be described using the table below:  
 
There shall be at least four stages (unless there is no difference between entry and input or 
output and exit – see section 2.4):  
– entry stage (the first QA stage where the material enters the facility),  
– input stage (where the plastic input enters the decontamination process)  
– output stage (where the material leaves the decontamination process)  
– exit stage (where the recycled plastic or the recycled plastic materials and articles 
leave  the facility)  
Additional intermediate stages shall be added where relevant for the quality of the material in 
other stages. Those intermediate stages shall be given a meaningful name.  
 
3.2. Relevant SOP applied at QAstages  
The table below shall provide a  reference to each standard operating procedure used 
at QA stages, provide a short description thereof, and indicate the location where it is 
carried out.  
Quality 
Assessment  
(QA) No 
(ref 3.1)  SOP code  Short description  Location (of QA)  
    
    
4. Section 4: Record repository  
4.1 QA Recording systems  
QA 
Assessment 
No (ref 3.1)  Name  Definition/Description  Location  Backup  SOP 
Code  Modification 
prevention  
       
       
 
4.2. List of SOP codes for recording system  
Quality SOP code  Short description  Location (of QA 
stage 
and 
number  Assessment 
name  Definition/Description  Criterion  Records  SOP Code  
       
EN 12  EN Assessment  
(QA) No 
(ref 3.1) entry into 
recording 
system)  
    
 
4.3. Other relevant records/systems  
Procedure  Description / Documentation  
  
  
EN 13  EN ANNEX III  
Templates for declaration of compliance  
 
Part A: Declaration of compliance to be used by recyclers  
RECYCLERS  DECLARATION of COMPLIANCE with REGULATION (EU) 202 2/XXX  
I, the undersigned , declare in name of [ADD NAME OF RECYCLER] as identified in section 1.1, that 
the recycled plastic material identified in section 1.2 was produced in accordance with Regulation 
(EU) 202 2/XXXX. The recycled material to which this declaration applies is suit able for use in contact 
with food, provided it is used in accordance with the restrictions set out section 3 of this declaration, to 
which purpose I provide  adequate instructions in this declaration and labelling on the product.  
Hereby I declare that the contents of this declaration is correct to the best of my knowledge and in 
compliance with Regulation (EU) 202 2/XXXX.  
Section 1 : Identification  
1.1 Recycler  1.2 Recycled product  1.3 Competent authority  
1.1.1  
Name  1.2.1  
Tradename / 
designation   1.3.1  
Name  
1.1.2  
FCM -RON*   1.2.2  
Batch N o.  1.3.2 
Address   
1.1.3  
Country   1.2.3  
FCM -RIN*   1.3.3 
Country / 
region   
1.1.4  
FCM -RFN*   1.2.4 Other 
information   1.3.4 
assigned 
Registration  
Number   
Section 2: Compliance  
2.1 Basis for authorisation or permission to operate (tick one box only ) 
     
2.1.1   Authorisation 
Decision  RAN*   
2.1.2   Recycling 
scheme  RSN*   
2.1.3   No 
authorisation 
or recycling 
scheme 
required    
2.1.4   Novel 
technology   NTN * 
2.2 Results of  compliance assessment as listed  the compulsory quality assessment stages  in table 3.1 of 
Annex II  to Regulation (EU) 2022/XXXX  
(Compulsory only if 2.1.1 ticked, 2.2.2 and 2.2.3 only to be filled in if different from 2.2.1 and 2.2.4  
respectively )  
Stage Decision criteria and outcome (s) Batch  Number(s)   
2.2.1 Entry    
2.2.2 Input   
2.2.3 Output    
2.2.4 Exit   
   
Section 3: Instructions and information to users of the product  
3.1 Instructions to converters   
EN 14  EN 3.1.1  Maximum recycled 
content  (w/w%) %  
3.1.2  Present recycled 
content (w/w%)  %  
3.1.3  Restrictions of use**   
3.1.4  Other instructions   
3.2 Instructions to users further down the supply chain, including end users  
3.2.1  Restrictions of use**   
3.2.2  Summary of labelling   
3.2.3  Other instructions   
Section 4: Signature  
4.1 Signature and company stamp   
 
 
 
4.2 Name of person signing   
4.3 Role/position of person signing   
4.4 Date and place   
 
* RAN – recycling authorisation number; RON – recycling operator number (recyclers); RIN 
– recycling installation number ; RSN – recycling scheme number ; NTN – novel technology 
number ; RFN – Recycling facility number . 
** Restrictions of use sh all correspond to any applicable conditions in the field of application 
of the recycled plastic , in accordance with Annex I for the applied technology, Article  7, 8, or 
9, the Authorisation of the recycling process, if any, or any other restriction the recycler 
deems necessary.   
Part B: Declaration of compliance to be used by converters if the converted material 
contains only recycled content   
 
CONVERTERS DECLARATION of COMPLIANCE with REGULATION (EU) 2022 /XXXX  
I, the undersigned in section 4 , declare in name of [ADD NAME OF CONVERTER] as identified in 
section 1.1, that the recycled plastic material identified in section 1.2 was produced in accordance with  
Regulation (EU) 202 2/XXXX. The recycled material to which this declaration applies is suitable for 
use in contact with food, provided it is used in accordance with the restrictions set out section 3 of this 
declaration, to which purpose I provided adequat e instructions and labelling on the product.  
Hereby I declare that the contents of this declaration is correct to the best of my knowledge and in 
compliance with Regulation (EU) 202 2/XXXX.  
Section 1 Identification  
1.1 Converter  1.2 Product with recycled  
content  1.3 Competent authority  
1.1.1  
Name  1.2.1  
Tradename / 
designation   1.3.1  
Name  
1.1.2  
Address   1.2.2  
Batch N o.  1.3.2 
Address    
EN 15  EN 1.1.3  
Country   1.2.4 Other 
info  1.3.3 
Country / 
region   
    1.3.4 Reg. 
number   
Section 2: Compliance  
2.1  
2.1.1  Origin of recycled content; FCM -RIN  
2.1.2  Batch numbers recycled content   
2.1.3 Maximum recycled content indicated by  recycler  (Part A, 3.1.1)  % w/w  
2.1.4 Actual recycled content of this product  % w/w  
2.1.5 Restrictions provided in the Declaration of compliance received 
from the recycler are met   
2.1.6 Addition of additives or other 
substances   Added in compliance 
with Regulation (EU) No 
10/2011   No additions  
Section 3: Instructions and information to users of the product  
3.2 Instructions to users further down the supply chain, including end users  
3.2.1  Type or types of food with which it 
is intended to be put in contact   
3.2.2  Time and temperature of treatment 
and storage in contact with the 
food  
3.2.3  The highest food contact surface 
area to volume ratio for which 
compliance has been verified   
3.2.4  List of added substances with 
migration limits ; add rows as 
required.  
(note: FCM Number and specific 
migration limit (‘SML’) may not 
exist  for certain substances)  
 FCM 
No.* Other designation 
(CAS No., chemical 
name)  SML*  
(mg/kg food)  
   
   
3.2.5  Other relevant information in 
accordance with points 7 and 9 of 
Annex IV of Regulation (EU) No 
10/2011   
Section 4: Signature  
4.1 Signature and company stamp   
 
 
4.2 Name of person signing   
4.3 Role/position of person signing   
4.4 Date and place