EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10932/2021 CIS 
(POOL/E2/2021/10932/10932 -EN 
CIS.docx)  
[…](2021) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
on recycled plastic materials and articles intended to come into contact with foods, and 
repealing Regulation (EC) No 282/2008  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
on recycled plastic materials and articles intended to come into contact with foods, and 
repealing Regulation (EC) No 282/2008  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the 
Council of 27 October 2004 on mate rials and articles intended to come into contact with food 
and repealing Directives 80/590/EEC and 89/109/EEC1, and in particular Article 5(1) , second 
subparagraph, points (h), (i), (k) and (n),  thereof,  
Whereas:  
(1) As part of the 2015 circular economy action  plan2, the Commission identified the 
increase in plastic recycling as an essential prerequisite for the transition to a circular 
economy and committed to address this sector in a targeted way. The Commission 
therefore adopted in 2018 a European strategy f or plastics in a circular economy3 
which presents key commitments for action at U nion level in order to curb adverse 
impacts of plastic pollution. It strives to extend the plastic recycling capacity in the 
Union, and to increase recycled content in plastic  products and packaging. As a large 
proportion of plastic packaging materials are used as food packaging, the policy can 
only achieve its objectives if also the recycled plastic content in food packaging 
increases.  
(2) A pre -requisite to any increase in recyc led content in food packaging and other food 
contact materials remains the need to secure a high level of protection of human 
health . However, w asted plastic materials and articles originating from food use may 
contain contaminants incidental to that  use, which potentially compromises the safety 
and quality of recycled plastic food contact materials and articles . While such plastic 
waste should not be contaminated with a relatively high amount of specific substances 
known to be hazardous to human health, as  could be the case for instance in plastics 
originating from industrial purposes, the identity and level of incidental contaminants 
that could be present in collected food packaging is undetermined, random,  depend on 
the source and collection method of the  plastic waste , and may vary between 
collections . Therefore, the plastic should always be decontaminated during its 
recycling to a level at which it is certain that remaining contaminants cannot endanger 
human health or affect the food otherwise, if used f or the production of recycled 
plastic food contact materials and articles. To ensure that food consumers and food 
                                                 
1 OJ L 338, 13.11.2004, p. 4.  
2 COM/2015/0614 final  
3 COM(2018) 28 final  EN 2  EN business operators can trust decontaminated materials, and that there is a uniform 
interpretation of the extent of decontamination that is reg arded as sufficient, the 
decontamination of recycled plastic materials and articles intended for contact with 
food should be subject to a uniform set of rules.  
(3) Commission Regulation (EC) No 282/20084 already established specific requirements 
for recycling  processes to ensure that recycled plastic materials and articles intended 
for food contact comply with Article 3 of Regulation (EC) No 1935/2004.  Regulation 
(EC) No 282/2008 did however not apply to all recycling technologies. At the time of 
its adoption , only a few recycling technologies existed, particularly the mechanical 
recycling of polyethylene terephthalate (‘PET’)  and chemical depolymerisation 
applied by feedstock recycling, as well as plastic materials originating from product 
loops which are in a  closed and controlled chain. Also scraps and off -cuts were being 
recycled, and functional barriers were used to contain contaminated recycled plastic. 
While Regulation (EC) No 282/2008 set out rules for plastic recycled with certain of 
these recycling tec hnologies, the use of other materials was subject to Commission 
Regulation (EU) No 10/20115. That Regulation however does not define rules for 
partially depolymerised substances or oligomers, does not allow  the presence of 
contaminants classified as ‘mutag enic’, ‘carcinogenic’ or ‘toxic to reproduction’ when  
used behind a functional barrier, and requires that impurities are identified and subject 
to risk assessment  in all cases . In addition, innovative novel technologies are 
constantly being developed.  It is, therefore, appropriate to replace Regulation (EC) No 
282/2008 with new rules covering all those existing recycling technologies  which 
cannot adequately be regulated by Regulation (EU) No 10/2011 as well as  capable of 
covering  future recycling technologi es.  
(4)  In natural language widely and loosely used terminology, such as ‘technology’, 
‘process’, ‘equipment’ and ‘installation’, may depending on context and user refer to 
the same or to similar concepts and the meaning may overlap. In order to make clear 
the sco pe and subject of the obligations laid down under this Regulation, it is 
appropriate to clearly define the se concepts for the purpose of this Regulation. In 
particular, it is necessary to distinguish ‘recycling technology’, which covers the 
general concept s and principles by which contaminants are removed from waste 
plastic, from the ‘recycling process’, which refers to the description of a specific 
sequence of operations and equipment designed using a specific recycling technology, 
and from the ‘recycling installation’, which should refer to the actual physical 
equipment used to operate the recycling process to manufacture recycled plastic 
materials and articles.  
(5) Recycling processes may consist of many sequential basic operations applying a single 
transform ation (‘unit operations’), but only some of these operations achieve 
decontamination. As plastic waste should always be decontaminated, and there should 
be clear rules applicable to decontamination, recycling operations that together ensure 
decontamination  should be referred to as the decontamination process  and should be 
distinguished from operations carried out before and after decontamination.  
                                                 
4 Commission Regulation (EC) No 282/2008 of 27 March 2008 on recycled plastic materials and articles 
intended to come into contact with foods and amending Regulation (EC) No  2023/2006  (OJ L 86, 
28.3.2008, p. 9 ). 
5 Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into 
contact with food (OJ L 12, 15.1.2011, p. 1).   EN 3  EN (6) Given the relevance of quality control of the material that is being recycled  to the 
eventual quality and safety  of recycled plastic materials  and articles,  and to 
traceability,  it is appropriate to define precisely the notion of ‘batches’  to which 
quality control rules apply . 
(7) Experience with the evaluation of processes under  Regulation (EU) No 282/2008 
shows that scientific criteria  and understanding  specific to a certain recycling 
technology  should be established prior to the evaluation of individual recycling 
processes using that technology , as  insufficient scientific understanding of 
contaminant levels in the inp ut as well as  on of the functioning of the technology may  
otherwise leave too many uncertainties to allow the European Food Safety A uthority 
(‘the Authority’) to conclude on the safety of those individual recycling processes.  
Experience has also shown that other  recycling technologies can ensure with  certainty 
that any recycling process applying them  result s in safe recycled plastic ,and that, 
therefore , the evaluation of each recycling process  using these technologies  bring s 
little benefit in comparison  with the burden  it represents for  both business operators 
and the Authority. Therefore, it is appropriate to provide that recycled plastic materials 
and articles may, in principle, only be placed on the market where they have been 
produced using a technol ogy which is sufficiently well understood as to allow the 
Commission to decide on whether it allows in principle to recycle waste plastic into 
plastic meeting the requirements of Article 3 of Regulation (EC) No 1935/2004, and 
on whether its use should be s ubject to specific requirements, including whether 
recycling processes applying that technology sufficiently differ among them  regarding 
the parameters of the decontamination treatment or the configuration of the process, as 
to require an individual author isation of each of them  in order to ensure  the safety and 
quality of the recycled plastic manufactured with them.  
(8) On the basis of the evaluations  done by the Authority  of the application s for 
authorisation submitted in accordance with Regulation (EC) No 28 2/2008,  for 
mechanical PET recycling and product loops in a closed and controlled chain (‘closed -
loop recycling’) may be considered as suitable  technologies  to recycle waste plastic 
into plastic meeting the requirements of Article 3 of Regulation (EC) No 1935/2004 
and the specific conditions concerning their use should be laid down. In particular, 
mechanical PET recycling processes  should be subject to indivi dual authorisation as 
the severity and duration of the treatment  of the plastic input  applied in the 
decontamination operations , and thus their capacity to decontaminate, depend on the 
specific configuration of those processes, and, therefore, requires a c ase-by-case 
evaluation on based on established criteria . Conversely, it is not necessary to require 
the authorisation of individual recycling processes applying the closed -loop recycling 
technology as for all those processes the introduction of contaminant s in the chain is 
sufficiently controlled  to ensure that the only contamination of the plastic input can be 
removed with the simple washing and heating processes needed in any case for the 
remoulding of the materials . 
(9) In order to ensure the safety and qual ity of recycled plastic materials and articles, rules 
on the placing on the market o f those products should be laid down.  
(10) Regulation (EU) No 10/2011 sets out compositional requirements that ensure the safe 
use of plastic food contact materials, including which substances are authorised for the 
manufacture and migration limits. To ensure the same level of safety of recycled 
plastic materials and articles , they should be of the same composition as plastics 
manufactured in accordance with Regulation (EU) No 1 0/2011, and comply with the 
restrictions and specifications, such as migration limits, laid down that Regulation. EN 4  EN However, as residual incidental contamination in plastic input is to be removed to a 
safe level in accordance with this Regulation, the rules on compliance set out in 
Regulation (EU) No 10/2011 should not apply to residual incidental contamination.  
(11) To ensure transparency and to facilitate quality control and traceability, a public 
register should be established that holds information on recycle rs, recycling 
installations and recycling processes  and registration in that register should be a 
requirement to place recycled plastic materials and articles on the market.  
(12) While Regulation (EC) No 1935/2004 lays down specific rules for the labelling of 
materials and articles to inform users on their appropriate use, such rules do not exist 
regarding the post -processing of decontaminated plastic. However, based on the extent 
of the decontamination certain instructions may apply to the further processing a nd use 
of recycled plastic, such as mixing requirements to achieve a maximum recycled 
content, or limitations on their use. While such instructions should be transferred via 
documentation, plastic materials may not be easily recognisable as requiring a spe cial 
treatment. To prevent mistakes and to facilitate controls, recycled plastic should 
therefore be labelled in a clearly legible way to ensure it is correctly used during post -
processing in accordance with the instructions from the recycler.   
(13) To ensure t hat plastic materials and articles are subject to  conditions throughout the 
recycling process  that ensure their safety and quality , and to  facilitate enforcement and 
the functioning of the supply chain , rules should be established on the operation of all 
recycling stages , from pre-processing  to decontamination and to  post processing. In 
particular, as the plastic input to the decontamination process should be of a reliable 
quality to allow for sufficient decontamination, it is appropri ate to provide that the 
rules laid down in Commission Regulation (EC) No 2023/20066 on good 
manufacturing practices apply , as appropriate,  also to waste management operations 
taking place before the decontamination process and that a quality assurance syst em is 
applied.  
(14) However, given the diversity of recycling technologies and of recycling processes 
there should be a possibility for adopting specific rules complementing or derogating 
from some of those general rules to take into account of the specific ca pabilities of a 
recycling technology or process.  Furthermore, those general rules should not  apply in 
relation to those recycling technolog ies that rely on the establishment of a special 
scheme  for using and collecting plastic materials and articles in whi ch recyclers, food 
business operators and other business operators participate and which aims at keeping 
the contamination of the collected plastic waste to a minimum and, therefore, at 
reducing the requirements for decontamination. However, in order to en sure that 
decontamination is always sufficient, it is appropriate that this Regulation sets out 
rules on the functioning such schemes. In particular, to ensure clarity and uniform 
application of a recycling scheme, only one entity should be responsible for  managing 
its overall functioning and it should be responsible to provide all participating 
operators with binding directions. It should also be ensured that participants, third 
parties and control authorities can easily recognise the plastic materials and  articles 
which must be used according to a specific recycling scheme.  
(15) Even if the  rule should be that only recycled plastic materials and articles produced 
using technologies that have been demonstrated to be suitable  may be placed on the 
                                                 
6 Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good manu facturing practice for 
materials and articles intended to come into contact with food  (OJ L 384, 29.12.2006, p. 75 ). EN 5  EN market, it is appropriate , in order to allow for, and encourage, the development of such 
technologies , to authorise, under strict conditions and for a limited time, the placing on 
the market of recycled plastic materials and articles produced using new technologies . 
This should allow developers to gather the data on a large and representative number 
of samples which is necessary to minimise the uncertainty as to the characterisation of 
the plastic input and of recycled plastic material s and articles and which is, therefore, 
necessary to assess  the suitability of a novel technology and to lay down the specific 
requirements, where appropriate.  
(16) However , rules should be laid down to ensure that recycled plastic materials and 
articles produc ed with new technologies are of minimal risk and that the possibility to 
place such materials  and articles  on the market is effectively used to collect the 
information and experience allowing for the evaluation of the technology. In 
particular, given the i mportance for the safety of recycled plastic materials and articles 
and for the understanding of a technology of the level of contamination in the input 
materials, as well as  of the contaminant levels in the final materials and articles and 
the potential o f their transfer to food , rules should be laid down concerning, in 
particular, the analytical monitoring of recycled plastic materials and articles produced 
with recycling technologies under development and the potential presence of 
hazardous substances . Moreover, to ensure trust , public knowledge and scrutiny on 
technologies that are being developed, it is important that the reports of such 
monitoring are made public regularly.  
(17) In order to ensure that the possibility to place on the market recycled plasti c materials 
and articles produced with new technologies remains limited to the time necessary to 
collect the information and experience necessary for the assessment  of the technology, 
rules should be laid down regarding the initiation of that assessment . However, s ince i t 
is not unlikely that several develop ers may simultaneously  and independently  be using 
similar installations based, in substance, on the same technology , a level of flexibility 
should exist regarding the start and the scope of the assessment of a novel technology 
so that  that assessment  may be inform ed with information originating from all 
concerned technology developers ,.  
(18) In case there is evidence or ind ication s showing that recycled plastic materials and 
articles recycled with a suitable recycling technology or with a novel technology may 
endanger the health of consumers, it should be possible for the Commission to analyse 
the technology  and the safety o f the recycled plastic materials and articles it produces,  
and to take appropriate and immediate action on it.  
(19) Since this Regulation requires the individual authorisation of recycling processes in 
certain cases, a procedure  should be laid down to this end.  This procedure should be 
similar to the procedure for authorisation of a new substance laid down in Regulation 
(EC) No 1935/2004, adapted as necessary for the individual authorisation of recycling 
processes. In particular, since preparing an application f or authorisation requires of the 
applicant an intricate knowledge of the recycling process concerned, and in order to 
avoid that several applications for the same recycling process are submitted, it is  
appropriate to lay down that only the business operato r who developed the recycling 
process, and not any recycler using it, may apply for authorisation. Furthermore, a s 
authorised recycling processes may be subject to minor and major technical and 
administrative changes over their life -cycle , this Regulation should ensure clarity over 
the procedures applicable to  changes to  authorised recycling processes.   EN 6  EN (20) Since recycling installations are complex and their configuration and operation may be 
subject to many parameters and procedures, it is appropriate , in order to facilitate 
compliance monitoring by the recyclers themselves and efficient audits as part of 
official controls,  to require that recyclers operating a decontamination installation keep 
available a document summarising in a standardised way the oper ation , control and 
monitoring  of that installation as well as of the recycling installation  of which it is part 
in a way that shows compliance with this Regulation,.  
(21) The decontamination of recycled plastic should be subject to inspection and control by 
competent authorities. Regulation (EU) 2017/625 on official controls and other official 
activities performed to ensure the application of food and feed law also covers official 
control on food contact materials and , therefore , includes decontamination 
install ations. However, while that Regulation provides for general rules for official 
controls, it does not set out any specific procedures to control decontamination 
installations. To ensure uniform application of official controls of decontamination 
installatio ns independent of where they are located, it is therefore appropriate to define 
appropriate control techniques, as well as rules that define when recycled plastic 
should be considered to be not in compliance with this Regulation.  
(22) To ensure that recycled pl astic and recycled plastic materials and articles are used 
appropriately and in a traceable manner by converters and food business operators, a 
declaration of compliance should be provided to accompany batches of recycled 
plastic, in order to establish the  identity of the recycler, the recycled origin of the 
plastic,  and to provide instructions to the converters and final users regarding its use. 
To ensure that that document can be understood in a uniform manner by anyone who 
receives it, operators should b e required to use a pre -defined template  
(23) Recycled materials and articles are presently placed  on the market subject to national 
rules . Therefore , provisions should be laid down to ensure that the transition to this 
Regulation is smooth and does not disturb  the existing recycled plastic materials and 
articles market. In particular, it should be possible  for a limited time  to apply for 
authorisation of existing  recycling processes subject to individual authorisation in 
accordance with this Regulation , and to continue placing on the market recycled 
plastic, and recycled plastic materials and articles, produced through those recycling 
processes until the authorisation procedure is finalised. Applications submitted in 
accordance with Regulation (EC) No 282/2008 c oncerning such recycling processes 
should be considered as applications submitted under this Regulation. Applications 
submitted in accordance with Regulation (EC) No 282/2008 concerning recycling 
processes not subject to individual authorisation in accorda nce with this Regulation 
should be terminated as there is no basis for authorisation of the concerned processes 
under this Regulation.  
(24) Recyclers operating recycling processes based on technologies that are not listed as 
suitable technologies should be allo wed sufficient time to consider whether they want 
to develop that technology further in order to allow the listing of the technology as 
suitable or otherwise to terminate the concerned recycling operations. Therefore, the 
placing on the market of recycled plastic, and recycled plastic materials and articles, 
produced through recycling processes based on those technologies and in accordance 
with current existing national rules should be allowed for a limited time  
(25) This Regulation requires that certain waste m anagement operators involved in the 
collection of plastic, as well as those involved in further operations as part of pre -
processing, set up a certified quality assurance system to ensure the quality and EN 7  EN traceability of the plastic input. As those operator s need time to fully prepare for such 
certification, sufficient time should be granted for those operators to adapt to that 
requirement.  
(26) Regulation (EC) No 282/2008 should be repealed.  
(27) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,   
HAS ADOPTED THIS REGULATION:  
Chapter I – Subject matter, s cope and definitions  
Article 1 
Subject matter and scope  
1. This Regulation lays down  rules for : 
(a) the placing on the marke t of plastic food contact materials  and articles , 
containing  plastic originating from plastic waste ; 
(b) the development and  operation of recycling processes to produce recycled 
plastic  for use in those plastic materials and articles ;  
(c) the use in contact with f ood of recycled plastic materials and articles and of 
plastic materials and articles which are intended to be recycled.  
2. This Regulation shall not apply to the use of plastic waste to manufacture substances 
included in the Union list of authorised substances in accordance with Article 5 of 
Regulation (EU) No 10/2011  when intended for subsequent use in accordance with 
that Regulation . 
Article 2  
Definitions  
1. For the purposes of th is Regulation, the definitions in Article 3 of  Regulation (EU) 
No 10/2011  and the definitions in Article 3 of Regulation (EC) No 2023/2006, shall 
apply.  
2. For the purposes of this Regulation, t he following definitions also apply:   
(1) ‘waste’,  ‘municipal waste’,  ‘waste management ’, ‘collection’, ‘re-use’, and 
‘recycling ’, as laid down in  Article 3 of Directive 2008/98/EC of the European 
Parliament and of the Council7; 
(2) ‘food business’  and ‘food business operator’ , as laid down in Article 3 of 
Regulation (EC) No 178/2002 of the European Parliament and of the Council8; 
(3) ‘competent authorities’,  and ‘audit’,  as laid down in  Article 3 of Regulation 
(EU) 2017/625 of the European Parliament and of the Council . 
                                                 
7 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste 
and repealing certain Directives  (OJ L 31 2, 22.11.2008, p. 3).  
8 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down the general principles and requirements of food law, establishing the European Food Safety 
Authority and laying down procedures  in matters of food s afety ( OJ L 31, 1.2.2002, p. 1 ). EN 8  EN 3. The following definitions also apply:  
(1) ‘recycling technology’  means a specific combination of physical and chemical 
concepts, principles, and practices to recycle  a waste stream of a certain type 
and collected in a certain way into recycled plastic materials and articles of a 
specific type and with a specific intend ed use , and includes a decontamination 
technology;  
(2) ‘decontamination technology’ means a specific combination of physical and 
chemical concepts, principles, and practices part of a recycling technology 
which have as primary purpose to remove contamination ; 
(3) ‘recycling process’ means a sequence of  unit operations that is  intended  to 
manufacture recycled plastic materials and articles  through pre -processing, a 
decontamination  process,  and post -processing , and which is based on a specific 
recycling technology ; 
(4) ‘recycled plastic’ means plastic resulting from the decontamination process  of 
a recycling process and  plastic resulting  from subsequent post-processing 
operations and that is not yet transformed into recycled plastic materials and 
articles ; 
(5) ‘recycled plast ic materials and articles’ mean s food contact materials and 
articles  in their finished state  that contain recycled plastic ;  
(6) ‘pre-processing’ means all waste management  operations carried out to sort, 
shred, wash, mix or otherwise treat plastic waste in order to make it suitable for 
the decontamination process ; 
(7) ‘plastic input’ means the plastic materials resulting from pre -processing which 
are entered into a decontamination process ; 
(8) ‘decontamination  process ’ means a specific  sequence of unit operations  which 
together have as primary purpose to remove contamination from plastic input  
in order to make it suitable for contact  with food , using a specific 
decontamination technology ; 
(9) ‘incidental contamination’  means  contamination present in  plastic input  
originating from food , from  plastic materials and articles intended and used for 
contact with food, from their use  or misuse  for non -food purposes, and from 
the unintentional presence of  other substances, materials and articles due to  
waste management ; 
(10) ‘post -processing’ means all  unit operation s by which recycled plastic  is 
converted  into recycled plastic materials and articles  in their finished state ;  
(11) ‘recycling installation’ means the equipment operating at least a part of a  
recycling proc ess;  
(12) ‘decontamination installation’ means specific equipment operating a 
decontamination process ; 
(13) ‘recycling facility’ means a location where waste management operations take 
place and where at least one decontamination installation  is located;  
(14) ‘recycling scheme’ means a single system that manages the use and separate 
collection of plastic materials and articles with the objective to limit or prevent EN 9  EN their contamination in order to reduce decontamination requirements during 
their recycling ; 
(15) ‘recy cler’ means any natural or legal person who applies a decontamination 
process ; 
(16) ‘converter’ means any natural or  legal person that  carries out one or more post -
processing  unit operations ; 
(17) ‘unit operation’ means a basic operation that is part of a process,  and applies a 
single transformation to its input, or more transformations if they occur in 
conjunction;  
(18) ‘manufacturing stage’ means one or more sequential unit operations and which 
are followed by a quality assessment of the material resulting from that sta ge; 
(19) ‘batch’ means a quantity of plastic of the same quality , and produced  using 
uniform production parameters  at a certain manufacturing stage , stored  and 
contained  to exclude mixing with other material s or contamination , and 
designated as such by a single production number . 
Article 3  
Suitable recycling technologies  
1. A recycling technology shall be considered suitable if it  is shown to be  capable of 
recycling waste into recycled plastic materials and articles  that comply with A rticle 3 
of Regulation (EC) No 1935/2004 .  
2. A suitable recycling technology shall be distinguished from other recycling 
technolog ies based on the following  properties :  
(a) the type, mode of collection and origin of the input material;  
(b) the specific combination of physical and chemical concepts, principles and 
practices used to  decontaminate that input material;  
(c) the type and the intended use of the recycled plastic materials and articles ; 
(d) the need or absence thereof for the evaluation and authorisation of recycling 
processes applying that technology , and the criteria  therefore .  
3. Where a suitable  recycling technology may be implemented through different 
recycling processes and that the capacity of each of those processes to recycle waste 
into recycled plasti c materials and articles that comply with Article 3 of Regulation 
(EC) No 1935/2004 may vary, each recycling process shall be individually 
authorised  by the Commission  in accordance with Article 19(1)  (‘the authorisation’) . 
4. Suitable recycling technologies are listed in Annex I. Annex I may be amended in 
accordance with Articles 15 and 16.  
Chapter II – Placing on the market of recycled plastic and 
recycled plastic materials and articles  
Article 4 
Requirements for recycled plastic materials and articles   EN 10  EN 1. Recycled plastic materials and articles shall only be placed on the market where the 
requirements set out in paragraphs 2 to 7 are met during  their manufacture . 
2. The compositional requirements and requirements on compliance set out in  Chapter 
II and Chapter V of  Regulation (EU) No 10/2011 shall apply to recycled plastic 
materials and articles . Those rules shall not apply to potential residual incidental 
contamination  present in recycled plastic materials and articles . 
3. The recycled mate rials and articles are manufactured using one of the following :  
(a) a suitable recycling  technology ; or, 
(b) a novel technology  as referred to in Chapter IV .  
4. Where the recycled plastic materials and articles are manufactured using a suitable 
recycling technology , the following requirements are met:  
(a) where relevant, the recycling process used to manufacture the recycled plastic 
materials and articles has been granted an authorisation.  
(b) the recycling and use of the  recycled  plastic  materials and art icles comply with 
the general requirements laid down in Article s 6, 7 and 8, and, where relevant, 
with the specific rules for the technology set out in Annex I and  with the 
specific rules for the recycling process set out in the authorisation.  
(c) by derogation to point (b), w here the suitable technology is to be implemented 
through a recycling scheme , the recycling and use of the recycled plastic 
materials and articles comply with the general requirements laid down in 
Article 9 , and , where relevant,  with the specific rules  for the technology  set out 
in Annex I .  
5. Where the recycled plastic materials and articles are manufactured using a novel 
technology, the requirements laid down in Articles 10 to 13 are met.  
6. The Union register established in Article 2 4 includes  the following information 
regarding the manufacture of recycled plastic : 
(a) on the basis of a notification in accordance with Article 25, the used 
decontamination installation , the recycling facility where that  is located, and 
the identity of the recycler  operating it;  
(b) the applied recycling process , if the applied suitable recycling technology 
requires the authorisation of recycling processes ; 
(c) the used recycling scheme , if the applied recycling technology requires the use 
of a recycling scheme;  
(d) and/or the novel technology , if the manufacture of the recycled plastic uses a 
novel recycling technology . 
7. Where relevant , the status in the Register established in Article 24 of the authorised  
recycling process  used for the manufacturing is not ‘suspended ’ or ‘revoked’ . 
8. The status in the Register established in Article 24 of the decontamination 
installation used for the manufacturing is not ‘suspended’.   
Article 5 
Requirements for d ocumentation,  instructions and  labelling EN 11  EN 1. Individual batches of recycled  plastic or recycled materials and articles  shall be 
subject to a single document or record regarding their quality, and shall be identified 
by a unique number and the name of the manufacturing stage  from which they 
originate.  
2. Recycled plastic  placed  on th e market shall be accompanied by  compliance 
documentation  in accordance with Article 29 . 
3. Containers with recycled plastic  delivered to converters  shall be labelled. The label 
shall  indicate:   
(a) the registry number of the recycling installation  where the recy cled plastic was 
manufacture d , and the batch number;  
(b) the percentage by weight of the plastic content that originates from recycling ; 
and, 
(c) the maximum percentage by weight of the recycled plastic  that final recycled 
plastic materials and articles  containing the recycled plastic  may contain, if this 
is less than 100%; and,  
(d) a brief summary of a ny other instructions provided in the documentation in 
accordance with paragraph 2. 
4. The label s referred to in paragraph 3 shall be at all times clearly legibl e and be 
located at a visible place on the packaging . 
The minimum font size on the labels shall be 17 points  (6 mm)  for containers  of 
which the largest dimension is 75 centimetres or smaller. The minimum point size 
(‘ps’) for containers  of which the larges t dimension (‘ld’) is larger than 75 
centimetres shall be determined according to the following formula: ps = 2*√ld, ps in 
points, and ld in cm.  
5. Restrictions and specifications laid down in Annex I  concerning the use of recycled 
material or article s manufa ctured with a suitable technology , and, where relevant, 
restrictions and specifications laid down in the authorisation  concerning the use of 
recycled material or articles manufactured with a recycling process  shall be included 
in the labelling  required by Article 15 of Regulation (EC) No 1935/2004  of recycled 
material or articles provided to food business operators or to final consumers.   
Chapter III – General r equirements  for plastic recycling and the 
use of recycled plastic   
Article 6 
Requirements for collection and pre -processing   
1. Waste management operators that participate in the supply  chain  of plastic input 
shall ensure that  the collected plastic waste meets the following requirements : 
(a) the plastic waste originates only from municipal waste , or from food retail  or 
other food business es if it was only intended and used for contact with food ;  
(b) the plastic waste originates only from plastic materials and articles 
manufactured in accordance with Regulation (EU) No 10/2011 or recycled 
plastic materials and  articles manufactured in accordance with this Regulation;  
(c) the plastic waste is subject to separate collect ion;  EN 12  EN (d) the presence of plastic material s and articles  that are different from the plastic 
for which the decontamination process  is intended , including caps, labels and 
adhesives, other materials and substances, and remaining food  is reduced to a 
level specified  in the requirements for the plastic input provided by the recycler  
and which shall not compromise the achieved level of decontaminati on.  
2. For the purposes of paragraph 1, point (c), the plastic waste shall be considered as 
collected separately when one of the following conditions is fulfilled:  
(a) it consists only of plastic materials and articles meeting the requirements of 
paragraph 1, points (a) and (b), and which have been collected separately for 
recycling from any other waste;  
(b) it is collected together with other waste packaging fractions of municipal waste 
or with other non -packaging plastic, metal, paper or glass fractions of 
munici pal waste collected separately for recycling  and the following 
requirements are met : 
(i) the collection system does not collect waste likely to contain hazardous 
substances;  
(ii) the collection of waste and the subsequent sorting are designed and 
carried out to minimise contamination of collected plastic waste from any 
plastic waste not meeting the requirements of paragraph 1, point s (a) and 
(b), or other waste;  
(iii) quality assurance systems are set up by the waste management operators 
in order to verif y that the conditions set out in points (i) and (ii) are 
fulfilled.  
3. The plastic waste shall be controlled throughout collection and pre -processing by 
means of quality assurance systems. The quality assurance systems shall : 
(a) ensure traceability of each batch  up to the point of the first sorting of collected 
plastic waste ; and, 
(b) be certified by an independent third party.  
Articles 4, 5, 6 and 7 of Commission Regulation (EC) No 2023/2006 as well as point 
B of the Annex to that Regulation shall apply mutatis muta ndis as regards good 
manufacturing practice, quality control and assurance systems and the relevant 
documentation . 
Article 7 
Requirements for decontamination  
1. The plastic input  and output of the applied decontamination process  shall  meet the 
specifications  set out in  column 3, 5, and 6 of  table 1 of Annex I for the relevant 
recycling technology and, as applicable, the specific criteria set out in the 
authorisation.   
2. Decontamination shall be carried out in accordance with good manufacturing 
practices. Recycle rs shall ensure compliance with Regulation (EC) No 2023/2006.  
3. The decontamination installation  shall meet  the following requirements:  EN 13  EN (a) it is located at a single recycling facility , which  is organised so as to ensure that 
no new contamination of recycled plastic or recycled plastic materials and 
articles can occur ; 
(b) its configuration  and operation  correspond s to that of the recycling process it 
applies ;  
(c) it is operated as described in the c ompliance monitoring summary sheet 
established in accordance with Article 2 6. 
4. A repository of records used to record information on the quality of individual 
batches as defined in section 4.1 of the compliance monitoring summary sheet 
referred to in paragr aph 3(c) shall be maintained. Records stored in that repository  
shall be retained for a period of at least three years.  
Article 8 
Post-processing and use of recycled plastic  materials and articles  
1. Converters  shall  comply with the following requirements : 
(a) post-process recycled plastic in accordance with  the instructions provided by 
the recycler  or other converter in accordance with Article 5(3);  
(b) where relevant, provide to subsequent  converters instructions  in accordance 
with Article 5 , paragraphs (3), (4) and (5), and  
(c) where relevant, provide instructions to the users of the recycled plastic 
materials and articles  in accordance with Article 5(5).   
2. Food business  operators  shall use recycled plastic materials and articles in 
accordance with the instructions received in accordance with Article 5(5) . 
They shall communicate relevant instructions to consumers of food packed in such 
materials and articles, and/or to other food b usiness operators , where relevant.  
3. Retailers  of recycled plastic materials and articles not yet in contact with food shall 
communicate relevant  instructions  to the users of such materials and articles , where 
relevant . 
Article 9 
Requirements  for the operati on of  recycling schemes  
1. A single legal entity  shall act as the manager of a recycling scheme , and  shall be 
responsible for the overall functioning of the recycling scheme .  
At least 15 working days prior to the start of the operation of a recycling scheme the 
manager of the recycling scheme shall inform the competent authority in the territory 
where it is located and the Commission  for the purpose of  its registration in the 
Union register established in accordance with  Article 2 4.  
The manager shall provide  its name, address, contact persons, the name of the 
scheme, a summary of the scheme not exceeding 300 words , the marking referred to 
in paragraph 5, a list of Member States where business operators participating in the 
schema are located, and refer ences to any recycling installations used by the scheme . 
Thereafter, t he manager shall ensure this information is kept up to date.  EN 14  EN 2. By derogation to the registration procedure referred to in Article 4(6)(a) , Article 
25(1)(c), and Article 26 shall not apply when recyclers notify the production of 
recycled plastic as part of a recycling scheme, unless in case of the used technology 
column 8 of table 1 to Annex I or table 4 thereof specifies this derogation shall not 
apply, or sets out alternative requirements.  When this derogation applies,  the 
registration status in accordance with paragraph 2, point ( g) of Article 24, as referred 
to in Article 25(2), shall be ‘active’.  
3. The manager of the recycling scheme shall provide a single document  to all 
participating business operators and other participating organisations . This document 
shall  set out the  objectives of the scheme, explain how it functions, provide 
instructions, and set out the detailed obligations it places on the participants. The 
explanation shall include a description of the recycling operations.  
4. Recy cling schemes shall be set up in accordance with the specific requirements 
applicable to the applied suitable recycling technology as laid down in table 1 in 
Annex I and , where appli cable, with the authorisation  of the applied recycling 
process . 
A waste collection system shall be part of a recycling scheme and shall be dedicated 
to the scheme so as to ensure that only materials and articles that were used subject 
to the scheme are collected.  
5. All m aterials and a rticles used subject to a recycling scheme shall bear a marking 
registered in  the Union register  established in Article 2 4. That marking shall be 
clearly visible, indelible  and unique to the recycling scheme . 
6. Any food business operator using materials and articles bearing a mark ing provided 
for in  paragraph 5 shall ensure that those materials and articles meet the following 
requirements :  
(a) they are labelled, used and cleaned in accordance with instructions obtained 
from t he manager of  the recycling scheme;  
(b) they are used only for the purpose of distribution, storage, display  and sale  of 
the foods which they are intended for;  
(c) they are not contaminated with materials or substances other than those 
permitted by the recycling scheme . 
Where any of the requirements set out in the first subparagraph is not fulfilled , the 
materials or articles shall be excluded from  the recycling scheme  and be discarded.  
7. Where a scheme permits collection from consumers, collection  shall take place 
separately from other waste at designated collection po ints suitable for ensuring that 
the collection of waste is compliant with the scheme . 
8. Recycled plastic materials and articles produced in accordance with the scheme may 
not be placed on the market for use outside of the scheme.  
9. Business o perators  and other  organisations  that participate in a recycling scheme  
shall : 
(a) operate a quality assurance system  in accordance with Regulation (EU) No 
2023/2006, designed  to ensure compliance with the requirements of the 
scheme ; or, EN 15  EN (b) alternatively, small food business operators, may implement the requirements 
of the scheme as part of their  permanent procedures based on the ‘hazard 
analysis and critical control points’ ( HACC P) principles,  as referred to in 
Article 5 of Regulation (EC) No  852/2004  of the European Parliament and of 
the Council9. 
Chapter IV – Development and listing of novel technolog ies 
Article 10 
Requirements for the development of a novel  technology  
1. Several developers may independently develop novel technologies at the same time, 
even if these technologies may be regarded as  similar or the same.  
Where  business operators or other organisations collaborate  on the development of a 
novel technology , a single legal entity shall  represent these operators or 
organisations , and act as  the developer  of the novel technology .  
2. At least four months  prior to the start of the operation of the first decontamination 
installation operated on the basis of Article 4(2)( b), the developer shall notify the 
competent authority in the territory where the developer is located and the 
Commission  of the novel technology . 
For the purpose of the registration of the novel technology in the Union register 
established in Article 24, the developer  shall include in this notification  its name, 
address, contact persons, the name of the novel technology, a summary of the novel 
technology not exceeding 300 words,  an Uniform Resource Locator ( ‘URL ’) locating 
the reports to be published in accordance with Article 13(3),  and the names and 
addresses or numbers of  any recycling facilities at which the development of the 
technology is foreseen to take place . It shall ensure this information is kept up to date 
thereafter .  
3. The notification  by the developer  shall also provide  detailed information concerning 
the following : 
(a) a characterisation of the novel tech nology  based  on the properties of recycling  
technologies set out in Article 3( 3); 
(b) an explanation of any applied deviations from the  requirements set out in 
Article s 6, 7 and 8, or whether the novel technology applies a recycling 
scheme.   
(c) reasoning and scientific evidence compiled by  the developer  demonstrating 
that the novel technology can manufacture recycled plastic materials and 
articles that meet the requirements of Article 3 of Regulation (EC) No 
1935/2004, including a characterisation of expected contaminant levels in the 
plastic input  and in the recycled plastic, and the expected transfer of these 
contaminants from the recycled plastic materials and articles to the food.  
(d) a description of one or more  typical recycling process es using  the technology, 
including a block diagram of t he main manufacturing stages , and, if relevant , 
                                                 
9 Regulation (EC) No  852/2004 of the European Parliament and of the Council of 29 April 2004 on the 
hygiene of foodstuffs  (OJ L 139 , 30.4.2004, p. 1) . EN 16  EN an explanation of the recycling scheme and of the rules governing its 
functioning . 
(e) an explanation based on point  (a) describing  why the technology is to  be 
considered different  from existing suitable technologies and is to be considered 
novel;  
(f) a summary proposing evaluation  criteria for evaluatin g recycling processes that 
apply the novel technology on which the installation is based  in accordance 
with Article 20(2)  
(g) an estimate of the expected number of decontamination  installations that will 
be operated to develop the novel technology, and the foreseen addresses of the 
recycling facilities where they will be located . 
The information referred to in the first subparagraph shall be available to the 
Member States , and to the Authority . The developer shall also provide it to all  
recyclers using the novel technology . It shall be updated without delay on the basis 
of new information forthcoming from development activities. The  information shall 
be considered of commercial rele vance to the developer , and  shall not be made 
public  prior to a request of  the Commission to the Authority to assess the recycling 
technology in accordance with Article 12 . 
4. The developer shall adapt the template of the compliance monitoring summary sheet 
provided for in Annex II to the extent necessary to reflect the particularities  of the 
novel technology . It shall provide th is adapted template to compliance monitoring 
summary sheet  to all recyclers using the novel technology.  
5. The developer shall ensure an on -going dialogue with all recyclers using the novel 
technology to exchange knowledge about its functioning and capacity to 
decontaminate the plastic input. It shall keep records thereof, setting out the matters 
discus sed and conclusions on the functioning and decontamination capacity of the 
technology, which shall be made avai lable upon request to any competent authorit y 
in a territor y where the developer and/or recyclers are located.   
6. Where a technology applies a recy cling scheme, it shall be operated in accordance 
with Article 9. The developer shall act as the manager of the recycling scheme 
referred  to in Article 9(1). Articles 6, 7 and 8, and Article 9(2) shall not apply.  
Article 1 1 
Conditions on the operation of recycling installations applying novel technologies   
1. A recycling installation  applying a novel recycling technology  shall be based on a 
novel technology notified in accordance with Article 10( 2). 
2. By derogation  to Articles 6, 7 , and 8,  a recycling installa tion used to develop a novel 
technology  may be operated in a way that deviates from one or more of the specific 
requirements set out in  those  Article s, or apply a recycling scheme, provided the 
deviation or the operation of the scheme is in accordance with  Article 10 ;  
3. The recycler shall have documented  supplementary  information available in 
accordance with Article 12 demonstrating that the recycled plastic produced with the 
recycling  installation  meet s the requirements of Article 3 of Regulation (EC) No 
1935/2004 .  EN 17  EN 4. The recycler shall have  a completed compliance monitoring summary sheet on the 
basis of the template provided by the developer in accordance with Article 10(4).   
5. The supplementary information  referred to in paragraph 3 including any supporting 
documentation, and the compliance monitoring summary sheet referred to in 
paragraph 4 shall be provided to  the developer and to  the competent authorities on 
their request.  
Article 12 
Supplementary i nformation requirements on  recycling installation s using novel technology   
1. A recycler shall keep available at the decontamination  installation  the following 
supplementary information:  
(a) a summary of the novel technology not exceeding 250 words;  
(b) a summary describing the complete recycling installation  and the process it 
applies , not exceeding 1 500 words. This summary shall demonstrat e the safety 
of the recycled plastic manufacture d with the installation, and shall be based  on 
the information prov ided by the developer in accordance with Article 10(3), as 
well as the evaluation  criteria referred to  in point ( f) of Article 10(3) ;  
(c) a detailed block diagram showing the sequence of the main manufacturing 
stages  of the recycling installation , including all individual unit operations  
operated at the recycling facility ; 
(d) a piping and instrumentation diagram of the decontamination process in 
accordance with section 4.4 of ISO 10628:2014, showing only the 
instrumentation relevant for decontamination ;  
(e) an URL  providing  the location on the website  of the developer where the 
reports published in accordance with Article 13(3) are or will be located . 
2. The supplementary information in paragraph 1  shall be updated without delay as a 
result of on -going dialogue between  the developer and the recyclers, when new 
information becomes available  either  as a result of the operation and development of 
the installation, or of the monitoring in accordance with Article 13, or where the 
developer changes the technology or collects new measurements on the performance 
or functioning of the novel technology . The recycler shall  then provide the developer 
with the updated information and supporting documentation.  
3. For the purpose  of paragraph 1 , point (b), the supporting documentation s hall include 
at least the follow ing elements : 
(a) information on t he level of incidental contamination  present in the plastic 
input;  
(b) information on t he amount or percentage of the contamination that the 
decontamination process  can remove  (‘the decontamination ef ficiency’) ; 
(c) information on estimated  residual incidental contamination present in the 
output of the decontamination process  taking the decontamination efficiency 
into account , including that of potentially remaining genotoxic  and endocrine 
disrupting substances and substances  referred to in Article 13(4)(a) of 
Regulation (EU) No 10/2011,  even if their occurrence is below the limit of 
their detection of the applied analytical techniques ;  EN 18  EN (d) information on t he fate of  contaminants removed in the  decontamin ation 
process ; 
(e) information on t he migration to food of the residual contamination present in 
the recycled plastic material or article , post-processed in accordance with the 
requirements of the recycling process, and  taking into account the conditions of 
use defined for the concerned materials and articles ;  
(f) an overall reasoning, discussion and  conclusion  on the safety of the recycled 
plastic materials and articles  based on the information set out in point s (a) to 
(e).  
The information referred to in this pa ragraph shall be  kept up to date and be based on 
the latest information  relevant to these elements, including information provided by 
the suppliers of the plastic input  and the users of the recycled plastic , and information  
forthcoming from the monitoring in accordance with Article 13  and the dialogue 
referred to in Article 10(5) . 
Article 13 
Monitoring and reporting of contamination levels   
1. A recycler operating a decontamination installation  in accordance with Article 11 
shall monitor the average contaminant level by sampling each batch of plastic input 
and the corresponding decontaminated output batch.  
The sampling strategy shall be designed to obtain the best possible estimate of the 
average contaminant level in a batch, particularly  by the sampling of shredded and 
mixed material. In case the input batch sizes exceed 30  tonnes, at least every 30 
tonnes of material shall be subject to sampling for the purpose of  this Article .  
Where determining the sampling frequency based on plastic input batches is 
impractical due to the particularities of the recycling process, the frequency shall be 
determined on the basis of batches used at the closest pre -processing operation for 
which such determination is practical.  
2. Recyclers shall provide the developer at leas t every six months  with the data 
forthcoming from the monitoring  and their updated reasoning in accordance with 
Article 12 (3)(f) if that has changed on the basis of the  data.  
3. The developer  shall publish every six months a report  on its website,  based on the 
latest information from all installations using  the novel technology  received in 
accordance with paragraph 2 . 
4. The report shall contain  at least : 
(a) a brief description of the novel technology on the basis of the information 
referred to in Article 10(3);  
(b) a summary of the reasoning on the capability of the novel technology and the 
recycling  process (es) to manufacture recycled plastic materials and articles that 
meet the requirements of Article 3 of Regulation ( EC) No 1935/2004  on the 
basis of the  information included in point s (a) to (e) of Article 1 0(3), and the 
information received in accordance with paragraph 2 ; 
(c) a list of all  chemical  contaminants found  in the plastic input s to each of the 
decontamination installation s and in the recycled plastic  output thereof,  sorted 
in descending order by their relative occurrence and of which at least the first EN 19  EN 20 detected substances have been identified ), and their amounts specified as 
weight fraction of the input and output ; 
(d) a list of other contaminants, including different polymer types, plastics not 
intended for contact with food, and other materials that are found in the inputs 
and outputs referred to in point (c) , and their amounts specified as weight 
fraction of t he input and output ;  
(e) an analysis of the most likely origin of the  identified  contaminants referred to 
in point s (c) and (d), a nd of whether those origins could give rise to the 
simultaneous presence of other more toxic substances that are either undetecte d 
or unidentified with the applied analytical techniques ; 
(f) a measurement or estimation of the migration levels to food of contaminants 
present in the recycled plastic materials and articles;   
(g) a detailed description of the analytical procedures and methods u sed, including 
sampling procedures and limits of detection and quantification;   
(h) an analysis and explanation of any discrepancies observed between 
contaminant levels expected in the input plastic and in the output of the 
installation and its decontamination  efficiency based on  the reasoning provided 
under point (b) and the actual results under point (c). 
(i) a discussion of the differences with the previous report published in accordance 
with this paragraph, if any.  
Article 14 
Assessment of novel technologies  
1. When the Commission  considers there is sufficient  data available on a novel  
technology, it may on its own initiative  request the Authority to assess that 
technology, and include other  novel technolog ies in that request , provided these 
technologies are subs tantially similar or the same .  
2. A developer may request the Commission to initiate  the assessment referred to in 
paragraph 1  once it published at least four consecutive reports in accordance with 
Article 1 3(3) concerning  a decontamination installation . 
In case the developer requests the assessment of the novel  technology, the 
Commission may  delay the request  to the A uthority  by up to two years in case  it 
considers that the available knowledge  on the novel technology is  still insufficient, or 
when other operators are developing  the same or similar novel  technologies .  
3. The Authority shall assess  the suitability of the decontamination technology  that the  
novel technology  applies taking into account  the recycling technology as a whole . 
The suitability assess ment shall thereto include  the capacity  of the employed  
chemical and /or physical principles to remove contamination from a specified plastic 
input to a level sufficiently low so that plastic materials and articles manufactured 
with the novel technology meet Article 3 of Regulation (EU) No 1935/2004 , based 
on a characterisation of the contaminant level in the plastic input and the intended 
use of the plastic output . 
Within one year after receiving the request for assessing the novel technology, t he 
Author ity shall publish an opinion  concerning the outcome of its assessment . That 
opinion shall contain:  EN 20  EN (a) a characterisation of the recycling technology based on the properties defined 
in Article 3(3);  
(b) a discussion and conclusion on its assessment of the capacit y of the novel 
technology to recycle plastic waste in accordance with paragraph 3, including 
specific observations or concerns the Authority has on the technology, and on 
processes and installations using it, and a definition and justification of any 
restrictions and specifications deemed necessary;  
(c) a conclusion on whether individual recycling processes applying that recycling 
technology require further individual evaluation in accordance with Articles 17 
to 20;  
(d) if the Authority concludes that individual evaluation of the recycling processes 
is necessary, specific guidance as referred to in Article 20(2);  
(e) in case that the Authority concludes that individual evaluation of the recycling 
processes is not necessary, information equivalent to the information re quired 
in Article 18(4), points (c) to (g).  
4. Where the Authority considers that it needs to involve new expert s to assess a novel 
technology  accordingly , it may extend the period provided for in paragraph 4 by up 
to one year.  
5. Where needed for completing  its assessment , the Authority may  request the  
developer s of the novel technolog ies under assessment  to supplement the information 
available to it with  information  compiled in accordance with Article s 10 and 12 , as 
well as with other information or explanations that it deems necessary  for that 
purpose , and  within time  limit s it specifie s, which shall not exceed 1 year  in total . 
Where the Authority requests  such supplementary  information, the time limit laid 
down in paragraph 4 is suspended until the requested information  is received, from at 
least one, several, or all developers as appropriate for the purposes of the assessment .  
6. Articles 39  to 39e of Regulation (EC) No 178/2004 and Article 20 of Regulation 
(EC) N o 1935/2004 shall apply mutatis mutandis  to the supplementary information 
requeste d in accordance with paragraph 6; for this purpose , the developer or 
developers of the novel technologies in the scope of the assessment shall be regarded 
as the applicant.  
For the purpose of assessing technologies, the Authority shall provide confidential 
treatment to supplementary information it requests on aspects specific to individual 
recycling processes and installations used by a recycler . Information referred to in 
Article 12(1)(b)  and (e),  and Article 12(3) shall not be treated as confidential.  
Information considered confidential in accordance with this paragraph shall not be 
shared with or between  other  developers , recyclers, or third parties  without the 
consent  of the owner of that information . 
7. When developers of other novel technologies not included in the scope of the 
assessment publish new information relevant for the assessment, the Authority may 
take this information into account.  
Article 15 
Decision on the suit ability of a novel technology  EN 21  EN 1. Taking into account the opinion of the Authority, relevant provisions of Union law 
and other legitimate factors relevant to the matter under consideration , the 
Commission shall decide whether the novel technology  is a new suitable recycling 
technology  in accordance with Article 3(1)  or be included in an existent suitable 
recycling technology .  
Where the Commission considers a novel technology is a suitable recycling 
technology, it shall set out, as necessary, the specific r equirements applicable to that 
technology and decide whether recycling processes applying it shall be subject to 
authorisation and whether a recycling scheme shall be used to apply the technology.  
2. Where the Commission considers that recycling processes ap plying a technology 
shall be subject to authorisation, it shall set out provisions concerning  the operation 
of recycling installations notified in accordance with Article 10(2).   
3. A technology that was not considered suitable in accordance with paragraph 1 shall 
no longer be considered a novel technology. Developers may use that technology as 
a basis to start the development of another novel technology, provided it is 
substantially changed so as to address the concerns of the Authority and/or the 
Commission.  
Article 16 
Safeguard  clause concerning the placing on the market of recycled plastic materials and 
articles manufactured with a novel or suitable technology  
1. On the request of a Member State or on its own initiative the Commission may 
analyse whether there  are grounds  to change the conditions of the placing on the 
market of recycled plastic materials and articles manufactured with a specific 
recycling technology , or fully prevent th eir placing on the market , even i f that 
technology has been considered suita ble. 
2. For the purpose of th e analysis  referred to in paragraph 1 , the developer  of the 
technology , developers, manufacturers or providers  of recycling processes  or 
installations using  the technology  such as those referred to in Article 17(1) , recyclers , 
converters  and Member States shall provide the Commission with all the information 
they have  obtained on th e recycling technology.  Where necessary , the Commission 
may consult the Authority.  
3. The Commission may call upon the actors referred to in  paragraph 2  to carry out  a 
specific monitoring programme  or migration testing . The Commission  may specify 
deadlines before which those actors  shall provide the required information or reports.  
4. On basis of the outcome of its analysis , the Commission may:  
(a) lay down restrictions and specifications regarding the technology , as necessary;  
(b) consider the recycling technology as unsuitable . 
Chapter V  – Procedure for the authorisation  of individual 
recycling processes   
Article 17 
Application  for the authorisation of  individual  recycling processes  EN 22  EN 1. To obtain  authorisation of an individual recycling process,  the natural  person  or legal 
entity  that developed the decontamination process  of the recycling process, either 
exclusively for its own purposes as a recycler or for  the sale or licensing of recycling 
or decontamination installations  to recyclers , ‘the applicant’,  shall submit an 
application in accordance with paragraph 2.  
2. The applicant shall submit the application to the competent authority of a Member 
State accompanied by the following:  
(a) the name and address of the applicant;  
(b) a technical dossier containing the information specified  in paragraph 5; 
(c) a summary of the technical dossier . 
3. The competent authority referred to in paragraph (2) shall:  
(a) acknowledge receipt of the application in writing to the applicant within 14 
days of its receipt , stating the date of the receipt ; 
(b) inform the Authority without delay;   
(c) make the application and any supplementary information supplied by the 
applicant available to the Authority . 
4. The Authority shall without delay:  
(a) inform the Commission and the other Member States of the application and 
make the application and any supplementary information supplied by the 
applicant available to them;  
(b) make public  the application, relevant supporting information and any 
supplementary information supplied by the applicant, in accordance with 
Articles 19 and 20  of Regulation (EC) No 1935/2004, unless otherwise 
provided for in paragraph 6 of this Article . 
5. The technica l dossier shall contain the following information:   
(a) any information required in the detailed guidance published by the Authority  in 
accordance with  Article 20(2); 
(b) a description of the pre -processing carried out to produce plastic input suitable 
for being entered into the decontamination process  and of the specific quality 
control procedures applied during  collection  and pre -processing , including a 
detailed specification of the pre -processed plastic in put;  
(c) a description of any required post-processing of the recycled plastic  and of the 
intended use of the resulting plastic materials and articles  and of uses for which 
it would not be suitable , including relevant  instructions and  labelling to be  
provided  to convertors and to end -users of the recycled plastic  materials and 
articles ; 
(d) a simple block diagram of all unit operations used in the decontamination 
process , that provides a reference to the input, output and quality control 
procedures applied by each  operation;   
(e) a piping and instrumentation  diagram of the decontamination process in 
accordance with section 4. 4 of ISO 10628:2014 , showing only the 
instrumentation relevant for decontamination ;  EN 23  EN (f) a description of the quality control procedures applied at  each unit operation  of 
the decontamination process , including:  
(i) the values of monitored parameters  such as  operating  temperatures, 
pressures, flowrates and concentrations,  and acceptable ranges thereof ;  
(ii) laboratory analysis and its frequency ; if any,   
(iii) correction and record keeping procedures ; and 
(iv) any other information the applicant deems relevant to fully describe  its 
quality control procedures.  
6. Information provided in accordance with paragraph 5, points (e) and ( f), and 
equivalent information submitted in accordance with paragraph 5, point (a), may be 
kept confidential pursuant to Article 20(2) of Regulation (EC) No 1935/2004.  
Article 18 
Opinion of the Authority  
1. The Authority shall publish  an opinion within  a time limit  of six months from the  
receipt of a valid application as to whether the recycling  process is capable of 
applying the suitable recycling technology it uses so that plastic materials and 
articles manufactured with it meet Article 3 of Regulation (EU) No 1935/2004 . 
The Authority may extend the time limit  provided for in the first subparagraph  by a 
maximum period of a further six months. In such a case , it shall provide an 
explanation for the  extension  to the applicant, the Commission and the Member 
States.  
2. The Authority may, where appropriate, request the applicant to supplement the 
particulars accompanying the application within a specified time, whether in writing 
or by oral explanation . Where the Authority requests supplementary information, the 
time lim it laid down in paragraph 1 is suspended until that information has been 
provided.  
3. The Authority shall:  
(a) verify that the information and documents submitted by the applicant are in 
accordance with Article 17(5), in which case the application shall be regard ed 
as valid;  
(b) inform the applicant, the Commission and the Member States if the application 
is not valid.  
4. The opinion of the Authority shall include  the following information:  
(a) the identification and address of the applicant ; 
(b) the number of the  suitable recyc ling technology  the process uses;   
(c) a short description of the recycling  process  including  a short description of the 
required pre -processing and post -processing stages , a characterisation of the 
plastic input,  and conditions and limitations of use of the output ;  
(d) a process flow diagram of the decontamination process  that discerns the order 
of the distinct  unit operations  that the Authority has evaluated  together with a 
description  of each of these operations  and ho w any parameters critical to their 
operation are controlled;   EN 24  EN (e) a scientific  evaluation  of the decontamination efficiency in accordance with the 
guidance set out in Article 20(2) ; 
(f) a discussion and conclusion on whether the recycling process can manufacture 
recycled plastic materials and articles that meet the requirements of Article 3 of 
Regulation (EC) No 1935/2004 , including a reasoning  justifying  restrictions 
and specifications that should  in the opinion of the Authority  apply to the 
plastic input, the co nfiguration and operation of the decontamination process  
and the use of the recycled plastic and recycled plastic materials and articles ; 
(g) where appropriate, any recommendations concerning monitoring  of the 
compliance of the recycling process with the condi tions of the authorisation.  
Article 19 
Authorisation of an individual  recycling process   
1. Taking into account the opinion of the Authority, relevant provisions of Union law 
and other legitimate factors relevant to the matter under consideration , the 
Commiss ion shall consider  whether the individual recycling process complies with 
the conditions of use of the suitable technology it applies and produces recycled 
plastic that meets the requirements of Article 3 of Regulation (EC) No 1935/2004 . 
The Commission shall then  adopt a decision addressed to the applicant granting or 
refusing the authorisation of the recycling process.  Article 23(1) of Regulation (EC) 
No 1935/2004 and Article 5 of Regulation (EU) No 182/2011 of the European 
Parliament and of the Council10 shall apply.  
Where the decision is not in accordance with the opinion of the Authority, the 
Commission shall explain the reasons for its decision .  
2. A decision granting the authorisation shall include the following:  
(a) a recycling process authorisation numbe r (‘RAN’) ; 
(b) the name of the recycling  process;  
(c) the recycling technology , as listed in Annex I,  for which the process is 
authorised;  
(d) the name and address of the authorisation holder;  
(e) a reference to the opinion of the Authority on which the decision is based ; 
(f) any specific requirements for the operation of the decontamination process , 
pre-processing and post -processing  complementing or derogating from the 
general requirements set out in Articles 6, 7 and 8 , or Article 9 ; 
(g) any specific requirements concerning mon itoring and verification of the 
compliance of the recycling process with the conditions of the authorisation;  
(h) any conditions, specifications, and specific labelling requirements concerning 
the use of the plastic with recycled content originating from the p rocess;  
                                                 
10 Regulation (EU) No 182/2011 of the European Parli ament and of the Council of 16 February 2011 
laying down the rules and general principles concerning mechanisms for control by Member States of 
the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).  EN 25  EN Article 20 
Guidelines published by the Authority  
1. The Authority shall publish detailed guidelines, following the agreement with the 
Commission, concerning the preparation and the submission of the application, 
taking into account standard data formats, where they exist in accordance with 
Article 39(f) of Regulation (EC) No 178/2002, which shall apply mutatis mutandis . 
2. For each suitable technology for which the authorisation of individual recycling 
processes is required, the Authority shall publish scientific guidelines describing the 
evaluation  criteria an d the scientific evaluation  approach it will use  to evaluate  the 
decontamination capability of those recycling processes. These guidelines shall 
specify the information required to be included in an application dossier for the 
authorisation of a recycling process applying that specific technology.  
Article 21 
General obligations arising from the authorisation of a recycling process  
1. The granting of an authorisation of a recycling process shall not affect the civil and 
criminal  liability of any business operator in respect of the authorised recycling 
process, a recycling installation applying the process, recycled plastic  and recycled 
plastic  materials and articles obtained with such a recycling installation,  and the food 
that i s in contact with such material or article .  
2. The authorisation holder or a ny recycler shall immediately inform the Commission 
of any new scientific or technical information  which  might affect the evaluation  on 
which the authorisation is based.  
3. An authorisa tion holder may permit third parties to  operat e a decontamination 
installation  under its licence  as recyclers . The authorisation holder shall ensure that 
those recyclers  receive all necessary information , instructions  and support  required to 
ensure  that the operation  of the installation  and the resulting recycled plastic 
complies with this Regulation.  
4. The authorisation holder shall communicate without delay to the competent authority 
in the territory where it is established  and to the Commission, any cha nges to its 
points of contact, its trade and company names, and other information relevant to the 
authorisation of a recycling process.  
5. The authorisation holder shall immediately inform the competent authority in the 
territory where it is established and  the Commission of a situation under which it can 
or will no longer assume its responsibilities as authorisation holder  in accordance 
with this Article . The authorisation holder shall provide all necessary information to 
allow the Commission to determine wh ether the authorisation of a recycling process 
should be modified or revoked.   
Article 22 
Request for the modification of an authorisation by the authorisation holder  
1. The authorisation holder  may apply for a modification  of the authoris ation of a 
recyclin g process . 
2. The modification  referred to in paragraph 1 shall be subject to the procedure laid 
down in Article s 17 to 20 , unless otherwise provided for in  this Article .  EN 26  EN 3. The application referred to in paragraph 1 shall be accompanied by the following:  
(a) the reference to the original application;  
(b) a technical dossier containing the information required in Article 17(5) in so -
far as that information is different from the information included in the 
technical dossier already submitted during the original applicat ion in 
accordance with Article 17(5) and Article 18(2);  
(c) a new complete summary of the technical dossier in a standardised form;  
(d) at least one complete compliance monitoring summary sheet related to a 
decontamination installation operating the authorised process as submitted to a 
competent authority in accordance with Article 26, and an updated version 
which includes all changes, if any, expected to be forthcoming from the 
requested change.  
4. In case the modification concerns a transfer of the authorisation of a recycling 
process to a third party, the authorisation holder shall notify the Commission before 
the transfer, indicating the name, address and contact information of that third party. 
At the time of the transfer, it shall provide the notified authoris ation, the technical 
dossier and all documents included therein to the third party. That third party shall 
contact the Commission without delay by a registered letter, stating that it accepts the 
transfer, has received all documents and accepts to meet all  the obligations arising 
from this Regulation and the authorisation.  
Article 23 
Modification, suspension and revocation of the authorisation of a recycling process on the 
initiative of the competent authorities, the Authority or the Commission   
1. On its own  initiative or following a request from a Member State or the Commission, 
the Authority shall evaluate whether the opinion , authorisation  of a recycling process 
rand/or the recycling process  is still in accordance with this Regulation , in 
accordance with t he procedure laid down in Article  18, which shall apply mutatis 
mutandis . The Authority may, where necessary, consult the authorisation holder.  
2. Prior to submitting a request in accordance with paragraph 1, the Commission or a 
Member State shall  consult the Authority on whether a new evaluation  or the 
authorised process  is necessary based on the particulars of the  request.  The Authority  
shall provide the Commission and, where appropriate, the requesting Member State 
with its views within a period  of 20 working days . In particular where the Authority 
considers that an evaluation is not necessary, it shall provide a written explanation to 
the Commission and , if applicable, to the requesting Member State.  
3. Based on the  opinion of the Authority  publis hed in accordance with Article 1 8(1), 
the Commission may  decide to  amend  or revoke  the authorisation . Where needed, 
the recycling process  or the operation of specific decontamination installations  may 
be suspended until these amendments  are implemented in the recycling installations 
based on the process.  The status of the registration in the Union register shall change 
accordingly.  EN 27  EN Chapter V I – Registration  of information necessary for controls   
Article 24 
Union register  of technologies,  recyclers, recycling processes , recycling schemes,  and 
decontamination installation s 
1. A public  Union register of novel technologies, recyclers, recycling  processes , 
recycling schemes  and decontamination installations  (‘the Register’)  is established.   
2. The Register shall contain:  
(a) the names of novel technologies and the names and addresses of the developers  
and the development status ; 
(b) the name s of authorised recycling processes and the name s and address es of the 
authorisation holder s; 
(c) the authorisation status  of each registered  recycling processes, including 
whether its authorisation is suspended, revoked, or subject to transitional 
provisions, and the latest date of change of the authorisation status;  
(d) the company name and the address of  the head office of  recyclers operating a 
decontamination  installation ; 
(e) the addresses of recycling facilities ; 
(f) decontamination installations, the technology they use, the facility at which 
they are located, and the authorised process it applies, if any ;  
(g) the registration status of decontamination installation s, including whether the 
installation is newly registered, being established, active or suspended, and the 
latest date of change of that status;  
(h) names of recycling schemes , and names and addresses of the entity managin g 
the scheme;  
(i) the marking s required in accordance with Article 9(5); 
(j) where relevant, the information required in accordance with Article 19(2); 
(k) cross -references between technologies, processes, schemes, recyclers, and 
installations and schemes;  
3. The Register shall maintain the above information in tables. It shall assign the 
following entities with unique numbers, as follows:  
– authorised recycling processes are assigned a recycling authorisation number 
(‘RAN’);  
– recyclers are assigned a recycler ope rator number (‘RON’) ; 
– recycling installations are assigned a recycling installation number (‘RIN’);  
– recycling schemes are assigned a recycling scheme number (‘RSN’);  
– recycling facilities are assigned a recycling facility number (‘RFN’);  
– novel re cycling tec hnologies are assigned a novel technology number (‘NTN’ ).  
4. The Register shall be made available to the public.  EN 28  EN Article 25 
Registration  of recyclers  and decontamination  installation s 
1. Recyclers shall comply with the following administrative requirements : 
(a) at least 15 working days prior to the start  date of the production of recycled 
plastic in  a decontamination installation , the recycler shall notify the 
installation  and either the address of the facility  where it is located  or the 
facility number to the Commi ssion and to the competent authority in the 
territory where the installation is located , as well as its  own registration number 
if the recycler is already registered , the recycling authorisation number if it 
applies an authorised process, and the number of  the suitable or novel 
technology, as applicable ; 
(b) upon notification of its first decontamination installation  in accordance with 
point (a), the recycler shall notify its  company  name , contact persons,  and the 
address of its head office to the Commission and to the competent authority in 
the territory where the head office  is located;  
(c) the recycler shall have a completed compliance monitoring summary sheet  in 
accordance with Annex II  available at the recyclin g installation and have 
submitted it to the competent authorit y in accordance with Article 26;  
2. Following the notification in accordance with paragraph 1 , point (a), the installation 
shall be registered in the Union r egister  and the registration status  in accordance with 
paragraph 2, point ( g), of Article 24  shall be ‘ newly registered ’.  
3. The notification referred to in paragraph 1 , point (a), shall include a reference to the 
authorised recycling process on which basis the decontamination  installation  is 
operated , if any,  to the suitable or novel technology that it applies,  and, if applicable, 
to the recycling scheme  it is subject to .  
4. The recycler shall notify any changes to the information for registration provided in 
accordance with this Article to the Commission and the competent aut hority in the 
territory where the decontamination installation  or the recycler, as relevant, is 
located.  
Article 26 
 Compliance monitoring summary sheet and verification of the operation of a 
decontamination installation   
1. Recyclers shall draw up the compliance monitoring summary sheet for each 
decontamination installation under their control using the template provided in 
Annex II , or in case of a novel technology, the template provided by the developer, if 
different . 
The compliance monitoring summary sheet shall provide a summary clearly 
describ ing the recycling installation, its operation, the relevant procedures and 
documents  in a way demonstrat ing compliance with this Regulation.  
Recyclers shall take into account th e applicable guidelines published by the 
Commission  concerning the compliance monitoring summary sheet , as well as the 
particular situation at the concerned recycling facility where the installation is 
located . EN 29  EN 2. Recycler s shall submit the compliance monitor ing summary sheet to the competent 
authority in the territory where the decontamination installation is located within one 
month from the start date of the production of recycled plastic with that installation . 
The status of the registration in accordance with Article 2 4(2), point (g), shall change 
to ‘being established’.  
3. The competent authority shall verify whether the information provided in the 
compliance monitoring summary sheet  complies with this Regulation  and perform a 
control of the recycling installation  to this purpose  in accordance with Article 27. 
When compliance cannot be established, the competent authority shall request the 
recycler to update the information in the compliance monitoring summary sheet, the 
operation of the recycling  insta llation, or both, as appropriate.  
When compliance is established, the competent authorit y shall inform the 
Commission thereof. The status of the registration in accordance  with Article 24(2), 
point (f), shall change to ‘active’.  
4. If the competent authority does not inform the Commission that compliance is 
established  within one year from the  start date of the production of recycled plastic in 
the decontamination installation, the status of the registration in accordance with 
Article 24(2), point (g), shall be change d to ‘suspended’.  
If the status of a decontamination installation is ‘suspended ’ for one year, the entry 
concerning the installation shall be removed from the Register.  
Chapter VII – Official controls  
Article 27 
Official co ntrols of recycling installations  
Official controls of recycling installations and recyclers shall include in particular audits in 
accordance with Article 14 , point (i), of Regulation (EU) 2017/625 .  
These audits shall be complemented by : 
(a) an assessment of procedures o n go od manufacturing practices  in accordance with 
Article 14 , point (d), of Regulation  (EU) 2017/625 ;  
(b) an examination  in accordance with Article 14, points (a) and (e), of Regulation (EU) 
2017/625, of the compliance monitoring summary sheet established in accordance 
with Article 26, and , on the basis of that summary sheet, of the controls that 
operators have put in place and of documents  and records referred to in that summary 
sheet .  
Article 28 
Non-compliance of recycled plastic  
1. A competent authority shall establish that a batch of recycled plastic is non-
compliant if it finds during official controls  that: 
(a) a recycler has placed it on the market without appropriate documentation or 
labelling;  
(b) a recycler cannot demonstrate on the basis of its records and other 
documentation that it was manufactured in accordance with this Regulation;  EN 30  EN (c) the batch was manufactured at a recycling installation that was not operated in 
accordance with this Regulation during a period established in accorda nce with 
paragraph 3 .  
2. When one or more batches are established as non -compliant, the competent authority 
shall take appropriate action in accordance with Article 13 8 of Regulation (EU) 
2017/625.  
3. The operation of a recycling installation shall be considere d not in accordance with 
this Regulation when the competent authority establishes that:  
(a) two batches are non -compliant on the basis of paragraph 1 , point (b), due to 
deficiencies in the operation of the recycling installation , and that these 
deficiencies du e to their nature are likely to affect other batches;  
(b) the manufacturing of recycled plastic at the recycling installation is not in 
accordance with the general requirements laid down in this Regulation and, 
where relevant, the specific requirements applic able to the suitable technology  
applied and the recycling process used, or with the requirements applicable to 
the novel technology  applied ; 
(c) where relevant, it could not verify the compliance monitoring summary sheet 
in accordance with Article 24(3) within  one year from the start date of the 
production of recycled plastic in the decontamination installation.  
When the competent authority establishes that the operation of a recycling 
installation is not in accordance with this Regulation, the competent authority shall 
establish the period during which it was the case , taking account of any available 
evidence or the lack thereof . In case of the first subparagraph, point (c), this shall be 
the entire  period of operation of the recycling installation.  
4. In case the competent authority considers changes are necessary to the recycling 
installation, the use of a decontamination installation part thereof may be suspended. 
If this suspension is expected to be  longer than two months, the suspension shall be 
indicated in the Union Register in accordance with Article 2 4(2)(f) . 
Chapter VIII  – Compliance documentation  
Article 29 
Specific requirements for d eclaration s of compliance  for recyclers and converters  
1. Recyclers shall provide  a declaration of compliance in accordance with the 
description and templ ate set out in Part A of Annex III. 
2. The declaration of compliance shall include instructions to converters that are  
sufficient for ensuring that converters can further process the recycled plastic into 
recycled plastic materials and articles that are in compliance with Article 3 of 
Regulation (EC) 1935/2004 . These instructions shall be based on the specifications, 
requirements or restrictions set out for the recycling technolog y applied and , where 
applicable,  the recycling process  used. 
3. Converters shall provide a declaration of compliance  in accordance with the 
description and the template set out in Part B of Annex I II; EN 31  EN Chapter IX – Final provisions  
Article 30 
Repeal  
Regulation (EU) No 282/2008 is repealed.  
Article 31 
Transitional provisions  
1. Recycled plastic materials and articles obtained by means of a recycling process 
based on a recycling technolog y for which this Regulation requires  the individual 
authorisat ion of  recycling processes and for which a valid application has been 
submitted to the competent authority in accordance with Article 5 of Regulation (EC) 
No 282/2008, or for which an application is submitted in accordance with Article s 
17(1) or 22(1)  of this Regulation  at the latest  on … [enter date 6 months after entry 
into force of this Regulation ], may be placed on the market until  the applicant 
withdraws its application, or until the Commission adopts a decision granting or 
refusing authorisation of the recycling process pursuant to Article 1 9(1). 
2. Recycled plastic materials and articles obtained by means of recycling processes  
based o n a recycling technology that is not considered suitable  by this Regulation  
may continue to be placed on the market  only until … [6 months after entry into 
force of this Regulation ], unless manufactured with a  recycling installation that is 
operated for the purpose of development of a novel technology in accordance with 
Chapter IV .  
3. Applications submitted in accordance with Regulation (EC) No 282/2008 for the 
authorisation of recycling processes based on a recycling technology that is not 
considered suitable by this Regulation  and for product loops which are in a closed 
and controlled chain , shall  be deemed terminated.  
4. For the purposes of this Regulation, the start date of a decontamination  installation 
that was used to produce recycled plastic before … [enter date of  entry into force of 
this Regulation ] shall be … [enter date 1 month after  entry into force of this 
Regulation ].  
Article 30 
Entry into force  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
Article 6(3)(b) shall apply from … [enter date 24 months after entry into force of this 
Regulation ].  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  EN 32  EN Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN