EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2022/1435 
(POOL/E2/2022/1435/1435 -EN.docx)  
Feedback  
[…](2024) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come 
into contact with food and amending Regulation (EC) No 2023/2006 on good 
manufacturing practice for materials and articles intended to come into contact with 
food as reg ards recycled plastic and other matters related to quality control and 
manufacturing of plastic materials and articles intended to come into contact with food.  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.   
Ref. Ares(2024)1923851 - 13/03/2024
 
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come 
into contact with food and amending Regulation (EC) No 2023/2006 on good 
manufacturing practice for materials and articles intended to come into contact with 
food as regards recycled plastic and other matters related to quality control and 
manufacturing of plastic materials and articles intended to come into c ontact with food.  
(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 mat erials 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), points 
(a), (c), (d), (e), (h) , (i) and (j)  thereof,  
Whereas:   
(1) Commission Regulation (EU) No 10/20112 lays down specific rules as regards plastic 
materials and articles intended to come into contact with foods. In particular Chapter II 
thereof sets out compositional requirements for plastic materials and articles that are to 
ensure that final plastic mate rials intended to come into contact with food are 
sufficiently safe, in order to meet the requirements of Article 3 of Regulation (EC) No 
1935/2004.  
(2) In its Chapter II, Regulation (EU) No 10/2011 sets out the compositional requirements 
for substances that c an be used to manufacture plastic materials and articles, 
specifically referring to ‘plastic layers ’ in plastic materials and articles . However, in 
many cases, plastic materials and articles do not conform to a layer structure but 
consist of a single homog enous material with a complex shape, leading to ambiguity. 
Therefore, Chapter II of Regulation (EU) No 10/2011 should refer to plastic materials 
and articles instead of to plastic layers. Since the new wording could raise doubts as to 
whether the compositional requirements laid down in Regulation (EU) No 10/2011 
apply to non -plastic layers  of plastic materials and articles , such as adhesives, printing 
inks, varnishes and coatings , it should be clarified that those layers do not fall under 
the scope of Regulation (EU) No 10/2011 . However, the reference to ‘plastic layers’ in 
Chapter III of Regulation (EU) No 10/2011 should be maintained since it allows, in 
relation to multi -layer materials and articles , for some of the provisions of that Chapter 
to apply to some layers and not to others . In particular , the plastic layer which is 
separated from the food by a functional barrier  in multi -layer materials may be 
 
1 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2024 on 
materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 
89/109/EEC ( OJ L 338, 13.11.2004, p. 4 , ELI: http://data.europa.eu/eli/reg/2004/1935/oj ). 
2 Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended 
to come into contact with food (OJ L 12, 15.1.2011, p. 1 , ELI: http://data.europa.eu/eli/reg/2011/10/oj ).  
EN 2  EN manufactured with substances not listed in the Union list.  It should also remain 
possible t o verify compliance with the migration limits  in accordance with Regulation 
(EU) 10/2011 o f materials and articles falling within its scope  that are held together by 
adhesives or that are printed and/or covered by a coating .  
(3) According to the definition in  Regulation (EU) No 10/2011 plastics consists of 
polymers to which additives or other substance may have been added. Th at Regulation 
authorises additives and starting substances separately. In most cases, additives do not 
chemically react with the polymers. However certain particles , fibres, or other solid 
materials that are added to the plastic to achieve a physical effect are coupled to the  
polymer by means of a chemical bond to ensure the overall integrity of the material. 
Given the definitions of plastics, additives, polymers and starting substances  in 
Regulation  (EU) No 10/2011 , this chemical bond may create uncertainty over whether 
such a solid material is to be regarded as an additive or as a starting substance. 
Therefore, also uncertainty ensues over whether that solid material should be 
authorised as an additive or a starting substance. However, it should be considere d that 
a solid material functions as an additive and not as a starting substance where it 
consist s of many individual molecules or substances of which only a small number 
located at the surface of that material becomes bonded to the polymer, it does not 
participate in the polymerisation process  and the physical effect achieved by that solid 
material is the reason for adding it. Therefore , it is appropriate to clarify the definition 
of additives by adding that solid materials that are chemically bonded to th e polymer 
to which they are added should be considered additives . 
(4) Biocidal products containing active substances may be incorporated into various 
materials, including plastics, which may enter into contact with food. Regulation (EU) 
No 10/2011 provides tha t, in order to be used in the manufacturing of plastic food 
contact materials and articles, such substances must have been authorised by the 
Commission or, pending such authorisation, be included in the provisional list referred 
to in Article 7 of that Reg ulation. However, Regulation (EU) No 528/2012 of the 
European Parliament and of the Council3 lays down rules for the authorisation of the 
types of biocidal products listed in its Annex V, including those intended to be 
incorporated into food contact mater ials, and the placing on the market of treated 
articles containing such products, such as food contact materials. In accordance with 
that Regulation, a biocidal product containing an active substance may be incorporated 
into food contact materials provided  that both the substance and the product containing 
that substance are approved and authorised respectively under Regulation (EU) No 
528/2012 for that use. Therefore, Regulation (EU) No 10/2011 should refer to 
Regulation (EU) No 528/2012 as to the active s ubstances and biocidal products that 
may be used in plastic food contact materials.  
(5) During the manufacture of plastic materials and articles, it is not possible to fully 
avoid the production of off -cuts, scraps and other by -products. Allowing the re -
proces sing of these by -products for manufacturing plastic materials and articles, can 
contribute to reduction of the occurrence of unusable manufacturing materials. By-
products are not considered waste if they can be used directly in the manufacturing of 
 
3 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 
concerning the making available on the market and use of biocidal p roducts (OJ L 167, 27.6.2012, p. 1, 
ELI: http://data.europa.eu/eli/reg/2012/528/oj).   
EN 3  EN plastic s without any further processing.  Therefore, Regul ation (EU) No 2022/16164 
does not apply to t hese by -products and  rules should be laid down to ensure the safety 
of the ir use.  
(6) In its Note for Guidance for the preparation of an application for the safety assessment 
of a substance to be used in plastic food contact materials5, the European Food Safety 
Authority (‘the Authority’) considers that in case a substance used in the 
manuf acturing of a food contact material or article exceeds a migration level of 0.05 
mg/kg into food, applicants are required to submit genotoxicity tests and additional 
toxicity tests to assess the potential adverse effects of chemical exposure on human 
healt h. On the other hand, no toxicity testing of the migrating substance would be 
needed if consumer exposure is below the threshold level of 0.00015 mg substance/kg 
food. It is appropriate to set out the purity specification for substances used in the 
manufac turing of food contact materials or articles in relation to these thresholds. The 
individual toxicological assessment for genotoxicity of a substance may be substituted 
with a group assessment of genotoxicity  under specific requirements . This is also 
possi ble if the substances are obtained as a mixture representative for migration into 
food. However, f or assessing the genotoxicity of mixtures, specific considerations are 
needed. The Authority  developed a statement clarifying how to perform genotoxicity 
assessment of chemical mixtures6. To evaluate expected consumer exposure to the 
substances used in the manufacturing of food contact materials or articles, it is 
appropriate to assume, for safety purposes, that substances could potentially migrate 
up to 100% into the food with which the plastic is in contact. However, in situations 
where high migration levels are clearly not expected, it is appropriate to reduce the 
assumed level of 100% migration into food of the substances in plastics.  
(7) Substances listed in table 1 of Annex 1 to Regulation (EU) No 10/2011 are denoted by 
FCM substance number, reference number and their chemical name and, where 
available, by their respective Chemical Abstracts Service (CAS) registry number. 
However, experience shows that there may remain doubts as to the precise identity of 
the substances authorised. Since the application for an authorisation of a substance is 
to contain information on the identity of the substance, such as the chemical name, 
chemical composition, level of purit y, molecular weight and spectroscopic data , and 
this information is verified by the Authority , the identity of the substances listed in 
table 1 of Annex I to Regulation (EU) No 10/2011 should be considered in relation to 
the identity of the substance speci fied in the opinion of the Authority. Therefore, i f a 
level of doubt over the designation of a substance remain s, the Authority should be 
consulted.  
(8) Regulation (EU) 2022/1616 on recycled plastic materials and articles aims, amongst 
others, at ensuring tha t incidental contamination is removed during the manufacture of 
recycled plastic materials intended to come into contact with food to an extent that the 
requirements of Article 3 of Regulation (EC) No 1935/2004 are met. Since Regulation 
(EU) 2022/1616 lays down that the requirements of Regulation (EU) No 10/2011 
 
4 Commission Regulation (EU) 2022/1616 of 15 September 2022 on recycled plastic materials and 
articles intended to come into contact with foods, and repealing Regulation ( EC) No 282/2008 (OJ L 
243, 20.9.2022, p. 3, ELI: http://data.europa.eu/eli/reg/2022/1616/oj).  
5 EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing 
Aids), 2008. Note for Guidance for the preparation of an application f or the safety assessment of a 
substance to be used in plastic Food Contact Materials. EFSA Journal 2008;6(7):21r, 41 pp.; 
https://doi.org/10.2903/j.efsa.2008.21r.  
6 EFSA Scientific Committee, 2018. Genotoxicity assessment of chemical mixtures. EFSA Journal 
2019;17(1):5519, 11 pp.  https://doi.org/10.2903/j.efsa.2019.5519.   
EN 4  EN apply to recycled plastic materials and articles , it is appropriate to include a reference 
to Regulation (EU) 2022/1616  in Regulation (EU) No 10/2011 .  
(9) Experience shows , that in order to ensure a high level of protection of human health, it 
should be required that substances  used in the manufacture of plastic materials and 
articles , are of high purity and this notion should be defined . However, specific rules 
need to be l aid down as regards the purity of substances of natural origin. While a  
well-defined substance with a known chemical composition may be obtained  if the 
natural material can be extracted and further purified , when a substance originates 
from a portion of an  organism that has not had any of its components removed , or 
when the natural material has only been slightly refined,  it has  many different 
constituents, some of which may be unknown , and its com position can be variable or 
difficult to predict . Therefore , as regards substances of natural origin,  it is appropriate 
to lay down the required level of purity in relation to the extent to which the chemical 
composition of those substance s can be defined .  
(10) Regulation (EU) No 10/2011 does not impose rest rictions on  the source  of substances 
that can be  used in the manufacture of plastic materials and articles and, t herefore , 
such substances may be manufactured  from waste.  However, substances manufactured  
from waste are likely to contain incidental contaminatio n. To ensure a high level of 
protection of human health, i t is appropriate to require that substances  manufactured  
from waste  are also of a high degree of purity . 
(11) Supporting documents should be kept available for the enforcement authorities at each 
stage of the manufacturing process. This documentation should also demonstrate 
compliance with the rules regarding the high level of purity introduced by this 
Regulation.   
(12) Since Regulation (EU) No 10/2011  sets out specifications for substances intended for 
the manufacturing of plastic materials and articles  and for products from intermediate 
stages  of that manufacturing , in order to ensure compliance with Regulation (EU) N o 
10/2011, Member States are to put in place effective control measures, including not 
only the sampling of plastic materials and articles, but also of those substances and 
products from intermediate stages . Therefore, it is appropriate to require that 
manufacturers facilitate inspections by ensuring that inspectors can take samples at 
each stage of the manufacturing process.  
(13) Since Directive (EU) 2019/9047 discourages the single use of plastic food contact 
materials due to  their environmental impact, increasingly plastic materials and articles 
in contact with food are designed for repeated use. However, repeated use may lead to 
unacceptable deteriorat ion of the plastic material or article , leading to an incr ease of 
constituents into food that may endanger human health.  Such deterioration of plastic 
materials and articles is indicated  by various signs , for example, by surface cracks 
(crazes), blisters, delamination, shrinkage or other deformation, and yellowin g or other 
permanent discoloration or loss of gloss or transparency.  However, u sage related 
changes such as tainting from colorants from foods, including from lycopene and 
curcumin, or mechanical damage such as scratches or breakage , is not in principle a 
deterioration of the material or article, unless so extensive that it may result in higher 
migration of the constituents of the material  or article . To prevent the use of 
unacceptable deteriorated plastic materials and articles, the manufacturer or other 
 
7 Directive (EU) 2019/904 of the European Parliament and of the Council of 5 June 2019 on the 
reduction of the impact of certain plastic products on the environment (OJ L155, 12.6.2 019, p.  1) aims 
to prevent and reduce the impact of certain single -use plastic products on the environment.   
EN 5  EN operator responsible for placing on the market of the plastic material or article should 
provide users of plastic food contact materials and articles with information about how 
to slow down deterioration  and the changes that indicate the deterioration by a 
repeated use .  
(14) Article 15 of Regulation (EC) No 1935/2004 provides that materials and articles which 
are not yet in contact with food when placed on the market, if necessary, are to be 
accompanied by special instructions to be observ ed for safe and appropriate use. 
Where Regulation (EC) No 10/2011 sets out restrictions to the use of plastic materials 
and articles, such special instructions should always be provided to consumers.  
(15) Article 14(4) of Regulation (EU) No 10/2011 sets out th at the rules on migration limits 
laid down in Articles 11 and 12 do not apply to plastic layers in multi -material multi -
layer materials and articles. Since final plastic multi -material multi -layer material s or 
article s, in which the layer in direct contact  with food is a plastic layer, may raise the 
same potential health risks as plastic material or articles , they  should comply with the 
provisions concerning migration set out in Regulation (EU) No 10/2011.  
(16) The real surface -to-volume ratio of the final arti cle serves as the basis for the rules on 
migration testing laid down in Regulation (EU) No 10/201 1. To simplify migration 
testing , several exceptions to these rules have been established . However, t o further 
increase food safe ty, it is appropriate to remov e the exception for containers and other 
articles containing less than 500 mil lilitres or grams , since experience shows that t his 
exception often leads to an underestimation of the real migration of substances  into 
food. 
(17) Point 07.04 of Table 2 of Annex III to Regulation (EU) No 10/2011 assigns food 
simulants to categories of cheese. However, the present assignments , in particular 
categories 07.04.B and 07.04.C , do not correspond to the common interpretation and 
usage of ‘n atural cheese’ and ‘processed cheese’. More concretely,  melting cheese is 
usually considered as a processed cheese, while cheeses similar to cottage cheese are 
commonly considered unprocessed natural cheeses. The present assignments also do 
not follow the terminology used in the ‘FoodEx2 classification ’ established  by the 
Authority8, in particular regarding unripened (fresh) and ripened cheese. Therefore, it 
is appropriate to amend  the respective categories in order to classify in a better manner  
natural a nd processed cheeses and ripened and unripened cheese , while setting out 
simulant assignments appropriate for these new categories of cheese on the basis of 
the existing assignments.  
(18) In order to ensure safety, business operators need to receive all informa tion relevant 
for the safety of the plastic materials and articles they manufacture or  use. However, 
Regulation (EU) No 10/2011 only requires that the written declaration of compliance 
contains information on the substances used or products of degradation thereof for 
which restrictions and/or specifications are set out in Annex I and II to that 
Regulation. Also , no information is required on the lifespan of a plastic article or 
material . Nevertheless, usage may result in a higher migration of the constituen ts of 
the material or article. To further increase safety , it is appropriate to require that the 
declaration of compliance contains information also on other substances , impurities  
and products present in the materials and articles  or intermediate material  and the 
maximum lifespan of the material or article.   
 
8 European Food  Safety Authority,  2015. The food classification and description system FoodEx2 
(revision 2). EFSA supporting publication 2015: EN -804. 90pp; 
https://doi.org/10.2903/sp.efsa.2015.EN -804.   
EN 6  EN (19) The current rules as regards the written declaration of compliance do not require 
specify ing whether the plastic material has been manufactured with substances 
manufactured  from waste material , despite  the fact that  such substances may contain 
contaminants derived from  wasted plastic materials and articles that could endanger 
human health. It is therefore necessary to amend the provisions for the declaration of 
compliance , so that the manufacturer of th e final plastic article gets adequate 
information that would enable it to ensure compliance  with the requirement la id down 
in Article 3 (1) of Regulation of Regulation (EC) No 1935/2004 that plastic materials 
and articles are not to endanger human health .  
(20) To achieve results that are comparable, l aboratories  need to  conduct compliance 
testing under standardised test conditions . In addition, analysis of the test result s need s 
to be carried out consistently. It is therefore appropriate to further specify the rules on 
the verification of compliance testing in Annex V to Regulation (EU) No 10/2011 .  
(21) Regulation (EU) 2022/1616 lays down rules regarding quality assurance systems for 
collection, preprocessing, decon tamination and recycling of plastic waste material  
were  introduced by  and this Regulation lays down rules for the reprocessing of plastic 
by-products of plastic manufacturing . To further increase food safety, detailed rules on 
good manufacturing practices should be laid down in Regulation (EC) No 2023/2006 
as regards reprocessing  and recycling.   
(22) Plastic by -products intended for re -processing might be re -processed at a 
manufacturing location other than the one from which they originally came. However, 
if it is not clear for what purpose these by -products would be suitable, or if they are 
contaminated during transport from the production facility from which they originate, 
their reprocessing could pose risks. Therefore, in order to prevent any use of plastic 
by-products for purposes for which they are not suitable and contamination of plastic 
by-products from the point where they are produced until their point of reprocessing, 
rules should be laid down in Commission Regulation (EC) No 2023/20069. In 
addition, when such by -products are placed on the market, the declaration of 
compliance referred to in Article 15 of Regulation (EU) No 10/2011 shall provide the 
information required for their reprocessing, in particular as regards their suitability for 
particular u ses. 
(23) In order to allow operators to adapt to the changes  provided for in this Regulation  and 
subject to Articles 89 to 94 of Regulation (EU) No 528/2012, where relevant , it is 
appropriate to provide that plastic materials and articles complying with Regula tion 
(EU) No 10/2011, as applicable before the date of the entry into force of this 
Regulation, are allowed to be first placed on the market for a period of 18 months after 
the entry into force of this Regulation and remain on the market until the exhausti on of 
stocks. However, the production of final plastic materials and articles typically 
involves the supply of several products and substances from intermediate 
manufacturing stages by other operators. For the sake of consumer safety, the 
transition to ful l compliance with this Regulation should be achieved as efficiently as 
possible, and with minimum delay. Therefore, operators placing on the market , as of 
nine months before expiry of the 18 -months transition period , intermediate products 
and substances th at do not yet comply with this Regulation , should be required to 
 
9 Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to 
come into contact with food (OJ L 384, 29.12.2006, p. 75, ELI: 
http://data.europa.eu/eli/reg/2012/528/oj ). 
  
EN 7  EN inform the users of th ose products that they cannot be used to manufacture plastic 
materials and articles to be placed on the market after the transition period expires.   
(24) The measures provide d for in this Regulation are in accordance with the opinion of the  
Standing  Committee  on Plants, Animals, Food and Feed.  
HAS ADOPTED THIS REGULATION:  
Article 1  
Amendments to Regulation (EU) No 10/2011  
(1) Article 2, paragraph 3 is replaced by the following:  
‘3 This Regulation shall be without prejudice to the U nion or national provisions 
applicable to printing inks, adhesives or coating on substances that may be 
used in the manufacture of adhesives, coatings and printing inks and applied on 
or inco rporated in plastic materials and articles, if that use complies with 
Article 3 of Regulation (EC) No 1935/2004.’  
(2) Article 3 is amended as follows:  
(1) Point (7) is replaced by the following:  
‘(7)  ‘additive’ means a substance or material which is int entionally added to 
the plastic to achieve a physical or chemical effect  during processing of 
the plastic or in the final material or article  and it is intended to be 
present in the final material or article , includ ing substances or materials  
in a solid st ate that become bonded to the polymer that constitute the 
plastic .’ 
(2) The following point is added:  
‘(20)  ‘reprocessing of plastic’ means remelt ing, mix ing, react ing or otherwise 
combin ing plastic materials resulting as a by -product from an 
intermediate or final manufacturing stage to use them again in the 
manufacture of plastic materials and articles  alone or combined with 
material originating from earlier manufacturing stages .’ 
(3) A new Article 3a is added:  
‘Article 3a   
High degree  of purity  
A substance used in the manufacture of plastic materials and articles shall be 
considered as having a high degree of purity where all of its constituents form part of 
its identity, and it otherwise  contain s only a minor amount of  contam inants and non -
intentionally added substances that fulfil one of the following conditions : 
(i) they comply with the specifications or restrictions specified in the authorisation 
of the substance in table 1 of Annex I, if any;  
(ii) they have been subject t o a risk assessment in accordance with Article 19 and 
considered compliant;  
(iii) they have been subject to a n individual toxicological assessment which 
concludes that genotoxicity is ruled out, in accordance with the relevant 
guidance adopted by the Auth ority , and they are present at a level in the plastic 
material or article that , assuming their full migration into food,  cannot give rise  
EN 8  EN to an individual migration of any of them resulting in their presence in food 
exceeding  0.05 mg/kg;  
(iv) they are unk nown or have not been subject to an assessment specified in points 
(ii) or (iii), but are present at a level in the plastic material or article that , 
assuming their full migration into food,  cannot give rise to individual migration 
into food of any of them resulting in their presence in food exceeding 0.00015 
mg/kg.  
For the purpose of point (iii) , the individual assessment of genotoxicity may be 
substituted with a group assessment of genotoxi city, if the assessed substances are 
chemically related and belong to the same or similar functional groups that could 
give rise to toxicity, or if the substances are obtained as a mixture representative for 
migration into food and th is mixture is assessed  through appropriate methods.   
By derogation from point s (iii) and (iv) , 10% migration into food may be assumed 
where the substance is only intended for the manufacture of plastic  materials and 
articles used to pack:  
– dry unpeeled fruit or vegetables that m ust be peeled or washed,  
– other dry non -fatty foods , if the packaging is in contact with less than 10% of 
the food surface and is open to the atmosphere, or,  
– foods packed in sealed metal or glass packaging. ’ 
(4) In Article 4, the following  paragraph is add ed: 
‘(f) comply with Commission Regulation (EU) 2022 /1616 * if they fall within the 
scope of that Regulation .’ 
*  Commission Regulation (EU) 2022/1616 of 15 September 2022 on recycled plastic materials 
and articles intended to come into contact with foods, and repealing Regulation (EC) No 
282/2008 (OJ L 243, 20.9.2022, p. 3, ELI: http://data.europa.eu/eli/reg/2022/1616/oj) . 
(5) In Article 5, paragraph 1  is replaced by the following:  
‘1. Only the substances included in the Union list of authorised subs tances 
(hereinafter referred to as the Union list) set out in Annex I may be 
intentionally used in the manufacture of plastic materials and articles.’  
(6) In Article 5, the following paragraph is added : 
‘4. In case of doubt over the resulting designated id entity of a substance , a 
Member State or the Commission may consult the Authority. ’ 
(7) Article 6 is amended as follows:  
(1) in paragraph s 1 and 2 , the phrase ‘plastic layers in’ is deleted;  
(2) in paragraph 4 the phrase ‘ the plastic layers of’ is deleted;  
(3) paragraph 5 is replaced by the following : 
‘5. By way of derogation from Article 5, substances with a biocidal function 
used in biocidal products authorised  to be made available on the Union 
market in accordance with Regulation (EU) No 528/2012 ** for product -
type 4 for use that covers incorporation into plastic materials and articles 
which may enter into contact with food, may be used as additives in the 
manufacturing of plastic materials and articles.   
EN 9  EN **Regulation (EU) No 528/2012 of the Europ ean Parliament and of the Council of 22 May 
2012 concerning the making available on the market and use of biocidal products (OJ L 
167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj) .’ 
(8) Article 7 is deleted.  
(9) Article 8 is replaced b y the following:  
‘Article 8  
General requirements on substances  
1. Substances used in the manufacture of plastic materials  and articles , including 
those manufactured from waste,  shall be of a high degree of purity and shall be 
of a technical quality suitable for the intended and foreseeable use of the 
materials or articles.  
Manufacturer s of plastic materials and articles and of products from 
intermediate stages of their manufact uring shall know the composition of the 
substance and ma ke it available to the competent authorities on request.  
2. By derogation from paragraph 1, as regards purity, t he following requirements 
shall apply to substances of natural origin:  
(i) if the subst ance is identified by a name  in this Regulation that refers to  a 
natural  multi constituent  material  where the source is biological , that 
substance  may be used as  obtained from  its natural  origin , provided it has 
been entirely separated  from other natural materials  from which the 
substance was obta ined and that are  not forming part of its identity , or,  
(ii) if the substance is identified by a name in this Regulation that refers to a 
natural multi constituent material where the source is mineral, that 
substance may be used as obtained from its natural origin, provided it has 
been entirely separated from the other natural matter that is not forming 
part of its identity of the substance.  
Any additional specifications or requirements applica ble to a substance or 
material of natural origin set out in Table 1 of Annex I, applicable to the 
substance  or material , shall apply.  
3. Manufacturers of plastic materials and articles, and of products from 
intermediate stages of their manufacturing shall ensure that d ocumentation 
showing  compliance with paragraph s 1 to 2 is part of the documentation 
referred to in Article 16 . 
4. Manufacturers of plastic materials and articles, and of products from 
intermediate stages of their manufacturing shall ensure that competent 
authorities can take samples to verify the ir degree of purity and their 
composition , including that of the substanc es and materials used for their 
manufacture .’ 
(10) In Article 9, paragraph 1 , the phrase ‘plastic layers in’ is deleted.  
(11) Article 10 is replaced by the following : 
‘Article 10  
General restrictions and requirements  concerning  the composition of plastic m aterials  
and articles    
EN 10  EN 1. The composition of plastic materials and articles shall meet the restrictions on 
plastic materials and articles laid down in Annex II.  
2. Plastic materials and articles may contain  reprocessed plastic  if such 
reprocessed plastic  meets the following conditions :  
(a) it is collected in accordance with section  B and C of the Annex to 
Regulation (EC) No 2023/2006;  
(b) it originates only from off -cuts and scraps from plastic materials and 
articles  referred to in point (a) of Article 2(1)  that meet the compositional 
requirements set out in chapter II of  this Regulation , and which are  
considered to be a  by-product in accordance with Article 5 of Directive 
2008/98/EC  of the European Parliament and of the Council10; 
(c) it does not  contain substances  in an amount which could:  
(i) exceed migration limits applicable  to the plastic materials and 
articles; or,   
(ii) cause any other non -compliance of those plastic materials and 
articles with Article 3 of Regulation (EC) No 1935/2004;  
(d) it does not contain  constituents originating from  the following sources 
unless each constituent is identified and complies with the conditions 
referred to in point (c)  demonstrated on the basis of an assessment in 
accordan ce with Article 19 : 
(i) food;  
(ii) printing, coating, or adhesive s; 
(iii) substances used for processing the plastic from which the off -cuts 
and scraps originate, such as lubricants or cutting fluids . 
3. Where intended for repeat ed use in contact with food , the  composition of 
plastic materials and articles shall be such , so as to  guarantee that no  increase 
in the migration  of constituents of the material or article  to the food  would 
occur during their maximum life span when subjected to subsequent use 
cycles .’ 
(12) The title of Chapter IV is replaced by the following:  
‘LABELLING, DECLARATION OF COMPLIANCE AND 
DOCUMENTATION’  
(13) A new Article 14a is added:  
‘Article 14a   
Labelling  
1. The manufacturer or other operator  responsible for placing on the mark et a 
material or article intended for repeated use  shall provide information about  its 
the maximum life span to its users by means of labelling or instructions, 
including appropriate instructions designed to slow down deterioration of the 
material or artic le, as well as a description of observable changes of the article 
 
10 Directive 2008/98/EC of the European Parliament  and of the Council of 19 November 2008 on waste 
and repealing certain Directives  (OJ L 312, 22.11.2008, p. 3, ELI: 
http://data.europa.eu/eli/dir/2008/98/oj) .  
EN 11  EN or material that may indicate the deterioration of the article or material and that 
it has reached its maximum life span.  
2. Plastic materials and articles intended to be brought into contac t with food but 
are not yet in contact with food shall be labelled with instructions of use 
directed at the final user of that material or article at the moment of their sale or 
supply to consumers, where they are manufactured with substances included in 
the Union list of authorised substances, for which column 10 of table 1 of 
Annex I sets out restrictions related to one or more of the following elements:  
– specific foods or groups of foods,  
– contact time and/or temperature, and/or,  
– to heating conditions such  as oven and microwave use,  
The instructions of use shall mention the restrictions and provide the user with 
adequate information to prevent using the material or article under conditions 
not complying with them.  
If such a material or article is intended f or repeated use, such labelling shall be 
indelibly affixed to the material or article, unless that is not possible for 
technical reasons. A minimum font size of 3 mm (9 pt.) shall apply.’  
(14) In Article 14 , paragraph 4 is replaced by the following:  
‘4. Articles 11 and 12 apply to multi -material multi -layer materials and articles  
when the surface  layer that is in contact with food is made of a material falling 
within the scope of this Regulation .’  
(15) Article 14 , paragraph 6 is replaced by the following:  
‘6. If the surface layer that is in contact with food is made of a material falling not 
within the scope of this Regulation , specific and overall migration limits for 
plastic layers and for the final material or article may b e established by national 
law.’  
(16) Article 17 (2), point (a)  is replaced with the following:  
‘(a)  containers and other articles, containing or intended to contain more than 10 
litres.’  
(17) Annexes III to V are amended in accordance with Annex I to this Regulation . 
Article 2  
Amendments to Regulation (EC) No 2023/2006  
The Annex to Regulation (EC) No 2023/2006 is amended in accordance with Annex II to this 
Regulation . 
Article 3  
Transitional measures  
1. Plastic materials and articles complying with Regulatio n (EU) No 10/2011 as 
applicable before the entry into force of this Regulation, which were first placed on 
the market before [enter date 18 months after the date of entry into force of this 
Regulation]  may continue to be placed on the market until the exha ustion of stocks.   
EN 12  EN 2. In case a product from an intermediate stage of the manufacturing of plastic materials 
and articles or a substance intended for the manufacturing of such a product, material 
or article, which complies with Regulation (EU) No 10/2011 a s applicable before the 
entry into force of this Regulation and which is first placed on the market after [enter 
date 9 months after the date of entry into force of this Regulation]  does not comply 
with this Regulation, the declaration of compliance accompanying that substance or 
product shall indicate that it does not comply with th is Regulation , and that it can 
only be used in the manufacture of plastic materials and articles to be placed on the 
market before [enter date 18 months after the date of entry into force of this 
Regulation] .  
Article 4 
This Regulation shall enter into force on the  twentieth  day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula V ON DER LEYEN