EN    EN  COMMISSION OF THE EUROPEAN COMMUNITIES  
Brussels,  
C(2007)  final 
Draft  
COMMISSION REGULATION  
of 
on recycled plastic materials and articles intended to come into contact with foods and 
amending Commissio n Regulation (EC) No 2023/2006  
(Memorandum from Mr M. KYPRIANOU)   
EN 2   EN Draft 
COMMISSION REGULATION  
of 
on recycled plastic materials and articles intended to come into contact with foods and 
amending Commission Regulation (EC) No 2023/2006  
(Text with EEA relevan ce) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES,  
Having regard to the Treaty establishing the European Community,  
Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the 
Council of 27 October 2004 on materials and articles intend ed to come into contact with 
food1, and in particular Article 5(1) thereof,  
After consulting the European Food Safety Authority ("the Authority"),  
Whereas:  
(1) Directive 94/62/EC of the European Parliament and of the Council of 20 December 
1994 on packaging an d packaging waste2 promotes the recovery and incineration at 
waste incineration plants with energy recovery and recycling of packaging waste.  
(2) Regulation (EC) No 1935/2004 sets out the general principles for eliminating the 
differences between the laws of M ember States as regards materials and articles in 
contact with food and provides in Article 5(1) for the adoption of specific measures for 
groups of materials and articles. That Regulation identifies that harmonisation of rules 
on recycled plastic material s and articles should be given priority.  
(3) Commission Directive 2002/72/EC of 15 August 2002 relating to plastic materials and 
articles intended to come into contact with foodstuffs3 sets out rules for plastic 
materials and articles which are intended to com e into contact with foodstuffs.  
                                                
1 OJ L 338, 13.11 .2004 , p. 4. 
2 OJ L 365, 31.12.1994, p. 10. Directive as last amended by Directive 2005/20/EC (OJ L 70, 16.3.2005, 
p. 17).  
3 OJ L 220, 15.08.2002, p. 18. Directive as last amended by Directive 2007/19/EC (OJ L  91, 31.3.2007, 
p. 17.  
EN 3   EN (4) Plastic packaging waste may contain residues from previous use , contaminants from 
misuse and contaminants from non -authorised substances. Therefore it is necessary to 
lay down special requirements to ensure that materials an d articles produced from 
recycled plastics and intended for food contact respect the requirements of Article 3 of 
Regulation (EC) No 1935/2004.  
(5) Commission Regulation (EC) No 2023/2006  of 22 December 2006 on good 
manufacturing practice for materials and art icles intended to come into contact with 
food4 lays down rules on good manufacturing practice for groups of materials and 
articles intended to come into contact with food listed in Annex I to Regulation (EC) 
No 1935/2004 and combinations of those materials  and articles or recycled materials 
and articles used in those materials and articles.  
(6) Plastic waste can be treated mechanically to produce recycled materials and articles or 
it can be broken down to monomers and oligomers by chemical depolymerisation. 
Mon omers and oligomers resulting from chemical depolymerisation should not be 
treated differently from monomers manufactured by chemical synthesis. Therefore, 
they are covered by the authorisation of monomers and additives in Directive 
2002/72/EC and they sho uld comply with the specifications and purity criteria 
established therein. Therefore, they should not be covered by this Regulation.  
(7) Offcuts and scraps from the production of plastic food contact materials, that has not 
been in contact with food or otherw ise contaminated and is re -melted on the premises 
into new products or sold to a third party as part of a quality control system in 
compliance with the rules for good manufacturing practice laid down in Regulation 
(EC) No 2023/2006 would be considered as s uitable for food contact applications and 
should not fall under the scope of this Regulation. All other offcuts and scraps from 
the production of plastic food contact materials  should fall within the scope of the 
present Regulation.  
(8) Recycled plastic used b ehind a plastic functional barrier as defined by Directive 
2002/72/EC should not be covered by the authorisation procedure in this Regulation. 
The rules set out in Directive 2002/72/EC for substances used behind a plastic 
functional barrier are regarded as  sufficient to ensure the safety also of recycled 
plastics used behind a functional barrier.  
(9) Directive 2002/72/EC lays down list s of substances authorised to be used in the 
manufacture of plastic food contact materials or articles. These substances have be en 
evaluated for their safety and migration limits have been set for their safe use. To 
ensure the same level of safety of recycled plastics materials and articles only 
authorised monomers and additives should be added to the recycled plastics and their 
migration limits should also be respected by recycled plastic food contact materials.  
(10) Directive 2002/72/EC provides for a declaration of compliance and record keeping to 
ensure that relevant information on the safe use of the plastic material is passed on 
between business operators and to the competent authorities. Those general rules are 
also valid for recycled plastics; therefore, they should apply also to recycled plastics 
food contact materials and articles.  
                                                
4 OJ L 384, 29.12.2006, p. 75.   
EN 4   EN (11) Only the combination of characteristic of the i nput, sorting efficiency, and the 
effectiveness of the process to reduce contamination together with the defined use of 
recycled plastic ensure the safety of the recycled plastic material and article. They are 
specific to the type of plastic and the recycl ing process applied. It is only feasible to 
evaluate all these aspects together in individual evaluations of the recycling processes 
followed by individual authorisations.  
(12) The safety of the recycled plastics can only be ensured if the recycling process is able 
to produce a reproducible quality of the recycled plastics. This can be controlled if an 
effective  quality assurance system  is applied. Therefore, only recycled plastics from a 
recycling process managed by an effective quality assurance system should be placed 
on the market.  
(13) Directive 2002/72/EC lays down  the  list of monomers and starting substance  
authorised to the exclusion of all others (positive list) to be used in the manufacture of 
plastic food contact materials or articles and, therefore, only m aterials and articles 
complying with the provisions  laid down  in Directive 2002/72/EC should  be used as 
input for the recycling process. This can be achieved by sorting the plastic articles 
before recycling. For certain materials , such as polyolefines, due  to their physico -
chemical properties, 100% sorting efficiency may be necessary to ensure recycled 
plastic  that complies with the requirements of Article 3 of Regulation (EC) 
No 1935/2004. This sorting efficiency can be achieved in product loops which are in a 
closed and controlled chain. For other materials , for example, PET the safety of the 
recycled plastic  can be ensured with a lower sorting efficiency as regards to its former 
use in food contact which is realistically achievable from kerbside collectio n systems. 
The sorting efficiency necessary for each material should be identified on a case by 
case basis.  
(14) Plastic waste may be contaminated by substances from the previous use or incidental 
misuse of the plastics  or by substances originating from non -food contact grade 
plastic . As it is not possible to know all possible types of contamination and as 
different types of plastics have different capacities to retain and release contaminants it 
is not possible to set defined characteristics for the final produ ct applicable to all types 
of recycled plastics. Therefore a combination of input characterisation together with an 
adequate process to remove possible contamination is necessary to control the safety 
of the final product.  
(15) In the mechanical treatment, in w hich the plastic waste is ground ed into small pieces 
and cleaned, special care has to be taken to remove these contaminations. The 
recycling process must demonstrate that it can efficiently reduce potential 
contamination to a level that does not pose a ris k to human health. The contaminants 
should only migrate in levels comparable to or well below levels demonstrated in the 
challenge tests of that recycling process or in other appropriate analytical test and 
should comply with the requirements of Article 3 of Regulation (EC) No 1935/2004. 
A safety assessment should verify that the recycling process fulfils these conditions.  
Alternatively, for non -fillable materials and articles, such as crates and pallets that are 
handled in product loops in a closed and con trolled chain in which all steps of 
manufacture, distribution and use are controlled, it may be sufficient to prove that 
contamination can be excluded when they are only used in contact with dry food such 
as fruits and vegetables.   
EN 5   EN (16) Certain types of plastic materials and articles manufactured with recycled plastics may 
only be suitable for contact with specified types of food under certain conditions. A 
safety assessment should identify these materials and articles and appropriate contact 
conditions.  
(17) Differen ces between national laws, regulations and administrative provisions 
concerning the safety assessment and the authorisation of recycling processes, used in 
the manufacture of materials and articles intended to come into contact with food, may 
hinder the fr ee movement of these materials and articles, creating conditions of 
unequal and unfair competition. An authorisation procedure should therefore be 
established at Community level on the basis of the authorisation procedure provided 
for in Articles 9 to 12 o f Regulation (EC) No 1935/2004.  
(18) The authorisation procedure provided for in Article 9 to 12 of Regulation (EC) 
No 1935/2004 is  intended  for the authorisation of substances. Changes to th at 
procedure should be introduced in the present Regulation to adapt t he authorisation 
procedure to the authorisation of recycling processes. These changes are specific 
procedural rules as referred to in Article 5(1)(n) of Regulation (EC) No 1935/2004.  
(19) A safety assessment of the recycling process should be carried out by the  European 
Food Safety Authority (“the Authority”). In order to inform the applicant  of the data to 
be provided for the safety assessment, the Authority should publish detailed guidance 
concerning the preparation and the submission of the application.  
(20) The s afety assessment of the recycling process should be followed by a risk 
management decision as to whether this recycling process should be  authorised.  That 
decision should be adopted in accordance with the regulatory procedure described in 
Article 23(2) of Regulation (EC) No 1935/2004 so as to ensure close cooperation 
between the Commission and the Member States.  
(21) The recycling process is company specific as regards technology and process 
parameters used. Therefore, only process specific authorisations should  be granted. 
The authorisation procedure provided for in Articles 9 to 12 of Regulation (EC) 
No 1935/2004 should be adapted accordingly.  
(22) It should be possible to apply the process in different production sites as long as 
technology and process parameters a s described in the application and authorisation 
are adhered to.  
(23) The public should be informed on the authorised recycling processes. For that purpose, 
a Community register , as referred to in Article 5(1)(m) of Regulation (EC) 
No 1935/2004 , of recycling pr ocesses authorised under this Regulation should be 
established including the description of the field of application for the recycled plastic 
of the authorised process.   
EN 6   EN (24) The recycling and the converting  plant should be subject to inspection and control by 
the Member State. Regulation (EC) No 882/2004 of the European Parliament and of 
the Council of 29 April 2004 on official controls performed to ensure verification of 
compliance with feed and food law, animal health and animal welfare rules5 also 
covers offi cial control on food contact materials. The most efficient way to control if 
the recycling process is applied as specified in the authorisation and to control if an 
effective quality assurance system is in place is the auditing of the recycling plant by 
the competent authorities. Therefore official controls performed to ensure compliance 
with this Regulation should include audits as specified in Article 10 of Regulation 
(EC) No 882/2004. The audits should be made in the most cost effective manner 
possible t o keep to a minimum the administrative and economic burden to competent 
authorities and small and medium enterprises.  
(25) To ensure an efficient control Member States and the Commission should be informed 
about the recycling or manufacturing sites in which the  authorised recycling process is 
being applied.  
(26) Industry should be enabled to label that their packaging contains recycled plastics. 
However, consumers should not be misled by labelling as regards recycled content. 
Rules for labelling of recycled plastics in relation to the content of recycled plastics 
have been laid down in EN ISO 14021. To ensure adequate information of the 
consumer when recycled plastics are labelled, they should follow transparent rules as 
those laid down in EN ISO 14021 or equivalent.  
(27) Article 16 of Regulation (EC) No 1935/2004 requires a declaration of compliance for 
materials and articles. The converter of a recycled plastic material and articles should 
declare that he is using only recycled plastic from an authorised process and that the 
final product respects Community and national provisions applicable to it, in particular 
Regulation (EC) No 1935/2004 and Directive 2002/72/EC. The recycler should 
provide the converter with the information that the recycled plastic is produced by an 
authorised process and specify its field of application. Therefore, both the finished 
recycled plastic materials and articles and the recycled plastic should be accompanied 
by a declaration of compliance. General information to be provided in the declaratio n 
is already laid down in Directive 2002/72/EC. Therefore, this Regulation should only 
specify the additional information in relation to the content of recycled plastics in the 
recycled plastic materials and articles.  
                                                
5 OJ L 165, 30.4.2004, p. 1; corrected version (OJ L 191, 28.5.2004, p. 1). Regulation as last amended by 
Council Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1).   
EN 7   EN (28) Since recycled materials and articles are already on the market in the Member States, 
provision should be made to ensure that the transition to a Community authorisation 
procedure is smooth and does not disturb the existing recycled plastic materials and 
articles market. Sufficient time should  be allowed for applicant s to make available to 
the Authority the information necessary for the safety assessment of the recycled 
plastic used in such products. Therefore, a certain time period, (the “initial 
authorisation phase” ), should be fixed during w hich time the information for existing 
recycling processes should be submitted by the applicant s to the Authority. 
Applications for authorisation s of new recycling processes may also be submitted 
during the initial authorisation phase. The Authority should  evaluate without delay all 
applications for existing , as well as new recycling processes for which sufficient 
information has been submitted during the initial authorisation phase.  
(29) Specific requirements need to be set on the quality assurance system appli ed in 
recycling processes. As the quality assurance is part of the good manufacturing 
practice which is covered by Regulation (EC) No 2023/2006 the specific requirements 
on the quality assurance system should be included in the Annex to that Regulation.  
(30) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health,  
 HAS ADOPTED THIS REGULATION:  
Article 1  
Subject matter and Scope  
1. This Regulation shall apply to the plastic mate rials and articles and parts thereof 
intended to come into contact with foodstuffs as referred to in Article 1 of Directive 
2002/72/EC which contain recycled plastic (hereafter "recycled plastic materials and 
articles").  
2. This Regulation shall not apply to the following recycled plastic materials and 
articles, provided that they have been manufactured according to good manufacturing 
practice, as laid down in Regulation (EC) No 2023/2006, : 
(a) recycled plastic materials and articles made with monomers and  starting 
substances, derived from chemical depolymerization of plastic materials and 
articles;  
(b) recycled plastic materials and articles made from unused plastic production 
offcuts and/or process scraps  in compliance with Directive 2002/72/EC, that 
are recycled within the manufacturing s ite or are used at another site;  
(c) recycled plastic materials and articles in which the recycled plastic is used 
behind a plastic functional barrier , as specified in Directive 2002/72/EC.  
3. The plastic materials and ar ticles that fall within the scope of this Regulation remain 
subject to Directive 2002/72/EC.   
EN 8   EN Article 2  
Definitions  
1. For the purposes of this Regulation, the definitions laid down in Regulation (EC) 
No 1935/2004 and Directive 2002/72/EC shall apply.  
2. The following definitions shall also apply : 
(a) “recycling process” means a process in which plastic waste is  recycled 
pursuant to the definition of recycling in point 7 of Article 3 of Directive 
94/62/EC on packaging and packaging waste ; for the purpose of this 
Regulation, th is term is limited to processes, in which a recycled plastic is 
produced ; 
(b) “plastic input” means collected and sorted post -use plastic materials and 
articles used as input into a recycling process ; 
(c) “product loops which are in a cl osed and controlled chain” means manufacture 
and distribution cycles in which products circulate with a controlled reuse and 
distribution system , and in which the recycled material originates only from 
these entities in the chain , so that the unintentional  introduction of external 
material is just the minimum technically feasible ; 
(d) “challenge test” means a demonstration  of the effectiveness of a recycling 
process to remove chemical contamination from plastic materials or articles;  
(e) "converter"  means t he natural or legal person responsible for ensuring that the 
requirements of this Regulation, as regards the recycled plastic materials and 
articles are met within the business under their control;  
(f) “recycler” means the natural or legal person responsib le for ensuring that the 
requirements of this Regulation, as regards the recycling process are met within 
the business under their control.  
Article 3  
Requirements  for recycled plastic materials and articles  
1. Recycled plastic materials and articles shall only be placed on the market if  they 
contain recycled plastic  obtained only from a recycling process, authorised in 
accordance with  this Regulation.  
2. The authorised recycling process , referred to in paragraph 1 of this Article, shall be 
managed by an app ropriate quality assurance system that ensures that the recycled 
plastic complies with the requirements set out in the authorisation.  
That quality assurance system shall comply with the detailed rules laid down in the 
Annex  to Regulation (EC) No 2023/2006.   
EN 9   EN Article 4  
Conditions for the authorisation  of recycling processes  
In order to be authorised, a recycling process shall comply with the following conditions:  
(a) the quality of plastic input must be characterised and controlled in accordance with 
pre-estab lished criteria that ensure compliance of the final recycled plastic material 
and article with Article 3 of Regulation (EC) No 1935/2004;  
(b) the plastic input must originate from plastic materials and articles that have been 
manufactured in accordance wit h Community legislation  on plastic food contact 
materials and articles, in particular Council Directive 78/142/EEC6 of 13 January 
1978 on the approximation of laws of the Member States relating to materials and 
articles which contain vinyl chloride monomer  and are intended to come into contact 
with foodstuffs and Directive 2002/72/EC;  
(c) (i) either the plastic input must originate from a product loop which is in a closed 
and controlled chain ensuring that only materials and articles which have been 
intende d for food contact are used and any contamination can be ruled out; or  
(ii) it must be demonstrated in a challenge test, or by other appropriate scientific 
evidence that the process is able to reduce any contamination of the plastic 
input to a concentratio n that does not pose a risk to human health;  
(d) the quality of the recycled plastic must be characterised and controlled in accordance 
with pre -established criteria that ensure compliance of the final recycled plastic 
material and article with Article 3 o f Regulation (EC) No 1935/2004;  
(e) there must be established conditions of use of the recycled plastic whereby it can be 
ensured that the recycled plastic materials and articles comply with Article 3 of 
Regulation (EC) No 1935/2004.  
Article 5  
Application for authorisation of recycling processes  and opinion of the Authority  
1. The procedure for authorisation laid down in Articles 9 to 10 of Regulation No (EC) 
1935/2004 shall apply mutatis mutandis for the authorisation of recycling processes, 
subject to the  specific provisions laid down in paragraphs 2 to 4 of this Article.  
2. The technical dossier shall contain the information specified in the guidelines for the 
safety assessment of a recycling process to be published by the Authority  at the latest 
six mont hs after the date of publication of this Regulation.  
3. The Authority shall give an opinion within six months of receipt of a valid 
application as to whether or not the recycling process complies with the conditions 
laid down in Article 4.  
                                                
6 OJ L 44, 15.2.1978, p. 15.   
EN 10   EN 4. In the event of an opinion in favour of authorising the evaluated recycling process , 
the opinion of the Authority shall include  the following : 
(a) a short description of the recycling process;  
(b) where appropriate, any recommendations on conditions or restrictions 
concerning the plastic input;  
(c) where appropriate, any recommendations on conditions or restrictions 
concerning the recycling process;  
(d) where appropriate, any criteria to characterise the recycled plastic;  
(e) where appropriate, any recommendations conce rning conditions in the field of 
application of the recycled plastic;  
(f) where appropriate, any recommendations concerning monitoring compliance of 
the recycling process with the conditions of the authorisation.  
Article 6  
Authorisation of recycling proces ses 
1. The Commission shall adopt  a Decision addressed to the applicant granting or 
refusing authoris ation of the recycling process.  
Article 11(3) of Regulation (EC) No 1935/2004 shall apply.  
2. The Decision shall take into account the opinion of the Autho rity, relevant provisions 
of Community law , and other legitimate factors relevant to the matter 
under  consideration.  
Where the Decision is not in accordance with the opinion of the  Authority, the 
Commission shall provide an explanation for the reasons for the differences.  
3. The Decision granting the authorisation shall include  the following:  
(a) the name of the recycling process ; 
(b) the name and address of the authorisation holder(s) ; 
(c) a short description of the recycling process ; 
(d) any conditions or  restrictions concerning the plastic input;  
(e) any conditions or restrictions concerning the recycling process;  
(f) any characterisation of the recycled plastic;  
(g) any conditions in the field of application of the recycled plastic that has been 
manufact ured by the recycling process;   
EN 11   EN (h) any requirements concerning monitoring of the compliance of the recycling 
process w ith the conditions of the authorisation ; 
(i) the date from which the authorisation is effective.  
4. The Decision  granting or refusing the  authorisation shall be published in the Official 
Journal of the European Communities.  
5. The authorisation  issued to the authorisation holder  shall be valid throughout the 
Community.  
The authorised recycling process shall be entered in the Register referre d to in 
Article 9(1). 
Article 7  
Obligations arising from the authorisation  
1. After the authorisation of a recycling process in accordance with this Regulation, the 
authorisation holder or any other business operator using the authorised recycling 
process under licence  shall comply with any conditions or restrictions attached to 
such authorisation.  
Any converter  using  recycled plastic  from the authorised recycling process or any 
business operator using materials or articles containing  recycled plastic  from the 
authorised recycling process shall comply with any condition or restriction attached 
to such authorisation.  
2. The authorisation holder  or any other business operator using the authorised 
recycling process under licence shall immediately inform the Com mission of any 
new scientific  or technical information, which might affect the safety assessment of 
the recycling process in relation to human health.  
If necessary, the Authority  shall then review the assessment.  
3. The granting of an authorisation shall n ot affect the general civil and criminal 
liability of any business operator in respect of the authorised recycling process, the 
material or article containing  recycled plastic  from the authorised recycling process, 
and the food that is in contact with such  material or article.  
Article 8  
Modification, suspension and revocation of authorisation of a recycling process   
1. The authorisation holder may, in accordance with the procedure laid down in Article 
5(1) apply for a modification of the existing authorisat ion.  
EN 12   EN 2. The application referred to in paragraph 1 shall be accompanied by the following:  
(a) a reference to the original application;  
(b) a technical dossier containing the new information in accordance with the 
guidelines referred to in Article 5(2);  
(c) a new complete summary of the technical dossier in a standardised form.  
3. On its own initiative or following a request from a Member State or the Commission, 
the Authority shall evaluate whether the opinion or the authorisation is still in 
accordance wit h this Regulation, in accordance with the procedure laid down in 
Article  5, where  applicable.  
4. The Commission shall examine the opinion of the Authority without delay and if 
necessary prepare a draft Decision to be taken.  
5. A draft Decision modifying an  authorisation shall specify any necessary changes in 
the conditions of use and, if any, in the restrictions attached to that authorisation.  
6. If appropriate, the authorisation shall be  modifi ed, suspen ded or revoked in 
accordance with the procedure refer red to in Article  6. 
Article 9  
Community Register  
1. The Commission shall establish and maintain a Community Register of authorised 
recycling processes.  
2. The Register shall be made available to the public.  
3. Each entry in the Register shall include the information referred to in Article 6 (3) . 
Article 10  
Official Control  
1. The official control of a recycling plant and converter shall be performed in 
accordance with the rules laid down in Regulation (EC) No 882/2004 and shall 
include in particular audits  as control technique as specified in Article 10 of 
Regulation (EC) No 882/2004.  
2. The official control shall verify that the recycling process corresponds to the 
authorised process and that an effective quality assurance system in accordance with 
Regulat ion (EC) No 2023/2006 is in place.  
3. The authorisation holder shall notify the competent authority in the Member State 
about the recycling or manufacturing site in which the authorised recycling process is 
being applied. Member States shall forward that i nformation to the Commission.   
EN 13   EN Manufacturing or recycling sites in third countries shall be notified to the 
Commission.  
The Commission shall make available and keep updated a register of recycling sites 
in the Community and third countries.  
Article  11 
Label ling of recycled plastic materials and articles  
Voluntary s elf-declaration of the recycled content in recycled plastic materials and articles 
shall follow the rules laid down in ISO 14021:1999  or equivalent . 
Article 12  
Declaration of Compliance and Record Keeping  
1. In addition to the requirements of Article 9 of Directive 2002/72/EC, the declaration 
of compliance of recycled plastic materials and articles shall contain the information 
laid down in  Part A of Annex  I to this Regulation . 
2. In addition to the  requirements of Article 9 of Directive 2002/72/EC, the declaration 
of compliance of recycled plastic shall contain the information laid in Part B of 
Annex  I to this Regulation . 
Article 13 
Transitional measures for the authorisation of  recycling processes  
1. For the  initial authorisation phase of recycling processes, the procedure provided for 
in Article s 5, 6 and 7  shall apply  subject to paragraph s 2 to 6 of this Article.  
2. During the 18 months following the publication of the guidelines for the safety 
assessment of a recycling process  of the Authority  as provided for in Article 5(2) , 
business operators seeking authorisation shall submit an application in accordance 
with Article 5 . 
3. The Commission shall ma ke available to the public  a register of recyclin g processes 
for which a  valid application has been submitted i n accordance with paragraph 2.  
4. The Authority shall issue an opinion on each recycling process for which a valid 
application has been submitted during the period  referred to in paragraph 2 of this 
Article . The deadline of six month for issuing the opinion , as referred to in Article 
5(3), shall not apply.  
5. Applications for which the Authority could not issue an opinion owing to the 
applicant's failure to comply with the time limits specified f or submission of 
supplementary information in accordance with Article 10(2) of Regulation (EC) 
No 1935/2004  shall be excluded from consideration for the initial authorisation .  
EN 14   EN 6. Within six months of receiving all the opinions referred to in paragraph 4, the 
Commission shall submit for opinion to the Standing Committee on the Food C hain 
and Animal Health draft Decisions granting or refusing authorisation of the recycling 
processes referred to in paragraph 1.  
Article 14 
Transitional Measures  for the trade in  and use of recycled plastic  
1. Trade in and use of recycled plastic from a recycling process already in place on the 
date of entry into force of this Regulation, for which authorisation is refused or for 
which no valid application has been submitted in ac cordance with Article 13 shall be 
permitted until six months after the date of adoption of the Decisions referred to in 
Article 13(6). 
2. Trade in and use of recycled plastic materials and articles containing recycled plastic 
from a recycling process alrea dy in place on the date of entry into force of this 
Regulation, for which authorisation is refused or for which no valid application has 
been submitted in accordance with Article 13 shall be permitted until exhaustion of 
stocks.  
Article 1 5 
Amendment 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 16 
Entry into force  
This Regulation shall enter into force on the 20th day following that of its publication in the 
Offic ial Journal of the European Union . 
However, Article s 3, 9, 10 and 12  shall apply from the date of the adoption of the Decisions 
referred to in Article 13(6) . Until that date, national provisions in force concerning recycled 
plastic materials and articles a nd recycled  plastic shall continue to apply in the Member 
States.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 Markos KYPRIANOU  
 Member of the Commission   
EN 15   EN ANNEX I  
PAR T A 
ADDITIONAL INFORMATION IN THE DECLARATION OF COMPLIANCE  
FOR RECYCLED PLASTIC  MATERIALS AND ARTIC LES 
The written decl aration referred to in Article 12(1) shall contain the following additional 
information:  
A declaration that only recycled plastic from an authorised recycling process has been used 
listing the EC Register number of the authorised recycling process.  
PART  B 
ADDITIONAL INFORMATION IN THE DECLARATION OF COMPLIANCE FOR 
RECYCLED PLASTIC  
The written declaration referred to in Article 12(2) shall  contain the following additional 
information:  
1. The declaration  that the recycling process has been authorised  listing the EC Register 
number of the authorised recycling process  
2. The declaration that the plastic input, the recycling process and the rec ycled plastic 
meet the specifications for which the authorisation has been granted.  
3. The declaration that a quality assurance system according to Annex Point B to 
Regulation 2023/2006 is in place.   
EN 16   EN ANNEX II  
The Annex to Regulation (EC) No 2023/2006 is ame nded as follows:  
(1) The following  section title  is inserted after the title:  
'A. PRINTING INKS ' 
(2) The following  section  is added : 
'B. QUALITY ASSURANCE SYS TEM FOR PLASTIC RECYCLING PROCESSES  
COVERED BY REGULATION (EC)  NO […/2008]  ON RECYCLED PLASTIC  
MAT ERIALS AND ARTICLES INTENDED TO COME INT O CONTACT WITH FOODS  
AND AMENDING COMMISSION REGULATION (EC)  NO 2023/2006  
1. The Quality Assurance System implemented by the recycler must give adequate 
confidence in the capability of the recycling process to ensure  the recycled plastic  
meets the requirements in the authorisation . 
2. All the elements, requirements and provisions adopted by the recycler for his quality 
assurance system must be documented in a systematic and orderly manner in the 
form of written policy  statements and procedures.  
That quality system documentation must permit uniform interpretation of the quality 
policy and procedures , such as quality programmes, plans, manuals, records and 
measures taken to ensure traceability.  
It must include , in partic ular: 
(a) a quality policy manual, containing a clear definition of the recyclers quality 
objectives, the organisation of the business and in particular the organisational 
structures, the responsibilities of the managerial staff and their organisational 
authority where manufacture of the recycled plastic  is concerned;  
(b) the quality control plans, including those for input and recycled plastic  
characterisation, suppliers qualification, sorting processes, washing processes, 
deep cleansing processes, heating  processes,  or any other part of the process 
relevant for the quality of the recycled plastic  including the choice of points  
which are c ritical for the quality control of the recycled plastics ; 
(c) the managing and operative procedures implemented to monit or and control the 
whole recycling process, including the inspection and quality assurance 
techniques at all the manufacturing stages, especially the  establishment of 
critical limits at  the points  which are critical for the quality of the recycled 
plastics ; 
(d) the methods of monitoring the efficient operation of the quality system and in 
particular its ability to achieve the desired recycled plastic  quality, including 
control of products which fail to conform;   
EN 17   EN (e) the tests and analytical protocols or any other scientific evidence applied 
before, during and after recycled plastic  production, the frequency with which 
they will take place, and the test equipment used; it must be adequately 
possible to trace back the calibration of the test equipment;  
(f) the recording documents adopted. '