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
(Text with EEA relevance)
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 2004on materials and articles intended to come into contact with
food and repealing Directives 80/590/EEC and 89/109/EEC (
1),
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 andpackaging waste (
2) promotes the recovery and incin-
eration at waste incineration plants with energyrecovery and recycling of packaging waste.
(2) Regulation (EC) No 1935/2004 sets out the general prin-ciples for eliminating the differences between the laws ofMember States as regards materials and articles in contactwith food and provides in Article 5(1) for the adoptionof specific measures for groups of materials and articles.That Regulation identifies that harmonisation of rules onrecycled plastic materials and articles should be givenpriority.
(3) Commission Directive 2002/72/EC of 6 August 2002relating to plastic materials and articles intended tocome into contact with foodstuffs (
3) sets out rules forplastic materials and articles which are intended to come
into contact with foodstuffs.
(4) Plastic packaging waste may contain residues fromprevious use, contaminants from misuse andcontaminants from non-authorised substances.Therefore it is necessary to lay down special requirementsto ensure that materials and articles produced fromrecycled plastics and intended for food contact respectthe requirements of Article 3 of Regulation (EC) No1935/2004.
(5) Commission Regulation (EC) No 2023/2006 of22 December 2006 on good manufacturing practicefor materials and articles intended to come into contactwith food (
4) lays down rules on good manufacturing
practice for groups of materials and articles intended tocome into contact with food listed in Annex I to Regu-lation (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 producerecycled materials and articles or it can be brokendown to monomers and oligomers by chemical depoly-merisation. Monomers and oligomers resulting fromchemical depolymerisation should not be treated
differently from monomers manufactured by chemical
synthesis. Therefore, they are covered by the authorisa-tion of monomers and additives in Directive 2002/72/ECand they should comply with the specifications andpurity criteria established therein. Therefore, theyshould 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 otherwise contaminated and is re-melted on thepremises into new products or sold to a third party aspart of a quality control system in compliance with therules for good manufacturing practice laid down in Regu-lation (EC) No 2023/2006 would be considered assuitable for food contact applications and should notfall under the scope of this Regulation. All otheroffcuts and scraps from the production of plastic foodcontact materials should fall within the scope of thepresent Regulation.EN 28.3.2008 Official Journal of the European Union L 86/9
(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, 15.8.2002, p. 18. Directive as last amended by Directive
2007/19/EC (OJ L 91, 31.3.2007, p. 17). (4) OJ L 384, 29.12.2006, p. 75.(8) Recycled plastic used behind a plastic functional barrier
as defined by Directive 2002/72/EC should not becovered by the authorisation procedure in this Regu-lation. The rules set out in Directive 2002/72/EC forsubstances used behind a plastic functional barrier areregarded as sufficient to ensure the safety also ofrecycled plastics used behind a functional barrier.
(9) Directive 2002/72/EC lays down lists of substancesauthorised to be used in the manufacture of plasticfood contact materials or articles. These substances
have been evaluated for their safety and migration
limits have been set for their safe use. To ensure thesame level of safety of recycled plastic materials andarticles only authorised monomers and additives shouldbe added to the recycled plastics and their migrationlimits should also be respected by recycled plastic foodcontact materials.
(10) Directive 2002/72/EC provides for a declaration ofcompliance and record keeping to ensure that relevantinformation on the safe use of the plastic material ispassed on between business operators and to thecompetent authorities. Those general rules are alsovalid for recycled plastics; therefore, they should applyalso to recycled plastic food contact materials andarticles.
(11) Only the combination of characteristic of the input,sorting efficiency, and the effectiveness of the processto reduce contamination together with the defined useof recycled plastic ensure the safety of the recycled plasticmaterial and article. They are specific to the type ofplastic and the recycling process applied. It is onlyfeasible to evaluate all these aspects together in individual
evaluations of the recycling processes followed by indi-
vidual 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 ifan effective quality assurance system is applied.Therefore, only recycled plastics from a recyclingprocess managed by an effective quality assurancesystem should be placed on the market.
(13) Directive 2002/72/EC lays down the list of monomersand starting substance authorised to the exclusion of allothers (positive list) to be used in the manufacture ofplastic food contact materials or articles and, therefore,only materials and articles complying with the provisionslaid down in Directive 2002/72/EC should be used as
input for the recycling process. This can be achievedby sorting the plastic articles before recycling. Forcertain materials, such as polyolefines, due to theirphysico-chemical properties, 100 % sorting efficiencymay be necessary to ensure recycled plastic thatcomplies with the requirements of Article 3 of Regu-lation (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 witha lower sorting efficiency as regards to its former use infood contact which is realistically achievable fromkerbside collection systems. The sorting efficiencynecessary for each material should be identified on acase by case basis.
(14) Plastic waste may be contaminated by substances fromthe previous use or incidental misuse of the plastics or bysubstances originating from non-food contact gradeplastic. As it is not possible to know all possible typesof contamination and as different types of plastics havedifferent capacities to retain and release contaminants itis not possible to set defined characteristics for the finalproduct 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 thefinal product.
(15) In the mechanical treatment, in which the plastic waste isground into small pieces and cleaned, special care has tobe taken to remove these contaminations. The recyclingprocess must demonstrate that it can efficiently reducepotential contamination to a level that does not pose arisk to human health. The contaminants should onlymigrate in levels comparable to or well below levelsdemonstrated in the challenge tests of that recyclingprocess or in other appropriate analytical test andshould comply with the requirements of Article 3 ofRegulation (EC) No 1935/2004. A safety assessmentshould verify that the recycling process fulfils theseconditions. Alternatively, for non-fillable materials andarticles, such as crates and pallets that are handled in
product loops in a closed and controlled chain in
which all steps of manufacture, distribution and use arecontrolled, it may be sufficient to prove that contamina-tion can be excluded when they are only used in contactwith dry food such as fruits and vegetables.
(16) Certain types of plastic materials and articles manu-factured with recycled plastics may only be suitable forcontact with specified types of food under certainconditions. A safety assessment should identify thesematerials and articles and appropriate contact conditions.EN L 86/10 Official Journal of the European Union 28.3.2008(17) Differences between national laws, regulations and
administrative provisions concerning the safetyassessment and the authorisation of recycling processes,used in the manufacture of materials and articlesintended to come into contact with food, may hinderthe free movement of these materials and articles,creating conditions of unequal and unfair competition.An authorisation procedure should therefore be estab-
lished at Community level on the basis of the authorisa-
tion procedure provided for in Articles 9 to 12 of Regu-lation (EC) No 1935/2004.
(18) The authorisation procedure provided for in Article 9 to12 of Regulation (EC) No 1935/2004 is intended for theauthorisation of substances. Changes to that procedureshould be introduced in the present Regulation to adaptthe 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 becarried 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 Authorityshould publish detailed guidance concerning the
preparation and the submission of the application.
(20) The safety assessment of the recycling process should be
followed by a risk management decision as to whetherthis recycling process should be authorised. That decisionshould be adopted in accordance with the regulatoryprocedure described in Article 23(2) of Regulation (EC)No 1935/2004 so as to ensure close cooperationbetween the Commission and the Member States.
(21) The recycling process is company specific as regardstechnology and process parameters used. Therefore,only process specific authorisations should be granted.The authorisation procedure provided for in Articles 9to 12 of Regulation (EC) No 1935/2004 should beadapted accordingly.
(22) It should be possible to apply the process in differentproduction sites as long as technology and process para-meters as described in the application and authorisation
are adhered to.
(23) The public should be informed on the authorisedrecycling processes. For that purpose, a Communityregister, as referred to in Article 5(1)(m) of Regulation(EC) No 1935/2004, of recycling processes authorisedunder this Regulation should be established includingthe description of the field of application for the
recycled plastic of the authorised process.
(24) The recycling and the converting plant should be subject
to inspection and control by the Member State. Regu-lation (EC) No 882/2004 of the European Parliament andof the Council of 29 April 2004 on official controlsperformed to ensure verification of compliance withfeed and food law, animal health and animal welfarerules (
1) also covers official control on food contact
materials. The most efficient way to control if therecycling process is applied as specified in the authorisa-tion and to control if an effective quality assurancesystem is in place is the auditing of the recycling plantby the competent authorities. Therefore official controlsperformed to ensure compliance with this Regulationshould include audits as specified in Article 10 of Regu-lation (EC) No 882/2004. The audits should be made in
the most cost effective manner possible to keep to a
minimum the administrative and economic burden tocompetent authorities and small and medium enterprises.
(25) To ensure an efficient control Member States and theCommission should be informed about the recycling ormanufacturing sites in which the authorised recyclingprocess is being applied.
(26) Industry should be enabled to label that their packagingcontains recycled plastics. However, consumers shouldnot be misled by labelling as regards recycled content.Rules for labelling of recycled plastics in relation to thecontent of recycled plastics have been laid down in ENISO 14021. To ensure adequate information of theconsumer when recycled plastics are labelled, theyshould follow transparent rules as those laid down inEN ISO 14021 or equivalent.EN 28.3.2008 Official Journal of the European Union L 86/11
(1) OJ L 165, 30.4.2004, p. 1; corrected version (OJ L 191, 28.5.2004,
p. 1). Regulation as last amended by Commission Regulation (EC)No 180/2008 (OJ L 56, 29.2.2008, p. 4).(27) Article 16 of Regulation (EC) No 1935/2004 requires a
declaration of compliance for materials and articles. Theconverter of recycled plastic material and articles shoulddeclare that he is using only recycled plastic from anauthorised process and that the final product respectsCommunity and national provisions applicable to it, inparticular Regulation (EC) No 1935/2004 and Directive2002/72/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 appli-cation. Therefore, both the finished recycled plasticmaterials and articles and the recycled plastic should beaccompanied by a declaration of compliance. Generalinformation to be provided in the declaration is alreadylaid down in Directive 2002/72/EC. Therefore, this Regu-lation should only specify the additional information inrelation to the content of recycled plastics in the recycledplastic materials and articles.
(28) Since recycled materials and articles are already on themarket in the Member States, provision should be madeto ensure that the transition to a Community authorisa-tion procedure is smooth and does not disturb theexisting recycled plastic materials and articles market.Sufficient time should be allowed for applicants to
make available to the Authority the information
necessary for the safety assessment of the recycledplastic used in such products. Therefore, a certain timeperiod, (the ‘initial authorisation phase ’), should be fixed
during which time the information for existing recyclingprocesses should be submitted by the applicants to theAuthority. Applications for authorisations of newrecycling processes may also be submitted during theinitial authorisation phase. The Authority shouldevaluate without delay all applications for existing, aswell as new recycling processes for which sufficient infor-mation has been submitted during the initial authorisa-tion phase.
(29) Specific requirements need to be set on the qualityassurance system applied in recycling processes. As thequality assurance is part of the good manufacturing
practice which is covered by Regulation (EC) No
2023/2006 the specific requirements on the qualityassurance system should be included in the Annex tothat Regulation.
(30) The measures provided for in this Regulation are inaccordance with the opinion of the StandingCommittee 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 materials and
articles and parts thereof intended to come into contact withfoodstuffs 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 depolymer-ization of plastic materials and articles;
(b) recycled plastic materials and articles made from unused
plastic production offcuts and/or process scraps incompliance with Directive 2002/72/EC, that are recycledwithin the manufacturing site or are used at another site;
(c) recycled plastic materials and articles in which the recycled
plastic is used behind a plastic functional barrier, asspecified in Directive 2002/72/EC.
3. The plastic materials and articles that fall within the scope
of this Regulation remain subject to Directive 2002/72/EC.
Article 2
Definitions
1. For the purposes of this Regulation, the definitions laid
down in Regulation (EC) No 1935/2004 and Directive2002/72/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 packagingwaste; for the purpose of this Regulation, this term islimited 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;EN L 86/12 Official Journal of the European Union 28.3.2008(c) ‘product loops which are in a closed and controlled chain ’
means manufacture and distribution cycles in whichproducts circulate with a controlled reuse and distributionsystem, and in which the recycled material originates onlyfrom these entities in the chain, so that the unintentionalintroduction of external material is just the minimum tech-nically feasible;
(d) ‘challenge test ’means a demonstration of the effectiveness
of a recycling process to remove chemical contaminationfrom plastic materials or articles;
(e) ‘converter ’means the natural or legal person responsible for
ensuring that the requirements of this Regulation, as regardsthe recycled plastic materials and articles are met within thebusiness under their control;
(f) ‘recycler ’means the natural or legal person responsible for
ensuring that the requirements of this Regulation, as regardsthe recycling process are met within the business undertheir 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 onlyfrom a recycling process, authorised in accordance with thisRegulation.
2. The authorised recycling process, referred to in paragraph
1 of this Article, shall be managed by an appropriate qualityassurance system that ensures that the recycled plastic complieswith 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) No2023/2006.
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-established criteria thatensure compliance of the final recycled plastic materialand 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 withCommunity legislation on plastic food contact materialsand articles, in particular Council Directive 78/142/EEC of30 January 1978 on the approximation of laws of theMember States relating to materials and articles whichcontain vinyl chloride monomer and are intended tocome into contact with foodstuffs (
1) 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 ensuringthat only materials and articles which have beenintended for food contact are used and any contamina-tion 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 toreduce any contamination of the plastic input to aconcentration that does not pose a risk to humanhealth;
(d) the quality of the recycled plastic must be characterised and
controlled in accordance with pre-established criteria thatensure compliance of the final recycled plastic materialand article with Article 3 of 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 plasticmaterials 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
and 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 arecycling process to be published by the Authority at thelatest six months 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 recyclingprocess complies with the conditions laid down in Article 4.EN 28.3.2008 Official Journal of the European Union L 86/13
(1) OJ L 44, 15.2.1978, p. 15.4. In the event of an opinion in favour of authorising the
evaluated recycling process, the opinion of the Authority shallinclude 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 concerning
conditions in the field of application of the recycled plastic;
(f) where appropriate, any recommendations concerning moni-
toring compliance of the recycling process with theconditions of the authorisation.
Article 6
Authorisation of recycling processes
1. The Commission shall adopt a Decision addressed to the
applicant granting or refusing authorisation of the recyclingprocess.
Article 11(3) of Regulation (EC) No 1935/2004 shall apply.
2. The Decision shall take into account the opinion of the
Authority, relevant provisions of Community law, and otherlegitimate 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 ofthe 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 manufactured by the recycling process;
(h) any requirements concerning monitoring of the compliance
of the recycling process with the conditions of the authori-sation;
(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 Union .
5. The authorisation issued to the authorisation holder shall
be valid throughout the Community.
The authorised recycling process shall be entered in the Register
referred 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 orany other business operator using the authorised recyclingprocess under licence shall comply with any conditions orrestrictions attached to such authorisation.
Any converter using recycled plastic from the authorised
recycling process or any business operator using materials orarticles containing recycled plastic from the authorised recyclingprocess shall comply with any condition or restriction attachedto such authorisation.
2. The authorisation holder or any other business operator
using the authorised recycling process under licence shall imme-diately inform the Commission of any new scientific ortechnical information, which might affect the safety assessmentof the recycling process in relation to human health.
If necessary, the Authority shall then review the assessment.EN L 86/14 Official Journal of the European Union 28.3.20083. The granting of an authorisation shall not affect the
general civil and criminal liability of any business operator inrespect of the authorised recycling process, the material orarticle containing recycled plastic from the authorisedrecycling process, and the food that is in contact with suchmaterial 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 modificationof the existing authorisation.
2. The application referred to in paragraph 1 shall be accom-
panied 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 evaluatewhether the opinion or the authorisation is still in accordancewith this Regulation, in accordance with the procedure laiddown in Article 5, where applicable.
4. The Commission shall examine the opinion of the
Authority without delay and if necessary prepare a draftDecision to be taken.
5. A draft Decision modifying an authorisation shall specify
any necessary changes in the conditions of use and, if any, inthe restrictions attached to that authorisation.
6. If appropriate, the authorisation shall be modified,
suspended or revoked in accordance with the procedurereferred 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 Regu-lation (EC) No 882/2004 and shall include in particular auditsascontrol 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 Regulation (EC)No 2023/2006 is in place.
3. The authorisation holder shall notify the competent
authority in the Member State about the recycling or manufac-turing site in which the authorised recycling process is beingapplied. Member States shall forward that information to theCommission.
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
Labelling of recycled plastic materials and articles
Voluntary self-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 inPart 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 plasticshall contain the information laid down in Part B of Annex I tothis Regulation.EN 28.3.2008 Official Journal of the European Union L 86/15Article 13
Transitional measures for the authorisation of recycling
processes
1. For the initial authorisation phase of recycling processes,
the procedure provided for in Articles 5, 6 and 7 shall applysubject to paragraphs 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 theAuthority as provided for in Article 5(2), business operatorsseeking authorisation shall submit an application in accordancewith Article 5.
3. The Commission shall make available to the public a
register of recycling processes for which a valid applicationhas been submitted in accordance with paragraph 2.
4. The Authority shall issue an opinion on each recycling
process for which a valid application has been submittedduring the period referred to in paragraph 2 of this Article.The deadline of six months 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 for submission of supplementary infor-mation in accordance with Article 10(2) of Regulation (EC)No 1935/2004 shall be excluded from consideration for theinitial authorisation.
6. Within six months of receiving all the opinions referred to
in paragraph 4, the Commission shall submit for opinion to theStanding Committee on the Food Chain and Animal Healthdraft decisions granting or refusing authorisation of therecycling 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 ofthis Regulation, for which authorisation is refused or forwhich no valid application has been submitted in accordancewith Article 13 shall be permitted until six months after thedate 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 already inplace on the date of entry into force of this Regulation, forwhich authorisation is refused or for which no valid applicationhas been submitted in accordance with Article 13 shall bepermitted until exhaustion of stocks.
Article 15
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 Official Journal of the European
Union .
However, Articles 3, 9, 10 and 12 shall apply from the date of
the adoption of the Decisions referred to in Article 13(6). Untilthat date, national provisions in force concerning recycledplastic materials and articles and recycled plastic shallcontinue to apply in the Member States.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 27 March 2008.
For the Commission
Androulla VASSILIOU
Member of the CommissionEN L 86/16 Official Journal of the European Union 28.3.2008ANNEX I
PART A
Additional information in the declaration of compliance for recycled plastic materials and articles
The written declaration 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 recycled plastic meet the specifications for which
the authorisation has been granted;
3. The declaration that a quality assurance system according to Section B of Annex to Regulation (EC) No 2023/2006 is
in place.EN 28.3.2008 Official Journal of the European Union L 86/17ANNEX II
The Annex to Regulation (EC) No 2023/2006 is amended as follows:
(1) The following section title is inserted after the title:
‘A.Printing inks ’
(2) The following section is added:
‘B.Quality assurance system for plastic recycling processes covered by Regulation (EC) No 282/2008 on
recycled plastic materials and articles intended to come into contact with foods and amending 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 particular:
(a) a quality policy manual, containing a clear definition of the recycler ’s 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 critical for the
quality control of the recycled plastics;
(c) the managing and operative procedures implemented to monitor 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;
(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. ’EN L 86/18 Official Journal of the European Union 28.3.2008