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)
Date: 2008-03-27
Institutions: European Commission
Subjects: food safety, foodstuff, foodstuffs legislation, packaging product, plastics, qualitative analysis, recycled product

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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,

plastic materials and articles which are intended to come
into contact with foodstuffs.

Having regard to the Treaty
Community,

establishing the European

the
Having regard to Regulation (EC) No 1935/2004 of
European Parliament and of the Council of 27 October 2004
on 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)

(2)

Directive 94/62/EC of the European Parliament and of
the Council of 20 December 1994 on packaging and
packaging waste (2) promotes the recovery and incin-
eration at waste
incineration plants with energy
recovery and recycling of packaging waste.

Regulation (EC) No 1935/2004 sets out the general prin-
ciples for eliminating the differences between the laws of
Member 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 materials and articles should be given
priority.

(3)

Commission Directive 2002/72/EC of 6 August 2002
relating to plastic materials and articles intended to
come into contact with foodstuffs (3) sets out rules for

(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)

(5)

(6)

(7)

use,

from
Plastic packaging waste may contain residues
and
contaminants
previous
from misuse
contaminants
substances.
from
Therefore it is necessary to lay down special requirements
to ensure that materials and articles produced from
recycled plastics and intended for food contact respect
the requirements of Article 3 of Regulation (EC) No
1935/2004.

non-authorised

(EC) No

2023/2006

Commission Regulation
of
22 December 2006 on good manufacturing practice
for materials and articles intended to come into contact
with food (4)
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 Regu-
lation (EC) No 1935/2004 and combinations of those
materials and articles or recycled materials and articles
used in those materials and articles.

depolymerisation should not

Plastic waste can be treated mechanically to produce
recycled materials and articles or
it can be broken
down to monomers and oligomers by chemical depoly-
resulting from
merisation. Monomers and oligomers
treated
chemical
differently from monomers manufactured by chemical
synthesis. Therefore, they are covered by the authorisa-
tion of monomers and additives in Directive 2002/72/EC
and they should comply with the specifications and
they
purity
should not be covered by this Regulation.

therein. Therefore,

established

criteria

be

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 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 Regu-
lation (EC) No 2023/2006 would be considered as
suitable for food contact applications and should not
this Regulation. All other
fall under
offcuts and scraps from the production of plastic food
contact materials should fall within the scope of
the
present Regulation.

the scope of

(4) OJ L 384, 29.12.2006, p. 75.

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(8)

(9)

Recycled plastic used behind a plastic functional barrier
as defined by Directive 2002/72/EC should not be
covered by the authorisation procedure in this Regu-
lation. The rules set out in Directive 2002/72/EC for
substances used behind a plastic functional barrier are
regarded as
to ensure the safety also of
recycled plastics used behind a functional barrier.

sufficient

Directive 2002/72/EC lays down lists of
substances
authorised to be used in the manufacture of plastic
food contact materials or articles. These substances
safety and migration
have been evaluated for
limits have been set for their safe use. To ensure the
same level of safety of recycled plastic 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.

their

(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 plastic food contact materials and
articles.

(11) Only the combination of characteristic of

the input,
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
is only
plastic and the recycling process applied.
feasible to evaluate all these aspects together in individual
evaluations of the recycling processes followed by indi-
vidual authorisations.

It

(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
applied.
an effective
assurance
quality
Therefore, only recycled plastics
recycling
process managed by an effective quality assurance
system should be placed on the market.

system is
from a

recycled plastic

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
that
complies 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 with
a lower sorting efficiency as regards to its former use in
from
food contact which is
kerbside
efficiency
necessary for each material should be identified on a
case by case basis.

collection systems. The

realistically achievable

sorting

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
recycled plastics.
product applicable to all
Therefore
characterisation
together with an adequate process to remove possible
contamination is necessary to control the safety of the
final product.

combination of

types of

input

a

In the mechanical treatment, in which the plastic waste is
ground 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
risk to human health. The contaminants should only
migrate in levels comparable to or well below levels
that recycling
demonstrated in the challenge tests of
process or
test and
in other appropriate analytical
should comply with the requirements of Article 3 of
Regulation (EC) No 1935/2004. A safety assessment
the recycling process fulfils these
should verify that
conditions. Alternatively,
for non-fillable materials and
articles, such as crates and pallets that are handled in
in a closed and controlled chain in
product
which all steps of manufacture, distribution and use are
controlled, it may be sufficient to prove that contamina-
tion can be excluded when they are only used in contact
with dry food such as fruits and vegetables.

loops

(14)

(15)

(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 materials and articles complying with the provisions

(16)

Certain types of plastic materials and articles manu-
factured 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.

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(17) Differences between national

provisions

regulations
the

laws,
concerning

and
administrative
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 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 to
12 of Regulation (EC) No 1935/2004 is intended for the
authorisation of substances. Changes to that procedure
should be introduced in the present Regulation to adapt
the 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
the
concerning
preparation and the submission of the application.

guidance

detailed

publish

(23)

(24)

meters as described in the application and authorisation
are adhered to.

The public should be informed on the authorised
that purpose, a Community
recycling processes. For
register, as referred to in Article 5(1)(m) of Regulation
(EC) No 1935/2004, of recycling processes authorised
under this Regulation should be established including
the description of
the
recycled plastic of the authorised process.

the field of application for

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 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
rules (1) also covers official control on food contact
materials. The most efficient way to control
the
recycling process is applied as specified in the authorisa-
tion 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 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 to
competent authorities and small and medium enterprises.

if

(20)

The safety 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.

(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.

(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.

(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
the
ISO 14021. To ensure adequate information of
consumer when recycled plastics are labelled,
they
should follow transparent rules as those laid down in
EN ISO 14021 or equivalent.

(22)

It should be possible to apply the process in different
production sites as long as technology and process para-

(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).

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(27) Article 16 of Regulation (EC) No 1935/2004 requires a
declaration of compliance for materials and articles. The
converter of 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 appli-
cation. 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 declaration is already
laid down in Directive 2002/72/EC. Therefore, this Regu-
lation should only specify the additional information in
relation to the content of recycled plastics in the recycled
plastic materials and articles.

foodstuffs as referred to in Article 1 of Directive 2002/72/EC
‘recycled plastic
which contain recycled plastic
materials and articles’).

(hereafter

This Regulation shall not apply to the following recycled
2.
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;

(28)

(29)

(30)

available

time should be allowed for applicants

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 authorisa-
tion procedure is smooth and does not disturb the
existing recycled plastic materials and articles market.
Sufficient
to
information
to the Authority
the
make
the recycled
the safety assessment of
necessary for
plastic used in such products. Therefore, a certain time
period, (the ‘initial authorisation phase’), should be fixed
during which time the information for existing recycling
processes should be submitted by the applicants to the
authorisations of new
for
Authority. Applications
recycling processes may also be submitted during the
initial
should
authorisation phase. The Authority
evaluate without delay all applications for existing, as
well as new recycling processes for which sufficient infor-
mation has been submitted during the initial authorisa-
tion phase.

Specific requirements need to be set on the quality
assurance system applied in recycling processes. As the
the good manufacturing
quality assurance is part of
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.

The measures provided for in this Regulation are in
accordance with
Standing
Committee on the Food Chain and Animal Health,

opinion

the

the

of

(b) recycled plastic materials and articles made from unused
plastic production offcuts
in
compliance with Directive 2002/72/EC, that are recycled
within the manufacturing site or are used at another site;

and/or process

scraps

(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.

The plastic materials and articles that fall within the scope

3.
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 Directive
2002/72/EC shall apply.

2.

The following definitions shall also apply:

HAS ADOPTED THIS REGULATION:

(a)

Article 1

Subject matter and scope

‘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;
this term is
limited to processes, in which a recycled plastic is produced;

for the purpose of

this Regulation,

1.
This Regulation shall apply to the plastic materials and
articles and parts thereof intended to come into contact with

(b) ‘plastic input’ means collected and sorted post-use plastic
materials and articles used as input into a recycling process;

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(c)

and distribution cycles

‘product loops which are in a closed and controlled chain’
means manufacture
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 tech-
nically 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 the 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 responsible 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 appropriate 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.

Article 4

Conditions for the authorisation of recycling processes

In order to be authorised, a recycling process shall comply with
the following conditions:

(b) the plastic input must originate from plastic materials and
articles that have been manufactured in accordance with
Community legislation on plastic food contact materials
and articles, in particular Council Directive 78/142/EEC of
laws of the
30 January 1978 on the approximation of
Member States relating to materials and articles which
contain vinyl chloride monomer and are intended to
and Directive
come
2002/72/EC;

into contact with foodstuffs (1)

(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
intended 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 to
reduce any contamination of
to a
concentration that does not pose a risk to human
health;

the plastic input

(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 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 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

The procedure for authorisation laid down in Articles 9
1.
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.

The

technical dossier

2.
information
specified in the guidelines for
the safety assessment of a
the
recycling process to be published by the Authority at
latest six months after the date of publication of this Regulation.

contain the

shall

(a)

the quality of plastic input 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 of Regulation (EC) No 1935/2004;

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.

(1) OJ L 44, 15.2.1978, p. 15.

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In the event of an opinion in favour of authorising the
4.
evaluated recycling process, the opinion of the Authority shall
include the following:

(e) any conditions or

restrictions concerning the recycling

process;

(a) a short description of the recycling process;

(f) any characterisation of the recycled plastic;

(b) where appropriate, any recommendations on conditions or

restrictions concerning the plastic input;

(g) any conditions in the field of application of the recycled
plastic that has been manufactured by the recycling process;

(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

concerning
conditions in the field of application of the recycled plastic;

recommendations

appropriate,

any

(f) where appropriate, any recommendations concerning moni-
recycling process with the
the

toring compliance of
conditions of the authorisation.

Article 6

Authorisation of recycling processes

(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.

The Decision granting or refusing the authorisation shall

4.
be published in the Official Journal of the European Union.

The authorisation issued to the authorisation holder shall

5.
be valid throughout the Community.

1.
The Commission shall adopt a Decision addressed to the
applicant granting or refusing authorisation of the recycling
process.

The authorised recycling process shall be entered in the Register
referred to in Article 9(1).

Article 11(3) of Regulation (EC) No 1935/2004 shall apply.

Article 7

Obligations arising from the authorisation

The Decision shall take into account the opinion of the
2.
Authority, 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 of
the reasons for the differences.

The Decision granting the authorisation shall include the

3.
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;

the

After

authorisation of

in
1.
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.

recycling process

a

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 imme-
diately inform the Commission of any new scientific or
technical information, which might affect the safety assessment
of the recycling process in relation to human health.

(d) any conditions or restrictions concerning the plastic input;

If necessary, the Authority shall then review the assessment.

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the
The granting of an authorisation shall not affect
3.
general civil and criminal liability of any business operator in
the material or
respect of
article
authorised
recycling process, and the food that is in contact with such
material or article.

the authorised recycling process,

from the

containing

recycled

plastic

Article 8

Modification, suspension and revocation of authorisation
of a recycling process

The authorisation holder may,

1.
in accordance with the
procedure laid down in Article 5(1) apply for a modification
of the existing authorisation.

Each entry in the register shall

3.
referred to in Article 6(3).

include the information

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 audits
as control technique as specified in Article 10 of Regulation (EC)
No 882/2004.

The application referred to in paragraph 1 shall be accom-

2.
panied by the following:

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.

(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.

On its own initiative or following a request

3.
from a
Member State or the Commission, the Authority shall evaluate
whether the opinion or the authorisation is still in accordance
in accordance with the procedure laid
with this Regulation,
down in Article 5, where applicable.

the
The Commission shall examine the opinion of
4.
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.

appropriate,

6.
If
suspended or
referred to in Article 6.

the

authorisation shall be modified,
revoked in accordance with the procedure

Article 9

Community register

The Commission

1.
Community register of authorised recycling processes.

establish

shall

and maintain

2.

The register shall be made available to the public.

The authorisation holder

3.
shall notify the competent
authority in the Member State about the recycling or manufac-
turing site in which the authorised recycling process is being
applied. Member States shall forward that information to the
Commission.

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 in
Part A of Annex I to this Regulation.

a

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 down in Part B of Annex I to
this Regulation.

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Article 13

Article 14

Transitional measures for the authorisation of recycling
processes

Transitional measures for the trade in and use of recycled
plastic

For the initial authorisation phase of recycling processes,
1.
the procedure provided for in Articles 5, 6 and 7 shall apply
subject to paragraphs 2 to 6 of this Article.

During the 18 months following the publication of the
2.
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 make available to the public a
register of recycling processes for which a valid application
has been submitted in accordance with paragraph 2.

The Authority shall

4.
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.
issuing the opinion, as
The deadline of
referred to in Article 5(3), shall not apply.

six months

for

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 the
initial authorisation.

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 Chain and Animal Health
the
draft decisions granting or
recycling processes referred to in paragraph 1.

refusing authorisation of

Trade in and use of recycled plastic from a recycling
1.
process already in place on the date of entry into force of
this Regulation,
for
which no valid application has been submitted in accordance
with Article 13 shall be permitted until six months after the
date of adoption of the Decisions referred to in Article 13(6).

for which authorisation is refused or

2.
Trade in and use of recycled plastic materials and articles
containing 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 accordance with Article 13 shall be
permitted 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
the European
that of
Union.

its publication in the Official

Journal of

However, Articles 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
shall
plastic materials
continue to apply in the Member States.

and recycled plastic

and articles

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 Commission

28.3.2008

EN

Official Journal of the European Union

L 86/17

ANNEX 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.

L 86/18

EN

Official Journal of the European Union

28.3.2008

ANNEX 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.’