Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food   (Text with EEA relevance)
Date: 2006-12-22
Institutions: European Commission
Subjects: food safety, foodstuff, product safety, qualitative analysis, quality control of industrial products, quality standard

29.12.2006

EN

Official Journal of the European Union

L 384/75

COMMISSION REGULATION (EC) No 2023/2006

of 22 December 2006

on good manufacturing practice for materials and articles intended to come into contact with food

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(6)

The rules on GMP should be applied proportionately to
avoid undue burdens for small businesses.

Having regard to the Treaty
Community,

establishing the European

Having regard to Regulation (EC) No 1935/2004 of
the
European Parliament and the Council of 27 October 2004 on
materials and articles intended to come into contact with
food (1), and in particular Article 5(1) thereof,

Whereas:

(7)

(8)

Detailed rules should now be set for processes involving
printing inks and should be established for other
processes as necessary. For printing inks applied to the
non-food contact side of a material or article GMP
should in particular ensure that substances are not trans-
through the
ferred into food by set-off or
substrate.

transfer

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

opinion

the

the

of

Groups of materials and articles 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 should be
manufactured in compliance with general and detailed
rules on good manufacturing practice (GMP).

HAS ADOPTED THIS REGULATION:

sectors of

industry have

established GMP
Some
guidelines, while others have not. Consequently,
it
appears necessary to ensure uniformity among Member
States as regards GMP for materials and articles intended
to come into contact with food.

(3)

In order to ensure such conformity, it is appropriate to
lay down certain obligations on business operators.

Article 1

Subject matter

for

(GMP)

This Regulation lays down the rules on good manufacturing
the groups of materials and articles
practice
intended to come into contact with food (hereafter referred to
as materials and articles) 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.

(1)

(2)

(4)

(5)

All business operators should operate an effective quality
management of
their manufacturing operations which
should be adapted to their position in the supply chain.

Article 2

Scope

The rules should apply to materials and articles intended
to be brought
into contact with food, or already in
contact with food and were intended for this purpose,
or those which can reasonably be expected to be brought
into contact with food or to transfer their constituents to
food under normal or foreseeable conditions of use.

This Regulation shall apply to all sectors and to all stages of
manufacture, processing and distribution of materials and
articles, up to but excluding the production of
starting
substances.

(1) OJ L 338, 13.11.2004, p. 4.

The detailed rules set out in the Annex shall apply to the
relevant individually mentioned processes, as appropriate.

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Official Journal of the European Union

29.12.2006

Article 3

Definitions

Article 5

Quality assurance system

For the purpose of this Regulation, the following definitions
shall apply:

The business operator shall establish,

1.
implement and
ensure adherence to an effective and documented quality
assurance system. That system shall:

(a)

‘good manufacturing practice (GMP)’ means those aspects of
quality assurance which ensure that materials and articles
are
consistently produced and controlled to ensure
conformity with the rules applicable to them and with the
quality standards appropriate to their intended use by not
endangering human health or causing an unacceptable
change in the composition of the food or causing a de-
terioration in the organoleptic characteristics thereof;

(b) ‘quality assurance system’ means the total sum of

the
organised and documented arrangements made with the
purpose of ensuring that materials and articles are of the
quality required to ensure conformity with the rules
applicable to them and the quality standards necessary for
their intended use;

(c)

‘quality control system’ means the systematic application of
measures established within the quality assurance system
that ensure compliance of starting materials and inter-
mediate and finished materials and articles with the specifi-
cation determined in the quality assurance system;

(a)

take account of the adequacy of personnel, their knowledge
the premises and
and skills, and the organisation of
equipment such as is necessary to ensure that
finished
materials and articles comply with the rules applicable to
them;

(b) be applied taking into account the size of the business run
by the operator, so as not to be an excessive burden on the
business.

2.
Starting materials shall be selected and comply with pre-
established specifications that shall ensure compliance of the
material or article with the rules applicable to it.

The different operations shall be carried out in accordance

3.
with pre-established instructions and procedures.

(d) ‘non-food-contact side’ means the surface of the material or

article that is not directly in contact with food;

Article 6

Quality control system

(e)

‘food-contact side’ means the surface of a material or article
that is directly in contact with the food.

The business operator shall establish and maintain an

1.
effective quality control system.

Article 4

Conformity with good manufacturing practice

2.
The quality control system shall include monitoring of the
implementation and achievement of GMP and identify measures
to correct any failure to achieve GMP. Such corrective measures
shall be implemented without delay and made available to the
competent authorities for inspections.

The business operator
operations are carried out in accordance with:

ensure

shall

that manufacturing

(a)

the general rules on GMP as provided for in Article 5, 6,
and 7,

(b) the detailed rules on GMP as set out in the Annex.

Article 7

Documentation

1.
The business operator shall establish and maintain appro-
priate documentation in paper or electronic format with respect
to specifications, manufacturing formulae and processing which
are relevant to compliance and safety of the finished material or
article.

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The business operator shall establish and maintain appro-
2.
priate documentation in paper or electronic format with respect
to records covering the various manufacturing operations
performed which are relevant to compliance and safety of the
finished material or article and with respect to the results of the
quality control system.

Article 8

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

3.
The documentation shall be made available by the
business operator to the competent authorities at their request.

It shall apply from 1 August 2008.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 22 December 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

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Official Journal of the European Union

29.12.2006

ANNEX

Detailed rules on good manufacturing practice

Processes involving the application of printing inks to the non-food contact side of a material or article

1. Printing inks applied to the non food-contact side of materials and articles shall be formulated and/or applied in such a

manner that substances from the printed surface are not transferred to the food-contact side:

(a)

through the substrate or;

(b) by set-off in the stack or the reel,

in concentrations that lead to levels of the substance in the food which are not in line with the requirements of Article
3 of Regulation (EC) No 1935/2004.

2. Printed materials and articles shall be handled and stored in their finished and semi-finished states in such a manner

that substances from the printed surface are not transferred to the food-contact side:

(a)

through the substrate or;

(b) by set-off in the stack or reel,

in concentrations that lead to levels of the substance in the food which are not in line with the requirements of Article
3 of Regulation (EC) No 1935/2004.

3. The printed surfaces shall not come into direct contact with food.