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            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,

Having regard to the Treaty establishing the European Community,

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:

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter

This Regulation lays down the rules on good manufacturing practice (GMP) for the groups of materials and articles 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.

Article 2

Scope

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.

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

Article 3

Definitions

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

Article 4

Conformity with good manufacturing practice

The business operator shall ensure that manufacturing operations are carried out in accordance with:

Article 5

Quality assurance system

1.   The business operator shall establish, implement and ensure adherence to an effective and documented quality assurance system. That system shall:

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.

3.   The different operations shall be carried out in accordance with pre-established instructions and procedures.

Article 6

Quality control system

1.   The business operator shall establish and maintain an effective quality control system.

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.

Article 7

Documentation

1.   The business operator shall establish and maintain appropriate 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.

2.   The business operator shall establish and maintain appropriate 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.

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

Article 8

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.

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

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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

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