Commission Regulation (EC) No 2023/2006Show full title

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:

(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 deterioration 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 intermediate and finished materials and articles with the specification determined in the quality assurance system;

(d)

‘non-food-contact side’ means the surface of the material or article that is not directly in contact with food;

(e)

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

Article 4 Conformity with good manufacturing practice

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

(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 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:

(a) take account of the adequacy of personnel, their knowledge and skills, and the organisation of the premises and 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.

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