- Latest available (Revised)
- Point in Time (22/12/2006)
- Original (As adopted by EU)
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)
When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.
Legislation.gov.uk publishes the UK version. EUR-Lex publishes the EU version. The EU Exit Web Archive holds a snapshot of EUR-Lex’s version from IP completion day (31 December 2020 11.00 p.m.).
Version Superseded: 31/12/2020
Point in time view as at 22/12/2006.
There are currently no known outstanding effects for the Commission Regulation (EC) No 2023/2006.
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
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.
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.
For the purpose of this Regulation, the following definitions shall apply:
‘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;
‘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;
‘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;
‘non-food-contact side’ means the surface of the material or article that is not directly in contact with food;
‘food-contact side’ means the surface of a material or article that is directly in contact with the food.
The business operator shall ensure that manufacturing operations are carried out in accordance with:
the general rules on GMP as provided for in Article 5, 6, and 7,
the detailed rules on GMP as set out in the Annex.
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.
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.
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.
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
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
Point in Time: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
This timeline shows the different versions taken from EUR-Lex before exit day and during the implementation period as well as any subsequent versions created after the implementation period as a result of changes made by UK legislation.
The dates for the EU versions are taken from the document dates on EUR-Lex and may not always coincide with when the changes came into force for the document.
For any versions created after the implementation period as a result of changes made by UK legislation the date will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. For further information see our guide to revised legislation on Understanding Legislation.
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: