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)

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

• (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.

Article 6

Quality control system

Article 7

Documentation

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.

ANNEX

Detailed rules on good manufacturing practice

A. Printing inks

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.

• 1. 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.

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

B. Minimum requirements for a quality assurance system to be operated at recycling facilities, where recycled plastic is manufactured in accordance with Regulation (EU) 2022/1616

• 1.The quality assurance system implemented by the recycler must give adequate confidence in the ability of all recycling operations taking place at the facility to ensure the recycled plastic meets the requirements set out in Regulation (EU) 2022/1616.

• 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.

• 3.The quality assurance system implemented by the recycler shall include specific operations in the recycling process, ‘Quality Assessment Stages’, at which the recycler shall assess the quality of each batch of material directly originating from a manufacturing stage.

• This assessment shall check the quality of that material by verifying:

• — whether the applicable critical limits referred to in point 2, point (c) have been met at each unit operation that is part of the manufacturing stage, and

• — whether the quality of the resulting material meets pre-defined criteria, using the tests, protocols and evidence referred to in point 2, point (e) applicable to the manufacturing stage.

• The assessment shall result in a decision on whether the quality of the batch is considered as complying with Regulation (EU) 2022/1616 and suitable for further processing, whether its quality requires correction before further processing or, whether the batch is to be discarded or used for non-food applications.

C. Reprocessing of plastics falling within the scope of Regulation (EU) No 10/2011

• 1.Plastic offcuts, scraps, and similar by-products of plastic manufacturing processes and intended to be reprocessed in accordance with Article 10(2) of Regulation (EU) No 10/2011 (‘materials intended for reprocessing’) shall be collected separately from waste as close as technically achievable to the point at which they are cut, scrapped or otherwise produced from a similar plastic manufacturing operation leading to offcuts and scraps and similar by-products of plastic.

• 2.Materials intended for reprocessing shall be collected either using a closed piping or belt system intended for that purpose only, or in clean bins, bags, or other containers designated to this purpose and which can easily be recognised as being intended only for this purpose. Those types of containers shall be closed as soon as they are fully filled. Up to the point of reinsertion in the plastic production process the applied containers shall be designed to prevent any contamination of the plastic material.

• 3.Such bins, bags or containers may be transferred for reprocessing individually or be grouped in secondary packaging. The resulting unit shall be considered as a batch of material intended for reprocessing. The definition of ‘batch’ in Article 2(3), point (20) of Regulation (EU) 2022/1616 shall apply.

• 4.At any stage of the reprocessing of plastic, operators shall ensure that the quality assurance system prevents it from being mixed with plastic of a different composition, other materials, or with waste. The transfer of batches of plastic by-products between operations prior to their use in the manufacturing of plastic materials and articles, including the mixing with plastic of the same composition, shall be recorded and their traceability shall be accounted for in the quality assurance system.