(EC) No 2023_2006 on good manufacturing practice for materials and articles intended to come into contact with food

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F60FDC7103E445E58C9F6BD7D59DD30D

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4

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日期:

2013-4-10

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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:,(1) 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).,(2) Some sectors of industry have established GMP,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.,(4) All business operators should operate an effective quality,management of their manufacturing operations which,should be adapted to their position in the supply chain.,(5) 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.,(6) The rules on GMP should be applied proportionately to,avoid undue burdens for small businesses.,(7) 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 transferred,into food by set-off or transfer through the,substrate.,(8) The measures provided for in this Regulation are in,accordance with the opinion of the Standing,Committee on the Food Chain and Animal Health,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.,29.12.2006 EN Official Journal of the European Union L 384/75,(1) OJ L 338, 13.11.2004, p. 4.,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 gene……

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