Good Manufacturing Practice Guide - British Printing Industries ...

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intended use. In particular, GMP shall ensure that materials and articles do notendanger human health or cause an unacceptable change in the composition of thefood or cause a deterioration in the organoleptic properties thereof (Article 3 ofFramework Regulation (EC) No 1935/2004).1.3.5 Compliance with Regulation (EC) No 1935/2004 and Regulation (EC) No 2023/2006has shared responsibility for the whole supply chain.1.3.6 Annex 1 to Regulation (EC) No 2023/2006 has rules on GMP for processes involvingthe application of printing inks to the non-food contact side of a material or article.P a g e | 5
2 Regulations, recommendations and guidance documents2.1 IntroductionThe legislation concerning materials and articles intended to be in contact with foodis complex. Paper and board, and also printing inks are not specifically covered by EUlegislation.This chapter gives an overview of the most relevant horizontal as well as materialspecific legislation and guidance.2.2 Horizontal legislation in the EU2.2.1 Horizontal legislation is applicable to all materials and articles.2.2.2 Regulations are directly applicable in the 27 Member States, which means thatnational authorities do not need any legislative measures to implement therequirements present in regulations, by contrast to Directives. The requirementswithin regulations also supersede any contradicting national provisions. In otherwords, the EU requirements in regulations must be complied with on the applicationdate set therein.2.2.3 Two legally binding regulations at EU level create the general legal “food contact”frame which label converters have to observe, the so-called “Food ContactFramework Regulation” and the “Good Manufacturing Practices Regulation”2.2.4 The Food Contact Framework Regulation (EC) N° 1935/2004 (27 October 2004)stipulates general requirements for all food contact materials and mentions howspecific measures for certain listed materials may be developed.2.2.5 Often reference is made to Article 3 of this Framework Regulation“Materials and articles ... shall be manufactured in compliance with goodmanufacturing practice so that, under normal foreseeable conditions of use, theydo not transfer their constituents to food in quantities which could endangerhuman health or, bring about an unacceptable change in the composition of thefood or, bring about a deterioration in the organoleptic characteristics thereof.”2.2.6 From the 17 product groups listed in Annex 1 of the framework regulation, specificmeasures were developed for food contact plastics, regenerated cellulose, ceramics,nitrosamines, lead from metal coatings, plasticisers in gaskets, recycling plastics, andactive and intelligent materials, not for paper and board, adhesives, coatings andprinting inks.2.2.7 The Good Manufacturing Regulation (EC) 2023/2006 applicable since August 2008,determines the minimum requirements for good manufacturing practices, the needfor a quality assurance system, appropriate documentation and the establishment ofquality control procedures.2.2.8 Annex 1 specifies how the printing inks applied to the non food contact side ofmaterials and articles shall not transfer substances to the food in concentrations
Page 1 and 2: labelsGood ManufacturingPractice Gu
Page 3 and 4: Contents1 Introduction and Objectiv
Page 5: 1.2.2 health hazards that may resul
Page 9 and 10: 2.4 Material specific legislation a
Page 11 and 12: In the absence of an EU harmonized
Page 13 and 14: Regulation (EU) No 10/2011, consoli
Page 15 and 16: of certain national technical rules
Page 17 and 18: 3.2 Sources of contaminationPossibl
Page 19 and 20: European industry bodies such as BP
Page 21 and 22: ‣ storage period (maximum shelf l
Page 23 and 24: 4.7 Goods In and Out and Storage4.7
Page 25 and 26: storage or production rooms for a s
Page 27 and 28: applicable legislation) or because
Page 29 and 30: 4.13.6 Sensoric testingRegulation (
Page 31 and 32: 5 Guidance on Inks and Varnishes5.1
Page 33 and 34: For digital printing ensure you com
Page 35 and 36: 6 Process Flow (A typical flow char
Page 37 and 38: November 2012 - EuPIA Guide to Inks
Page 39 and 40: Functional barrier: A “Functional
Page 41 and 42: Set-off: Transfer from the printed
Page 43 and 44: Q9 What are quality management syst
Page 45 and 46: Q26 How does one correctly manage h
Page 47 and 48: 11 Document Evidence11.1 Statement

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