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Information on Good Manufacturing Practice (GMP)

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The availability of documentation on Good Manufacturing Practice – GMP from MS and industry

Class Document

GMP – Mentions generic to FCM

CH VKCS AGFCM Checklist Konformitätsbewertung E140725. The Swiss Packaging Institute (SVI) has developed and revised a checklist for Industry to assess declaration of compliance. It is used by inspectors for controls. No guidance document is available, but they provide courses.

CZ Zakon 258-2000 expresses the need to follow GMP, without any specific detail. (Hlava V, díl 1, oddíl, § 84 (2), § 108 (1))

DE Good Manufacturing Practice (GMP) and Compliance Declaration for Food Contact Materials: Interpretation of the Official Control (2009/52)

DK DVFA Chemicals Contaminants in Food Checklist only specifies the necessity of following GMP. (p.13)

EE suggests business operators to use GMP guidelines elaborated by industry organizations in addition to UK GMP guidelines

ES Guía de trazabilidad en empresas fabricantes de artículos monouso de plástico para alimentación y bebidas, ANAIP/FAMA

HU Regulation 49/2014 states that GMP can minimise the presence of pollutants in foods, without any more detail. (3. § (1-2))

IT Nota del Ministero della Salute n° 2964 del 24/01/2006 mentions the need to produce FCM according to GMP.

IT Rapporti Istisan 11/37- CAST project: Guidelines for the application of the Regulation 2023/2006 to the supply chain of materials and articles intended to come into contact with foodstuffs ISSN 1123-3117. Edited by M.R: Milana, M. Denaro, R. Feliciani, A. Maggio, A. Maini and G. Padula

LT Medžiagų ir gaminių, skirtų liestis su maistu, Geros gamybos praktikos taisyklės – medžiagų ir gaminių, skirtų liestis su maistu, geros gamybos praktikos taisyklės © Lietuvos Pakuotojų Asociacija, 2007

NL “Infoblad documentatie FCM mei 2014” May 2014: short guidance document on how to apply Reg. 2023/2006 and dir. 1935/2004

PE, PP, LDPE,HDPE, PEG – what exactly plastic masterbatch is made out of from GMP

Norden: there are three Norden guidance documents (on paper and board, on printing inks and on food contact materials in general)

Nordic check lists to industry and trade, ANP 2008:709 © NCM, 2008 ISBN 978-92-893-1645-3

SE Normpack General guide on food packaging safety specifies the importance of following GMP EU requirements. (p7)

SK Foodstuffs Code 1799/2003 states that FCM have to be manufactured according to GMP. (§ 4 (1)) regionálne úrady verejného zdravotníctva v sr metodický návod – externé audity, Správne výrobné postupy u výrobcov materiálov a predmetov určených na styk s potravinami; Doc. MUDr. Ivan Rovný, PhD., MPH, 2010, KONTROLNÝ LIST – auditu systému SVP (správne výrobné postupy): “GMP requirements”, “Check list for control GMP” and “Guidance for performing audits in producers of FCM” are still in use

UK Guide to United Kingdom Legal Compliance and Good Practice for Business Documentation, materials and articles in contact with food, June 2009; UK is revising the GMP guidance. The new version is not available yet (the 2009 guide is no longer in use)

GMP – Cork

CoE Policy statement concerning cork stoppers and other cork materials and articles intended to come into contact with foodstuffs states that cork FCM should be manufactured according to the CE Liege guidance “Code of cork stoppers manufacturing practice”.

GMP – Glass

SK Foodstuffs Code 1799/2003 states that glass FCM have to be manufactured according to GMP. (§ 36 (1))

GMP – Metals and alloys

IT Legge n. 243 dell’1 giugno 1988 states that varnished tin free steel FCM have to be produced according to GMP, no further details (Art. 1, Allegato I); Nota n. 12174 del 23/04/2010 states that tin free steel and tinplate FCM have to be produced according to GMP.

HU Regulation 9/2014 states that GMP can minimise the presence of pollutants in foods, without any more detail. (3. § (1-2))

CoE Metals and alloys used in food contact materials and articles states that metallic FCM shall be manufactured in accordance with Regulation (EC) No. 2023/2006. (Chapter 1, 3.1)

GMP – Paper and board

Norden guidelines on paper and board “Paper and Board Food Contact Materials, (TemaNord 2008:515, Copenhagen, Nordic Council of Ministers). It is a GMP document intended for producers of P&B, to ensure compliance, and it is based on the CoE Resolution on paper and board materials and articles intended to come into contact with foodstuffs and its related 5 Technical documents. DK FI NO SE Norden Paper and Board Food Contact Materials provides information on GMP. (Chapter 3, Annex 3).

HR NN125-2009 only states that P&B products must be manufactured according to GMP requirements, no detail. (Članak 100)

ES BUENAS PRÁCTICAS DE FABRICACIÓN para la fabricación de papel y cartón para contacto con alimentos, Primera publicación – Septiembre 2010 (based on CEPI document)

Food contact materials (FCMs) and its briefing, purposes, and its influence on the Member States and related corporation for certain materials- from GMP

CoE Policy statement concerning paper and board materials and articles intended to come into contact with foodstuffs state that paper and board FCM should be manufactured in accordance with the “CEPI guide for good manufacturing practice for paper and board for food contact”. The document reports also the text of the CEPI guidance document. (Resolution RESAP (2002)1, 3.1, 3.1)

CoE Policy statement concerning tissue paper kitchen towels and napkins presents GMP based on the “CEPI guide for good manufacturing practice for paper and board for food contact” and adapted to the production processes used in tissue mills and to reflect the specific characteristics of kitchen towels and napkins. (Chapters 1.2.4, 8)

GMP – Printing ink

CoE Policy statement concerning packaging inks applied to the non-food contact surface of food packaging states that packaging inks should be manufactured according to the “Good Manufacturing Practices for the production of packaging inks formulated for use on the non-food contact surfaces of food packaging materials and articles intended to come into contact with foodstuffs” (prepared by CEPE), and they should be applied according to the “Code for Good Manufacturing Practices for flexible and fibre based packaging for food” (prepared by FPE in co-operation with CITPA). (Chapter 3.2.2, 3.2.3, Technical document n.2 part 1, part 2)

Norden Guidance on Printing inks. Note: The ‘Nordic check lists to industry and trade’ is solely used as a guidance for establishing declarations of compliance and supporting documentation for FCM, and this report will be updated later this year

LU no national tools available regarding details on GMP; but the Switzerland legislation on printing inks (RS 817.023.21 Ordonnance du DFI sur les objets et matériaux) is used as well as the EUPIA guidelines on printing inks and the norden guidelines on printing inks

GMP – Rubber

CoE Policy statement concerning rubber products intended to come into contact with foodstuff only states that rubber FCM should be manufactured according to GMP. (Chapter 3.2.1)

GMP – Varnishes coatings

CoE Policy statement concerning coatings intended to come into contact with foodstuffs states that coatings should be manufactured in accordance with guidelines on GMP for coatings intended to come into contact with foodstuffs.

Note: no mentions were found for silicones, waxes, wood, adhesives, ion exchange resins, multimaterials, and ceramics. No GMP beyond 2023/2006 for CY, IE, LV, LU, MT, PL, PT, RO, SI. No answer from AT, BE, BG, HR, CZ, FR, EL, HU.

 

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