Regulations, Swiss Ordinance, Guidance and more…. Thomas Polster hubergroup Content: 1. Regulation EU 1935/2004 2. Regulation EU 2023/2006 3. Swiss Ordinance 817.023.21 4. Nestlé Guidance Note on Packaging Inks 5. EuPia Guidline 6. GMP EU Regulation 1935/2004 Article 3 Food packaging shall be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could: • endanger human health • bring about an unacceptable change in the composition of the food • or bring about a deterioration in the organoleptic characteristics thereof. EU Regulation 1935/2004 Article 16 Declaration of compliance Materials and articles shall be accompanied by a written declaration stating that they comply with the rules applicable to them Appropriate documentation shall be available to demonstrate such compliance. EU Regulation 1935/2004 Article 17 Traceability (1) The traceability of materials and articles shall be ensured at all stages (2) Business operators shall have in place systems and procedures to allow identification of the businesses from which and to which materials or articles and where appropriate, substances or product covered by this regulation used in their manufacture are supplied. EU-Regulation 2023/2006 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 • Effective quality system • Starting materials in compliance with pre-established specifications • Pre-established instructions and procedures • Migration or Invisible Set off of components of printing inks shall not exceed the limits • No direct contact of printed surface with food • Apply from 1 August 2008 Swiss Ordinance 817.023.21 The 2008 revision of the Swiss Ordinance on Materials and Articles in Contact with Food (Swiss Bedarfs-gegenständeverordnung) introduced new provisions for food packaging inks and printed food packaging (section 8b) Printing Inks for food packaging must be formulated only from raw materails covered by the inventory list of the Swiss Ordinance. Annex 1: list I and II – Annex 6: list I - V ) Migration values of eveluated substances shall not exceed the limits Migration values of non-eveluated substances (Part B of the lists) must be below 10 ppb (0,01 mg/kg) Ink and coating production regarding GMP Swiss Ordinance 817.023.21 Responsibilities The verification of compliance can only be done on the finished printed and/or varnished food packaging The manufacture of the final article has the legal responsibility to ensure that it es fit for the intended purpose and for the compliance with the Swiss Ordinance on materials and Articels in contact with food. No direct food contact with the printed layer Conventional inks and coatings could only be used if migration and invisible set-off is impossible. Possible due to packaging design and/or production process. Nestlé Guidance on Packagin Inks The document refers to the Nestlé Initiative on Packaging Safety and Compliance and adresses the ink usage for decoration on packaging materials. The document applies to printing inks and coatings. General requirements Specific requirements Part 1. UV & EB inks and coatings Part 1. Conventional inks and coatings for offset printing Part 3. Solvent-based & water based inks and coatings Part 4. Ink-jet printing Annex Guidance on Packagin Inks General requirements Only ink and coatings that are carefully formulated for food packaging applications ca be used. The principle of low migration must be proved by the converter of packaging materials. The ink and coating rawmaterials must be comply with either existing restrictions, e.g. specific migration limits, or – when no toxicolagical evaluation has been made – with migration limit of 10 ppb. The use of „Fanal“ type pigments must be avoided Guidance on Packagin Inks General requirements (continued) The use of printed packaging materials at high temperature must be thoroughly evaluated The sensory impact of inks and coatings must be thoroughly evaluated It´s the final converter´s responsibility to ensure the best combination of inks and coatings Guidance on Packagin Inks Efficient barrier An efficient barrier consists of either glass, plain aluminium (proven sufficient thickness), silica, or the following virgin resins: PET, PVDC and EVOH The following examples fall in this category: Bag in a box where the bag is made of a barrier material (with plain aluminium) All types of labels/sleeves on cans, glass jars or rigid containers (e.g. minimum thickness 90 um) wher the plastic is a demonstrated barrier material and only if applied filling and closing. Cans printed by litho and with UV-coating on the external face, without inner coating Guidance on Packagin Inks UV & EB inks and coatings (offset and flexo printing) Both following requirements must be fulfilled: Inks formulation must comply with the approved list of photo-initiators and the restrictions of acrylates (see Tables 2 and 3 in Annex) Migration must be tested by the converter before the first application and results must be below: - regulatory limits or - any other existing limits or - 10 μg/kg food for non-evaluated substances. (see protocol in Annex for details) Guidance on Packagin Inks Conventional inks and coatings for offset printing • Many conventional offset inks are available on the market place. Thus, to avoid using inadequate inks (newspaper inks, non-food grade inks), only inks and coatings that are designed for food packaging and that are recommanded by the ink makers must be used. Guidance on Packagin Inks Conventional inks and coatings for offset printing Inks complying with the following two sets requirements will be preferred: Composition: • No mineral oils are used (traditional offset printing). • Only selected vegetable oils and fatty acid esters minimizing migrations and off-flavors are used. • No Cobalt-based drying systems are used. Migration must be tested by the converter before the first application and results must be below: - regulatory limits or - any other existing limits or - 10 μg/kg food for non-evaluated substances. (see protocol in Annex for details) Guidance on Packagin Inks Solvent-based & water-based inks and coatings (rotogravure and flexo printing) The inks must be formulated taking into account the following elements: TAA (Titanium Acetyl Acetonate) must not be used as an adhesion promoter Phthalate plasticisers must not be used Solvents composition must be conform to Nestlé restriction (see Table 4 in Annex) The use of Nitrocellulose inks is allowed in cases where the packaging is heated with food prior to consumtion only it the temperature of the printed layer does not exceed 100°C and for an exposure below 30 min. Guidance on Packagin Inks References • • • • • • • Commission Regulation (EC) 1935/2004 Directive 2002/72/EC and subsequent amendments Commission Regulation (EC) 2023/2006 Resolution of Council of Europe on packaging inks AP(2005)2 EUPIA Website: www.eupia.org Ultra –Violet Curing, GPMU Safety Reps Handbook, October 2004 Swiss ordinance 817.023.21 as applied on April 1st, 2010 Guideline Guideline Printing Inks applied to the non-food contact surface of food packaging materials and articles • Raw materials according to the selection scheme • Manufacturing in accordance with GMP • No direct contact ink/food • No visible set-off • Global and specific migration shall not exceed the limits Guideline Selection scheme for raw materials • Colorants in compliance with AP(89)1 • Raw materials shall not belong to: • classification as cmr (cancerogenic mutagenic toxic for reproduction) • classified to ‘toxic‘ or ‘very toxic‘ • pigments based on toxic heavy metals • substances listed in the EU Directive 76/769/EEC Guideline Selection scheme for raw materials • Limits for migration (molecular weight < 1000 D) • < 10 ppb*) for insufficient toxicological datas • < 50 ppb for 3 neg. mutagenicity tests • > 50ppb for favourable toxicol. Datas (EFSA, FDA, etc.) *) migration limit deadlines: 50 ppb until 2010, 10ppb until 2015 What is the Point of Good Manufacturing Practice? It is: "a management tool designed to prevent migration, organoleptic changes and contamination and to ensure compliance with the most important requirements laid down with regard to packaging." GMP - Ink manufacturers Good Manufacturing Practices for the Production of packaging Inks for the use on the non food contact surfaces of food packaging and articles intended to come into contact with food EuPIA October 2005 EuPIA - GMP in the hubergroup • Only approved raw materials • Contamination free production • Production plant in Ireland for vehicles, concentrates and CORONA MGA® - Process inks • Separate mixing station in Munich • GMP - requests in the whole dispersion varnish line • Traceability to the raw materials • Special cleaning systems • Control of contamination GMP - Converters (FPE/CITPA) 4. Method „Designing the packaging material for compliance“ This means that the combination of: • the choice of substrates • the choice of other raw materials • the composition of laminates • the application of inks, adhesives, varnishes and other coatings • and the choice of production techniques will be such, that protection against migration, organoleptic changes and contamination and compliance with the essential requirements is, as it were, „built into“ the finished product.