Demonstrating Compliance of Printing Inks

Transcription

1 Demonstrating Compliance of Printing Inks European Coatings Symposium, 15 May, 2012, Düsseldorf Hazel O Keeffe Senior Associate Keller and Heckman LLP Avenue Louise Brussels, Belgium 32(2) okeeffe@khlaw.be Washington, DC Brussels San Francisco Shanghai

2 A preliminary word This presentation provides information about the law. Legal information is not the same as legal advice, which involves the application of law to an individual s specific circumstances. The interpretation and application of the law to an individual s specific circumstances depend on many factors. This presentation is not intended to provide legal advice. The information provided in this presentation is drawn entirely from public information. The views expressed in this presentation are the author s alone and not those of the author s clients. 2

3 Keller and Heckman LLP Recognized world leading law firm in particular in the sectors of chemical control food and food-contact materials A pioneer in use of interdisciplinary approaches to problem-solving Over 20 in-house scientific staff that works closely with attorneys (90) on matters of technical complexity Offices in Brussels, Washington DC, San Francisco and Shanghai Firm expanding: fifth office opened in Paris 3

4 What do we do? E.g.: Opinion Letters GMP Audit Inspections and Advice Test Protocols Filings in the US, EU and China including Food Contact Substance Notifications in the US (FDA) Food Contact Petitions in the EU (before EFSA and national authorities) Grandfathering petitions in China (MoH; ~250 petitions filed) Advocacy with Agency and Legislative Officials Product recall and liability 4

5 Agenda Overview of main current/draft legislation in Europe applicable to food-contact printing inks Overarching harmonized EU legislation Draft German Ordinance on Printing Inks Swiss Ordinance Demonstrating compliance of printing inks with EU food contact legislation 5

6 Harmonized EU legislation 6

7 Harmonized EU legislation No specific legislation regulating printing inks at the EU level Framework Regulation (EC) 1935/2004 and GMP Regulation (EC) 2023/2006 apply to all food contact materials and articles (M&A) 7

8 Framework Regulation Applies to M&A which, in their finished state, are intended to be brought into contact with food already in contact with food and were intended for that purpose; or can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable circumstances (e.g. printing inks used on packaging) 8

9 Framework Regulation general requirements (Article 3.1) Must not, under normal or foreseeable conditions of use, transfer constituents to food in quantities, that could: Endanger human health; or Bring about an unacceptable change in the composition of the food; or Deteriorate the organoleptic characteristics (taste/odor) of the food 9

10 GMP Regulation (EC) 2023/2006 GMP = those aspects of quality assurance which ensure that: - M&A are consistently produced - controlled to ensure conformity with - the rules applicable to them - the quality standards appropriate to their intended use by complying notably with Article 3.1 of Framework Regulation 10

11 GMP Regulation (EC) 2023/2006 The core text of the GMP Regulation applies to printing inks on the food contact side of packaging and on the non-food contact side Part A (Printing inks) of Annex of the GMP Regulation applies to printing inks that are on the non-food contact side only 11

12 Draft German Ordinance on Printing Inks 12

13 Germany draft German Ordinance on Printing Inks Draft Ordinance on printing inks intended to amend the German Commodities Regulation (Bedarfsgegenständeverordnung) Initially issued for consultation on 7 January 2011 until 4 February 2011 and industry hearing took place on 11 April 2011 Second draft dated 31 October 2011 issued to address industry concerns 13

14 Translation of definition of printing inks «Preparations which are applied in a printing or coating process on food contact material surfaces or are inserted into them for purposes of inscription, coloring, imaging or achieving gloss effects as well as to serve as adhesion promoter or protection. Printing inks are also preparations which can be used for technological reasons during the printing or coating process.» 14

15 Definition/Exemption Food-contact materials are exempted if substance transfer from the ink to the food can be ruled out For example, if there is an absolute barrier to migration separating the ink from the food 15

16 Positive list Set out in Annex 14: I. Monomers or other starting substances II. Colorants (pigments and dyes) III. Solvents IV. Additives (additives used for pigments are not included) V. Photoinitiators Restrictions, specifications and purity requirements Cross-reference to the Plastics Regulation (EU) 10/2011 with some restrictions 16

17 Nanomaterials European Commission recommendation 2011/696/EU on the definition of nanomaterial included Unevaluated nanomaterials may be used provided there is no transfer to the food 10 ppb detection limit is not applicable to nanomaterials 17

18 Inventory List Substances not included in the positive list in Annex XIV may be used if they are not CMRs are not nanomaterials migrate at less than 10 ppb are in Inventory list to be published on website of BVL (Federal Office of Consumer Protection and Food Safety) Businesses must notify substances not included in Inventory list (or positive list) to the BVL before placing them on the market in Germany Inventory list will be updated and published every 2 months 18

19 Declaration of Compliance (DoC) Required for the printed food contact material the printing ink, AND the substances intended to be used in the manufacture of the printing ink Must be in the German language or another easily understandable language Alternatively, information from which such a declaration available free of charge 19

20 DoC information to be included DoC must include Information similar to that set out in Annex IV of the Plastics Regulation But also the following supporting documentation must be kept Description of test conditions and test results Calculations, including modelling Further analyses Certification of non-objection or a justification proving conformity Supporting documentation must be made available to the authorities on request 20

21 Industry comments Shortcomings in updated draft already highlighted by Industry such as: Printing inks on the food-contact side of FCM should be clearly excluded from the draft this is not clear from the current definition The inapplicability of the 10 ppb detection limit to unlisted nanomaterials is not justified DoC provisions confusing also should leave it to industry to decide how much information must be provided at each stage in the supply chain 21

22 Path to adoption of German draft Ordinance on Printing Inks Expected to be notified to the European Commission soon (?) Thereafter, it should be published in German legal bulletin (Bundesgesetzblatt) in first half 2013 Would enter into force 1 year after publication 22

23 Swiss Ordinance

24 Regulation of Printing Inks in Switzerland Ordinance of 23 November 2005 includes specific provisions on packaging inks, i.e. Articles 26e to 26i of Section 8b 24

25 Regulation of Printing Inks in Switzerland Scope The provisions on inks do not apply if: The packaging ink layer is in direct contact to food (for those, only colorants are regulated) if migration into food of ink substances is rendered impossible Set off or transfer via a gas phase can be excluded 25

26 Regulation of Printing Inks in Switzerland Positive Lists List of permitted substances : Printing inks may be manufactured only using substances mentioned in Annex I and Annex 6: Annex I, lists I and II (plastics) Annex 6 provides the following lists: I. Binders (monomers) II. Colorants and pigments III. Solvents (including energy curing monomers) IV. Additives (does not include those used in the preparation of pigments and aids to polymerization) V. Photoinitiators => Subject to the conditions specified therein 26

27 Regulation of Printing Inks in Switzerland Positive Lists Annex 6: the lists are divided into two parts Part A: Evaluated substances Part B: Non-evaluated substances; these are permitted provided that no transfer into food or food simulants may be detected; relevant evidence may be provided by means of worst case calculation or analytical data 0.01mg/kg limit 27

28 Regulation of Printing Inks in Switzerland -- Non-Listed Substances Their use must be notified prior to marketing to Swiss authorities (Office Public de la santé publique) along with tox data, information on the nature and concentration of the substances migrating to foods or to food simulants, the analytical methods, the technological need for using such substances Swiss authorities will set up the conditions of use of the notified substances 28

29 Enforcement Revision of Ordinance completed to address errors and entered into force on 1 May 2011; no transition time It indicates which substances are currently under re-evaluation 29

30 Demonstrating compliance of printing inks with EU food contact legislation 30

31 Demonstrating Compliance Many different sources available to help demonstrate compliance, notably safety, including The Plastics Regulation (EU) 10/2011 Member State legislation (even when not directly applicable) such as Spanish Real Decreto 847/2011, Dutch Packaging and Utensils Regulations, 1979, etc. Council of Europe Resolution AP (2005) on packaging inks or RESAP (2004) 1 on coatings and related policy documents 31

32 Demonstrating Compliance EU Food Additives legislation The European Commission s Synoptic document (note: updated to 2005 only) Swiss Ordinance on Printing inks or FDA s Code of Federal Regulations (CfR) or listing in another jurisdiction EuPIA guidelines 32

33 Demonstrating Compliance Guidelines issued by national authorities (e.g. Nordic printing ink check lists for compliance in industry and trade and control by food inspection dated 2012) EFSA opinions/opinions of scientific authorities in EU Member States or in other jurisdictions Conclusion founded upon well-accepted scientific principles 33

34 Useful links The Plastics Regulation (EU) No 10/2011 (consolidated version) Council of Europe Resolutions/Policy Statements Link to resolutions: Link to policy statements: asp#topofpage Food Additives legislation

35 Useful links The European Commission s Synoptic document mentaire/fichiers_documents/avis_de_aesa/synoptic_doc_en_- _version_june_2005.pdf Swiss Ordinance on Printing inks en EuPIA guidelines 8E&eas:dat_im=05048E Nordic printing ink check lists for compliance in industry and trade and control by food inspection 35

36 Conclusions Ongoing developments re regulation of printing inks in the EU important to keep up to date In the absence of specific national legislation regulating printing inks, they must simply meet general harmonized requirements Several ways in which safety can be demonstrated The future potentially different national legislation on printing inks - barrier to trade? 36

37 Thank you Hazel O Keeffe Senior Associate Keller and Heckman LLP Avenue Louise Brussels, Belgium 32(2) okeeffe@khlaw.com Washington, DC Brussels San Francisco Shanghai