Recent developments in Member State legislation impacting the food-contact coatings industry

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1 Recent developments in Member State legislation impacting the food-contact coatings industry Packaging and Can Coatings, Düsseldorf, 11 June 2013 Hazel O Keeffe Associate Keller and Heckman LLP Avenue Louise Brussels, Belgium 32(2) okeeffe@khlaw.com Washington, DC Brussels San Francisco Shanghai

2 Keller and Heckman LLP (KH) KH serves clients in numerous countries throughout the world in regulatory law, litigation, and business transactions. San Francisco Washington DC Brussels Shanghai 2

3 Several Offices for Broad Geographic Coverage Thanks to the strategic location of its Offices: Washington DC, founded in th Anniversary in 2012 Brussels; opened in th Anniversary in 2012 San Francisco; opened in 2001 Shanghai office; opened in 2004 Firm expanding: Fifth office to be opened in Paris 3

4 KH Facts KH is a pioneer in the use of interdisciplinary approaches to problemsolving Recognized world leading law firm in the sectors of food, food-contact materials and chemicals Food contact practice is not a new or recent practice of the Firm It is an old practice and one of the strongest 4

5 Lawyers Working with In-House Scientists Currently, Keller and Heckman has over twenty staff scientists, including: Five senior chemists and toxicologists from Center for Food Science and Applied Nutrition at U.S. Food and Drug Administration (FDA) Two senior scientists from U.S. Environmental Protection Agency (EPA) Former European Commission's Principal Administrator for the food contact materials sector Two board-certified toxicologists One former scientist of research institute TNO Quality of Life in the Netherlands Another one working on a case-by-case basis Most have advanced degrees in analytical chemistry Integrated into the various practices of the Firm 5

6 Agenda Update on draft coatings legislation in Belgium the Netherlands Recent legislation on Bisphenol A ( BPA ) enacted in France Belgium Sweden (+ existing legislation in Denmark) Nanomaterials Declaration requirement in France Draft measures in other EU Member States 6

7 Belgium Forthcoming New Order on Coatings Currently, no specific legislation on coatings in Belgium 7 th Draft has been issued; expected to be notified to the European Commission shortly Took into consideration CEPE industry guide but also CoE resolution (2004)1 7

8 Belgium Forthcoming New Order on Coatings Scope Coatings for metal packaging Flexible packaging coatings Heavy-duty coatings Composition Substances authorized on the basis of listing in Plastics Regulation, national listings or other authorizations Other substances may be used under certain conditions Indicative list Will be set out on website of Belgian SPF Public Health, Food Chain Safety and Environment 8

9 Belgium Forthcoming New Order on Coatings Includes provisions on dual-use additives OML of 10 mg/dm² (60mg/kg food in specific instances) Generic SML of 60 mg/kg (except for dual use additives) DoC requirement and defines its content Test times, temperatures set out in the Plastics Regulation Food simulants also the same except citric acid at 5mg/l can be used (instead of 3% acetic acid) for coatings on metal Transitional provisions Nanomaterials not specifically addressed Mutual recognition clause 9

10 Update on National Legislation The Netherlands The Warenwet of 28 December 1935, as amended, is the framework legislation setting out the general provisions for food contact materials, food, cosmetics and a number of other areas The implementing Decree or besluit known as the Warenwetbesluit Verpakkingen en Gebruiksartikelen (Packaging and Utensils Decree) of 30 May 2005 defines the scope of the food contact legislation and outlines the general requirements that food contact materials must meet A specific regulation entitled Regeling Verpakking en Gebruikartikelen, 20 November 1979 (Packaging and Utensils Regulation), as amended, implements the Decree. The Regeling consists of a core text setting out general food contact provisions as well as appendices. In particular, Appendix A sets out the positive lists for the various categories of materials and articles covered, which is divided into various chapters 10

11 The Netherlands Current Legislation Chapter X (Coatings) of Regeling Verpakking en Gebruikartikelen, 20 November 1979 (Packaging and Utensils Regulation), contains a positive list of components that may be used in food-contact coatings (monomers, additives, PPAs ) Chapter X is divided into 9 types of coatings Dispersions of macromolecular substances in water Dispersions of paraffins and waxes in water Dispersions of macromolecular substances in organic liquids Solutions in water Solutions in organic solvents Solvent-free surface coatings on the basis of waxes and wax-like products Other solvent-free surface coatings 11

12 The Netherlands Current Legislation Coatings to be used on paper only (Chapter II) Coatings to be used on metal only (Chapter IV) Section 4 of Chapter I - purity requirements for dyes and pigments 12

13 The Netherlands Revision of Chapter X Outline of latest draft of Chapter X: Four sections Generic coatings Metal coatings Wax coatings High temperature coatings Generic coatings Two positive lists Monomers Additives/Polymer production aids/aids to polymerization Substances in current chapters II, IV and in most of chapter X + CEPE lists of substances evaluated by a Member State/the EFSA Cross-reference to the Plastics Regulation 13

14 The Netherlands Draft Chapter 0 New generic chapter (chapter 0) General provisions proposed: Declaration of Compliance and supporting documentation Dual use additives Generic SML of 60 mg/kg (apart from food additives) 14

15 The Netherlands Draft Chapter 0 Unlisted substances not CMRs, migrate at less than 10 ppb, not nano (only for non-plastics) Non-intentionally added substances must be addressed in compliance assessment No specific listing requirement for nano substances 15

16 The Netherlands Timing & Other Developments Chapters I (Plastics), II (Paper and paperboard), IV (Metals) also being revised New Chapters XI (Colorants) and XII (Epoxy Plastics) Notification to the European Commission expected in second semester 2013 for new chapters 0, XI and XII, updated chapter I, other basically unchanged chapters and Appendix B (analytical testing) in 2014 for updated chapters II, IV and X 16

17 Relevant Developments in Member State legislation BPA France, Belgium, Sweden (+ existing legislation in Denmark) 17

18 BPA France Law n of 24 December 2012 suspending the manufacture, import, export, and placing on the market of any packaging intended for contact with food containing BPA Amends Law no of 30 June January 2013: suspension of the manufacture, import, export and marketing, free of charge or for payment, of any packaging, container or utensil for direct food contact use containing BPA, intended for infants and young children 1 January 2015: suspension of the manufacture, import, export and marketing, free of charge or for payment, of all packaging, containers or utensils for food contact use containing BPA intended to enter into direct contact with food 18

19 BPA France Health warning for pregnant and nursing women and for children up to 3 years until the general ban on BPA applies (draft implementing measure notified to the European Commission (2013/230/F) on 2 May 2013) Prohibits baby bottles containing BPA which fall within the definition of medical devices (Art. L of the Public Health code) the use of BPA in mouth shields on teats, in pacifiers and in teething rings tubes containing di-(2-ethylhexyl) phtalate (DEHP) in pediatric, neonatal and maternity services (from 1 July 2015) Report due by government to Parliament on endocrine disruptors 19

20 BPA France ANSES (French Agency for Food, Environmental and Occupational Health & Safety) 4 reports on BPA dated April 9, 2013 Re-confirmed their findings re suspected risks associated with BPA, notably the potential risk to the unborn children of exposed pregnant women Next EFSA opinion on BPA scheduled for November 2013 Complaint lodged by Plastics Europe to the European Commission against French BPA ban 20

21 BPA - Belgium Belgian ban applicable since 1 January, 2013 Amendment of 24 September 2012 of Belgian Law of 24 January 1977 on consumer health protection with regard to foodstuffs and other products Article 3(1): prohibition for sale or placement on the market and manufacturing of containers which are intended to hold foodstuffs for children of 0 to 3 years old, and which contain BPA 21

22 BPA - Belgium Belgian authorities indicated that the ban should be interpreted applicable only to products exclusively intended for children between 0 and 3 years old «exclusively» not used in Belgian law Article 13(3): sanctions for infringement 22

23 BPA Sweden Decree of December 20, 2012 amending the Food Decree (2006:813) BPA, and compounds containing BPA, must not be used in varnish and coating in the packaging of foods particularly intended for children between 0 and 3 years of age The ban should apply as from 1 July

24 BPA Denmark Executive Order n 579/2011 of June 1, 2011, on Food Contact Materials Fødevarestyrelsens Bekendtgørelse nr. 579 af 1. juni 2011 om materialer og genstande bestemt til kontakt med fødevarer Chapter 3, Article 8, par.2 BPA is banned in all materials and articles for infants and young children from 0 to 3 years old 24

25 Legislation potentially impacting all food contact materials Nanomaterials 25

26 Nanomaterials - French Annual Declaration Law n of 12 July 2010, Art. 185 Creates a new title in the Environmental Code re the Prevention of risks to health and the environment from exposure to substances in the nanoparticle size (Art.L to L.523-5) Establishes the obligation to notify the manufacture, import or distribution of substances in nanoparticle size Decree n of 17 February 2012 relating to the yearly declaration of substances in nano size Creates a new Chapter IV in the Environmental Code (R to R ) Sets terms and conditions of notification Entry into force: 1 January 2013 Penalties: 1 July 2013 Implementing Order of 6 August 2012 Content and conditions of presentation of the annual declaration 26

27 Nanomaterials - French Annual Declaration Who should submit declaration? Manufacturers, importers, and distributors in France of substances intentionally manufactured in nano size, in volumes of more than 100 grams per year Broad scope would also apply to nanomaterials used for food contact When should the declaration be submitted? By May 1 of each year (timeline extended to 30 June 2013 for first declaration) The French Agency ANSES may require additional data and details if declaration considered incomplete: to be provided within two months 27

28 Nanomaterials - French Annual Declaration To whom should the declaration be submitted? To the French Ministry of Environment How should the declaration be submitted? Electronic submission except when the declaration comprises classified documents in accordance with the Defense Code What is the unique declaration number? A number attributed to any declaration made and communicated to the declarer To be communicated by the declarer when transferring the ownership of a nanoparticle substance to a professional user or distributor 28

29 Nanomaterials - French Annual Declaration What information is required? 1. Identity of the declarer 2. Identity of the substance with nanoparticle status - compulsory information vs. information to be provided if available at the time of the notification - information notified elsewhere is presumed available 3. Quantity of nanoparticle substance produced, distributed or imported during the course of the year to which the declaration applies: expressed in kilogrammes 4. Uses of the nanoparticle substances 5. Identity of professional users to whom the declarer has transferred ownership of the substance with nanoparticle status 29

30 Nanomaterials - French Annual Declaration Further information: 30

31 Nanomaterials other Member States Belgium and Denmark Draft measures for mandatory registration of nano products under preparation Sweden and Italy National nanomaterial registers under consideration but not likely to be mandatory 31

32 Conclusions Member States getting more active in drawing up national measures that would impact on the regulation of coatings This trend is set to continue Need to monitor developments closely to ensure continued compliance 32

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