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LEGAL FRAMEWORK
3-D FOOD PRINTING
3 D Food Printing Conference
Venlo, NL, 28 June 2017
Karin Verzijden
www.axonlawyers.com
Agenda
• Current and potential applications of 3 D food printing
• Legal positions & liabilities various parties involved
• Legal qualification of printed food & implications
• Legal requirements for marketing printed food
2
Applications 3 D printed food
Current applications
• mainly “fun products”
Future applications
• are expected to include mass production consumer products and house
appliances (cf. home breweries)
• are likely to extend to care setting (cf. medtech) for preventing
malnutrition, addressing swallowing issues and enabling personalized
approach
NRC, 19 April 2017
(Dutch national paper)
De Stentor, 26 augustus 2016 (Dutch regional paper)
Liabilities parties involved (1)
Manufacturer food printer
• Food printer must comply with EU Machinery Directive 2006/42 and
national implementing legislation.
• “Machinery”: assembly fitted with a drive system, consisting of linked
components, at least one of which moves, joined together for specific
application.
• Machinery should conform to essential health and safety requirements
re. design and construction.
• Before placing on the market, manufacturer should assess conformity to
safety standards > CE mark
• Enforcement by national MS authorities
Liabilities parties involved (2)
Raw materials supplier
• Raw materials = ingredients = food stuffs >
General Food Law Regulation 2002/178 and its national
implementations (NL: Commodities Act / Warenwet)
• Food: every substance intended to be ingested by humans
• Basic requirement: food safety!
• Food safety is responsibility of so-called Food Business Operator
(FBO): any person or entity active in the production / processing /
distribution of foodstuffs
• Traceability requirement: identification of FBO one level up, one
level down.
• ISO 22000: self-regulatory standards applied by food industry
Liabilities parties involved (3)
Consumer
• Consumer takes role of producer > ”prosumer”
• Home appliances: in case of safety or quality issues, consumer has
claim against printer manufacturer and supplier of raw materials >
what is his own share of responsibility?
• Care setting: hospital / elderly home takes on responsibilities of food
manufacturer > What share of responsibilities when when patients
experience problems with 3 D printed food?
• In both settings, clear contractual arrangements are required for all
conceivable safety and quality issues.
Status of printed food (1)
Potential Novel Food
• 3 D printed food may qualify as a Novel Food under the Novel Foods
Regulation 2283/2015.
• Novel Foods are foods that prior to 1997 did not form part of the regular
diet within the EU.
• Current NF Regulation contains 10 product categories, including the
new production process:
• Little is yet know about the effects of the 3D production process on the
food > any safety issues?
Status of printed food (2)
Implications of NF status
• If and when 3D printed food qualifies as Novel Food > prior marketing
authorization will be required.
• FBO involved needs to prepare application dossier for Commission >
competent authorities MS.
• EFSA will be asked for safety opinion if a MS has reasonable safety
concerns.
• Advantage of new NF Regulation: general authorizations.
Consumer setting: authorization requirement not likely to apply.
Care setting: hospitals are recommended to take NF requirements
seriously.
Marketing requirements (1)
3D printed food could be used for personalized nutrition:
• Fortified foods: Regulation 1925/2006
• Food supplements: Directive 2002/42 and national implementing
legislation (MS have some liberty to set national rules)
e.g. level of Vit. D should not exceed 4.5 microgram per 100 Kcal foodstuff
• Medical foods: Regulations 609/2013 and 2016/128
• Infant formula: Regulations 609/2013 and 2016/127
These are highly regulated foods for vulnerable groups > should meet strict
compositional criteria
Marketing requirements (2)
Labelling requirements & claims
• Raw materials to be used as ingredients for 3D printing should contain
clear instructions for use > Food Information Regulation 1169/2011.
• If any nutrition or health claims are made re. those ingredients > relate
to the foodstuff as prepared > Health Claim Regulation 1924/2006.
e.g. high in fibers > requires 6 g fibers / 100 g food product
e.g. high protein > requires that 20 % of the energy of the food is provided
by protein
• No health claims may be made re. medical foods > Regulation
2016/128.
Conclusions
• 3D printed food is obtained by using a technology relatively new in the
food supply.
• Such new technology presents new challenges for defining the
responsibilities of the stakeholders involved and its end user.
• 3D printed may qualify as Novel Food > prior market authorisation
required for professional trade in such products.
Axon Lawyers
14
• Amsterdam based law firm with international focus
• Fully dedicated to life sciences, focus on food business
• Assisting high tech companies marketing innovative food products
• Founder of European Alliance of Life Sciences Law Firms
• Reporting current food law developments at blog FoodHealthLegal

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Legal framework 3 D food printing

  • 1. LEGAL FRAMEWORK 3-D FOOD PRINTING 3 D Food Printing Conference Venlo, NL, 28 June 2017 Karin Verzijden www.axonlawyers.com
  • 2. Agenda • Current and potential applications of 3 D food printing • Legal positions & liabilities various parties involved • Legal qualification of printed food & implications • Legal requirements for marketing printed food 2
  • 3. Applications 3 D printed food Current applications • mainly “fun products” Future applications • are expected to include mass production consumer products and house appliances (cf. home breweries) • are likely to extend to care setting (cf. medtech) for preventing malnutrition, addressing swallowing issues and enabling personalized approach
  • 4. NRC, 19 April 2017 (Dutch national paper)
  • 5. De Stentor, 26 augustus 2016 (Dutch regional paper)
  • 6. Liabilities parties involved (1) Manufacturer food printer • Food printer must comply with EU Machinery Directive 2006/42 and national implementing legislation. • “Machinery”: assembly fitted with a drive system, consisting of linked components, at least one of which moves, joined together for specific application. • Machinery should conform to essential health and safety requirements re. design and construction. • Before placing on the market, manufacturer should assess conformity to safety standards > CE mark • Enforcement by national MS authorities
  • 7. Liabilities parties involved (2) Raw materials supplier • Raw materials = ingredients = food stuffs > General Food Law Regulation 2002/178 and its national implementations (NL: Commodities Act / Warenwet) • Food: every substance intended to be ingested by humans • Basic requirement: food safety! • Food safety is responsibility of so-called Food Business Operator (FBO): any person or entity active in the production / processing / distribution of foodstuffs • Traceability requirement: identification of FBO one level up, one level down. • ISO 22000: self-regulatory standards applied by food industry
  • 8. Liabilities parties involved (3) Consumer • Consumer takes role of producer > ”prosumer” • Home appliances: in case of safety or quality issues, consumer has claim against printer manufacturer and supplier of raw materials > what is his own share of responsibility? • Care setting: hospital / elderly home takes on responsibilities of food manufacturer > What share of responsibilities when when patients experience problems with 3 D printed food? • In both settings, clear contractual arrangements are required for all conceivable safety and quality issues.
  • 9. Status of printed food (1) Potential Novel Food • 3 D printed food may qualify as a Novel Food under the Novel Foods Regulation 2283/2015. • Novel Foods are foods that prior to 1997 did not form part of the regular diet within the EU. • Current NF Regulation contains 10 product categories, including the new production process: • Little is yet know about the effects of the 3D production process on the food > any safety issues?
  • 10. Status of printed food (2) Implications of NF status • If and when 3D printed food qualifies as Novel Food > prior marketing authorization will be required. • FBO involved needs to prepare application dossier for Commission > competent authorities MS. • EFSA will be asked for safety opinion if a MS has reasonable safety concerns. • Advantage of new NF Regulation: general authorizations. Consumer setting: authorization requirement not likely to apply. Care setting: hospitals are recommended to take NF requirements seriously.
  • 11. Marketing requirements (1) 3D printed food could be used for personalized nutrition: • Fortified foods: Regulation 1925/2006 • Food supplements: Directive 2002/42 and national implementing legislation (MS have some liberty to set national rules) e.g. level of Vit. D should not exceed 4.5 microgram per 100 Kcal foodstuff • Medical foods: Regulations 609/2013 and 2016/128 • Infant formula: Regulations 609/2013 and 2016/127 These are highly regulated foods for vulnerable groups > should meet strict compositional criteria
  • 12. Marketing requirements (2) Labelling requirements & claims • Raw materials to be used as ingredients for 3D printing should contain clear instructions for use > Food Information Regulation 1169/2011. • If any nutrition or health claims are made re. those ingredients > relate to the foodstuff as prepared > Health Claim Regulation 1924/2006. e.g. high in fibers > requires 6 g fibers / 100 g food product e.g. high protein > requires that 20 % of the energy of the food is provided by protein • No health claims may be made re. medical foods > Regulation 2016/128.
  • 13. Conclusions • 3D printed food is obtained by using a technology relatively new in the food supply. • Such new technology presents new challenges for defining the responsibilities of the stakeholders involved and its end user. • 3D printed may qualify as Novel Food > prior market authorisation required for professional trade in such products.
  • 14. Axon Lawyers 14 • Amsterdam based law firm with international focus • Fully dedicated to life sciences, focus on food business • Assisting high tech companies marketing innovative food products • Founder of European Alliance of Life Sciences Law Firms • Reporting current food law developments at blog FoodHealthLegal

Editor's Notes

  1. Annex I, par. 2.1 contains specific health and safety requirements for foodstuff machinery: smooth surface of parts in contact with foodstuffs those parts should be easily cleaned and desinfected Substances and living creatures should be prevented from entering Substances hazardous for health (lubricants) should be prevented from entering into contact with foodstuffs
  2. NB processing aids = non-food, but also subject to safety requirements.
  3. Examples of NF: high pressurized yoghurt (…)
  4. Check Health Claim Regulation mbt Artikel Vo 2016/128 verbiedt gebruik claims voor medische voeding.