Food Contact Requirements in Asia and Latin America

Transcription

1 Food Contact Requirements in Asia and Latin America

2 Agenda Types of regulatory systems Overview of regulatory requirements and new developments Japan South Korea India China MERCOSUR A comparison: similarities and differences Obtaining premarket approval

3 A Word of Caution Requirements vary from country to country Can encounter a mix of a general safety standard, positive list systems, mandatory standards, and/or voluntary standards National laws are continually evolving

4 Global Regulatory Systems Types Safety Safety Plus Premarket Clearance

5 Common Thread Safety

6 Safety Do No Harm Prohibit change in organoleptic properties of food Taste Odor Color Prohibit poisonous, toxic, or harmful materials likely to harm human health

7 Safety Plus In addition to a overarching general safety requirement, some countries have established: Specific limits on certain chemicals of toxicological concern Standards for specific types of packaging products Standards for specific end-use applications Specifications for certain polymers Restrictions on the use of recycled materials in food packaging Voluntary industry standards or negative lists

8 Safety Plus vs. Premarket Clearance Safety Plus India Japan (but moving toward positive list system) Premarket Clearance South Korea (for polymers) China MERCOSUR

9 Japan General Safety Requirement But, colors for packaging materials need MHLW approval, unless color doesn t migrate Specifications for certain material types Synthetic resins, metal cans, glass and ceramics, rubber Akin to FDA end-tests, include heavy metals limits, extraction limits Additional specifications for certain end-uses Such as packaging for food pasteurized under pressure, vending machines Generally performance based (strength, pinhole test) Specifications for packaging for milk/milk-based products Only specific materials and a limited number of additives permitted

10 Japan Voluntary standards Mix of positive and negative lists JHPA Japan Hygienic PVC Association JHADVC Japan Hygienic Association of Vinylidene Chloride JHOSPA Japan Hygienic Olefin and Styrene Plastics Association Not legally binding, but widely-recognized and followed in Japan Positive lists cover various polymers and include Identity of base polymer (permitted monomers, concentrations, etc.) Material specifications (end tests) List of acceptable additives

11 Japan New Developments MHLW working on a positive list system Substances not authorized will be banned First focus is synthetic resins Proposed positive list of 32 resins Based on the existing positive lists developed by industry associations Will apply to inner layers of multi-layered structures (which do not contact food) if components are likely to migrate to food Eventually, system will also address colorants, adhesives, coatings, and printing inks Guidance MHLW released GMP guidelines in 2017 Developing guidance on supply chain communication

12 South Korea General Safety Standard Mandatory Standards Suitable purity, printing inks, colorants Material specifications Synthetic resins, cellophane, rubber, paper, metal, wood, glass, ceramic, porcelain enamel, pottery, starch Limits on heavy metals, residual monomers, TNVs Premarket Clearance Premarket clearance needed for polymers not covered by regulations

13 South Korea New Developments Registration Requirement (August 2016) Applies to all foreign manufacturing facilities that produce food and food packaging articles sold/marketed in Korea (renew every 2 years) Authorizes MFDS to conduct on-site inspections of foreign facilities Considering a new food safety model based on the U.S. paradigm Reviewing CFs and FTs Researching Korean consumption patterns

14 India General Safety Standard Mostly focused on suitability requirements Mandatory requirements for certain foods Milk/milk products, edible oils, fruits and vegetables, canned meat, bottled water Voluntary Standards Bureau of Indian Standards (BIS) Standards on polymers and other materials (e.g., paper) Plastics should conform

15 India New Developments New draft Food Safety and Standards (Packaging) Regulations Make compliance with many standards mandatory Plastics, but also paper, metals Notified to WTO Nov EU filed comments Standards are old, many currently marketed products wouldn t comply, need for sufficient transition period, mechanism for petitioning BIS for new specifications

16 China Mandatory Standards Food Safety Law Generally Applicable Standards Materials Standards Testing Methods Standards GMP Standards General Safety Standard GB Plastic Paper Migration Testing Standard General Hygiene Practices GB Additives GB Coatings Testing Methods for Individual Substances Metal Rubber * Materials Standards include positive lists

17 China New Developments Very active last 4-5 years Consolidating, amending, and issuing new standards Ongoing revision to the Migration Testing Standard (GB ) Standards on adhesives and printing inks under development 2 Draft Food Safety National Standards on migration testing methods for specific chemicals National Health Commission published for public comment Sept. 2018

18 MERCOSUR Mercado Común del Sur (Common Market of the South) Created by the Treaty of Asunción del Paraguay (March 26, 1991) Members: Argentina, Brazil, Paraguay, Uruguay, Venezuela (suspended), Bolivia (under integration) Trade group intended to: Promote free trade Harmonize national regulations while maintaining Member State sovereignty

19 MERCOSUR Two basic requirements Premarket approval - positive list system for certain harmonized materials Registration requirement applies to final packaging only (Brazil is an exception) GMC Resolutions Framework Resolution (3/92) similar to EU Plastics - hybrid of U.S. & EU systems, but mostly EU Resolutions covering other types of FCMs Some positive lists, others only general requirements Members must transpose into their national legislation

20 New Developments Additives Resolution (GMC Res. 32/07) Undergoing revision since 2013 Proposed Resolution August 2018 Published for public consultation in individual Member States Sept Timeline for finalization: end of 2019 or 2020? Notable changes Alignment with EU Plastics Regulation (Additive listings current June 2018) Partial exemption for solvents

21 Comparison of Regulatory Systems Japan South Korea India China MERCOSUR Safety Standard Food Sanitation Act Food Sanitation Act Food Safety Law General Safety Standard GB Positive Lists No (but proposed) Mandatory Standards Yes Yes, cellophane, rubber, paper, metals, wood, glass and ceramics GMC Res. 3/92 Yes, for polymers BIS Standards Yes Yes, plastics, paper, and a few others No Yes, paper, plastics, coatings, rubber, metal No Specifications for certain material types Yes Yes Yes No No Voluntary Standards Yes No Yes, plastics, paper, metals, glass GMP Required Guidance on GMP published in 2017 Yes, part of Standards and Specifications for Food Utensils, Containers and Packages Proposed Safety Standard includes some GMP-type requirements No Yes, General Hygiene Practices GB No Yes, part of GMC Res. 3/92

22 Functional Barrier Clearance System Toxicity Requirements Registration Requirement Recycled Plastics Prohibited Enforcement Japan South Korea India China MERCOSUR Comparison No No of Regulatory No Yes, included Systems in GB (need barrier No (proposed) N/A No No Ministry of Health, Labour, and Welfare (MHLW) Petition; information requirements similar to U.S./EU Yes, effective August 2016; applies to foreign manufacturing facilities (but not starting materials) Tertiary recycling of PET/PEN resins expressly permitted Korean Ministry of Food and Drug Safety (MFDS) Can apply for new standards through FSSAI/BIS; no standardized format No; significant weight attached to international clearances layer, migration 0.01 mg/kg, not a CMR) Petition; information requirements similar to U.S./EU Tiered based on migration level; required tox data similar to EU No Petition for inclusion on GMC Resolution; information requirements similar to U.S./EU Tiered; thresholds and required tox data similar to EU No No Yes, with some exceptions Yes Yes Yes, unless authorized in GMC Resolution Food Safety and Standards Authority of India (FSSAI) Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) Member States

23 Obtaining Premarket Approval Premarket clearance only required for polymers Review period 30 days or more Can request a letter of advice for additives; response in as little as 10 days if Korean agent used Multi-step approval process Need clearance for petitioned use in at least two jurisdictions Multi-step approval process Need clearance in another jurisdiction Can take several years Not bound until transposed by Member States

24 Concluding Thoughts Variety of regulatory systems in force in Asian and Latin American countries National laws are continually changing Use caution before marketing!

25 Questions?

26 THANK YOU Jeff Keithline Partner Keller and Heckman LLP Washington, DC Office Rachel Bond Associate Keller and Heckman LLP Washington, DC Office