Food Contact & Additives 2017 Agenda: Day 1

Day 1- Joint Morning Sessions

Registration & Welcome

  1. Registration

  2. Welcome & Opening Remarks

    Smithers Pira

Session I: Update on Regulations

In this session we’ll review the latest updates for FDA and GRAS Notices, as well as Food Safety Modern Act. Also we’ll have a talk considering the need of harmonized legislative regulations for a market that it’s constantly changing.

  1. Keynote Address: GRAS Final Rule: Value Added

    Dr. Shayla West-Barnette | Supervisory Consumer Safety Officer (OFAS) of FDA

    In 1997, FDA began administering the Generally Recognized as Safe (GRAS) Notification Program to continue to provide a voluntary mechanism for food ingredient manufacturers to share their GRAS conclusions with the agency. FDA successfully operated the GRAS Notification Program under a proposed rule for 19 years. The agency issued its GRAS final rule on August 17, 2016, and it became effective on October 17, 2016. The final rule clarifies the GRAS criteria and replaces one voluntary procedure with another voluntary procedure. In this presentation, I will discuss what has changed under the GRAS final rule, focusing on the value that these changes offer to our stakeholders. I will also share FDA’s experience evaluating GRAS notices since finalizing the rule. 

  2. Food Safety Modern Act Update (FSMA) - New considerations and current challenges

    Deborah Attwood | Associate of Steptoe & Johnson LLP

    Now that FDA has finalized the major FSMA regulations, the agency is moving to the next phase of implementation – compliance.  FDA indicates that it is focusing on education, training, and technical assistance as companies work to meet the many new burdens imposed by FSMA.  Yet many questions remain as to how FDA will approach compliance enforcement activities, and even whether FSMA is applicable to the food contact industry.  In this session we will review current challenges for industry and discuss business considerations as companies implement these new regulatory mandates.

  3. Harmonized Food Regulations - Mercosur - Asia - EU - US

    Kevin C. Kenny | Chief Operating Officer of Decernis, USA

    This session will look at the impact of global and regional harmonization efforts in different areas of food legislation, focusing on harmonization efforts through Codex Alimentarius, European Union, Mercosur and GCC, as well as brief looks at other important regional harmonization efforts in Asia, Latin America and Africa.  Patterns and trends in harmonization will be identified, as well as counter-examples such as the United States.

  4. Networking Break and Coffee

  5. EU Food Contact Regulations and Compliance Guidelines: What's New?

    Alistair Irvine | Manager, Food Contact Compliance of Smithers Pira

    • An update on the most recent amendments to EU Regulation 10/2011 and what we expect in the future.
    • Progress on the Testing Guidelines intended to support EU Regulation 10/2011
    • Challenges for the Regulation of Future Material Classes.  Ink, paper, coatings and beyond

Session II: Food Supply Chain, Data Management and Transparency

In this session we’ll focus on analyzing the importance of the supply chain in food contact and additives; different ecosystems and considerations on how food interacts with them. Safety concerns in food processing and data management. Transparency Challenges for companies eliminating chemicals of concern in food packaging.  

  1. Challenges to Eliminate Chemicals of Concern in Food Packaging

    Dr. Stephen Klump | Global Head of Packaging Quality and Safety of Nestlé

    The packaged food industry faces challenges to meet evolving safety concerns and regulations for food packaging.  Many considerations are needed to transition to new materials across the supply chain, from the base chemicals to the finished packaging article.  This presentation will outline a process for identification and elimination of chemicals of concern in food packaging.

  2. Supply Chain: Strategic Approach to Food Packaging Transparency

    Weldon Williams | Sr. Director, Quality Assurance, Packaging of HAVI

    With the rapid advances in technology, the changing regulatory landscape and the increased scrutiny that packaging is undergoing, it becomes even more critical to have a robust governance program in place to understand what is in and on your packaging to ensure the safety of your consumers and prevent food adulteration. We will discuss how HAVI approaches this challenge to help protect some of the world’s leading brands.

  3. Day 1 Networking Lunch

  4. Day One Afternoon Tracks

    Tracks will begin after lunch, starting at 2:00 pm

Day 1: Food Additives Track

Session III: Parallel Paths in the Food Industry

This conference has two main sub groups inside the food industry: Contact and Additives, both are equally important to ensure safety and quality for the final consumer. We’ll dedicate this part of the program to work in divided groups in order to cover in more depth concerns for each side of the industry.  

  1. Partially Hydrogenated Oils (PHOs): Change in Regulatory Status - The good, the bad and the ugly

    Dr. Emilia Lonardo | Principal Consultant of StatRegAssociates

    The discussion will focus on current regulatory status changes, the documented health impact of the recent elimination of PHOs and trans fats from the diet, and the legal and commercial consequences of changing the regulatory status from generally recognized as safe (GRAS) to a that of a food additive.

  2. Safety Determination of Substances Added to Food Via US FDA’s Voluntary GRAS Notification Rule

    Leslie A. Beyer, M.S., DABT, CIH | Principal Scientist of Gradient Corp


    • Leslie Beyer, Principal Scientist
    • Rosemary Mattuck, Senior Environmental Engineer 

    In the US, submitting a Food Additive Petition (FAP) to the US Food and Drug Administration (FDA) is the conventional approach for requesting approval for the intended use of a food additive, defined as a substance that is "reasonably expected to become a component of food."  However, if information to support the safe use of a substance added to food is publicly available, it may be prudent to demonstrate safety using FDA's Generally Recognized As Safe (GRAS) Rule.  This presentation provides an overview of FDA's voluntary GRAS Notification process and discusses our experience working with the Agency to demonstrate the safe use of a unique sea salt for seasoning processed foods (e.g., meats, cereal) as well as our experience developing and working with a panel of scientific experts to evaluate the safety of caffeine in an energy drink.  When feasible, the GRAS route can be used in place of a FAP, providing advantages regarding time, resources, and confidentiality.  Also, demonstrating that the use of a New Dietary Ingredient (NDI) is GRAS can increase its use options, and the information gathered for the GRAS evaluation can help meet FDA's NDI Notification requirement.  We discuss when a GRAS evaluation is a viable path to show the safe use of a food or new dietary (supplement) ingredient, and we reveal key considerations when providing data to FDA, assessing exposure, selecting experts for a GRAS panel, and deciding whether to notify the Agency of the GRAS determination.

  3. Networking Break and Coffee

  4. Comparison & analysis of food additive regulations in China, India, Indonesia, Malaysia, Singapore & Vietnam.

    Nhat Nguyen | Chief Analyst of Chemical Watch

    Following several public scandals and regulatory improvement efforts, food regulations in India and Southeast Asian countries have seen rapid changes in the last few years.  In many ways, the changes have been welcomed by the industry because of its transparency and ability for the regulatory framework to keep up with food innovation and initiatives.  However, these changes have also added complexity to the existing framework, spurred increased enforcement, and increased public attention to food and food safety issues. This presentation will provide a comparison analysis of how food additives are regulated in India and certain Southeast Asian countries.  It will also provide strategies on how to manage the various regulatory demands to ensure that the products are safe for customer consumption while maintaining market competitive edge.

    • A look at India and its Food Acts, Regulations, and Various Standards
    • A look at how some of the bigger food market countries in Southeast Asia (Indonesia,  Malaysia, Philippines, Singapore, Thailand & Vietnam) regulate food additives
    • Challenges, lessons-learned, and approach in accessing and competing in these markets 
  5. New Perspective: Making the Case for Modernizing Food Additives Safety Assessment

    Dr. Maricel Maffini | Food Safety Expert of Independent Consultant

    I will discuss how the current approach on assessing the safety of food additives is inadequate to protect public health and has neglected a fundamental statutory mandate to investigate the cumulative effects of chemicals in the diet and the potential chronic health effects. I will use brain development as a case study.

  6. US, Canada and Mercosur regulatory landscape for edible fats and oils used in the food industry

    Dr. Ioan Paraschiv | Regulatory Affairs Manager of Knoell NL B.V.

    • Edible fats and oils used in food industry – at glance
    • Overview on regulatory requirements in US, Canada and Mercosur (with focus on Brazil and Argentina)
    • Safety Standards and Certification on edible fats and oils used as food ingredients
    • Recycling market and legislative grounds on recycling waste (cooking) oils 
  7. Closing Remarks

    Smithers Pira

  8. Decernis User Meeting

  9. Opening Reception - Networking

Day 1: Food Contact Track

Session III: Parallel Paths in the Food Industry

This conference has two main sub groups inside the food industry: Contact and Additives, both are equally important to ensure safety and quality for the final consumer. We’ll dedicate this part of the program to work in divided groups in order to cover in more depth concerns for each side of the industry.  

  1. Non Intended Added Substances - Migration Assessment

    Dr. Mitchell Cheeseman | Managing Director Environmental and Life Sciences of Steptoe & Johnson LLP

    NIAS are chemical compounds that are non-intentionally added to the food they may be present in materials but have not been added for technical reasons during the process. In this session we’ll explore in detail the migration assessment process view from the regulatory side.

  2. Global View: Safety Compliance Process for Food Contact Packaging Materials

    Katja Tuomola | Business Development Director of Metsä Board

    Food-related product safety issues are making the news and headlines more and more often. Recently, packaging materials have been in the spotlight for the usage of fluorinated chemicals or phthalates. Health concerns become global in matter of seconds, and knowing what food contact materials are made of is becoming increasingly important. In this presentation Metsä Board will share and highlight the complicated process of evaluating paperboard according to global food contact material regulations. The presentation will cover the global regulatory process, from raw materials to the finished product, from a European paperboard manufacturer’s point of view. The importance of good communication in the whole supply chain is critical in a world where news travel fast, as the examples presented will illustrate. A global view is being taken because Metsä Board’s customers – and brand owners, especially – distribute their products globally. Fulfilling global regulation and recommendations is becoming an increasingly onerous task as they become more stringent. Global demands and their differences will be highlighted and analyzed because, for example, the simple analysis of lead differs from one continent to another. The main legislations (EU, USA and China) and their differences will be covered, giving the American audience a chance to learn how a European packaging material producer handles these subjects.

  3. Networking Break and Coffee

  4. Complying with Global Food Packaging Safety Regulations - The Ink Manufacturer's Perspective

    George Fuchs | Director Regulatory Affairs and Technology of NAPIM

    Food packaging safety continues to be near top of mind for consumers, brand owners and throughout the food packaging supply chain.  This presentation will focus on the role of, and challenges for, today's printing ink manufacturer in the ever evolving realm of global food packaging safety regulations.

  5. Analytical Challenges and Solutions Related to Food Migration Testing

    Gyorgy Vas, Ph.D. | Technical Scientific Liaison of Intertek

    Food packaging is an essential part for almost every commercial food product. As it has direct or indirect contact with the consumed food product, it is expected to have no impact for the quality and the safety of the finished products. The packaging provides multiple excellent “features” for the food, as they are protecting the food from different environmental impact and they are extending its shelf-life, and making them transportable for long distances.

    Packaging materials are made out from different materials including metal, polymer, paper and their various combinations. Some of the packaging material can be used universally, some of them are limited to use for certain types of food.

    Testing of the packaging materials are important part of the safety risk assessment, therefore those testing being performed for different materials and different food types as part of the safety risk evaluation process. This presentation will focus on the analytical challenges related to packaging materials addressing the issues related to low level testing, and deal with interferences from the food products or the different used simulation media. Sate of the art sample preparation and analytical detection techniques will be presented through various test cases. 

  6. Closing Remarks

    Smithers Pira

  7. Decernis User Meeting

  8. Opening Reception - Networking