Food Ingredients Regulatory Framework, Business Challenges and … · 2019. 12. 12. · ©2015, 3E...

Food Ingredients Regulatory Framework, Business Challenges

and Solutions

Zeina Attar

Senior Regulatory Analyst

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Disclaimer

Zeina Attar Senior Regulatory Analyst

Miss Attar has been with 3E Company for more than 4 years specializing in the Middle East and Africa regions by providing regulatory research, analysis and customer support for clients in the chemical, cosmetics and food safety arenas. Some of her areas of expertise include Halal/Kosher global requirement, food additives and flavors, and food ingredients. Miss Attar received a Bachelor of Arts in Sociology from Columbia University. She is a native speaker of Arabic. Prior to joining 3E Company, Miss Attar worked as a Global Media Analyst at Brightwire Company.

Guest Speaker

Agenda

• Understanding Food Ingredients

• Food Ingredients Regulatory Overview

– CODEX

– U.S.

– EU

• Ways 3E Company Can Help

– ArielLogic: global compliance formulation checks

– Integrated Content: load regulatory data to power

compliance check functionality in your formulation system

Understanding Food Ingredients

• There is no clear definition like for food additives

• Many countries do not make a clear distinction between additives and ingredients

Understanding Food Ingredients

Food Ingredients Food Additives

• Don’t have identifiers (CAS,

INS…etc.)

• Natural components of food

• Some are actual foods (Ex: honey, milk)

• Make up the identity of a given food product

• Have identifiers

• They are artificial and natural substances

• Intentionally added to food for functional purposes like adding a certain color (colorant) or prolonging the shelf life for products (preservatives)

• Food ingredients are regulated at the food product standard level

• Over 200 Standards

• CODEX Standards make clear distinction between food additives and food ingredients

CODEX Classical Sections

• Scope: How and to which products this standard applies

• Description: Usually lists the products

• Essential composition and quality factors

- Raw Materials

- Permitted Ingredients

- Composition

• Food Additives

• Hygiene

• Contaminants

• Labeling

CODEX standard for milk powders and cream powder:

Many different definitions! • Food Additives: "any substance the intended use of which results or may

reasonably be expected to result - directly or indirectly - in its becoming a component or otherwise affecting the characteristics of any food."

• Color Additive: “means a material which is a dye, pigment, or other substance which, when added to food, “is capable of imparting color thereto.”

• Direct Additives: which means they were added for a specific purpose, such as flavor and texture. (Most direct additives must be declared on the ingredient label)

Many different definitions! • Secondary Direct Food Additives: are those substances which are needed

during the manufacture or processing of the food, but which are then removed from the final product. While some residual amounts of the additive may remain in the food, they must not “exhibit any technical effects.” (not required to be included on the label)

• Indirect Additives: are those substances which find their way into food incidentally in trace amounts, due to packaging, storage, or other handling.

• GRAS: Generally Recognized as Safe is a category of substances which would normally be considered food additives, but which have been determined to be safe under specific conditions and for certain uses, and so do not require premarket review and approval by the FDA.

Main Laws/Regulations:

• The Food, Drug, and Cosmetics Act (FD&C Act, Section 201).

• Regulations: Title 21 CFR, Parts 130 to 169)

21 CFR, Part 152: §152.126 Frozen Cherry Pie:

(a) Identity. (1) Frozen cherry pie (excluding baked and then frozen) is the food prepared by incorporating in a filling contained in a pastry shell mature, pitted, stemmed cherries that are fresh, frozen, and/or canned. The top of the pie may be open or it may be wholly or partly covered with pastry or other suitable topping. Filling, pastry, and topping components of the food consist of optional ingredients as prescribed by paragraph (a)(2) of this section. The finished food is frozen.

(2) The optional ingredients referred to in paragraph (a)(1) of this section consist of suitable substances that are not food additives as defined in section 201(s) of the Federal Food, Drug, and Cosmetic Act or color additives as defined in section 201(t) of the act; or if they are food additives or color additives as so defined, they are used in conformity with regulations established pursuant to section 409 or 721 of the act. Ingredients that perform a useful function in the formulation of the filling, pastry, and topping components, when used in amounts reasonably required to accomplish their intended effect, are regarded as suitable except that artificial sweeteners are not suitable ingredients of frozen cherry pie.

Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety:

• Food(s) are defined as: “any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. ‘Food’ includes drink, chewing gum and any substance, including water, intentionally incorporated into the food during its manufacture, preparation or treatment.”

Regulation (EC) No 1333/2008 on food additives:

• Food additives are defined as: “substances not normally consumed as a food in itself and not normally used as a characteristic ingredient of food, whether or not they have nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in them or their by-products becoming directly or indirectly a component of such foods.”

• Food ingredients are regulated at the food product level

• There are very few union level legal acts on food products (EX: Directive 2000/36/EC relating to cocoa and chocolate products intended for human consumption)

• These directives are legally binding

• Threshold limits are available for composition and food ingredients

The directive leaves some provisions open to the discretion of each member state:

“The addition to chocolate products of vegetable fats other than cocoa butter, up to a maximum of 5 %, is permitted in certain Member States.”

In other instances all member states have to comply:

“The addition of certain vegetable fats other than cocoa butter to chocolate products, up to a maximum of 5%, should be permitted in all Member States; those vegetable fats should be cocoa butter equivalents and therefore be defined according to technical and scientific criteria.”

• More guidelines available on food products at the member state level

• Germany: meat products, bread, fish, bakery products, fruit juices, spices, honey…etc.

• Not legally binding

Poll Question 1

Which one of the following regions are the most challenging/important to your business in terms of regulatory compliance?

Challenges!

• How to manage the regional and global regulations increasing volume and complexity?

• How to contain the costs of venturing into the global market? (what is permitted in one country maybe restricted or prohibited in another)

• How to make sure that your products are compliant throughout the food supply chain cycle?

- Halal and Kosher requirements/certificates

- Keeping track of what you are getting from your suppliers

Solutions!

ArielLogic – Current Scope

• Regulatory checks for:

North America

• US

• FEMA

• Canada

• Mexico

Asia Pacific

• Australia

• China

• Japan

• Hong Kong

• India

• Indonesia

• Korea

• Malaysia

• New Zealand

• Singapore

• Philippines

• Taiwan

• Thailand

• Vietnam

• EU level Regulations and directives

• Russia

• Switzerland

• Belarus

• Kazakhstan

Latin America America • Argentina

• Brazil

• Mercosur

Middle East/Africa

• GCC • South Africa

International

• CODEX • JECFA

ArielLogic – Current Scope

• Full Text:

• North America

• Asia Pacific

• European Union

• Latin America

• Middle East/Africa

• CODEX

ArielLogic - Benefits

1. Reduces costs by reducing time to market: Eliminate substances early in the

development cycle

Alleviate overloaded regulatory departments

2. Improve resources allocation and efficiency: Empower staff with the ability to

focus on strategic activities, such as expansion into new markets

Provide faster, more efficient way

to research regulatory requirements

3. Provide supplier audit tool: Quickly respond to supplier

questionnaires or use the tool to audit your own suppliers

ArielLogic

How do we do it?!

ArielLogic

How do we do it?!

Application compliance check tool

ArielLogic

How do we do it?!

Database section

ArielLogic

How do we do it?!

Database section

Full text section

ArielLogic

How do we do it?!

Database section

Full text section

News section

ArielLogic

How do we do it?!

Database section

Full text section

News section

Customer ticketing system

ArielLogic - The Application

Hosted Reference Application • Rules based substance level checks on country level food

additives, flavor and ingredients regulatory requirements

• CAS driven system - with ability to enter and search on other identifiers:

- FEMA, INS, CoE, CI (Color Index)

• Ability to enter formulation data and perform checks on: - Usage Type, functional class and Quantity for each ingredient

• Full Text and Overviews (documents in English) of food regulations

ArielLogic - Report Presentation

Results showing that decision was based on FEMA since the ingredients were not listed on the respective country’s regulation and the country accepts FEMA GRAS

ArielLogic - News

ArielLogic news section helps you to keep on you of regulatory trends, changes, and up and coming regulations

Poll Question 2

Which IT solution do you use to maintain your regulatory content and formulations?

ArielLogic – Ticketing System

The Ariel Cloud Content Delivery System

Proven Regulatory Expertise

Integration and Data

Management Knowledge

Single Cloud Solution for Substance Regulatory

Loading Data into the SAP Spec Database

3E Supply Chain Solution

• Gathering food & packaging certifications, organic/kosher/halal/non-GMO certificates and more Gathering

• Validate that your suppliers meet your company’s requirements and the regulations Validate

• Enrich supplier content with Global Food & Food Packaging Regulatory Content Enrich

• Contextualize with current and relevant food safety news alerts Contextualize

Poll Question 3

I am interested in speaking with a 3E specialist on how 3E can assist me with Food Ingredient related regulatory compliance?

Upcoming Webinars

• Product Safety Summaries - Enhance Safety Immediately

– Wednesday, April 22nd

• 3E Regulatory Compliance Solutions for SAP Recipe Development

– Tuesday, April 28th

Upcoming Tradeshows

• 2015 FDA Cosmetic Regulations Workshop

– April 23 in New York, NY

• Food Safety Summit

– April 28 – 30 in Baltimore, MD

To learn more about upcoming events or to register—please go to 3ecompany.com

3E is nominated – please vote!

3E is nominated for ISHN Readers’ Choice Award! The ISHN Readers’ Choice Award program is an annual poll in which thousands of magazine subscribers vote on the most innovative and effective EH&S-related products and services available today. Please help give us recognition. Voting is easy – just follow these simple steps and get a chance to win $50 gift card from ISHN. 1. Click here: http://awards.ishn.com/readers 2. Enter your name, email address, and job function 3. Scroll all the way down (7th from the bottom list) and click on ‘MSDS Management’ 4. Click on the radio button on the far right of ‘3E Online – SDS’ (first one from the list) 5. Click on ‘Submit’ Voting closes on May 1, 2015. Thank you for your participation and support!

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Thank you!

Food Ingredients Regulatory Framework, Business Challenges and … · 2019. 12. 12. · ©2015, 3E...

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