FDA Requirements for Exporting Food and Beverage … Overview •Registration, U.S. Agent, & Prior Notice •Labeling •Food Canning Establishment (FCE) Registration •HACCP •Food

FDA Requirements for Exporting Food and Beverages to the U.S.

Presented by David Lennarz

Vice President

December 5th, 2016

Presentation Overview

• Registration, U.S. Agent, & Prior Notice

• Labeling

• Food Canning Establishment (FCE) Registration

• HACCP

• Food Safety Modernization Act (FSMA)

• Summary / Questions & Answers

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How does the FDA work?

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• Common myths –FDA “approves” facilities

–FDA “approves” products

–FDA requires submissions of labels or an inspection before marketing products

• For food and beverages – Regulator / Rulemaker

–Enforcer / Police

How does FDA work?

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• Enforcement – Inspections

– Import Refusals

– Import Alerts

–Warning Letters

–Suspension of registration

–Civil and criminal penalties

Basic FDA Requirements

Registration, U.S. Agent, & Prior Notice

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Registration

• Companies that handle human food: – Manufacture

– Process

– Pack

– Hold

• Exemptions – Farms

– Retail establishments

– Restaurants

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U.S. Agent

• Different than a commercial agent, food broker, or customs broker

• Must be available 24/7

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• Responsibilities

– Coordinate inspections • Fees for re-inspection

– Answer questions about shipments

– General day-to-day communications

Prior Notice

• Notification to FDA

• NOTE: Required even for samples

• Detention in port if not filed

• Includes information about the shipment and the facility

• May be filed by exporter, importer, or third party

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Product Labeling

New changes for 2016.

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Labeling

• Definition of “Misbranded”

• Top reason for import issues

• Broad requirements

– Principal display panel

– Nutrition facts

– Advertising (including online)

– Health claims

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Labeling

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Food Canning Establishment (FCE) Registration

An Additional Requirement

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Food Canning Establishment

• Low-Acid Canned Food

– Final pH > 4.6 ( certain tomato products > 4.7)

– Water activity (aw) > 0.85

– Common examples: green olives in brine, artichokes, figs in syrup, roasted peppers, etc.

• Acidified Food

– Final pH ≤ 4.6

– Water activity (aw) > 0.85

• In cans, glass, semi-rigid and flexible pouches…

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Food Canning Establishment

• Food Canning Establishment (FCE) – 5 digits

– Different than regular registration

– Requires a specific street number

• Submission Identifiers (SID)

– Filings with FDA containing process information

– Each product is assigned an SID number

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HACCP

For seafood and juice.

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HACCP

• Hazard Analysis and Critical Control Points (HACCP)

– Hazard Analysis (HA): identification and evaluation of the known or reasonably foreseeable hazards associated with the food

– Critical Control Points (CCP): a step in the process which controls the hazard identified in the HA

• Example: Salmonella in salmon, controlled by heating fish to 90° for 5 minutes

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HACCP

• Required for:

– Juice (100%)

– Seafood

• U.S. customer has specific regulations for importing HACCP-mandated products

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Food Safety Modernization Act

The biggest change in 70 years…

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Preventive Controls

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Food Safety

Plan

Preventive Controls

• Exemptions and modified requirements:

– Retail establishments (restaurants and stores)

– Qualified facilities

– Juice and Seafood HACCP

– Alcoholic beverages

– Dietary supplements

– USDA products

– Farms

– Unexposed, packaged food in warehouses

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Preventive Controls

• Deadlines

• Food Safety Plan

– Facilities with >500 full-time equivalent employees: September 19th, 2016

– Small business (<500 employees): September 18th, 2017

• Qualified facility attestation

– Qualified facilities and very small businesses: September 2018

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FSMA Compliance Wizard

• Go to www.fsmawizard.com to assess your requirements under FSMA free.

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Summary / Questions & Answers

Registrar Corp’s solutions.

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Registrar Corp’s Solutions

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• Registrar Corp provides a full range of fixed-fee compliance services:

– Registration & U.S. Agent Service

– Prior Notice Filings

– Label, Ingredient, and Product Review

– LACF and Food Safety Services (Mock FDA Inspections)

– FSMA Compliance Services

– Detention Assistance

– DWPE Petition Submissions

– FDA Compliance Monitor

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Questions & Answers

Let us be your resource on FDA regulation.

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Contact Us

Registrar Corp -Headquarters

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USA 23666

P: +1-757-224-0177

F: +1-757-224-0179

[email protected]

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Registrar Corp –Greece

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GR-115 26 Athens Greece

P: (+30) 210-699-3559 ext. 25

F: (+30)210-698-5686

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