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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Hampton, Virginia

USA 23666

P: +1-757-224-0177

F: +1-757-224-0179

info@registrarcorp.com

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Registrar Corp –Greece

109-111 Mesogion Avenue Building A

GR-115 26 Athens Greece

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

F: (+30)210-698-5686

greece@registrarcorp.com