NOTE: The following information is relevant for DHL Express customers only. DHL Danzas Air & Ocean customers should contact their local office for further details.

As a follow up to our communication of 19 November 2003, we would like to update you on some important developments that will shortly take effect with regards to the new importation requirements for the United States.

On June 12, 2002, the USA's "Public Health Security and Bio-terrorism Preparedness and Response Act of 2002", (also known as the bio-terrorism Act or BTA) was signed into law. This included provisions designed to protect the United States against bio-terrorist threats to its food supply including food from foreign sources. These provisions were implemented on December 12, 2003 but not fully enforced to allow a period of education and information exchange on the technicalities.

The FDA has announced that effective immediately, US Customs can return or abandon all shipments that do not comply with the new provisions and that as of August 12, 2004, the US government will enforce all fines/penalties described for non-compliance.

This law has two major provisions impacting DHL Express Customers:

• Registration of Facilities: The FDA will require that domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States register with the FDA. US based farms, retail facilities, restaurants and non-profit food facilities in which food is prepared for or served directly to the consumer are exempt from these requirements.

• Prior Notice of Importation of Food: The FDA will require that U.S. purchasers or U.S. importers or their agents submit to the FDA prior notice on the importation of food. Prior notice must be submitted no less than four hours before flight arrival but may not be submitted more than five days prior to shipment arrival.

Registration and Prior Notice has a significant impact on the trading community. This document aims to provide an overview of the relevant provisions that may impact on you as customers of DHL Express.

Further guidance on the relevant requirements and the assistance that DHL can provide is available through your local DHL office. Further details on the Act and the Notices of Proposed Rulemaking are available on the FDA Web site at www.fda.gov/oc/bioterrorism/bioact.html.

Should you have any questions regarding this change, please do not hesitate to contact your local DHL Office. Additionally, please find an enclosed list of questions and answers which may also be of assistance.

GUIDELINES FOR SHIPPING FOOD TO THE US

1. What types of commodities are covered?

Examples of commodities the FDA consider to be food include:

• Dietary supplements and dietary ingredients
• Infant formula (baby food)
• Beverages including alcoholic beverages and bottled water
• Fruits and vegetables
• Fish and seafood
• Dairy products and shell eggs
• Raw agricultural commodities for use as food or components of food
• Canned and frozen foods
• Live food animals
• Bakery goods, snack foods, candy and chewing gum
• Animal feed and pet food

The FDA has the sole authority to determine the scope of the covered commodities. Further details are available on the FDA website at www.fda.gov

2. What types of commodities are exempted?

The following are exempt from Prior Notice requirements:

a) Meat food products, poultry products and egg products that are subject to the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) and comply with the USDA rules and regulations

b) Food that was made by an individual in his/her personal residence and sent by that individual as a personal gift (i.e. for non-business reasons) to an individual in the United States. FDA recently expanded exemptions (or authorized enforcement discretion) to include all personal food shipments. These are shipments sent person to person for non-commercial purposes. Examples include:

• Food in household goods, including military, civilian, governmental agency, and diplomatic transfers;
• Food purchased by a traveler and mailed or shipped to the traveler's U.S. address by the traveler;
• Gifts purchased at a commercial establishment and shipped by the purchaser, not the commercial establishment;
• Food contained in diplomatic pouches.

Note: This does not include shipments sent from a retailer or distributor to an individual. Such shipments do require Prior Notice. (See also "Gift Baskets" below)

c) Samples of food for non-consumption valued below $200 have also been identified as exempt from PN requirements. This would include shipments clearly identified as samples destined for food manufacturers or testing labs, but would not include shipments to retailers or individuals.

The FDA has the sole authority to determine the scope of the covered commodities. Further details are available on the FDA website at www.fda.gov.

3. Registration

3.1 Who needs to register?

All facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must register with the FDA.

3.2 What information is required?

Each registration must include:

• the name, address and phone number for the facility and its parent company (if applicable);
• the name, address and phone number of the owner operator or agent in charge;
• all trade names the facility uses;
• applicable food product categories; and
• a statement certifying that the information submitted is true and accurate and that the person is authorized to submit the registration.

All non-US facilities must also designate a U.S. Agent who must live or maintain a place of business in the U.S. and be physically present in the U.S. for purposes of registration.

3.3 When should any changes to a previous facility application be submitted?

When any required element of a facility's registration changes, an update must be submitted within 60 days of the change.

3.4 How can customers register their company facilities details with the FDA?

Customers can register either through DHL or as self registration.

Registering through DHL

DHL Danzas Air and Ocean US is offering two separate services to our customers via the DHL Technical Services Department in Southfield Michigan. The contact for these services is Paul Vroman or phone +1(810) 987-0527.

1. DHL would file the application and any subsequent changes on behalf of the customer. Charges for these services will be as follows:

• Facilities Registration: $ 75.00 per facility registered
• Subsequent Changes: $ 75.00 per change registered

2. DHL can also act as the U.S. Agent for Foreign Facilities.This service includes providing updates on the BTA act but is in addition to the facility registration fee without a U.S. location. Charges for this service will be as follows:

• Agent Service annual fee $ 600.00

Self registration

This can be done directly by each customer through the FDA website at www.fda.gov

4. Prior Notice of Importation

4.1 How can customers ensure that the FDA receives timely prior notice?

DHL will require submission of a Prior Notice confirmation number or the required data elements to submit a Prior Notice application on the shipping documentation at the time of pick up.

The FDA also allows food importers to submit the Prior Notice application directly. Prior notice must be submitted electronically at www.access.fda.gov.

Please download the "PNSI Web Entry" presentation at the bottom of this bulletin for details on how to submit the application.

DHL will accommodate both options.

4.2 Are there any other information requirements?

In addition to standard invoice requirements, the following elements must be included on the shipping invoice and be available at the time of pick up:

• Identification of each article of food, including the common or usual name or market name, the quantity described at the smallest package size, and the lot or code numbers or other identifier.
• In order to be able to submit a proper Prior Notice DHL requires English language description of each food item shipped. (The FDA product code, if known (available from www.accessdata.fda.gov/SCRIPTS/ORA/PCB/PCB.HTM), will speed up the process.)
• Complete name and address of the manufacturer or grower and their FDA registration number (if available)
• Country of production
• Complete name and address of shipper and their FDA registration number (if available)
• Complete name and address of the importer, purchaser or ultimate consignee and their FDA registration numbers (if available)

The "Required Information for FDA Prior Notice Submission" can be completed and included with the shipping documents to ensure all details necessary are available.

The "Required Information for FDA Prior Notice Submission" is available to download and complete at the bottom of this bulletin.

Note that a separate prior notice is required for each article of food when any of the above items varies or changes. This also includes changes in the size or kind of packaging or container.

4.3 What information does DHL require if customers choose to submit prior notification directly to the FDA?

DHL will require a copy of the prior notice confirmation to accompany the shipment. The confirmation number must also be clearly identified on the shipping invoice. The DHL air waybill should state Food or Foodstuff.

4.4 What will occur if customers do not follow the above requirements?

Food that is imported or offered for import with inadequate Prior Notice is subject to refusal and holding at the port or in secure storage. The FDA will provide its staff with enforcement guidelines containing the Agency's policies on injunctions, prosecution, seizure, destruction, fines, and penalties related to failure to provide timely and accurate Prior Notice.