Are you a canned food manufacturer looking to export your products to the United States? Is your product acid food (AF) or low acid food (LACF)? If so, you will need to register for two important numbers: FCE and SID. Contact us for further advice.
The United States Department of Agriculture (USDA) is a federal agency responsible for food safety, animal and plant health, and animal and plant inspection. The USDA has strict regulations for imported goods into the United States to protect public health and the environment. Applying for a USDA license is complicated, let us help you!
Are you a canned food manufacturer looking to export your products to the United States? Is your product acid food (AF) or low acid food (LACF)? If so, you will need to register for two important numbers: FCE and SID. Contact us for further advice.
As a food exporter to the United States, you know that complying with FDA regulations is essential to ensuring that your products meet U.S. food safety standards. However, if your product is placed on an Import Alert by the FDA, you could face some serious problems. Are you struggling with an Import Alert? Let us help!
If you are an exporter of food to the United States, you need to understand the Prior Notice requirement!
FDA requires all food imported or offered for import into the US to be accompanied by a Prior Notice (PN). This notice provides the FDA with essential information about the food, including its source, type, and quantity.
All domestic and foreign food facilities that manufacture, process, pack, hold, or distribute food for human or animal consumption in the United States are required to register with FDA.
FDA issues a unique identifier for your facilities and you must renew your registrations every two years during the period between October 1st and December 31st of even-numbered years.
It’s crucial that your registration is renewed timely to avoid penalties and latent disruptions to your business operations. We will help you keep track of expiration dates and seamlessly handle the renewal process.
Contact us today to unlock the doors to the U.S. market.
Navigating FDA Food Facility Registration and Renewal can be complex, but with Hollis, it becomes easy.
We guide you through the necessary documentation and procedures for a thorough FDA registration process. Our experts ensure that you meet all the regulatory requirements, making compliance a piece of cake.
Registration process must be done online through FDA’s Electronic Food Facility Registration System (eFFR). You need to complete each step presenting the information below:
Facility name and address
Food types handled
Activities performed
Responsible person contact information
Unique Facility Identifier (UFI)
We take care of this for you with precision and efficiency.
One of the most important requirements for FDA compliance is to have a U.S. agent. A U.S. agent is a person or organization that is responsible for representing a foreign company to the FDA. The U.S. agent must be a U.S. citizen or permanent resident and have a physical address in the United States.
Below are the responsibilities of US Agent:
The US Agent must always respond as quickly as possible to information and requests from the FDA, especially issues related to resolving goods incidents such as when the FDA warns, holds, refuses or Request re-export… as well as advise you on appropriate actions in each specific situation.
Your US Agent should be capable of effectively handling FDA communications and transmitting the information received from the FDA without any delay.
A professional U.S. agent with deep FDA expertise is the best choice for ensuring compliance and success in the U.S. market.
From regulatory hurdles to market insights, we’re your one-stop shop for US success. Don’t just choose a US agent, choose a partner.
To learn more about U.S Agent service, contact us today!
Are you a canned food manufacturer looking to export your products to the United States? Is your product acid food (AF) or low acid food (LACF)? If so, you will need to register for two important numbers: FCE and SID.
FCE stand Food Canning Establishment. It is a unique identification number that is assigned to each food canning establishment by the US Food and Drug Administration (FDA).
SID stands for Submission Identifier. It is a unique identification number that is assigned to each canned food product by the FDA.
Notice that commercial establishments are not responsible for and do not have the authority to register for FCE and SID numbers.
Registering for FCE and SID numbers for canned foods is a complex and specialized process that is difficult for most in-house staff to complete successfully. That’s why you should let us help you with the process. Our team of experts will advise you on how to meet the FDA’s complex regulations and ensure that you are 100% successful in registering for your FCE and SID numbers.
Acidified foods are low-acid foods (such as beans, cucumbers, cabbage, artichokes, and broccoli) that have been added acid or acidic foods. They have a water activity (aw) greater than 0.85 and a final equilibrium pH of no more than 4.6.
Low-acid canned foods, except alcoholic beverages, include any food with a final equilibrium pH greater than 4.6 and a water activity (aw) greater than 0.85. However, tomatoes and tomato products are an exception, although they have a final equilibrium pH of less than 4.7, they are not considered low-acid food.
Contact us now, we are experts in Heat Penetration Study (HPS) and Challenge Study.
If you are exporting AF or LACF foods to the United States, you will need to conduct a Heat Penetration Study (HPS) and a Challenge Study. These studies are required to ensure that your canned food is safe for consumption.
The United States Department of Agriculture (USDA) is a federal agency responsible for food safety, animal and plant health, and animal and plant inspection. The USDA regulates the commercial quality of many types of imported goods, including meat, fish, eggs, fruits, vegetables, and dairy products. These regulations ensure that imported goods meet standards for size, weight, freshness, and quality.
The FDA Food Safety Modernization Act (FSMA) is a landmark piece of legislation that was signed into law in 2011. The law’s goal is to strengthen the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it in the first place.
Hollis with many years of experience and a team of highly qualified experts will help you make FSMA compliance faster, more economical and easier.
All food facilities must conduct a hazard analysis to identify potential hazards that could cause foodborne illness. They must then implement preventive controls to reduce or eliminate those hazards.
Produce growers and handlers must follow strict sanitation and safety practices to prevent contamination of fresh fruits and vegetables.
Food facilities that import food from foreign countries must develop and implement programs to verify that their suppliers are following proper food safety practices.
Food facilities can voluntarily have their food safety systems certified by a third-party organization. This certification can help them meet FSMA requirements and demonstrate their commitment to food safety to their customers.
Prior Notice helps to ensure that imported food meets all applicable U.S. laws and regulations. The information provided in the PN can be used by the FDA to verify that the food is properly labeled, meets all labeling requirements, and is safe to eat.
The answer is all food importers and exporters must submit Prior Notice. This includes food for human consumption, as well as food for animals.
There are a few exceptions to the Prior Notice requirement. These exceptions include:
Food that is sent by mail.
Food that is imported in small quantities for personal use.
Food that is imported for immediate consumption.
Prior Notice can be submitted electronically through the FDA’s Prior Notice System Interface (PNSI). PNSI is a web-based application that allows importers to submit PNs quickly. Failure to comply with Prior Notice may result in your shipment being refused.
Let us help you quickly complete the Prior Notice procedure!
An Import Alert is a public health notification issued by the FDA to inform the public and FDA staff that a particular product has been detained without physical examination (DWPE).
This means that the FDA has determined that there is enough evidence to believe that the product may be adulterated, misbranded, or otherwise violate the law.
If your product is placed on an Import Alert, you could face some risks, including:
Your product could be destroyed by the FDA.
You could be fined.
Your reputation could be damaged.
If you are struggling with an Import Alert, contact us today to learn more about how we can help you.
We will be your go-to team of experts, ready to help you with any issue.
We will contact you for consultation as soon as possible.