Food and Beverages Blog Archives - rfxcel.com

FSMA Rules: A Guide to FDA Food Safety Modernization Act Regulations

The Food Safety Modernization Act (FSMA) is transforming the food supply chain in the United States. Learn about FSMA requirements and how they affect the food industry.

Understanding the FDA Food Safety Modernization Act (FSMA)

The Food Safety Modernization Act (FSMA), signed into law in 2011, aims to reduce foodborne illness, protect the U.S. food supply, and ensure public health. The law gives the U.S. Food and Drug Administration (FDA) authority to regulate the production, processing, packing, and transport of food throughout the country.

The FDA has finalized nine major rules through FSMA that address different aspects of the food supply chain. FSMA covers both human and animal food, and the rules are designed to address issues such as traceability, sanitation, produce safety, and supplier verification.

Key FSMA rules and requirements

Through FSMA, the FDA has issued rules that govern food production and distribution. FSMA final rules include:

      • Food Traceability Final Rule: Established additional traceability recordkeeping requirements for persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL).
      • Preventive Controls for Human and Animal Food: Require food facilities to meet Current Good Manufacturing Practice (CGMP) requirements, conduct hazard analyses, and establish risk-based preventive controls.
      • Produce Safety Rule: Established science-based standards for the production, packing, and storage of fruits and vegetables on farms in the U.S. and other countries.
      • Foreign Supplier Verification Program (FSVP): Requires foreign suppliers to show that they are meeting food safety standards required in the U.S.
      • Sanitary Transportation Rule: Established regulations for the sanitary transportation of human and animal food.
      • Accredited Third-Party Certification Rule: Crated a program to accredit specific third-party certification bodies to conduct food safety system audits of foreign facilities.

Other rules concern protection against intentional adulteration of food and guidelines for the use of agricultural water.

Compliance strategies for FSMA

Navigating FSMA can be complicated, especially as rules are proposed, reviewed, and finalized. To implement effective compliance strategies, organizations should:

      • Review: Start by conducting a thorough review of FSMA requirements to understand which rules apply to your business.
      • Develop: Create a robust FSMA food safety plan that’s tailored to your operations, including hazard analysis and critical control points (HACCP).
      • Implement: Establish preventive controls and monitoring systems across the organization and have a plan in place for food recalls.
      • Verify: Use audits and validation procedures to ensure compliance.

Implementing FSMA’s Preventive Controls and Hazard Analysis

FSMA’s Preventive Controls for Human Food, finalized in 2015, was created to minimize and prevent hazards at food facilities. Key components of this rule include:

      • Current Good Manufacturing Practice (CGMP) revisions: FSMA updated FDA’s existing CGMP requirements to create binding requirements for employee education and training.
      • Food safety plans: The rule created new requirements for risk-based preventive controls and hazard analysis at food facilities, including sanitation practices and allergen controls.

Businesses covered under the Preventive Controls rule must perform a hazard analysis of their facilities and products, implement food safety practices, and provide ongoing monitoring and verification of all preventive controls.

Ensuring FSMA compliance in supply chain management

Even if you’re confident about your organization’s food safety practices, you need to know that your supply chain partners are holding themselves to the same standards. Establishing clear supplier approval and verification processes can help you thoroughly vet the growers, suppliers, processors, or distributors you work with.

By implementing traceability and documentation requirements, you’ll be able to track specific products and lots in real-time. As with your internal processes, conduct regular assessments to ensure suppliers and co-manufacturers are maintaining FSMA compliance.

Final thoughts: FSMA rules and regulations

The worldwide food industry should monitor events in the United States as FSMA traceability requirements evolve. It’s not just about compliance and being able to sell products in America; it’s about being able to anticipate regulatory trends, keeping your supply chain moving at peak performance, and leading in the industry through adaptation and innovation. It’s also about leveraging the FSMA regulations to create business opportunities.

We understand the importance of complying with FSMA and other regulations for the food and beverage industry. We have extensive experience delivering tailored traceability, visibility, and transparency solutions that not only help ensure compliance, but also create added value for operational efficiency, brand protection, and customer loyalty. Contact us today and one of our traceability experts will show you how it works.

And be sure to download our “Traceability in the Food Supply Chain” white paper, which explains the FSMA Food Traceability List and the Food Traceability Final Rule in detail.

The Importance of Food Traceability: Impacts on Safety and Business

As food traceability regulations continue to evolve, it can be difficult to navigate requirements and ensure you remain compliant everywhere you do business. Find out more about the traceability of food products in this guide from Antares Vision Group and rfxcel.

Understanding food traceability

In broad terms, traceability is the process of utilizing data to know the history of everything in your supply chain — every input and ingredient, every finished product. Traceability empowers you to know where something came from, where it has been, and where it is right now. It’s the ability to find granular details about the past and present of an item.

No matter your role in the supply chain, food traceability can play a vital role in securing and improving your business, from ensuring you comply with regulations to helping manage risks (e.g., making recalls faster and more accurate) and connecting with consumers.

Benefits of food traceability

The advantages of a strong food traceability system for you, your partners, and your customers include:

      • Food safety: Traceability reduces the risk of foodborne illnesses and helps ensure your products are safe for consumption.
      • Risk mitigation: If a food safety issue does arise, traceability facilitates prompt, informed responses. For example, traceability speeds food recalls and targeted product withdrawals to minimize the impact on public health and lessen interruptions to your operations.
      • Operational efficiency: Food traceability solutions act across your supply chain to improve operations and make it easier to manage your inventory.
      • Trust: Food traceability can help build consumer trust and confidence through transparent processes and demonstrating that you are a reliable brand whose products are exactly what you say they are.

Key elements of food traceability

The primary components of a good food traceability system include:

      • Identification: Companies must be able to trace individual products and raw materials back to specific locations, batches, lots, etc.
      • Product tracing: Each product must be traceable from farm to fork, with granular documentation that captures its journey at every stage of the supply chain.
      • Data capture and management: A strong, centralized system is needed for collecting, analyzing, sharing, and storing traceability records.
      • Authentication: Verification tools ensure the accuracy and integrity of food traceability data and can help resolve errors before they affect other parts of the supply chain.

Implementing food traceability systems

Here are some things to consider if you want to implement a new food traceability solution or improve your existing systems:

      • Evaluate: Start by assessing traceability requirements and regulatory obligations. Examine what industry leaders are doing to identify best practices and opportunities.
      • Select tools: Choose the appropriate traceability technologies and systems for the type of products you grow, pack, process, distribute, etc. (Working with a reliable, experienced solution provider is essential.)
      • Implement processes: Establish your traceability protocols and standard operating procedures, training relevant staff. (Again, make sure you’re working with a solution provider that will work with you and your team to ensure implementation is quick and efficient.)
      • Collaborate: Work with partners and stakeholders to implement traceability measures across the supply chain.

Food traceability in action: U.S. FDA Food Safety Modernization Act

Passed in 2011, the Food Safety Modernization Act (FSMA) made sweeping reforms to food safety regulations in the United States. The legislation empowered the U.S. Food and Drug Administration (FDA) to create and enforce rules on how food is harvested, processed, stored, and distributed throughout the United States.

FSMA’s No. 1 goal is to reduce the rates of illness from foodborne pathogens; food traceability is an important component of the FDA’s strategy to achieve that goal. The Agency’s primary guidance for traceability is the Food Traceability Final Rule, which went into effect in November 2022. It establishes additional traceability recordkeeping requirements for businesses that manufacture, process, pack, or hold foods on the Food Traceability List (FTL).

These food supply chain stakeholders are responsible for establishing and maintaining critical tracking events (CTEs) and associated key data elements (KDEs) for events such as harvesting, cooling, packing, and receiving. CTEs and KDEs are the building blocks of food traceability under FSMA. Read our food traceability white paper to learn how they work.

What food products are required to be traced under FSMA?

FSMA’s Food Traceability Final Rule sets the recordkeeping requirements for any business that manufactures, processes, packs, or holds foods on the Food Traceability List, which includes almost 20 types of food, such as:

  • Fresh fruits and vegetables
  • Leafy greens
  • Melons
  • Nut butters
  • Finfish
  • Crustaceans
  • Soft cheeses
  • Ready-to-eat deli salads

Final thoughts: food traceability

Traceability is essential to ensure the safety, transparency, and quality of the global food supply chain. Our goal is to equip businesses with modern food traceability solutions that improve operational efficiencies, comply with regulations, foster consumer confidence, and help create a more secure and transparent food industry. Offering end-to-end traceability, visibility, and transparency, our solutions for the food and beverage industry make it easy to track and trace products across every step of the supply chain. Contact us today to speak with one of our traceability experts and see a short demo of how our solutions work.

The U.S. Uyghur Forced Labor Prevention Act and Supply Chain Ethics

Signed into law on Dec. 23, 2021, the U.S. Uyghur Forced Labor Prevention Act (UFLPA) prohibits the importation of certain goods into the United States and aims to ensure that businesses are not complicit in human rights abuses. It’s one of many regulations around the world that aim to make supply chains more ethical, transparent, and sustainable.

Let’s see what the act says and examine why supply chain transparency is the key to making such legislation viable and successful. For another example of recent laws, see our blog post about Germany’s Supply Chain Due Diligence Act.

What is the Uyghur Forced Labor Prevention Act?

The Uyghur Forced Labor Prevention Act, or UFLPA, is a response to concerns over forced labor and human rights violations in the Xinjiang Uyghur Autonomous Region in northwest China.

It’s worth quoting the U.S. Customs and Border Patrol website at length for a thorough description. It says the act:

“establishes a rebuttable presumption that the importation of any goods, wares, articles, and merchandise mined, produced, or manufactured wholly or in part in the Xinjiang Uyghur Autonomous Region of the People’s Republic of China, or produced by certain entities, is prohibited by Section 307 of the Tariff Act of 1930 and that such goods, wares, articles, and merchandise are not entitled to entry to the United States.

“The presumption applies unless the Commissioner of U.S. Customs and Border Protection (CBP) determines that the importer of record has complied with specified conditions and, by clear and convincing evidence, that the goods, wares, articles, or merchandise were not produced using forced labor.”

Furthermore, the act required the Forced Labor Enforcement Task Force, chaired by the U.S. Department of Homeland Security, to develop a strategy for supporting the legislation. This strategy was published on June, 1, 2021, and includes the UFLPA Entity List, which names “entities in Xinjiang that mine, produce, or manufacture wholly or in part any goods, wares, articles and merchandise with forced labor.”

Key provisions

The Uyghur Forced Labor Prevention Act has provisions to combat forced labor and enhance supply chain transparency, including:

      • Import restrictions: As we noted above, the act bans the importation of goods produced wholly or in part in China’s Xinjiang Uyghur Autonomous Region, unless importers can provide clear and convincing evidence that the goods were not produced with forced labor.
      • Enhanced due diligence: The act places the responsibility on companies to exercise due diligence and conduct comprehensive risk assessments of their supply chains to identify any forced labor risks or links to Xinjiang.
      • Publicly available information: Companies must disclose information on their efforts to ensure their supply chains are free from forced labor, including the specific measures they have implemented and the results of their due diligence assessments.
      • Coordination with government agencies: The act requires collaboration between government agencies, including the Department of Homeland Security, Department of Labor, and Department of State, to ensure effective enforcement and implementation of the legislation.

Implications and challenges for businesses

The act has very real implications for businesses operating in the United States. They must have the means to see into their partners’ operations, as well as into the often opaque landscape of secondary and tertiary suppliers. Other challenges include:

      • Not being able to produce audits that meet Forced Labor Enforcement Task Force credibility requirements
      • Traceability challenges in the supply chain (e.g., aggregated and commingled products with difficult-to-prove provenance)
      • Regulations in other countries that make compliance more difficult/complicated
      • Challenges related to sourcing (i.e., not being able to find a crucial raw material or item outside of China)

The government provides resources for businesses concerning the Uyghur Forced Labor Prevention Act. For example, see the U.S. Customs and Border Protection’s UFLPA Operational Guidance for Importers and its FAQs about the act.

Final thoughts

The Uyghur Forced Labor Prevention Act is part of broader regulatory efforts to eliminate forced labor and human rights abuses in global supply chains. Businesses must be prepared (and willing) to audit and assess their operations, engage with their suppliers (and their suppliers’ suppliers), and establish mechanisms to trace the origin of goods to ensure compliance.

And they should be proactive about it. A first step is contacting us to talk about supply chain transparency. Our transparency solutions enable companies to track and trace their supply chains in real time from virtually anywhere in the world. Our technology makes every product a “digital asset” with a certified, provable, and sharable provenance. We can show you how it works with a short demo.

If you’re interested in learning more about supply chain transparency, check out the articles below. “Transparency” means just about the same thing in every supply chain, so consider these as case studies about how it works, why it’s important, and the business benefits it can bring.

 

 

Understanding the German Supply Chain Due Diligence Act

The German Supply Chain Due Diligence Act (SCDDA) is a significant piece of legislation that aims to promote corporate responsibility and ensure human rights and environmental standards in global supply chains.

Let’s take a look at its key provisions, its objectives, and its potential impact on businesses operating in Germany and beyond.

Background and objectives

Enacted on Jan. 1, 2023, the German Supply Chain Due Diligence Act aims to hold companies accountable for their actions and foster transparency in global trade. Its overarching goal is to prevent and address human rights abuses, enhance sustainability, and create a level playing field for responsible businesses.

Broadly speaking, the law is based on major human rights conventions and uses those conventions to establish requirements or prohibitions to prevent child labor, forced labor, and slavery; maintain occupational safety and health standards; ensure adequate wages and workers’ right to form trade unions or representation bodies; and access to food and water.

By introducing mandatory due diligence measures, the law will enhance supply chain transparency, mitigate risks, and help ensure corporate accountability. While compliance may present challenges, it also opens opportunities for companies to embrace sustainability, protect their brands, and contribute to a more sustainable and ethical business environment.

What are the provisions of the Supply Chain Due Diligence Act?

The Supply Chain Due Diligence Act mandates that German companies (i.e., those with their central administration, principal place of business, administrative headquarters, legal registration, or branch office in Germany) are required to respect human rights by implementing defined due diligence obligations.

This year (2023), the law applies to companies with 3,000 or more employees in Germany; in 2024, it will apply to companies with at least 1,000 employees in Germany. It applies to the actions of companies, their contractual partners, and other suppliers. Practically, this means a company is responsible for everything that happens along its entire supply chain. Key requirements include the following:

      • Risk assessments: Companies are required to conduct regular risk assessments to identify potential human rights and environmental risks associated with their suppliers and business partners.
      • Preventive measures: Companies must implement appropriate measures to prevent or mitigate any identified risks. This could include engaging with suppliers, establishing and enforcing codes of conduct, and training employees to raise awareness and promote responsible practices.
      • Remediation and grievance mechanisms: Companies must have effective grievance mechanisms to enable workers and stakeholders to report abuses and seek redress. They must demonstrate their commitment to resolving issues and rectifying any harm caused.
      • Transparency and reporting: Companies must disclose relevant information related to their supply chains, including their risk assessment procedures, preventive measures, and the effectiveness of their due diligence efforts. Transparency helps stakeholders hold companies accountable and facilitates informed consumer choices.

How could the act affect businesses?

The German Supply Chain Due Diligence Act has significant implications for businesses operating in Germany. Regulated companies will need to invest in developing robust due diligence systems, which may require additional resources and expertise. Compliance costs will likely vary depending on how large a company is, the complexity of its supply chain, and its existing practices and procedures.

Benefits of compliance include improved brand reputation, trust among partners and stakeholders, and reduced risk of legal and reputational damage resulting from human rights violations. Moreover, companies that embrace responsible supply chain practices can gain a competitive advantage by attracting socially conscious consumers and investors who prioritize ethical sourcing.

Final thoughts

In the global context, the spirt of the German Supply Chain Due Diligence Act aligns with other international efforts, such as the United Nations Guiding Principles on Business and Human Rights and the Organisation for Economic Co-operation and Development (OECD) Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas. It also aligns with other legislation in Europe, such as France’s Duty of Vigilance Law, the UK’s Modern Slavery Act, and the proposed European Union mandatory due diligence legislation.

As we said in our article about the U.S. Uyghur Forced Labor Prevention Act, companies should anticipate the passing of more regulations aimed at eliminating forced labor and human rights abuses in global supply chains. They must be prepared (and willing) to audit and assess their operations, engage with their suppliers (and their suppliers’ suppliers), and establish mechanisms to trace the origin of goods to ensure compliance.

Supply chain transparency is the key to compliance. To see how it works, contact us today for a short demo of our transparency solutions, which will empower you to track and trace your supply chain in real time from virtually anywhere in the world and provide a certified, provable, and sharable provenance for your products.

And if you’re interested in learning more about supply chain transparency, check out our blog articles below. “Transparency” means just about the same thing in every supply chain, so consider them as case studies about how it works, why it’s important, and the business benefits it can bring.

 

FSMA 204 Data Carrier Requirements: FDA Guidance & GS1 Standards

We’ve recently talked about Food Safety Modernization Act (FSMA) traceability requirements and GS1 standards and the FSMA traceability lot code. Today, we’re covering FSMA 204 data carrier requirements: FDA guidance and — once again — GS1 standards, including incorporating the mandated traceability lot code into compliant barcodes.

Like our previous post, we’re basing much of this discussion on GS1’s March 1, 2023, industry guidance document, “Application of GS1 System of Standards to Support FSMA 204.” For an in-depth description of GS1 data carriers, check out our “Understanding GS1 Barcodes in the Global Supply Chain” article.

Data carriers: a quick definition for context

A building block for traceability in any supply chain, data carriers enable product information to be quickly and accurately captured, stored, shared, and leveraged for business needs. Companies can mark their entire product hierarchy — from individual items and inner packs to cases/boxes and pallets — with data carriers, which include barcodes (e.g., linear, 2D DataMatrix codes, and QR codes).

Do GS1 barcodes meet FSMA 204 data carrier requirements?

The short answer is “yes.”

However, FSMA does not mandate the use data carriers to provide product information and the FDA does not say what data must be present to meet the FSMA traceability requirements. This is stated clearly in Federal Register Response 524, in which the FDA says that “firms may use product labels to provide the information required [our emphasis] to their supply chain partners if that suits their business practices.”

In the context of this question, suggestions for “product labels” included twist ties, bags, food-grade stickers, and traditional-type labels on produce or customer order forms. For GS1, product labels mean data carriers, primarily barcodes.

What does GS1 say about FSMA 204 data carriers?

In its guidance document, GS1 says this about the FSMA 204 data carrier requirements (or lack thereof):

“Data carriers are not required to meet the requirements of the Final Rule. For this reason, there is no clear prescription of what data must be present in a data carrier to fulfill traceability for the Final Rule. Instead, companies must evaluate what data will enable rapid access to the necessary information in the event the FDA requests their records.”

GS1 explains three types of data carriers that might have applications for the FSMA 204:

      1. GS1 Element String (1D and 2D), which can contain the primary identifier (e.g., Global Trade Item Number, or GTIN) and attribute data (e.g., lot/batch number, expiration date, sell-by date, net weight)
      2. GS1 Digital Link URI (2D), a web-compatible format that can contain the primary identifier and attribute data
      3. Electronic Product Code Uniform Resource Identifier (EPC URI), which can contain the primary identifier with a serial number plus attribute data for use in RFID tags, primarily UHF passive tags (also called RAIN RFID).

Using GS1 barcodes as a FSMA 204 data carrier

Below are some examples of how GS1 barcodes might look when used as FSMA 204 data carriers. (We’re not going to get into RAIN RFID today.)

Specifically, we want to illustrate how these barcodes could meet the FSMA traceability lot code requirement, which GS1 says a GTIN + batch/lot numbers would satisfy. (Read our article here for more about the traceability lot code.) In the illustrative images below, we’ve highlighted the GS1 Application Identifiers (AIs) for GTIN (01), lot/batch number (10), and expiration date (17). AIs tell systems what information is being interacted with and enable them to process that information accordingly.

GS1-128. GS1-128 is a 1D barcode that can be up to 6.5 inches long and have up to 48 data characters. In terms of FSMA 204 data carriers, GS1 includes an “important” note that “1D barcodes cannot be removed until all stakeholders expected to scan the barcode are fully capable of interacting with 2D barcodes. This means that both a 1D and 2D barcode would be required during any transition period.”

GS1 DataMatrix. GS1 DataMatrix codes are omnidirectional and support attributes and all GS1 identification keys. They can hold 3,116 numeric or 2,335 alphanumeric characters.

GS1 DataMatrix + GS1 Digital Link URI. The GS1 Digital Link URI essentially turns data carriers into web links. GS1 says that “scanning capabilities are not widely available for GS1 Digital Link URI in general distribution,” so companies would  have to update their systems in order to process these barcodes and the data they contain.

GS1 QR Code + GS1 Digital Link URI. Like GS1 DataMatrix codes, GS1 QR codes are omnidirectional and support attributes and all GS1 ID keys; however, they can hold 7,089 numbers or 4,296 alphanumeric characters. Some mobile device cameras cannot process DataMatrix codes, so GS1 says QR Codes are “the current preference for engagement through mobile devices.”

GS1 Barcodes FSMA 204 data carrier

Final thoughts

Let’s repeat what we said in our post about GS1 and FSMA traceability requirements:

One takeaway from today’s article is that the FDA might be telling food companies what the FSMA traceability requirements are, but it’s not telling them how to comply. This is why it’s important to understand GS1’s “take” on the situation and the rationale behind its suggestions.

Food companies are already using GS1 barcodes; adapting them as FSMA 204 data carriers or “product labels” makes good sense. GTINs, batch/lot numbers, Serialized Shipping Container Code (SSCC) data, and other information can be encoded into GS1-128, GS1 DataMatrix, GS1 QR code barcode configurations, as well as Electronic Product Code-enabled RAIN RFID tags and labels.

Contact us today if you’d like to learn more about using a barcode as a FSMA 204 data carrier, how to integrate data capture technology into you FSMA 204 compliance strategy, and everything else you need to have in place by the January 2026 deadline. A short talk with one of our supply chain experts will get you going in the right direction or help you course-correct if you feel like you’ve been treading water with your FSMA initiatives.

And if you’re interested in learning how we’ve put more than 1.5 billion of barcodes on as many products to help a major berry producer control product safety and quality, click here.

Read more about FSMA:

Understanding FSMA 204 Data Carrier: FDA Guidance and GS1 Standards

People have been asking us about the Food Safety Modernization Act (FSMA), so we’ve recently written about the Final Rule, the Food Traceability List, and the FSMA traceability lot code. Now we’re going to cover what GS1 is saying about the FSMA traceability requirements.

It’s a timely — and important — topic for the food industry. About two weeks ago, GS1 published an industry guidance document about applying its standards to support FSMA 204. Among other things, the 62-page paper “defines the recommendations for product and location identification, structured product descriptions, and recording common industry defined events to support the additional traceability records required in the Final Rule.”

Today, we’re looking at three things:

      1. What the FDA says about complying with FSMA traceability requirements
      2. GS1 standards for identification
      3. GS1 standards and the FSMA traceability lot code

Caveats and context

GS1 says its guidance document, which was developed by its US FSMA 204 Workgroup, “does not provide any guidance or advice regarding regulatory compliance.”

It also states that the “guideline reflects current industry understanding of the Additional Traceability Records for Certain Foods. Those requirements, and the statutes and regulations affecting them, are subject to change and may evolve in a manner this guideline cannot anticipate.”

Keep these statements in mind as you’re reading. Also know that the purpose of this blog post is to summarize what GS1 is saying about its standards and FSMA traceability requirements, not to advise on or advocate for the use of GS1 standards for FSMA compliance.

Of course, if you do want to get into specifics of ensuring you’re FSMA-compliant, contact us today and start that conversation with one of our supply chain experts.

Last, we’re going to be getting into technical aspects of GS1 standards, including Application Identifiers, identification keys, and barcodes. We’ll explain everything, but read our “Understanding GS1 Barcodes in the Global Supply Chain“ article for more detailed information.

What does the FDA say about complying with FSMA traceability requirements?

The answer is pretty simple: The FDA does not provide concrete guidance about how to meet FSMA traceability requirements; instead, it speaks in general terms. For example:

      • In Federal Register Final Rule Response 507 to a question about “requiring the use of globally unique product identifiers” — including GS1 identifiers — the Agency says, “we are not making this a requirement under the final rule.”
      • In Federal Register Final Rule Response 516 to a question about GS1 Serial Shipping Container Codes (SSCCs), the Agency says, “we encourage the use of any tools that will improve a firm’s procedures for traceability and support the maintenance and sharing of the required traceability records under the final rule.”
      • Though it does mention the GS1 Global Trade Item Number (GTIN) in a response about the traceability lot code, it says “firms are not required to use GTIN or any other particular coding system or technology.”

In this regulatory context, let’s see what GS1 says about using its standards for the FSMA traceability requirements.

GS1 standards for identification

GS1 says food companies can use GTINs, SSCCs, and Global Location Numbers (GLNs) for the FSMA traceability requirements.

      • GTINs identify individual products. They can be linked to key data elements (KDEs) in a database; food companies wouldn’t need to maintain required information in a separate location. (See our simple explanation of KDEs here.)
      • SSCCs identify single logistics units (e.g., pallets). They can be paired with the mandated FSMA traceability lot codes to improve traceability.
      • GLNs identify the “who” and “where” of a product/company. They would provide required company and location identification.

GS1 standards and the FSMA traceability lot code

Though the FDA does not commit to a standard for the traceability lot code, it does indicate some options. For example:

      • In Final Rule Response 324, the Agency says there are “industry-supported traceability initiatives [to use] a combination of a globally unique product identifier, firm-assigned internal lot code, and standard date code [that] could be used as a traceability lot code.”
      • In Response 361, it says “a traceability lot code may include a product identifier such as a GTIN and/or an internal lot code (provided the definition of ‘traceability lot code’ in § 1.1310 is met).”

GS1 says a GTIN plus batch/lot numbers would meet the FSMA traceability lot code requirements. Here’s a step-by-step explanation of why it would work:

      • GS1 uses Application Identifiers (AI) to indicate identification keys, attribute information, and secondary information.
      • There are 12 identification keys, including GTINs, SSCCs, and GLNs. Every identification key also has an AI. (Read our article about GS1 barcodes for a more thorough explanation of identification keys.)
      • The GTIN AI is 01 and “uniquely identifies [a] trade item.” It can be 8, 12, 13, or 14 digits long.
      • The batch/lot number is AI 10 and “identifies a group of the same product, all of which were manufactured under identical conditions to support traceability and other use cases.” It can be up to 20 characters (letters, numerals, and a defined subset of special characters).
      • The batch/lot number must be expressed in conjunction with a GTIN (AI 01) because it is a product attribute.

Final thoughts about FSMA Traceability Requirements

One takeaway from today’s article is that the FDA might be telling food companies what the FSMA traceability requirements are, but it’s not telling them how to comply. This is why it’s important to understand GS1’s “take” on the situation and the rationale behind its suggestions.

It also reinforces a point we’ve been making for quite some time: Companies that see regulations as a chance to lead in their industry and create business value will win the day, and companies that think only about the mechanics of compliance will likely miss these opportunities.

So, like we said above, if you want to talk turkey about ensuring you’re FSMA-compliant, contact us today to start the conversation. In about 15 minutes, one of our supply chain experts can show you Antares Vision Group’s solutions for the food industry and how rfxcel technology drives them.

Also check back next week. We’ll continue this discussion with a piece about data carriers — 1D and 2D barcodes, QR Codes, RFID tags — and what the FDA and GS1 is saying about their role in FSMA traceability requirements. Last but not least, click here to learn how we barcoded more than 1.5 billion products help a major berry producer control product safety and quality.

Read more about FSMA:

 

What is the FSMA Traceability Lot Code and Who Must Comply?

If you read our blog (and we know you do), you’re up to speed on the fundamentals of Food Safety Modernization Act (FSMA) Section 204, including the Food Traceability List (FTL) and the food traceability “Final Rule.” Today, we’re looking at an important part of the regulations — the FSMA traceability lot code — and who must comply.

What is the FSMA traceability lot code?

The FDA defines the FSMA traceability lot code as “a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the firm that assigned the traceability lot code.”

Certain types of companies must assign, record, and share with their trading partners the traceability lot codes for foods on the FTL. These companies must also link the codes to information that identifies FTL foods as they move through the supply chain. (More on this below.)

A traceability lot code must be assigned when any of the following occur:

      • Initial packing of a raw agricultural commodity (RAC*), other than a food obtained from a fishing vessel
      • Performing the first land-based receiving of a food obtained from a fishing vessel
      • Transformation of a food

Section 201(r) of the Federal Food, Drug, and Cosmetic Act defines a RAC as “any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.”

The FSMA traceability lot code in action: CTEs and KDEs

To fully understand the FSMA traceability lot code, we have to talk about the cornerstones of FSMA traceability: critical tracking events (CTEs) and key data elements (KDEs), which are required for foods on the FTL.

In broad terms:

      • CTEs include events that happen during growing and processing, such as harvesting, cooling, initial packing, and distribution.
      • KDEs provide the granular details for food traceability, including time, location, unit measurements, and information about the businesses handling the food.
      • Different companies are responsible for different types of KDEs (e.g., for receiving, shipping, transformation).

A FSMA traceability lot code is typically assigned during the “initial packing” CTE, which the law describes as “packing a RAC, other than a food obtained from a fishing vessel, for the first time.” This means that a code is not assigned at previous supply chain nodes, such on a farm, during harvest, or at a cooling facility.

Once a traceability lot code has been assigned, the records required at each CTE must include that code. Furthermore, companies shouldn’t change the traceability lot code they receive from their partners (e.g., a shipper shouldn’t change the code it receives from an initial packager).

Do you have to comply? Are you exempt?

The Final Rule does have exceptions to the requirements we’ve discussed above.

Overall, the law stipulates that “persons who manufacture, process, pack, or hold foods on the FTL [must] maintain records containing KDEs associated with CTEs” and “provide information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed.”

Therefore, speaking generally, initial packagers, shippers, and receivers have to assign, record, and/or share include a FSMA traceability lot code. Companies that transform FTL foods into other products must include the traceability lot code for each ingredient received and a new traceability lot code for the product you’ve created.

However, companies that receive an FTL food from a partner that is exempt from the regulations must assign a traceability lot code if one has not already been assigned — unless the receiving company is a retail food establishment or a restaurant.

Again, we’re speaking generally. The FDA has an online tool to determine if you’re exempt from the Final Rule.

Final thoughts about the FSMA traceability lot code

This is a lot to digest. Online tools are fine, but the better option is to contact us and nail down your FSMA traceability lot code obligations — and to make sure you’re ready to comply with every FSMA requirement.

As we wrote in our last FSMA update about two weeks ago, the deadline to comply is January 20, 2026. That seems like a long way off, but it’s really not when you factor in the complexity of the Final Rule, the FTL, and the other mandates.

Antares Vision Group can help. We’ll answer your questions. We’ll demonstrate how our traceability and compliance solutions meet your exact needs. And we’ll show you how technology from rfxcel brings added value for brand protection, risk mitigation, customer engagement. Drop us a line today and let’s get started.

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FSMA Traceability: What the Food Industry Needs to Know Today

U.S. regulators want a more robust, technology-driven approach to traceability and safety in the food supply chain. Their strategy has several components, but the FSMA traceability requirements published in November 2022 should be top-of-mind for the food industry in the United States and elsewhere.

Let’s take a look at the Food Safety Modernization Act (FSMA) and FSMA traceability requirements. Even though the compliance deadline is about three years away, now is the time to start planning your strategy.

FSMA implementation and goals

The Food and Drug Administration (FDA) is the primary implementing regulatory agency of FSMA, a law that seeks to transform the United States’ food safety system “by shifting the focus from responding to foodborne illness to preventing it.” It focuses on five areas:

    1. Preventive controls
    2. Inspection and compliance
    3. Imported food safety
    4. Response (i.e., recalls)
    5. Enhanced partnerships

In terms of FSMA traceability, the regulations address the “need for rapid and effective tracking and tracing of foods.”

FSMA Section 204 and the three pillars of FSMA traceability

Section 204 of FSMA is entitled “Enhancing Tracking and Tracing of Food and Recordkeeping.” It has three traceability requirements and instructs the FDA to develop additional recordkeeping requirements for certain foods. Quoting verbatim from the Agency’s website, the FDA must:

    1. Establish pilot projects in coordination with the food industry to explore and evaluate methods and appropriate technologies for rapid and effective tracking and tracing of foods.
    2. Designate foods for which additional recordkeeping requirements are appropriate and necessary to protect the public health.
    3. Publish a notice of proposed rulemaking to establish such additional recordkeeping requirements for the designated foods, to help in tracing such foods.

Today, we’re going to focus on Nos. 2 and 3, which concern the FDA’s Food Traceability List and the Final Rule on Requirements for Additional Traceability Records for Certain Foods (“Final Rule”).

The Food Traceability List and the Final Rule

The Food Traceability List (FTL) was developed with input from a 2014 Request for Comments and for Scientific Data and Information in the Federal Register, members of the FDA and the Centers for Disease Control and Prevention, and external subject matter experts. It includes “high-risk foods” such as leafy greens, shell eggs, crustaceans (e.g., shrimp, crab, lobster), and finfish (e.g., cod, tuna, salmon).

In September 2020, the FDA published “Requirements for Additional Traceability Records for Certain Foods.” Known as the “Food Traceability Proposed Rule” or “Proposed Rule,” it defined additional recordkeeping requirements for businesses that manufacture, process, pack, or hold foods on the FTL.

After making modifications and holding a period for public comments, The FDA in November 2022 announced the Final Rule on Requirements for Additional Traceability Records for Certain Foods.

The gist of the Final Rule and FSMA traceability is that businesses are responsible for establishing and maintaining records of critical tracking events (CTEs) and associated key data elements (KDEs).

CTEs are typically events that occur during growing and processing (e.g., harvesting, initial packing, and shipping). KDEs provide the granular details for FSMA traceability, such as time, location, unit measurements, and a company’s contact information.

The information companies must keep and share with their partners depends on the type of supply chain activities they perform with respect to food(s) on the FTL. The activities encompass the entire food supply chain, from harvesting or production, to processing, distribution, and receipt at a retail location or other point of service.

The FDA says this “framework forms the foundation for effective and efficient tracing and clearly communicates the information that FDA needs to perform such tracing.”

Final thoughts

The deadline to comply with FSMA traceability requirements is January 20, 2026. (That’s a Tuesday, if you’re wondering.) The FDA is giving the food industry the extra time because it wants all regulated businesses to come into compliance by the same date — and because it acknowledges that trading partners have to get their systems in place.

The worldwide food industry should monitor events in the United States as FSMA traceability requirements evolve. It’s not just about compliance and being able to sell products in America; it’s about being able to anticipate regulatory trends, keeping your supply chain moving at peak performance, and leading in the industry through adaptation and innovation. It’s also about leveraging the FSMA regulations to create business opportunities.

This is where Antares Vision Group can help. We offer a full-stack solution for the food industry. A “soup to nuts” solution, if you will. We can answer your questions, show you in concrete detail how we create end-to-end traceability in supply chains, and discuss how to use traceability to safeguard your brand and protect your bottom line. Contact us today to talk with us and schedule a demo.

And read this if you’re interested in learning about how rfxcel technology helped a major berry producer control the safety and quality of more than 1.5 billion products.

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Antares Vision Group Will Be at GS1 Connect 2022 in San Diego Next Month!

We’re getting excited for GS1 Connect, June 7-9 at the Marriott Marquis San Diego Marina! Not only are we a Premier Sponsor — we’ll be speaking about supply chain traceability and smart hospital systems.

We’ll also be at Booth 115 with our award-winning Traceability System, demonstrating solutions for the food and beverage, pharmaceuticals, and cosmetics industries.

So take 20 seconds (really) to sign up to meet us. We have a limited number of discount codes for 10 percent off your registration fee. And while you’re at Booth 115, take our short survey and you could win a $500 DoorDash gift card.

More about GS1 Connect and our speakers

The theme of this year’s conference is “Adapt.” The focus is on how businesses have used GS1 Standards to overcome challenges to thrive in uncertain times. There will be 40+ live sessions (including ours!), 50+ exhibitors (including us!), trading partner roundtables, and other events centered on user stories and leadership insights for supply chain optimization.

As GS1 says, the event is a place to “network with the greatest supply chain minds and learn how to leverage GS1 Standards to optimize your business.” Indeed.

In “Supply Chain Traceability: Can Your Business Survive Without It?” Herb Wong, our vice president of product and strategy, will discuss why traceability is foundational to business success in a rapidly evolving landscape of digitalization, ever-changing consumer expectations and power dynamics, tougher regulations, and supply chain uncertainty. He’ll be speaking on Thursday, June 9, at 1:45 p.m.

In on-demand session 509, “Smarter and Safer Hospitals: When Innovative Technologies Meet Patient Safety, our Digital Healthcare Department Director Adriano Fusco and Dr. Alberto Sanna, director of the Research Center for Advanced Technologies for Health and Well-Being of the IRCCS San Raffaele Hospital in Milan, Italy, will discuss how traceability and GS1 Standards enable end-to-end visibility of medications from arrival at the hospital to dispensation and optimized resources to focus on patient safety.

Final thoughts

We’ve always valued GS1 Standards, and we’ve always ensured our customers can adhere to them and take full advantage of them to maximize efficiency and create value across their operations everywhere they do business.

And who took the time to note the 50th anniversary of the venerable Global Trade Item Number (GTIN)? We did, with a blog post devoted to GS1 barcodes.

As we said in that article, “Where would we be without standards?” We’d love to see you at GS1 Connect and talk about those standards and how they fuel traceability. We hope you’ll take those few seconds to sign up to meet us at Booth 115, get 10 percent off your registration, and enter to win a nice prize when you take our survey.

In the meantime, drop us a line if you have any questions or want to know more about our traceability solutions for pharma, food and beverage, cosmetics, and other industries. We never pass on an opportunity to talk about what makes us your best partner for end-to-end supply chain solutions, from L1 all the way to L5!

See you in San Diego June 7-9!

Understanding the Supply Chain in Africa: Essential Insights for the Track and Trace Industry

Welcome to Part 2 of our look at the supply chain in Africa. In Part 1, we did “Africa by the numbers,” getting into the details of the continent’s geography, demographics, economy, and goals of “Agenda 2063.” Today, we’re talking about three challenges and three opportunities. There’s a lot to cover, so let’s get started.

Three challenges for the supply chain in Africa

As we said in Part 1, Africa is big: about 11.7 million square miles (30.3 million square km). The continent has eight primary physical regions — the Sahara, the Sahel, the Ethiopian Highlands, the savanna, the Swahili Coast, the rain forest, the African Great Lakes, and Southern Africa — and traversing these diverse landscapes is not always easy.

Which brings us to the first challenge for the supply chain in Africa: physical and electronic infrastructure. Stated simply, Africa has a long way to go with infrastructure. McKinsey & Company’s “Solving Africa’s infrastructure paradox” (March 2020) provides a good overview of this challenge, the paradox being that there’s a high demand for projects and sufficient capital, but not much action. Specifically,

“… infrastructure investment in Africa has been increasing steadily over the past 15 years, and … international investors have both the appetite and the funds to spend much more across the continent. The challenge, however, is that Africa’s track record in moving projects to financial close is poor: 80 percent of infrastructure projects fail at the feasibility and business-plan stage.”

One eye-opening statistic from the McKinsey article: More than two-thirds of the world’s population that does not have access to electricity lives in sub-Saharan Africa. That’s 600 million people. The challenge is self-evident. Agenda 2063 has ambitious infrastructure components (e.g., rail, air, water) and could very well smash this paradox. But it will take time.

Here are two other key challenges for the supply chain in Africa:

The informal economy. The Center for Global Development reports that Africa’s informal sector is the largest in the world, citing International Labor Organization statistics that it accounts for almost 90 percent of the economy in sub-Saharan Africa and about two-thirds in North Africa. Research from 2019 showed that the informal sector provided 90 percent of all new jobs and 70 percent of all employment across sub-Saharan Africa.

In Africa’s urban areas — the fastest-growing in the world — World Bank data shows that almost 81 percent of jobs are in the informal sector, while the International Labor Organization reported that almost 96 percent of youth ages 15-24 and a little more than 93 percent of women work in the informal economy.

This means that a significant part of the supply chain in Africa is informal, operating through non-official channels and without government oversight, regulation, or taxation. This makes it difficult for businesses to operate in Africa and enables an environment in which other supply chain problems can arise.

Counterfeits. Illegal copying and counterfeiting is widespread in Africa, as it is in other parts of the world with unregulated informal economies and insufficient supply chain protections. Bad actors are only too happy to exploit these conditions.

For example, 42 percent of all fake medicines reported to the World Health Organization from 2013 to 2017 came from Africa. (WHO estimates one of every 10 medical products in low- and middle-income countries is substandard or fake.) Reading between the lines, the proliferation of counterfeit medicines in Africa’s supply chain might be even greater, as weak regulations and lax enforcement often results in under reporting.

To illustrate the problem, last year an Interpol-supported operation in Southern Africa targeting “trafficking of illicit health products and other goods” nabbed 179 suspects and seized products worth approximately $3.5 million. Examples of similar events include the following:

    • 2015-2018: Almost 20 tons of fake medicines seized in Mali
    • 2017: More than 420 tons of illegal pharmaceutical products seized in seven West African countries
    • 2018: 19 tons of counterfeit medicines seized in Ivory Coast, Guinea-Bissau, Liberia, and Sierra Leone
    • 2019: 12 tons of counterfeit pharmaceuticals intercepted in Ghana

But official channels are working to address the problem, including these initiatives:

    • The United Nations Office on Drugs and Crime announced a “holistic strategy” to combat crime and fake drugs in West and Central Africa.
    • The African Union announced that the African Continental Free Trade Area (AfCFTA) Secretariat had signed a letter of intent to work with other partners to combat counterfeit trade.
    • The Lomé Initiative is a binding agreement among the Republic of the Congo, Niger, Senegal, Togo, Uganda, Ghana, and the Gambia to criminalize trafficking falsified medicines.
    • The legal profession is also aware of the problem.

Three opportunities for the supply chain in Africa

The rise of manufacturing. African manufacturing made headlines last month when Afrigen Biologics and Vaccines in Cape Town, South Africa, announced it had successfully copied Moderna’s COVID-19 vaccine with no input from the U.S.-based company. At about the same time, the director of the Africa Centers for Disease Control and Prevention said 10 countries were making vaccines right now or planning to do so, with South Africa, Senegal, Rwanda, Algeria, and Morocco taking leading roles.

Led by organizations such as the African Partnership for Vaccine Manufacturing and the African Vaccine Manufacturing Initiative, a coordinated push is underway to manufacture vaccines in Africa “from scratch” (i.e., not merely “filling and finishing” imported products) and make the continent “vaccine independent.”

And this is emblematic of an African manufacturing renaissance of sorts. In the second quarter of 2021, for example, United Nations’ growth estimates indicated a 17.8 percent expansion of manufacturing output. (Output had dropped by 17.1 percent during the same period in 2020, primarily attributable to the pandemic.) Also in the second quarter of 2021, manufacturing output increased “in many African countries,” including South Africa (39.3 percent), Rwanda (30.2 percent), Senegal (22.6 percent), and Nigeria (4.6 percent).

Other examples are abundant: Carmaker Nissan is opening new facilities, and analysts see Africa emerging as an auto industry hub, including for electric vehicles. Overall, research shows that manufacturing on the continent is growing, or strongly rebounding from the pandemic, especially in key economies in sub-Saharan Africa.

A healthy manufacturing sector means a supply chain with opportunities to modernize alongside production facilities, to adopt international standards (e.g., GS1) and best practices, and to build the infrastructure to secure products from the time they leave the manufacturing floor to the time they reach consumers.

A large — and young — labor force. As we noted in Part 1 of our series, approximately 1.4 billion people live in Africa (about 17 percent of the world population) and the median age is 19.7, making it the youngest continent on the planet. According to the World Bank, half of the population in Sub-Saharan Africa will be under 25 by 2050.

This could poise African countries for an employment/ongoing manufacturing boom similar to what’s happened in Vietnam, Malaysia, Singapore, Mexico, and India. With more jobs in more sectors, including technology, and more products originating on the continent, the supply chain will need to grow and adapt. This will create opportunities for modernization and synchronization with global standards and best practices.

A consumer-centric economy. Africa is an enormous market for domestically produced and imported goods and services. As AfCFTA matures and projects under Agenda 2063 and other initiatives are completed, hundreds of millions of consumers should have more and easier access to these goods and services. They should also be willing to spend more money: As of 2021, the final household consumption expenditure in Africa was a little more than $1.9 trillion; McKinsey says this could reach 2.5 trillion by 2025.

This will have a huge impact on the supply chain in Africa — for manufacturing, logistics, distribution, warehousing, and “the last mile.” The more vigorous Africa’s economy becomes, the more businesses should anticipate development of new industries, dissipation of the informal sector, increased demand for better products, and a growing “consumer class” that will come to expect the supply chain to work everywhere on the continent.

Final thoughts

The supply chain in Africa is a work in progress. Some countries, particularly those in Sub-Saharan Africa, are farther along than others. The reasons for this are diverse, ranging from stronger institutions and more stable infrastructure to fortunate geography that facilitates better access to the flow of global trade.

It’s the wise organization that follows the progress and continuously prepares to do business in Africa. This means being able to work with the supply chain, complying with regulations as they’re rolled out and refined, optimizing your systems — and finding the right solution provider.

Contact us today to speak with one of our digital supply chain experts. In just a few minutes, they’ll demonstrate how our Traceability System will ensure your business can integrate with the supply chain in Africa. After doing that, move on to the last installment of our Africa supply chain series, which highlights the pharmaceutical regulatory environment. In the meantime, think about your supply chain and consider the words of Dr. Akinwumi Ayodeji Adesina, president of the African Development Bank Group:

The future belongs inexorably to the continent of Africa. By 2050, it will have the same population as China and India do now. There will be burgeoning consumer demand from a growing middle class, a population of nearly 2 billion people, of which around 800 million young people will be looking for meaningful and sustainable employment.

If we can harness this potential by aligning supply with demand, markets with customers, and skills with jobs, and keep most of these elements and links largely within Africa, then Africa will become an unstoppable economic force, capable of feeding itself and the rest of the world for good measure. That is the future scope for Africans to shape in their own interests and for their own economic ambitions.