rfxadmin, Author at rfxcel.com

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

Posted on May 23, 2023May 23, 2023 by rfxadmin

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

Posted on May 23, 2023May 23, 2023 by rfxadmin

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.

Antares Vision Group Acquires SmartPoint Technologies

Posted on May 2, 2023May 2, 2023 by rfxadmin

Travagliato (Brescia), May 2, 2023 – Antares Vision Group (EXM, AV:IM), a leading provider of track and trace and quality control systems, has acquired through its subsidiary rfxcel 100 percent of SmartPoint Technologies Ltd (SmartPoint), an Indian software product development company that builds powerful and intuitive software solutions.

SmartPoint, founded in 2010 by three entrepreneurs and headquartered in Chennai, offers diverse services and solutions to clients in more than 30 countries. It helps its customers to enhance their business prospects through software enhancement and development options in the IT arena. In Fiscal Year 2022–23 (year end March), Smart Point had 124 employees in India and Germany, and revenues of approximately €3.9 million, of which about 90 percent were generated with rfxcel.

“We have been working with SmartPoint for many years,” said rfxcel CEO Glenn Abood. “With this acquisition, we are internalizing very skilled and talented people, with exceptional expertise and specific abilities that match our interests. SmartPoint’s software development team has been working together for a long time and their know-how is a valuable asset for Antares Vision Group as we continue to invest in technological development to support our growth and to drive the innovation and digitalization process of supply chains.”

Strategic rationale

- - SmartPoint has proven expertise in pharmaceutical track and trace business verticals, and its software developments are directly implemented within the IT systems of top pharmaceutical companies that are rfxcel customers.
  - Its software development team will support rfxcel’s robust future growth.
  - The acquisition is an opportunity for rfxcel to prioritize software initiatives.
  - SmartPoint has approximately 20 full-time staff whose capabilities could be useful to other AV Group subsidiaries.
  - Having stronger in-house capacity will allow rfxcel to better negotiate with other software development companies for any excess work.
  - The deal prevents rfxcel’s competitors from acquiring the company and its know-how.

AV Group was assisted in the acquisition by Gandhi & Associates as legal consultants and Prakash Kotak for financial due diligence.

For more information, contact rfxcel Senior Communications and Content Manager Garrison Spik at garrison@rfxcel.com.

ABOUT ANTARES VISION GROUP
Antares Vision Group is an outstanding technology partner in digitalization and innovation for companies and institutions, guaranteeing the safety of products and people, business competitiveness and environmental protection. The Group provides a unique and comprehensive ecosystem of technologies to guarantee product quality (inspection systems and equipment) and end-to-end product traceability (from raw materials to production, from distribution to the consumer) through integrated data management, applying artificial intelligence and blockchain technology. Antares Vision Group is active in life science (pharmaceutical, biomedical devices and hospitals) and Fast-Moving Consumer Goods (FMCG), including food, beverage, cosmetics, and glass and metal containers. As a world leader in track and trace solutions for pharmaceutical products, the Group provides major global manufacturers (over 50% of the top 20 multinationals) and numerous government authorities with solutions, monitoring their supply chains and validating product authenticity. Listed since April 2019 on the Italian Stock Exchange in the Alternative Investment Market (AIM) segment and from 14 May 2021 in the STAR segment of Euronext; furthermore, from July 2022 included in the Euronext Tech Leaders index, dedicated to leading tech companies with high growth potential. In 2022, Antares Vision Group recorded a turnover of €223 million, operates in 60 countries, employs more than 1.180 people, and has a consolidated network of over 40 international partners. To learn more, please visit www.antaresvisiongroup.com.

Spherity and Antares Vision Group further partnership to ensure life sciences customers will comply with upcoming DSCSA regulations

Posted on April 25, 2023April 24, 2023 by rfxadmin

Antares Vision Group, through rfxcel technology, has integrated Spherity’s Credentialing Service into its DSCSA solutions to verify authorized trading partners’ identities and licensing in all regulated interactions.

Reno, Nevada, April 25, 2023 — Spherity, a German leading provider of digital wallet and credentialing solutions, and Antares Vision Group, an Italian multinational and a leading provider of track and trace and quality control systems, are continuing a partnership that helps ensure life sciences customers comply with this year’s U.S. Drug Supply Chain Security Act (DSCSA) regulations.

By November 27, 2023, manufacturers, distributors, dispensers, and other actors in the life sciences supply chain must prove that they are legitimate organizations, or authorized trading partners (ATPs), as defined by the DSCSA.

The two companies first partnered in 2021, when Spherity’s Credentialing Solution, CARO, was integrated into the Group’s Verification Router Service (VRS) solution, enabled by rfxcel technologies, to allow life science customers to confirm their ATPs status. The combined solution also allows customers to exchange DSCSA-compliant electronic Product Identifier (PI) messages, trace products, and create an audit trail of their VRS business interactions.

CARO uses Self-Sovereign Identity (SSI) technology to establish a secure, verifiable digital enterprise identity for every ATP. By integrating the service into its VRS solution, rfxcel customers can ensure secure, authenticated data exchange with other ATPs and verify they have the credentials required by the DSCSA, including state licenses and U.S. Food and Drug Administration Entity Identifiers (FEIs).

“We partnered with Spherity to enable our customers to comply with this year’s DSCSA authorized trading partner (ATP) requirements,” said rfxcel Senior Vice President of Product and Strategy Herb Wong. “With Spherity’s CARO, our VRS solution automatically confirms whether a company is an ATP. Now, every customer can add ATP credentialing to our entire product portfolio and secure their VRS interactions.”

“Spherity will ensure that Antares Vision Group’s customers can securely exchange data with previously unknown entities,” said Georg Jürgens, Spherity’s Manager for Industry Solutions. “The concept of exchanging and verifying credentials using Digital Wallets supports company and product compliance use cases that require communication between regulators, existing supply chain partners, and new trading partners.”

Spherity and Antares Vision Group are members of the Open Credentialing Initiative (OCI), and both contribute to the standardization and industry-wide interoperability of credentialing technology.

For more information about the Spherity-Antares Vision Group partnership, their solutions for DSCSA compliance with ATP requirements, and the Open Credentialing Initiative, contact Spherity’s Manager for Industry Solutions Georg Jürgens at georg.juergens@spherity.com and visit caro.vc, and rfxcel Senior Vice President of Product and Strategy Herb Wong at hwong@rfxcel.com.

ABOUT ANTARES VISION GROUP

Antares Vision Group is an outstanding technology partner in digitalization and innovation for companies and institutions, guaranteeing the safety of products and people, business competitiveness, and environmental protection. The Group provides a unique and comprehensive ecosystem of technologies to guarantee product quality (inspection systems and equipment) and end-to-end product traceability (from raw materials to production, from distribution to the consumer) through integrated data management, applying artificial intelligence and blockchain technology. Antares Vision Group is active in life science (pharmaceutical, biomedical devices and hospitals) and Fast-Moving Consumer Goods (FMCG), including food, beverage, cosmetics, and glass and metal containers. As a world leader in track and trace solutions for pharmaceutical products, the Group provides major global manufacturers (over 50% of the top 20 multinationals) and numerous government authorities with solutions, monitoring their supply chains and validating product authenticity. Listed since April 2019 on the Italian Stock Exchange in the Alternative Investment Market (AIM) segment and from 14 May 2021 in the STAR segment of Euronext; furthermore, from July 2022 included in the Euronext Tech Leaders index, dedicated to leading tech companies with high growth potential. In 2022, Antares Vision Group recorded a turnover of €223.5 million. The Group operates in 60 countries, employs more than 1,100 people, and has a consolidated network of over 40 international partners. To learn more, please visit www.antaresvision.com and www.antaresvisiongroup.com.

ABOUT SPHERITY

Spherity is a German software provider bringing secure and decentralized identity management solutions to enterprises, machines, products, data and even algorithms. Spherity provides the enabling technology to digitalize and automate compliance processes in highly regulated technical sectors. Spherity’s products empower cybersecurity, efficiency and data interoperability among digital value chains. Spherity is certified according to the information security standard ISO 27001.

India iVEDA Deadline Delayed for Track and Trace, Reporting

Posted on April 3, 2023April 4, 2023 by rfxadmin

Our team in India just let us know that the iVEDA deadline for track and trace and reporting has been delayed. Here are the details.

As we wrote in early March, the Indian government had stipulated March 31 as the deadline for full track and trace and reporting to the Integrated Validation of Exports of Drugs from India and its Authentication (iVEDA) portal. The rules were to apply to both small-scale industry (SSI)- and non-SSI-manufactured drugs.

Today, however, the government extended the iVEDA deadline to August 1, 2023. The announcement was made through Public Notice 3/2023, which was signed by signed by Director General of Foreign Trade Santosh Kumar Sarangi.

As of today, the August deadline for barcoding the Top 300 domestic pharma brands is still valid. This requires eight data points to be incorporated into a bar code or QR code, including a unique product identification code (e.g., GTIN), the brand name, and manufacturing and expiry dates. The codes must be printed on or affixed to the primary packaging.

Final thoughts about the iVEDA deadline and requirements

We will of course continue to monitor these regulations and post news when necessary. Bookmark our blog and check back often to make sure you’re keeping up to date. And contact us today if you have any questions about this delay or compliance in any other country where you do you business.

For a good overview of India’s pharma regulations, read our update from September 2022. If we may say, our “Final thoughts” section in that article was prescient. We wrote that “India’s track and trace requirements are obviously evolving” and the pharma industry should “expect more changes as the deadlines for APIs [active pharmaceutical ingredients], iVEDA reporting, and barcoding get nearer.”

That post also cited some statistics from India’s Department of Pharmaceuticals’ 2020-21 Annual Report. Check those out and compare them with the highlights from the 2021-2022 Annual Report below. India remains one of largest and most important pharma markets in the world — and we can help ensure you stay compliant as its regulations evolve.

India pharma stats, 2021-2022

• India provides generic medicines to more than 200 countries.
• India is home to 8 of the world’s 20 largest manufacturers of generic medicines.
• More than 55 percent of its pharma exports to go to “highly regulated markets.”
• Ninety percent of World Health Organization (WHO) pre-qualified APIs are sourced from India.
• Sixty-five to 70 percent of the WHO’s vaccine requirements are sourced from India.
• As of August 2021, there were 741 U.S. FDA-compliant manufacturing sites in India.
• As of December 2020, Indian companies had secured nearly 4,400 abbreviated new drug application (ANDA) market authorizations.

FSMA 204 Data Carrier Requirements: FDA Guidance & GS1 Standards

Posted on March 23, 2023April 6, 2023 by rfxadmin

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. 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.”

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:

FSMA Traceability Requirements: FDA Guidance & GS1 Standards

Posted on March 16, 2023April 6, 2023 by rfxadmin

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. 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

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?

Posted on March 14, 2023April 6, 2023 by rfxadmin

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

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.

Read more about FSMA:

Antares Vision Group, Through rfxcel, Begins Partnership with Renown Health Network for DSCSA-Compliant Pharmaceutical Tracking

Posted on March 8, 2023March 7, 2023 by rfxadmin

rfxcel, part of Antares Vision Group, will implement DSCSA compliance solutions to help ensure pharmacies across the northern Nevada healthcare network comply with the regulations.

Reno, Nevada, March 8, 2023 — Antares Vision Group (EXM, AV:IM), a leading provider of track and trace and quality control systems, today announced that rfxcel, which is part of the Group, has begun a partnership with Renown Health Foundation to implement compliance software so the network can track and trace pharmaceuticals in compliance with the Drug Supply Chain Security Act (DSCSA).

With rfxcel’s DSCSA compliance solutions, Renown Health’s medical groups and pharmacies will achieve real-time electronic tracing of drug products at the package level to identify and trace prescription drugs as they are distributed throughout the health system. This will enhance Renown’s ability to help protect patients from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.

“Reno has been our home since 2018 and many of our employees live and work in the northern Nevada region,” said rfxcel CEO Glenn Abood. “Renown is one of the leading not-for-profit healthcare organizations here and is the perfect partner to team with to give back to our community. We are excited about the opportunity to work with them and to help improve the health and well-being of our friends and neighbors.”

“Ensuring our patient’s medications are safe and legitimate is of the upmost importance to us,” said Renown’s Vice President of Pharmacy Services Adam Porath. “When members of our community get involved in our work, it brings us all closer together. We are thankful that Antares Vision Group and rfxcel are partnering with us on our healing mission. They are making it possible for us to keep our patients safe, comply with the demanding DSCSA requirements, and respond quickly to changing supply chain requirements.”

For further information, write us at news@rfxcel.com.

ABOUT ANTARES VISION GROUP

Antares Vision Group is an outstanding technology partner in digitalization and innovation for companies and institutions, guaranteeing the safety of products and people, business competitiveness, and environmental protection. The Group provides a unique and comprehensive ecosystem of technologies to guarantee product quality (inspection systems and equipment) and end-to-end product traceability (from raw materials to production, from distribution to the consumer) through integrated data management, applying artificial intelligence and blockchain technology. Antares Vision Group is active in life science (pharmaceutical, biomedical devices and hospitals) and Fast-Moving Consumer Goods (FMCG), including food, beverage, cosmetics, and glass and metal containers. As a world leader in track and trace solutions for pharmaceutical products, the Group provides major global manufacturers (over 50% of the top 20 multinationals) and numerous government authorities with solutions, monitoring their supply chains and validating product authenticity. Listed since April 2019 on the Italian Stock Exchange in the Alternative Investment Market (AIM) segment and from 14 May 2021 in the STAR segment of the Mercato Telematico Azionario (MTA), Antares Vision Group recorded a turnover of €179 million in 2021, operates in 60 countries, employs more than 1,000 people, and has a consolidated network of over 40 international partners. To learn more, please visit www.antaresvision.com and www.antaresvisiongroup.com.

ABOUT RENOWN HEALTH

Renown Health is Nevada’s largest, not-for-profit integrated healthcare network serving Nevada, Lake Tahoe, and northeast California. With a diverse workforce of more than 9,000 employees, Renown has fostered a longstanding culture of excellence, determination, and innovation. The organization comprises a trauma center, two acute care hospitals, a children’s hospital, a rehabilitation hospital, a medical group and urgent care network, and the locally owned not-for-profit insurance company, Hometown Health. Renown is currently enrolling participants in a community-based genetic population health study, the Healthy Nevada Project®.

India Track and Trace Regulations: March 31 Deadline for Exports & More

Posted on March 2, 2023April 4, 2023 by rfxadmin

This year will be a busy one for pharmaceutical compliance as governments around the world continue to roll out their serialization and traceability plans. India track and trace regulations are no exception: There was a deadline in January, there’s one at the end of this month, and another is coming in August.

Let’s take a look at the India track and trace regulations and what the pharma industry has to do to be ready.

January 1: Labeling APIs

As of January 1, 2023, all imported and domestically manufactured active pharmaceutical ingredients (APIs) must be labeled with QR codes “at each level packaging that store data or information.” This is the culmination of a process that began in June 2019, when the Drugs Technical Advisory Board (DTAB) approved a proposal mandating QR codes on APIs. At that time, DTAB estimated that the regulation would affect approximately 2,500 APIs.

The QR codes must contain 11 data points, including a unique product identification code, the name of the API, and the manufacturing and expiry dates. The QR codes must link to a national database with pricing data from the National Pharmaceutical Pricing Authority.

March 31: Full track and trace and reporting to the iVEDA Portal for exported drugs

For all exported drugs, March 31 is the deadline for full track and trace and reporting to the Integrated Validation of Exports of Drugs from India and its Authentication (iVEDA) portal. The rules apply to both small-scale industry (SSI)- and non-SSI-manufactured drugs. The iVEDA portal is used for only registering and reporting exported drugs.

August 1: Barcoding for the Top 300 domestic pharma brands

These rules were originally scheduled to come into force on May 1, but that was pushed back to August 1. The rules stipulate that eight data points must be incorporated into a “Bar Code or Quick Response Code” to be printed on or affixed to the primary packaging, including a unique product identification code (e.g., GTIN), the brand name, and manufacturing and expiry dates.

Final thoughts about the India track and trace regulations

We talked about these regulations in more detail last year. See that article here. As we said then, our team has worked in the India pharma market for many years and understands its complexities, challenges, and benefits. We have offices and experienced staff in the country. Contact us today to learn more about the India track and trace regulations and to arrange a demo. In about 15 minutes, one of our supply chain experts can show you how we can help ensure you comply while maximizing your impact in this huge market.