supply chain Archives

FSMA Produce Safety Rule: Cultivating Compliance in Agriculture

Posted on February 13, 2024February 14, 2024 by rfxadmin

The Food Safety and Modernization Act (FSMA) is going to have a major impact on the food industry. FSMA gives the Food and Drug Administration (FDA) enforcement capabilities to promote food safety, transparency, and quality, and the FSMA Produce Safety Rule is particularly important to the changes.

The FSMA Produce Safety Rule applies to commercial growers, harvesters, and packers of produce. The rule includes preventive controls designed to mitigate the spread of pathogens and foodborne illness through agricultural water, wild animals, and any raw agricultural commodity designed for human consumption. Here’s what you need to know.

Importance and Business Value of the FSMA Produce Safety Rule

In effect since January 26, 2016, the FSMA Produce Safety Rule (“Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption”) is a major step forward for agricultural traceability, food safety, and public health. As the FDA explains, it “establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. The rule is part of the Agency’s ongoing efforts to implement the FDA Food Safety Modernization Act.”

Familiarizing yourself with the FSMA Produce Safety Rule will help comply USDA and FDA regulations, avoid fines or other regulatory penalties, and promote business continuity. From a value-addition perspective, compliance means you’ll safeguard your products, appeal to consumer demands for transparency and accountability, and protect your brand reputation.

Key Components of the FSMA Produce Safety Rule

The FSMA Produce Safety Rule is built around Good Agricultural Practices. Those practices address the following areas:

Agricultural Water

Water, essential in agriculture, can be a major source of contamination. Both production and post-harvest water require careful management, which may include:

- - Regular testing and monitoring of surface and ground water for pathogens
  - Water treatment to meet safety standards
  - Maintenance and inspection of water sources

Strictly monitoring and protecting water is vital for ensuring compliance with the FSMA Produce Safety Rule.

Employee Health and Hygiene

Employee health and hygiene are paramount when dealing with produce for human consumption. When workers are sick or lacking training, they’re more likely to become (unintentional) sources of contamination.

Examples of health and hygiene requirements include instructing employees to notify their supervisors if they may have a health condition that may result in contamination of covered produce or food contact surfaces, using hygienic practices when handling such produce or surfaces (e.g., washing and drying hands, and taking measures to prevent visitors from contaminating produce and surfaces).

Domesticated and Wild Animals

Grazing animals (e.g., livestock), animals used for work applications, and wild animals (e.g., deer and feral swine), can compromise produce safety. The FSMA Produce Safety Rule requires farmers “to take all measures reasonably necessary to identify and not harvest produce that is likely to be contaminated.”

These measures include visually examining the growing area and all covered produce to be harvested and, in some circumstances, conducting an additional assessment during the growing season and taking reasonable steps to assist during harvest if significant evidence of potential contamination by animals is found, such as placing flags outlining an affected area.

Biological Soil Amendments

Biological soil amendments of animal origin (BSAAO) are soil amendments that contain materials of animal origin. These materials may include raw manure or non-fecal byproducts such as table waste, animal carcasses, or any combination thereof.

Though biological soil additives can enhance the quality and nutrient profile of soil, they also carry some risks. Therefore, make sure that any additives are properly treated to reduce pathogens.

Production of Sprouts

Sprouts are particularly vulnerable to contamination by dangerous microbes due to the warm, moist, and nutrient-rich conditions needed to grow them. The FSMA Produce Safety Rule has requirements to help prevent the contamination of sprouts, such as:

- - Taking measures to prevent the introduction of dangerous microbes into or onto seeds or beans used for sprouting
  - Treating seeds or beans that will be used for sprouting (or relying on prior treatment by the seed/bean grower, distributor, or supplier with appropriate documentation)
  - Testing irrigation water for certain pathogens and attaining negative results
  - Testing the growing, harvesting, packing, and holding environment for the Listeria species or Listeria monocytogenes
  - Taking corrective actions if spent sprout irrigation water, sprouts, and/or an environmental sample tests positive

Equipment, Buildings, Tools, and Sanitation

The condition and cleanliness of your farm’s infrastructure — greenhouses, germination chambers, and toilet and hand-washing facilities — play a crucial role in compliance and safety. The FSMA Produce Safety Rule establishes standards related to equipment, tools, and buildings to prevent them from contaminating produce, including from inadequate sanitation.

Therefore, you should establish a routine for cleaning and sanitizing tools, equipment, and buildings. Regularly inspect and maintain equipment to prevent it from becoming a contamination source. Where possible, design facilities and equipment to be easily cleaned and to prevent harborage of pests and accumulation of dirt.

Compliance Guidelines for Farmers

The FDA provides resources explaining FSMA requirements, including the Produce Safety Rule. Let’s look at some practical tips for promoting and simplifying compliance.

One major hurdle is creating an actual compliance policy. If you run a farm, you need a comprehensive policy that addresses all facets of the Rule. This fact sheet from USDA is a helpful tool for designing and implementing your policy. If you operate a large farm, read the FDA’s “What to Expect Now That Larger Farms Must Comply with the FSMA Produce Safety Rule” here. Also check out the Sprout Safety Alliance at the Illinois Institute of Technology and the Produce Safety Alliance at Cornell University’s College of Agriculture and Life Sciences, for example.

Once you know which rules apply to your farm, develop a plan to address each relevant area. Remember, incremental improvements to enhance safety is a place to start; you don’t have to revamp your entire operation overnight.

Recordkeeping and Documentation

FSMA 204 establishes additional traceability recordkeeping requirements for companies that manufacture, process, pack, or hold foods included on the Food Traceability List (FTL). If the Produce Safety Rule applies to your business, you should also familiarize yourself with The Final Rule on Requirements for Additional Traceability Records for Certain Foods — also known as the “Food Traceability Final Rule.”

FSMA 204 requires you to maintain (keep) and share accurate records of your products as they move through the supply chain. If you get audited, you’ll have to produce these records. Download our food traceability white paper to learn more about these requirements.

Water Quality and Agricultural Practices

The water quality provision (and most other provisions) of the FSMA Produce Safety Rule went into effect in 2018. Since then, the FDA has been ramping up enforcement actions. They have paid particularly close attention to water quality. Under the rule, you have to test the untreated groundwater for generic E. coli. If you use water that has been treated with a validated process or from a public source, testing is not required. Additionally, you are prohibited from using any untreated surface water for harvest or post-harvest purposes.

Soil Amendments

The FSMA Produce Safety Rule includes other provisions regarding soil usage — specifically, the introduction of animal byproducts into your soil. If using raw manure or any other animal byproducts to enhance soil productivity, you must take precautions to mitigate the risk of contamination. Be careful when sourcing manure and other animal-based soil enhancements, and always verify that the provider is compliant with FSMA provisions.

Final Thoughts: Being Proactive Simplifies FSMA Compliance

The FSMA Produce Safety Rule is being enforced now, and the deadline to comply with FSMA 204 traceability requirements is January 20, 2026. As we’ve said all along, the key to FSMA success is to be proactive. Specifically:

- - Study the law and know your obligations and your trading partners’ obligations.
  - Talk with your trading partners to ensure they’re compliant now and preparing for January 2026.
  - Assess your operations for compliance with the FSMA Produce Safety Rule and Food Traceability Final Rule.
  - Make sure you’re working with a knowledgeable and reliable solution provider — someone who can help you comply while keeping your supply chain moving at peak performance and leveraging the FSMA regulations to create business opportunities.

This is where we can help. We offer a full-stack solution for the food industry. 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.

Foreign Supplier Verification Program (FSVP): What It Means for FSMA

Posted on February 12, 2024February 14, 2024 by rfxadmin

The Food and Drug Administration Food Safety and Modernization Act (FSMA) is going to change how the U.S. food supply chain works. And not just for U.S. companies. When the law takes effect in January 2026, foreign companies that import food to the United States must also comply. This is what the FSMA Foreign Supplier Verification Program (FSVP) is all about.

If you’re an importer, you’re subject to the FSVP under FSMA. If you’re a U.S.-based company, you want to make sure your non-U.S. trading partners are compliant.

Here is everything you need to know about the FSVP so that you can achieve and maintain FSMA compliance.

What Is an Foreign Supplier Verification Program? What Is the Significance?

Technically, FSVP stands for Food Supplier Verification Programs (plural). An FSVP is a program that promotes traceability, food safety, and transparency across the entire food supply chain. It mandates that importers perform certain activities to facilitate public health protection and verify that imported food meets the FSMA safety requirements.

Under a Foreign Supplier Verification Program, importers are required to verify that the food they import meets U.S. safety standards. They must develop, maintain, and follow an FSVP for each food imported, unless an exemption applies. The goal, therefore, is to ensure that every imported food has been produced in a way that delivers the same level of public health protection as the applicable FSMA requirements, and that food is not adulterated or misbranded with respect to allergen labeling.

Why is the Foreign Supplier Verification Program necessary? The answer is simple: The United States imports billions in food each year. According to the USDA, the U.S. imported $148 billion in agricultural products in 2020. U.S. food also includes a huge amount of imported animal products.

By extending FSMA requirements to importers and their suppliers, the Foreign Supplier Verification Programs promote increased safety and accountability. It also provides insights into each foreign supplier’s performance, enabling U.S. food businesses to make informed decisions about their trade relationships and promote good manufacturing practices.

Who Is Covered by the FSVP?

It defines an importer as “the U.S. owner or consignee of the food offered for import (i.e., owns the food, has purchased it, or has agreed in writing to purchase it at the time of U.S. entry).” If there isn’t a U.S. owner or consignee at time the product enters the USA, the FSVP defines the importer as “the U.S. agent/representative of the foreign owner/consignee, as confirmed in a signed statement of consent.”

The important takeaway is that there must be a U.S.-based FSVP importer who takes responsibility for meeting the FSVP requirements.

Key Components of the FSVP

The Foreign Supplier Verification Program is built on widely accepted food safety standards and preventive controls rules. Key FSVP requirements include the following:

- - Hazard analysis: Importers must analyze hazards associated with each food.
  - Supplier verification: The FSVP outlines appropriate supplier verification activities that importers must complete.
  - Corrective actions: Procedures must be in place to address identified issues.

Requirements for Importers

An FSVP importer may need to perform the following activities, unless they’re exempt or subject to modified requirements.

Verify Suppliers

Conduct appropriate supplier verification to assure that the hazards requiring a control in the food you import have been significantly minimized or prevented. These activities may include annual onsite audits by a qualified auditor, sampling and testing food, and reviewing the supplier’s food safety records.

Perform a Hazard Analysis

Hazard analyses must include identifying “known or reasonably foreseeable hazards” and determining if they require a control. The FDA notes several types of hazards, including the following:

- - Biological (e.g., parasites and disease-causing bacteria)
  - Chemical (e.g., radiological hazards, pesticide and drug residues, natural toxins, unapproved additives, food allergens, and nutrient deficiencies or toxicities in animal food)
  - Physical (e.g., objects in food products such as glass)

Evaluate Risks

You must evaluate risks that the food itself and the foreign supplier’s performance could pose. In doing so, you must consider the following:

- - Your hazard analysis for the food
  - Who will apply the hazard controls (e.g., the supplier or its ingredient supplier)
  - The supplier’s food safety practices and procedures
  - Applicable U.S. food safety regulations and information about the supplier’s compliance
  - The supplier’s food safety performance history, which should include testing and audit results and the supplier’s record of correcting identified problems.

Perform Periodic Reassessments

You have to reassess your foreign suppliers every three years — or sooner if the FSVP importer becomes aware of new information about hazards in the food or changes in the foreign supplier’s performance.

Identify the FSVP Importer

As an FSVP importer, you are required to provide the U.S. government with the following information about your organization:

- - Legal business name
  - Electronic mailing address
  - Unique facility identifier (UFI)

The FDA accepts the Data Universal Numbering System (DUNS) number as a UFI. FSVP importers temporarily unable to obtain a DUNS number have since May 2017 been permitted to transmit the value “UNK” (i.e., “unknown”) in the UFI field, allowing food to be processed through the Customs and Border Patrol (CBP) Automated Commercial Environment (ACE) system, even if the importer has not yet provided a DUNS number.

Other Requirements

You must use a qualified person to develop an FSVP and to perform FSVP activities.

Furthermore, you must take corrective actions (if necessary) and investigate the adequacy of the FSVP (when appropriate). The corrective action will depend on the circumstances; for example, the best course of action may be to stop using the foreign supplier until the problem (e.g., noncompliance, adulteration, misbranding) has been adequately addressed.

Last, you’re required to maintain detailed FSVP records. A U.S. agent can request these records during an audit. Alternatively, they might review them during a randomized compliance assessment. Make sure you retain all digital records related to your FSVP compliance activities for at least two years.

Role of Technology in FSVP Compliance

Old-school compliance strategies can’t keep pace with the stringent recordkeeping and analytics mandates found in the Foreign Supplier Verification Program framework. Instead, you need a robust suite of technologies designed to accelerate and simplify compliance.

Adopting food supply chain software will empower your team to gather and manage key details about trading partners. With the right tools in place, you can transform food safety and regulatory compliance into an integrated part of your company culture.

Collaboration with Foreign Suppliers

FSVP compliance is a joint effort; you cannot achieve and maintain compliance without the support of your foreign suppliers. Reputable and successful foreign suppliers will embrace FSVP, as they understand that they cannot import their goods to the United States without complying.

Use this to your advantage. Reach out to your trading partners, relay what requirements apply to your organization and its operations, and develop a cohesive strategy to meet FSVP provisions. Building strong relationships with suppliers is key to a successful verification and hazard mitigation program.

FSVP Rollout and Influence

To date, compliance with the Foreign Supplier Verification Programs has been a challenge for many importers. According to a 2020 FDA report, in 2019 the Agency issued 340 citations to companies for failing to develop an FSVP — a 17 percent increase over 2018. In total, there were 354 non-compliance citations, including for failing to:

- - Follow or maintain the FSVP
  - Translate the FSVP into English when applicable
  - Sign and date the FSVP upon modification
  - Make adequate assurances of a supplier’s food safety

Over the last two years, the FDA has ramped up enforcement, which means that preparedness and diligence are more important than ever. As the Agency itself says, “Being prepared is key to avoiding a citation.”

Even with these challenges, the food industry should anticipate that FSVP will have a broader, sustained impact on global food supply chains. Along with FSMA, it encourages international suppliers to elevate their food safety standards, adopt best practices, and embrace food safety in a digital, traceable supply chain. This will lead to a more uniform global food safety system, enhancing consumer confidence in the safety of foods everywhere.

It’s likely that more and more countries will enact or continue rolling out similar food safety regulations on imported goods. When they do, it will accelerate the push toward safer, more sustainable food production practices.

Final Thoughts: Achieve Foreign Supplier Verification Program Compliance

As we’ve seen, the FSVP requires a lot of importers and their foreign suppliers, and many organizations have struggled with compliance.

The keys to success (and avoiding citations and fines) are preparedness and proactive implementation of FSVP practices and technologies that will yield a safer and more transparent food importation process.

If you don’t know where to start, contact us today to book a demo. Our traceability and transparency solutions for the food and beverage industries not only take the guesswork out of compliance — they transform all your supply chain data into true business value.

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

Posted on August 7, 2023October 12, 2023 by rfxadmin

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.

7 FSMA rules and requirements

Through FSMA, the FDA has issued rules that govern food production and distribution. The 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). Additionally, there are seven main roles that the FDA implemented in the final FSMA rules.

- 1. 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.
  2. 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.
  3. Foreign Supplier Verification Program (FSVP): Requires foreign suppliers to show that they are meeting food safety standards required in the U.S.
  4. Sanitary Transportation Rule: Established regulations for the sanitary transportation of human and animal food.
  5. Accredited Third-Party Certification Rule: Created a program to accredit specific third-party certification bodies to conduct food safety system audits of foreign facilities.
  6. Protection Against Intentional Adulteration: Aims to address the probability of an outbreak due to potential food safety risks of intentional adulteration.
  7. Voluntary Qualified Importer Program (VQIP): fee-based program provided by the FDA FSMA to foreign food facilities that intend to import their products into the country.

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

Posted on August 7, 2023 by rfxadmin

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 Ultimate Guide to Supply Chain Visibility: Enhancing Efficiency and Performance

Posted on July 7, 2023August 4, 2023 by rfxadmin

The ability to monitor each part of your supply chain helps your business mitigate risk, serve customers better, and work more efficiently. Find out more about the importance of supply chain visibility in this guide from Antares Vision Group and rfxcel.

Understanding Supply Chain Visibility

Modern business operations require a high level of coordination and logistics. A company may source raw materials from one location, have a manufacturing facility in another location, and deliver products to customers all over the world. To produce, package, and ship goods efficiently, they need a centralized tracking system.

Supply chain visibility traces a product from its raw materials and through the manufacturing process to the point at which it reaches a customer’s doorstep. A visibility solution allows a business to track all its goods through every step in the supply chain. Supply chain visibility can:

Increase efficiency
Ensure customer satisfaction
Inform decision-making
Improve sustainability

Ultimately, visibility – or lack thereof – affects your bottom line.

Benefits of Supply Chain Visibility

To stay competitive in today’s globalized economy, businesses need efficient systems for monitoring supply and demand. Supply chain visibility benefits include:

Tracking: Real-time tracking and traceability tools streamline inventory management, offering automation for many routine tasks.
Efficiency: Visibility tools enhance the accuracy of demand forecasting and reduce the likelihood of stockouts.
Risk management: Full visibility means that teams can respond more quickly when there is a supply chain disruption, mitigating the risk and minimizing delays.
Optimization and better collaboration: Supply chain management systems help companies communicate better with suppliers, optimizing relationships and fostering collaboration.

Key Components of Supply Chain Visibility

Although supply chain visibility systems may differ from company to company, they all focus on transparency at each node of the supply chain. This includes:

Inventory visibility: Companies can track and manage inventory levels and procurement across all their locations.
Transportation visibility: All products in transit can be tracked and monitored in real time.
Demand visibility: Robust supply chain network data allows businesses to understand customer patterns and forecast demand more accurately.
Supplier visibility: Real-time visibility tools allow you to monitor supplier performance and ensure timely deliveries.
Data visibility: By collecting information about inventory, transportation times, and more, companies can turn data analytics into actionable insights and adjust workflows or supply chain processes.

Implementing Supply Chain Visibility

Putting supply chain visibility tools into place takes time and effort, but it’s well worth the benefits you’ll reap in operational efficiency and better business performance. To implement supply chain visibility, start by assessing your current systems. Look for areas of improvement across the supply chain – have you experienced stockouts in a particular product line? Do you struggle to meet customer demand at a certain time of year?

Next, look for the right technology solutions that can enhance visibility across your entire ecosystem. Perhaps you have a good system in place for monitoring customer orders but need a better way to manage suppliers. Look for supply chain software that can integrate with your existing systems and address gaps in visibility.

You need a seamless flow of information across your technology platforms. Additionally, prioritize data security in any supply chain visibility initiative. Compliance with data privacy regulations is a must for your company, as well as any suppliers, shippers, or distributors you work with.

Best Practices for Supply Chain Visibility

Whether you work in pharmaceuticals or food and beverage, certain practices will improve visibility across the entire supply chain. These include:

Metrics: Have a clear set of goals and metrics in place that you will use to measure your success.
Collaboration: Build strong partnerships with suppliers to enhance transparency and efficiency.
Technology: Invest in cloud-based platforms and advanced analytics tools with built-in supply chain security.

Above all, adopt a proactive approach to risk management and contingency planning. While some supply chain disruptions are out of your control, having a plan in place will make it easier to minimize inefficiencies and shortages.

Overcoming Challenges in Supply Chain Visibility

Even with the best-laid plans, you may face roadblocks when trying to improve end-to-end supply chain visibility. Potential challenges include:

Supply chain data quality issues and data silos
Resistance to change and organizational barriers
Regulatory compliance and data privacy concerns

Managing a significant volume of data, especially when you are working in the context of a complex global supply chain with multiple partners and stakeholders, can feel overwhelming. That’s why it’s so important to find supply chain visibility software that integrates with all your data collection systems. You should look for a software service provider that is well-versed in regulatory compliance and has built-in data protections.

Understand that even when you choose an intuitive, user-friendly system, you’re likely to face pushback from some employees or partners. Plan a thoughtful implementation and roll-out process, with time built in for staff training. This will help address any concerns.

The Future of Supply Chain Visibility

Emerging technologies and digital transformation are changing the supply chain management landscape. Already, we’re seeing the value of artificial intelligence (AI) and machine learning in supply chain software solutions. AI-powered tools can analyze real-time data to inform forecasting, using predictive analytics to inform orders, pricing, warehouse placement, and more.

The Internet of Things (IoT) and blockchain technology are also shaping supply chain visibility. By giving all supply chain stakeholders access to the same information, blockchain tools can potentially reduce fraud and data errors while improving communication. And the proliferation of IoT devices means that real-time tracking is easier throughout order processing and delivery.

We’ll Help You Achieve Supply Chain Visibility

We offer supply chain visibility solutions that prioritize efficiency and compliance management. With offices in the United States and abroad, we serve clients in sectors including:

Pharmaceuticals
Food
Beverage
Consumer goods
Government

For information on our supply chain visibility tools or to request pricing, contact us today.

Food Safety Modernization Act (FSMA): Guidelines, Regulations, and Impact

Posted on June 12, 2023June 12, 2023 by rfxadmin

Passed in 2011, the Food Safety Modernization Act (FSMA) authorized major changes to how the U.S. food supply chain operates. Growers, processors, and food manufacturers are all subject to new regulations intended to prevent foodborne illness and make the food supply safer, traceable, and more transparent. Learn more about FSMA, what it covers, and how it affects food safety compliance in this guide from rfxcel.

Food Regulations and Enforcement in the USA

Before the introduction of the Food Safety and Modernization Act, the Food and Drug Administration (FDA) provided industry guidance on how to reduce food safety hazards. While food businesses could become certified in Good Agricultural Practices (GAP) and Good Handling Practices (GHP), the guidelines offered by FDA were not enforceable.

FSMA expands FDA’s oversight, offering a clear regulatory framework and a set of preventive controls designed to take a proactive approach to food safety.

Importance of Food Safety

A safe and reliable U.S. food supply is critical, both for public health and national food security. According to the Centers for Disease Control and Prevention, foodborne illness affects one in six Americans each year and accounts for 3,000 deaths annually. Investing in food safety measures is important for many reasons. Robust federal support for food safety:

Improves consumer confidence in America’s food supply
Reduces the burden on the U.S. healthcare system by keeping people healthier
Helps detect and contain foodborne illness outbreaks before they spread

What Is the Food Safety Modernization Act (FSMA)?

The Food Safety Modernization Act (FSMA), signed into law in January 2011, authorizes the U.S. Food and Drug Administration (FDA) to take a preventive approach to food safety problems. This new approach gives FDA the authority to establish food safety standards for stakeholders throughout the food and beverage industry supply chain. FSMA amends the Federal Food, Drug, and Cosmetic Act, first passed in 1938.

Why Did the Food and Drug Administration Pass FSMA?

Bacteria, parasites, and other foodborne pathogens make 48 million Americans sick each year. And the nature of today’s global economy means that the food Americans eat could be grown in one state or country, processed in another, then distributed nationwide. By the time an outbreak of E. coli, listeria, or another foodborne disease is identified, hundreds – or even thousands – of consumers could have purchased food that is potentially contaminated.

With FSMA’s new regulations, the goal is to stop these kinds of outbreaks before they happen. Without proper preventive controls, including mandated food traceability requirements, food businesses risk losing valuable time and money dealing with food recalls that can damage their public image.

CDC and FSMA

While FDA is the primary U.S. federal agency tasked with implementing FSMA regulations, the law also provides a directive to the Centers for Disease Control and Prevention (CDC). This agency is tasked with improving the collection, analysis, and reporting of data on foodborne illnesses and outbreaks. CDC must also create and manage Integrated Food Safety Centers of Excellence in partnership with state health departments.

These centers offer technical assistance and training for local health departments, improving their ability to track and trace foodborne disease outbreaks. CDC is also responsible for developing guidelines to manage food allergy and anaphylaxis risks in educational institutions.

When Did FSMA Take Effect?

FSMA was signed into law in January 2011. However, new food safety regulations did not go into effect right away upon passage. Through FSMA, Congress simply authorized FDA to establish food safety requirements for growers, processors, and packers. Implementation of various regulations is ongoing. That means that food businesses must navigate a shifting regulatory landscape as new rules are proposed, finalized, and implemented.

Food Safety Modernization Act Compliance

Under FSMA, FDA has the authority to create and enforce policies through the federal rulemaking process. To date, FDA has finalized nine major rules concerning food production, traceability, transportation, and more. The FSMA guidelines also give FDA new authority to inspect facilities that manufacture, process, or store food for consumption, both in the U.S. and abroad.

The Food Safety Modernization Act Regulations

FSMA’s regulations affect each step of the food chain from field to fork. Per the administrative rulemaking process, federal agencies must publish a proposed rule, then accept and review feedback during a public comment period. The agency may make changes to the final proposed rule based on these comments. Once an agency publishes a final rule in the Federal Register, it typically goes into effect thirty days or more after publication.

FDA’s proposed and final rules and related programs under FSMA include:

Agricultural Water
Accredited Third-Party Certification
Food Traceability
Foreign Supplier Verification Programs (FSVP)
Laboratory Accreditation for Analyses of Foods (LAAF)
Mitigation Strategies to Protect Food Against Intentional Adulteration
Preventive Controls for Human Food
Preventive Controls for Animal Food
Produce Safety
Sanitary Transportation of Human and Animal Food
Voluntary Qualified Importer Program (VQIP)

FSMA Section 204 and the Three Pillars of 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:

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.
Designate foods for which additional recordkeeping requirements are appropriate and necessary to protect the public health.
Publish a notice of proposed rulemaking to establish such additional recordkeeping requirements for the designated foods, to help in tracing such foods.

The Food Safety Modernization Act Impact

The passage of FSMA fundamentally changed FDA’s approach to outbreaks of foodborne illness and risk management. Instead of focusing on responding to outbreaks that have already occurred, FSMA prioritizes taking steps to prevent foodborne illness and cross-contamination on farms and food facilities. The legislation means that food businesses are now subject to:

FDA-mandated recalls
Facility inspections
Updated registration requirements

Additionally, FDA guidelines for food safety empower the agency to review facility records and suspend a food facility’s registration if its products are likely contaminated.

How FSMA Affects the Food Industry

FSMA implements new FDA standards for farmers who grow fruits and vegetables. The Produce Safety Rule applies to any grower with average annual produce sales of $25,000 or more. This rule establishes requirements for:

Training for workers who harvest or handle produce
Water quality testing
Preventing contamination from on-farm animals and wildlife
Sanitizing tools and equipment
Recordkeeping

The Produce Safety Rule does not apply to certain fruits and vegetables that are rarely consumed raw, such as beans and potatoes. Furthermore, FSMA does not apply to meat and poultry products, which are regulated by the United States Department of Agriculture (USDA).

How FSMA Affects the Food Supply and Food Facilities

Any food facility that manufactures, processes, packs, or holds food for domestic consumption is required to register with the FDA. This requirement was in place before the passage of the FDA Food Safety Modernization Act. However, FSMA revised this regulation to include:

Mandatory registration renewal every two years
Explicit assurance in the registration documentation that FDA facility inspections are permitted
Additional details on facility activities

The Amendments to Registration of Food Facilities final rule also updated registration requirements to ensure that records are submitted to FDA electronically.

Some of the fresh produce available in U.S. grocery stores year-round is shipped from countries in warmer climates. Recognizing that Americans often consume food that was grown or processed abroad, FDA created a separate final rule on Foreign Supplier Verification Programs (FSVP) that establishes requirements for food producers in other countries. These suppliers must show that their growing, harvesting, or packing practices:

Ensure food is not adulterated
Provide the same level of public health protection as U.S. suppliers
Ensure appropriate labeling for food allergens

These regulations are intended to improve the safety of imported food.

FSMA Preventive Controls and Hazard Analysis

FSMA’s Final Rule for Preventive Controls for Human Food establishes minimum standards for manufacturing, processing, packing, and holding food for human consumption. A separate rule governs the production of animal feed.

Under the preventive controls rule, domestic and foreign food facilities must:

Use Current Good Manufacturing Practices (CGMPs)
Create and implement a written food safety plan that includes a hazard analysis
Train employees on food hygiene and safety practices, from handwashing to sanitizing food prep surfaces

FSMA Compliance and rfxcel

If your business is struggling to implement an effective Food Safety Modernization Act compliance strategy, rfxcel is here to help. Our Traceability System offers a comprehensive, customizable set of solutions to help enact FSMA-compliant preventive controls across all your products and ensure your food safety plan is complete. With rTS, you can:

Record product data at each step of the supply chain
Access real-time data tracing
Audit each pallet, lot, or case of product

Plus, our in-house supply chain experts are well-versed in food safety laws and can provide the technical assistance you need. For more information about compliance management and how we can help you navigate federal food safety regulations, contact rfxcel today.

Compliance Management: Key Challenges and How to Overcome Them

Posted on June 12, 2023August 4, 2023 by rfxadmin

Effective compliance management takes time and effort, but it’s much better to be prepared and prevent problems before they occur. Violating the regulations that govern your industry means you risk losing customers, damaging your reputation, and hurting your bottom line. Fortunately, taking a proactive approach means you can address many of the compliance challenges that companies face. Let’s take a closer look at compliance management systems and their benefits.

What Is Compliance Management?

Companies in any sector must understand and follow the local, state, federal, or international regulations that affect how they do business. Compliance management is the set of tools and procedures that a business uses to ensure they follow the laws that govern its industry. Regulatory requirements may be established by:

Government entities
Labor unions
Trade associations or other industry organizations

For example, pharmaceutical companies have to comply with the U.S. Drug Supply Chain Security Act (DSCSA), whose requirements include product serialization and electronic, interoperable data exchange. Similarly, the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) has specific requirements for traceability and data-sharing.

Why Is Compliance Management Important?

Compliance requirements are often in place to ensure ethical behavior toward customers or competitors. Clear, enforceable regulations set standards for businesses, governments, and civil society organizations.

Failure to adhere to applicable laws or regulations could result in fines, fees, suspension of business operations, revocation of licenses or certifications, or other compliance issues. Thus, many businesses create and establish governance, risk management, and compliance (GRC) programs to minimize their risk.

Three Approaches to Compliance Management

A compliance management solution can vary from simple to complex and must be uniquely tailored to suit an organization’s structure and industry. Three common methods of compliance management are:

Strict, Top-Down Approach

This is the most rigid approach to compliance management. Internal policies are created and implemented by the person or team at the top of the organizational chart. There is no room for flexibility or interpretation. A top-down model is usually needed when the health, safety, and welfare of employees or the people they serve are paramount. For example, a daycare operator must follow all the state and local regulations created to keep minors safe.

Hands-Off Approach

In contrast, a hands-off approach is the most flexible type of compliance management. In this model, leadership may establish compliance standards, but the implementation of day-to-day business processes is handed off to middle managers or other employees.

This approach can work in certain situations. For example, a franchisor that has retail food establishments in different states may be subject to health department inspections in each state. Recognizing that each franchisee is subject to a different set of regulations, they may leave it up to each site manager to implement training or an inspection checklist at their respective franchise.

Shared or Distributed Model

In this approach, compliance activities are shared by employees across the organization. Instead of receiving strict guidelines from a central authority, departments or teams may share the responsibility of creating and implementing compliance activities. Or, the organization may issue a central policy and solicit feedback from employees on what to change or improve. A distributed model can work especially well when companies are implementing newly issued regulations and need feedback from staff on the front lines of their industry.

Compliance Management Challenges

Thoughtful, proactive implementation of compliance measures helps save time and money down the line. But compliance management is not without its challenges, which can include:

Evolving regulatory landscape: Whether you’re a startup or a multinational corporation, keeping up with new and changing regulations can be difficult. In an increasingly complex corporate environment, it makes sense that organizations may struggle to stay up to date.

Changing working environments: In recent years, more and more businesses have embraced a hybrid work model. While letting employees work from anywhere can help organizations stay nimble, it also exposes them to a new set of cybersecurity risks and HR challenges.

Vendor management: You can’t be an expert in everything. Understandably, businesses often partner with third-party vendors for certain services, whether it’s benefits management, IT support, or legal services. Improper vetting or insufficient due diligence can mean that you end up working with vendors that are out of compliance with your industry requirements.

Pharmaceutical, Food and Beverage, and Cosmetics

Companies in the pharmaceutical, food, and beverage, and cosmetics industries face unique challenges when it comes to compliance management. Consumers need to know that the food they eat, the medicine they take, and the personal care products they use are safe.

Pharmaceutical compliance regulations such as the U.S. DSCSA and the EU Falsified Medicines Directive (EU FMD) are in place to improve patient safety, ensure product integrity, and keep counterfeit drugs out of the supply chain. For the food industry, the Food Safety Modernization Act (FSMA) and guidelines like the Global Food Safety Initiative (GFSI), are in place to make the food supply safer and reduce rates of foodborne illness. Regulations for cosmetics vary widely from country to country, but generally, companies must take steps to ensure their products are safe, have complete ingredient labels, and they can verify their labeling claims.

Throughout all these industries, regulatory bodies are increasingly looking to improve supply chain transparency and traceability.

Compliance Management Best Practices

Companies can support regulatory compliance through best practices such as:

Thorough documentation: When in doubt, document everything, even if it’s not mandated by law. A central document repository makes it easy for employees across the organization to find the information they need and prevent non-compliance.

Set data standards: Be sure that you’re meeting the industry standards for high-quality data across all business operations. Inaccurate or incomplete data means you’ll be less prepared for accurate compliance reporting.

Education and engagement: Know your industry inside and out. Staying connected with industry associations, participating in continuing education, and attending events and conferences helps the organization stay up to date on industry changes and trends.

How to Create a Compliance Management Program

Whether you’re implementing compliance management at a new business or overhauling an existing compliance program, these steps are critical:

Conduct a Thorough Risk Assessment

Start by assessing internal and external risks that could affect regulatory compliance. Review each department to identify and document potential issues and to collect qualitative and quantitative data that you can compare against regulatory standards.

Establish Corporate Policies and Procedures

Look to industry guidance to help you create an initial draft of your compliance policy. You’ll likely need input from stakeholders across the organization, including IT, HR, legal, financial, and risk management leaders. If you don’t already have a compliance officer in place, you’ll need to appoint (or hire) one.

Communicate the Plan and Provide Training

Once your organization has a final compliance policy, it must be communicated to all staff and board officers. Set aside time for dedicated training on the policy, how to use a compliance checklist, and how to conduct an internal audit. Make sure all staff is familiar with any regulatory changes or new rules for recordkeeping and reporting.

Account for Routine Maintenance

Schedule regular reviews of your organization’s compliance policy to ensure it reflects changes in your industry or business operations. Budget the resources to help your compliance team stay abreast of changes in the industry and new regulations.

Conduct Periodic Compliance Audits

Routine internal audits can help identify potential issues before they snowball. Plus, periodic audits ensure your company is better prepared to respond to inquiries from government or regulatory bodies. If violations or vulnerabilities are discovered through an internal audit, take remediation steps immediately and review existing policies to see if there’s a way to prevent similar problems in the future.

Compliance Management Solutions

In addition to a set of internal procedures, a compliance management solution should include:

Auditing tools
Ongoing compliance training and education for staff
Board and management oversight

Additionally, workflow tools and apps can help organize compliance processes and automate certain tasks, like data analysis.

Compliance Management Systems

Today, many organizations rely on digital tools to streamline their compliance efforts. A well-designed compliance management system (CMS) can:

Improve data quality and business analytics
Ensure consistency across multiple business locations or branches
Make tracking, traceability, and reporting easier
Automate routine tasks so employees can focus on other business priorities
Minimize an organization’s overall risk exposure

Compliance Management Software

Compliance management software offers a central platform for communicating, overseeing, and documenting compliance activities across an enterprise. We’re committed to improving compliance management through supply chain transparency. With our tailored industry solutions, you can track your supply chain in real-time, no matter where your business is located. rfxcel serves businesses in the pharmaceutical, food and beverage, and consumer goods industries around the world. To learn more about our compliance software solutions or schedule a demo, contact us today.

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.

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

Posted on March 8, 2023November 10, 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®.

Sustainability in the Cosmetics Supply Chain: Tracking and Tracing for a Greener Future

Posted on August 30, 2022August 4, 2023 by rfxadmin

The health and beauty industry is under increasing pressure from regulatory bodies and consumers to maintain and demonstrate due diligence in their supply chains. Forward-thinking companies are responding by making cosmetics supply chain sustainability an integral part of their mission statements and consumer engagement activities.

For example, “The Big 3” are prioritizing cosmetics supply chain sustainability. L’Oréal puts environmental and social performance at the heart of its business to drive value. Estée Lauder’s mission is “to bring the best to everyone we touch and to support the environment in which we live.” And Unilever reports thoroughly on environmental and ethical statistics, including water, energy, greenhouse gases, waste and plastic packaging, sustainable sourcing, and community investment.

So let’s take a look at sustainability in the cosmetics supply chain. The industry faces a slew of challenges with sustainability, such as environmental and human rights issues, counterfeiting, an evolving regulatory landscape, changes in consumer behavior, and utilizing new technologies, and all affect their decisions and processes.

What is “sustainability”?

Before we get into cosmetics supply chain sustainability, let’s take a step back for a moment and talk about sustainability generally.

Sustainability might seem to be a relatively new concept, but it has been around since the 19th century, when some industries sought to improve working environments and create less pollution. In the 1960s, new laws and organizational bodies were introduced to address pollution in the United States and Europe.

The U.S. Food and Drug Administration (FDA) “is required under the National Environmental Policy Act of 1969 (NEPA) to evaluate all major agency actions to determine if they will have a significant impact on the human environment.” Federal agencies implement NEPA and evaluate the possibility for environmental impacts by condcuting categorical exclusions, environmental assessments, and environmental impact statements.

The European Commission says it “aims to ensure coherence between industrial, environmental, climate and energy policy to create an optimal business environment for sustainable growth, job creation and innovation.”

In 2015, the Association of Southeast Asian Nations (ASEAN) adopted the ASEAN Socio-Cultural Community Blueprint 2025, which “promotes and ensures balanced social development and sustainable environment that meet the needs of the peoples at all times.”

If you read our Global Cosmetics Market white paper, you’ll know why we used the United States, Europe, and Asia as examples: They’re the world’s top cosmetics markets — and their regulators are concerned about sustainability.

What is cosmetics supply chain sustainability?

Cosmetics supply chain sustainability addresses the environmental and human impact of products, from the sourcing and production of raw materials, through to manufacturing, packaging, distribution to the final customer, and post-consumer activities.

Increasingly, there are calls for cosmetics supply chain sustainability standards to be made mandatory. The European Parliament in March passed a resolution to tackle environmental and human rights in EU supply chains. This new Supply Chain Act will require organizations to integrate sustainability into corporate governance and management systems, and frame business decisions in terms of human rights, climate, and environmental impact.

The United States is yet to follow suit, but consumer groups are letting the government know they want tighter standards for the raw materials used in cosmetics.

Even without government mandates, organizations that want to burnish their environmental credentials would do well start with their supply chains. In a January 2021 report called Net Zero Challenge: The Supply Chain Opportunity, the World Economic Forum states that companies wanting to improve their environmental and social performance can look to their supply chains to make cost-effective improvements.

Environmentally responsible production: the rise of “Clean Beauty”

Much of the drive toward sustainability is coming from consumers, who want to know that ingredients are pure (or at the very least safe) and have been ethically sourced. For example, 62 percent of Generation Z consumers (born in the late 1990s) prefer to buy from sustainable brands, and 73 percent will pay more for sustainable products.

In the United States, where the Food and Drug Administration (FDA) from being used in cosmetics, there is mounting pressure for stricter regulations. For example, environmental and consumer advocate groups such as the Environmental Working Group (EWG) believe more chemicals should banned, like in the EU, where 1,300+ substances are prohibited from being used in cosmetics.

This is part of larger “Clean Beauty” movement that advocates for safe, clean ingredients and transparency in product labeling. According to a

Clean Beauty is also concerned with ethical sourcing of ingredients. Consumers want reassurance that their cosmetics are not linked to issues such as deforestation, pollution, and animal or child cruelty. The primary problem here is that a wide variety of cosmetic products use a few “core” ingredients, many of which pose unique challenges for achieving sustainability in the cosmetics supply chain. They are difficult to obtain sustainably and ethically, and child labor, poor working conditions, and illegal mining are common.

For example, a 2016 report from the Amsterdam-based nonprofit Centre for Research on Multinational Corporations (SOMO) found that more than 20,000 children are forced to work in mica mines while their families live in severe poverty. Similarly, palm oil, the global market for which is expected to reach $57.2 billion by 2026, has a history of human rights problems. Palm oil is used for moisturizing or texture effects.

As more companies stake their reputations on being sustainable and consumers become more aware and demanding, it’s certain that the call for cosmetics supply chain sustainability will only get stronger.

How can we achieve cosmetics supply chain sustainability?

As we’ve seen, cosmetics companies operate in a challenging environment where many groups — including consumers, perhaps their most important audience — are calling for them to achieve sustainability in their supply chains.

To be successful, they must be able to adapt to changes in the market as technology, product development, and consumer sentiment shape the industry. Whether it’s faster production methods, demand for new products, or desire for ethical and sustainable options, companies must be able to change with the market if they want to survive and succeed.

The key takeaway is that cosmetics supply chain sustainability is not a pipe dream. Technology and solutions exist right now to help companies evaluate their operations and identify strengths, weaknesses, and pain points and take corrective action. These include supply chain digitalization, cloud-based data systems, and real-time monitoring. For instance, a 2021 report by Gartner said that digitalization is a key enabler of agility because it supports a more transparent, automated, intelligent, and orchestrated end-to-end supply chain.

Final thoughts

Sustainability. Consumers want it. More and more regulators are demanding it. It’s good for the planet. It’s good for people. It’s a business best practice.

Is it difficult to attain sustainability? Yes and no. It is a process. It has a lot of moving parts that may require tough decisions. But if a company has the will to be sustainable, it can develop strategies, chart a course, and get to work … and reap the benefits.

Technology is essential for sustainability. rfxcel and Antares Vision Group are committed to helping companies meet their sustainability goals and empowering them to protect product, profit, people, and planet.

Our Traceability System enables you to see and follow everything in your supply chain in real time from virtually anywhere in the world. It makes every product a “digital asset” with a certified, sharable provenance that proves to consumers and regulators that your sustainability initiatives are real and working as intended. Its intuitive, scalable solutions can be used individually or as a complete platform to shepherd sustainability initiatives to completion and create end-to-end traceability, transparency, and visibility.

Contact us today to see how it works. And be sure to check out our other resources about the cosmetics industry, sustainability, and traceability: