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Uzbekistan ASL BELGISI Update: Deadline for Pharma Serialization Extended

Posted on by rfxadmin

On February 7, 2022 — just 10 days after we posted our Uzbekistan ASL BELGISI update — the country’s State Tax Committee announced that it was “extending the timeframe for the phased introduction of mandatory digital markings” of pharmaceutical products.

The requirements were originally scheduled to take effect on February 1.

The extension was announced in a letter signed by Mubin Mirzaev, the first deputy chairman of the State Tax Committee. A new deadline was not stipulated, so the country’s serialization scheme for pharmaceuticals is effectively on hold until further notice. The letter did not mention 2022 deadlines for other regulated product categories (e.g., tobacco products; alcohol, including wine and wine products; beer and brewing products; appliances; and water and soft drinks).

Delay or not, we expect the serialization and labeling requirements, which are based on Russia’s Chestny ZNAK system, to remain the same. Read our Uzbekistan ASL BELGISI update for more details about the regulations.

More provisions for Uzbekistan ASL BELGISI from the State Tax Committee

Deputy Chairman Mirzaev’s letter outlined two provisions:

      • A provision to instruct the State Tax Committee and CRPT Turon, which operates Uzbekistan ASL BELGISI, to submit proposals to the country’s Cabinet of Ministers for a system to recognize marking codes from other countries, “primarily markings applied [in] the territory of the Russian Federation.”
      • A provision to “implement a mechanism for electronic registration of non-resident foreign manufacturers of pharmaceutical products with the tax authorities.” Manufacturers would be assigned a non-resident taxpayer identification number (TIN) and would have to obtain a non-resident electronic digital signature (EDS).

The letter also said that the “norms for amending the Technical Regulations for the production of pharmaceutical products were transferred from the project for labeling ‘household appliances’ to the project for mandatory digital labeling of pharmaceutical products.”

As we wrote in our Uzbekistan ASL BELGISI update, a pilot for appliances began on July 1, 2021, and mandatory labeling is being introduced in phases. Vacuum cleaners, refrigerators, freezers, washing machines, TVs, and monitors were required to be labeled beginning December 1, 2021.

Final thoughts

The Uzbekistan ASL BELGISI delay illustrates a truth about supply chain regulations: Deadlines change. All the time. Announcements like the one we talked about today should never come as a surprise or catch you off guard.

The good news is that deadline changes are not the end of the world. What’s important is for you to have a supply chain solution that meets established standards, such as the world-leading GS1 standard. If your solution is fast, flexible, scalable, and automated — like our Traceability System — you will be ready to comply and keep your supply chain moving. All the time.

We’ll continue to monitor Uzbekistan ASL BELGISI as we do with other supply chain regulations. In just the last two weeks or so, we’ve written about the Africa supply chain (first of a two-part series), Egypt’s pharmaceutical regulations, Russia Chestny ZNAK requirements for beer and dietary supplements, the United Arab Emirates’ “Tatmeen” platform, and the U.S. Drug Supply Chain Security Act (DSCSA). Count on us to keep you informed about regulations around the world.

And contact us if you have any questions or want to see our solutions in action. Our digital supply chain experts are always here to listen to you, help you evaluate your needs, and work directly with you to design a solution customized for your business.

Understanding the Africa Supply Chain, Part 1

Posted on by rfxadmin

Supply chains are about people. Yes, technology — like the digital solutions we provide — and regulations are important, but people are the true drivers, the alpha and omega. People design supply chains and make them run (efficiently and legally, we all hope). As consumers, people are the final destination of every supply chain; if you don’t understand their needs, wants, and habits, and if your products cannot reach them reliably, you’re out of business. The Africa supply chain is no exception.

In Part 1 of our series about the Africa supply chain, we’re looking at facts and figures about the almost 1.4 billion people on the continent. By understanding the people — where they live, their economies and how they work, and ambitious initiatives that will affect their daily lives — we provide the context for a broader discussion and understanding of the Africa supply chain. Let’s get started.

Africa by the numbers

Geography and population

Africa is big. It’s about 11.7 million square miles (30.3 million square km) total, and about 5,000 miles (8,000 km) from north to south and 4,600 miles (7,400 km) from east to west. Only Asia is bigger: 17.2 million square miles (almost 44.6 million square km).

There are 54 countries in Africa. As we said above, the population is approximately 1.4 billion — that’s about 17 percent of the world population. For comparison, there are roughly 4.6 billion people in Asia, 748 million in Europe, 654 million in Latin America and the Caribbean, 370 million in North America, and 42.5 million in Oceana. Africa is also the youngest continent in the world: The median age is 19.7 years. According to the World Bank, half of the population in Sub-Saharan Africa will be under 25 by 2050.

Africa has the highest growth rate in the world, and its population has increased every year since 2000, when it was approximately 811 million. By 2100, the population will approach parity with Asia. Nigeria is the most populous country, with 206 million people, followed by Ethiopia, which has 115 million. Egypt ranks third — 102 million people — and is the most populous country in in North Africa. (Be sure to read our overview of the Egypt pharmaceutical supply chain to learn about what’s happening there.)

The continent is home to between 1,500 and 2,000 languages, about one-third of the world’s languages. At least 75 of those have more than 1 million speakers.

Urbanization

Africa has led the world in urbanization this decade. As of 2021, 609 million people lived in urban areas; this could reach 722 million by 2026. According to the Population Division of the United Nations Department of Economic and Social Affairs, 22 cities in Africa are expected to grow at an average annual rate of more than 5 percent in the first half of the 2020s, and 58 are expected to grow at 4-5 percent. The two fastest-growing cities in the world are Gwagwalada, Nigeria, and Kabinda, Democratic Republic of the Congo. Cities in Angola, Tanzania, and Mozambique are topping current growth statistics, and by 2035, Africa’s fastest-growing cities are forecasted to be Bujumbura, Burundi, and Zinder, Nigeria.

Proliferation of mobile technology

According to the GSMA, an association representing mobile network operators around the world, 495 million people — 46 percent of the population — were subscribed to mobile services in Sub-Saharan Africa at the end of 2020. This was an increase of almost 20 million over 2019. By 2025, adoption of 4G will double to 28 percent (the global average is 57 percent), and 5G will reach 3 percent of total mobile connections.

GSMA reports that 40 percent of the population in Sub-Saharan Africa is under the age of 15. Overall, Africa’s very young population will drive mobile use. Importantly, we can also assume that this demographic will use their mobile devices for everything from banking and shopping to entertainment, creating opportunities for companies to connect to consumers and involve them in the Africa supply chain.

Economy

Pre-pandemic, United Nations statistical data showed that Africa’s economy grew by about 3.4 percent in 2019, “creating one of the longest stretches of uninterrupted positive economic expansion in [the continent’s] history.” This helped fuel a growth of the middle class year over year.

In 2020, Africa experienced a 3.4 percent contraction in gross domestic product (GDP).

According to the United Nations Industrial Development Organization (UNIDO) Industrial Development Report 2022: The Future of Industrialization in a Post-Pandemic World, the pandemic has caused considerable output loss in Africa, as it has in most of world. Here are projected output losses by 2021 for the “economy groups” in Africa:

    • North Africa (four economies): 7.3 percent
    • Less-developed countries (14 economies): 6.8 percent
    • Sub-Saharan Africa (12 economies): 6.4 percent

For perspective, estimated output losses were 7.5 percent in West Asia (5 economies), 4.1 percent in Northern and Western Europe (4 economies), 2.7 percent in North America and Pacific (4 economies), 10.3 percent in less-developed countries in Asia, and 1.4 percent in China.

According to a quick online survey of Africa-based websites, the top job sectors on the continent are agriculture, which accounts for 15 percent of GDP; infrastructure; mining; service; banking and finance; information and communications technology; entrepreneurship; entertainment; and tourism. See here and here for more information.

In 2020, 453 million people were employed in Africa, with the majority in Eastern Africa. The two most populous countries, Nigeria and Ethiopia, had the highest working populations, about 56.6 million and 51.3 million, respectively.

According to the World Bank, regional growth in Africa projections look like this:

    • Sub-Saharan Africa: Growth for 2022 and 2023 will remain just below 4 percent.
    • East and Southern Africa: Growth of 3.4 percent in 2022; excluding Angola and South Africa, 4.3 percent growth is expected in 2022.
    • West and Central Africa: Growth of 5.3 percent in 2022; the West African Economic and Monetary Union (Benin, Burkina Faso, Côte D’Ivoire, Guinea-Bissau, Mali, Niger, Senegal, and Togo) is projected to grow at 6.1 percent in 2022. Nigeria is expected to grow by 2.9 percent (African Development Bank Group).

Agenda 2063 and the Africa Supply Chain

Agenda 2063 “is Africa’s blueprint and master plan for transforming Africa into the global powerhouse of the future.” It is being implemented through five 10-year plans, the first of which is scheduled to end next year. Many of its Flagship Projects relate to modernizing and expanding infrastructure; therefore, they are directly related to the Africa supply chain. For example:

African High-Speed Train Network: The network will connect all countries’ capitals and commercial centers, including connecting the 16 landlocked countries to major seaports and neighboring countries.

Single African Air-Transport Market (SAATM): The goal is “the full liberalization of intra-African air transport services in terms of market access [and] traffic rights for scheduled and freight air services by eligible airlines, thereby improving air services connectivity and air carrier efficiencies.”

Continental Commodities Strategy: The goal is to move Africa away from being a raw materials supplier to “developing [its] commodities as a driver for achieving the structural, social, and economic transformation of the continent.” Integrating into regional and global value chains is a key part of the strategy.

The African Continental Free Trade Area (AfCFTA): The goal is to accelerate intra-African trade and boost Africa’s “trading position in the global market by strengthening [its] common voice and policy space in global trade negotiations.” Thirty-six countries had ratified the AfCFTA agreement as of February 5, 2021.

Final thoughts

To understand your supply chain, you have to understand people. We hope this overview of Africa was informative, showing where people live, how they work, the continent-wide trends, and what’s being done to ensure the Africa supply chain better serves every person in all 54 countries.

Everything we’ve talked about today influences the Africa supply chain; however, urbanization could be the most telling and important. As cities continue to grow — remember, urban populations are projected to reach 722 million by 2026 — people will demand more access to goods and services, and the supply chain will have to respond nimbly and efficiently. The proliferation of mobile devices and networks, especially among young people, is another important driver.

rfxcel understands supply chains. The technology, the regulations, and how they affect people. Move on to Part II of our Africa supply chain series, where we discuss recent developments and regulations in specific countries. And be sure to contact us if you have any questions or want a short demonstration of our solutions. We’d love to hear from you.

Last but not least, take a look at our other news from the Africa and Middle East region:

UAE Pharmaceutical Traceability: Ensuring Transparency with the “Tatmeen” Platform

Posted on by rfxadmin

The global push for pharmaceutical traceability and serialization continues at a furious pace. Today, we’re looking at the United Arab Emirates (UAE), whose Ministry of Health and Prevention (MOHAP) in June 2021 announced the “Tatmeen” platform for UAE pharmaceutical products traceability. There are key deadlines this year, so let’s take a look.

UAE Pharmaceutical Products Traceability and the Tatmeen System

MOHAP established Tatmeen, which means “assurance” in Arabic, in Ministerial Decree No. 73 on June 14, 2021. Described as a “central command center,” it’s a GS1-based platform for UAE pharmaceutical products traceability. MOHAP’s partners include the Dubai Health Authority (DHA), Department of Health (Abu Dhabi), and EVOTEQ, a “digital transformation catalyst” based in the UAE, and GS1 UAE.

Tatmeen’s goals should sound familiar:

    • Fight counterfeits and illegal and substandard medications
    • Eliminate unauthorized imports
    • Improve recall management
    • Ensure expired and about-to-expire drugs don’t reach consumers
    • Forecast demand and avoid shortages
    • Move drugs where they’re needed quickly and safely
    • Protect pharma companies, including their intellectual property rights

These other aspects should also sound familiar:

    • Products are scanned at every node of the supply chain
    • Product information is reported into to a central repository (in this case GS1’s BrandSync platform)
    • Scanning captures and verifies data in real time and reports information into a central database
    • Hospitals and pharmacies scan when drugs arrive at their facility and when they’re dispensed
    • Patients and consumers can scan with mobile devices to validate products, report expired products, fakes, and suspected gray market activity

Tatmeen will integrate with the DHA’s electronic medical record system, Salama (incorrectly identified as “Salam” in some industry sources). It will also utilize DHA’s Tarmeez, a paperless drug and medical supplies management system that gives authorized users access to a centralized electronic catalog of all available inventory.

Tatmeen labeling and reporting requirements

All conventional medicines sold, distributed, or stored in the UAE are regulated and must be serialized. These products are exempt:

    • Free samples
    • Products imported for personal use only
    • Medical devices and supplies
    • General sales list (GSL) products

And —surprise, surprise — UAE pharmaceutical products traceability requirements should sound familiar. Secondary packaging must contain four data points in a GS1 DataMatrix code and in human-readable form:

    1. Global Trade Item Number (GTIN)
    2. Randomized serial number (up to 20 characters)
    3. Expiry date (in YYMMDD format)
    4. Batch or lot number

This example is adapted from the MOHAP’s serialization guide:

UAE DataMatrix Code

Aggregation requirements should also ring a bell: All logistic units must be aggregated and labeled with a GS1-128 barcode encoded with a serial shipping container code (SSCC). Manufacturers are responsible for aggregation.

If a brand owner regards an item as a trade item, “it may additionally be identified with a GTIN.” Distributors, wholesalers, and health facilities that unpack and re-pack products to deliver to points of dispensing are required to aggregate the logistic units using their own SSCC codes.

Marketing authorization holders (MAHs), brand owners, manufacturers, or their subsidiaries must register and upload the mandated product master data into the BrandSync platform.

Domestic and foreign manufacturers, third-party logistics providers, batch releasers, contract manufacturing organizations, distributors, licensing agents, and MAHs are responsible for collecting serialized product item traceability records and reporting them to Tatmeen.

UAE pharmaceutical products traceability rollout and 2022 deadline

There was a 6-month “status adjustment” period after Tatmeen was announced for manufacturers and marketing authorization holders to register with the BrandSync platform and begin using 2D DataMatrix codes. This deadline passed on December 13, 2021.

The next major deadline is December 13, 2022. By that date, all supply chain actors in the UAE must obtain a Global Location Number (GLN) from GS1 UAE to identify their organization, where it’s located, and other required information. Relevant stakeholders must also begin reporting serial numbers to Tatmeen and begin aggregation with GS1-128 barcodes and SSCCs.

Final thoughts

We noted a few times that parts of the Tatmeen regulations should sound familiar. If you follow our blog and read our articles about pharmaceutical regulations in other countries — DSCSA in the United States, Chestny ZNAK in Russia, ANVISA in Brazil, ASL BELGISI in Uzbekistan, and so on — everything about UAE pharmaceutical products traceability should ring a bell.

As we said right at the start today, the global push for pharmaceutical traceability and serialization continues at a furious pace. Requirements may vary from country to country, but their essence is the same (e.g., protecting consumers, serialization, traceability, electronic reporting, central repositories, GS1 standards). Tatmeen is just one more example in a very large regulatory ocean.

It’s easy to feel swept up in this current. And, truth be told, if you’re not complying now or preparing to comply by published deadlines, you’re putting your business in jeopardy. If you have questions about Tatmeen or complying with pharmaceutical serialization and traceability regulations in any country, contact us today. In just a few minutes, our supply chain specialists can demonstrate how our award-winning Traceability System ensures you’re compliant in any country, today, tomorrow — always.

For even more information, check out our Global Compliance Page, download our Worldwide Pharmaceutical Compliance Requirements white paper, and catch up on other pharma news in our blog:

DSCSA Compliance Library: Comprehensive DSCSA Information in One Location

Posted on by rfxadmin

Welcome to the rfxcel DSCSA Compliance Library. It’s a collection of our key DSCSA resources (as of September 2023) and is a convenient place to get information as the industry navigates the “extended stabilization period” until FDA enforcement begins on November 27, 2024.

We will, of course, continue writing about the DSCSA and providing the best supply chain solutions to ensure manufacturers, wholesalers, dispensers, repackagers, third-party logistics providers — all pharmaceutical stakeholders — meet the requirements and remain compliant forever.

So bookmark this page and our blog. You can also subscribe to our newsletter to make sure you don’t miss anything about the DSCSA and other important developments in the pharma industry. Just fill out the short form at the bottom of any page on our website.

And of course, contact us today with your questions about the DSCSA or anything else about the pharma supply chain. Our experts are here to help.

A note about the rfxcel DSCSA Compliance Library

Please note that that we haven’t included everything we’ve written or presented about the DSCSA. Deadlines and requirements have changed since the law was enacted in November 2013, so some of our earlier pieces are, logically, outdated.

The DSCSA in our blog

DSCSA compliance white papers

Our top DSCSA news items

­­Our top DSCSA webinars

The DSCSA timeline

A timeline showing key dates of the U.S. Drug Supply Chain Security Act (DSCSA) from 2013 to 2024

Uzbekistan Traceability: Advancing Supply Chain Transparency and Safety

Posted on by rfxadmin

Note about Uzbekistan traceability: On February 7, 2022 — just 10 days after we posted this article — Uzbekistan’s State Tax Committee announced that it was “extending the timeframe for the phased introduction of mandatory digital markings” for pharmaceutical products. The February 1 deadline is longer in effect for this product category. Read the details here.

 

On February 1, 2022, Uzbekistan traceability requirements for medicines and medical devices will go into effect. It’s the latest compliance deadline in the country’s push for serialization and digital marking regulations that will affect an array of industries. Here’s a breakdown of the law and the latest Uzbekistan traceability updates.

The Uzbekistan Traceability System: ASL BELGISI

The Uzbekistan traceability system is called ASL BELGISI. It’s managed by CRPT Turon, the equivalent of Russia’s Center for Research in Perspective Technologies (CRPT), which manages Russia’s National Track and Trace Digital System (Chestny ZNAK).

On November 20, 2020, the Uzbekistan government published Decree PKM-737, “Establishment of Obligatory Digital Labeling.” It mandates serialization for tobacco products; alcohol, including wine and wine products; beer and brewing products; appliances; medicines and medical devices; and water and soft drinks.

Furthermore, it requires supply chain participants to register with a national catalog of labeled goods; when an application is approved, the participant receives an account and is granted access to the system.

According to the CRPT Turon website, the “main task” of ASL BELGISI “is to guarantee consumers the authenticity and declared quality of the purchased products.” Like Chestny ZNAK, consumers can download a mobile app to scan products, report suspect products, and provide feedback about the system.

Marking requirements

Uzbekistan traceability requirements mirror those mandated in Chestny ZNAK. All domestically produced and imported goods must be marked with DataMatrix codes that are traced across the supply chain through a four-step process:

    1. CPRT Turon assigns a unique DataMatrix code to each product and the manufacturer or importer places it on the packaging.
    2. The product’s movements are traced throughout the supply chain, from the factory or point of importation to the consumer, via scanning of the DataMatrix code.
    3. Retailers scan the codes when products are stocked and sold.
    4. Consumers can use the ASL BELGISI app to check a product’s legitimacy (i.e., confirm that it’s not a counterfeit) and access product information.

To get DataMatrix codes, participants must be registered with ASL BELGISI, describe the goods in a national catalog of labeled goods, then formally order the codes and apply them to the products. The codes must be applied to packaging or a product label according to the ISO/IEC 16022-2008 “Automatic identification and data capture techniques – Data Matrix bar code symbology” specification. At present, each DataMatrix code costs 68 som (excluding VAT), which is quite literally a fraction of a U.S. dollar: $0.0063.

Like its Russian counterpart, ASL BELGISI uses “verification keys” and “verification codes.” These are also commonly known as crypto codes. CRPT Turon generates these codes.

Generally, the DataMatrix codes for products in every regulated industry must include four data points:

    • A 14-digit product code (i.e., Global Trade Item Number, or GTIN)
    • A 13-character randomized serial number generated by CRPT Turon or a supply chain participant
    • A four-character verification key generated by CRPT Turon
    • A 44-character verification code generated by CRPT Turon

For aggregation, a Serial Shipping Container Code (SSCC) number must be provided in a one-dimensional barcode following the ISO 15394:2009 “Packaging – Barcode and two-dimensional symbols for shipping, transport and receiving labels” specification.

Regulated industries and key dates/requirements

Uzbekistan traceability regulations currently apply to five product categories: tobacco; alcohol, including wine and wine products; beer and brewing products; appliances; medicines and medical devices; and water and soft drinks. Below, we list the latest information about each category.

Filter cigarettes

    • January 1, 2021: only labeled products may be produced and imported
    • July 1, 2021: manufacturers may ship only labeled products to wholesalers
    • October 1, 2021: distributors may ship only labeled products to retailers
    • January 1, 2022: sale of unmarked cigarettes is prohibited
    • October 1, 2022: mandatory labeling for all types of tobacco products

Alcohol

    • January 1, 2021: only labeled products, including wine and wine products, may be produced and imported
    • December 1, 2021: alcoholic beverages packaged in metal containers, including aluminum containers, must be labeled
    • December 1, 2021: aggregation required for alcoholic beverages, including wine and wine products
    • November 1, 2022: aggregation required for alcoholic beverages packaged in metal containers, including aluminum containers

Beer and brewing products

Mandatory labeling began on April 1, 2021.

Appliances

A pilot for appliances began on July 1, 2021. Mandatory labeling is being introduced in phases. Vacuum cleaners, refrigerators, freezers, washing machines, TVs, and monitors were required to be labeled beginning December 1, 2021.

Medicines and medical devices

    • June 1, 2021: 6-month pilot for medicines and medical devices begins
    • January 28, 2022: CRPT Turon announces that the pilot is officially closed
    • February 1, 2022: only labeled products may be produced and imported

CRPT Turon reported that, during the pilot, all participants successfully registered with ASL BELGISI and registered agreed-upon product in the national catalog of labeled goods. They also successfully installed marking equipment on production lines, trained employees to use the equipment, and released batches of properly labeled, serialized products.

More about the requirements for medicines and medical devices

In addition to a DataMatrix code that includes a 14-digit product code (i.e., GTIN), a 13-character randomized serial number, a 4-character verification key, and a 44-character verification code, packaging must have a human-readable GTIN, lot number, expiration date, manufacturing date, and serial number.

Digital marking must be applied directly to packaging on the production line in a “specially designated place” and not be larger than 10×10 millimeters. The codes must be affixed in a way that prevents them from being separated from packaging during the entire shelf life of the product. Codes may not be printed on external packaging material, including transparent film/wraps, and my not be obscured by other information.

Water and soft drinks

This product category includes bottled water, soft drinks, and fruit and vegetable juices.

    • June 1, 2021: pilot for water and soft drinks begins
    • March 1, 2022: only labeled products may be produced and imported

Final thoughts

In June 2021, CRPT Turon announced that it had issued more than 350 million codes, including more than 200 million for tobacco products, almost 130 million for alcohol products, and approximately 20 million for beer products.

As of today (January 28, 2022), it reports that it has issued nearly 583 million codes for tobacco products, more than 300 million for alcohol products, almost 143 million for beer products.

These figures illustrate a simple fact: Strict serialization and traceability regulations are here to stay in Uzbekistan. Russia has led the way with Chestny ZNAK, which arguably has the world’s toughest supply chain requirements, and we should watch the regulatory landscape in the other Newly Independent States (NIS) — Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, and Ukraine.

As we said above, ASL BELGISI, the Uzbekistan traceability system, mirrors Russia’s Chestny ZNAK. rfxcel is an undisputed leader in Chestny ZNAK compliance. Consider these facts:

  • We’re an official CRPT partner for medications, bottled drinking water, tobacco, footwear, tires, light industry, perfumes, dairy, bicycles, and wheelchairs.
  • We’ve demonstrated to the CRPT that our solutions for traceability and compliance meet its stringent requirements.
  • We’re accredited as an IT company by Russia’s Ministry of Digital Development, Communications, and Mass Media.
  • We’re one of the few providers with active implementations in Russia (e.g., major global consumer goods and pharmaceutical companies).
  • We have an ever-growing Moscow-based team that knows the regulations and brings expertise in key areas of supply chain management and technology.
  • We’ve led the way in thought leadership with white papers and industry updates and information. (See the list below for a sample.)

We’ve also developed end-to-end traceability and compliance hubs for governments that want to lock down their supply chains with the best digital technologies and solutions. Read more about those here and here.

Contact us today to learn more about our traceability and compliance solutions. Our digital supply chain experts will share a short demo of our award-winning Traceability System and show you how to remain compliant and agile no matter where you do business.

A sample of our Chestny ZNAK coverage:

 

Wine Brand Protection and the Fight Against Counterfeits

Posted on by rfxadmin

Today we’re talking about wine brand protection. Why it’s important for the industry and how to use your supply chain to make it as strong as it can be. Specifically, we’re focusing on counterfeits, an evergreen problem for the industry.

Talking about brand protection is a fitting conclusion to our series of articles about wine and a great way to mark the last day of the Unified Wine and Grape Symposium. Speaking of which, stop by Booth 807 to meet us and our other Antares Vision Group team members, FT System and Applied Vision. We’d love to see you before everybody heads home.

Now on to wine brand protection and the fight against counterfeits.

Why is wine brand protection important?

In the wine industry, your brand is critical to success. Whether you’re a multi-generational operation or the new kid on the block trying to make your mark, it’s one of your most valuable assets.

Your brand tells the story of your wine, from the soil and the vines to the bottle to your customers’ tables. It connects you to your partners and consumers. It sets you apart from your competition. It’s your identity out there in the world.

Alas, wine — and spirts — are under a constant barrage of brand protection threats and challenges. The circumstances range from bad actors trying to rip you off to the ebb and flow of the market and the trends that are defining it as we’ve made our way into the 2020s. Today, we’re focusing on the bad actors. Let us know if you’d like us to write more about factors or have anything to add to our discussion.

Counterfeits and fakes

Counterfeits and fakes are the undisputed champion of threats to wine brand protection. It’s an age-old problem, though industry observers rightly note that the pandemic has created more opportunities for fraud. The increase in online sales, including auctions, and less in-person due diligence because of travel restrictions are two examples.

How is wine counterfeited? Let us count the ways. There can be theft at production and storage sites. Theft and diversion also happen as wine is being delivered across the supply chain.

Counterfeiters also like to misrepresent a wine’s origin, vintage, variety, blend — really anything that distinguishes a brand and increases their chances of making a profit.

“Damaged wines” also manage to get into the marketplace. These might have been stored at the wrong temperature or have torn labels and bad corks. Adulterated or cheap wine is bottled in a prestige package.

In Part 1 of our wine traceability series, we mentioned the notorious Rudy Kurniawan. But the daily reality of counterfeit wine (and spirts) is much less dramatic. Consider these news items:

In 2011, hundreds of bottles of fake Jacob’s Creek wine were seized in the UK. More recently, a shopkeeper in England was fined more than $5,000 for having 142 bottles of fake Yellow Tail on his shelves. He said he bought the wine from a man who popped by his shop in an unmarked van; authorities say he could have profited in excess of $600 by selling the plonk. He didn’t get a receipt or an invoice, and the man in the van has not been found. Interestingly, analysis showed that the bogus Yellow Tail was less than 12 percent alcohol. Real Yellowtail is 13.5 percent. This is another example of how counterfeit wine is adulterated.

In 2020, 4,200 counterfeit bottles of Bolgheri Sassicaia, a prestigious (and very expensive) wine, were seized in operation “Bad Tuscan.” Revealing the international nature of counterfeiting, investigators said the fake wine originated in Sicily, the bottles came from Turkey, and the labels and wooden boxes came from Bulgaria. Furthermore, “The 2010 and 2015 vintages, celebrated by Italian and international critics, were the most prevalent among the fakes.”

As for the spirts industry, fake bourbon is hot right now and authorities nabbed 400+ liters of counterfeit vodka this month in Scotland.

To illustrate the problem more broadly, about 1.7 million liters of counterfeit alcohol was seized in Europe between December 2020 and June 2021. That haul was part of a joint INTERPOL-Europol operation called OPSON X, which netted almost 15,500 tons of illegal products with an estimated street value of nearly $60 million. Upwards of 68,000 checks were carried out by 72 participating countries, resulting in more than 1,000 criminal cases.

The upshot is that up to 20 percent of wine sold worldwide is fake and counterfeits cost the industry as much as $3 billion every year.

What can we do about it?

Counterfeiters and fraudsters exploit weaknesses. This is what gives them openings to assault your brand. The good news is that you can mitigate these weaknesses and gather real-time intelligence for effective brand protection strategies using your supply chain.

Your supply chain mirrors your brand. It’s the embodiment of your business. If it’s not healthy, your brand can’t be healthy. You need to be able to continuously scan it, diagnose it, and take immediate action should a threat arise.

Four supply chain solutions in particular are vital for wine brand protection: serialization, real-time monitoring, end-to-end traceability, and mobile traceability.

We talk about these in Part 2 of our brand protection series, “Brand Protection Strategies and Your Supply Chain.” Part 1 talks about top supply chain threats and your brand protection strategy. We encourage you to read these articles, as well as our consumer engagement series.

Final thoughts

Your success and reputation depend on how seriously you take brand protection. This means being able to authenticate every ingredient and every bottle. You have to monitor and prove storage conditions and provenance. You have to have deep, real-time insight into what you’re doing and where your products were, are, and will be. And you have to have the granular data to back up every claim and demonstrate to your customers that your wine is exactly what you say it is.

If you read our “Wine Consumer Engagement: Ten Things to Know for 2022” post from the other day, you saw that our mantra for wine consumer engagement is “A message in every bottle.” For wine brand protection, we like to say that you should tap into the “Brut” force of your supply chain. The short list of benefits includes:

    • Fortify with supply chain data and protect with unique digital IDs
    • Create an indelible provenance and create your product story
    • Monitor in real time 24/7
    • Inspire consumer trust and crowdsource brand protection
    • Leverage IoT to eliminate blind spots
    • Maintain chain of ownership
    • Protect trading partners and consumers

And, of course, combat counterfeits and theft. Contact us today to learn more about pairing your brand with the finest supply chain solution for wine brand protection. Also be sure to read our other articles about the wine supply chain and why your supply chain is vital for effective brand protection and consumer engagement:

Wine Consumer Engagement: Ten Things to Know for 2022

Posted on by rfxadmin

Virtual tastings are so 2020. Don’t get us wrong: They’re still a thing. But to do wine consumer engagement right in 2022, winemakers have to do a lot more than ask people to hop on a Zoom call. That’s why today we’re talking about 10 things that are vital to successful wine consumer engagement.

Also, don’t forget that the Unified Wine and Grape Symposium starts today! We’ll be exhibiting with our fellow Antares Vision Group member companies FT System and Applied Vision, so sign up today and visit us at Booth 807.

Ten things to know about wine consumer engagement in 2022

Like our recent “Five Wine Supply Chain Trends for 2022” and “Trends for the Digital Wine Supply Chain” blog posts, we’re not ranking these aspects of wine consumer engagement. They’re all important. Winemakers should consider each carefully when crafting their engagement strategies.

1. Nail your story

Your brand’s story is vital to wine consumer engagement. (All consumer engagement, actually.) It’s the foundation of “the face” and the heart of the personality you’re going to project to your customers and potential customers. What do you want people to know about you? Where is your brand “coming from”? What sets you apart from other brands?

Many of the other aspects of wine consumer engagement we’re discussing today stem from and overlap with the decisions you make about your story. To get this right, expect to do some soul-searching and ask yourself some tough questions about who and what your brand is.

2. Know your customers

It’s Marketing 101, right? If you don’t know who’s buying your products, you’re missing opportunities and wasting money. Today, however, knowing your customers requires elbow grease. You have to devote time and resources to gather information (i.e., data) and develop profiles to inform your wine consumer engagement.

Here’s a handy tool: ALE. It’s an appropriately wine-and-spirits-flavored abbreviation for ask, listen, and engage. Ask consumers questions. Listen — really listen — to their answers, feedback, suggestions, opinions, etc. Importantly, what they say might not jibe with your own vision of your brand, so be willing to adapt and pivot and do the extra work to give people what they want, not what you want them to want.

To engage, pull out all the stops. Social media, of course. But you can also get out into the real world. Talk with sommeliers to see what’s trending with wine lovers. Talk with retailers to learn what people are thinking and buying. For instance, is there a cheaper brand that people are being drawn to? What brands have buzz?

We all know that wine can be a very personal experience. It’s part of its appeal. It’s why people get excited about wine and anticipate the purchase as much as the uncorking. Take advantage of that. Ask, listen, and engage.

3. Customer first, brand second

So, you’ve done the research and know who your customers are. Time to let them know all about your brand, right?

Not really.

Always remember that wine consumer engagement is about the consumer. They are the hero, not you. It can be a difficult lesson to learn, but your job is to guide people toward what they want and demonstrate the value your brand brings. Don’t make it all about you, because it’s not. Give people what they want to see and share, not what you want to show them.

4. Accept that you might not be that special

This might sting. You have to be self-aware. You have to know your strengths and weaknesses. You have look in the mirror and do an honest self-assessment.

What, if anything, makes you unique? Remember, unique means unlike anything else. One of a kind. Are your competitors saying they’re unique while making the same claims you’re making?

Industry observers are noting that wineries are saying the same thing. “Estate-grown,” “multi-generational,” “visionary winemaker,” and “terroir” are on their short list of traits and lingo that are decidedly not unique in the market. You can talk about these things, but don’t pin your identity on them.

Knowing your customers is what will make your brand stand out. What do they like (and dislike) about your wines? Where do they drink your wines? How do they “use” your wines? Are they talking about and sharing your wines on social media? What do they expect from you? Meeting their demands is what will make your brand special.

5. Be yourself

All this said, it is critical to be yourself. Don’t put on airs. Don’t pretend to be something you’re not. Don’t be a bore. Today’s consumers have a nose for you-know-what. If they get even a whiff of phoniness, watch out. So, you have to be authentic. Keep it real.

6. Focus on sharing

Think of wine consumer engagement as a self-perpetuating chain in which the links are interactions, including sharing between and among your customers. For this to happen, you have to create content that people want to see, experience, and share. The possibilities are virtually limitless — videos, contests, loyalty programs, giveaways, prizes … . Just remember to focus on your consumers, not yourself.

7. Always bring value to consumers

Ask yourself this question every day: What have you done for them lately?

You must always bring value to your customers. “ABV” — another industry-appropriate abbreviation. This means different things to different people, of course. For some, it might mean proving the provenance of your wines and demonstrating that you’re focused on transparency and sustainability. For others, it could mean sharing a picture of your team out in the vineyard or a fun promotion, such as winning a prize for sharing a video. If you’re not always bringing value to your customers, who are the heroes of your wine consumer engagement, you’re going to push them away.

8. Devote resources

Wine consumer engagement isn’t a “set it and forget it” proposition. It shouldn’t be an afterthought delegated to whoever might happen to have some spare time.

You need a person or a team to conceptualize and create content, push it out across all your channels, monitor and analyze reactions, make changes, and respond to what people are saying and asking. You also need to pay attention to what your competitors are doing and saying.

In other words, you have to be fully engaged in your consumer engagement.

9. Business as usual probably won’t cut it

It’s a cliché because it’s true: You have to think outside the box. Running an email campaign* or posting a video on Facebook then kicking back with a nice Pinot to watch your sales boom isn’t how wine consumer engagement works. It’s called consumer engagement for a reason: You want to get a response. You want to build that self-perpetuating chain of interactions. Creativity is key. It’s another reason to devote resources to make sure you’re doing it right.

*A note about email and marketing: Some people say it’s dead; others say it’s alive and well. Only you can decide if it works for your brand and if it should be part of your consumer engagement strategy.

10. Leverage supply chain data

We’ll let you in on our secret: The key to effective wine consumer engagement is your supply chain, which is a goldmine of actionable data.

The basic building block is serialization, which turns every product into what we call a “digital asset.” Each digital asset has a unique digital identity that can be monitored from production all the way to the person who buys it. With rich, traceable data about every item in your supply chain at your fingertips, you can establish and maintain connections with consumers before, during, and after the sale. For example:

    • Link every product to unique content and brand interactions
    • Give consumers the information they demand (e.g., provenance, transparency, sustainability)
    • Hyper-personalize and hyper-target every engagement based on location, time, or purchasing data
    • Empower consumers to reject counterfeits, alert for diversions/gray markets, authenticate products, help with recalls
    • Gain valuable insight into your customers

Final thoughts

“A message in every bottle.” This is rfxcel’s mantra for using your supply chain for wine consumer engagement. Our Traceability System provides granular data from the vineyard all the way into your customers’ daily lives. You can use it to define and tell your story, know your customers and bring them value, and inspire your brand to think outside the box.

If you’re at the Unified Wine and Grape Symposium this week, stop by Booth 807 to see our solutions in action and learn more about how we can help your brand stand out in a very crowded market. If you aren’t there, contact us today to schedule a short demo with one of our digital supply chain experts.

And be sure to read our other articles about the wine supply chain and why your supply chain is vital for effective consumer engagement and brand protection:

Trends for the Digital Wine Supply Chain

Posted on by rfxadmin

As we said in our post about wine supply chain trends, it’s definitely not a Dry January in our blog. Today’s topic: the digital wine supply chain.

First, though, we’re excited about exhibiting at the Unified Wine and Grape Symposium next week. Head over to our sign-up page. We have some complimentary passes available (on a first-come basis) and we’ll be giving away a few bottles of fine Italian wine at Booth 807! Sign up and visit us at the show!

Now, on to the digital wine supply chain.

What are the benefits of a digital wine supply chain?

If you follow our blog (and we know you do), you know we’ve been talking about the digital supply chain for years. For us, digitization isn’t a fad or a trend; it is the No. 1 most important “thing” you can do for your business.

In broad terms, the benefits of building a digital wine supply chain are visibility, traceability, and transparency; sustainability; optimized efficiency and productivity; and creating value and enabling new business models.

It’s important to note that visibility, traceability, and transparency make all the other benefits possible. This “trifecta” in a digital wine supply chain enables longevity, brand strength, innovation, and compliance.

Digital wine supply chain trends

We’re not ranking these digital wine supply chain trends, just noting some of the most important and prominent technologies that are driving the industry. This is also a very high-level summary, as getting into granular details is far beyond the scope of our blog. If you have any questions or want more information, contact us!

Furthermore, these technologies are important in every supply chain. It doesn’t matter what your business is: a digital supply chain is your most important strategic asset.

Blockchain

If you had to describe blockchain in one word, it would probably be “security.” Specifically, it’s about forwarding (i.e., sharing, utilizing) encrypted data that’s virtually impossible to corrupt, alter, or otherwise modify. For details about what it is and how it works, download our “Blockchain-Based Supply Chain Traceability” white paper.

For the digital wine supply chain, blockchain’s primary appeal — as you might have guessed — concerns visibility, traceability, and transparency. Put simply, it’s a powerful tool to verify everything in your supply chain, from the vineyard to distribution to final sale to the person who will be pouring your wine into a glass. It makes traceability accessible and verifiable for everyone in the chain (e.g., your trading partners).

Blockchain has other applications, such automatically verifying, validating, and enforcing contracts. These “smart contracts” can be implemented throughout the digital wine supply chain, to set up and confirm deliveries and pay suppliers, for example. There’s even been some buzz about non-fungible tokens (NFTs) in the wine industry.

Adoption of blockchain is far, far from universal. People still don’t fully understand what it is, how it works, and the value it can bring. However, the consensus seems to be that it will blossom and proliferate during the 2020s. Nowadays, data is king; blockchain safeguards data, so keep it on your radar.

Internet of Things (IoT)

IoT technology puts you everywhere your supply chain goes. It’s the heart of real-time data collection, monitoring, adjusting, risk mitigation, and brand empowerment.

For the wine industry, this means using sensors to cultivate “smart vineyards” and build a supply chain with end-to-end visibility, traceability, and transparency. (Are you detecting a theme?) For example, IoT-enabled sensors can be buried in soil, embedded in vines, or hung in leaves to monitor environmental conditions, collect data, forecast weather conditions, reduce risks during harvesting, and improve productivity.

IoT also promotes sustainability, including water and soil conservation and lowering/eliminating pesticides; combined with satellite imaging, these capabilities safeguard vineyards and promote sustainability.

IoT has applications in every facet of the wine the supply chain. The upshot is data. Lots and lots of data. Collected and transmitted in real time, the data tells you exactly what’s happening in every part of your operations on land, air, and sea.

E-labels and e-certificates

Electronic labels, or e-labels, make life easier for everyone: You, your employees, your trading partners, regulators, packaging designers, graphic designers, and your customers. They are foundational to the digital wine supply chain. And because they replace multiple paper labels, e-labels are better for the environment and promote sustainability.

DataMatrix codes and QR codes are examples of e-labels. Essentially, they can be “loaded” with information about ingredients, product provenance, traceability data, compliance data — virtually anything. They can also link to social media, websites, apps, rewards programs, and special content such as videos. E-labels are an all-in-one solution for every member of the digital wine supply chain.

Importantly, e-labels are powerful tools to fight fraud and counterfeits, problems that have a huge negative impact on the wine industry. Full traceability data, accessible with a single scan by a supply chain partner or a consumer in a store, proves a that a bottle of wine is genuine. E-labels are critical to our trifecta of traceability, transparency, and visibility.

A good case study is the EU’s “U-label” digital platform, which allows wine and spirts producers to easily create e-labels (in this case QR codes) and give consumers product information in their native language. It’s a collaborative effort of the Comité Européen des Entreprises Vins (CEEV), the association representing the European wine industry, and SpiritsEUROPE, whose mission is to “represent, defend and promote the European spirits sector and help members achieve sustainable business growth.”

For a deep dive on QR codes, DataMatrix codes, and other barcodes, read our “Understanding GS1 Barcodes in the Global Supply Chain” blog post.

Electronic certificates are similar to e-labels. They too are “loaded” with data that prove a product meets certain requirements and certifies key information such as origin, import-export status, tax status, and sanitary/phytosanitary compliance.

In the wine industry, common certificates include certificates of origin, free sale certificates, quality certificates, organic certificates, and environmental certificates/certifications. However, the industry has not established standards for e-certificates and to a large degree still relies on a paper-based system.

With the push for a digital wine supply chain, standard-making bodies for e-certificates should consider what certifications to include (e.g., origin, export, quality, sanitary), relevant categories of information (e.g., producer, brand, batch, Harmonized System code), and how the information will be exchanged (e.g., through central hubs).

Other things to watch in the digital wine supply chain

We’ve run out of space for now, but here are few other things to keep an eye on as the digital wine supply chain evolves.

    • Artificial intelligence to manage and process data, monitor crops, make decisions about watering and fertilizing, predictive maintenance on lines, warehouse management, and distribution
    • Robotics in planting, fertilizing, pruning, harvesting, and warehousing
    • Geographical Information Systems (GIS) and satellite imaging for “digital cartography” to monitor land use, study the effects of climate change, conduct surveys, track diseases, generate thermal and infrared imaging
    • Creating “digital assets” to leverage in brand protection and consumer engagement strategies. Note: Our upcoming articles will discuss this in detail.

Final thoughts

The wine industry has always maintained a balance between tradition and innovation. Winemakers, grapegrowers, and other stakeholders want to preserve the past while embracing current and developing technologies.

The digital wine supply chain brings the industry the best of both worlds: Technology ensures traditions endure. But technology also creates new traditions for traceability, transparency, visibility, and sustainability — the very things that, as we said at the outset, enable longevity, brand strength, innovation, and compliance.

Contact us today to learn more. And be sure to read our other articles about the wine supply chain and why your supply chain is vital for effective consumer engagement and brand protection:

 

Antares Vision Digital Supply Chain

Cosmetics Supply Chain Challenges in 2022

Posted on by rfxadmin

In our last two blog posts of 2021, we talked about the global problem of counterfeit cosmetics and who investigates them when they’re discovered. For our first article of 2022, we’re talking about cosmetics supply chain challenges the industry should consider as we make our way through what will likely be another trying year for the global supply chain.

Please note that this isn’t a ranked list or a “countdown” to the No. 1 cosmetics supply chain challenge. That said, let’s get started.

Five Cosmetics Supply Chain Challenges

Counterfeits and fakes

Yes, we’ve been talking about counterfeits a lot lately. But they’re one of the cosmetics supply chain challenges that bears repeating and re-emphasizing. Cosmetics and perfumery products are consistently among the Top 5 products “targeted by counterfeiters,” with fakes accounting for just under 10 percent of all customs seizures in 2019.

There are two main reasons why counterfeits are a challenge. First, they are a public health threat because they can contain hazardous materials. Second, they are a major threat to companies’ brand security. Traceability in a digital supply chain, including serialization and real-time environmental monitoring solutions, is your best defense. Read more in our brand protection blog series.

Sustainability

Sustainability is top of mind for all supply chain stakeholders. Consumers are one of the main drivers here, as they’re demanding accountability from the brands they buy. And if they don’t get it, they’re happy to take their business elsewhere. More and more regulatory bodies are also calling for sustainability.

Traceability, visibility, and transparency are how you can prove to consumers and regulators that you’re operating a sustainable supply chain with environmentally friendly/conscious processes and products. We wrote a good summary about “The Trifecta” of traceability, visibility, and transparency in our “Top Supply Chain Trends of 2021” post. Read that for more details about this important trend.

Refrigeration/Climate control

Some cosmetics must be shipped at specific temperatures. If the temperature dips or rises beyond that specified point — an event known as an excursion — products can be damaged, resulting in loss of revenue and, possibly, a knock to your brand reputation. This is a risk that’s simply not worth taking.

Climate control should be part of a larger real-time environmental monitoring solution. We call ours Integrated Monitoring. It’s an Internet of Things (IoT)-enabled solution that seamlessly integrates with your supply chain to monitor more than a dozen conditions, including temperature, on land, sea, and air.

Ethical considerations

One of the first cosmetics supply chain challenges is sourcing high-quality ingredients. (Indeed, this is a challenge in most industries; the concerns here should be on everyone’s radar.) In addition to the ethics involved in creating and maintaining a sustainable, environmentally friendly supply chain, cosmetics companies must contend with the issues of child labor and trafficked workers —even slavery.

To illustrate: mica and palm oil. The former is a sparkling mineral used in eye shadow, lipsticks, and highlighter; the latter is used for moisturizing or texture effects.

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 a global value of $57.2 billion by 2026, is plagued by human rights problems.

Companies must be vigilant. A digital supply chain with end-to-end traceability, visibility, and transparency is crucial.

Market changes

The cosmetics industry must continue to address changes in three areas: technology, regulations, and consumer sentiment. Of course, these changes are happening within the context of the pandemic, which arguably makes them more challenging.

In “The Global Cosmetics Market”, a white paper we published at the end of 2021, we get into the details of these challenges. Here are the broad strokes:

    • Technology is changing how consumers buy products and even how they interact with them. To adapt, companies can employ tools such digitalization and IoT devices to expand their supply chains without compromising efficiency.
    • Regulations are an ongoing concern in every industry. For example, in the United States, the Personal Care Products Act, if passed, would amend the Federal Food, Drug, and Cosmetic Act and give the Food and Drug Administration more oversight of production and authority over cosmetics products, including the power to demand recalls.
    • Everchanging consumer sentiment means cosmetics companies must pay attention to what people want, expect, and demand. This makes supply chain traceability, visibility, and transparency vital to success.

Final thoughts

We ended our “Top Supply Chain Trends of 2021” blog post with a questionnaire. These questions absolutely pertain to cosmetics supply chain challenges:

    • Are you keeping up with the trends we talked about today?
    • Are there gaps and blind spots in your supply chain?
    • Are counterfeits a problem in your industry?
    • Are you doing everything you can to protect your brand?
    • Are you actively reaching out to your customers to bring them closer to your brand?
    • Are there compliance deadlines on the horizon?
    • Are you certain your current supply chain solutions are truly optimal?
    • Are you using your supply chain as a strategic asset?

We encourage you to contact us to discuss why your supply chain is the key to keeping up with challenges. Our digital supply chain experts can share a short demo of our award-winning Traceability System that will clearly show why it’s the best solution for cosmetics companies.

We also encourage you look through our blog. To learn more about how transparency works, for example, read our “Transparency Trilogy,” which unpacks transparency in the global seafood supply chain. You can also subscribe to our quarterly newsletter, which tracks the latest news and trends in traceability, regulations, and other industry news. Find the subscription form at the bottom of any page on our website.

Who Investigates Counterfeit Cosmetics Products?

Posted on by rfxadmin

In our last blog post, we talked about the global problem of counterfeit cosmetics. Today, we’re talking about who investigates counterfeit cosmetics products, starting with how cosmetics are regulated in the United States and the EU.

Regulation of cosmetics products varies greatly from country to country, so our discussion today should not be taken as an overview of what to expect everywhere cosmetics are sold. Enforcement of laws and the actions authorities take to target counterfeits also vary.

What is universal, however, is that the cosmetics industry faces unique challenges with consumer safety, increased consumer demand for transparency, and being targeted by counterfeiters. It’s good to know who investigates counterfeit cosmetics products and what measures you can take to be part of the solution.

Who investigates counterfeit cosmetics products: USA and EU

Counterfeit cosmetics are dangerous because the criminals who make them don’t follow regulations or standards for production. Fakes are often contaminated with “stuff” you really don’t want to think about, let alone put on your face, such as bacteria, animal and human feces, arsenic, and mercury. So, regulators keep an eye on cosmetics.

United States

In the United States, the Food and Drug Administration (FDA) is the governing body for cosmetic regulations. Cosmetics products do not require FDA approval — but they are regulated. The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA) explain the FDA’s requirements, restrictions, and disciplinary actions regarding cosmetics.

The FDA focuses on preventing adulteration and misbranding, mislabeling, and harmful ingredients or drugs. Adulteration refers to products or product ingredients that are not in line with FDA regulations or that have been contaminated. A misbranded product is “improperly labelled or deceptively packaged,” which could include counterfeit cosmetics products. The FDA prohibits 11 chemicals from being used in cosmetics products.

Additionally, the FDA reserves the authority to request recalls and work with the Department of Justice, Federal Bureau of Investigation (FBI), and Border Customs if any violations are found. It maintains a “Cosmetics Recalls & Alerts” page and has a searchable “Enforcement Report” database of recalled products.

The European Union

Cosmetics products manufactured in and imported to Europe are regulated under the EU Cosmetic Regulation. Like the FDA, the EU regulates ingredients and labeling; generally, however, the regulations are broader and more precisely defined.

For example, more than 1,300 substances (e.g., chemicals, colorants, and preservatives) are banned from cosmetic use, and hundreds more are permitted only under certain conditions. The regulations also mandate Good Manufacturing Practices (GMP), whereas the FDA only suggests GMP as “guidelines for effective self-inspection.”

Furthermore, the EU requires significant product documentation. Every cosmetics company must have a “responsible person” for every product they make. This person is responsible for ensuring products are safe and comply with regulations, and must submit a cosmetics product notification through an online portal before a product can be sold.

The responsible person must also create a product information file that includes the name, description, and nature of the product; description of the manufacturing methods; statement of compliance with regulations and GMP; a product safety report; and data about animal testing, if any. They must also assemble a product safety report that contains product safety information and a product safety assessment.

Do consumers have a role?

Yes, and it begins with vigilance with prices, packaging, and product quality:

      • Prices: If the price is too good to be true or just noticeably cheaper than the last time you bought it, there’s a good chance it’s a fake.
      • Packaging: The printing might look shoddy or the colors might seem off. There might not be a barcode. There might not be packaging at all, and the products might be offered in bulk.
      • Product: If the consistency or texture seem different, it’s likely a fake

In the United States, consumers can “report suspicions concerning the manufacture or sale of counterfeit or pirated goods” to the FBI. For suspected counterfeit cosmetics products seen online, consumers can contact the FBI Internet Fraud Complaint Center. The FBI has also partnered with the National Intellectual Property Rights Coordination Center to create a tip line where consumers can report products they suspect to be fake.

In the EU, consumers are encouraged to contact their local authorities about counterfeit cosmetics products. Depending on the nature of the situation, the authorities might investigate themselves or contact the appropriate investigative body, which could include Europol. The United Kingdom has Action Fraud, an online reporting tool for fraud and cybercrime.

Consumers should also be aware of what brands are doing to combat counterfeits and consumer engagement programs that encourage people to report suspicious products.

Final thoughts

If you really want to drill down into the U.S. and EU regulations, download our “Global Cosmetics Market” white paper today. It also has a section about regulations in Singapore, plus more information about counterfeit cosmetics products.

In “Top Supply Chain Trends of 2021,” we posed some important questions companies should ask themselves as we move toward what is likely to be another challenging year for supply chains. Many of those questions, listed below, fit perfectly with what we talked about today — regulations, counterfeits, brand protection, consumer engagement.

Your supply chain is where all of these concerns converge. Which is why you should schedule a short demo of our solutions. In about 15 minutes, we can show you the basics of our Traceability System and how it transforms your supply chain into a strategic asset that will improve and protect every facet of your business.

 

  • Are you keeping up with supply chain trends?
  • Are there gaps and blind spots in your supply chain?
  • Are counterfeits a problem in your industry?
  • Are you doing everything you can to protect your brand?
  • Are you actively reaching out to your customers to bring them closer to your brand?
  • Are there compliance deadlines on the horizon?
  • Are you certain your current supply chain solutions are truly optimal?
  • Are you using your supply chain as a strategic asset?
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