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Tackling Regulations at Fast-Moving Consumer Goods Companies-Part Two

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This is the second part of a three-part series examining the various regulations that fast-moving consumer goods companies must consider as part of their production and distribution processes. In our last discussion, we explored the various regulations that affect the pharmaceutical industry. Today, we will focus on medical devices, hazardous ingredients, water and beer serialization, and food and allergens.

Medical Device Regulations

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In the EU, the Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) were issued in 2017. These regulations establish a device identification system based on a Unique Device Identifier (UDI) to enhance the traceability of medical devices. The unique numeric or alphanumeric code consists of a device identifier (UDI-DI) and a production identifier (UDI-PI) to:

Provide clear identification of the device
Facilitate traceability
Simplify recalls
Expedite adverse event reporting
Combat counterfeiting
Reduce medical errors
Boost patient safety
Improve buying, inventory management, and waste disposal for health institutions

The UDI must be placed on the label of the device and on all higher levels of packaging4 in both machine-readable and human-readable formats. Direct marking on the device itself is required for some reusable devices. The EU requires a Basic UDI-DI to be uploaded to the European Databank on Medical Devices, or EUDAMED. The alphanumeric Basic UDI-DI identifies a group of similar medical devices, like catheters. Purely administrative, it has no supply chain value. Without the proper coding, devices cannot be sold in the EU.

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UDIs also are required in the US and were implemented on a phased schedule beginning with Class III products in 2014 and Class I and unclassified devices in 2020.4 Manufacturers must submit device identifier information to the Global Unique Device Identification Database (GUDID) for each model they manufacture. The FDA requirement also assumes that manufacturers use a barcode verifier to confirm the code quality meets Grade C or higher.In the EU, the deadline for UDI assignment and submission of core UDI data elements to the database was May 26, 2020. Like the US, effective dates for UDI placement on labels and packaging are organized on a staggered schedule according to device classification. Initial deadlines have passed, others are pending.

EU MDR Implementation Schedule by Device Class

Compliance

Class of Device

Deadline

Placing UDI carriers on the labels of devices

MDR Article 123(3)(f), Article 27(4)

Implantable and Class III devices

May 26, 2021

Class IIa and Class IIb devices

May 26, 2023

Class I devices

May 26, 2025

Direct marking of the reusable devices

MDR Article 123(3)(g), Article 27(4)

Implantable and Class III devices

May 26, 2023

Class IIa and Class IIb devices

May 26, 2025

Class I devices

May 26, 2027

IVDR devices, UDI carriers must be placed on the labels

IVDR Article 113(3)(e), Article 24(4)

Class D IVDs such as HIV or hepatitis tests

May 2025

Class C such as certain influenza tests IVDs

May 2026

Class B and A sterile IVDs

May 26, 2027⁶

 

MDR Medical Device Classification Definitions

Class I devices

Class II devices

Class III devices

Considered lowest risk. This category includes some high- volume consumer products such as adult incontinence briefs.

  • Class Is consists of sterile devices such as stethoscopes or examination gloves.
  • Class Im devices are similar low-risk measuring devices, such as thermometers, droppers, or non-invasive blood pressure devices.

Considered somewhat higher risk and classified by risk level and the amount of time spent in contact with the body.

  • Class IIa devices such as contact lenses and epidural catheters are characterized as low to medium risk and installed in the body for periods between 60 minutes and 30 days.
  • Class IIb devices are more complex, rated medium to high risk, and installed in the body for 30 days or longer. Examples include glucose monitors, dental implants, and infusion pumps.

Considered high risk and include long-term, perhaps permanent, implants like pacemakers, stents, and prosthetic joints.

Classifications for IVDs also are organized by risk level with Class A being the lowest risk and Class D the highest.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Adding a UDI can necessitate major changes to assembly and packaging lines to install code marking and verification technologies and may require the redesign of line layouts and the adoption of automation. The most common UDI coding options include inkjet, laser, thermal-transfer label printing/application, and direct part marking.4 To verify codes and capture data, machine vision sensors and systems must deliver accurate read rates at high speeds and be able to decipher codes applied on curved or shiny surfaces. Code reading consistency is imperative to prevent parts from being scrapped.

Hazardous Ingredients

To identify the composition of toxic household products such as laundry detergent, cleaning supplies, biocides, fertilizers, and glue, the EU has issued marking regulations to help poison centers and medical personnel quickly provide the most appropriate emergency treatment in cases of ingestion or other exposure.
Regulation (EU) No 2017/542 amends its CLP Regulation (Regulation (EC) No 1272/2008 on classification, labeling, and packaging of substances and mixtures) by adding Annex VIII. It requires the addition of a Unique Formula Identifier (UFI) to the label/package of potentially dangerous products, which already must include a hazardous material pictogram, or icon, to provide an alert that the product is flammable, corrosive, explosive, poisonous, etc. The 16-character, human-readable UFI provides information about toxic ingredients without disclosing the exact, often proprietary, formula of the product.

Harzard Ingredients

The pictogram and alphanumeric code may be printed at the same time as the label or packaging but often are applied on the packaging line to ensure the information reflects the most recent changes in the formula. Since each code must be readable and correct, each item must be inspected to ensure the code is printed clearly and properly identifies the toxin. The regulation took effect on January 1, 2021, for products being sold in Europe or being introduced to the market. The deadline for mixtures intended for industrial use is January 1, 2024. By 2025, the UFI is mandatory on the label of all products classified for health or physical hazards.

Although not a member of the EU, Switzerland also requires a UFI on chemical preparations, biocides, and fertilizers and complies with the requirements of Annex VIII of the EU CLP Regulation. New products intended for consumers and products imported from the European Economic Area (the EU states plus Iceland, Liechtenstein, and Norway) must carry a UFI as of January 1, 2022. All other preparations, biocidal products, and fertilizers that are classified as hazardous must be labeled with a UFI by January 1, 2026.

Water and Beer Serialization

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By 2024, virtually all products sold in Russia, regardless of country of origin, must carry a Crypto Code. Mineral water and beer must comply in 2022. The Crypto Code carries more data than other serialized track-and- trace codes, but printers can be modified to reproduce the format, and barcode readers and vision systems can be set to read it. The code consists of an identification element (a Global Trade Item Number, known as GTIN, plus a serial number) and a verification element. The verification element combines a public key with a crypto key, a sequence of characters generated by a cryptographic transformation of an identification code. Both elements are printed in pure text form and encoded in an ECC200 DataMatrix code with enhanced error correction. Print quality must achieve a minimum rating of C, graded according to the ISO 15415 Bar Code Symbol Print Quality Test Specification.

Food and Allergens Labeling 

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In the EU, under Regulation No. 1169/2011, products containing any of the Big Eight Allergens (wheat, fish, shellfish, milk, soybeans, eggs, peanuts, and tree nuts) must display an icon to provide an alert to its presence. Packaging and labeling also must display a numeric code that identifies the allergen and the destination market. This regulation affects any food and beverage company selling products in the EU. The icon and numeric code typically are printed at the same time as the label/packaging. In some cases, a QR code or a two-dimensional barcode is used.

Machine vision on the packaging line confirms the correct label is being applied to the correct product. This is particularly important on lines for products like baked goods that experience frequent product changeovers. Confirming label correctness also is essential on lines where runs may be long, but labels frequently change to fill orders for different customers or markets where requirements, e.g., language or nutrition information, may differ.

Inkjet printers, thermal printers, or laser coders may need to be installed on these packaging lines if code information is not part of the preprinted label/package graphics. Whether preprinted or live, machine vision technology, capable of reading the code and checking it against a database, is needed to confirm the allergen information is correct for the product being run.

In the US under the Food Allergen Labeling and Consumer Protection Act of 2004, food labels must identify the food source of the eight major food allergens if present. According to FDA, this requirement is met if the name in the ingredient list identifies the allergen’s food source name (for example, buttermilk). If the name listed does not identify the food source of the major allergen, it must be provided by noting it in parentheses following the name of the ingredient, e.g., lecithin (soy), flour (wheat), and whey (milk) or by positioning a ‘contains’ statement below or next to the ingredient list, e.g., “Contains wheat, milk, and soy.” These labeling rules now also apply to sesame, which was recognized as the ninth major food allergen with passage of the Food Allergy Safety, Treatment, Education, and Research Act on April 23, 2021. Labeling requirements for sesame take effect on January 1, 2023.

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