U.S. CPSC Releases Guidance for COVID-19 Products

The U.S. Consumer Protection Safety Commission (CPSC) has released regulatory guidance on the product types such as face coverings, face shields, gowns, gloves, and disinfectant and cleaning products pertinent to the COVID-19 pandemic.

Given the current public health crisis, these products are being manufactured and consumed beyond their typical intended usage. From the regulatory standpoint, industry stakeholders have been eagerly waiting for this direction i.e. regulatory requirements and applicability from CPSC. 

Complete information can be found at the CPSC’s Coronavirus Disease – (COVID-19) Related Products Business Guidance webpage.

Flammability

The CPSC classifies face coverings, gowns and gloves as “articles of wearing apparel” and thus must comply with the flammability requirements of “Flammable Fabrics Act”.

Specific exemptions from testing as indicated below shall apply to them:

• Products made from plain surface fabrics, regardless of fiber content, weighing 2.6 ounces per square yard or more and
• All fabrics, both plain surface and raised surface textiles, regardless of weight, made entirely from any of the following fibers or entirely from a combination of the following fibers:
  Acrylic, modacrylic, nylon, olefin, polyester, wool
• For gloves that are 14 inches in length or shorter, and not affixed to or not an integral part of another garment

Note:

• Disposable gowns not meant to be washed or dry cleaned do not require laundering before being subjected to flammability testing
• Disposable children’s gowns sized up to 9 months must comply with 16 CFR 1610 (Standard for the Flammability of Clothing Textiles)
• Disposable children’s gowns sized 9-14 months must comply with the flammability requirements of children’s sleepwear of 16 CFR part 1615 (for size 0 to 6X) or 16 CFR part 1616 (for sizes 7 to 14). 

The CPSC requires domestic manufacturers and U.S. importers of these products to issue a General Certificate of Conformity (GCC), certifying that the products meet all applicable requirements. GCC exemptions exist for products that are exempted from flammability testing per 16 CFR §1610.1(d). 

Children’s Products (designed or sized for children ages 12 and under)

Children’s face coverings, gowns, and gloves in addition to complying with flammability requirements must also comply with the labeling, testing, and certification requirements of the Consumer Product Safety Act (CPSA).

Per guidance, all children’s products, including children’s face masks, must: 

• Bear permanent tracking information 
• Meet total lead content limits (unless material exempted by 16 CFR 1500.91(d)(7)(i), and
• Meet lead in paint/similar surface coating limits

Testing must be conducted at a CPSC-Accepted Testing Lab, and domestic manufacturers and U.S. importers of these product must also issue a Children’s Product Certificate.

Face Shields (marketed for non-medical purpose)

Face shields marketed as non-medical use (e.g. sun-protective clothing) are subject to CPSC requirements for general wearing apparel. If they are designed or sized for children age 12 &and under, they must comply with CPSIA requirements. 

Face shields intended for medical purpose are under the jurisdiction of the U.S. Food and Drug Administration (FDA). 

Disinfectant and Cleaning Products

Disinfectant and cleaning products are regulated by various federal agencies, depending upon the product’s ingredients and intended use. In addition, the Poison Prevention Packaging Act (PPPA) requires certain household products containing any of the substances listed in 16 CFR §1700.14 to have special packaging to protect children from serious injury or illness from handling, using, or ingesting such substances.

The CPSC also highlights that certain products may fall out of their scope and/or fall within other US agencies jurisdiction: 

• Medical Use Products: intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease are “medical devices” under the jurisdiction of the FDA 
• Commercial Use Only Products: sold exclusively to commercial entities, they must meet OSHA requirements
• Antimicrobial Products/Disinfectants Products: regulated by the U.S. Environmental Protection Agency (EPA) under the Toxic Substances Control Act (TSCA)
• Ultraviolet (UV) Disinfecting Devices: UV disinfecting medical devices that use ultraviolet light to disinfect a surface by producing a germicidal effect, and that are intended to augment disinfection of health care environmental surfaces after manual cleaning has been performed, are “medical devices” under the jurisdiction of the FDA

For additional EPA Guidance on List N: Disinfectants for Coronavirus (COVID-19), you may click here. 

SGS is committed to providing information about development in regulations for consumer products as complimentary services. Through a global network of laboratories, SGS provides a wide range of services including physical/mechanical testing, analytical testing and consultancy work for technical and non-technical parameters applicable to a comprehensive range of consumer products. Please do not hesitate to contact us for further information.

Next Step

For direction regarding medical purpose PPE, the FDA has issued recommendations and policies about PPE which can be found here: Recent Final Medical Device Guidance Documents.

SGS can assist with testing to the methods specified in this CPSC guidance, as well as other FDA guidances and regulations. 

For enquiries, please contact:

Matthew McGarrity
Hardlines Technical Manager
t: +9738978889

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