This specification covers hand hygiene and personal care products, including hand cleaners and hand soaps (both foams and lotions), and products regulated by the U.S. Food and Drug Administration (FDA) as consumer antiseptic hand washes, consumer antiseptic hand rubs, and cosmetic hair shampoos and body washes. Covered use settings include routine, nonspecialized hand and personal care cleansing in residences, office buildings, schools, retail and other public buildings, and heavy duty uses to remove oil, grease, ink, or other hard to remove soils in garages, print shops, and other industrial settings. Products regulated by FDA as health care antiseptics, first aid antiseptics, or drugs (such as medicated shampoos) are not addressed in this specification. In addition, use in specialized settings where infection control measures are in place, such as use by food service or day care workers, are not covered.
Consumer Antiseptic Hand Wash and Consumer Antiseptic Hand Rub - product categories defined by the FDA under the "Over the Counter" drug monograph rulemaking program. Hand wash products are topical antiseptic products intended to include a water rinse step. Hand rub products (including antiseptic wipes) are topical antiseptic products intended to be used when soap and water are not available, and are left on and not rinsed off with water. The FDA monograph for each product category defines the active ingredients that are determined by the FDA to be "Generally Recognized as Safe" and "Generally Recognizes as Effective," and therefore which products can be legally marketed and not misbranded.
Cosmetic - a product category defined by the federal Food, Drug, and Cosmetic Act by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body … for cleansing, beautifying, promoting attractiveness, or altering the appearance" (§201(g)(1)). Among the products included in this definition are cleansing shampoos.
Drug - a product category defined by the federal Food, Drug, and Cosmetic Act by their intended use as "articles intended for the use in diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" (§201(g)(1)).
Hand Cleaners/Hand Soaps - products designated to be used with water to remove both organic and inorganic soil from skin. Soap products are distinguished from other cleaners in FDA regulations as products where: (1) the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the detergent properties of the article are due to the alkali-fatty acid compounds; and (2) the product is labeled, sold, and represented only as soap (21 CFR 701.20). Cleansing products that contain synthetic detergents, or make other label claims such as skin moisturizing, deodorizing the body, or treating or preventing disease are not soap, and are regulated by FDA as either cosmetic or drug products, or both.
Green Seal - is a non-profit, independent, third party standard setting and certification organization that follows the Guiding Principles and Procedures for Type I Environmental Labeling adopted by the International Organization for Standardization (ISO 14024). Green Seal has developed environmental standards and certifies products for more than 40 major product categories. It has a standard for hand cleaners.
UL EcoLogo - is an independent, third party standard setting and certification program that follows the Guiding Principles and Procedures for Type I Environmental Labeling adopted by the International Organization for Standardization (ISO 14024). Since its establishment in 1988, EcoLogo has been recognized or referenced in more than 350 specifications and standards. It has standards for hand cleaners, personal care products, and instant hand antiseptic products.
Hand hygiene is a highly regulated activity in health care, food service, and child care settings. These specifications do not supersede or change existing health and education regulations and professional guidance related to hand hygiene practices.
Hand Cleaners and Hand Soaps
All covered hand cleaners and hand soaps must meet the following criteria:
Matching dispensers must be offered free of charge, and battery-free dispenser options are encouraged.
All hand cleaners and hand soaps included on the "approved green cleaning products" list at https://greencleaning.ny.gov/ meet the GreenSeal or UL EcoLogo criteria.
Consumer Antiseptic Hand Washes
All consumer antiseptic hand wash products must meet the following criteria:
Consumer Antiseptic Hand Rubs
All consumer antiseptic hand rubs products must meet the following criterion:
All consumer antiseptic hand rub products 8 oz. or greater are encouraged to hold the following certification:
All consumer antiseptic hand rub products less than 8 oz. are encouraged to contain ethyl alcohol or isopropanol active ingredients only.
NOTE: The Center for Disease Control and Prevention's "Guideline for Hand Hygiene in Health Care Settings" states that alcohol solutions containing 60% to 90% alcohol are most effective. In the United States, alcohol-based hand sanitizers usually contain 60% to 95% ethanol or isopropanol.
Personal Care Cleansing Products
All covered hair shampoos and body washes are encouraged to hold at least one of the following certifications:
Packaging shall comply with Environmental Conservation Law subsection37-0205. Packaging shall not contain inks, dyes, pigments, adhesives, stabilizers, or any other additives to which any lead, cadmium, mercury, or hexavalent chromium is intentionally added or contain incidental concentrations of lead, cadmium, mercury, or hexavalent chromium which together are greater than 100 parts per million by weight (0.01%). New York State encourages affected entities to adopt the following: