United States (U.S.) Cosmetics Regulation
Cosmetics and personal care products were regarded as poorly regulated in the United States (U.S). But in 2019, the new federal bill HR 4296 (Safe Cosmetics and Personal Care Products Act) was introduced in order to replace HR 2359, envisioning a more progressive and robust regulatory framework for cosmetics and personal care products. What are the main challenges that authorities are currently facing in light of this proposed legislation?
Marta Pinto

Marta Pinto

Regulatory Affairs Associate

SAFE COSMETICS AND PERSONAL CARE PRODUCTS ACT

The U.S. Safe Cosmetic Act (H.R. 2359) was introduced on June 24th, 2011. In 2019, the Safe Cosmetics and Personal Care Products Act (H.R.4296) was introduced in the House of Representatives. This update was considered a major breakthrough, since previously the Food and Drug Administration did not even require safety testing of ingredients present in cosmetics and personal care products. The new federal bill holds cosmetic companies accountable for the safety of the ingredients in their products and requires supply chain transparency and industry sharing of safety data. Moreover, the FDA may order a recall if a product is likely to cause serious harm and it also encourages the use of alternatives to animal testing, providing guidance to companies on appropriate non-animal methods.

The congresswoman Jan Schakowsky, who has introduced the new bill, stated that the “bill will provide cosmetics safety that consumers and workers want and deserve; address the over-exposure to toxic chemicals that communities of colour and professional salon workers experience everyday; and hold companies accountable for the safety of the ingredients in their products”. She also added that “we should restore consumer confidence in the safety of beauty and personal care products by making safe cosmetics the new normal”. 

The Safe Cosmetics and Personal Care Products Act bans a number of toxic chemicals in cosmetics, protects vulnerable populations (including, infants, children, pregnant women workers and other highly exposed populations), requires companies to register their facilities, products and ingredients with the FDA, and to comply with Good Manufacturing Practices (GMP). It also provides public access to serious adverse event reports.

SUBSTANCES AND AREAS OF CONCERN

Previously, the federal law allowed secret (often toxic) fragrance chemicals that were ‘hidden’ in cosmetic products. The HR 4296 requires full fragrance disclosure. According to the federal bill, any fragrance allergen in a cosmetic shall be included on the label of the cosmetic and identified as a fragrance allergen if such allergen is included in Annex III of the European Union Cosmetics Regulation (No 1223/2009) and present at a concentration equal or above 0.01% in rinse-off products or 0.001% in leave-on cosmetic products. The FDA is working with trade associations regarding labelling and public health concerns and encouraging voluntary compliance with labelling. For example, it was created a web page, in order to educate the public and create awareness.

The FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and the Personal Care Product Council (PCPC), during its virtual summit (May 2021), have expressed concern on particular areas: VOCs, CBD, 1,4-dioxane, talc, PFAs (per- and polyfluoroalkyl substances), formaldehyde, allergens, packaging and some elements of the Safe Cosmetics Act.

As defined by Environmental Protection Agency (EPA), a Volatile Organic Compound (VOC) is “any compound of carbon, excluding carbon monoxide, carbon dioxide, carbonic acid, metallic carbides or carbonates, and ammonium carbonate, which participates in atmospheric photochemical reactions”. EPA also includes a list of dozens of exceptions for compounds “determined to have negligible photochemical reactivity”. VOCs may have short- and long-term adverse health effects. Collaboration of the PCPC with the California Air Resources Board (CARB) allowed to set emission level standards for certain types of products (e.g. dry shampoos, fragrance and other sprays). These VOC level changes will come into effect in 2023 and a higher reduction is expected in 2027.

Similarly to Europe, packaging and plastics are considered a big point of concern. Governments worldwide are making an effort to reduce pollution, especially plastic residues.

Since 2019, the FDA has been assessing formaldehyde for potential effects, including sensitization and cancer. For example, hair-smoothing products can release formaldehyde. Formaldehydes and formaldehyde-releasing preservatives are among the immediately prohibited ingredients indicated in the Safe Cosmetics and Personal Care Products Act (H.R.4296).

U.S. and EU legislation differ when it comes to cosmetic and personal care products and it can be difficult to keep up and to comply. CRITICAL CATALYST is here to help and guide you, either if you want to market your cosmetic products in the EU or United States. Do not hesitate to contact us as ask for more information at info@criticalcatalyst.com.

References:

  1. H.R. 4296 – Safe Cosmetics and Personal Care Products Act of 2019. 116th Congress. 1st session. Available at: https://www.congress.gov/bill/116th-congress/house-bill/4296/text
  2. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.

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