With product safety a top priority among cosmetics companies, firms could rely more heavily on safety data from animal tests conducted for non-cosmetic purposes, or testing undertaken to comply with outside regulations, if a U.S. ban on cosmetic animal testing passes Congress.

According to personal-care industry advocates, most cosmetics firms do not conduct animal testing in today's marketplace, particularly on finished products.

However, they occasionally do use animals to verify the safety of a new ingredient vis-a-vis endpoints that lack accepted alternative methods for evaluation.

Legislation banning cosmetic animal testing in the U.S. would challenge companies' ability to ensure product safety as required by the Federal Food, Drug and Cosmetic Act, particularly with respect to safety-assessment components that can't be readily or confidently addressed by alternative strategies.

This could prompt firms to begin culling animal data from chemical testing performed in non-cosmetic contexts in order to compile safety-substantiation files and feel comfortable going to market with products containing such substances.

The Humane Cosmetics Act, introduced in the House June 23 with bipartisan support, would prohibit use of animals to test cosmetics or cosmetic ingredients in the U.S. one year after its enactment, and bar companies from selling cosmetic products tested on animals two years later, regardless of whether validated alternative methods are available for industry use. The bill now has 52 cosponsors ([A#02150629009]).

However, the legislation ostensibly would permit cosmetic manufacturers to benefit from safety data generated via animal testing to comply with outside regulations that aren't specific to cosmetics, similar to the situation with the European Union's cosmetic animal-testing ban in full effect since March 2013.

As drafted, the Humane Cosmetics Act seeks to eliminate "cosmetic animal testing," defined as "the internal or external application or exposure of any cosmetic to the skin, eyes or other body part of a live non-human vertebrate for purposes of evaluating the safety or efficacy of a cosmetic."

Given that many chemicals used in cosmetics require animal testing for uses in other sectors, there may be in some cases a wealth of non-cosmetic animal data that firms could incorporate in their risk assessments, TSG Senior Regulatory Consultant Bob Stewart noted in a July 24 interview with "The Rose Sheet."

"They may not be directed to cosmetics, but the cosmetic companies will benefit from the fact that the studies have been conducted and the data are generally available," he said.

According to Stewart, such animal testing data rarely are kept confidential, which could facilitate information sharing between cosmetic manufacturers and companies in other sectors.

The EU's cosmetic animal-test ban does not apply to chemical testing required under regulations outside of the jurisdiction's Cosmetics Regulation, such as the Registration, Evaluation, Authorization and Restriction of Chemicals program. The European Commission and European Chemicals Agency issued a statement in October 2014 clarifying the scope of the ban along those lines Also see "ECHA Clarifies Exceptions To Cosmetic Animal-Test Ban; NGOs Regroup" - HBW Insight, 30 October, 2014..

The permissibility of animal testing on cosmetic ingredients to comply with third-country cosmetic regulations, such as those in China and Japan, is a gray area in the European ban that may be clarified with a pending case in the EU's highest court Also see "Highest EU Court To Interpret Cosmetic Animal-Test Ban’s Scope" - HBW Insight, 18 December, 2014..

The proposed U.S. ban could help to address what animal-welfare groups see as an unintended loophole in the EU legislation regarding third-country testing. The Humane Cosmetics Act would make it unlawful to sell "any cosmetic if the final product or any component thereof was developed or manufactured using cosmetic animal testing conducted or contracted for after the effective date."

If the language goes unchanged and the bill advances, the ban ostensibly would extend to products and ingredients subject to cosmetic animal testing outside of the U.S. to meet foreign safety requirements. Multinationals would then have to choose between testing their ingredients on animals under any circumstances and their associated stakes in the U.S. market.

Liability Concerns Will Drive Outside Data Use

From a regulatory standpoint, cosmetics manufacturers have every reason to avoid animal testing, with a growing number of countries legislating bans on the practice consistent with the EU's example.

However, companies still face liability risks and the threat of consumer lawsuits if a product they launch to market proves hazardous to users' health.

"When you get right down to it, there is a liability that a company has for putting out a product [in the event that it] injures someone, so they do want to have safety information, they do want to know that the product is not going to generate issues," Stewart said.

The animal-welfare community maintains that alternative strategies are available to accommodate industry's testing needs without use of animals, but industry is quick to point out that just because a test exists does not mean it has been validated and accepted by regulatory authorities.

Skin sensitization, for example, is a problematic endpoint on that basis Also see "Physicians Group Urges Acceptance Of Non-Validated Animal Test Alternatives" - HBW Insight, 21 July, 2014..

If the Humane Cosmetics Act gains traction in Congress and passes, firms may be compelled to resort to in vitro tests and computational models that have not been scientifically validated as reliable, reproducible and relevant to human health through expert study and review.

Advocates for streamlined regulatory acceptance of alternative methods point out that traditional animal tests have never been through a comparably rigorous validation process. However, they are backed by an extensive history of use demonstrating their capacity to predict human safety issues.

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) maintains an online list of alternative test methods that are accepted by U.S. and other regulatory authorities around the world.

Both industry and animal-rights advocates have been critical of FDA's acceptance of alternative methods, and the agency's stance on the proposed Humane Cosmetics Act is unclear. Currently, FDA requires manufacturers to substantiate their products' safety prior to market launch through whatever tests – laboratory, animal and/or human – that companies deem necessary.

The agency does not mandate that specific tests be conducted and does not require companies to share their safety information – at least not until a situation arises prompting enforcement action. If a ban on cosmetic animal testing were enacted, it could raise questions as to what testing the agency deems appropriate and sufficient to support product safety Also see "Humane Cosmetics Act Lacks FDA Assurance Regarding Alternative Methods" - HBW Insight, 10 August, 2015..

"If the law tells a company that it can't run a test [on animals], does that mean that the company has an excuse for not doing the test, even though there's an ingredient in the product for which FDA may decide the data aren't sufficient?" Stewart asked. "That creates a situation where FDA may be concerned that this is interfering with their ability to have the data they need."

TSCA Reform Could Yield Useable Animal Data

In the U.S., safety-data requirements under non-cosmetic chemical regulations are on the rise, which could assist cosmetics manufacturers in accumulating data to support their use of substances with functions in other sectors.

According to TSG Consulting's Stewart, ingredients often found in cosmetics, such as emulsifiers, solvents, propellants and fragrances, are sometimes used as inert ingredients in pesticides, an area facing increasing calls for transparency, review and testing, including animal experimentation.

Additionally, under a proposed recast of the U.S. Toxic Substances Control Act – the TSCA Modernization Act of 2015, H.R. 2576 – which passed the House by a near-unanimous vote June 23, more stringent chemical-safety data requirements in affected industries likely would trigger new animal research that cosmetics manufacturers may be able to leverage, he suggested.

TSCA excludes the food, drug and cosmetics sectors, among others. A related bill, the Frank R. Lautenberg Chemical Safety for the 21^st Century Act, S. 697, currently is making its way through the Senate.

Steward expects that TSCA reform efforts are "going to give EPA more authority to require studies to meet their risk-assessment needs for the uses that are being proposed," Stewart said.

Ultimately, the more uses a compound has, the more data are going to be required.

The consultant noted the dichotomy between NGO efforts on this side of the chemicals space versus those in the cosmetics sector.

"On the one hand we have the people trying to prevent the testing of cosmetics and maybe cosmetic ingredients that are only for use in cosmetics, and other parts of the chemical regulatory world are being asked to generate more data," he observed.

Industry May Lean On Outside Animal Data If Humane Cosmetics Act Passes

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