To Ban Animal Testing or Not:
Humane Cosmetics Act vs Safe Cosmetics Acts
Three proposed laws on cosmetics testing have been introduced into the US Congress. One, the Humane Cosmetics Act, would ban animal testing of cosmetics in the US, similar to bans already in effect in the European Union and other countries. The other proposed laws would increase animal testing, but by differing degrees: The Personal Care Products Safety Act would require the FDA to evaluate five ingredients of concern each year, and animal tests could be required; the Safe Cosmetics and Personal Care Products Act would trigger animal testing of all cosmetics ingredients, resulting in much larger scale animal testing.
It's clear what the different approaches mean for animals, but what do they mean for consumer safety? It helps to first have a little background on today's approach to cosmetics safety testing.
Safety Testing Today: A Tiered Approach to Reduce Animal Testing
Today's ingredient testing typically uses a two-step approach:
First step: New ingredients undergo non-animal tests to evaluate irritation, allergic reactions, toxicity, and skin penetration (see a description here).
Second step (only if needed): If a test indicates a potential concern, the ingredient may be dropped or it may be evaluated further. In some cases, animal testing can still be avoided by comparing the ingredient to similar, known ingredients. Novel new ingredients, however, typically will have long-term animal tests, called repeated-dose tests. Currently, about 2% of cosmetics ingredients have had these animal tests (1).
This tiered approach, where ingredients are first screened for potential concerns and then only those of potential concern are further tested, was laid out in a landmark 2007 paper by the National Research Council (2). Before the tiered approach, ingredients tended to be tested for a rote checklist of tests, regardless of the need for the test.
With this backdrop, let's look at the three proposed Acts and see how they would change this approach.
Safe Cosmetics and Personal Care Products Act: A Safety Standard that Requires Animal Tests
The Safe Cosmetics and Personal Care Products Act would change the current approach in these ways:
Return to a checkbox approach. The proposed Act would require the same level of safety evaluations for all ingredients. The proposed legislation doesn't include a rationale for this, but likely it's the precautionary principle, which simply put is: "If you don't have complete information, assume the worst case." This rationale isn't unusual: the European Union (EU) invokes the precautionary principle in its cosmetics legislation, too. Unlike the proposed US law, though, the EU law bans animal testing to achieve it and recommends a tiered testing approach.
Trigger animal tests for all ingredients. The proposed Act would require every ingredient, including existing ingredients, to be tested for the No Observed Adverse Effect Level (NOAEL). The NOAEL is a toxicological term, and currently the NOAEL can be derived only through an animal test, typically the 90-day repeated dose test. The Act also could require the prenatal developmental toxicity test, also an animal test. Remember that only 2% of existing ingredients probably have these tests now. That means about 98% of existing ingredients and all new ingredients would need new repeated-dose tests under the proposed Act.
With over 20,000+ known ingredients, 80 animals/test for the 90-day test, and 750 animals/test for the prenatal test, you can see how the animal numbers quickly add up to millions. This would be one of the most profound changes under the Safe Cosmetics and Personal Care Products Act: It would dramatically increase animal testing until alternative methods are available for these tests, about 10 years out.
Would this provide greater safety for consumers? Maybe, but likely by only a small amount. On the one hand, some potential problem ingredients may slip through the screening tests of today. On the other hand, the animal tests are poor predictors of human response, so problem ingredients could slip through those, too. In drug testing, for example, most drugs that successfully undergo animal tests must be withdrawn from the market because of human responses the animal tests didn't detect.
Personal Care Products Safety Act: Animal Testing Likely
The Personal Care Products Act (S. 1014) does not specify a safety standard; rather, it simply requires that brands demonstrate that their ingredients and finished products are safe. It leaves the FDA to issue guidance later about what it considers adequate evidence of safety, so we must look to FDA's current guidance documents to estimate the impact on animal testing.
The FDA's guidance document on nanoparticles in cosmetics gives insight about their preferred approach. The FDA recommends "at a minimum, testing for acute toxicity, skin irritation, ocular irritation, dermal photoirritation, skin sensitization, mutagenicity/ genotoxicity, repeated dose (21-28 days) toxicity, and subchronic (90 days) toxicity"(3). The repeated dose and subchronic toxicity tests are animal tests with no alternative methods available, so animal testing would likely occur under this proposed act.
The act would require brands to supply this information for all ingredients used in their formulas. Most ingredients have never undergone the 21-28 day repeated dose and subchronic toxicity tests, so most existing and all new ingredients used in current formulations would likely need these tests.
The estimate for the subchronic toxicity test is about 1 to 1.5 million animals over 10 years (1). The 21-28 day repeated dose test uses about half the number of animals as the subchronic test, so about 0.5-0.75 million animals over 10 years. If both tests are done, the total animals sacrificed is about 1.5 to 2.25 million animals over 10 years.
In addition, this proposed act requires the FDA to evaluate at least 5 ingredients of concern every year. Given these would be ingredients of higher concern, they would be more likely to need the second-tier type of tests. Second-tier tests are the long-term animal studies, all of which require hundreds of animals for each test, and one of which requires over 3,000 animals per test. These high-concern ingredients, however, are more likely to have already had these second-tier tests done in the past, so data may already exist for them.
When we ask the key question: "Will this make us safer?" we get the same answer as above. Maybe, but if so, likely by only a small amount. It may catch some potential problem ingredients that slip through today's screening tests, but problem ingredients can slip through animal tests, too.
Safety Testing under the Humane Cosmetics Act: No Animal Testing, so Fewer New Ingredients
The Humane Cosmetics Act (H.R. 2858) has just one requirement: It bans animal testing of cosmetics. It doesn't address any other aspect of cosmetic safety testing. If the Humane Cosmetic Act passes, repeated dose animal tests like the 21-28 day and the subchronic toxicity test would be banned for cosmetics. How would ingredients of potential concern be assessed for safety then? For example, if a screening test showed an ingredient penetrated skin and was potentially bioactive, how could it be evaluated for safety?
This question is most important for unique new ingredients, and less important for existing ingredients and similar new ingredients. For existing ingredients, the small percentage of ingredients that both penetrate skin and are bioactive likely underwent repeated dose testing in the past; and if they didn't, they often may be evaluated now by comparison to similar ingredients. For new ingredients that are similar to existing ingredients, they usually can be evaluated based on the existing ingredient.
For new ingredients that are unique, though, no similar ingredients exist, so their safety can't be evaluated by comparing them to known ingredients. If no new animal tests were allowed, most regulatory agencies would consider that the safety of the ingredient could not be established. The upshot is that we likely would have fewer new unique ingredients until alternative test methods are developed for the animal tests. That would be the trade-off for the ban.
How It All Shakes Out
Two of the proposed acts, The Safe Cosmetics and Personal Care Products Act and the Personal Care Products Safety Act, could increase product safety, at the cost of millions of animal lives. The increase in safety would likely be slight and could be offset by the error introduced by the animal tests.
The Humane Cosmetics Act would ban animal tests, at the cost of slower innovation in the industry. Fewer novel ingredients could be introduced, because repeated dose tests would be banned. This could spur faster development of alternative methods to replace these tests.
(1) Knight, J. and C. Rovida, 2014. "Safety Evaluations under the Proposed Safe Cosmetics and Personal Care Products Act of 2013: Animal Use and Cost Estimates." ALTEX 31, February 2014.
(2) National Research Council, 2007. Toxicity Testing in the 21st Century, A Vision and a Strategy.
(3) FDA, 2014. Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.
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