The Safe Cosmetics Act of 2010, (H.R. 5786) passed by the House of Representatives into committee, is starting to look like it is going to be a reality, not in small part due to the lobbying of very large cosmetics concerns who would like the House to stop artisans from competing with them. You can read the full text of the bill here.
H.R. 5786, like the recently defeated Colorado law which would have put organic producers out of business, is a product of a lobbying group consisting of: Campaign for Safe Cosmetics (SFSC) and the Environmental Working Group (EWG) which are in turn linked to the Skin Deep database.
H.R. 5786 is being opposed by groups representing small businesses such as the Handcrafted Soapmaker’s Guild, Opposesca.com, the Indie Beauty Network and Personal Care Truth and most cosmetic chemists and formulators. A petition opposing H.R. 5786, (also known as SCA 2010) can be found here.
Most artisan formulators believe that cosmetics, soaps, and other body products should be safe, sustainable and good for body and planet. Those are the reasons most of us starting making products in the first place. But it’s important to note that the laws demanding that sort of quality already exist, but are unenforced by the FDA.
If H.R. 5786 is passed as written, it will cause most artisan and small shops to close, shuttering the doors of hundreds of American small businesses. It would be regulatory madness, requiring multiple forms and papers for every bar of soap sold, and establishing a scientific standard so poorly written by non-scientists, and so overreaching that almost no product will be approved.
For instance, one of the regulations requires: “data demonstrating that exposure to all sources of the ingredient or cosmetic present not more than 1 in a million risk for any adverse effect in the population of concern”…but doesn’t define “population of concern”, nor does it suggest how this risk should be quantified or calibrated. (For the record; bottled drinking water doesn’t meet that standard.)
“Ingredient”, as defined in the bill, includes every substance “present at levels above technically feasible detection limits”. The problem here is that we can “technically” detect one part per trillion (ppt), or 0.0000000001%.
So, for example; I make an olive oil soap that includes lavender oil. Lavender oil has about 100 constituents that can be measured using the PPT standard. So, for my lavender soap to be acceptable under this Bill, each of the 100 constituents of the oil must be separated, and tested, and must not cause a reaction in any one person of a million people tested.
I cannot think of a single substance; natural or synthetic, which would pass that test. First off, even in huge test trials for skin reaction, the participants will only number in the thousands. Secondly, even if you could find a million people who would do a patch test, and you had a 100 million dollar budget to test your product, there is nothing, possibly not even distilled water, that isn’t going to cause a reaction in at least one person out of a million people.
That said; lavender will be banned under this Bill. It contains linalool, which can be deadly if you were to break into a vat of it and drink your own weight. You can have more cyanide (allowable…1 part per million), than you could have lavender oil.
In fact, the lobbyists who are working to pass this bill, are actively campaigning to put an end to all natural substances used in soap and beauty products. They would rather have petroleum distillates, provided by companies like Dow, than to let you have a basil hair tonic, or a lavender soap. Any guesses on where their funding is coming from? Do you think it’s the organic growers that I buy from, or do you think it’s the chemical companies who push artificial flavors and coal based colorants?
These regulations are significantly more stringent than are required for food. Personally, I’d rather my food chain be more regulated. People die every year from badly regulated food production, but to the best of my knowledge, nobody has ever faced a horrible demise because of their face powder.
A member of the Handcrafted Soapmaker’s Guild mentioned the labeling nightmare on the horizon as well. H.R. 5786 will require that every constituent or trace contaminant of every ingredient be listed on the product label, which given the parts per trillion standard means that a product label that once listed: olive oil, blue chamomile extract, and essential oils of orange, rose and vetiver – would require an ingredient list looking something like this:
oleic acid, palmitic acid, stearic acid, linoleic acid, linolenic acid, squalene, hydroxytyrosol, tyrosol, oleuropein, ligstroside, elenolic acid, acetoxy-pinoresenol, oleocanthal, a-tocopherol, herniarin, hyperoside, umbelliferone, methylumbelliferone, caffeic acid, chlorogenic acid, quercetin, rutin, flavanone, isorhamnetin, quercimeritin, anthemic acid, choline, triacontane, patuletin, patulitrin, apigetrin, apigenin-7-glucoside, apigenin-7-apiosylglucoside, luteolin-7-glucoside, apigetrin-7-acetylglucoside, luteolin-4-glucoside, luteolin, patuletin, matricin, matricarin, galacturonic acid, d-limonene, citronellol, geraniol, myrcene, linalool, a-pinene, sabinene, ß-phellandrene, geranial, neral, decanal, citronellal, (Z)-ß-ocimene, ß-pinene, valencene, ß-elemene, terpinolene, dodecanal, ?-terpinene, ß-sinensal, a-sinensal, d-cadinene, a-copaene, ?-muurolene, nerol, d-3-carene, (Z)-3-hexenol, perillaldehyde, octanol, cis-sabinene hydrate, undecanal, nonadecane, heneicosane, 1-nonadecene, 2-phenylethanol, (E)-ß-ocimene, methyleugenol, eugenol, 1-heptadecene, eicosane, trans-linalool oxide, ß-caryophyllene, 1-tricosene, a-terpineol, a-farnesene, farnesyl acetate, citronellyl formate, pentadecane, a-guiaiene, benzaldehyde, (Z)-ß-farnesene, terpinen-4-ol, geranyl acetate, isogeranyl acetate, farnesyl propionate, methyl salicylate, citronellyl acetate, hexanol, a-humulene, methyl geranate, a-terpinene, cis-rose oxide, isogeraniol, ß-bergamotene, d-2-carene, cis-linalool oxide, octadecane, heptadecane, a-phellandrene, cis-rose oxide, ß-maaliene, ethyl benzoate, geranyl acetone, 3-methylbutanol, docosane, 1-heneicosene, p-cymene, 1-eicosene, bourbonene, ?-cadinene, hexadecane, 1-tricosene, octanal, nerolidol, 2-undecanone, benzyl benzoate, a-muurolene, 2-phenylethyl phenylacetate, farnesol, geranyl formate, guaiol, heptanal, allo-ocimene, 1-octadecene, 2-phenylethyl-3-methyl valerate, hexadecanol, hexanal, 3-hexenyl formate, 2-phenylethyl benzoate, khusimol, vetiselinenol, cyclocopacamphan-12-ol (epimer A), a-cadinol, a-vetivone, ß-vetivenene, ß-eudesmol, ß-vetivone, khusenic acid, ß-vetispirene, ?-vetivenene, a-amorphene, (E)-eudesm-4(15),7-dien-12-ol, ß-calacorene, (Z)-eudesm-6-en-11-ol, ?-amorphene ziza-5-en-12-ol, ß-selinene, (Z)-eudesma-6,11-diene, salvial-4(14)-en-1-one, khusinol, cyclocopacamphan-12-ol (epimer B), selina-6-en-4-ol, khusian-ol d-amorphene, 1-epicubenol, khusimene, ziza-6(13)-en-3ß-ol, ziza-6(13)-en-3-one, 2-epi-ziza-6(13)-en-3a-ol, 12-nor-ziza-6(13)-en-2ß-ol, a-vetispirene, eremophila-1(10),7(11)-diene, dimethyl-6,7-bicyclo-[4.4.0]-deca-10-en-one, 10-epi-?-eudesmol, a-calacorene, (E)-opposita-4(15),7(11)-dien12-ol, prekhusenic acid, 13-nor-eudesma-4,6-dien-11-one, isovalencenol, spirovetiva-1(10),7(11)-diene, 2-epi-ziza-6(13)-en-12-al, (E)-isovalencenal, preziza-7(15)-ene, (Z)-eudesma-6,11-dien-3ß-ol, intermedeol, isoeugenol, isokhusenic acid, elemol, eremophila-1(10),6-dien-12-al, juniper camphor, khusimone, eremophila-1(10),4(15)-dien-2a-ol, eremophila-1(10),7(11)-dien-2ß-ol, (Z)-isovalencenal, allo-khusiol, methyl-(E)-eremophila-1(10),7(11)-dien-12-ether, (E)-2-nor-zizaene, (Z)-eudesm-6-en-12-al, funebran-15-al
I don’t know about you, but I can’t figure out how to fit that on to a 2×4 label for a bar of soap. The short list makes sense to the consumer. The long list takes a chemist to decipher. How is that providing any benefit to the consumer at all?
As well, H.R. 5786 has been written with very little understanding of toxicology, chemistry, or testing protocol; demanding that thousands of ingredients be tested in unrealistic time frames, and provides no criteria for either the test or the acceptable results. As well, it would allow states to overrule regulations, so every single state could have different standards, making it impossible for manufacturers to engage in interstate commerce.
Even some of the larger cosmetics companies believe this law is egregiously out of touch with scientific reality. Lezlee Westine, President and CEO of the Personal Care Products Council, which represents the larger cosmetics companies issued a statement where she said: “We are concerned that the Safe Cosmetics Act of 2010 as written is not based on credible and established scientific principles, would put an enormous if not impossible burden on FDA, and would create a mammoth new regulatory structure for cosmetics, parts of which would far exceed that of any other FDA-regulated product category including food or drugs. The measures the bill would mandate are likely unachievable even with the addition of hundreds of additional FDA scientists and millions more in funding and would not make a meaningful contribution to product safety.”
H.R. 5786 is a solution to a problem that doesn’t exist. It will cost billions of dollars. It will devastate any small business making natural products, those supplying natural ingredients, and the farmers that grow the plants they come from. It is bad law, badly written, and with no real plan for implementation. It will put an end to the astounding market growth of artisans, crafters, formulators and organic essential oil farmers. We here at Soapy Hollow throw our voices in with the rest of the chemists, formulators, small manufacturers and mom-based businesses who say that these regulations should not be enacted as written. Furthermore, we believe that future legislation should only be written with the help of toxicologists, chemists and scientists.