You sell a 5-fold orange oil. What exactly does the term "folded oil" mean?

Folded oils are concentrated citrus oils. They offer several benefits. Through distillation, the turpenes are removed, thereby rendering the folded oil safe for use in leave-on products, such as lotions. The concentrated scent offers resistance to oxidation: the fragrance lasts longer and the color is far more intense.

HELP! My SHEA or MANGO BUTTER feels grainy! What happened and how do I make it smooth again?

Shea and mango are very high in unsaponifiable matter. If they are incorrectly heated, upon solidification they will form little fat granules or crystals that feel bumpy to the skin. These bumps will melt down when rubbed into the skin, but they can be annoying and unsatisfactory if added to a formulation that is supposed to be smooth.

To remove the graininess from your shea or mango butters simply heat the butter in a doubleboiler on the stovetop. Gas works best as it keeps a more steady temperature than electric. Heat the butter to 170-185F. This is NOT hot enough to damage the properties of the butters. Keep the temperature steady - between 170-185F - for 10-15 minutes. The steady heat will cause the fat crystals to be obliterated. Rapid cooling may help stop the crystals from reforming. If you find that crystals have reformed upon solidification, go back and repeat these steps, paying close attention to time and temps.

What are "PEG" oils?

PEG stands for polyethylene glycol. PEG is prepared by reacting ethylene oxide, an odorless, tasteless gas, with itself under the influence of a solid catalyst, such as platinum. When a partially saponified oil is reacted with the ethylene oxide, a PEG results, which becomes attached to the fixed oil. As the PEG end is water-loving (hydrophillic), you now have a water-dispersable oil.

With all the confusion over the FDA gudelines for soap, can you help me understand the "rules" a little better?

The FDA has established an exemption for soaps that are predominantly composed of fixed oils saponified with potassium or sodium hydroxide. You must call your product "soap" and make no other claims. Under this exemption, you may add fragrances and other similar ingredients at reasonable levels, to cause the desired effects (scent, texture, etc). The only important exemption for additions is natural oil of wintergreen (which has extensive restrictions, due to the high methyl salicyclate content). Under this scenario, an ingredients list is not required.

If you make cosmetic claims, such as moisturizes skin, defeats cellulite, anti-aging, etc., then you must list the ingredients used and you must be capable of demonstraing your claims. If you add substantial amounts of ingredients such as SLS, DEA, TEA, etc., these items must also be listed on the label. If you make drug claims (ie, cures psoriasis, or other skin conditions) you need only list the "active" ingredient (the item/s that make the action happen) on the label.

The burden of proof of claims made is quite high and would require extensive testing and proof to pass FDA muster.

Please explain exactly what Glyceryl monostearate is, and how it works in lotions.

Glyceryl monostearate (GMS) is a natural emulsifying agent. It is prepared from glycerine and stearic acid. It is oil soluble, but poorly soluble in water. As a consequence it should be added to the oil during use. GMS may also be used with a variety of co-emulsifiers. The most common ones are potassium stearate, alkyl ethoxylates such as laureth 3 and sodium lauryl sulfate. Cold process soap flakes may also be used in a mixture of 2 parts GMS to 1 part soap.

GMS has an HLB value of 3.8 which makes it useful for preparing water in oil emulsions. These emulsions have the water phase surrounded by the oil phase. Water in oil emulsions are desirable because they are similar to the natural conditions in the skin.

Lotion and Cream Preparation

You should experiment since these guidelines are only designed to give you a starting point. The usual ratio of oil/water/emulsifier is around 4/2/1. Often it is possible to reduce the emulsifier to 5 % of the oil content of the lotion. In general higher emulsifier contents result in smaller droplets and stiffer lotions. The high melting oils and waxes make stiffer emulsions, but may have an oily or waxy feel. Usually a mixture will be required to give the desired properties. Make small batches before committing to a large batch.

Prepare the water and oil phases separately. Both phases should be warmed to about 60 to 70 C (140 to 160 F) before combining. Ensure that all of the components are dissolved before preparing the emulsion. Once the oil and water is mixed its too late. The water phase should be added to the stirred oil phase. Use a high shear mixer (stick blender) to combine the phases. Pour the resulting warm emulsion into sterilized bottles or jars before it congeals. Allow to cool undisturbed.

Preservation: Lotions and creams must be preserved against rancidity and microbial and fungal growth. This improves your shelf life and more importantly protects your customer from potential injury. Use .5 to 1 g of rosemary oleoresin antioxidant per kg of oil to prevent rancidity. Use methylparaben to prevent bacteria. An alternative water soluble preservative is potassium sorbate which should be used at .5 to 1.0 g/ Kg of product. The antioxidants and preservatives should be dissolved in the warm oils prior to mixing of the phases.

How do I use menthol crystals?

Menthol crystals should be dissolved in your mixture before use. Crystals will expose people to unsafe levels of menthol. See www.ifraorg.org for more info on menthol use. FDA also has rules on menthol in certain applications. See www.FdA.gov.

Menthol is generally soluble in alcohol and essential oils. Dissolution in these carriers simplifies the safe addition of menthol to products. Menthol crystals also may be melted with oils, but may not be soluble. Melting is generally sufficient for incorporation into lotions and soaps, but is unsafe for oil only products since separation may occur.

How do I choose and use preservatives?

Although preservatives should be effective when dissolved in either the oil or water phase, better results are obtained when the preservative is present in the water phase. The microbes do not live in the oil phase, but consume the water dissolved components of the oil phase and live in the water phase or at the interface between oil and water.  Preservatives are more effective when they are in the same phase as the food is. The water soluble preservatives including potassium sorbate, cosmocil CQ and alcohol are present only in the water phase because they are insoluble in the oil phase. In this case since all of the alcohol is present in the water phase, its concentration will be 14 % in the water phase which is the minimum for preservation. Slightly higher alcohol content would be desirable for insurance though.

Many preservatives are dosed on a percentage of batch weight because of other considerations like irritancy limitations. The water soluble preservatives have higher effective concentrations in the water phase which also increases the level of protection.

The oil soluble preservatives like phenoxyethanol and the parabens must be coaxed into the water phase. Dissolve one part preservative in 2 parts of glycerin or propylene glycol. Disperse into the hot water phase prior to beginning mixing. These preservatives will partition between the oil and water phases during the life of the lotion reducing the concentration in the water phase. These preservatives have a long history of successful use though.

What preservative should I use in my sugar or salt scrub? Should I add a preservative tp my massage oil or lip balm?

Products which contain only oils, glycerin and sugar are self preserving. Moist additives do not carry wnough water to matter.

No water = no life. No antimicrobial preservative is required.

While some manufacturers and people believe scrubs should be preserved, but the preservative in the oil phase in inaccessible to the microbes which are growing in the introduced water.

Rosemary oleoresin and vitamin E are commonly used as antioxidants to extend the life of oils. An antioxidant will increase shelf life by helping slow down the onset of rancidity. ROE is more effective though. Use .1 oz ROE per 100 oz of oil. Use a similar amount of Vitamin E as an antioxidant or use both together. http://www.snowdriftfarm.com/

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The evolution of the MRSA organisms is fueled by the inappropriate use of antimicrobial pesticides. Cosmetics often err in this direction too.

A product must contain substantial amounts of free water to sustain life. Water that is tightly associated with salts or sugars will not support life. The presence of substantial amounts of free water as part of the formula is required to ensure a viable environment for microbes. In these cases a preservative is required. Many options are available from natural products like alcohol and glycerin to compound preservatives like Phenonip and Germaben. While each preservation system has its strengths and weaknesses, all universally rely upon being bioavailable in the water phase at effective levels to ensure protection of the product. This means that all preservatives must be dissolved in the water phase to be effective.

What happens when you dissolve or disperse a preservative into an oil based product such as in a scrub? An oil soluble preservative like Phenoxyethanol or parabens will only partially partition into the water phase from the oil phase even if the water is mixed in using a high shear mixer. The majority of the preservative stays in the oil phase. Now we are left with a water phase which contains sub lethal amounts of the preservative. Microbes can flourish in this environment which allows them low level contact with the toxic compounds. This sub lethal contact allows organisms to develop defenses against these preservatives. Adding preservatives to oil based scrubs guarantees the creation of this environment, not protection against microbes from introduced water. Preservative resistant organisms can eventually develop in this environment.

A commonly discussed alternative to dissolving the preservatives in the oil phase is to coat the salt or sugar with a preservative / glycerin mixture. This approach may keep the preservative in the correct phase for water solubility, but thorough mixing would be required to ensure the glycerin / preservative completely mixed into the water to ensure effective dosages. How much preservative do you need to add to ensure an effective concentration in introduced water? There is no real answer, but it would probably be higher than generally accepted use rates because of phase transfer issues.

Dunking your hands into the jar will not mix the water with the oil or the salt / sugar. sufficiently well to transfer effective amounts of preservative to the water phase. Small amounts of water which absorbs into the salt or sugar will not support life, but a large puddle of water left on top of the scrub in the jar will support life. Consumers do have to take some responsibility. Oil phase preservatives will not prevent microbes from growing in this introduced water. Fortunately consumers who allow puddles of water to form soon find the scrub converted to an unusable brick rendering microbial issues moot.

Tottles rather than jars as packaging will provide both greater safety and longer shelf lives. Consider single use packaging also.

Occasionally recipes will appear where you are directed to dissolve the preservative in the oil phase. This may have been done for convenience with oil soluble preservatives; however the preservative will often not be bioavailable in the water phase where it is needed. Modify these recipes by combining the preservative with glycerin or a dissolving aid like Polysorbate 20 or Cremophor CO40 http://www.snowdriftfarm.com/

cremophor.html and adding it to the water phase. This will ensure that the preservative is effective. Proceed with the formula as instructed once the preservative has dissolved.

Preservatives should always be used correctly and only when absolutely required. Improper use is a waste of material with potential unacceptable unintended consequences. Antimicrobial preservatives are never needed for scrubs, salves , body butters and other exclusively oil based products.

My lotion has separated. Why?

There are two common causes for separation. The most common is improper mixing. A whisk or a stand mixer will not break the oil droplets small enough to ensure that they will not recombine. A table top or stick blender is needed.

How do I measure small amounts of ingredients when I am making small batches?

The method of measurement depends upon the type of ingredient. Liquid ingredients are easiest since they can be measured by volume, but many recipes are measured by weight. .

I added fresh fruit or aloe gel and other natural ingredients to my lotion and it became moldy.

This post illustrates an important aspect of proper preservation. Pureed fruits and food derived items like blueberry seeds are very difficult to preserve because they are foods. They will mold quickly regardless of the type of preservative that is added. Fresh fruits are never sterile and this microbial load will often overwhelm any preservative.

Preservatives are designed to prevent the growth of microbes that are introduced during use, but they can not cope with an overload from a contaminated ingredient.  This is especially important with Cosmocil CQ because it is a bit slower against mold than parabens. Fresh fruit and veggies are often contaminated with mold spores because this is the natural decay mechanism.  Outer surfaces of fresh plant material should be washed, dipped in bleach water and rinsed prior to processing to minimize surface contamination, the usual source of problems. A hard freeze of the recovered material also helps.

Adding greater than 10% glycerin or propylene glycol may work, but there are no guarantees.  A better alternative is to create sealed single use packings and preserve them using standard canning methods. However high acid products are difficult to preserve and may have problems with botulism. See the example of tomatoes.

More preservative may also help, but also a more robust choice against mold like parabens would be appropriate. Some applications may use up to 1.5% Cosmocil CQ. It is also alleged that the addition of K sorbate will help boost activity against yeast and mold. The basic problem with this is that ARCH states that Cosmocil CQ is incompatible with the class of compounds that K sorbate is in. However ARCH has suggested its use verbally, but I can find no written documentation of effectiveness from ARCH.

Although FDA considers 10% alcohol or glycerine to be effective, I have seen wines ferment to above 10% alcohol. I believe that 15% is far safer for this type of preservation. If you use enough alcohol, glycerine or propylene glycol, you should not need any other preservative.

Potassium sorbate (K Sorbate) is a naturally occurring fatty acid with anti-microbial and anti-fungal properties. It is found in the mountain laurel ash (sorbus species) whose dried berries were used as a traditional food preservative. It is commonly available as a synthesized product.

FDA regards K sorbate as GRAS (generally regarded as safe). K Sorbate is water soluble and can be used effectively in both lotions and water-based liquid soap and shampoo formulations. Although the minimum inhibatory concentration for many fungi and bacteria is approx. 100 ppm, common usage levels range from 0.5 - 1.0%.

Dissolve K sorbate in your water phase at the beginning, to ensure proper dispersion of the product.

What's the difference between Vitamin E, grapefruit seed extract (GSE) and rosemary extract or oleoresin? Are they all preservatives?

There are significant differences between GSE, Vit. E and Rosemary Extract (ROE).

The differences between Vit. E and ROE occur in two major areas. Since oxidation leading to rancidity occurs only on the hydrophobic (oil soluble) portion of the molecule, the antioxidant must be in the physical area of the oil molecule's double bonds to be effective. The reaction must be prevented at these sites. A water soluble antioxidant will not be physically mobile enough in the oil domain of the molecule to participate in the reaction. Therefore, oxidation will proceed unimpeded. However, oil soluble antioxidants will be physically present in the right locations.

The principal active ingredients in GSE are water soluble bioflavanoids. These compounds do have antioxidant properties, BUT these compounds are not available to the oil of the soap molecule, where they are needed. Instead, they reside in the residual water or near the hydrophillic (saponified) end.

A similar situation occurs with Vitamin E. Vit. E is usually supplied as the oil soluble tocopherol acetate. During saponification, the acetate group is removed by the same reaction which makes soap from triglycerides. The tocopherol is now water soluble and not available where it is needed.

Vitamin E acetate may be used as an effective preservative in non-saponified products. It is not as stable as the compounds in Rosemary oleoresin. Rosemary oleoresin is oil soluble. The antioxidants in it do not react with sodium hydroxide. They retain their antioxidant qualities and are available in the oil molecules where they are needed.

The effectiveness of ROE and Vitamin E acetate were measured using a Rancimet assay in various oils. They appear to have similar initial activity, although the results can not be directly compared due to the use of different concentrations. Both appear to be as effective as butylated hydroxytoluene (BHT). GSE was not tested.

How much antioxidant should I use?

Antioxidants are usually effective at levels of about 200 mg to 1000 mg per kg of product. This translates roughly to .2-1 gram per kilogram. (Trina's note: a standard teaspoon measure should be more than sufficient per 10 pounds of oils.) Antioxidants may be used together. The mobile compounds in ROE may act as a transfer agent, increasing its effectiveness when used in tandem with water soluble antioxidants.

How are antioxidants made?

GSE is made from the dried, ground seeds and pulp of the grapefruit. The pectin and fiber are removed using distilled water and the mixture is spray dried. This concentrate is dissolved in glycerin. Ammonium chloride and citric acid are added to break the glucosides down and release the bioflavinoids. The mixture is then heated under pressure to complete the reaction. The bioflavinoids are converted to water soluble quaternary compounds during this reaction. Vitamin E is available from a wide variety of sources, both natural and synthetic. It has strict USP and FCC standards. Most GSE available on the market today contains significant amounts of active preservatives, such as triclosan. It is not the GSE that is working, rather the active preservative. There are no studies that conclude that GSE is an effective anti-bacterial or preservative.

Rosemary extract or oleoresin (ROE) is prepared by extraction and the removal of the extractant. The standards for ROE are listed in the FCC (food chemical codex) Snowdrift Farm's ROE has a faintly herbal odor. It is FCC antioxidant grade with no volatile oils.

Can you explain who can buy and sell specially denatured alcohol, such as you sell? Who can ship it and are there any restrictions?

The Alcohol, Tobacco and Firearms rules concerning the use of alcohol in cosmetics are reasonable, and fairly easy to understand. The FDA also has rules about the use of alcohol. The FDA rule is straightforward: Bitrex must be added to prevent ingestion and accidental poisoning. There are no exceptions.

The first ATF rule is that beverage alcohol MAY NOT BE USED in cosmetics. Technically, they consider you to be selling beverage alcohol without a license, and proper reporting and payment of taxes. Specially denatured alcohol (SDA) must be used. Only certain formulas may be used. Some denatured alcohol formulas contain toxic denaturants that are unsuitable for skin contact. These forbidden formulas include the paint and lacquer thinners available from the hardware store. Formulas legal for use in cosmetics may be directly distributed only to permitted users.

Many of the legal formulas contain undesirable denaturants such as phthalates and coumarins. A few are good choices because of the easily metabolized denaturants. Some formulas actually use essential oils as denaturants, but this can restrict your fragrance choices. SDA 40 B is one of the better choices because it is denatured with other alcohols and Bitrex.

Once you have chosen the SDA alcohol you need, you must legally obtain it in order to use it in your formulation. Sellers of SDA alcohol must possess an ATF permit to sell such material. They are only allowed to sell SDA alcohol to a permitted user. A permitted user is someone or an organization (such as Snowdrift Farm) that registers with ATF and pays the $250 annual tax. NOTE: Only users and sellers of SDA alcohol are required to pay the $250 per year tax. Pres. Bush recently waived the tax for all distillers, brewers, warehousers, sellers and importers of beverage alcohols.

The 5 gallon "sample exemption" allows potential users to develop a formula without paying taxes. Their materials may not be sold until they obtain a permit (pay taxes).

Obtaining a permit from ATF simply allows you to obtain SD alcohol. It does not allow you to sell products made from it. ATF MUST APPROVE YOUR FORMULA before you can begin selling. You must submit your formula and possibly samples to the ATF national laboratory for examination. An ATF agent will approve/reject your formula.

Once your formula is approved, it may be sold WITHOUT RESTRICTION to unlicensed individuals who may use it as they desire. No one may attempt to convert it to beverage alcohol.

There are a few exemptions to the formula pre-approval rule. The two most notable are 1) mixtures which contain greater than 30% essential oils and 2) low alcohol content products. Low alcohol content is defined as less than 7% alcohol.

Snowdrift Farm submitted our formulas for Artisan's, Perfumer's and Formulator's alcohols to the ATF for approval. These formulas have been approved for distribution to unlicensed users. Purchasers of these approved products may use or modify them in any manner and sell their resultant products without restriction. Snowdrift Farm's Artisan's, Perfumer's and Formulator's alcohol blends allow users to create perfumes and colognes without needing ATF permits, prior approvals or paying taxes.

Shipping: Two organizations govern shipping of dangerous goods (i.e., alcohol). The Dept. of Transportation (DOT) has created rules for shipping dangerous goods by ground transport. The International Air Transport Association (IATA) has rules for shipping dangerous goods by air. The IATA rules are FAR more stringent than the DOT ground shipping rules, for obvious reasons.

SDA alcohol is defined as a dangerous good because of its flammability. Bulk shipments of SDA alcohols or products containing SDA alcohols must conform to the shipping rules. These rules include selection of the proper container, proper labeling of the container and any packaging, and the preparation of shipping documents. Additionally, training is required for all shippers. We do not recommend that individuals undertake bulk shipping.

For the producers of consumer products, exemptions from these rules exist. DOT allows an exemption from the labeling and documentation requirements for consumer commodities. IATA, however, DOES NOT. Consumer commodities are defined as products which are packaged and designed for direct use by consumers, (i.e. - a bottle of perfume. Finished toiletries are generally defined as consumer commodities). Ground shipments of consumer commodities offer the path of least resistance.

Both DOT and IATA rules provide limits on the size and construction of the inner containers as well as the gross amount of product per package. Air Parcel, Express and Priority Mail are air shipments. USPS forbids shipment of alcohol via these services. Parcel Post may be used, but there are limits on the percentage of alcohol that may be shipped using this method. Refer to www.usps.com for more details. Additionally, your outer boxes must be labeled "ORMD" and "inner packings comply with prescribed requirements".

UPS ground service is the simplest option for the shipment of consumer commodities. Even they have some restrictions, though. 1) UPS will not accept consumer commodities at UPS Stores or drop-off locations 2) you must have a UPS account and pick-up service 3) UPS will also accept consumer commodities for air shipments if you label and document the shipments correctly. Expensive third party software is required for documentation of all UPS air shipments plus a $35 fee applies to EACH shipment. Obviously, ground shipping makes the most sense.

UPS ground shipments do have several requirements, though. 1) All packages must weigh less than 20 pounds if packed in EC32 boxes (the most common type of box -- a single wall box); 2) a label bearing the notation "ORMD" and the statement "inner packings comply with prescribed requirements" must be affixed to the outside of the box; 3) the inner packages must be tightly sealed and properly cushioned to prevent breakage and spillage. All lids must be sealed to prevent opening during transit. Tape or tamper-evident seals are required. Secondary containment, such as over-bagging, is also desirable.

Glass, metal or plastic containers may be used. Glass containers may hold no more than 500 mL. Metal or plastic containers may hold up to one liter. NOTE: These are ground restrictions. Air shipments may require smaller containers.

I want to make flea, tick of mosquito repellants.

Actually FDA will never have anything to do with human and pet products like tick, flea or mosquito sprays and repellants. EPA regulates those under FIFRA (Federal Insecticide, fungicide & rodenticide act). If you do not use minimum risk active ingredients and inerts, you must apply for registration of your pesticide. .pesticide registration is very expensive since you need to demonstrate acceptable environmental risks http://www.epa.gov/oppbppd1/

biopesticides/regtools/25b_list.htm contains more information on minimum risk pesticides and what is allowed.

Since flea sprays are pesticides, they must be labeled according to the FIFRA rules rather than cosmetic rule. Active ingredients must be declared separately from the inert carrier ingredients.  Some ingredients that are commonly known to have activity may appear on the inert list only and not as an active. You may use the material in your formula, but you may not claim their activity on the label. For example, edible triglyceride oils appear as exempt ingredients in the law http://ecfr.gpoaccess.gov/cgi/t/

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&idno=40 . This will allow you to use almost any oil as part of your product, but you can not claim activity from the oil. These categorical exemptions are very helpful because they allow the use of many common body care ingredients since they are also used in foods.

Flavor and fragrance materials are excluded from edible oils, and thus appear to be not allowed, but edible essential oils appear to be allowed under the food category as readily available food additives. The laws on inerts are fuzzy, but the actives list is very strict. Several people have problems with EPA for selling products containing non listed actives like lemon eucalyptus. Note that the FIFRA restrictions only apply to commercial products. But misuse of pesticide products can put you at risk.

I want to add sun screening agents to my product. Or l want to make sunscreens. How do I get an SPF reading?

The real problem with hand crafters producing sunscreens for resale is the FDA rules regarding sunscreens. Sunscreens have always been considered over the counter (OTC) drugs by the FDA, but recently the requirements became much stricter. OTC classification places a new set of requirements upon facilities that produce these products over cosmetic production facilities. The first difference is in the labeling which is a problem that is easily solved. But the other issues are not easily solved.

All sunscreen products must be lab tested to document the SPF factor and may only contain FDA authorized sunscreen agents. No butters or other hokey extracts are acceptable to the FDA.

Premade SPF lotions may not be modified by the repacker. The first issue is that the lotion must be sold as tested. It cannot be modified even with fragrance. Some essential oils can cause photo sensitization and this would alter the SPF radically. You would need to determine the SPF factor of your modified lotion. But an even bigger hurdle is the requirement that all processing operations take place in an FDA registered facility which meets the requirements for pharmaceutical processing. Then there is the Good Manufacturing Practices (GMP) system and it associated documentation which needs to be there before any sunscreen may be processed.

Sunscreen production carries a large burden because people’s health is involved and serious injury can occur from an inadequate sunscreen. Snowdrift Farm does not sell sunscreen agents.

I am looking for a natural emulsifier other than borax / beeswax.

Several alternatives exist but each has some advantages and disadvantages. lecithin can be used, but because it is a food ingredient, It can be unstable and difficult to work with.

Another alternative is the mixture of glycerol monostearate with soap which is also known as GMS self emulsifying..