Dimethyl Phthalate, Diethyl Phthalate and Dibutyl Phthalate

What Is It?

Phthalates are a diverse group of materials that make plastics more flexible and are used in a wide variety of products, such as toys, vinyl flooring and wall covering, detergents, lubricating oils, food packaging, pharmaceuticals, blood bags and tubing, and some cosmetic and personal care products.  Because phthalates are widely used in many consumer products, their safety has been extensively researched and reviewed. Phthalates make up a diverse family of substances each with its own, unique spectrum of properties.  The safety profiles of different phthalates are not all the same, with some possessing undesirable properties while others do not (much in the same way, mushrooms as a family includes both edible nutritious mushrooms and poisonous toadstools). In the same way, it is quite wrong to consider all phthalates as the same: they are not.

Why is it used in cosmetics and personal care products?

Historically, the phthalates used in cosmetic products have been dibutyl phthalate (DBP), used as a plasticizer in products such as nail polishes to reduce cracking by making them less brittle; dimethyl phthalate (DMP), used in hair sprays to help avoid stiffness by allowing them to form a flexible film on the hair; and diethyl phthalate (DEP), used as a solvent and fixative in fragrances. DEP can also function as an alcohol denaturant , rendering alcoholic products unfit for oral consumption.  DBP and DMP have been discontinued in cosmetics and personal care products by manufacturers; and according to The Food and Drug Administration’s (FDA) analytical survey of cosmetic products, conducted in 2010, DBP and DMP were only rarely detected.  DEP is the only phthalate still periodically used in cosmetics, and its use is very limited; in fact, many personal care product manufacturers are discontinuing its use as an ingredient. Other phthalates, such as Di(2-ethylhexyl) phthalate (DEHP), have no history of use in cosmetics and personal care products.

Scientific Facts:

Dimethyl Phthalate, Diethyl Phthalate and Dibutyl Phthalate are prepared by reacting phthalic acid with methyl alcohol, ethyl alcohol and butyl alcohol, respectively. These ingredients should not be confused with Di(2-ethylhexyl) phthalate (DEHP), a compound not used in cosmetics and personal care products.

Safety Information:

The safety of DMP, DEP and DBP has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. In 1985, the CIR Expert Panel evaluated the scientific data and concluded that these phthalates were safe for use in cosmetics and personal care products. In 2002 and 2005, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on these three ingredients and ultimately reaffirmed their safety. The only phthalate which still has some usage in cosmetic and personal care products is diethyl phthalate (DEP).  The safety of DEP is well supported among the scientific community.  Recognized scientific experts and governmental agencies have concluded repeatedly that DEP is safe for use in cosmetics and personal care products as currently used. DEP has been reviewed by the CIR Expert Panel and the European Commission’s independent scientific expert committee (the Scientific Committee on Consumer Safety, SCCS, formerly known as the SCCNFP). Both scientific groups have positively affirmed the safe use of DEP in cosmetic products without restriction. In addition to confirming the safety of DEP, the SCCS also reviewed the safety of other phthalates that might be present in trace amounts in products due to their use in product packaging.  This included those phthalates that are banned as ingredients in cosmetic products in the European Union.  The EU’s expert scientific committee concluded that, in view of the high Margins of Safety (MoS) determined for the other phthalates,  traces of up to 100 ppm total or per substance do not pose a risk to consumers’ health.To see reviews from CIR and SCCNFP of DEP and trace levels of phthalates in cosmetic products visit:

 A few, but by no means all phthalates have been found to be harmful to reproduction when tested at high doses in laboratory rodents.  It must be emphasized that DEP and DMP have no harmful reproductive effects.  The CIR Expert Panel considered the issue of DBP reproductive toxicity in their review.  The Panel estimated historical exposure to DBP from cosmetic and personal care products and found it to be far below levels that did not cause reproductive and developmental effects in animals.  Therefore, the CIR Expert Panel reaffirmed their original conclusion that DBP is safe as used in cosmetic products.

More safety Information:

The U.S. Food and Drug Administration(FDA) has stated that, at the present time, it does not have evidence that phthalates as used in cosmetics pose a safety risk.  FDA noted that an expert panel convened from 1998 to 2000 by the National Toxicology Program (NTP), headquartered at the National Institute of Environmental Health Sciences (NIEHS), concluded that reproductive risks from exposure to phthalates from all sources were minimal to negligible in most cases.

FDA has reviewed all of the available safety and toxicity data for phthalates, including biomonitoring data from the Centers for Disease Control (CDC) measuring levels in human urine, as well as the CIR conclusions based on reviews in 1985 and 2002. None of the data reviewed by FDA established an association between the use of phthalates in cosmetic products and a health risk. Based on this information, FDA determined that there wasn’t a sound, scientific basis to support taking regulatory action against cosmetics containing phthalates.

FDA’s factsheet on Phthalates  

FDA includes Dimethyl Phthalate (DMP), Diethyl Phthalate (DEP) and Dibutyl phthalate (DBP) on its list of indirect food additives. For example, all three ingredients may be used in adhesives that contact food, DEP and DBP may be used in food contact polymers, and DBP may be used as a slimicide in paper and paperboard used for food packaging.

DMP and DEP may  be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European Union . DBP is not permitted for use in cosmetics and personal care products in the European Union (see Annex II).

DBP was banned in Europe because all substances classified as carcinogenic, mutagenic or toxic to reproduction (categories 1 and 2) under EU chemical hazard classification legislation are automatically banned from use in cosmetics and personal care products, regardless of use concentration. The low exposure to DBP in cosmetics and personal care products was not considered when this ban went into effect.  As mentioned earlier, the CIR Expert Panel estimated that exposure to DBP from using cosmetic and personal care products would be well below the dose that did not cause any reproductive and developmental effects in animals. Therefore, the CIR Expert Panel did not see the need to change their original conclusion that DBP was safe as used in cosmetic products.

Similar, when considering exposure European experts, (SCCNFP) agree with CIR and concluded in their 2002 opinion that “the safety profile of diethyl phthalate supports its use in cosmetic products at current levels.” This opinion was confirmed in a second opinion in 2004.

Learn more about EU Cosmetic Regulation

Learn more about SCCNFP’s 2004 opinion on Dibutyl phthalate

 

It’s a myth that phthalates are ‘hidden’ in fragrances

Fragrances are usually composed of numerous individual substances that are blended together to achieve the desired scent. If a cosmetic product contains a fragrance, this is labelled using the word ‘fragrance’ or ‘parfum’ in the ingredients list rather than having to list out all of the individual components. This is legally allowed by the strict cosmetic safety laws and is common practice around the world.

It is, however, not a way of ‘hiding’ ingredients as is sometimes, wrongly, claimed. All of the ingredients that make up the fragrance are still assessed very carefully as part of the overall product safety assessment.  DEP and DMP may legally and safely be used as part of the fragrance mix.  No substances banned from use as cosmetic ingredients are allowed to be used as components of cosmetic fragrances.

 

Can phthalates be used in personal care products intended for use by children?

Phthalate ingredients can be used in personal care products intended for use by children – e.g., in lotions, shampoos, etc.  Like personal care products intended for use by adults, the only phthalate that is sometimes present in personal care products intended for children and infants is DEP.  The safety of DEP is well accepted among the scientific community.  To date, all scientific reviews around the world by key scientific experts and governmental agencies have concluded that DEP is safe for use in cosmetics and personal care products under the current conditions of use. DEP has been reviewed by the U.S. Cosmetic Ingredient Review (CIR) Expert Panel and the European Commission’s independent scientific expert committee (the Scientific Committee on Consumer Safety, SCCS and formerly known as the SCCNFP). Both expert scientific groups have approved the safe use of DEP in cosmetic products and have not deemed it necessary to impose any specific warnings or restrictions for its use.