IFRA Position Statement on Diethyl Phthalate (DEP)
The Fragrance Industry reaffirms its support of the use of DEP in fragrances as safe for the consumer and the environment.Recent misleading reports on the use of phthalates as fragrance ingredients have raised questions regarding their safety in consumer products. Not all phthalates have safety concerns. Diethyl phthalate (DEP), as used in fragrances, is safe for human health and the environment. The fragrance industry would like to make clear that consumers can use fragranced products containing DEP with confidence.
"Phthalates" is a broad term that refers to a wide variety of compounds of differing chemical structure. General, undifferentiating statements about "phthalate toxicity" have created confusion about potential safety concerns that are in fact only associated with specific materials within this group. Safety concerns have been raised most recently about Dibutyl Phthalate (DBP) and Diethyl Hexyl Phthalate (DEHP). However, neither DBP nor DEHP is permitted for use in cosmetic products in Europe. On a global basis they have never been important as fragrance ingredients and today their use in fragrances is virtually nil.
As in so many other examples, broad generalizations of hazard or risk can be misleading and lead to unfounded public concern. For example, nobody would consider all berries or mushrooms to be unsafe, though specific types have a known toxicity at certain levels.
DEP, which continues to be used in fragrance applications, does not have the safety concerns raised for DBP or DEHP. DEP was recently re-examined by authorities and expert scientific groups both in the U.S. and Europe. The European Commission’s Scientific Committee on Consumer Products (1), as well as the U.S. Cosmetic Ingredient Review (CIR) Expert Panel (2) have reaffirmed that DEP is safe for use in cosmetic products. Moreover, DEP is present in consumer products at extremely low levels.
While some reports continue to raise questions about "phthalates" in general, it is important to define the specific chemicals of concern, as well as the scientific legitimacy of the associated data. The scientific validity of some highlighted results remains very much in question. For example, recent studies reporting the potential association of "phthalates" with male reproductive biomarkers are inconsistent (3)(4). Moreover, since DEP does not demonstrate a potential for adverse reproductive effects, it is inaccurate to imply that there are concerns similar to those of other phthalates, such as DBP or DEHP. DEP presents no safety concern from use in fragrances (5).
The safety of fragrance ingredients is a top priority for the industry. New scientific data is constantly evaluated to ensure that the highest standards are applied to the creation of fragrance. The Research Institute for Fragrance Materials (RIFM, http://www.rifm.org ) provides ongoing evaluation of all new materials with an independent assessment made by RIFM’s Expert Panel (REXPAN). REXPAN is composed of internationally renowned scientific experts who are independent from the fragrance industry.
The International Fragrance Association (IFRA, http://www.ifraorg.org ) continues to set strict self-imposed safety standards for the use of fragrance ingredients, as advised by RIFM. IFRA Member companies, which include all major suppliers of fragrance, must adhere to the IFRA Code of Practice and agree to product fragrances to meet these high standards of safety.
1 Scientific Committee on Cosmetics & Non-Food Products SCCNFP/0411/01, 2002
2 Cosmetic Ingredient Review (CIR), 2004, Annual Review of Cosmetic Ingredient Safety Assessment – 2002/2003, p 37-47, Washington DC: CIR
3 Swan et al., (2005) Environ. Health Perspectives, doi 10.1289/ehp 8100
4 Jonsson et al., 2005, Epidemiology 16(4); 487-93
5 Api A.M. (2001) Food Chem. Toxicol. 39:97-108
6 D.R. Bickers et al., The safety assessment of fragrance materials, (2003) Regulatory Toxicology and Pharmacology 37:218-273
Questions & Answers about Phthalates Source: American Chemistry Council
https://phthalates.americanchemistry.com/FAQs
The U.S. phthalates industry, represented by the Phthalate Esters Panel of the American Chemistry Council (ACC), is dedicated to the continued safe use of phthalates, a family of compounds primarily used to soften vinyl. Phthalates provide many product and consumer benefits (public health, performance, durability and function) and are used in many important applications for these reasons, from recreational and safety equipment to building and construction materials. With more than 50 years of use, phthalates are among the most thoroughly studied families of compounds in the world and have been reviewed by multiple regulatory bodies in the United States and Europe.
Q. What are phthalates?
Phthalates are a family of compounds whose primary use is as a vinyl softener. They are colorless, oily liquids with little or no odor and low volatility. Phthalates provide many product and consumer benefits - public health, performance, durability and function—and are used in many important applications for these reasons, from recreational and safety equipment to building and construction materials.
Q. What are phthalates used for?
Phthalates are primarily used as plasticizers to make vinyl soft and flexible, without sacrificing durability. Flexible vinyl is used for many consumer products, from recreation equipment to flooring to medical devices. For example, phthalates are an important ingredient in vinyl blood bags and IV tubing used to help save lives. Other phthalates are used in cosmetics and personal care products to prevent nail polish from chipping or to make fragrances last long.
Q. What is known about the safety of phthalates?
Phthalates are one of the most thoroughly tested families of compounds in use today and have been extensively reviewed by multiple regulatory agencies in the United States and abroad. An immense amount of information on the safety profiles of various phthalates is available to the public - click here.
Q. Why have phthalates been banned from personal care products in Europe?
This ban is not due to the finding of any human health effects. The European Cosmetics Directive states that any substance known or strongly suspected to have certain health effects in laboratory animals—even if this occurs only at extremely high doses—is assumed to present similar risks to humans, and may not be used in cosmetics. The directive is not based on any evidence that there is actual risk to humans. In fact, an European Union (EU) safety review stated that there is "no concern for consumers" who use nail polish containing the phthalate DBP.
Q. Why did the EU restrict the use of phthalates in toys?
The European legislature voted to pass the restriction, even though the draft conclusion of an exhaustive safety review of the principal phthalate used in toys stated it was "unlikely to pose a risk" even for newborns. In other words, the decision to restrict phthalates was political and not based on the science.
Q. Are phthalates restricted in the United States?
In August 2008, President Bush signed into law the Consumer Product Safety Improvement Act (CPSIA), which included provisions to restrict six phthalates in toys and children’s products. Of the six phthalates restricted by the CPSIA, three were put under interim restrictions until a final rule is issued based on a scientific review by a Chronic Hazard Advisory Panel (CHAP) convened by the Consumer Product Safety Commission (CPSC). A previous CHAP review found in 2002 that the principal phthalate used in toys presented "no demonstrated health risk" to children.
Q. Shouldn’t the effects of phthalates be studied as a whole, because various phthalates can act in the same ways on organisms?
Even if you add up the effects of the different phthalates that might be expected to act in the same way on organisms, data from the U.S. CDC tells us that exposure is still below federal safety levels.
Q. We are exposed to phthalates every day, in many ways. Doesn’t that add up to trouble?
We are exposed to many things every day. But phthalates do not build up in the body. Phthalates begin to break down within minutes and are quickly metabolized.
Q. Isn’t it true that phthalates cause health problems in laboratory animals?
Some—not all—phthalates interfere with the development of the reproductive systems of male rodents when administered in huge doses—doses far larger than CDC data reports of humans experiencing. Rodent effects are not necessarily relevant to humans.
Q. Is there any evidence that phthalates don’t affect humans?
Tests on male marmosets, which are primates, concluded that even huge doses administered from weaning until sexual maturity had no effect on their reproductive organs. Other studies indicated that humans do not absorb phthalates as readily as rodents do. Humans break them down and excrete them much more readily than rodents do. This evidence suggests that rodent effects may not apply to humans.
Q. Haven’t phthalates been linked to human sexual development?
A few studies have attempted to link phthalates to human reproductive effects. But, these studies often have severe limitations and flaws in the study designs, such as small sample sizes, uncontrolled variables or poor statistical methodology. Therefore, conclusions they draw regarding human health effects are often inconsistent from study to study or contradict the animal data. None of these studies established a causal link between phthalates exposure and reproductive health effects. Furthermore, the National Institutes of Health, through its National Toxicology Program, reviewed multiple studies claiming to show human effects and, in late 2006, called them "insufficient" to warrant drawing any conclusions.
Q. Does that include the "Swan" study?
The "Swan" study, which garnered much media attention, was conducted by Dr. Shana Swan, but failed to establish a causal link between changes in the reproductive development of infants and exposure of their mothers to a combination of four phthalates. Dr. Rebecca Goldin, a mathematician at Statistical Assessment Services (STATS), questioned the credibility of this study: "How much data fiddling was required to find a result?" Others have criticized the study’s methodology, its clinical data, and even its biological plausibility.
Q. Aren’t phthalates endocrine disruptors?
In lab tests with rodents, phthalates do not block the action of male or female hormones, or mimic their behavior.
Q. Do phthalates cause cancer?
Phthalates are not a known carcinogen. The International Agency for Research on Cancer (IARC), an arm of the World Health Organization, stated that one phthalate ester in particular—DEHP—is "not classifiable" as a human carcinogen. The basis for that decision is ample evidence that the biological process leading to cancer in rodents does not occur in humans. The IARC has also looked into BBP and found available studies "inadequate to evaluate the carcinogenicity of butyl benzyl phthalate to mice and rats." In 1982, the National Toxicology Program (NTP), which classifies substances according to their tendency to be cancer causing in animals, placed DEHP in its second category, as a compound "reasonably anticipated" to be carcinogenic to humans. (The top category is "known carcinogen.") However, extensive research over the years has questioned this assumption. In an opinion presented by the EU Scientific Committee for Health and Environmental Risks in October 2008, the Committee stated that at the DEHP doses observed in humans, DEHP exposure did not represent a relevant cancer risk to humans.
Q. Haven’t phthalates been linked to asthma?
Some claims to that effect have been made, but laboratory studies have shown that phthalates do not trigger immune responses in rodents, and do not intensify existing asthma attacks. Tests for phthalates presence in house dust have been shown to be very low.
Q: Is there any scientific evidence linking phthalates to autism? <br/ >A: No. There are no studies that have demonstrated a causal link between phthalates and autism. One study by Swedish and U.S. researchers looked at the association between indoor environmental factors and autism and found the results "far from conclusive." Contrary to some news reports connecting phthalates to the disorder, the study did not track, measure or record any exposure to phthalates. The authors cautioned their conclusions were "puzzling, even baffling, and not readily explicable at this time" and that "further and more extensive exploration" is needed.
