Search FDA.gov Check the FDA Archive Contact FDA. In 2007, the EU found them safe. Can phthalates be used in personal care products intended for use by children? We’re sorry. Search to the right to find information on the ingredient you are looking for >>>. Low-molecular-weight phthalates (e.g., diethyl phthalate (DEP) and dibutyl phthalate (DBP)) can be used in personal care products (e.g., perfumes, lotions, cosmetics, and nail polish), as solvents and additives, and in making lacquers, varnishes, and timed-release coatings for some medications (see Table 5). 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. Recognized scientific experts and governmental agencies have concluded repeatedly that DEP is safe for use in cosmetics and personal care products as currently used. The low exposure to DBP in cosmetics and personal care products was not considered when this ban went into effect. None of the data reviewed by FDA established an association between the use of phthalates in cosmetic products and a health risk. Cosmeticsinfo.org, The Science & Safety Behind Your Favorite Products. Phthalates are also employed as … The safety of DEP is well supported among the scientific community. Health All Health allergens/irritants cancer developmental & reproductive toxicity endocrine … 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. 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. Before sharing sensitive information, make sure you're on a federal government site. All of the ingredients that make up the fragrance are still assessed very carefully as part of the overall product safety assessment. Therefore, the CIR Expert Panel reaffirmed their original conclusion that DBP is safe as used in cosmetic products. 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. The link to this page may not be correct or is out-of-date. Phthalates (THAL-ates) are chemicals that make plastic soft and flexible. The CIR Expert Panel considered the issue of DBP reproductive toxicity in their review. Several studies -- both in animals and humans -- … The only phthalate which still has some usage in cosmetic and personal care products is diethyl phthalate (DEP). The page you are looking for is not available for one of the following reasons. This study aims at determining phthalate levels in cosmetic and personal care products obtained from the Canadian market. 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 2009, a study published in Critical Reviews in Toxicology found that BPA poses no risk from to humans. Phthalates with small R and R' groups are used as solvents in perfumes and pesticides. The safety of DEP is well accepted among the scientific community. DEP and DMP may legally and safely be used as part of the fragrance mix. 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. However, no category of consumer products is subject to less government oversight than cosmetics and other personal care products. Chances are, you have phthalates to thank for how pliable they are. Chemicals and contaminants linked to cancer can be found in food, water and many other everyday products. They're also used as solvents in household products: 1. self-care products, such as: 1.1. cosmetics 1.2. non-prescription drugs 1.3. natural health products 2. construction and renovation products, such as: 2.1. building materials 2.2. lubricants and greases 2.3. paints and coatings 2.4. adhesives and sealants 3. fabrics and textiles 4. electrical items and electronics 5. children's toys and child care articles Phthalates may also … Phthalates are often called plasticizers and can be found not only in personal care products to help them maintain a gel-like consistency but also in garden hoses, inflatable toys and medical tubing. These ingredients should not be confused with Di(2-ethylhexyl) phthalate (DEHP), a compound not used in cosmetics and personal care products. The CIR also reported that DBP, DMP, DEP (common phthalates found in cosmetics) were safe for cosmetic use. 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. Phthalates are also known to be hormone-mimicking chemicals, many of which disrupt normal hormonal processes, raising concern about their implications for increased breast cancer risk. They are in … Happily, several types of phthalates are now banned from children's toys, teethers, bottles, and feeding products. Phthalates make up a diverse family of substances each with its own, unique spectrum of properties. Phthalates are chemical compounds that are commonly added to plastics to increase their flexibility, transparency, durability and longevity. 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. Think about your raincoat or your shower curtain. Phthalates in cosmetics and personal care products. 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. Bisphenol A (BPA) is sometimes confused with phthalates, but is a completely unrelated substance. to phthalates during the use of many personal care products containing phthalates, such as hair products, cosmetics, and lotions. It is, however, not a way of ‘hiding’ ingredients as is sometimes, wrongly, claimed. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Phthalates are one of the most commonly used plasticizers in the world and are categorized as “high” or “low,” depending on molecular weight. FDA includes Dimethyl Phthalate (DMP), Diethyl Phthalate (DEP) and Dibutyl phthalate (DBP) on its list of indirect food additives. 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. 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 . Consumer goods manufacturers add them to hard plastics to make those plastics soft and flexible. 37 Setting safety standards for phthalates individually or for individual products without considering their interactions and cumulative effects could underestimate the real-world risks of phthalates to the health of children and adults. Low-phthalates like DBP, DEP are also used as solvents in cosmetics products such as nail-polish, perfumed personal care products such as shampoos, lotions, and even in some pharmaceutical products. In 2001 the fragrance industry was using around 4,000 tons of DEP annually. Since the 1930s, scientists have used a family of chemicals called phthalates in an astonishing array of consumer products—from shower curtains to cosmetics to food containers. Based on this information, FDA determined that there wasn’t a sound, scientific basis to support taking regulatory action against cosmetics containing phthalates. DBP is not permitted for use in cosmetics and personal care products in the European Union (see Annex II). Why is it used in cosmetics and personal care products? It must be emphasized that DEP and DMP have no harmful reproductive effects. Individuals may be exposed to phthalates during the use of many personal care products containing phthalates, such as hair products, cosmetics, and lotions 25). Most of the mainstream hair sprays, deodorants, nail polishes and perfumes that millions of people use every day contain these harmful chemicals. Let us know. Because phthalates are widely used in many consumer products, their safety has been extensively researched and reviewed. Links to the Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP) opinions on DEP: 2021 Copyright. According to a survey conducted by the FDA in 2010, DEP is the only phthalate still commonly used in cosmetics as solvent and fixative in fragrance. Learn more about SCCNFP’s 2004 opinion on Dibutyl phthalate, It’s a myth that phthalates are ‘hidden’ in fragrances. Some products were found to have phthalates present and we’ve collated these in a list, ordered by type of product for your information. DEP has been reviewed by the U.S. In the same way, it is quite wrong to consider all phthalates as the same: they are not. The site is secure. Both scientific groups have positively affirmed the safe use of DEP in cosmetic products without restriction. These phthalates can be absorbed into the body by touching or other direct contact with phthalate-containing products. Phthalates are a group of chemicals used in hundreds of products, such as toys, vinyl … Phthalates in these products may be absorbed through contact with the skin or may be inhaled if some of the product is present in the air. 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. 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. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Partnerships: Enhancing Science Through Collaborations With FDA, The History of FDA's Fight for Consumer Protection and Public Health. Phthalates are found in many scented and cosmetic products, where they stabilize the fragrance, increase spreadability, and enhance absorption. Overall 252 products including 98 baby car … Phthalates are used in a wide range of cosmetic and food products — plus, they’re released into the environment. 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. You can find them in: Cosmetics and personal care products, from perfume, nail polish, and hair spray to soap, shampoo… 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. 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. This is due to the phthalates in cosmetics and other fragranced products that we use every day on our faces and our entire bodies. The following is a list of companies that have contacted BCA to confirm that they do not use phthalates in their products. 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. T The FDA continues to survey phthalate use in the ingredients of cosmetics and has even found a decreasing trend of the levels of phthalates used in … Phthalates are found in human urine. [ 3] In short, if you look around, you might find phthalates in: DEP can also function as an alcohol denaturant , rendering alcoholic products unfit for oral consumption. 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