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Control on Phthalates: Usage Limits in South Korea, Japan, E.U., U.S., and Canada

Phthalates are a group of chemicals commonly used as plasticizers to increase the flexibility and durability of plastics. Widely used in cosmetics, toys, food utensils, personal care products, and other household items, they are exposed to human beings in various ways. Therefore, it is necessary for enterprises to acknowledge the phthalates requirements. ChemLinked compiles the requirements for phthalates in South Korea, Japan, E.U., U.S., and Canada for enterprises' references.

1. U.S.

In 2008, the U.S. Congress passed the Consumer Product Safety Improvement Act (CPSIA)1, banning the sale of children’s toys or child care articles containing concentrations of more than 0.1 percent of three types of phthalates: di-(2-ethylhexyl) phthalate (DEHP); dibutyl phthalate (DBP); or, benzyl butyl phthalate (BBP). A child care article refers to a consumer product that is designed or intended by the manufacturer to facilitate sleep or the feeding of children aged 3 and younger, or to help children aged 3 and younger with sucking or teething.

The CPSIA also temporarily prohibited children’s toys that can be placed in a child’s mouth or child care articles that contain concentrations of more than 0.1 percent of diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), or di-n-octyl phthalate (DNOP), The interim prohibition concerning DINP, DIDP, and DNOP remained in effect until the Commission’s final phthalates rule (16 CFR part 1307) took effect on April 25, 2018.

On October 27, 2017, the Consumer Product Safety Commission issued a final phthalates rule (16 CFR part 1307) with an effective date of April 25, 2018. The final phthalates rule extended the prohibition, permanently prohibiting children's toys that can be placed in children’s mouth and childcare articles that contain concentrations of more than 0.1% of DINP. The phthalates rule also lifts the interim prohibitions on children's toys that can be placed in a child's mouth and childcare articles that contain concentrations of more than 0.1% of DNOP or DIDP. In addition, the phthalates rule prohibits children's toys and childcare articles that contain concentrations of more than 0.1% of diisobutyl phthalate (DIBP), Di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and dicyclohexyl phthalate (DCHP).

The permanent prohibition concerning DEHP, DBP, and BBP are still effective. Thus, any children's toy or childcare article containing more than 0.1% of the following phthalates is prohibited:

  • di-(2-ethylhexyl) phthalate (DEHP)

  • dibutyl phthalate (DBP)

  • benzyl butyl phthalate (BBP)

  • diisononyl phthalate (DINP)

  • diisobutyl phthalate (DIBP)

  • di-n-pentyl phthalate (DPENP)

  • di-n-hexyl phthalate (DHEXP)

  • dicyclohexyl phthalate (DCHP)

Additional bans on phthalates in various products are enacted at the state level in the U.S.  

In 2020, California published the California Toxic-Free Cosmetic Act2 to the most toxic chemicals from beauty and personal care products sold in California. According to the Act, starting from 2025, cosmetic products containing any of the highly toxic chemicals referenced below are prohibited from selling in California:(1) Dibutyl phthalate; (2) Diethylhexyl phthalate; (3) Formaldehyde; (4) Paraformaldehyde; (5) Methylene glycol; (6) Quaternium-15; (7) Mercury; (8) Isobutylparaben; (9) Isopropylparaben; (10) m-Phenylenediamine and its salts; (11) o-Phenylenediamine and its salts; and (12) 13 kinds of specific per- and polyfluoroalkyl substances (PFAS) and their salts.

In 2023, Washington issued Washington Toxic-Free Cosmetic Act3. This law bans the usage of some risk chemicals in cosmetic and personal care products, including PFAS, phthalates, formaldehyde, and formaldehyde releasing agents. This bill is deemed as the strongest state law in the country regulating toxic chemicals in beauty and personal care products.

2. South Korea

Korean authority mainly inspects seven substances of phthalates, namely, DEP, DBP, BBP, DEHP, DNOP, DIDP, and DINP. The usage limits in cosmetics, food packages, medical devices, and sanitation products are specified as below:

Product Category

Usage Requirements and Limits

Relevant Regulations

Cosmetic

  • DEHP, DBP, BBP: Less than 100 μg/g in total

  • DEHP, DBP, BBP, n-Pentyl iso-pentyl phthalate, di-n-pentyl phthalate, diisopentyl phthalate, Bis(2-methoxyethyl) phthalate: prohibited to be used in cosmetics

Regulation on Safety Standards, etc. for Cosmetics4

Food Utensil, Food package, and Food Container

  • DEHP: Prohibited to be used in food utensils, containers, and packages;

  • DEHA: Prohibited to be used in wrap film;

  • DBP, BBP: Prohibited to be used in utensils, containers, and packages of foods for infants and young children;

  • Allowed usage limits in PVC(mg/L): DBP (less than 0.3), BBP (less than 30), DEHP (less than 1.5), DNOP (less than 5), DINP+DIDP (less than 9 in total), DEHA (less than 18).

Standards and Specifications of Utensil, Package, and Container for Food5

Medical Devices

  • DBP, BBP, DEHP: Devices with these substances cannot be permitted, certified, or reported for infusion sets or artificial kidney blood circuits

Regulation on Medical Device Approval, Report, and Evaluation6

Sanitation Products

  • DBP, BBP, DEHP: The total amount should be less than 0.1% in cotton swabs, diapers, and sanitary pads (mats) for children.

Standards and Specifications of Sanitation Products7

 3. Japan

In Japan, the control of phthalates mainly focuses on toys. According to the Japan Toy Safety Standard8, DEHP, DBP, and BBP should be less than 0.1% in toys made of plasticized materials.

For the toys that are intended to come in contact with mouth, , the usage of DINP, DIDP, and DnOP should be below 0.1% in the parts that might be placed into mouth. In addition, DINP is prohibited from being used for PVC parts that do not come into contact with the mouth.

4. E.U.

In Europe, there are three regulations specifying the usage limits of phthalates in chemical products, electronic products, and toys. Details are as follows:

Usage Requirements and Limits

Relevant Regulations

  • DEHP, DBP, BBP, DIBP, DMEP, nPIPP, DIPP, DPENP(DNPP), DHEXP(DNHP): Less than 0.1%, each

REACH Regulation(EC) No 1907/20069

  • DEHP, BBP, DBP, DIBP: Less than 0.1% each

E.U. RoHS 210

  • DEHP, BBP, DBP: Less than 0.1% in total;

  • DINP, DIDP, DNOP: Less than 0.1% in total for products that can be put into a child's mouth. 

Safety of toy(EU Directive 2009/48/EC)11

5. Canada

The phthalates management in Canada also focuses on children’s products. Canada introduced the Phthalates Regulations12 under the Canada Consumer Product Safety Act13 in 2016. It stipulates that in a toy or child care article, the DEHP, DBP, and BBP should be less than 1,000 mg/kg. For products that may be placed in the mouth by children under 48 months, the DINP, DNOP, DIDP usage limit should be under 1,000 mg/kg. Besides, a toy or childcare article that can be placed in the mouth of a child under four years must not contain more than 1,000 mg/kg of DINP, DIDP or DNOP.

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