November 2017 Regulatory Update

In the final rule, the ASTM F2670-17 Standard Consumer Safety Specification for Infant Bath Tubs is adopted. An infant bath tub is defined as a tub, enclosure, or other similar product intended to hold water and be placed into an adult bath tub, sink, or on top of other surfaces to provide support or containment, or both, for an infant in a reclining, sitting, or standing position during bathing by a caregiver. Products commonly known as bath slings typically made of fabric or mesh are excluded from the scope of the standard.

The Final Rule updates the Consumer Product Safety Improvement Act (CPSIA), Section 108, as summarized below:

1. The interim prohibition of DINP for any children’s toys and child care articles that can be placed in a child’s mouth has been revised to a permanent prohibition.
2. Four additional phthalates are now prohibited:
• Diisobutyl Phthalate (DIBP)
• Di-n-pentyl Phthalate (DPENP)
• Di-n-hexyl Phthalate (DHEXP)
• Dicyclohexyl Phthalate (DCHP)
3. The interim ban of DNOP and DIDP has been removed since they do not lead to certain developmental reproductive toxicity according to the Chronic Hazard Advisory Panel (CHAP)’s advice.

The rule will become effective on April 25, 2018. Upon enforcement, any children’s toy or child care article that contains concentrations over 0.1 percent of DEHP, DBP, BBP, DINP, DIBP, DEPENP, DHEXP and DCHP is prohibited.

Upon enforcement, manufacturers, wholesalers and retailers cannot manufacture, knowingly sell, offer for sale or distribute for use in the state any children’s product or residential upholstered bedding or furniture, which contains over 100 ppm of any organohalogen flame retardant chemical applied to plastic, foam or textile. The implementation schedule is summarized as below:

Ninety days before the implementation date of the prohibition, a manufacturer of products that are prohibited shall notify persons or entities that sell the products in the state.

Upon approval, any person who manufactures or imports mercury or mercury added products (including mercury compounds) or otherwise intentionally uses mercury in a manufacturing process is required to report to the EPA.

The proposed rule is now receiving comments until December 26, 2017.

For the complete list click here

Under the current rule, most clothing, textile and fur products are required to have a label identifying the manufacturer or other business responsible for handling the item. The updated webpage allowing real-time data validation of RN makes it easier for companies to obtain an RN, which can avoid putting long company names on labels. The use of the updated RN webpage will streamline the application process for participating businesses and increase the efficiency to deliver RN services.

In the final decision and order, CPSC Commissioners held that Zen Magnets are defective, and that the defect creates a substantial risk of injury to the public. Additionally, they found that it is reasonably foreseeable that children will ingest Zen Magnets and the warnings do not mitigate the risk. When two or more magnets are ingested, they can attract to each other or to other ingested metallic objects resulting in catastrophic injuries or death. Therefore, it is illegal under federal law for any person to sell, offer for sale, manufacture, distribute or import into the United States any Zen Magnets.

The key amendments, which are aligned with few exceptions to ASTM F963-16, are summarized below:

1. Updated definitions
2. Added requirements for magnetic toys: any magnetic toy or magnetic component that is a small part shall have a magnetic flux index of less than 0.5 T2mm2, except a magnetic component that is:
1. Necessary for the operation of motors, relays, speakers and other electrical components in a magnetic toy, provided that the magnetic properties are not part of the play or learning pattern of the toy; and
2. Part of a kit intended for carrying out educational experiments involving both magnetism and electricity. The product shall be intended for a child of at least 8 years of age and labeled with appropriate warnings.
3. Added testing method for magnetic flux index measurements
4. Added warning requirements for magnetic toys that are intended for carrying out educational experiments

The key requirements of the four approved Acts are summarized below:

Within three months from the effective date of this Act, the Philippine Food and Drug Administration (FDA) shall prepare a list of prohibited chemicals and substances, which may cause harm, injury, or death to children. In the list, the following chemicals shall also be included:

Any toys or games containing the following components shall bear a suitable warning on the packaging:

1. Small part intended for use by children less than 14 years of age
2. Any marble intended for use by children less than 14 years of age
3. Any latex balloon or any ball with a diameter of 1.75 inches or less intended for use by children less than 10 years of age

The cautionary statement in the warning label shall be written in English, Filipino or both languages.

(See Regulatory Recap: September 2016-2).