November 2016 Regulatory Update

Previously, the CPSC had proposed to exempt four plastics from phthalates testing. (See Regulatory Recap: August 2016). In support of the CPSC’s continued efforts to reduce third party testing burden, TERA has studied an additional eleven plastics to determine the presence of ten specified phthalates including the six Consumer Product Safety Improvement Act (CPSIA) regulated phthalates. The results of study may lead to further inclusion of plastics that are proposed to be exempted from CPSIA phthalate testing.

The overview of phthalates found in certain plastics is summarized below:

Remarks:
1: Study found that the presence of DBP could be additives.
2: One study reported DBP at unspecified concentration in an unspecified toy.

The proposed bill bans the following food containers composed of BPA or which can release BPA into food:

1. Reusable food containers; and
2. Other food containers that are packed with food and are introduced or delivered for introduction into interstate commerce

Despite the proposed ban, the Food and Drug Administration (FDA) may grant waivers to a particular facility (defined in section 415 of the Federal Food, Drug, and Cosmetic Act) that manufactures, processes, packs holds or sells food product. However, the facility receiving such waivers must:

1. Demonstrate that it is not feasible to replace BPA in the certain type of container
2. Demonstrate that is it not feasible to use an alternative container without BPA
3. Have a plan and timeline for BPA removal
4. Display a prominent warning label on the product as below:
   “Bisphenol A (BPA) is a chemical that can leach into food and may harm prenatal development and the health of children and adults.”

According to the Consumer Product Safety Improvement Act (CPSIA), the updated standard will be enforced and become mandatory 180 days after ASTM has notified the Consumer Product Safety Commission (CPSC) of the update. However, the CPSC may reject the revision within 90 days.

The following requirements or test methods are amended:

For more detail, please see our ASTM F963-16 Toy Safety Standard page.

The emergency regulation continues the adoption of a standard point-of-sale warning message for BPA for canned and bottled foods and beverages addressed in the previous amendment on California Code of Regulations (See Regulatory Recap: April 2016). The emergency regulation will expire on January 18, 2017.

In addition, OEHHA initiated a regular rulemaking process for BPA warnings (See Regulatory Recap: September 2016) but the rulemaking procedure has not been completed yet.

The added chemical meets the requirements for listing as known to the State of California to cause cancer for purposes of Proposition 65. The chemical details are provided below:

Recent 60-day notices from September and October of 2016 include the following:

According to the Maine Toxic Chemicals in Children’s Products Law, manufacturers of children’s products are required to submit a report to DEP within 180 days after a priority chemical is newly identified if the product contains:

1. A priority chemical that is intentionally added to a component of children’s product at concentration above the Practical Quantification Limit (PQL); or
2. A priority chemical that is a contaminant present in a component of children’s product at a concentration above 100 ppm

In the draft rule, the following products are exempted from the reporting requirements:

1. Used products
2. Food and beverage packaging (except for product intended for use by children under 2 years old)
3. Transportation, such as motor vehicles and watercraft (except detachable car seats)

The draft rule was under comment period until November 14, 2016.

The key changes in the updated guidance are summarized as follows:

1. Updated the type of product information that is required to be reported:
   
   1. Manufacturers will download an Excel template, which will be used to submit brand name and product model data.
   2. If a product is offered for sale in different sizes or variations, the individual variations may need to be reported separately if the concentration of the chemical within the component is significantly different.
   3. If a specific item that contains one of the 66 chemicals is sold in multiple toy sets (for example, one screw driver is sold as part of three different children’s toy construction sets) the disclosure would include the following:
      
      1. The chemical used in the screw driver
      2. The Product Model/Brand Name Excel form upload containing all product model and brand names that use the screw driver (as well as any other product models and brand names that use the chemical being reported)
      3. The details about the screw driver (function of chemical, component, concentration of chemical, brick)
2. Added a guideline for manufacturers to report chemicals that are trade secret
3. Clarified that there is no additional waiver for small business or manufacturers
4. Clarified that there is not a phased-in schedule for reporting
5. Added a new section for payment information

* Other Hazards include Burn Hazard, Choking Hazard, Electrical shock Hazard, Entanglement Hazard, Failure to Operate in an Emergency, Ingestion Hazard, Laceration Hazard, Microbial Hazard, Strangulation Hazard and Violation of Federal Flammability Standard with frequency less than 4.

^ Other Categories include Art Materials, Fabric / Textile / Garment / Home Textile, Footwear, Heating / Cooling

Download the complete Recalls Summary - US (October 2016)

* Other hazards include Burn Hazard, Chemical Hazard, Drowning Hazard, Impact Hazard, Electric Shock Hazard, Entrapment Hazard, Laceration Hazard, Microbial Hazard, Strangulation Hazard and Violation of Packaging and Labeling Requirements with a frequency of less than 5.

^ Other categories include Computer / audio / video / other electronics & accessories, Cosmetics / Bodycare, Footwear, Furniture, Home electrical appliances (hair dryer, iron, etc.), Homeware (non-food contact), Lighting, Tools and Hardware and Toys and Childcare Articles with frequency less than 4.

Download the complete Recalls Summary - Canada (October 2016)

Upon enforcement, the proposed regulations will amend the Annex XVII of REACH Regulation List of Restriction by adding following 2 chemicals and their conditions:

The Turkey Toy Safety Regulations adopt the European Toys Safety Directive 2009/48/EC and it will become effective on April 4, 2017. The new regulations address certain requirements for toys:

1. EC Declaration of Conformity
2. “CE” Mark
3. Conformity assessment requirement including physical and mechanical, flammability, chemical and electrical requirements
4. Technical documentation
5. Standards showing presumption of conformity

This regulation does not apply to the following toys:

1. Playground equipment
2. Automatic coin-operated gaming machines
3. Combustion engines for toy vehicles
4. Toy steam engines
5. Slings and catapults

The proposed amendments add new conditions for electronic and electrical products that may not be required to have markings directly on the product such as components, parts and raw materials. (Examples: display components, circuit boards, resistors, etc.) However, the marking is still required on the product instructions. The amendment was under comment period until November 13, 2016.

Key proposed amendments of the regulation related to labeling information on consumer products are summarized below:

• Consumer products with product labels written in a foreign language shall have a corresponding English or Pilipino translation to allow better understanding of the product contents, features and uses
• A new provision is added to ban suppliers from importing defective goods
• The requirements for consumer products with specific claims are further strengthened by the ingredient list requirement. A specific claim can appear only when the ingredient’s quantities and properties as well as the material benefit that results from its inclusion in the product formulation have been technically substantiated.

In addition to changes in labeling requirements, the amendment also adds a new provision to ban suppliers from importing defective goods.

The key proposed amendments in the notice are summarized below:

• Clarifies types of toys that fall under the scope and under exempted products
• Strengthens safety, labeling and user manual requirements for electric riding toys (modeling ASTM standard)
• Strengthens the safety requirements of hazardous chemical substances and changes test methods accordingly (modeling EN-71, Part 3 standard for migration of 19 heavy metal elements)
• Adds Tris(2-chloro-1-methylethyl)phosphate (TCPP) and Tris(1,3-dichloro-2-propyl) phosphate (TDCP) to flame retardant chemical requirements
• Adds microbial requirements for toys containing liquids