August 2016 Regulatory Update

In an effort to reduce the cost of third party testing requirements consistent with assuring product compliance, the CPSC issued a draft notice of proposed rulemaking for determinations that certain plastics with specified additives would not contain phthalates that are prohibited in children’s toys and childcare articles. Upon approval, a draft rule will be published in the Federal Register and a public comment period will be open for 75 days.

Under the proposed rule, companies that manufacture or import children’s toys or childcare articles that contain accessible polyethylene, polypropylene, high impact polystyrene, or acrylonitrile butadiene styrene will not be required to third party test to assure compliance with Section 108 of the Consumer Products Safety Improvement Act (CPSIA). However, compliance with the 0.1% limit for the currently six prohibited phthalates is still be required.

Formaldehyde is a colorless, flammable gas commonly found in resins used in the manufacture of composite wood products. It can cause irritation of the skin, eyes, nose, and throat. Additionally, high levels of exposure to formaldehyde may cause some types of cancers. To avoid adverse health effects caused by formaldehyde, the final rule includes emission limits that are applicable to domestic or imported hardwood plywood, medium-density fiberboard, particleboard, and finished goods containing these products. The reference standards will be ASTM E1333-10 and ASTM D6007-02 and the formaldehyde emission limits are listed below:

Apart from the emission standards, the final rule also establishes a certification program for third party certifiers (TPCs) of composite wood products. Under this program, TPCs will have to meet several qualifications in order to obtain accreditation to perform laboratory testing and provide oversight of formaldehyde emissions from manufactured and/or imported composite wood products.

The final rule is in prepublication stage and has not yet been published in the Federal Register. Once it is published, it will enter into force 60 days after the publication. One year after publication, composite wood products that are sold, supplied, offered for sale, manufactured, or imported in the United States will need to be labeled as TSCA Title VI compliant.

The added chemicals meet the requirements for listing as known to the State of California to cause cancer, developmental toxicity and female reproductive toxicity for purposes of Proposition 65. The chemical details are provided below:

As part of the Department of Toxic Substances Control (DTSC) Safer Consumer Products regulations that took effect October 1, 2013, an initial list of Priority Products containing “Candidate Chemicals” - that is chemicals that have a hazard trait that can harm people or the environment - was to be identified. A proposed list of three product-chemical combinations was released on March 13, 2014 and includes:

• Paint Stripper with Methylene Chloride
• Spray Polyurethane Foam Systems Containing Unreacted Methylene Diphenyl Diisocyanates (MDI)
• Children's Foam-Padded Sleeping Products with TDCPP or TCEP

Through research, the DTSC determined that children may be at risk for adverse health effects if they use or are near children’s foam-padded sleeping products that contain the following flame retardant chemicals:

1. Tris(1,3-dichloro-2-propyl) Phosphate (TDCPP) (CAS No. 13674-87-8)
2. Tris(2-chloroethyl) Phosphate (TCEP) (CAS No. 115-96-8)

The rulemaking to list Children’s Foam-Padded Sleeping Products containing the flame retardants TDCPP and TCEP as a Priority Product began with the initiation of the comment period. Examples of products that may be impacted by the pending SCP regulations include:

1. Nap mats
2. Soft-sided portable cribs
3. Play pens
4. Infant sleep positioners
5. Co-sleepers

Once Children’s Foam-Padded Sleeping Products are finalized as Priority Products, the rulemaking may take up to one year, after which businesses that manufacture, import, distribute, sell, or assemble the products will have to identify and evaluate alternatives that reduce adverse impacts of the product containing the chemicals of concern. The comment period will end with a public hearing on August 29, 2016.

The amendment revises the existing law that requires using compostable or recyclable food service ware in restaurants, by retail food vendors etc. As a result of the amendment, common food service products made of polystyrene such as plates, cups, egg cartons, coolers, and “to-go” containers, as well as other consumer products such as pool toys, beach toys, and packing peanuts will no longer be allowed after the effective dates, as detailed below:

The amendment to the Vermont Chemicals of High Concern to Children rule entered into force on July 1, 2016. It revises the deadline for manufacturers to report children’s products containing a listed CHCC that is intentionally added to a children’s product at a level above the Practical Quantification Limit (PQL) or is present as a contaminant at concentrations of 100 parts per million or greater. The new reporting requirements are summarized below:

In addition, Vermont has opened their online reporting system to allow manufacturers to begin reporting chemical disclosures now. A User Manual is available to guide manufacturers through the process. For the first reporting period beginning in 2017, data must be disclosed separately to the State of Vermont even if companies are also reporting to other states with CHCC reporting rules. It is expected that Vermont and other states will consider data sharing options at a later date.

In the amendment, Plastic Microbeads that are less than or equal to 5mm in size are added to the List of Toxic Substances in Canadian Environmental Protection Act, 1999. Adding plastic microbeads to this list enables the Minister of the Environment to propose risk management instruments under CEPA to manage environmental risks posed by plastic microbeads, should such instruments be deemed necessary.

When CCPSA came into force in 2011 and replaced HPA, several regulations under HPA were amended, replaced or newly enacted in order to prevent regulatory gaps from occurring during the transition. However, other regulations were not addressed at that time. Of particular concern was that the scope of application of some regulations was inconsistent with that of the CCPSA and some regulations still contained provisions more relevant to the HPA than the CCPSA, among other areas of misalignment. As announced in the Canada Gazette on July 13, 2016 these regulations have been repealed and amended as summarized below:

Once the amendment passes, the migration limit of BPA lowered from 0.1 to 0.04 mg/L (ppm). The referenced methods for the determination are:

1. EN 71-10:2005 Safety of toys - Organic chemical compounds - Sample preparation and extraction
2. EN 71-11: 2005 Safety of toys - Organic chemical compounds - Methods of analysis

The standards showing presumption of conformity to Decree No. 91-1292 are listed in the table below:

^ The new standard applies to products that are manufactured or imported after the effective date.

^ Chemical Hazard includes Violation of Cosmetic Product Regulation, Violation of Directive on Packaging and Packaging Waste, Violation of National Legislation, Violation of POP Regulation, Violation of REACH Regulation and Violation of Toy Safety Directive

* Other Hazards include Asphyxiation Hazard, Drowning Hazard, Entrapment Hazard, Laceration Hazard, Microbial Hazard, Suffocation Hazard, Violation of Cosmetic Product Regulation, Violation of Low Voltage Directive and Violation of RoHS 2 Regulation with frequency less than 5.

# Other Categories include Food Contact Material, Furniture, Jewelry, Personal Protective Equipment (exclude eye protection), Sporting Goods / Equipment and Tools and Hardware with frequency less than 5.

Download the complete Recalls Summary - Europe (Last Update Date: July 31, 2016)

The mandatory standards required for hoverboards are identical to those listed during the previous 60-Day interim ban (See Regulatory Recap: April 2016). The notice replaced the interim ban and the safety standards became mandatory under the Australian Consumer Law. They will be in force for two years from July 17, 2016 while regulators develop a longer-term solution.

In the guidance document, essential requirements for safe button cell containing products are provided. Consumer products containing one or more replaceable button batteries that are likely to be accessible to young children under normal use or reasonable foreseeable misuse must meet following requirements:

1. Be designed and manufactured so that the batteries are inaccessible to young children
2. Have a battery compartment that requires a tool to access the battery, or that requires two or more independent and simultaneous actions to remove its cover
3. Provide information indicating that button battery is required for operation at point of sale

Apart from the essential requirements to be safe, the document suggests several safety standards that are helpful to assess the safety of the products containing button batteries. The standards are listed below:

1. AS 1928 -2007 - Child-resistant packaging - Requirements and testing procedures for reclosable packages (ISO 8317:2003, MOD)
2. AS 5808 -2009 - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products (EN 862:2005, MOD)
3. AS/NZS 3820 - Essential safety requirements for electrical equipment
4. AS/NZS 3100 - General requirements for electrical equipment
5. AS/NZS 60335.1:2011 + A1 + A2 + A3 - Household and similar electrical appliances -Safety - Part 1: General requirements
6. AS/NZS 60950.1:2015 Information Technology Equipment -Safety, Part 1: General requirements
7. AS/NZS 62115: 2011 - Electric toys—Safety
8. AS/NZS 60065:2012 A1:2015 - Audio, video and similar electronic apparatus—Safety requirements
9. ASTM F963-11 - Standard Consumer Safety Specification for Toys Safety
10. ANSI C18.3 Parts 1, 2 & 3 - American National Standard for Portable Lithium Primary Cells and Batteries
11. IEC 60086 Part 4 & 5 -Primary batteries
12. IEC 62368-1 Ed. 2 Audio/video, information and communication technology equipment - Part 1: Safety requirements
13. UL 4200A:2015 - Standard for Safety for Products Incorporating Button or Coin Cell Batteries of Lithium Technologies

The AS/NZS 8124 standards provide testing methods for physical and mechanical, flammability and heavy metal requirements. The updates of the AS/NZS ISO 8124 standards are summarized below:

Currently, the new standards are not adopted as mandatory standards in Australia and New Zealand for toys safety.

Due to the risk of respiratory disease caused by exposure of asbestos, the existing ban of raw asbestos is expanded to products which contain asbestos, such as gaskets, seals and brake linings. Existing asbestos containing buildings and products will continue to be managed through the Health and Safety at Work Act Regulations and, therefore, are out of the scope of this new prohibition.

The amendment adds new requirements for the Specific Migration Limit (SML) of Germanium (Ge) and evaporation residue requirements in the JFSL (See Regulatory Recap: April 2016). The new requirements will be enforced on December 8, 2016.