December 2018 Regulatory Update

The key proposed amendments to 16 CFR 1130 are summarized below:

• Reaffirmed the definition of a “durable infant or toddler product” from CPSIA section 104 and specified that the product categories are further defined in the individual mandatory standards
• Defined sling carriers, soft infant and toddler carriers, handheld infant carriers and frame child carriers as a subset of infant carriers
• Clarified bedside sleepers to be a subset of bassinets in the consumer registration rule
• Replaced the term “changing tables” to be “baby changing products”

The proposed rule is under a comment period until December 24, 2018.

Since the reference material cigarettes required for the testing are under shortage, the CPSC’s Office of Compliance and Field Operations will allow mattress pad manufacturers to reduce flammability testing samples from 6 mattress pad surfaces to 2 mattress pad surfaces for new mattress pad prototypes assessed against the 16 CFR 1632 standard.

This enforcement policy became effective on November 1, 2018 and will remain effective until further notice.

Composite wood products are defined as any wood products made of binding strands, particles, fibers, veneers, or boards of wood together with adhesives. Hardwood plywood, medium-density fiberboard and particleboard are examples of composite wood products commonly used in the manufacture of furniture, picture frames and wooden children’s toys. Exposure to formaldehyde released by composite wood products can pose adverse health effects, including irritation of the skin, eyes, nose, and throat. High levels of formaldehyde exposure are deemed to be carcinogenic.

Addressing technical issues with the testing and certification provisions of the rule, the EPA decided to improve regulatory clarity and further align the rule with the California Air Resources Board (CARB) Airborne Toxic Control Measures (ATCM) Phase II program by amending certain provisions of the TSCA Title VI regulations.

Key proposed amendments to 40 CFR 770 are summarized below:

• Testing and certification provisions are amended to further align the rule with the California Air Resources Board (CARB) Airborne Toxic Control Measures (ATCM) Phase II program
1. Increase number of minimal quality control test of no-added formaldehyde (NAF)-based resin and ultra-low-emitting formaldehyde (ULEF) resin
2. Align ASTM E1333-14 and any other test method used for quarterly or quality control testing
• Added panel sampling to non-complying lots
• A statement showing products are TSCA Title VI compliant shall be added to composite wood product panels that are made of NAF based resin and ULEF resin
• All panels and finished goods shall be properly labelled before being imported into the United States
• Included latest version of voluntary consensus standards

The public comment period for these proposed amendments ends on December 03, 2018.

Antimony Trioxide is the most commercially significant form of antimony and is primarily used as a synergist for halogenated flame retardants in plastics, rubber and textiles, which are used in a wide variety of consumer products. It is also used in polyethylene terephthalate (PET) plastics, in glass and ceramic products additives and as a catalyst in the chemical industry. People may be exposed to antimony trioxide in the workplace, in consumer products, or by breathing contaminated air. NTP conducted a cancer hazard assessment of antimony trioxide for possible listing in the RoC which is a document mandated by the US Congress to provide information on cancer hazards for people residing in the United States. The NTP concluded antimony trioxide to be reasonably anticipated to be a human carcinogen based on sufficient evidence of carcinogenicity from studies with experimental animals and supporting evidence from mechanistic studies.

Nickel is well known for its industrial applications in electroplating baths, batteries, textile dyes and as a chemical intermediate in a number of manufacturing processes. Individuals can be exposed to Nickel and Nickel compounds from welding, batteries, pigments, electroplating and consumer products made of nickel alloys.

The added chemical meets the requirements for listing under Prop 65 as known to the State of California to cause male developmental toxicity. With the aim of controlling the exposure of chemicals to people and the environment, the OEHHA determined to add soluble Nickel and Nickel Compounds to the Proposition 65 List.

The addition of Nickel to the list of chemicals was effective on October 26, 2018 and the corresponding warning requirement for this listing will be in force one year afterward.

The proposal of the Prohibition of Asbestos and Asbestos Product Regulations was prepared by the Department of the Environment (DOE) and the Department of Health (DOH) in January 2018. (See Regulatory Recap: March 2018) The key requirements in the approved regulation are summarized below:

• A person must not manufacture
• A product containing processed asbestos fibres unless those fibres are the result of the degradation of asbestos integrated into a product
• A consumer product containing asbestos in greater than trace amounts
• A person must not import, sell or use:
• Processed asbestos fibres
• A product containing processed asbestos fibres unless those fibres are the result of the degradation of asbestos integrated into a product, a structure or infrastructure
• A consumer product containing asbestos in greater than trace amounts

The regulation will enter into force on December 30, 2018.

Under the proposed amendment, several exemptions to existing restrictions on the manufacture, use, sale and import of HBCD, PBDEs, PFOS, PFOA, and LC-PFCA will be removed. Meanwhile, DP and DBDPE are proposed to be added to Schedule 1 of CEPA, the List of Managed Toxic Substances. The 7 targeted flame retardants are as follows:

• Hexabromocyclododecane (HBCD)
• Polybrominated diphenyl ethers (PBDEs)
• Perfluorooctane sulfonate and its salts and precursors (PFOS)
• Perfluorooctanoic acid and its salts and precursors (PFOA)
• Long-chain perfluorocarboxylic acids and their salts and precursors (LC-PFCAs)
• Dechlorane plus (DP)
• Decabromodiphenyl ethane (DBDPE)

The proposed amendment is under a public comment period until the end of 2018.

According to an article recently published by European Parliament (EP), single-use plastic products and fishing gear account for 70% of marine litter found on European shores. Drinking bottles, cigarette butts, cotton bud sticks, cutlery, straws and stirrers are some examples of single-use plastics that can cause plastic pollution and threats to marine and coastal biodiversity in the oceans.

With an objective to lessen the impact on the environment, the EP is introducing a series of measures to reduce the consumption of single-use plastic products. Under the proposal, single-use plastics such as straws, plates, cutlery and cotton-swab sticks will be banned by 2021. Additionally, the use of plastics for which no alternatives currently exist will have to be reduced by 2025. Examples are single-use drink cups and food containers that will have to be cut down by 25% and plastic-containing cigarette filters will have to be reduced by 50%. Plastic beverage bottles will also be required to be collected and recycled at a rate of 90% by 2025. The proposal extends the responsibility of the producer to manage the waste of the products and add new labelling requirements showing how to properly dispose of single-use plastic products.

Negotiation with government ministers in the European Council has been scheduled and a final decision on the legislation is expected to be available on December 16, 2018.

Under the new rule, the following certification standards are changed from mandatory national standards to voluntary standards:

It is important to note that moving forward, only new certification standards will be accepted by the CQC for compliance. Certificate holders shall renew existing certificates according to current certification rules.

All importers are expected to start using the system for product registration on the effective date.

The mechanism of the SABER is divided into three steps:

• Step 1: Product Registration - Basic information, such as HS (Harmonized System) code and product category
• Step 2: Product Certificate - The system will separate the product based on the HS code and classify products into 4 different risk levels including free trade, low, medium and high risk. A product certificate is mandatory for all items except free trade items. The certificate is valid for one year.
• Step 3: Shipment Certificate (also known as a SASO COC) - It is the normal shipment Certificate of Conformity (COC). It is required for every single shipment and is only valid for the specific shipment.

In contrast to the current certification system, electronic certificates will be issued using the SABER system.

The limitation of maximum Energy Efficiency Index (EEI) will be tightened upon implementation of stage 3 and is summarized in the below table:

Products with EEI higher than the limitation will not be allowed to register with SASO, and therefore, will not be allowed to enter Saudi Arabia.

The workshop will be held in Riyadh, Saudi Arabia at SASO Headquarters, and it is expected that SASO will address the official enforcement date and plans for implementation during the workshop.

SASO 2902 provides the energy efficiency, functionality, marking, labelling and hazardous chemical requirements for lighting products. Upon enforcement, products within the scope (listed below) must comply with the requirements and register with SASO before arriving at the port of Saudi Arabia.

The following products are under the scope of SASO 2902:

Details about the recall cases are as follows:

1. Nikai refrigerator
   Model recalled: Nikai 16 ft. refrigerator, model # NRF460F5, serial number from # 460F505170001 to #460F512170272
   Reason for recall: Did not comply with the SASO Energy Efficiency Standard.
2. Mamas & Papas baby footwear
   Style recalled: 1) Suede Detail, 2) Fringe Moccasins, 3) Pom Pom
   Reason for recall: Ornamental pieces on shoes may detach, posing a risk of suffocation to children.

At the same time, MCI published statistics on the number of items recalled from the market. There are more than 2.7 million products in total being recalled with the breakdown as follows: