January 2017 Regulatory Update

The final rule implements formaldehyde standards for composite wood products to reduce formaldehyde emissions as required by the Compliance Monitoring Strategy of the Toxic Substances Control Act (TSCA). In the rule, emission limits are included for domestic or imported hardwood plywood, medium density fiberboard, particleboard and finished goods containing these products (See Regulatory Recap: August 2016).

The final rule is effective February 10, 2017. One year after official publication on December 12, 2017, 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 evaluations will be used to determine whether these chemicals present an unreasonable risk of injury to health or the environment and are required to be completed within 3 years. If the EPA determines any chemical presents an unreasonable risk, the EPA must mitigate the risks within 2 years.

The first 10 chemicals selected for evaluation from the list of 90 chemicals on the 2014 update to the TSCA work plan are summarized below:

By the end of 2019, the EPA must have at least 20 chemical risk evaluations ongoing. Therefore, additional chemicals will be designated for evaluation in the near future.

TCE is a volatile organic compound used in industrial and commercial processes and has some limited uses in consumer and commercial products. However, the use of TCE may potentially lead to unreasonable health risks such as developmental toxicity, immunotoxicity, kidney toxicity, reproductive and endocrine effects, and neurotoxicity. Therefore, the EPA is proposing a prohibition of TCE under section 6 of the Toxic Substances Control Act (TSCA).

The proposed rule (40 CFR Part 751) is summarized below:

The comment period is now open until February 14, 2017.

In the approved rule, the use of a standard point-of-sale warning for BPA exposures from canned and bottled foods and beverages is continued. However, the only difference between the emergency and regular rulemaking is that a new provision is added to require businesses to provide the below information to the Office of Environmental Health Hazard Assessment (OEHHA):

1. A list of all food products for which a warning is being provided because BPA was intentionally used in the manufacture of the can lining or jar or bottle seals. The food product must be identified by:
   
   1. Brand name
   2. Product description, including the Federal Food and Drug Administration product category for the food.
   3. Universal Product Code or other specific identifying designation
   4. Where BPA is no longer used in the manufacture of the product packaging but the product is still available in commerce, the last expiration or “use by” date for the product where BPA was intentionally used in the can linings or seals.

The approved rule entered into force on January 1, 2017 and remains effective until December 31, 2017 while the emergency regulation expired on December 31, 2016.

Recent 60-day notices from November and December of 2016 include the following:

DEGME is a substance specified in the List of Toxic Substances under the Canadian Environmental Protection Act, 1999, since DEGME is entering the environment in a quantity that constitutes a danger in Canada to human life or health. Therefore, to mitigate the exposure to DEGME, the guidance recommended that the total concentration of DEGME present in a surface coating material available to a consumer in Canada shall not exceed 10,000 mg/kg when a wet sample is tested.

The amendments in Toys Regulations are summarized below:

1. Editorial changes:
   
   • Section 7: Small parts
   • Section 26: Corrosive substances, irritants or sensitizers
   • Section 27: Substances in plastic materials — prohibition
     
     • Removed Phthalate Regulations from Toys Regulations
     • Removed Exception: “Such a substance may be used to manufacture the plastic material in an amount of 1% or less if the substance meets the requirements of sections 25 and 26.”
   • Section 29: Stuffing
2. Removed the following battery requirements and test method:
   
   • Section 43: Leakage
   • Schedule 9: Test Method for Batteries Used in Toys
3. Added definition:
   
   • Good Scientific Practices
   • Human experience data
4. Amended Permissible Limits of Toxicity (Schedule 2)
5. Amended Criteria for Determining if a Substance or Stuffing Material is an Irritant, Corrosive or Sensitizing (Schedule 3)

* Other Hazards include Amputation Hazard, Burn Hazard, Choking Hazard, Drowning Hazard, Electrical Shock Hazard and Ingestion Hazard with frequency less than 4.

^ Other Categories include Candles & Burning Items and Accessories, Fabric / Textile / Garment / Home Textile, Food Contact Material, Footwear, Juvenile Product, Tools and Hardware and Toys and Childcare Articles with a frequency of less than 3.

Download the complete Recalls Summary - US (Last Update Date: December 31, 2016)

* Other Hazards include Burn Hazard, Laceration Hazard, Microbial Hazard and Strangulation Hazard with frequency less than 5.

^ Other Categories include Candles & Burning items and Accessories, Consumer Chemicals, Footwear, Furniture, Homeware (Non-Food Contact) and Juvenile Products with a frequency of less than 3.

Download the complete Recalls Summary - Canada (Last Update Date: December 31, 2016)

The new standard replaced the previous standard NOM-231-SSA1-2002 for food contact ceramics and expands the scope of products to also include glass materials, with relevant limits for soluble lead and cadmium.

Compared to the draft standard, the maximum permissible limits of soluble lead and cadmium in glassware is amended to include a new type of article. Changes are bolded below.

Table 1. Maximum permissible limits for soluble lead and cadmium in pottery, ceramics, and porcelain

Table 2. Maximum permissible limits for soluble lead and cadmium in glassware

In the guidance, clarifications and explanations are provided to each Article of the Directive. Apart from the explanation, the guidance also lists example products that are within or outside the scope in the Directive. In addition, a comparison table of harmonized standards between LVD, 2014/35/EU and Machinery Directive (MD), 2006/42/EC is provided since they share some standards.

The following new standards relating to product testing are issued:

The following product standards are amended:

To fulfill the requirements of the Environmental Protection Law and reduce adverse effects on human health and the environment, the new standard sets forth the following requirements for textiles products with reference to certain standards including but not limited to GB 18401 and GB 31701:

1. Azo Dyes
2. Carcinogenic Dyes
3. Allergenic Disperse Dyes
4. Flame Retardants
5. Surfactants
6. Asbestos
7. Heavy Metals
8. Formaldehyde
9. pH Value
10. Phthalates
11. Polycyclic Aromatic Hydrocarbons (PAH)
12. Perfluorinated Chemicals (PFC)
13. Organotin
14. Dimethyl Fumarate (DMF)
15. Chlorinated Phenol
16. Chlorobenzene

The new standard replaces following standards:

1. HJ/T 307-2006 Technical Requirement for Environmental Labeling Products - Ecotypic Textiles
2. HJ/T 309-2006 Technical Requirement for Environmental Labeling Products - Woolens

The proposed adoption of updated standards is summarized below: