June 2017 Regulatory Update

In the proposed rule, the newly published ASTM F2640-17e1 Standard Consumer Safety Specification for Booster Seats was adopted in order to reduce the chance of injury associated with booster seats which are defined as:

1. A juvenile chair, which is placed on an adult chair to elevate a child to standard dining table height
2. Made for the purpose of containing a child, up to 5 years of age, and normally for feeding or eating
3. A booster seat that may be height adjustable and include a reclined position

The proposed rule is currently under comment period until August2, 2017.

The implementation timeline is summarized below:

The Final Rule will be effective on July 10, 2017 unless the EPA receives any adverse comment by June 8, 2017.

The EPA is required under TSCA section 5(g) to publish in the Federal Register a statement of its findings after its review of a TSCA section 5(a) notice when the EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. The two notices present statements of findings during December 2016 and February 2017 separately. The case numbers and the chemical substances that were reviewed are listed below:

The chemical details are provided below:

The comment period for listing of Pentabromodiphenyl Ether Mixture intention ended on June 5, 2017.

Recent 60-day notices from April to May of 2017 include the following:

Instead of notifying the OHA, a manufacturer may alternatively submit a request for the reporting exemption if a children’s product contains a HPCCCH as a contaminant at or above the de minimis level. In order to be approved for the exemption, manufacturers must also demonstrate that the contaminant is effectively controlled under a Manufacturing Control Program (MCP). To make it clear, the guidance explains the elements of a MCP that the OHA will evaluate. They include:

1. Manufacturer name, mailing address, contact information
2. Manufacturer should specify if they believe that any confidential business records or trade secrets are included in the MCP
3. The HPCCCHs covered by the MCP
4. Description of the product and description of how and when in the process the HPCCCH is generated
5. Categories MCP is being structured around (manufacturing processes, materials or groups of materials, component parts, or finished products)
6. Description of the mechanisms covered by the MCP
7. Information of best manufacturing practice and process (generally recognized in the industry) that the MCP meets
8. Document and describe manufacturing control practices and processes from point #7

In addition, the OHA will accept exemption requests beginning June 28, 2017.

In Directive (EU) 2017/774, the following new entry regarding the limit of phenol will be added to Annex II (Appendix C) of Directive 2009/48/EC:

Beginning from November 4, 2018, toys intended for use by children under 36 months and other toys intended to be placed in the mouth will be subject to the above phenol requirements.

In addition, Directive (EU) 2017/898 made the following changes in the same section of Directive 2009/48/EC regarding the migration limit of BPA:

Upon implementation of the amendment regulation on May 19, 2018, the following changes to the food contact plastic regulation will be implemented:

1. Updated list of authorized monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer product aids to:
1. Include 6 new entries of substances
2. Remove verification of compliance by residual content per food contact surface area for 10 substances
2. Transformed food simulant assignment for testing overall migration into table form for clarity (Technically unchanged)
3. Updated information required for the declaration of compliance

Upon implementation of the amendment regulation on May 19, 2019, the following changes on food contact plastic regulation will be implemented:

1. Add new specific migration limits (0.02mg/kg food or food simulant) for Nickel

The guidance document is based on the RED and the new legal framework described in the “Blue Guide 2016”. In conjunction to the Blue Guide, the guidance explains clearly the definition of radio equipment and provides examples which are excluded from the scope of the RED. The guidance also lists out and provides further information on the obligations of different economic operators, such as manufacturer, importer and distributor.

Other than the definition and obligations, the guidance addresses the essential technical requirements applicable to all and other specific types of radio equipment separately and provides a comparison between the current RED and the repealed Radio Equipment and Telecommunications Terminal Equipment Directive (R&TTED).

* Other Hazards include Asphyxiation Hazard, Cut Hazard, Entrapment Hazard, Fire Hazard, Environmental Hazard, Microbial Hazard, Sight Hazard and Suffocation Hazard with a frequency of less than 10.

^ Other Categories include Candles & Burning Items and Accessories, Consumer Chemicals, Footwear, Furniture, Home Electrical Appliances (Hair Dryer, Iron, etc.), Jewelry, Watch or other Fashion Accessories, Personal Protective Equipment (excludes eye protection), Sporting Goods / Equipment and Tools and Hardware,with a frequency of less than 10.

Download the complete Recalls Summary - EU (April and May 2017)

The key updates of the requirements are summarized below:

The updated requirements are currently under a transition period until July 1, 2019. Therefore, products may comply with either the current or updated standard during this period. However, the updated standards will become mandatory after the transition.

The key changes of the Food Regulations are summarized below:

1. Updates the migration limit of Cadmium (Cd) for:

	Migration Limit of Cadmium in small hollow-ware	Migration Limit of Cadmium in large hollow-ware
Previous limit	0.20 mg/L	0.20 mg/L
Amended limit	0.50 mg/L	0.25 mg/L

2. Updates the adopted test method standards

	Standard
Previously adopted standard	MS 1817-1 Ceramic Tableware - Specification
Amended adopted standard	MS ISO 6486-1 Ceramic Ware, Glass Ceramic Ware And Glass Dinnerware In Contact With Food - Release Of Lead And Cadmium - Part 1: Test Method

The amendment regulation has been in effect since April 15, 2017.

The specified standards for toys and various products have been updated to new versions. Meanwhile, two new toys standards will be added upon enforcement. The key changes are summarized below:

The updated standards will be effective on April 1, 2018.