March 2017 Regulatory Update

NORTH AMERICA NEWS

US CPSC Issues Final Rule to Remove Safety Standard for Magnet Sets from CFR

On March 7, 2017, the US Consumer Product Safety Commission (CPSC) issued a final rule in Federal Register, 82 FR 12716. The final rule removes the Code of Federal Regulations, 16 CFR 1240 Safety Standard for Magnet Sets.

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On October 3, 2014, the CPSC published the Safety Standard for Magnet Sets to establish requirements for magnet sets and individual magnets marketed to be used with or as magnet sets. However, on December 2, 2014, Zen Magnets LLC (Zen) filed a petition in the Tenth Circuit United States Court of Appeals challenging the standard. The Tenth Circuit concluded that the CPSC’s rule has provided incomplete and inadequately explained findings. To be consistent with the Tenth Circuit’s decision, 16 CFR 1240 is removed through this final rule with an effective date of March 7, 2017.


US CPSC Issues Direct Final Rule to Revise Safety Standard for Toddler Beds

On February 22, 2017, the US Consumer Product Safety Commission (CPSC) issued a direct final rule in Federal Register, 82 FR 11317. The direct final rule revises 16 CFR 1217 to adopt the updated Safety Standard for Toddler Beds, ASTM F1821-16.

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In the direct final rule, the ASTM F1821-16 Standard Consumer Safety Specification for Toddler Beds is adopted to replace its 2013 version. According to the standard, a toddler bed is defined as:

  1. Any bed sized to accommodate a full-size crib mattress having minimum dimensions of 51 5/8 inches (1310 mm) in length and 27 ¼ inches (690 mm) in width; and
  2. Any bed intended to provide free access and egress to a child not less than 15 months of age and weighing no more than 50 pounds (27.7 kg)

he standard was developed to minimize the following hazards in toddler beds:

  1. Entrapment in bed end structures
  2. Entrapment between the guardrail and side rail
  3. Entrapment in the mattress support system

The effective date of the standard adoption is June 6, 2017.


US State of California First Proposition 65 Settlement Related to BPA in Food Contact Materials

Previously on November 3, 2016, a 60-Day Notice was filed to address the violation of California Proposition 65. The violation involves exposure to Bisphenol A (BPA), which is listed as a chemical to cause female reproductive toxicity, in wine glasses made of polycarbonate. As a result, a settlement agreement regarding the violation was signed by both parties on February 9, 2017.

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In the settlement, it is required to reformulate the polycarbonate wine glasses and the reformulated product shall not contain BPA in concentrations more than 1000 ppm. Alternatively, an appropriate California Proposition 65 warning label is allowed to be used.


US States Bills Summary

In early 2017, there are a number of State issued bills related to chemical restrictions or labeling requirements. They are summarized below:

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States Bill Number Bill Title Proposed Detail
New York
Assembly Bill A00994
An Act to amend the general business law, in relation to prohibiting the manufacture, distribution and sale of toys and child care products containing phthalates - No person shall sell toys or child care products containing DEHP, DBP or BBP (Limit: 0.1%)
- No person shall sell toys or child care products intended for use by a child under 3 years of age and may be placed in the child’s mouth containing DINP, DIDP or DnOP (Limit: 0.1%)
New York
Senate Bill S2085
An Act to amend the general business law, in relation to requiring warnings on certain lithium batteries and products containing such batteries - Requires all products utilizing lithium batteries of less than 1 inch in diameter to contain the following warning:
“WARNING: THIS PRODUCT IS POWERED BY A LITHIUM BATTERY. DUE TO THEIR SMALL SIZE, LITHIUM BATTERIES CAN EASILY BE SWALLOWED BY CHILDREN. INGESTION OF SUCH BATTERIES HAS BEEN KNOWN TO CAUSE DEATH.”
- Requires all lithium batteries of less than 1 inch in diameter shall be printed with the following warning:
"WARNING: THIS IS A LITHIUM BATTERY WHICH IF SWALLOWED HAS BEEN KNOWN TO CAUSE DEATH."
New York
Senate Bill S636
An Act to amend the general business law, in relation to products containing small magnets - Prohibits the sale of any jewelry product that contains a small magnet and which is marketed as a product designed to mimic a tongue, lip or nose piercing
- Prohibits the sale of any magnet novelty consumer product containing a small magnet unless this warning is present:
"THIS PRODUCT CONTAINS (A) SMALL MAGNET(S). SWALLOWED MAGNETS CAN STICK TOGETHER ACROSS INTESTINES CAUSING SERIOUS INFECTIONS AND DEATH. SEEK IMMEDIATE MEDICAL ATTENTION IF MAGNET(S) ARE SWALLOWED OR INHALED."
- Prohibition is not applied to products that comply with the magnet safety and labeling requirement of ASTM F963
New York
Senate Bill S86
An Act to amend the environmental conservation law, in relation to the regulation of toys, and food and beverage containers containing bisphenol A Starting from December 1, 2017,
- Prohibits the sale of any toy containing Bisphenol A
- Prohibits the sale of any food and beverage container containing Bisphenol A which is designed for use by children 3 years of age or younger
New York
Senate Bill S742
An Act to amend the environmental conservation law, in relation to prohibiting the use of chemical flame retardants Starting from July 1, 2018,
- Prohibits residential upholstered furniture from containing intentionally added flame retardants
Starting from December 1, 2020,
- Residential upholstered furniture shall meet the “open flame flammability standard” which requires furniture not to lead to flashover for at least 15 minutes of time
New York
Assembly Bill A1884 & Senate Bill S3438
An Act to amend the environmental conservation law, in relation to banning formaldehyde in certain children's products Starting from April 1, 2019,
- Prohibits the sale of children’s products that intentionally contain formaldehyde
- Prohibits the sale of children’s products containing ingredients that are able to degrade and release free formaldehyde exceeding 0.05%
Alaska
House Bill No. 53
An Act relating to flame retardants and to the manufacture, distribution, and sale of products containing flame retardants; and providing for an effective date. - Prohibits the sale of upholstered furniture or children’s items containing the following flame retardants:
  1. Tris (1,3-dichloro-2-propyl) phosphate (TDCPP)
  2. Tris (2-chloroethyl) phosphate (TCEP)
  3. Tetrabromobisphenol A (TBBPA)
  4. Decabromodiphenyl ether
  5. Antimony
  6. Hexabromocyclododecane
  7. Bis (2-ethylhexyl) -3,4,5,6-tetrabromophthalate (TBPH)
  8. 2-ethylhexyl-2,3,4,5-tetrabromobenzoate (TBB)
  9. Chlorinated paraffins
  10. Tris(1-chloro-2-propyl)phosphate (TCPP)
- If the product contains a flame retardant, the following statement shall be affixed to the product:
"This product contains a chemical flame retardant."
Alaska
House Bill No. 27
An Act relating to chemicals that are of high concern for children and to the manufacture and sale of products containing certain flame retardant chemicals; relating to an interstate chemicals clearinghouse; adding an unlawful act to the Alaska Unfair Trade Practices and Consumer Protection Act; and providing for an effective date - Prohibits the sale of consumer products containing the following flame retardants:
  1. Tris (1,3-dichloro-2-propyl) phosphate (TDCPP)
  2. Tris (2-chloroethyl) phosphate (TCEP)
  3. Tris (1-chloro-2-propyl) phosphate (TCPP)
Massachusetts
Senate Bill 1191
An Act relative to the disclosure of toxic chemicals in children’s products - A list of toxic chemicals in children’s product shall be published by the Department of Environmental Protection. The list shall include, at minimum, the chemicals which have already been listed in the Washington Chemicals of High Concern to Children (CHCC) list
- Promulgate regulations that require the manufacturer or distributor of a children’s product to notify the Department if the product contains a listed chemical exceeding the de minimis level
Massachusetts
Senate Bill 474
An Act for a competitive economy through safer alternatives to toxic chemicals - A list of chemical substances shall be designated annually from the list of chemicals of high concern
- Prohibits the sale of consumer products containing a priority chemical unless the manufacturer has submitted notification to the Department of Environmental Protection

US Recalls Summary (January – February 2017)

In the US, when hazards are identified in consumer products, they will be recalled and published in the Consumer Product Safety Commission (CPSC) Recent Recalls on the CPSC website, which is updated daily. The US recalls from January 1 to February 28, 2017 are summarized below:

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Hazards Frequency
Fall Hazard 9
Fire Hazard 9
Burn Hazard 4
Electric Shock Hazard 4
Injury Hazard 4
Tip-Over Hazard 4
Other Hazards* 13

*Other Hazards include Amputation Hazard, Chemical Hazard, Choking Hazard, Entrapment Hazard and Laceration Hazard with frequency less than 4.


Product Categories Frequency
Furniture 10
Computer / Audio / Video / Other Electronics & Accessories 4
Sporting Goods / Equipment 4
Toys and Childcare Articles 3
Homeware (Non-Food Contact) 3
Lighting 3
Other Categories^ 8

^Other Categories include Fabric / Textile / Garment / Home Textile, Food Contact Material, Home Electrical Appliances (Hair Dryer, Iron, etc.), Homeware (Non-Food Contact), Juvenile Product and Lighting with a frequency of less than 4.

Download the complete Recall Cases Summary – US (Last Update Date: February 28, 2017)


Canada Recalls Summary (January – February 2017)

In Canada, when hazards are identified in consumer products, they will be recalled and published in the Recalls and Safety Alerts Database on the Health Canada website, which is updated daily. The Canada recalls from January 1 to February 28, 2017 are summarized below:

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Hazards Frequency
Fire Hazard 6
Injury Hazard 5
Fall Hazard 5
Choking Hazard 4
Flammability Hazard 4
Other Hazards* 9

*Other Hazards include Burn Hazard, Chemical Hazard, Electric Shock Hazard and Laceration Hazard with a frequency of less than 4.


Product Categories Frequency
Furniture 5
Fabric / Textile / Garment / Home Textile 5
Toys and Childcare Articles 5
Home Electrical Appliances (Hair Dryer, Iron, etc.) 3
Sports/Fitness Equipment 3
Food Contact Material 3
Other Categories^ 5

^Other Categories include Candles & Burning Items and Accessories, Computer / Audio / Video / Other Electronics & Accessories, Juvenile Products and Lighting with a frequency of less than 3.

Download the compete Recall Cases Summary – Canada (January – February 2017)


EUROPE NEWS

ECHA Approves Amendment of Annex XVII List of Restriction Introducing DecaBDE

On February 10, 2017, Commission Regulation (EU) 2017/227 was published to add Decabromodiphenyl ether (DecaBDE) to Annex XVII List of Restriction under Regulation (EC) No. 1907/2006 (REACH). The effective date of the regulation was March 2, 2017.

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Starting March 2, 2019, decaBDE is restricted and shall not be manufactured or placed on the market. The summary of restriction are as follows:

Item Chemical Chemical Abstract Service (CAS) Number (Euopean Community (EC) Number) Conditions
67 Bis(pentabromophenyl)ether(decabromodiphenyl ether; decaBDE) 1163-19-5 (214-604-9)
  1. Shall not be manufactured and placed on the market as a substance on its own after March 2, 2019.
  2. Shall not be used in the production of, or placed on the market in
    • Another substance, as a constituent
    • A mixture
    • An article in a concentration equal to or greater than 0.1 %

In addition, the restriction does not apply to electrical and electronic product within the scope of Directive 2011/65/EU (RoHS 2).


ECHA Proposes Amendment of Annex XVII List of Restriction Introducing Two New Chemicals

In February 2017, the European Chemical Agency (ECHA) proposed to amend Annex XVII of Regulation (EC) No. 1907/2006 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) through World Trade Organization (WTO) notifications. The added chemicals are Octamethylcyclotetrasiloxane (D4) and Decamethylcyclopentasiloxane (D5).

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

Item Chemical Chemical Abstract Service (CAS) Number (Euopean Community (EC) Number) Conditions
70 Octamethylcyclotetrasiloxane (D4)
Decamethylcyclopentasiloxane (D5)
556-67-2 (209-136-7)
541-02-6 (208-764-6)
  1. Shall not be placed on the market in wash-off cosmetic products in a concentration equal to or greater than 0.1% by weight
(Wash-off cosmetic products mean cosmetic products that are washed off with water after application)

In addition, the restriction does not apply to electrical and electronic product within the scope of Directive 2011/65/EU (RoHS 2).


ECHA Issues a Draft Guidance for PAH Restriction

On January 23, 2017, the European Chemical Agency (ECHA) issued a draft Guideline on the Scope of Restriction, Polycyclic Aromatic Hydrocarbons (PAHs) under Entry 50 of Annex XVII in Regulation (EC) No. 1907/2006 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

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To assist producers, importers and distributors in complying with the PAHs restriction under REACH, a draft guideline was published in order to provide clear definition to the products that are within the scope.

Generally according to the guideline, PAHs in consumer products including toys may be found in the following sources:

  1. Use of mineral oil- or coal-based extender or plasticizer oils in the production of rubber and plastics
  2. Carbon black (soot), which is intentionally added to elastomers to achieve the properties of the material (Examples include: color, damping, flexibility, or solubility in the polymer matrix)
  3. Plastic materials, lacquers or varnishes
  4. Coatings (Example: plastic coating made of synthetic organic polymers)

Apart from the sources, examples of articles within or excluded from the scope of the restriction are summarized below:

Example articles within the scope Example articles excluded from the scope
- Toys
- Sport equipment such as bicycles, golf clubs
- Household utensils, trolleys, walking frames
- Tools for domestic use
- Clothing, footwear, gloves and sportswear
- Watch-straps, wrist-bands, masks, head-bands
- Inaccessible or internal components
- Components that are only accessed during simple maintenance or upgrading work (e.g. printer cartridges, batteries and battery compartment)
- Articles or components in short and infrequent contact with the skin or oral cavity

Currently the comment period of the draft guideline is opened until April 19, 2017.


CEN Publishes Updated EN Standard Related to N-Nitrosamines and N-Nitrosatable Substances

The European Committee for Standardization (CEN) published updated standards, EN 71-12: 2016 Safety of Toys - Part 12: N-Nitrosamines and N-nitrosatable Substances in December 2016 and EN 12868:2017 Child Use and Care Articles - Method for Determining the Release of N-Nitrosamines and N-Nitrosatable Substances from Elastomer or Rubber Teats and Soothers in January 2017.

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In EN 71-12:2016, requirements and test methods are set forth for N-nitrosamines and N-nitrosatable substances for the following products:

  1. Toys and parts of toys made from elastomers and intended for use by children under 36 months
  2. Toys and parts of toys made from elastomers and intended to be placed in the mouth
  3. Finger paints for children under 36 months

Examples of toys made from elastomers are balloons and teethers

Currently, the old version EN 71-12:2013 is still harmonized under Toys Safety Directive 2009/48/EC.

Meanwhile in EN 12868:2017, a determination method is provided for testing the release of N-nitrosamines and the content of N-nitrosatable substances in elastomer or rubber teats in contact with an artificial saliva salt solution in order to verify compliance to Directive 93/11/EEC. The limits set forth in the directive are summarized below:

  • 0.01 mg in total of N-nitrosamines released per kg
  • 0.1 mg in total of N-nitrosatable substances per kg

France – Decree Restricting Foam Toy Puzzle Mats Containing Formamide

In December 2016, the Decree of December 22, 2016 entered into force to extend the restriction on toy puzzle mats containing formamide. These items are banned from import and placing on the market.

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In July 2011, France adopted an interim restriction on formamide in toy puzzle mats. This new publication extends the restriction for the fifth time, while also repealing the previous Decree of October 26, 2014.

A summary of the new decree is as follows:

Substances CAS No. Scope Limit Effective Date
Formamide 71-12-7 Toy puzzle mats ≤ 200 mg/kg December 9, 2016

The decree is effective immediately until May 23, 2017 and the restriction will be continued by European Commission Directive 2015/2115 thereafter.



This summary is not intended to be exhaustive nor should it be construed as legal advice.

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