September 2016 Regulatory Update

Currently, the policy statement provides guidance and sets forth general principles and examples for labeling to warn consumers of the potential cancer hazard resulting from certain household products, including paint strippers and adhesive removers, which contain methylene chloride. However, it does not address any acute hazard posed by inhalation of methylene chloride vapor. Therefore, the petitioner, Halogenated Solvents Industry Alliance, Inc., asked the CPSC to expand the policy statement to address the need for an acute hazard warning label on household products containing methylene chloride that are readily available for consumers to purchase and use.

The comment period concerning the petition is open until October 31, 2016.

The standard ASTM F1235-15 defines portable hook-on chairs as usually a legless seat constructed to locate the occupant at a table in such a position and elevation so that the surface of the table can be used as the feeding surface for the occupant (supported solely by the table on which it is mounted).

The standard includes performance requirements and test methods designed to ensure the satisfactory performance, and hence, minimize injuries to children resulting from normal use and reasonably foreseeable misuse or abuse of portable hook-on chairs.

In the direct final rule, a new version of the standard, ASTM F833-15 Standard Consumer Safety Performance Specification for Carriages and Strollers, will be adopted and replace the current 2013b version. The key changes in the new standard are summarized in our previous Regulatory Recap: July 2016.

Key changes of ASTM F2601-16a are summarized below:

1. Definitions of the following terms are updated:
   
   1. "Candle burner" is now defined as a candle holder that restricts the free flow of exiting combustion gases, including, but not limited to, lanterns, potpourri burners and food warmers.
   2. "Shade" is newly added and is defined as a candle accessory placed above the candle, whose function is to modify light from the flame and change the appearance of the candle.
   3. "Topper" is newly added and is defined as a vented candle accessory, which is placed directly on top of a container candle, to modify airflow.
2. There are additional requirements that apply to all types of burners designed to use a candle as a source of heat or light, or both. Candles accessories marketed as food warmers must be assessed to determine whether the item qualifies as a candle burner, a candle holder or other type of accessory and evaluated accordingly. Candle burners and potpourri burners are also subject to the requirements. Updated requirements include:
   
   1. A new warning label is required for all candle burners which have the capability of accepting multiple types of candles, For example: "WARNING: For use with one, single wick container candle (Quantity, size, number of wicks and type of candle) up to 22 ounces."
   2. If the appropriate candle in burner is a tealight, it must meet the requirements of fire safety. If the unit can be used with multiple candles, the unit is to be tested with the largest candle and the maximum number of candles specified on the label of the burner.
   3. The new determination method requires exactly three identical candle burner samples to be tested. Each of them must be tested for at least 8 candle burn cycles. If candle reaches end of life before the 8th cycle, the test will be continued with a new candle until 8 cycles are completed.
   4. For burner that requires tea light or candle that reach end of life within 4 hours, each candle burned to the end of life is considered a complete cycle. Thus, eight complete cycles are required.
   5. Any candle burner shall be tested to the manufacturer’s specified instructions for use.

60-day notices from July and August of 2016 include the following:

The amendments repeal all of the current regulatory provisions of title 27 of the CCR except those added via emergency rulemaking in April 2016, which related to warning for exposures to bisphenol A in canned foods and beverages.

Key changes to the regulation are summarized below:

1. New definitions for terms are provided, for example:
   
   1. Consumer product means any article, or component part thereof, including food that is produced, distributed or sold for the personal use, consumption or enjoyment of a consumer.
   2. Consumer information includes warnings, direction for use, ingredient lists, and nutritional information. It does not include the brand name, product name, company name, location of manufacture or product advertising.
2. The amended regulation will no longer require a person to provide separate warnings to each exposed individual.
3. New regulations outline clearly and separately for:
   
   1. The methods of transmission of each type of warning, and
   2. The content requirements of each type of warning
4. New types of warnings are added to the regulations, for examples (in related to consumer product):
   
   1. Raw wood product exposure warnings
   2. Furniture product exposure warnings

In general for the consumer product exposure warning, following elements are required:

1. A symbol consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline (on the left of word "WARNING")
2. The word "WARNING" in all capital letters and bold print followed by warning detail according to the type of risk, for example:
   
   1. "This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.", or
   2. "This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov."

On April 18, 2016, OEHHA implemented an emergency regulation regarding labeling requirements for BPA for canned and bottled foods and beverages to allow temporary use of a standard point-of-sale warning messages (See Regulatory Recap: April 2016). However, the regulation was only valid for 180 days. Thus, OEHHA proposed an amendment to the CCR in a regular rule making process to continue the use of this standard point-of-sale warning with a sunset date of December 30, 2017.

The CIC is a group of expert scientists appointed by the Governor to identify chemicals that have been clearly shown though scientifically valid testing according to generally accepted principles to cause cancer. The CIC will provide the OEHHA with advice on the prioritization of following chemicals or chemical groups:

1. Aspartame
2. Asphalt and Asphalt Emissions Associated with Road Paving and Asphalt and Asphalt Emissions Associated with Roofing
3. Methyl Chloride
4. Type I Pyrethroids
5. Vinyl Acetate

A 45-day public comment period is open until October 24, 2016 and will be followed by a meeting on November 15, 2016. At the meeting, no listing decisions will be made for the above chemicals. The OEHHA will select chemicals for preparation of hazard identification materials in consideration for listing the chemicals under California Proposition 65 and announce those decisions in a separate notice at a later date.

* Other Hazards include Burn Hazard, Choking Hazard, Crash Hazard, Electric Shock Hazard, Impact Hazard & Laceration Hazard with frequency less than 4.

^ Other categories include Computer / Audio / Video / Other Electronics & Accessories, Consumer Chemicals, Fabric / Textile / Garment / Home Textile, Food Contact Material, Homeware (non-food contact), Jewelry, Juvenile Product, Lighting, Watch or other Fashion Accessories, Tools & Hardware, Toys and Childcare Articles with frequency less than 4.

Download the complete Recalls Summary - US (Last Update Date: August 30, 2016)

* Other Hazards include Chemical Hazard (combination of methylisothiazolinone and methylchloroisothiazolinone (MI/MCI)), Electric Shock Hazard, Entrapment Hazard, Fire Hazard, Impact Hazard, Injury Hazard, Violation of Child-Resistant Closure Requirement, Violation of Flammability Requirements, Violation of Lead Standard & Violation of Packaging and Labeling Requirements with frequency less than 3.

^ Other categories include Computer / audio / video / other electronics & accessories, Consumer Chemicals, Cosmetics / Bodycare, Home Electrical Appliances (Hair dryer, iron, etc.), Homeware (non-food contact), Juvenile Product, Lighting, Tools and Hardware less than 3.

Download the complete Recalls Summary - Canada (Last Update Date: August 30, 2016)

The proposed bill prohibits the manufacturing, importing or distributing of products, including toys, clothing, accessories, jewelry, decorative objects, edible products, sweets, food, furniture and dietary supplements, that contain:

1. Any accessible part handled by children with a lead content greater than 90 ppm (0.009%), or
2. Any articles with a lead content greater than 1000 ppm (0.1%)

In addition to the above products,

1. Paintings for decorative use at home or work shall not contain more than 90 ppm (0.009%) of lead.
2. In water distribution systems for human, animal or irrigation that are composed of more than 1% metal, the metal components shall not contain greater than 2000 ppm (0.2%) lead if components contact water.

After a 2-year transition period, the new LVD replaced Directive 2006/95/EC on April 20, 2016. A list of standards was published that shows presumption of conformity to the new directive. In the list, there are more than one hundred standards, some of which cover common appliances as noted below:

1. EN 60335-2-25:2012 Household and similar electrical appliances - Safety - Part 2-25: Particular requirements for microwave ovens, including combination microwave ovens
2. EN 60335-2-29:2004 Household and similar electrical appliances - Safety - Part 2-29: Particular requirements for battery chargers
3. EN 60335-2-90:2006 Household and similar electrical appliances - Safety - Part 2-90: Particular requirements for commercial microwave ovens
4. EN 61558-2-7:2007 Safety of power transformers, power supplies, reactors and similar products - Part 2-7: Particular requirements and tests for transformers and power supplies for toys
5. EN 62196-2:2012 Plugs, socket-outlets, vehicle connectors and vehicle inlets - Conductive charging of electric vehicles - Part 2: Dimensional compatibility and interchangeability requirements for a.c. pin and contact-tube accessories
6. EN 62368-1:2014 Audio/video, information and communication technology equipment - Part 1: Safety requirements (IEC 62368-1:2014, modified)
7. EN 62477-1:2012 Safety requirements for power electronic converter systems and equipment - Part 1: General
8. EN 62560:2012 Self-ballasted LED-lamps for general lighting services by voltage > 50 V - Safety specifications
9. EN 62868:2015 Organic light emitting diode (OLED) panels for general lighting - Safety requirements

Upon enforcement, the limit of lead will be amended as noted below:

The proposed lead limits are identical to those in the past-proposed amendment from September 25, 2014. However, the date entering into force is now postponed to the 3rd quarter of 2018 instead of the 1st quarter of 2017.

On September 14, 2017, following key amendments will be effective:

1. Currently, the term "hot-fill" is used in the context of setting restrictions on the use of certain materials and articles intended to act as a receptacle for hot food. In order to clarify the scope, a new definition is added for "hot-fill", which means the filling of any article with a food with a temperature not exceeding 100oC at the moment of filling, after which the food cools down to 50 oC or below within 60 minutes, or to 30oC or below within 150 minutes. Therefore, if the material or article is intended to be employed only for hot-fill conditions, only a 2-hour test at 70°C shall be carried out.
2. The specific migration testing condition is updated to include new selection of test temperature:
   

   Worst foreseeable contact temperature	Contact temperature to be selected for testing
   175°C < T ≤ 200°C	200°C
   T > 200°C	225°C

3. Food simulant D2 is updated as follows:
   

   Food Simulant D2 (Before)	Food Simulant D2 (After)
   Vegetable oil	Any vegetable oil containing less than 1% unsaponifiable matter

In addition, effective September 14, 2018, the Specific Migration Limit (SML) for Zinc and Aluminum will be updated as summarized below:

The non-compliant products were recalled due to the fact that children can suffer serious burns when nightwear can catch fire easily and quickly. Therefore, the ACCC Deputy Chair, Delia Rickard, stated that all retailers who sell garment products covered by an Australian mandatory safety standard must verify their products are compliant with the standard.

The Australian mandatory standard, AS/NZS 1249:2003, covers safety testing and labeling information regarding the flammability of children’s nightwear. For some garments, the standard mandates the mass of certain fabrics. For garments made of certain materials such as cotton, the denser the material, the quicker it will burn.

The standard also sets the maximum allowable length for trims and attachments. Lengthy trims or attachments increase the risk of a garment being exposed to a heat source, even when parents or caregivers may think a child is an adequate distance away from the heat source.

Compared to EU RoHS, Singapore RoHS applies to a narrower group of EEE products that are designed for household use, as listed below:

1. Air-conditioner
2. Flat panel display television
3. Mobile phone
4. Phablet
5. Portable computer
6. Refrigerator
7. Washing machine

The restricted chemicals (Limits) set forth in the amendment act are summarized below:

• Cadmium and its compounds (0.01%)
• Hexavalent chromium (0.1%)
• Lead and its compounds (0.1%)
• Mercury and its compounds (0.1%)
• Polybrominated biphenyls (0.1%)
• Polybrominated diphenyl ethers (0.1%)

The implementation date of the Singapore RoHS is July 1, 2017.

In general, the amended ordinance will adopt an updated version of standards (See Regulatory Recap: March 2016) for the following products:

1. Toys
2. Babies dummies
3. Carry cots and stands
4. Children’s high chairs and multi-purpose high chairs for domestic use
5. Children’s paints

The GDA label provides energy value information and the amount of sugar, fat and sodium in the product. Apart from the content information requirement, the notification also provides the format requirements for the GDA label (See Regulatory Recap: July 2016).

The standards provide requirements and applicable testing methods for foods, food additives, food contact materials and nipples (See Regulatory Recap: May 2016), such as:

1. GB 1886-2015 National Food Safety Standard - Food Additives (Part 1 to Part 168)
2. GB 4806.2-2015 National Food Safety Standard - Nipples
3. GB 31604.1-2015 National Food Safety Standard - General Rules for Migration Test of Food Contact Materials and Articles

Compared to the US Consumer Product Safety Improvement Act (CPSIA), the definitions of "Childcare article", "Toy", "School Implement" and "School Supplies" are different (see below).

Within three months from the effective date of this Act, the Philippine Food and Drug Administration (FDA) shall prepare a list of prohibited chemicals and substances, which may cause harm, injury, or death to children. In the list, following chemicals shall also be included:

In the proposed bill, any toys or games containing the following components shall bear a suitable warning on the packaging:

1. Small part intended for use by children less than 14 years of age
2. Any marble intended for use by children less than 14 years of age
3. Any latex balloon or any ball with diameter of 1.75 inches or less intended for use by children less than 10 years of age

The cautionary statement in the warning label shall be written in English. Filipino or both languages. Below warnings are examples: