July 2016 Regulatory Update

Upon enforcement, the roadmap of TSCA related actions is summarized below:

In the final rule, a new version of the standard, ASTM F833-15 Standard Consumer Safety Performance Specification for Carriages and Strollers, is adopted and replaces the current 2013b version. The key changes in the new standard are summarized below:

1. Adds definition for “convertible car seat/ stroller” to clarify the difference between convertible car seat/stroller and combined unit of a car seat on a stroller
2. Adds exemption of the following requirements for products that are used as a car seat and that can convert to a stroller using the same restraint as the car seat:
   
   1. Stroller restraint system anchor points
   2. Crotch strap location
3. Requires testing of all applicable positions of the adjustable grab bar or tray which may cause a hazardous opening
4. Requires the warning label (no change in warning content) to be displayed for:
   
   1. Strollers with removable-wheel fork assembly
   2. Three wheeled strollers with a locking front wheel intended to be used for running, jogging or fast walking

In the final rule, the key amendments to the labeling regulations related to medical devices are summarized below:

1. In 21 CFR 801.15, a new section c(I) is added to address the possible labeling formats:
   
   1. Labeling information in English language
   2. In case of distributing solely in Puerto Rico or in a Territory where the predominant language is the one other than English, the predominant language may be used instead of English in labeling information.
   3. A symbol accompanied by explanatory English text or predominant language text
   4. A symbol not accompanied by explanatory text only when the symbol is:
      
      1. Contained in FDA recognized standard in section 514 (c) of the Food, Drug and Cosmetic (FD&C) Act;
      2. Used according to the specifications for use of the symbol set forth in FD&C Act section 514 (c) recognition; and
      3. Explained in paper or electronic symbols glossary that is included in the labeling for the device and the labeling within the packaging
   5. A symbol not accompanied by explanatory text only when the symbol is:
      
      1. Established in a standard developed by Standards Development Organization (SDO);
      2. Not contained in FDA recognized standard in section 514 (c) of the FD&C Act;
      3. Determined by the manufacturer to be likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 5802 (c) of the FD&C Act;
      4. Used according to specifications for use of the symbol set forth in the SDO developed standard; and
      5. Explained in paper or electronic symbols glossary that is included in the labeling for the device and the labeling within the packaging
   6. Symbol “Rx only” or “℞ only”
2. In 21 CFR 801.109 Prescription devices, section (b) is revised to add symbol “Rx only” or “℞ only” as one of the exemption criterion for “adequate directions for use” requirement

Recent settlements from May and June of 2016 include the following:

In addition, a list of recent 60-day notices for May and June of 2016, inclusive of the chemicals and products under scrutiny, are provided in this chart.

The approved MADL (dermal exposure from solid materials) is 3 microgram per day for BPA (See Regulatory Recap: April 2016). It will be effective on October 1, 2016.

According to the proposed bill, reporting of the presence of a CHCC is required if the CHCC is present in any accessible component of the product at a level above the Practical Quantification Level (PQL) if it is intentionally added or present as a contaminant at a concentration above 100 ppm.

In addition to the listed CHCC, all phthalates specified as permanently banned by the Consumer Product Safety Improvement Act (CPSIA) are included in the reporting requirements.

The format to report CHCC is summarized below:

1. Name of the CHCC with Chemical Abstracts Service Registry Number (CAS Number)
2. Description of the category of the product containing the CHCC
3. Amount of chemical by weight or parts per million (ppm)

Once the bill is passed, reporting will be required:

1. Within 90 days of the effective date of the bill; or
2. Within 90 days of the addition of a new chemical to the list of CHCC

Upon enforcement, no retailer of children’s products is allowed to distribute, sell or offer for sale in the County a children product containing certain heavy metal chemicals (See Regulatory Recap: Issue 3, July 2015):

1. 90 ppm lead in surface coatings
2. 100 ppm lead content in accessible parts
3. 75 ppm cadmium
4. 40 ppm for each of the metal elements mercury, antimony, arsenic and cobalt

The law includes a reverse preemption indicating that state or federal laws incorporating either the same or substantially similar provisions and state or federal regulations preempting County law render the County law null and void.

According to the Statutes, no person shall manufacture, sell, offer for sale or distribute children’s jewelry containing 0.0075% (by weight) of cadmium. Children’s jewelry is defined as jewelry that is designed or intended to be used by children under twelve years of age, such as charms, bracelets, pendants, necklaces, earrings and rings.

* Other Hazards include Crash Hazard, Explosion Hazard, Gunshot Hazard, Impact Hazard, Magnet Ingestion Hazard, Microbial Hazard, Suffocation Hazard, Tip-over Hazard, Violation of Federal Flammability Standard and Violation of Lead Paint Standard with frequency less than 5.

^ Other categories include Candles & Burning Items and Accessories, Computer / Audio / Video / Other Electronics & Accessories, Fabric / Textile / Garment / Home Textile, Food Contact Material, Homeware (non-food contact), Lighting and Personal Protective Equipment (exclude eye protection) with frequency less than 5.

Download the complete Recall Cases Summary - US (Last Update Date: June 30, 2016)

The transportation of lithium ion batteries as cargo on passenger aircraft is now prohibited. The prohibition applies to lithium ion batteries packed on their own and not to lithium ion batteries contained in equipment such as cell phones and electronic equipment. In addition, the lithium ion batteries carried by passengers and crew are not subjected to the prohibition.

The transportation of lithium ion and lithium batteries in cargo aircraft is still permitted. Additional requirements for packing instruction are added:

1. Packing Instruction 965 (for lithium ion) of the 2015-2016 ICAO Technical Instructions
2. Packing Instruction 968 (for lithium metal) of the 2015-2016 ICAO Technical Instructions

The above packing instructions have been revised by ICAO to include stricter provisions such as transporting lithium ion batteries at a state of charge not exceeding 30% of the capacity and limiting the number of packages.

There are other key changes in the regulations:

1. National Standard CAN/GCSB-43.151-2012 is replaced by GCSB-43.151-2012
2. If the dangerous goods are covered by UN2037, UN0012, UN0014, UN0055, UN0378 & UN0501, the 150 kg Gross Mass Exemption is not applicable
3. Warning “POISON - INHALATION HAZARD” is replaced by “INHALATION HAZARD”
4. Part 8 “Accidental Release and Imminent Accidental Release Report Requirements” is amended to “Reporting Requirement”. The content of the reporting requirements has changed for:
   
   1. Road, rail and marine reports
   2. Air reports
   3. Security reports

A number of substantial issues relating to cribs, cradles and bassinets safety, including hazards associated with traditional crib drop-sides, crib mattress supports and entrapment hazards from openings in fabric-sided product, have been reported in Canada. As a result, Health Canada issued new regulations for the products, strengthening the construction and performance requirements through:

1. Prohibiting the sale, manufacturing and importing of cribs, cradles and bassinets with sides that are not rigidly attached
2. Updating the structural integrity test method for the mattress supporting cribs and cradles
3. Adding additional performance requirement and test method for crib slat strength
4. Including performance requirement to safeguard against incorrect assembly of structural components
5. Including performance requirement and test method for accessories, such as sleep or change table accessories
6. Including performance requirements for the maximum rest angle and maximum flatness angle
7. Updating the completely bounded openings performance requirement and test method
8. Changing the performance requirement for the maximum height of corner posts from 3 to 1.5 mm
9. Including performance requirement and test method for stability
10. Introducing performance requirements and test method for stands that are designed or advertised for use with cribs, cradles and bassinets
11. Adding performance requirement prohibiting the use of occupant restraints

* Other Hazards include Chemical Hazard, Electric Shock Hazard, Entanglement Hazard, Laceration Hazard, Microbial Hazard, Pinch Hazard, Strangulation Hazard, Violation of Flammability Requirements and Violation of Packaging and Labeling Requirements with frequency less than 5.

^ Other categories include Candles & Burning Items and Accessories, Consumer Chemicals, Computer / Audio / Video / Other Electronics & Accessories, Cosmetics / Bodycare, Fabric / Textile / Garment / Home Textile, Footwear, Food Contact Material, Home Electrical Appliances (Hair dryer, iron, etc.), Homeware (non-food contact), Jewelry, Watch or Other Fashion Accessories and Lighting with frequency less than 5.

Download the complete Recall Case Summary - Canada (Last Update Date: June 30, 2016)

Due to the risk of posing injury to the eyes of consumers, starting from June 1, 2016, the production, sale and distribution of laser pointers with an output power of 1mW or higher and 450 nm was suspended for 60 days. Laser pointers for medical, scientific, industrial or military use are excluded from the suspension. The Resolution also addresses that a new notice to extend the suspension may be issued in the future.

The chemical added is:

1. Benzo[def]chrysene (Benzo [a] pyrene) (EC No. 200-028-5, CAS No. 50-32-8)

The deadline for notification about the presence of the new SVHC in articles is December 20, 2016, six months after its inclusion on the List.

The new requirement is applicable to glass, crystal, ceramic, ceramic and enameled food contact product excluding those covered by DM/4B/COM/001 (See Regulatory Recap: April 2016). The following specific migration limits have been added to the requirement:

1. Specific migration limits established for products made of ceramic and enameled ceramic:

   Category	Lead (mg/L)	Cadmium (mg/L)
   1: Non-refillable and refillable objects (internal depth between the lowest point and horizontal plane passing through the upper edge is less than or equal to 25 mm)	0.8	0.07
   2. Fillable objects other than those covered by category 1 and 3	4.0	0.3
   3. Cooking utensils, packaging and storage container (> 3 Liters), including articles for use in the oven or microwave oven	1.5	0.1
   Oral contact (for product with 20mm external width, measured from the outer edge)	2	0.2

2. Specific migration limits established for products made of glass, crystal, ceramic hob and enameled product (other than ceramic):

   Category	Lead (mg/L)	Cadmium (mg/L)	Chromium (VI) (mg/L)
   1: Non-refillable and refillable objects (internal depth between the lowest point and horizontal plane passing through the upper edge is less than or equal to 25 mm)	0.8	0.07	0.005
   2. Fillable objects other than those covered by category 1 and 3	4.0	0.3	0.03
   3. Cooking utensils, packaging and storage container (> 3 Liters), including articles for use in the oven or microwave oven	1.5	0.1	0.03
   Oral contact (for product with 20mm external width, measured from the outer edge)	2	0.2	0.015

3. In addition to the above requirements, the following specific migration limits are also required for all products addressed in this rule:
   
   1. Aluminum: 1 mg/kg
   2. Cobalt: 0.02 mg/kg
   3. Arsenic: Not detected (detection limit at most equal to 0.002 mg/kg)

In the notification, a list of targeted products is provided with their own test parameters. The products will be audited according to the test parameters as summarized below:

This is the second extension to the original 60-Day interim ban (See Regulatory Recap: April 2016). Currently, the end date of interim ban is extended to July 16, 2016.

The following foods are required to include GDA information on the nutrition label:

1. Snack foods
2. Chocolate and same kind products
3. Bakery products
4. Semi processed foods such as noodles
5. Chilled and frozen ready-to-eat meals

The GDA shall be provided with energy value, sugar, fat and sodium content according to the following format:

1. The information of energy value, sugar, fat and sodium are separated into four vertical cylinders (See following example GDA label)
2. The color of the frames shall be in contrasting colors with the background (black, dark blue or white)
3. The background color of cylinders shall be in white
4. Each line inside the cylinders shall be in black or dark blue and they shall be in the same color of the letters inside