December 2016 Regulatory Update

NORTH AMERICA NEWS

US CPSC and CBP Collaborate to Keep Unsafe Toys Off Store Shelves

This holiday season, the Consumer Product Safety Commission (CPSC) and Customs and Border Protection (CBP) are joining forces to stop dangerous toys which violate safety standards from reaching children in the United States (US).

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On November 17, 2016, the CPSC reiterated their commitment to work alongside CBP to stop shipments of dangerous toys and issued a new report indicating that there were an estimated 185,500 toy-related, emergency department-treated injuries and 11 deaths in 2015 to children younger than 15 years old. Most of the injuries were related to riding toys, specifically non-motorized scooters and they included cuts and bruises, with the head and face being the most commonly affected areas.

Safety tips were also provided for consumers to keep in mind:

  1. Magnets: Children’s magnetic toys are covered by a strong safety standard (ASTM F963) that aims to prevent magnets from being swallowed.
  2. Balloons: Children can choke or suffocate on deflated or broken balloons. Keep deflated balloons away from children younger than 8 years old. Discard torn balloons immediately.
  3. Small balls and other toys with small parts: For children younger than age 3, avoid toys with small parts, which can cause choking.
  4. Scooters and other riding toys: Riding toys, skateboards and in-line skates go fast, and falls could be deadly. Helmets and safety gear should be worn properly at all times, and they should be sized to fit.

US CPSC Issues Statement Regarding Crib Bumper Safety

On November 3, 2016, the Consumer Product Safety Commission (CPSC) issued a statement jointly published by Chairman Elliot Kaye and several Commissioners recommending parents and caregivers not use padded crib bumpers. The statement strongly advises the public to stop using padded crib bumpers as dozens of infants and children have died each year from soft bedding in their sleeping environments.

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Crib bumpers are infant bedding accessories intended to line the sides of an infant’s crib. They are commonly made of fabric and fiberfill or foam panels. Although some caregivers may think that the bumpers assist in protecting against head injury or limb entrapment, the CPSC believes that there is a clear risk of injury or death associated and the risk definitely outweighs any purported benefits.

The CPSC also advises parents and caregivers that the best way to have a safe sleep environment is to assemble crib with only an appropriately sized mattress and a snugly fitted sheet. The parent should never place soft bedding or other padded objects such as padded bumpers, pillows, sleep positioners, stuffed animals or cushions in child’s crib, bassinet or play yard.


US CPSC Issues Notice Regarding Standard for the Flammability (Open Flame) of Mattress Sets

On November 9, 2016, the Consumer Product Safety Commission (CPSC) issued Notice of Availability of Regulatory of Flexibility Act (RFA) Section 610 Review of the Standard for the Flammability (Open Flame) of Mattress Sets. The notice concludes that the 16 CFR part 1633 mattress standard should be maintained without change.

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16 CFR part 1633, Standard for the Flammability (Open Flame) of Mattress Sets under the Flammable Fabrics Act (FFA) sets forth test procedures and performance requirements that all mattress sets must meet before being introduced into commerce.

Section 610 of the FFA requires federal agencies including the CPSC to review regulations that have a significant economic impact on a substantial number of small entities within 10 years of their adoption as final rules. Therefore, on April 3, 2015, the CPSC issued a notice to propose a review of the mattress standard and received 16 written comments from different sectors including manufacturers and third party testing bodies. The comment shows strong support for the mattress standard and the CPSC staff does not see the need to have the standard updated at this moment.


US EPA Proposes to Add NPEs to the TRI List

On November 16, 2016, the Environmental Protection Agency (EPA) proposed a rule to add Nonylphenol Ethoxylates (NPEs) to the Toxics Release Inventory (TRI) list of reportable chemicals.

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The TRI tracks the management of listed toxic chemicals that may pose a threat to human health and the environment. United States facilities in different industry sectors must report annually how much of each chemical is released into the environment or managed through recycling, energy recovery and treatment.

The reason for this proposed inclusion is that the EPA believes longer-chain NPEs can break down to short-chain NPEs and nonylphenol which are toxic to aquatic organisms. Therefore, once it is approved to add NPEs to the TRI list, facilities that manufacture, process or otherwise use these chemicals in amounts above established levels must submit annual TRI reports.

NPEs are nonionic surfactants widely used in adhesives, detergents, wetting agents, paints, coatings etc. There are 13 NPEs proposed by the EPA for inclusion in the TRI list as listed below:

Chemical Name CAS Number
Ethanol,2-[2-[2-[2-(4-nonylphenoxy)ethoxy]ethoxy]ethoxy]- 7311-27-5
Poly(oxy-1,2-ethanediyl), α-(nonylphenyl)-ω-hydroxy- 9016-45-9
Ethanol, 2-[2-(4-nonylphenoxy)ethoxy]- 20427-84-3
Poly(oxy-1,2-ethanediyl), α-(4-nonylphenyl)-ω-hydroxy- 26027-38-3
3,6,9,12,15,18,21,24-Octaoxahexacosan-1-ol, 26-(nonylphenoxy)- 26571-11-9
Ethanol, 2-[2-(nonylphenoxy)ethoxy]- 27176-93-8
3,6,9,12,15,18,21-Heptaoxatricosan-l-ol, 23-(nonylphenoxy)- 27177-05-5
3,6,9,12,15,18,21,24,27-Nonaoxanonacosan-1-ol, 29-(nonylphenoxy)- 27177-08-8
Ethanol, 2-(nonylphenoxy)- 27986-36-3
Poly(oxy-1,2-ethanediyl), α-(isononylphenyl)-ω-hydroxy- 37205-87-1
Poly(oxy-1,2-ethanediyl), α-(2-isononylphenyl)-ω-hydroxy- 51938-25-1
Poly(oxy-1,2-ethanediyl), α-(nonylphenyl)-ω-hydroxy-, branched 68412-54-4
Poly(oxy-1,2-ethanediyl), α-(4-nonylphenyl)-ω-hydroxy-, branched 127087-87-0

US EPA Adds Flame Retardants to the TRI List

On November 28, 2016, the Environmental Protection Agency (EPA) finalized a rule adding the hexabromocyclododecane (HBCD) category to the Toxics Release Inventory (TRI) list of reportable chemicals.

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The TRI tracks the management of certain listed toxic chemicals that may pose a threat to human health and the environment. United States facilities in different industry sectors must report annually how much of each chemical is released into the environment or managed through recycling, energy recovery and treatment.

The reason for this category inclusion is that the EPA determined that HBCD presents potential human developmental and reproductive health concerns. HBCD is also highly toxic to aquatic and land dwelling organisms, bioaccumulates and is persistent in the environment. Therefore, facilities that manufacture, process or otherwise use these chemicals in amounts above 100 pounds must submit annual TRI reports.

HBCD is a brominated flame retardant used widely in expanded polystyrene foam and extruded polystyrene foam. HBCD may also be used as a flame retardant in textiles. There are 2 HBCDs added to the list:

Chemical Name CAS Number
1,2,5,6,9,10-hexabromocyclododecane 3194-55-6
hexabromocyclododecane 25637-99-4

Updates of ASTM Standards

Below is a summary of recently updated ASTM standards that may be of interest to our clients:

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Below is a summary of recently updated ASTM standards that may be of interest to our clients:

CPSIA / CFR Reference ASTM Standard No. Detail
- ASTM F3118 – 16a

Standard Consumer Safety Specification for Infant Inclined Sleep Products

Establishes safety performance requirements, test methods, and labeling requirements to minimize the hazards to infants presented by infant inclined sleep products as identified in the introduction.

- ASTM F2879 – 16

Standard Specification for Eye Protective Devices for Airsoft Sports

Applies to eye protective devices (EPDs) designed for use by participants in the sport of airsoft with 6-mm airsoft projectiles. These EPDs are designed to minimize or significantly reduce injury to the eye and adnexa as a result of impact and penetration of airsoft projectiles.

- ASTM F1045 – 16

Standard Performance Specification for Ice Hockey Helmets

Covers performance requirements for ice hockey helmets to reduce the risk of injury to the head without compromising the form and appeal of the game.


US State of California Issues Latest List of Proposition 65 NSRLs and MADLs

On October 7, 2016, the Office of Environmental Health Hazard Assessment (OEHHA) issued a list summarizing the latest No Significant Risk Levels (NSRLs) for Carcinogens and Maximum Allowable Dose Levels (MADLs) for reproductive toxic chemicals. The NSRLs and MADLs provide safe harbor limits for Proposition 65 chemicals.

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For Proposition 65 chemicals, if the exposure levels and discharges to drinking water sources are below the safe harbor levels (NSRLs and MADLs), the labeling requirement of Proposition 65 will be exempted. In some cases, enforcement actions may have resulted in negotiated exposure levels relative to specific settlement agreements.


US City and County of San Francisco, California Prohibition of Certain Polystyrene Foam Products Soon to be In Force

On January 1, 2017, the ban of certain products made from polystyrene foam will be implemented at the first phase (See Regulatory Recap: August 2016 Issue).

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The following products are subject to the first phase of polystyrene foam prohibition:

  • Food service ware that is not recyclable nor compostable
  • Packing materials including shipping boxes and packing peanuts
  • Coolers, ice chests or similar containers
  • Pool or beach toys
  • Dock floats, mooring buoys or anchor or navigation markers

On July 1, 2017, the following products are subject to the second phase of polystyrene foam prohibition:

  • Egg cartons and meats trays that are not recyclable nor compostable

US State of Washington Proposes Changes to the CHCC Reporting Rule and List

In October 2016, the Department of Ecology (DOE) proposed to amend Chapter 173-334 WAC Children’s Safe Products – Reporting Rule under the Children’s Safe Product Act (CPSA).

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The key proposed changes to the reporting rule are summarized below:

  • Adds Definition:
    • De minimis level: the Practical Quantification Limit (PQL) for intentionally added chemicals, or the concentration of 100 ppm for contaminant chemicals.
    • Internal component: a children’s product component that during reasonably foreseeable use and abuse of the product would not come into direct contact with the child’s skin or mouth.
  • Provides an updated schedule for manufacturers to report children’s product containing a CHCC that is higher than the de minimis level:
    On January 1, 2018 and annually thereafter, the report is due on January 1, 2018 for children’s products that are sold or offered for sale in Washington between January 1 and December 31, 2017.
  • If the reporting party determines that there is no change in the information required to be reported since the prior annual notice, the party may copy the previous notice and resubmit the same data without submitting a written statement indicating that the previous reported data is still valid.
  • Clarifies that the annual reporting for internal components will no longer be required based on a case-by-case evaluation by the DOE except by amendment of the rule.
  • Removes requirements related to the manufacturer product category and reporting tier system.

Apart from the proposed reporting rule amendments, the DOE issued potential changes to the current CHCC list in a separate notice as noted in the below table. These chemicals will continue to be evaluated by the DOE before addition to and delisting from the CHCC list:

  • Potential added chemicals:
    CAS Number Acronym Chemical Name
    78-33-1 TBPP Tris(p-tert-butylphenyl) phosphate
    80-90-1 BPS Bisphenol S
    84-61-7 DCHP Dicyclohexyl phthalate
    84-69-5 DIBP Diisobutyl phthalate
    115-86-6 TPP* or TPHP Triphenyl phosphate
    126-72-7 TDBPP Tris (2,3-dibromopropyl) phosphate
    126-73-8 TNBP or TBP Tri-n-butyl phosphate or Tributyl phosphate
    335-67-1 PFOA Perfluorooctanoic acid and related substances
    620-92-8 BPF Bisphenol F
    1241-94-7 EHDPP or DPEHP Ethylhexyl diphenyl phosphate or Diphenyl (2ethylhexyl) phosphate
    1330-78-5 TCP Tricresyl phosphate
    13674-84-5 TCPP* or TCIPP Tris (2chloroisopropyl) phosphate
    26040-51-7 TBPH* or BEH-TEBP Bis (2-ethylhexyl) 2,3,4,5- tetra bromophthalate
    38051-10-4 V6* V6 (based onTCEP as an impurity)
    68937-41-7 IPTPP* Isopropylated triphenyl phosphate
    84852-53-9 DBDPE Decabromodiphenylethane
    85535-84-8 SCCP Short-chain chlorinated paraffins
    183658-27-7 TBB* or EH-TBB 2-ethylhexyl-2,3,4,5- tetrabromobenzoate

    * Flame retardants identified in RCW 70.240.035

  • Potential delisted chemicals:
    CAS Number Acronym Chemical Name
    85-44-9 --- Phthalic anhydride
    7439-98-7 Mo Molybdenum

Remarks: Another table listing chemicals from stakeholder comments that are not currently under consideration is not addressed in this recap. For more detail, please refer to the notice.


Canada Proposes Updated Children’s Jewellery Regulations

On December 3, 2016, an update to the Children’s Jewellery Regulations was proposed through the Canada Gazette. This update aims to reduce adverse health effects resulting from exposure to lead and cadmium among young children because of their natural habit to place objects into their mouth.

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Compared to current Children’s Jewellery Regulations under the Canada Consumer Product Safety Act (CPSA), the proposed updates to the regulations change the lead and cadmium content requirements as summarized below:

Cadmium Lead
Current regulations Not required Total Limit: 600 mg/kg
Migratable Limit: 90 mg/kg
Updated regulations Total Limit: 130 mg/kg
(for children’s jewellery that is small enough to be swallowed by a child)
Total Limit: 90 mg/kg

The updated regulations will enter into force six months after the adopted version has been published in the Canada Gazette. Meanwhile, current regulations will be repealed.


Canada Proposes Updated Consumer Products Containing Lead Regulations

On December 3, 2016, as part of the lead risk reduction strategy for consumer products, updates to the Consumer Products Containing Lead Regulations were proposed in the Canada Gazette. The updates aim to reduce health risks from exposure to lead, especially in young children.

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Once approved, the proposed Consumer Products Containing Lead Regulations will replace the current version. The total lead content limit remains unchanged (90 mg/kg) however revisions to the regulations are summarized below:

  • Apart from products that are brought into mouth, the scope of the regulations is expanded to include following products:
    • Any clothing or clothing accessory that is intended for use by a child under 14 years of age
    • A product that is intended for use in learning or play by a child under 14 years of age (age requirement is increased from 3 to 14 years of age)
    • A book or similar printed product that is intended for a child under 14 years of age, except if it is:
      • Printed on paper or cardboard, and
      • Printed and bound in a conventional manner using conventional materials
    • A product whose primary purpose is to facilitate the relaxation, sleep, hygiene, carrying or transportation of a child under 4 years of age
  • Removes the standard EN 71-3:1994/A1:2000/AC:2002 Safety of Toys – Part 3: Migration of Certain Elements from the verification method of 90 mg/kg lead release for exemption and requires good laboratory practice testing for demonstration.

The updated regulations will enter into force six months after the adopted version has been published in Canada Gazette.


Health Canada Updates Guidance Web Page for Cosmetic Notification

On November 25, 2016, Health Canada (HC) published an updated guidance document web page for the Cosmetic Notification Form. The guidance contains general information related to the Food and Drug Act and Cosmetic Regulations, and provides information on how to complete a cosmetic notification form correctly.

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In general, a cosmetic notification form must be submitted by the manufacturer or importer for each unique cosmetic product to notify HC within 10 days after they first sell a cosmetic in Canada. Therefore, a guidance document was issued to support manufacturers or importers for the cosmetic notification. Failure to notify may result in a product being denied entry into Canada or removed from sale.

The cosmetic notification form is comprised of nine sections and they are:

  • Notification Type
  • Product
  • Notifier
  • Manufacturing and Distribution
  • Product Ingredients
  • Documents and pictures
  • How to submit your Cosmetic Notification Form
  • How to save your Cosmetic Notification Form
  • How to view/edit your previous Cosmetic Notification Form

Canada Proposes Microbeads in Toiletries Regulations

On November 5, 2016, the Microbeads in Toiletries Regulations were proposed in Vol. 150, No. 45 of the Canada Gazette. The proposed regulations prohibit the manufacture, sale and importation of any toiletries containing microbeads.

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Toiletries are defined as any personal hair, skin, teeth or mouth care products for cleansing or hygiene, including exfoliants and any of those products that is also a natural health products or a non-prescription drugs. However, prescription drugs are not applicable to this regulation and will not be subject to the prohibition addressed.

The proposed enforcement date for the regulations is January 1, 2018 upon approval and the timeline for implementation is summarized below:

Date Action
January 1, 2018 Prohibit the manufacture or importation of any toiletries, which are not natural health products or non-prescription drugs, containing microbeads
July 1, 2018 Prohibit the manufacture or importation of any toiletries, which are also natural health products or non-prescription drugs, containing microbeads
Prohibit the sale of any toiletries, which are not natural health products or non-prescription drugs containing microbeads
July 1, 2019 Prohibit the sale of any toiletries, which are also natural health products or non-prescription drugs, containing microbeads

Apart from prohibition, the proposed regulation also addresses that the presence of microbeads must be determined by an ISO/IEC 17025 accredited laboratory covering the scope of determination of microbeads. The determination may also be conducted by a laboratory that holds a certificate of accreditation issued under the Environment Quality Act, CQLR c. Q-2 covering the scope of determination of microbeads.


EUROPE NEWS

ECHA Issues Recommendation Regarding Inclusion of 9 SVHC Chemicals in the REACH Authorization List

On November 10, 2016, the European Chemical Agency (ECHA) issued 7th Annex XIV Recommendation to propose inclusion of 9 Substances of Very High Concern (SVHC) in Annex XIV, List of Authorisation of Regulation (EC) No. 1907/2006 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

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The details for the 9 proposed SVHCs to be added to Annex XIV, List of Authorisation, are listed below:

Substance CAS Number EC Number SVHC-relevant intrinsic properties
1,2- Benzenedicarboxylic acid, dihexyl ester, branched and linear 68515-50-4 271-093-5 Toxic for Reproduction (category 1B)
Dihexyl phthalate 84-75-3 201-559-5 Toxic for Reproduction (category 1B)
Trixylyl phosphate 25155-23-1 246-677-8 Toxic for Reproduction (category 1B)
Sodium perborate; perboric acid, sodium salt - 239-172-9;
234-390-0
Toxic for Reproduction (category 1B)
Sodium peroxometaborate 7632-04-4 231-556-4 Toxic for Reproduction (category 1B)
Pentalead tetraoxide sulphate 12065-90-6 235-067-7 Toxic for Reproduction (category 1A)
Tetralead trioxide sulphate 12202-17-4 235-380-9 Toxic for Reproduction (category 1A)
Orange lead (lead tetroxide) 1314-41-6 215-235-6 Toxic for Reproduction (category 1A)
Lead monoxide (lead oxide) 1317-36-8 215-267-0 Toxic for Reproduction (category 1A)

Recall Cases Summary - Europe Recalls Summary (October and November 2016)

In Europe, when hazards are identified in consumer products, the products will be recalled and published in the Rapid Alert System, which is updated weekly. The European recalls for October and November 2016 are summarized below:

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Hazard Frequency
Chemical Hazard 66
Choking Hazard 63
Electric Shock Hazard 43
Injury Hazard 35
Fire Hazard 33
Strangulation Hazard 26
Damage to Hearing Hazard 12
Other Hazards* 31

* Other Hazards include Asphyxiation Hazard, Burn Hazard, Entrapment Hazard, Environment Hazard, Laceration Hazard, Microbial Hazard & Suffocation Hazard with frequency less than 10.


Product Categories Frequency
Toys and Childcare Articles 106
Fabric / Textile / Garment / Home Textile 49
Computer / Audio / Video / Other Electronics & Accessories 24
Lighting 19
Candles & Burning Items and Accessories 16
Other Categories # 51

# Other Categories include Cosmetics / Bodycare, Food Contact Material, Footwear, Furniture, Home Electrical Appliances (Hair Dryer, Iron, etc.), Homeware (Non-food Contact), Jewelry, Watch or other Fashion Accessories, Personal Protective Equipment (excludes eye protection), Sporting Goods / Equipment & Tools and Hardware with frequency less than 10.

Download the complete Recalls Summary – EU (November 2016)


ASIA NEWS

China NHFPC Issues Updated Food Contact Material Standards

On November 18, 2016, the China National Health and Family Planning Commission of the People’s Republic of China (NHFPC) approved and issued a list of updated or new standards related to food contact materials in accordance to the Food Safety Law.

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There are total 53 food contact materials standards issued and they are summarized below:

Standard Code Title Implementation Date
GB 4806.1-2016 National Food Safety Standard - Food Contact Materials and Products - General Safety Requirements October 19, 2017
GB 4806.3-2016 National Food Safety Standard – Enamel Products April 19, 2017
GB 4806.4-2016 National Food Safety Standard – Ceramic Products April 19, 2017
GB 4806.5-2016 National Food Safety Standard – Glass Products April 19, 2017
GB 4806.6-2016 National Food Safety Standard – Food Contact Plastics Resins April 19, 2017
GB 4806.7-2016 National Food Safety Standard – Food Contact Plastic Materials and Articles April 19, 2017
GB 4806.8-2016 National Food Safety Standard – Food Contact Paper and Paperboard Materials and Products April 19, 2017
GB 4806.9-2016 National Food Safety Standard – Food Contact Metallic Materials and Products April 19, 2017
GB 4806.10-2016 National Food Safety Standard – Food Contact Coatings Materials and Surface Coatings April 19, 2017
GB 4806.11-2016 National Food Safety Standard – Food Contact Rubber Materials and Products April 19, 2017
GB 4789.15-2016 National Food Safety Standard – Food Microbiology - Examination Of Mold and Yeast Counts April 19, 2017
GB 5009.156-2016 National Food Safety Standard – Food Contact Materials and Products - Migration Test - General Rules For Preparation April 19, 2017
GB 9685-2016 National Food Safety Standard – Standard For The Use Of Additives In Food Contact Materials and Products October 19, 2017
GB 14934-2016 National Food Safety Standard – Sterilized Food Wares Or Drink Wares April 19, 2017
GB 31604.11-2016 to GB 31604.49-20161 National Food Safety Standard – Food Contact Materials and Products April 19, 2017

1 A total of 39 separated standards which include testing methods for content of different chemicals, for example, heavy metals, phthalates and sulphur dioxides etc.


China MIIT Issues New and Updated Industrial Standards

On October 22, 2016, the Ministry of Industry and Information Technology of the People’s Republic of China (MIIT) published Notice 2016-56 regarding the issuance of industrial standards. 74 out of 605 of the issued standards are related to the textile industry.

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In the notice, 605 industrial standards were issued and they cover the following industries:

Industries Number of Standards Issued
Machinery 220
Aviation 8
Chemical Industry 171
Building Materials 8
Metallurgy 48
Nonferrous Metals 1
Textiles 74
Light 6
Gold 7
Electronic 15
Communication 47

Among the textile standards, they cover different requirements, for example:

  • FZ/T 01028-2016 Textiles - Determination of Flammability - Horizontal Burning Rate
  • FZ/T 01134-2016 Textiles - Quantitative Chemical Analysis - Mixtures of Aromatic Sulfonates with Certain Other Fibers
  • FZ/T 01135-2016 Textiles - Quantitative Chemical Analysis - Mixtures of Polypropylene Fibers with Certain Other Fibers
  • FZ/T 01136-2016 Textiles-Quantitative Chemical Analysis - Carbon Fibers and Mixtures of Certain Other Fibers Etc.

All 74 textile industrial standards will be implemented on April 1, 2016.


China MIIT Issues Comprehensive Standardization System for Lithium-Ion Battery

On October 25, 2016, the Ministry of Industry and Information Technology of the People’s Republic of China (MIIT) issued Notice 2016-155 Related to Comprehensive Standardization System For Lithium-Ion Batteries. The system aims to ensure that the lithium-ion battery industry has a good and sustainable development process to establish new standards or update current standards related to lithium-ion batteries.

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To improve the quality of lithium-ion batteries in the China market, MIIT planned to introduce more lithium-ion battery standards. The total number of standards will be increased from 50 currently to 231 by the year 2020. Meanwhile, current enforced standards will be reviewed and updated to provide better protection to citizens and their properties.

The number of standards expected by 2020 is summarized below:

Number of National Mandatory Standards Number of Industrial Standards
Current 26 24
Expected for new draft 43 138
Total 69 162

Japan New Textile Care Labeling System in Effect

On December 1, 2016, the newly adopted care label system in standard JIS L 0001 (2014) is effective and replaces JIS L0217(1995). Only textile products with new care labeling symbols are allowed to be sold in the Japanese market.

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The symbols used in the care label will align with the international standard ISO 3758:2012 which applies to all textile articles in the form in which they are supplied to the end users. (See Regulatory Recap: March 2016)



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

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