March 2019 Regulatory Update


Updates of ASTM Standards

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

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CPSIA / CFR Reference ASTM Standard No. Detail
--- ASTM F3317-18a Standard Consumer Safety Specification for Infant Floor Seats
Covers the performance requirements and test methods to ensure the satisfactory performance of infant floor seats.
--- ASTM F659-2010 (2018) Standard Specification for Ski and Snowboard Goggles
Covers the minimal requirements of ski and snowboard goggles (intended for non-motorized use) to provide a reasonable degree of protection against snow and moisture striking or lodging in the eye or surrounding soft tissue.
16 CFR 1217 ASTM F1821-18 Standard Consumer Safety Specification for Toddler Beds
Establishes a consumer safety specification regarding the design and performance of toddler beds including the labeling and instructional material requirements.
--- ASTM F1967-18 Standard Consumer Safety Specification for Infant Bath Seats
Establishes performance requirements, test methods, and labeling requirements to promote the safe use of infant bath seats. Products commonly referred to as bath rings also are included in the scope of this specification. Traditional infant bath tubs that are used to bathe an infant are not within the scope of this standard.
--- ASTM F1816-18 Standard Safety Specification for Drawstrings on Children's Upper Outerwear
Covers the performance requirements intended to reduce strangulation and vehicular dragging hazards associated with drawstrings on children's (both boys' and girls') upper outerwear, such as jackets and sweatshirts, which are generally intended to be worn on the exterior of clothes. The sizes covered here are sizes 2T to 12 for neck/hood drawstrings and sizes 2T to 16 for waist/bottom drawstrings. Upper outerwear with fully retractable drawstrings is not addressed here.

US State of California OEHHA Adds New Chemicals to Proposition 65 List

In November 2018, the California Office of Environmental Health Hazard Assessment (OEHHA) added 2 new chemicals to the Proposition 65 List. The new chemicals are:

  1. Gentian violet (Crystal violet)
  2. N-Nitrosohexamethyleneimine

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The added chemicals meet the requirements for listing under the Proposition 65 law as known to the State of California to cause cancer. The chemical details are provided below:

Date of addition Chemical Chemical Abstracts Service Number (CAS No.) Types of Toxicity
November 23, 2018 Gentian violet (Crystal violet) 548-62-9 Cancer
November 23, 2018 N-Nitrosohexamethyleneimine 932-83-2 Cancer

US State of California OEHHA Reviews BPA in Eyewear

The Office of Environmental Health Hazard Assessment (OEHHA) has received a request for a Safe Use Determination (SUD) for exposure to Bisphenol A (BPA) in certain eyewear products manufactured, distributed or sold by the Vision Council member companies.

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Eyewear included in this SUD are prescription glasses, over-the-counter (OTC) reading glasses, non-prescription sunglasses, and safety glasses. If confirmed, the specified eyewear would not require a Prop 65 warning statement for BPA as it will have been determined that exposure to BPA in the specified eyewear does not present significant risk of birth defects or reproduction harm. Exposure to other Prop 65 listed substances in eyewear may still require a Prop 65 warning.

The SUD is currently in a 30-day public comment period. If you manufacture, distribute or sell the specified eyewear, or are otherwise an interested party, written comments should be submitted to OEHHA by April 8, 2019.

US State of Vermont Proposes Amendments to CHCC List

On January 2, 2019, the Government of Vermont announced a proposal to add twenty chemicals to the List of Chemicals of High Concern (CHCC) as well as amend the related reporting rule.

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The proposal refined the requirement for the disclosure and reporting of toxic substances that are intentionally added to children's products. Twenty new chemicals have been proposed to be added based on this new proposal. Manufacturers of children's products will be required to report the presence of chemicals once the proposed rule becomes effective.

The proposed amendment was under a comment period through February 8, 2019.

US State of Alaska Proposes to Prohibit Flame Retardants in Furniture and Juvenile Products

On January 15, 2019, the US State of Alaska proposed Bill AO No. 2019-15 to prohibit the manufacture and sale of certain consumer products containing flame retardants, including children’s products, toys and furniture. A labeling requirement was also introduced for manufacturers to declare that their covered products are free from the prohibited substances.

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According to the proposed bill, the following flame retardants are subject to the prohibition in furniture and juvenile products after January 01, 2020 if they are at a concentration level above 1000 ppm:

  • Halogenated, organophosphorous, organonitrogen, or nanoscale flame retardant chemical
  • The penta- or octa- polybrominated diphenyl ethers, the deca- polybrominated diphenyl ethers (PBDEs), or decabromodiphenyl ether
  • Antimony
  • A chemical defined as a “designated chemical” under Section 105440 of the California Health and Safety Code;
  • A chemical listed on the Washington State Department of Ecology's list of Chemicals of High Concern to Children, and identified as a flame retardant or as a synergist to flame retardants in the rationale for inclusion in the list.

All covered products are required to have a label affixed to declare the presence or absence of the flame retardants as per the following:

  • “The materials in this product contain [or do not contain] added flame retardant chemicals.”

A public consultation was scheduled on February 12, 2019 to receive comments on the bill.

US Recalls Summary (May 1, 2018 to December 20, 2018)

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 May 1, 2018 to December 20, 2018 are summarized below:

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Hazards Frequency
Fire Hazard 24
Burn Hazard 23
Injury Hazard 23
Fall Hazard 21
Choking Hazard 13
Laceration Hazard 11
Other Hazards* 42
*Other Hazards include Cause Adverse Health Issues, Chemical Hazard, Collision Hazard, Crash Hazard, Drowning Hazard, Electric Shock Hazard, Electrocution Hazard, Entrapment Hazard, Explosion Hazard, Functional Failures, Impact Hazard, Poisoning Hazard and Strangulation Hazard with a frequency of less than 10.*Other Hazards include Cause Adverse Health Issues, Chemical Hazard, Collision Hazard, Crash Hazard, Drowning Hazard, Electric Shock Hazard, Electrocution Hazard, Entrapment Hazard, Explosion Hazard, Functional Failures, Impact Hazard, Poisoning Hazard and Strangulation Hazard with a frequency of less than 10.
Product Categories Frequency
Sporting Goods / Equipment 21
Furniture 15
Toys and Childcare Articles 13
Fabric / Textile / Garment / Home Textile 12
Home Electrical Appliances (Hair Dryer, Iron, etc.) 11
Computer / Audio / Video / Other Electronics & Accessories 11
Other Categories^ 49
^Other Categories include Lighting Equipment, Candles & Burning Items and Accessories, Children’s Products, Consumer Chemicals, Cosmetics / Bodycare, Food Contact Material, Footwear, Homeware (Non-food Contact), Jewelry, Watch or other Fashion Accessories, Juvenile Products, Packaging, Personal Protective Equipment, Supplements and Tools and Hardware with a frequency of less than 15.

For the complete list click here

Health Canada Proposes to Amend Tent Regulations

On January 24, 2019, Health Canada issued a notice to propose an amendment to the existing Tent Regulations (SOR/2016-185) and related revisions to the toy regulations (SOR/2011-17).

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In order to address the flammability risks of tents available to consumers, Health Canada is considering replacing the current flammability and labelling requirements of tents with a new National Standard of Canada titled CAN/CGSB-182.1, Flammability and Labelling Requirements for Tents. Play tents are currently excluded from the scope of CAN/CGSB-182.1, but new requirements for these products are proposed to be added into the Toys Regulations.

The proposed amendment is under a comment period through March 23, 2019.

Canada Publishes Guidance Regarding New Asbestos Regulations

Environment and Climate Change Canada published a guidance clarifying the definition of asbestos and the amount allowed in consumer products.

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The Canada Regulation SOR/2018-196 was published in October 2018 to regulate the manufacture, import, sale and use of processed asbestos fibres and consumer products containing asbestos. (See Regulatory Recap: December 2018). According to the regulation, consumer products containing asbestos in greater than trace amounts are prohibited.

In the guidance document, asbestos is defined as:

  • Actinolite
  • Anthophyllite
  • Amosite
  • Chrysotile
  • Crocidolite
  • Tremolite

The presence of asbestos in more than a trace amount can be demonstrated by test results identifying asbestos at 0.1% or more and having both of the following characteristics:

  1. Fibres longer than 5 µm, with a mean aspect ratio greater than 3:1. Aspect ratios should be determined for fibres, not bundles; and
  2. Very thin fibrils, less than 3 µm in width

Canada Province of Manitoba Revokes Bedding and Other Upholstered or Stuffed Articles Regulation

On January 24, 2019, the Government of Manitoba issued a notice to revoke the Bedding and Other Upholstered or Stuffed Articles Regulation, 78/2004. The province of Manitoba became the second province in Canada, after the province of Ontario, to revoke the Upholstered and Stuffed Articles Labeling Regulation. (See Regulatory Recap: January 2019)

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In order to reduce the regulatory burdens, manufacturers, renovators, and home hobby/craft operators of bedding and other upholstered or stuffed articles will no longer be required to register in Manitoba or meet the label standards starting January 1, 2020. The Consumer Protection Office will continue to administer the legislation until the revocation.

It is important to note that upholstered and stuffed articles destined for sale in Quebec are still required to fulfill the necessary labeling requirements in the province.


EU Proposes to Amend Aluminum Requirement in Toys

On December 10, 2018, the European Commission (EC) published a proposed amendment, through World Trade Organization (WTO) notification, to strengthen the migration limits of Aluminum under Toy Safety Directive 2009/48/EC.

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According to the proposed amendment, migration limits of Aluminum were reduced as below:

Material Category I - in dry, brittle, powder-like or pliable toy material Category II - Liquid or sticky toy material Category III - Scrapped-off toy material
Current Aluminum limit (mg/kg) 5,625 1,406 70,000
Proposed new Aluminum limit (mg/kg) 2,250 560 28,130

EU Proposes to Introduce Restrictions for Formaldehyde in Certain Toys

On December 18, 2018, the European Commission (EC) published a proposed amendment, through World Trade Organization (WTO) notification, to introduce formaldehyde restrictions under Toy Safety Directive 2009/48/EC.

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In the proposed amendment, 3 levels of restriction for formaldehyde were established for toys intended for use by children under 36 months or in other toys intended to be placed in the mouth:

Material Requirements Proposed Formaldehyde limit
Polymeric toy material Formaldehyde (Migration) 1.5 mg/L
Resin-bonded wood toy material Formaldehyde (Emission) 0.1 ml/m3
Textile toy material Formaldehyde (Content) 30 mg/kg
Leather toy material 30 mg/kg
Paper toy material 30 mg/kg
Water-based toy material 10 mg/kg

ECHA Proposes Inclusion of 6 SVHCs to the REACH Authorization List

On January 15, 2019, the European Chemical Agency (ECHA) issued Annex XIV Recommendation to propose the inclusion of 6 Substances of Very High Concern (SVHCs) to the List of Authorisation under Annex XIV of Regulation (EC) No. 1907/2006 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

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The details for the 6 proposed SVHCs to be added to the List of Authorisation are listed below:

Substance CAS Number EC Number SVHC-Relevant Intrinsic Properties
2,2-bis(4'-hydroxyphenyl)-4-methylpentane 6807-17-6 401-720-1 Toxic for reproduction
Benzo[k]fluoranthene 207-08-9 205-916-6 Carcinogenic Persistent, bioaccumulative and toxic (PBT) Very persistent and very bioaccumulative (vPvB)
Fluoranthene 206-44-0 205-912-4 Persistent, bioaccumulative and toxic (PBT) Very persistent and very bioaccumulative (vPvB)
Phenanthrene 85-01-8 201-581-5 Very persistent and very bioaccumulative (vPvB)
Pyrene 129-00-0 204-927-3 Persistent, bioaccumulative and toxic (PBT) Very persistent and very bioaccumulative (vPvB)
1,7,7-trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one 15087-24-8 239-139-9 Endocrine disrupting properties

EU Approves Amendment to Food Contact Plastic Regulation

On January 10, 2019, the European Commission (EC) published the Regulation (EU) 2019/37 to amend Regulation (EU) No. 10/2011 regarding plastic materials and articles intended to come into contact with foodstuffs.

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Under the amendment, 3 new substances are approved and may be used in the manufacturing of food contact materials.

  • Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) (CAS 147398-31-0)
  • Dimethyl carbonate (CAS 616-38-6)
  • Isobutane (CAS 75-28-5)

In addition, other changes included:

  • Modifying the specific migration limits and
  • Modifying the usage condition of specific listed substances
  • Clarifying the selection criterion of food simulants condition for overall migration:
  Updated Regulation (EU) 10/2011 Current Regulation (EU) 10/2011
Food simulant to be used for food type Food simulant D1 for aqueous and alcoholic food and milk products with a pH ≥ 4.5 Food simulant D1 for aqueous and alcoholic food and milk products
Food simulant D1 and simulant B for aqueous and alcoholic food and milk products with a pH < 4.5 Food simulant D1 and simulant B for aqueous, acidic and alcoholic food and milk products

The amendment came into force on January 31, 2019.

EU RoHS 2 Directive Enters into Force

On March 31, 2015, the European Commission (EC) approved Directive 2015/863, which adds 4 phthalates to Directive 2011/65/EU Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS). The phthalates restrictions will be effective as of July 22, 2019 except where exemptions are permitted as stated.

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RoHS is a directive regulating the manufacture, import and distribution of Electronics and Electrical Equipment (EEE) within the EU. It bans the use of 6 chemical substances, including Lead, Mercury, Cadmium, Hexavalent Chromium, Polybrominated Biphenyls, and Polybrominated Diphenyl Ether.

In the new RoHS directive (RoHS 3), the requirements expand the scope of monitoring to 10 chemical substances with the addition of 4 phthalates (DEHP, BBP, DBP and DIBP), which are primarily used as plasticisers to soften plastics. Details as below:

Substance CAS number Requirement
Bis(2-ethylhexyl) phthalate (DEHP) 117-81-7 0.1%
Butyl benzyl phthalate (BBP) 85-68-7
Dibutyl phthalate (DBP) 84-74-2
Diisobutyl phthalate (DIBP) 84-69-5

The new restriction on all EEE will enter into force on July 22, 2019.


ISO Publishes Updated Standard for Phthalates Requirements in Toys and Children's products

On November 7, 2018, the International Standard Organization (ISO) published a new version of method standard, ISO 8124-6:2018, regarding the determination of phthalates in toys and children’s products.

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ISO 8124-6 is an international standard for the determination of certain phthalate substances present in toys and children’s products made of plastic, textile, coatings and liquid. Below is a summary of the key revisions in the updated version of the standard:

  • Addition of diisobutyl phthalate (DIBP). Total number of phthalates specified in the standard increases from 6 to 7 (DIBP, DBP, BBP, DEHP, DNOP, DINP and DIDP)
  • Inclusion of liquid material in toys and children’s products in the scope of standard
  • Introduction of ultrasonic bath method


China CNCA Amends the List of Products and Self-declaration Mode under CCC Certification System

On December 5, 2018, the Certification and Accreditation Administration of the People’s Republic of China (CNCA) issued a notice to move 4 items to Self-declaration Mode from compulsory certification and remove 12 items from the list of products under the China Compulsory Certification (CCC) system.

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The CCC system is mandatory for all products specified in the catalogue, including certain types of toys. A CCC certificate is required to be granted and a CCC mark must be affixed to each product being imported, sold or used.

The recent changes are summarized below:
  • The following products are removed from the CCC Product list
Product name Related CCC implementation rule
Reciprocating saws CNCA-C05-01:2014
Internal concrete vibrators CNCA-C05-01:2014
Electric routers and edge trimmers CNCA-C05-01:2014
Electric marble cutters CNCA-C05-01:2014
Wire feeder for welders CNCA-C06-01:2014
TIG welding blow lamps CNCA-C06-01:2014
MIG/MAG welding machines CNCA-C06-01:2014
Electrode holders CNCA-C06-01:2014
Duplicators CNCA-C09-01:2014
Retro reflectors for motor vehicles CNCA-C011-07:2014
Burglary resistant safe cabinets CNCA-C019-02:2014
Burglary resistant safe boxes CNCA-C019-02:2014
  • The following products were changed from compulsory certification to self-declaration procedure.
Product name Adjusted mode
Radio receivers Self-declaration Procedure A (Type testing by internal lab, non-CCC testing lab or designated lab + Self-declaration)
Rear view mirrors for motor vehicles, Rear-view Mirror for Motorcycle Self-declaration Procedure B (Type testing by CCC designated testing lab + Self-declaration)
Vehicle travelling data recorder
Retro-reflective markings

Thailand Publishes New Safety Standard for Portable Power Banks

On January 9, 2019, the Thai Ministry of Industry published a new industrial standard, TIS 2879-2560, regarding safety requirements for portable power banks.

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The standard provides safety requirements, testing specifications, markings and instructions for the use of portable power banks and any portable energy-storage device containing secondary batteries. In addition, external Thai Industrial Standards TIS 2217 and TIS 1561 are also applied to ensure compliance with the security requirements of portable power banks.

The new safety standard came into force on January, 09, 2019.


SABER Platform Update

Saudi Standard, Metrology and Quality Organization (SASO) has decided to change the implementation plan of the SABER system. The implementation will be done based on the release of the technical regulation (TR).

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The first implemented TR is for Gas appliances and their accessories, which was implemented in January 2019. Specific TRs have not been implemented on SABER yet for other products that are regulated by any TR. Certificates of Conformity (CoC) shall be issued through the existing CoC program. For all other non-regulated products, self-declaration according to the approved forms by SASO is sufficient, and shall be applied through the SABER system.

On April 1, 2019, the following regulations will be enforced and implemented on SABER as well:

  1. Gulf Technical Regulations for Low Voltage Electrical Equipment and Appliances
  2. Gulf Technical Regulations for Children’s Toys
  3. Technical Regulations for Lubricating Oil

Products falling within the scope of the above TR will be required to be registered through the SABER system for acquiring a CoC. (See Regulatory Recap: December 2018)

View the complete regulatory update

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