July 2018 Regulatory Update


US CPSC Approves Updated Safety Standard for Non-Full-Size Baby Cribs

On June 6, 2018, the US Consumer Products Safety Commission (CPSC) issued a rule in Federal Register, 83 FR 26206, to approve adoption of the updated version of ASTM F406 with modifications (exclusions to certain clauses) under 16 CFR 1220. The updated standard becomes mandatory for Non-Full-Size Baby Cribs.

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The updated ASTM F406-17 is adopted to replace the F406-10a version in 16 CFR 1220. Various changes in the revisions have been reviewed by the CPSC, and it is aligned with the rules in 16 CFR 1220. The key changes from F406-10a to F406-17 are summarized as follows:

  • Revised the definition of "non-full-size cribs" and "drop-side / drop-gate"
  • Removed allowance to retighten screws and bolts during testing
  • Clarified that the force to be applied on spindles/slats shall be on each side that can be folded or moved
  • Revised a warning to replace the word "play yard" with "product" to cover all non-full-size cribs
  • Clarified the requirement for entrapment in accessories, while adding requirements for cantilevered accessories
  • Clarified that "removing the mattress" is considered one of the two required actions for releasing the "double-action locking or latching device" located under the mattress

The rule will enter into force on September 10, 2018 unless significant adverse comments are received by July 6, 2018.

US CPSC Approves Rule to Adopt Safety Standard for High Chairs

On June 19, 2018, the US Consumer Products Safety Commission (CPSC) approved rule 16 CFR 1231 in Federal Register, 83 FR 28358, regarding safety standard adoption for High Chairs.

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In the rule, the ASTM F404-18 Standard Consumer Safety Specification for High Chairs was adopted to reduce the risk of injury associated with the product. A high chair is defined as:

  • A free-standing chair for a child up to 3 years of age, which has a seating surface more than 15 inches above the floor and elevates the child normally for the purposes of feeding or eating.

The standard also specifies that a high chair may be sold with/without a tray, have adjustable heights, or recline for infants.

The rule will enter into force on June 19, 2019.

US CPSC Proposes Rule to Adopt Safety Standard for Stationary Activity Centers

On June 19, 2018, the US Consumer Products Safety Commission (CPSC) issued proposed rule 16 CFR 1238 in Federal Register, 83 FR 28390 regarding safety standard adoption for Stationary Activity Centers.

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In the proposed rule, the newly published ASTM F2012-18, Standard Consumer Safety Specification for Stationary Activity Centers was adopted in order to reduce the chance of injury associated with stationary activity centers. A stationary activity center is defined as:

  • A freestanding product intended to remain stationary that enables a sitting or standing occupant whose torso is completely surrounded by the product to walk, rock, play, spin or bounce, or all of these, within a limited range of motion.

The proposed rule is currently under comment period until September 4, 2018.

US State of California DTSC Publishes Final 2018-2020 Priority Product Work Plan

In May 2018, the California Department of Toxic Substances Control (DTSC) published the Final 2018-2020 Priority Product Work Plan to identify product categories that will be evaluated for priority products regulated under the Safer Consumer Products (SCP) Regulations.

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In the work plan, a total of seven product categories have been selected and five of them are carry-over categories from the 2015-2017 work plan:

Category Remarks
Beauty, Personal Care, and Hygiene Products Carry-over categories from 2015-2017 work plan
Cleaning Products
Household, School, and Workplace Furnishings and Décor
Building Products and Materials Used in Construction and Renovation
Consumable Office, School, and Business Supplies
Food Packaging New Category
Lead-acid batteries

DTSC will evaluate these product categories through robust scientific review and information exchange with all stakeholders including industry experts, government agencies and academic researchers. Upon approval of a product to be a priority product, the manufacturer of the priority product is required to notify the DTSC.

US State of California OEHHA Approves NSRL for Vinylidene Chloride

On May 17, 2018, the California Office of Environmental Health Hazard Assessment (OEHHA) issued notice to approve No Significant Risk Level (NSRL) for Vinylidene Chloride, which was listed in 2017 under Proposition 65 as being known to the state to cause cancer (See Regulatory Recap: January 2018).

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The chemical details and issued NSRL are provided below:

Chemical Chemical Abstracts Service Number (CAS No.) Types of Toxicity No significant risk level (NSRL)
Vinylidene chloride (1,1-Dichloroethylene) 75-35-4 Cancer 0.88 mg/day

The NSRL was effective July 1, 2018.

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

On May 25, 2018, the California Office of Environmental Health Hazard Assessment (OEHHA) added a new chemical to the Proposition 65 List. The added chemical meets the requirements for listing as known to the State of California to cause cancer for purposes of Proposition 65.

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The chemical details are provided below:

Chemical Chemical Abstracts Service Number (CAS No.) Types of Toxicity
TRIM® VX --- Cancer

US State of California OEHHA Updated Proposition 65 Warning Coming into Force

On August 30, 2018, the updated Proposition 65 Warning requirements under Title 27, California Code of Regulations, Article 6, Clear and Reasonable Warnings will enter into force. Businesses shall comply with the amended requirements by providing safe harbour warnings using the new methods and content.

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Summary of useful information for the amended requirements:

Canada Recalls Summary (February 2018- May 2018)

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 February 1 to May 29, 2018 are summarized below:

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Hazards Frequency
Choking Hazard 20
Burn Hazard 16
Fire Hazard 16
Injury Hazard 10
Chemical Hazard 7
Fall Hazard 6
Other Hazards* 18
*Other Hazards include Toxicity Hazard, Overheating Hazard, Flammability Hazard, Crash Hazard, Inhalation Hazard, Laceration Hazard, Microbial Hazard, Strangulation Hazard and Bruising Hazard with a frequency of less than 6.

Product Categories Frequency
Toys and Childcare Articles 22
Computer / Audio / Video / Other Electronics & Accessories 11
Home Electrical Appliances (Hair Dryer, Iron, etc.) 9
Fabric / Textile / Garment / Home Textile 7
Juvenile Products 4
Sporting Goods / Equipment 4
Other Categories^ 23
^Other Categories include Candles & Burning Items and Accessories, Consumer Chemicals, Cosmetics/ Bodycare, Food Contact Material, Footwear, Furniture, Homeware (Non-food Contact), Outdoor/Recreational Appliance and Tools and Hardware with a frequency of less than 4.

For the complete list click here.


EU Approves Amendment on Migration Limit of Chromium (VI) for Toys

On May 17, 2018, the EU published Commission Directive (EU) 2018/725 in the Official Journal of the EU (OJEU) to lower the migration limit of chromium (VI) for scraped-off materials in Toys Safety Directive 2009/48/EC.

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The new Directive has amended the migration limit of Chromium (VI) in Category III - Scraped-off Toy Materials, in Point 13 of Part III of Annex II in Toys Directive 2009/48/EC, from 0.2 mg/kg to 0.053 mg/kg. The comparison of requirements is shown below:

Elements Category I - in dry, brittle, powder-like or pliable toy material Category II -in liquid or sticky toy material Category III - in scraped-off toy material
Chromium (VI) 0.02 mg/kg 0.005 mg/kg 0.2 mg/kg
0.053 mg/kg

The updated requirement will be effective from November 18, 2019.

REACH - Candidate List Expanded to Include New SVHC

On June 27, 2018, the European Chemicals Agency (ECHA) added several substances of very high concern (SVHC) to the SVHC Candidate List under Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). The added chemicals can be carcinogenic, persistent, bioaccumulative and toxic (PBT), very Persistent and very Bioaccumulative (vPvB), respiratory sensitising properties, endocrine disrupting properties and toxic for reproduction. These additions bring the SVHC Candidate List total to 191 substances.

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The chemicals added are:

  • Benzene-1,2,4-tricarboxylic acid 1,2 anhydride
  • Benzo[ghi]perylene
  • Decamethylcyclopentasiloxane (D5)
  • Dicyclohexyl phthalate (DCHP)
  • Disodium octaborate
  • Dodecamethylcyclohexasiloxane (D6)
  • Ethylenediamine (EDA)
  • Lead
  • Octamethylcyclotetrasiloxane (D4)
  • Terphenyl, hydrogenated

The deadline for notification about the presence of the new SVHCs in articles is December 27, 2018, six months after their inclusion on the List.


Nepal MOFE Proposes Technical Regulations on Toys

On May 30, 2018, the Ministry of Forests and Environment (MOFE) published draft Technical Regulations on Toys. The draft regulations propose to add chemical limit requirements to toys.

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In the draft regulations, the Government of Nepal has established the maximum permissible limit (in concentration) for certain elements in children’s toys and products defined as toys, which is any product or materials designed or clearly intended for use in play by children (0-16 years if age). The requirements are summarized below:

Elements Proposed limit (ppm) Test Methods
Antimony (Sb) 60 (Migration) ISO 8124-3:2010
Arsenic (As) 25 (Migration)
Barium (Ba) 1000 (Migration)
Cadmium (Cd) 75 (Migration)
Chromium (Cr) 60 (Migration)
Mercury (Hg) 60 (Migration)
Selenium (Se) 500 (Migration)
Lead (Pb) Paints and Coating: 90 (Total) Substrate: 100 (Total) X-Ray Fluorescence (XRF) Spectroscopy

Upon approval, the draft regulations will enter into force from the 181st day after the notification was published in the Nepal Gazette.

China: CCC scope change and implementation methods

On June 11, 2018, the China State Administration for Market Regulation and Certification and Accreditation Administration (CNCA) published Notice No. 11 of 2018 to amend the Compulsory Product Certification Catalog under China Compulsory Certification (CCC) Scheme and update the scheme implementation method.

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In the notice, certain products have been removed from the Catalog and therefore, are no longer within the scope of CCC Certification. Some examples are listed:

Starting from October 1, 2018, certain products are added within the scope of the self-declaration evaluation scheme (See Annex 2 of the Notice). Therefore, manufacturers of products that fall within the scope will require CCC compliance in accordance to the new scheme as below (scheme is based on product type):

  • Scheme A: Tested in any laboratory (which is ISO 17025 accredited) and provide self-declaration
  • Scheme B: Tested in designated CCC laboratory and provide self-declaration


Saudi Ministry of Commerce and Investment (MCI) Inspection Teams Seizes Counterfeit Sports Clothing

A joint effort to eliminate marketing counterfeit and fake goods, MCI inspection teams have seized more than 17,000 pieces of counterfeit sports clothing, bearing famous world brands.

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MCI inspection teams, supported by the joint security campaign in Riyadh, have surveyed and checked the warehouses located on Al-Hayer road in Riyadh during which various counterfeit sports clothes bearing fake famous world brands were seized and confiscated. During the investigation, it became clear that the relevant Establishment is importing counterfeit clothes from Turkey bearing fake world brands, and then marketing these items by claiming that they are originals. MCI inspection teams in cooperation with the joint security authorities seized all the fake clothes and closed the relevant warehouses. The information was sent immediately to the General Authority of Customs to follow up on the products that are imported by the said Establishment. The owner was summoned by the Ministry for taking the legal procedures and then referred the case to the public prosecution.

For more details, please visit: https://mci.gov.sa/en/MediaCenter/News/Pages/01-07-18-01.aspx

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