September 2018 Regulatory Update


US State of Minnesota Publishes Educational Handout Related to Children's Personal Care Products

In August 2018, the Minnesota Department of Health issued an educational handout to raise consumers’ awareness of children’s personal care products that contain formaldehyde.

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The use of formaldehyde has been prohibited in children’s products since 2013. The Minnesota Department of Health published an educational handout to educate consumers on the possible health hazards that may be posed when using children’s creams, lotions, and similar personal care products that contain high levels of formaldehyde.

In the educational handout, the below possible health hazards have been identified.

  • Development toxicity, especially in a fetus or as a child develops
  • Formation of cancer, genetic damage, or reproductive harm
  • Endocrine and hormonal system disruption
  • Damage to the nervous system and causing other systemic toxicity

US State of Oregon Proposes Amendments Related to HPCCCH

On July 14, 2018, the Oregon Health Authority proposed to amend Toxic Free Kids Act by updating the list of high priority chemicals of concern (HPCC) for children’s products and the notification requirement.

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According to the proposed amendment, the list of HPCC is updated to include 5 new chemicals while removing 3 existing chemicals simultaneously. The list of HPCC will contain 68 chemicals in total once the amendment is approved.

5 new chemicals to be included

Chemical Name CAS Number
Bisphenol S 80-09-1
Triphenyl phosphate 115-86-6
Tris(1-chloro-2-propyl) phosphate 13674-84-5
Short-chain chlorinated paraffins 85535-84-8
2-ethylhexyl-2,3,4,5-tetrabromobenzoate 183658-27-7

3 previous chemicals to be removed

Chemical Name CAS Number
Phthalic anhydride 85-44-9
Octamethylcyclotetrasiloxane 556-67-2
Molybdenum and molybdenum compounds 7439-98-7

Furthermore, the proposed amendment intended to clarify the notification requirements as below:

  • The number of children's products that contain HPCCCH either sold or offered for sale in Oregon shall be notified once every two years.
  • The notification shall cover the period from January 1, 2018 through December 31, 2019.

US State of California - City and County of San Francisco Announces Prohibition on PFAS in Single-use Food Service Ware

On August 10, 2018, the Mayor of San Francisco approved Ordinance 201-18 in amending the existing Environmental Code on Food Service and Packaging Waste Reduction Ordinance, and became the first city in the US to prohibit perfluoroalkyl and polyfluoroalkyl (PFAS) in single-use food service ware used for prepared, takeout and leftover food.

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PFAS are synthetic chemicals commonly used in single-use service ware products to repel water and grease. They are extremely persistent in the environment and believed to pose adverse health effects to people.

“Food service ware” is defined as any food contact products designed for a single use for prepared foods, such as food containers, utensils, napkins and other similar items. “Food service ware accessories” are also mentioned and covered under the “Food service ware” category for all types of single-use items usually provided alongside prepared food for single usage, such as condiment packets, chopsticks, cup sleeves, stirrers and toothpicks. Items made of completely of aluminum or polystyrene foam coolers and ice chests are not included in the scope of this change.

Starting from January 1, 2020, restaurants, food retailers and vendors in San Francisco are not allowed to use single use food services wares containing PFAS.

Health Canada Announces Safety Concerns Regarding Teething Necklaces Worn

On August 13, 2018, Health Canada issued an informational letter related to possible safety hazards of teething necklaces worn by children under three years of age. Manufacturers, importers and retailers of teething necklaces are responsible for properly addressing the safety concerns and ensuring their products comply with the requirements in the letter.

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Health Canada has identified strangulation, choking and aspiration hazards as posed by teething necklaces worn by children under three years of age. These hazards could potentially lead to the death of a child.

Therefore, by considering current international safety standards and available Canadian regulations, four requirements have been published to determine the safety of teething necklaces.

Hazard Related Requirements
Strangulation 1. ASTM F2923-14 Standard Specification for Consumer Product Safety for Children’s Jewelry Section 13.1 - Breakaway Tension Test (apply a 22.2 N force instead of the 66.6 N (15 lb) force)
2. ASTM F963-17 Standard Consumer Safety Specification for Toy Safety Section - Cords, Straps, and Elastics Containing a Breakaway Feature
Choking and Aspiration 3. Toys Regulations1 (SOR/2011-17) Section 7 - Small parts
Labelling 4. The following warning or its equivalent must appear on the product or its packaging in English and French:
WARNING! Strangulation hazard. Adult supervision required at all times. Always remove for sleep.
MISE EN GARDE! Risque d’étranglement. La supervision d’un adulte est requise en tout temps. Toujours retirer pour dormir.

An evaluation of teething necklaces worn by children under three years of age from the local market is scheduled by Health Canada. Importers, manufacturers or retailers of such products are required to ensure their products meet the performance criteria listed above. Failure to demonstrate compliance may lead to further enforcement, including seizure, orders to take corrective action, a mandatory recall of products, administrative monetary penalties and criminal prosecution.


EU Publishes Updated List of Harmonised Standards Related to Toys

On August 10, 2018, the European Union published Commission Communication C2018 282/02 in the Official Journal of the European Union (OJEU). The journal lists the updated new harmonised standard under Toy Safety Directive 2009/48/EC.

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The 5 harmonised standards are summarized below:

Standard (Updated) Standard (Superseded) Titles
EN 71-1:2014+A1:2018 EN 71-1:2014 Safety of toys — Part 1: Mechanical and physical properties
EN 71-3:2013+A3:2018 EN 71-3:2013+A1:2014 Safety of toys — Part 3: Migration of certain elements
EN 71-7:2014+A2:2018 EN 71-7:2014 Safety of toys — Part 7: Finger paints — Requirements and test methods
EN 71-8:2018 EN 71-8:2011 Safety of toys — Part 8: Activity toys for domestic use
EN 71-14:2014+A1:2017 EN 71-14:2014 Safety of toys — Part 14: Trampolines for domestic use

Starting March 1, 2019, the updated standards are required to show conformity to the toy safety directive.


Australia Recalls Summary (Feb to July 2018)

In Australia, when hazards are identified in consumer products, the products will be recalled and published in the Product Safety Australia, which is updated daily. The Australia recalls from February to July 2018 are summarized below:

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Hazards Frequency
Choking Hazard 25
Injury Hazard 17
Allergic Hazard 13
Fire Hazard 13
Burn Hazard 6
Suffocation Hazard 6
Electric Shock Hazard 5
Other Hazards* 14
*Other Hazards include Chemical Hazard, Drowning Hazard, Entrapment Hazard, Fall Hazard, Laceration Hazard, Microbial Hazard, Sight Hazard, Strangulation Hazard and Tip-Over Hazard with a frequency of less than 5.

Product Categories Frequency
Toys and Childcare Articles 27
Cosmetics/ Bodycare 16
Computer / Audio / Video / Other Electronics & Accessories 11
Furniture 7
Home Electrical Appliances (Hair Dryer, Iron, etc.) 5
Other Categories^ 19
^ Other Categories include Candles & Burning Items and Accessories, Consumer Chemicals, Eyewear, Fabric / Textile / Garment / Home Textile, Food Contact Material, Homeware (Non-food Contact), Lighting Equipment, Sporting Goods / Equipment, Tools and Hardware with a frequency of less than 5.

For a complete list click here


South Korea Amends Children’s Products Safety Standards Regarding Heavy Metals

On July 24, 2018, the Ministry of Trade, Industry and Energy (MOTIE) of South Korea issued Notice 2018-151 in amending Safety Standards for Children’s Products Subject to Safety Confirmation. The amendment relates to heavy metals.

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In South Korea, children’s products are defined as a product or its component that are intended to be used by children under 13 years of age. According to the Special Act on Safety Management of Children’s Products, children’s products shall be tested and certified before entering the market.

In the latest amendment, 8 new heavy metals are introduced with the existing 11 heavy metals in the Harmful Substance Release requirement. A list of the new regulated heavy metals is shown as below.

  1. Aluminum (Al)
  2. Boron (B)
  3. Cobalt (Co)
  4. Manganese (Mn)
  5. Strontium (Sr)
  6. Tin (Sn)
  7. Organic tin
  8. Hexavalent chromium (Cr (Ⅵ))

This amendment will come into force on February 1, 2019 and a transition period is in place until February, 1 2022.


SASO Changes the Implementation Date of the Degradable Plastic Product Regulation

On September 2, 2018, conformity assessment bodies were informed by SASO that the implementation of phase 2 of the SASO Degradable Plastic Products Regulation has been postponed until February 1, 2019.

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SASO Technical Regulation M.A-156-16-03-03 aims at determining the specific environmental requirements of certain degradable plastic products and requiring affixation of the SASO degradable logo on licensed products.

Plastic products under phase 2 include the following:

  • Bubble wrap and cushioning packaging
  • Bags for postal use (such as carrier bags, courier and security bags, magazine and newspaper bags)
  • Disposable tableware (such as plates, spoons and cups)
  • Flower wraps
  • Stretch films (packaging)
  • Overwraps (plastic covers used for secondary packaging)
  • Shrink Films
  • Cling films (packaging)
  • Packaging bags used for bread, nuts, sweets and all bakery items

The summary of the change in the implementation schedule is as follows:

Phase Origin implementation date New implementation date
Phase 1 April 14, 2017 (no change)
Phase 2 February 1, 2018 February 1, 2019
Phase 3 August 1, 2019 (no change)

SASO Drafts Technical Regulation for the Safety of Batteries

On July 20, 2018, the World Trade Organization (WTO) published Notification (G/TBT/N/SAU/1078) regarding the draft Technical Regulation for the General Safety of Electric Batteries by Saudi Standards, Metrology and Quality Organization (SASO).

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The draft Technical Regulation applies to all batteries and accumulators regardless of size, weight and components. Batteries used in military, national defense, and space equipment are excluded from the scope of the regulation.

The draft set forth provisions for the following:

  • Restriction on the use of cadmium and mercury in the manufacture of batteries and their plastic packaging
  • International standards related to the placement of electric batteries on the market
  • Conformity assessment for ensuring compliance
  • Labelling requirements
  • Information to customers prior to placing products on the market, such as information on recycling and disposal
  • Setting the following chemical limits for the marketing and import of batteries:
  General batteries, either independent or built into device or into vehicle Button cell batteries used in alarm systems, medical devices and wireless equipment
Mercury 0.0005% by weight 2% by weight
Cadmium 0.002% by weight 0.002% by weight

Upon approval, the requirement will be adopted and enter into force 1 year from the date of publication in the KSA official gazette.

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