June 2018 Regulatory Update

NORTH AMERICA NEWS

US State of California OEHHA Approves NSRL for Glyphosate

On April 10, 2018, the California Office of Environmental Health Hazard Assessment (OEHHA) issued notice to approve a No Significant Risk Level (NSRL) for glyphosate, which was listed in 2017 under Proposition 65 as being known to the state of California to cause cancer (See Regulatory Recap: July 2017).

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The chemical details and issued NSRL are provided below:

Chemical Chemical Abstracts Service
Number (CAS No.)
Number (CAS No.) No significant risk
level (NSRL)
Glyphosate 1071-83-6 Cancer 1100 µg/day
The NSRL is effective July 1, 2018.

US Recalls Summary (October 1, 2017 to April 30, 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 October 1, 2017 to April 30, 2018 are summarized below:

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Hazards Frequency
Fire Hazard 30
Fall Hazard 18
Injury Hazard 17
Burn Hazard 16
Choking Hazard 11
Laceration Hazard 10
Other Hazards* 43
*Other Hazards include Allergy Hazard, Chemical Hazard, Crash Hazard, Electric Shock Hazard, Entanglement Hazard, Entrapment Hazard, Explosion Hazard, Failure to Meet Child Resistant Closure Requirement, Impact Hazard, Strangulation Hazard, Suffocation Hazard, Tip-over Hazard and Violation to Federal Flammability Standard with a frequency of less than 10.

Product Categories Frequency
Fabric / Textile / Garment / Home Textile 19
Sporting Goods / Equipment 15
Home Electrical Appliances (Hair Dryer, Iron, etc.) 14
Furniture 12
Toys and Childcare Articles 12
Computer / Audio / Video / Other Electronics & Accessories 11
Other Categories^ 29
^Other Categories include Candles & Burning Items and Accessories, Cosmetics / Bodycare, Food Contact Material, Footwear, Homeware (Non-food Contact), Juvenile Products, Lighting Equipment and Tools and Hardware with a frequency of less than 10.

For the complete Recall List Click Here


Canada Approves Updated Children’s Jewellery Regulations

On May 2, 2018, SOR/2018-82 Children’s Jewellery Regulations were approved and published in 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 (See Regulatory Recap: December 2016).

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The key updates to the regulations change the lead and cadmium content requirements as summarized below:

  Cadmium Lead
Current regulations (SOR/2016-168) Not required Total Limit: 600 mg/kg Migratable Limit: 90 mg/kg
Updated regulations (SOR/2018-82) 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 (SOR/2018-82) will enter into force on November 2, 2018. Meanwhile, the current regulations (SOR/2016-168) will be repealed.

Canada Approves Updated Consumer Products Containing Lead Regulations

On May 2, 2018, SOR/2018-83 Consumer Products Containing Lead Regulations were approved and published in the Canada Gazette. The updates aim to reduce health risks from exposure to lead, especially in young children (See Regulatory Recap: December 2016).

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The approved updated regulations (SOR/2018-83) will replace the current version (SOR/2010-273The Consumer Products Containing Lead (Contact with Mouth) Regulation). The total lead content limit remains unchanged (90 mg/kg), however, revisions have been made to expand the scope and update the test method (See Regulatory Recap: December 2016):

  • 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 (SOR/2018-82) will enter into force on November 2, 2018. Meanwhile, the current regulations (SOR/2010-273) will be repealed.


EUROPE NEWS

ECHA Approves Amendment of Annex XVII List of Restriction Introducing Methanol

On April 19, 2018, Commission Regulation (EU) 2018/589 was published to add Methanol to the Annex XVII List of Restriction under Regulation (EC) No. 1907/2006 (REACH). The effective date of the regulation was May 9, 2018.

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In the regulation, usage of methanol is restricted and enforcement began on May 9, 2018 (See Regulatory Recap: November 2016).

Item Chemical Chemical Abstract Service (CAS) Number (European Community (EC) Number) Conditions
69 Methanol 67-56-1 (200-659-6) Shall not be placed in windscreen washing or defrosting fluids in a concentration equal to or greater than 0.6% by weight.

ECHA Approves Amendment of Annex XVII List of Restriction Introducing NMP

On April 19, 2018, Commission Regulation (EU) 2018/588 was published to add 1-methyl-2-pyrrolidone (NMP) to the Annex XVII List of Restriction under Regulation (EC) No. 1907/2006 (REACH). The effective date of the regulation was May 9, 2018.

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In the regulation, usage of NMP is restricted and enforcement will begin on May 9, 2020 (See Regulatory Recap: August 2017).

Item Chemical Chemical Abstract Service (CAS) Number (European Community (EC) Number) Conditions
71 1-methyl-2-pyrrolidone (NMP) 872-50-4 (212-828-1)
  1. Shall not be placed on the market as a substance on its own or in mixtures in a concentration equal to or greater than 0.3% unless manufacturers, importers and downstream users have included in the relevant chemical safety reports and safety data sheets, the Derived No-Effect Levels (DNELs) relating to exposure to workers of 14.4 mg/m3 for exposure by inhalation and 4.8 mg/kg/day for dermal exposure.
  2. Shall not be manufactured, or used, as a substance on its own or in mixtures in a concentration equal to or greater than 0.3% unless manufacturers and downstream users take the appropriate risk management measures and provide the appropriate operational conditions to ensure that exposure of workers is below the DNELs specified in paragraph 1.

Turkey Proposes Amendment to Prohibit Certain Consumer Products and Adopts Certain Safety Standards

The Turkey Minister of Customs and Trade has published a draft Communique on the Amendment of Communique on Conformity Inspection of Some Consumer Products, Official Gazette No. 29701. The draft communique was amended to include restrictions on certain consumer products and introduced reference standards for conformity assessment.

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The key proposed changes of the Communique No. 29701 are summarized below:

  1. The following consumer products shall be prohibited from being placed in the market:
    1. Novelty lighters
    2. Food imitation products or detachable parts thereof, which may lead to drowning, poisoning, or puncturing or blockage in the digestive system when consumed, sucked or swallowed by consumers and especially by children
    3. Decorative products growing in liquid, which market in stationery, toy shop and school canteens
    4. Balloons filled with volatile gas other than helium gas
  2. The following standards shall be added to the Annex for showing conformity:
    Products Standards
    Baby walking frames TS EN 1273 Child use and care articles - Baby walking frames - Safety requirements and test methods
    Carry cots and stands TS EN 1466 Child care articles - Carry cots and stands - Safety requirements and test methods
    Cribs and cradles for domestic use TS EN 1130-1 Furniture- Cribs and cradles for domestic use- Part 1: Safety requirements
    TS EN 1130-2 Furniture- Cribs and cradles for domestic use- Part 2: Test methods
    Wheeled child conveyances TS EN 1888 Child care articles - Wheeled child conveyances - Safety requirements and test methods
    Soother holder TS EN 12586 Child use and care articles - Soother holder - Safety requirements and test methods
    Children's clothing TS EN 14682 Safety of children's clothing - Cords and drawstrings on children's clothing - Specifications
    TS EN 14878 Textiles - Burning behaviour of children's nightwear - Specification
    TSE CEN/TR 16792 Safety of children's clothing - Recommendations for the design and manufacture of children's clothing - Mechanical safety
    Food imitation products TS EN 71-1 Safety of toys- Part 1:Mechanical and physical properties
    Laser products TS EN 60825-1 Safety of laser products - Part 1: Equipment classification and requirements
    Baby/ Child carriers TS EN 13209-1 Child use and care articles - Child carriers; Safety requirements and test methods - Part 1: Framed back carriers
    TS EN 13209-2 Child use and care articles - Baby carriers - Safety requirements and test methods - Part 2: Soft carrier
    Baby bouncers TS EN 14036 Child use and care articles - Baby bouncers - Safety requirements and test methods

ASIA NEWS

HKSAR Updates Certain Adopted Toys and Children’s Products Safety Standards

On March 26, 2018, the Hong Kong Administrative Region (HKSAR) Government published in the Gazette the Toys and Children’s Products Safety Ordinance (Amendment of Schedules 1 and 2) Notice 2018. The notice amends the Toys and Children’s Products Safety Ordinance (Cap. 424) to update certain adopted safety standards.

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The specified standards for toys and various products have been updated to new versions. The key changes are summarized below:

Product Repealed Version Updated Version
Toys Standards
International standard IEC 62115 Edition 1.2 IEC 62115:2017 Edition 2.0
European standard BS EN 71-12:2013 BS EN 71-12:2016
ASTM standard ASTM F963-11 ASTM F963-17
Products Standards
Babies’ dummies ASTM F963-11 ASTM F963-17
Children’s high chairs and multi-purpose high chairs for domestic use ASTM F404-16a ASTM F404-17
Children’s paints ASTM F963-11 ASTM F963-17
AS/NZS ISO 8124.3:2012 AS/NZS 8124.3:2012 + A1:2016

The updated standards will be effective on August 1, 2018.


Jordan Ministry of Health Prohibits Toy Slime

On March 11, 2018, the Ministry of Health announced to prohibit importation, production, processing, preparation, storage, possession, distribution and sale of toy slime. The prohibition aims to protect children from the potential health risk associated with slime.

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Toy slime is commonly made up of boric acid powder and glue (polyvinylacetate or polyvinyl alcohol). These ingredients should be avoided from touching or inhaling by children since they are harmful to the respiratory system. Therefore, the decision of prohibition comes from the potential health risks caused by the abuse of slime.


Malaysia Proposes to include Labeling Requirements for Feeding Bottles and Teats

In March, 2018, Malaysia published a draft amendment of Regulation 27A, Food Regulation 1985. The draft amendment includes new labeling requirements for feeding bottles and teats.

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The key changes are summarized below:

Generally according to the guideline, PAHs in consumer products including toys may be found in the following sources:

  • Provides definitions:
    • A feed bottle refers to a container used specifically for storing milk or other liquid for consumption by infants and children, which consists of a bottle, lid, teat, and teat cover. It shall also include containers of other forms made intentionally to be used in the same manner as that of a feeding bottle.
    • Teat refers to a substitute nipple that when attached to a container holding a fluid permits a baby to obtain the fluid from the container by sucking
  • The feeding bottle shall be labeled with:
    • Scale mark
    • The words “PENGGUNAAN BOTOL SUSU BOLEH MENJEJAS PENYUSUAN SUSU IBU” in the size and format stated in the requirements
  • The teats shall be labeled with:
    • Shelf life
    • The words “PENGGUNAAN PUTING SUSU BOLEH MENJEJAS PENYUSUAN SUSU IBU” in the size and format stated in the requirements
  • Feeding bottles or teats to be sold separately from feeding bottle shall not contain:
    • On its label any picture, graphic or text, which suggests similarity of the product with a mother’s breast
    • On its label any picture or graphic of infants or parts of infants or any other persons
    • Any descriptive matter attached to or supplied with it for the promotion or advertisement of another product

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