May 2021 Regulatory Update

EUROPE NEWS

European Union (EU) Toy Safety Standard update to EN 71-3:2019+A1:2021 on Migration of Certain Elements

An amended version of the EU Toy Safety Standard has been published on April 14, 2021. The amendments mainly focus on the Aluminum limit. The new migration limits apply from May 20, 2021.

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The European Committee for Standardization (CEN) published an amended version of the European Standard EN 71-3:2019+A1:2021, Safety of toys – Part 3: Migration of certain elements on April 14, 2021.

The amendments update the limits of allowable Aluminum. The updates are shown below:

  1. Category I material: Aluminum migration limit updated from 5625 mg/kg to 2250 mg/kg.
  2. Category II material: Aluminum migration limit updated from 1406 mg/kg to 560 mg/kg.
  3. Category III material: Aluminum migration limit updated from 70000 mg/kg to 28130 mg/kg.
For More Information About This Story:
Contact: Andy Choi (Senior Manager)
Phone: (852) 3185 8045
Email: regulatoryupdates@qima.com

EU-REACH: EN 12472:2020 is a harmonized Standard Now

In April 2021, the European Union (EU) published the list of standards to be used to identify the test methods for demonstrating compliance with nickel release under REACH Annex XVII Entry 27.

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In April 2021, the EU published on its website: Titles and references of standards to be used as the test methods for demonstrating the conformity of articles under entry 27 of Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

The three harmonized standards are summarized below:

European standardisation organisation Reference and title of the standard Reference of superseded standard
CEN EN 1811:2011+A1:2015
Reference test method for release of nickel from all post assemblies which are inserted into pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin
EN 1811:2011
CEN EN 12472:2020
Method for the simulation of accelerated wear and corrosion for the detection of nickel release from coated items
EN 12472:2005+A1:2009
CEN EN 16128:2015
Ophthalmic optics – Reference method for the testing of spectacle frames and sunglasses for nickel release
EN 16128:2011
For More Information About This Story:
Contact: Andy Choi (Senior Manager)
Phone: (852) 3185 8045
Email: regulatoryupdates@qima.com

Europe Recalls Summary (December 1, 2020 – May 15, 2021)

In Europe, when hazards are identified in Non-food Consumer Products, the Products will be recalled and published in the Safety Gate system, which is updated weekly. The European recalls for December 1, 2020 through May 15, 2021 are summarized below:

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Hazards Frequency
Chemical Hazard 240
Choking Hazard 125
Health Risk Hazard 63
Electric Shock Hazard 89
Fire Hazard 65
Injury Hazard 98
Burn Hazard 50
Other Hazards* 79

*Other Hazards include Burn Hazard, Cut Hazard, Damage to Hearing Hazard, Damage to Sight Hazard, Drowning Hazard, Entrapment Hazard, Environmental Hazard, Microbial Hazard, Strangulation Hazard and Suffocation Hazard with a frequency of less than 45.


Product Categories Frequency
Toys and Childcare Articles 225
Electrical Appliances and Equipment 85
Personal Protective Equipment 56
Jewelry 97
Clothing, Textiles and Fashion Items 74
Other Categories^ 65

^Other Categories include Cosmetics, Decorative Articles, Eyewear, Kitchen and Accessories, Furniture, Gadgets, Lighting Equipment, Hobby/Sporting Equipment, with a frequency of less than 17.


For a complete list click here


NORTH AMERICA NEWS

Health Canada is Proposing to Revise the Surface Coating Regulation Under the Canada Consumer Product Safety Act (CCPSA)

On April 24, 2021, Canada published Regulations Amending Certain Regulations Made Under the Canada Consumer Product Safety Act (Surface Coating Materials) (‘the Proposal’) in Canada Gazette, Part I, to address gaps in the regulatory framework and align the requirements for surface coating materials across various regulations under the CCPSA for consistency.
According to the Proposal: Comments will be accepted until July 3, 2021. The amendments will become effective on the 180th day after the day on which they have been published in the Canada Gazette, Part II.

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Health Canada is proposing the Regulations Amending Certain Regulations Made Under the Canada Consumer Product Safety Act (Surface Coating Materials) to address these issues by:

  1. Amending the definition of surface coating material in ‘Regulation 1’ for better consistency with ASTM F963 ‘Standard Consumer Safety Specifications for Toy Safety’. The requirement of no more than 90 mg/kg total lead applies to a sticker, film or other similar material (such as a decal) that can be removed, or a surface coating material that is applied to an accessible part of the following products: Furniture, Products for Children, Pencils and Artist Brushes;
  2. introducing a 90 mg/kg total lead limit in surface coating materials applied to furniture;
  3. removing the restrictions on lead, mercury and certain other harmful elements in surface coating materials applied to parts of products that are inaccessible;
  4. removing an outdated test method for certain harmful elements in applied surface coating materials: Deletes the outdated hydrochloric acid testing method (5% hydrochloric acid at 20 °C for 10 minutes) for the migration of antimony, arsenic, cadmium, selenium and barium;
  5. requiring testing to be done in accordance with a method that conforms to good laboratory practices;
  6. ensuring consistency between regulations.

A few “housekeeping” amendments are also proposed.

For More Information About This Story:
Contact: Andy Choi (Senior Manager)
Phone: (852) 3185 8045
Email: regulatoryupdates@qima.com

Health Canada Published a New Regulation - Corded Window Coverings Regulations (CWCR)

On May 1, 2021 a new regulation, Corded Window Coverings Regulations (CWCR) (SOR/2019-97), came into force. The CWCR serves an important purpose in helping to eliminate the strangulation hazard associated with corded window coverings to help protect the health and safety of children. CWCR (SOR/2019-97) replaced the previous Corded Window Covering Products Regulations (SOR/2016-172).

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The Corded Window Covering Products Regulation (SOR/2016-172) requires the product to comply with product safety requirements, information and labeling requirements of the national standard.

The CWCR (SOR/2019-97) describes additional specifics on requirements for:

  • Small parts
  • Lead content
  • Unreachable cords
  • Reachable cords with one free end – length
  • Loop created by a reachable cord – perimeter
  • Two reachable cords
  • Information and advertising
  • Warnings
For More Information About This Story:
Contact: Vivian Chan (Technical Consultant)
Phone: (852) 3185 8052
Email: regulatoryupdates@qima.com

Health Canada Proposed Amendments to the Carriages and Stollers Regulations (SOR/2016-167)

The Consumer and Hazardous Products Safety directorate identified opportunities to strengthen the Carriages and Strollers Regulations (CSR) with proposed amendments to help improve health and safety.
In the proposal, Health Canada is proposing a transition period of 6 months for documents incorporated by ambulatory reference.

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Proposed amendments to the CSR cover five types of requirements:

  1. Mechanical
    Health Canada is proposing to address the mechanical hazards that emerged after 1985 by aligning Canadian requirements with international requirements, where appropriate. Health Canada proposes that alignment can be achieved by replacing the mechanical requirements of the CSR with one of the two following options:
    1. By requiring compliance to the mechanical requirements from ASTM F833-19, incorporated by ambulatory reference; or
    2. By requiring compliance with at least one of the following:
      1. the mechanical requirements from ASTM F833-19, incorporated by ambulatory reference; or
      2. the mechanical requirements from ISO 31110:2020, incorporated by ambulatory reference, and in addition, the entrapment requirements from ASTM F833-19 sections 6.8 and 6.10.
  2. Surface coating materials
    1. Health Canada is proposing to amend the CSR to remove the reference to the Toys Regulations, and make the requirements directly in the text of the amended CSR consistent with the following:
      A sticker, film or other similar material that can be removed, or a surface coating material, that is applied to an accessible part of a carriage or stroller must not contain, when it is tested in accordance with a method that conforms to good laboratory practices,
      1. more than 90 mg/kg total lead;
      2. any compound of antimony, arsenic, cadmium, selenium or barium if more than 1000 mg/kg of the compound migrates from the material; or
      3. more than 10 mg/kg total mercury.
  3. Toxicological hazards
    Health Canada is proposing to maintain these requirements by providing them directly within the text of the amended CSR.
  4. Phthalates
    Health Canada is proposing to require that vinyl parts of a carriage or stroller comply with the Phthalates Regulations
  5. Information and warnings
    Health Canada is proposing to remain flexible regarding the content of the information and warning requirements of the CSR to allow for potential alignment with ASTM F833-19 or ISO 31110:20. However, Health Canada will maintain the official language requirement for all information and warnings to be written in both English and French.
For More Information About This Story:
Contact: Vivian Chan (Technical Consultant)
Phone: (852) 3185 8052
Email: regulatoryupdates@qima.com

Health Canada Revised Product Safety Laboratory Reference Manual Test Method M18

Health Canada revised the Product Safety Laboratory Reference Manual Test Method M18, Magnetic flux index to magnetic toys. In additional to considering the magnetic flux index on toys, this revision includes the safety requirements of magnetic toys.

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The revision is in direct reference to international standard ASTM F963.
The product is evaluated by performing the following test sections in sequence, as applicable:

  1. Confirmation of Toy Age Classification
  2. Warning Labels
  3. Initial Small Components
  4. Soaking of Magnetic Toys and Components
  5. Cycling of Magnetic Connection
  6. Drop Test
  7. Tipover Test for Large, Bulky Toys
  8. Torque Test for Removal of Components
  9. Tension Test for Removal of Components
  10. Impact Test
  11. Compression Test
  12. Magnetic Flux Index

The warning label is only applicable to kits intended for carrying out educational experiments involving both magnetism and electricity and intended for a child of at least 8 years of age.

The warning label should be present on the kit’s container and instructions using the following text or text that is similar:

WARNING!

Not suitable for children under 8 years of age. This kit contains small magnets. Swallowed magnets can stick together across intestines causing serious injuries. Seek immediate attention if a magnet may be swallowed.

MISE EN GARDE!

Cette trousse ne convient pas a un enfant de moins de 8 ans. Elle contiets de petits aimants. Les aimants qui sont avles peuvent s'attirer mutuellement a travers l'interstin et engendrer ainsi de graves blessures. Consultez immediatement un medecin si un enfant semble avoir avale un aimant.

For More Information About This Story:
Contact: Vivian Chan (Technical Consultant)
Phone: (852) 3185 8052
Email: regulatoryupdates@qima.com

MAY CONTRIBUTORS

Andy Choi

Vivian Chan

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