April 2021 Regulatory Update

NORTH AMERICA NEWS

The US Consumer Product Safety Commission (CPSC) Issues a Final Rule for Federal Regulation 16 CFR 1231 Safety Standard for High Chairs

In June 2018, under section 104(b)(1) of the Consumer Product Safety Improvement Act (CPSIA), the CPSC adopted a mandatory rule for high chairs, codified in 16 CFR 1231. At the time the Commission published the final rule, ASTM F404-18 was the current version of the voluntary standard. In January 4, 2021, ASTM notified CPSC that it had again revised the voluntary standard for high chairs, approving ASTM F404-20 on October 1, 2020. Based on the CPSC’s staff’s review of ASTM F404-20, the Commission will allow the revised voluntary standard to become the mandatory standard. This final rule is effective on July 3, 2021.

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ASTM has revised the standard for high chairs twice since ASTM F404-18, which is the current mandatory standard.
ASTM F404-20 includes several substantive changes, several revisions to clarify existing requirements, and editorial revisions that do not alter substantive requirements in the standard or affect safety.

  1. Substantive Revisions

    ASTM F404-20 contains substantive revisions from the current mandatory standard to distinguish performance requirements and test methods for two types of high chairs:
    1. high chairs and high chair accessories that have adjustment positions that, per the manufacturer’s instructions, are recommended for use only for children able to sit upright unassisted (approximately 6 months of age) or weigh more than 20lb (9.1kg) (hereinafter referred to as upright seat high chairs) and
    2. high chairs and high chair accessories that have adjustment positions that are manufacturer’s recommended use positions for use with children who are unable to sit upright unassisted (birth to approximately 6 months of age) or weigh 20lbs or less (9.1kg or less), when adjusted into the most onerous manufacturer’s recommended use and/or adjustment position for each direction to be tested” (hereinafter referred to as reclined seat high chairs)
  2. ASTM F404-20 provides new requirements and associated test methods to test the stability of reclined seat high chairs.
    1. Performance Requirements
    2. Stability Test Methods
    3. Static Load Test Methods
      1. High Chair Seat
      2. Step/Footrest
      3. High Chair Tray
    4. Dynamic High Chair Test Methods
  3. Non-substantive Changes

    ASTM F404-20 also includes minor additions and revisions that are editorial and do not alter any substantive requirements in the standard. Because they do not change any substantive requirements, these revisions are neutral regarding the safety of high chairs, including:
    1. Referenced documents
    2. Section Changes
      2.3 Adds a reference to ANSI Z535.1 Safety Colors 2.4 (to be consistent with other ASTM standards that reference the ANSI standard for safety colors for use in distinguishing warning labels)
      2.4 Adds a reference to new test equipment, the Civil Aeronautical Medical Institute (CAMI) Infant Dummy Mark II and the CAMI Newborn Dummy, which are used in the new stability testing for reclined seat high chair products
    3. Terminology
    4. Section Changes
      3.1.7.2 A new note stating that a product that has an elevated seat and is designed or promoted for eating and feeding or is shown near a dining table would be considered within the scope of the high chair standard
      3.1.21 Vertically downward load applied by weights or other means
    5. Calibration and Standardizations, General Requirement, and Performance Requirements

      ASTM made a few editorial changes to the sections of ASTM F404-20 on calibrations and standardizations, general requirements, and performance requirements, to clarify provisions and to be consistent with other ASTM standards.
For More Information About This Story:
Contact: Vivian Chan (Technical Consultant)
Phone: (852) 3185 8052
Email: regulatoryupdates@qima.com

USA: Oregon State Revises its Toxic-Free Kids Act

On March 1, 2021, the state of Oregon published the Oregon Administrative Rules (OARs) for the final implementation phase of its Toxic Free Kids Act.

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In 2015, Oregon passed the Toxic-Free Kids Act legislation. This law requires manufacturers of children's products sold in Oregon to report products containing one or more high priority chemicals of concern for children's health (HPCCCH), if found at or above specific levels in those products. Ultimately, manufacturers are to remove these chemicals from certain products or seek a waiver.

The Oregon Health Authority's (OHA) Toxic-Free Kids program is responsible for implementing this law. The OHA writes rules to govern what manufacturers must do to comply with the law. The rules and rulemaking processes were established over Phases 1 to 3.

Phase 1 established a list of high priority chemicals of concern for children's health (HPCCCH) and criteria by which the list can be updated in the future.

Phase 2 established detailed manufacturer reporting requirements and the priority order of those entities responsible for providing product notifications.

Phase 3 established detailed requirements for manufacturers of three specific categories of children's products (those for children under three years-old; "mouthable" items and children's cosmetics), which were effective beginning March 1, 2021. Accordingly, the manufacturer of specific categories of children's products must remove HPCCCH from product models in these categories or substitute HPCCCH with an alternative to make the product less hazardous or have a waiver approved by the Authority.

Additionally, Phase 3:

  • Established rules so that manufacturers may comply with their obligations under the law by January 1, 2022
  • Established rules for manufacturers to apply for exemptions from removal or substitution requirements

Phase 3 did not add or remove any HPCCCHs.

The corresponding Oregon Administrative Rules (OARs) are newly established as well, to guide the manufacturers to comply with the requirements. The complete rules can be found at: OAR 333-016, starting at 333-016-2001.

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

Canada Recall Summary (November 17, 2020 –April 16, 2021)

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 November 17, 2020 to April 16, 2021 are summarized below:

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Hazards Frequency
Fall Hazard 6
Fire Hazard 20
Injury Hazard 16
Burn Hazard 5
Chemical Hazard 11
Choking Hazard 6
Other Hazards* 23

*Other Hazards include Flammability Hazard, Electrical Hazard, Tip-over Hazard, Entrapment Hazard, Health Problem, Crash Hazard, Scald Hazard, Physical Hazard, Strangulation Hazard, Explosion Hazard, Suffocation Hazard, Entanglement Hazard, and Laceration Hazard, with a frequency of less than 4


Product Categories Frequency
Sporting Goods / Equipment 5
Children's Products 16
Chemicals 6
Household Items 22
Tools and Electrical Products 11
Other Categories^ 20

^Other Categories include Accessories, Cosmetics /Bodycare, Food Contact Materials, Home Electrical Appliances, Juvenile Products, Furniture, Toys, and Miscellaneous, with a frequency of less than 4


For a complete list click here


EUROPE NEWS

European Union (EU): Belgium Regulates Food Contact Metals and Alloys

On March 15, 2021, Belgium published its Royal Decree of February 17, 2021 to regulate food contact metals and alloys. It does not specify an effective date, therefore; the publishing date of March 15, 2021 should be considered as the effective date.

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On March 15, 2021, Belgian Federal Public Service (FPS) Public Health, Food Chain Safety and Environment, published the decree to regulate metal and alloy materials and articles intended to come into contact with food.

This decree applies to materials and articles in their final state, whether they consist totally or partially of metals or alloys and whether coated or non-coated, which:

  • are intended to come into contact with food; or
  • are already in contact with food and are intended for this purpose; or
  • which can reasonably be expected to come into contact with food or transfer their constituents to food under normal or foreseeable conditions of use.

In conformity with this decree, metal and alloy materials and articles must be manufactured in accordance with:

  • EU Framework Regulation (EC) No. 1935/2004
  • EU Regulation (EC) No. 2023/20065 on good manufacturing practices
  • Belgian Royal Decree of May 11, 1992

This decree adopts the specific release limits (SRLs) (see below Table 1) from the Council of Europe Resolution CM/Res (2013) 9 ‘Metals and Alloys Used in Food Contact Materials and Articles’. The test methods and the instructions are described in the guidelines of the Royal Decree of February 17, 2021.

Name Specific Release Limit (mg/kg of food)
Aluminium 5
Antimony 0.04
Silver 0.08
Chromium 0.25
Cobalt 0.02
Copper 4
Tin 100
Iron 40
Magnesium -
Manganese 1.8
Molybdenum 0.12
Nickel 0.14
Titanium -
Vanadium 0.01
Zinc 5
Arsenic 0.002
Barium 1.2
Beryllium 0.01
Cadmium 0.005
Lithium 0.048
Mercury 0.003
Lead 0.01
Thallium 0.0001

This decree requires a DOC (declaration of conformity) and the declaration must contain the following information:

  • the identity and address of the operator who manufactures or imports the materials and articles or the substances intended for the manufacture of these materials and articles
  • the identity of metals and alloys intended for the manufacture of materials and objects
  • the date of the declaration
  • confirmation of the materials and articles that are in conformity with the relevant provisions of this decree or other specific legislation concerning metals and alloys published by another EU Member State or Turkey or an EFTA State which is a contracting party to the EEA agreement, and Regulation (EC) No. 1935/2004
  • adequate information to enable downstream operators to ensure compliance with the restrictions
  • adequate information on restricted metals in foodstuffs, obtained by experimental data or a theoretical calculation of their specific release level
  • specifications regarding the use of the material or article such as:
    • the type (s) of foodstuff intended to contact with them
    • the duration and temperature of processing and storage in contact with the foodstuff
    • the surface / volume ratio in contact with the foodstuff, used to establish the conformity of the material or article

Note: For all products which are not yet considered as final products, above points 1, 2, 3 and 5 of the declaration of conformity, must be completed, at a minimum.

If no modification occurs in the raw materials, in their treatment, in the use, in the production process, etc., a declaration of conformity can remain valid for a period of maximum five years.

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

APRIL CONTRIBUTORS

Andy Choi

Vivian Chan

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