October 2022 Regulatory Update

On 21 September 2022, the U.S. Consumer Product Safety Commission (CPSC) published a final rule for Magnet Safety Standard, 16 CFR 1262, to address the hazards associated with ingestion of one or more high-powered magnets. The CPSC has determined that unreasonable risks of injury are associated with small, powerful magnets that, when ingested, can interact internally through body tissue, which can lead to acute and long-term health consequences or death.

As summarized in the standard, the final rule applies to “subject magnet products,” which are consumer products that are designed, marketed, or intended to be used for entertainment, jewelry (including children's jewelry), mental stimulation, stress relief, or a combination of these purposes, and that contain one or more loose or separable magnets. Excluded are products sold and/or distributed solely to school educators, researchers, professionals, and/or commercial or industrial users exclusively for educational, research, professional, commercial, and/or industrial purposes.

Products that are subject to this rule that contain magnets, loose or separable, that fit entirely within the CPSC's small parts cylinder must have a flux index of less than 50kG²mm². The flux index is determined by the method described in the ASTM F963 Standard Consumer Safety Specification for Toy Safety. The rule exempts from its requirements, toys which are subject to ASTM F963 requirements.

Manufacturers, importers, and distributors who will import products including magnet / magnet components need to be aware of this rule which had an effective date of 21 October 2022. It also should be noted that magnet products that are children's products must have product tested by a CPSC approved 3rd party testing laboratory after 20 December 2022.

On 1 September 2022, the U.S. Consumer Product Safety Commission (CPSC) published a final rule of 16 CFR 1230 Safety Standard for Frame Child Carriers incorporating by reference voluntary standard ASTM F2549-22 Standard Consumer Safety Specification for Frame Child Carriers.

ASTM F2549-22 Standard Consumer Safety Specification for Frame Child Carriers contains substantive revisions, as well as editorial, non-substantive revisions from previous version ASTM F2549-14a.

Substantive changes include the following (but note that not all changes are listed),

1. Adds a flammability requirement in Section 5.12 for fabric components of the frame carrier which only permits the use of Class 1 fabrics, which have a lower flammability that is acceptable for use in clothing.
2. Adds new Section 5.12.3, that states "Non-toy accessories that are sold with and intended to be attached to the product shall also meet the requirement of 5.12."
3. Replaces a generic photo of a typical torso that is used for trainingwith a specific drawing of a rigid torso with dimensions in Figure 5.
4. Revises multiple elements pertaining to dynamic strength
   1. Section 6.2 adds to the dynamic strength requirements, an evaluation of the system that attaches the frame carrier to the user's torso, in addition to the existing evaluation of the system that retains the child occupant in the frame carrier.
   2. Sections 7.2.1 - 7.2.6 of the standard are revised. The changes consist of a new test torso and evaluating the attachment system, adding weights to the external pockets, and modification of the test sequence.
   3. Section 7.2.3 now states, "Pockets, pouches, and other carrying receptacles of the product shall be loaded with weight(s), in such a way that will create the most onerous test condition. The most onerous test condition may include no weight(s) or lower than maximum weight(s) in some receptacles."
   4. Section 7.2.5 is modified to provide for readjustment or re-tightening of all adjustable components, such as straps in the occupant retention system and attachments to the test torso after completion of a 90-cycle vibration test and before the carrier is subjected to a 49,900-cycle vibration test.
5. Removes note at Section 7.1.1 Leg Openings Test to avoid confusion which could potentially lead to not testing the carrier in the most onerous condition.
6. Modifies sections 7.4.3 and 7.4.4 to increase the test load from "at least 40 lb (18.1 kg)" to "40 lb (18.1 kg) or equal to the manufacturer's maximum recommended weight for the occupant, if greater."
7. Modifies section 7.10.3 to increase the applied torque from 2lbf-in to 4 lbf-in.
8. Adds section 8.5 Warning Statements to improve the safety of frame child carriers and clarify the fall hazard.

Non-substantive changes and editorial changes include the following (but note that not all changes are listed),

1. Changes Section 5.5 from "shall not be permissible" to "exists"
2. Modifies Section 5.8 to exempt the frame child carrier's kickstand
3. Adds section 6.2 which provides that the frame carrier "shall show no damage that will impair its function"
4. Changes section 7.2.3, "alternating vertical movement at amplitude of 4.7 inches and a frequency of 2 cycles/second (Hz)" to "alternating vertical sinusoidal movement through 4.75 inches at a frequency of 2Hz."
5. Adds section 8.4 Warning Design for Product for the design and layout of the warning.

Because of the many substantive changes in ASTM F2549-22, manufacturers of frame child carriers need to start to review their products according to the new standard and make modifications, if needed.

16 CFR 1229 Safety Standard for Infant Bouncer Seats was published by the U.S. Consumer Product Safety Commission (CPSC) as a final rule on 6 September 2022. This standard incorporated by reference updated voluntary standard ASTM F2167-22 Standard Consumer Safety Specification for Infant Bouncer Seats.

The revisions from ASTM F2167-19 to ASTM F2167-22 consist of changes to the infant bouncer seat warning label language, as well as changes that do not impact safety (those that do not modify the meaning of the standard and are editorial adjustments).

Substantive changes in ASTM 2167-22 are listed in the table below:

Changes were made to the wording in the corresponding Figures indicated below,

• 11, Fall Hazard Warning;
• 12, Suffocation Hazard Warnings; and
• 13, Instruction Warning Statements.

Non-substantive changes in ASTM F2167-22 include:

1. Modified X1.9 Subsection 8.5.2.1 - Change in the form of an added statement to explain the non-relevance and removal of "even if baby is sleeping" from the Appendix Rationale in the new standard.
2. Several minor editorial changes adding hyphens to language in the standard.

16 CFR 1229 will become effective on 19 December 2022. Infant bouncer seat manufacturers should start to update their instruction manual or related material accordingly.

ASTM F2088 Standard Consumer Safety Specification for Infant and Cradle Swings applies to swings with a powered mechanism used to provide a swinging or gliding seat/cradle in any direction relative to the frame. The swinging or gliding mechanism can be powered by batteries, AC adapter, wind-up mechanism, or other means. A cradle swing allows the infant to swing while lying flat. The cradle swing is intended for children from birth until the infant begins to push up on hands and knees (approximately 5 months). An infant swing enables the infant to swing in a seated position and is intended for children from birth until the infant attempts to climb out of the product (approximately 9 months).

On 20 September 2022, the U.S. Consumer Product Safety Commission (CPSC) published a final rule of 16 CFR 1223 Safety Standard for Infant Swings, incorporating by reference updated voluntary standard ASTM F2088-22 Standard Consumer Safety Specification for Infant and Cradle Swings. The rule will be effective on 1 January 2023.

Substantive changes in updated ASTM F2088-22 include:

The word "infant" is replaced with "baby" in the first sentence. The order of the warnings is switched in the second sentence, first to warn that the product is not safe for sleep, and then to warn against unsupervised use. Lastly, a third new sentence provides guidance advising caregivers to remove a baby who has fallen asleep to a product that is safe for sleep.

Infant Swing manufacturers should start to update their instruction manual or related material accordingly.

On 14 September 2022, the U.S. Consumer Product Safety Commission (CPSC) proposed to amend the Standard for the Flammability of Clothing Textiles (16 CFR Part 1610).

The proposed revisions by the CPSC would:

• Clarify existing provisions
• Expand permissible equipment and materials
• Update equipment requirements that are outdated

The proposed amendments cover:

• Burn Codes Update
• Stop Thread Specification
• Dry Cleaning Specification
• Laundering Specification

The potential benefits of the proposed amendments include the following:

• Improving consumer safety. Improving testing laboratories' abilities to conduct testing and obtain consistent and reliable results as the proposed amendments provide comparable flammability results to the current standard. This should improve consumer safety by ensuring that textiles intended for use in clothing are properly tested and classified so that dangerously flammable textiles are not used in clothing.
• Reducing burdens for testing laboratories. The proposed amendments cover clarifying existing requirements and updating the specifications for stop thread, dry cleaning, and laundering to include options that are identifiable, permissible for use, and currently available on the market.

Important notes:

• Deadline for Written Comments: comments to be submitted by 14 November 2022.

Deadline for Request to Present Oral Comments: Any person interested in making an oral response must send an email to the Office of the Secretary at cpsc-os@cpsc.gov by 31 October 2022 identifying their objective.

On 26 August 2022, California's Office of Environmental Health Hazard Assessment (OEHAA) published a notice of proposed rulemaking to establish a No Significant Risk Level (NSRL) for the flame retardant antimony trioxide under Proposition 65. The proposed NSRL for antimony trioxide is 0.13 micrograms per day. OEHAA solicited public comments on the proposed NSRL for antimony trioxide. Public comments were accepted until 11 October 2022.

Antimony trioxide was listed as a carcinogen under Proposition 65 in 1990. It is a "component of flame retardant treatment for polymers; opacifying agent for glasses, ceramics, and enamels; specialty pigments; naturally occurring as valentinite and senarmontite," according to OEHHA.

Proposition 65 requires companies to provide warning statements where their products cause an "exposure" to carcinogens and/or reproductive toxicants, unless an exemption or exception under the law applies. Any exposure to a listed chemical at or below the NSRL does not require a warning.

*Other Hazards include Drowning Hazard, Lead Poisoning Hazard, Crushing Hazard, Strangulation Hazard, Crash Hazard, Health Risk Hazard and Choking Hazard with a frequency of less than 2.

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*Other Hazards include Aspiration Hazard, Entanglement Hazard, Impact Hazard and Fire Hazard with a frequency of less than 2.

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The Department for Business, Energy & Industrial Strategy issued Notice of Publication 0065/22 of 8 September 2022 of References to Standards for Electrical Equipment Designed for Use Within Certain Voltage Limits in Support of the Electrical Equipment (Safety) Regulations 2016 (S.I. 2016/1101).

• Part 1 of Annex I to this notice, in relation to England, Wales and Scotland, lists additional standards as an amendment for Annex 1 to notice 0061/22, such as EN 50520:2020 + A1:2021, EN 60598-2-13:2006 + A1:2012 + A11:2021 + AC:2006, EN IEC 61010-2-030:2021 + A11:2021, EN IEC 61010-2-051:2021 + A11:2021, EN IEC 61010-2-061:2021 + A11:2021, EN 61534-1:2011 + A1:2014 + A11:2021 + A2:2021, EN 61534-21:2014 + A11:2021 + A1:2021, EN 61534-22:2014 + A11:2021 + A1:2021, EN 62135-1:2015 + AC:2016.
  Part 2 of Annex I to this notice sets out the complete list of standards in support to regulation 2A of S.I. 2016/1101.
  Annex I came into effect on 8 September 2022.
• Part I of Annex II to this notice lists additional standards which will be removed from publication from the date set out in the table; each of these standards will not be valid on or after the date set out in respect of it, such as EN 50520:2009, EN 60898-2:2006, EN 61010-2-051:2015, EN 61010-2-030:2010, EN 61010-2-061:2015, EN 60598-2-13:2006 + A1:2012 + AC:2006, EN 61534-1:2011 + A1:2014, EN 61534-21:2014, EN 61534-22:2014, EN 62135-1:2015.
  Part 2 of Annex II to this notice sets out the complete list of standards which will be removed from publication.

On 21 September 2022, the European Chemical Agency (ECHA) launched the public consultation on the proposal of restriction of medium-chain chlorinated paraffin (MCCP) and other substances containing chloroalkanes with carbon lengths from C14 to C17 (CA:C14-17) under REACH Annex XVII. The public consultation period will end on 22 March 2023, and the final opinion of ECHA is expected to be available by September 2023. The final opinion will then be sent to the European Commission (EC) for the decision of inclusion of such proposed restriction of MCCP and CA:C14-17 under REACH Annex XVII.

Table 1. The details of proposed restriction of MCCP and CA:C14-17

On 2 September 2022, the European Chemical Agency (ECHA) launched the public consultation of the 28^th update of the REACH candidate list. Nine new Substances of Very High Concern (SVHC) have been added. This will bring to total, 233 entries of SVHCs in the candidate list, upon approval. The consultation period ended on 17 October 2022.

The details of the nine new SVHC substances are listed below:

*Other Categories include Household Items, Tools and Hardware, Stationery, Accessories, Machinery, Car Components, Jewelry, Food Contact Material, Sporting Goods / Equipment and Footwear with a frequency of less than 4.

*Other Countries include Latvia, Belgium, The Netherlands, Slovakia, Finland, Slovenia and Sweden with a frequency of less than 3. 

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In September 2022, the World Trade Organization (WTO) circulated document 22-6570 which is a draft ministerial regulation issued by Thailand’s Ministry of Industry to mandate Thai Industrial Standard (TIS) 3206-2564 (2021) “Stainless Steel Utensils For Food: Safety Requirement” as the safety standard. The scope covers the stainless steel utensils used in households, restaurants and canteens such as bowls, dishes, food trays, frying pans, pots and spoons or utensils with stainless steel as the main material/component in contact with food. On the other hand, the draft regulation exempts stainless steel seamed stockpots (TIS 2440-2552 (2009)) and utensils used for storage or transportation, as well as tools used in non-thermal processing of food or at slaughterhouses. According to the draft ministerial regulation, TIS 3206-2564 (2021) will become mandatory 270 days after its publication in the Government Gazette.

Standard TIS 3206-2565 (2021) directs the use of set documents for analysis including:

1. Chapter 3 of Metals and alloys used in food contact materials and articles, published by the European Directorate for the Quality of Medicines & Healthcare (EDQM) of the Council of Europe
2. Guidelines on testing conditions for articles in contact with foodstuffs (with a focus on kitchenware); a CRL-NRL-FCM Publication, 1^stEdition [2009], by the European Commission Joint Research Center Institute for Health and Consumer Protection
3. Testing conditions for kitchenware articles in contact with foodstuffs: Plastics and Metals; the EURL-FCM harmonized approach series by the Joint Research Center (JRC), the European Commission's science and knowledge service

The requirements of the specific migration (specific release limit, SRL, mg/kg of food) of heavy metals in TSI 3206-2564 are listed below:

• Arsenic (As): 0.002 mg/kg
• Cadmium (Cd): 0.005 mg/kg
• Chromium (Cr): 0.250 mg/kg
• Lead (Pb): 0.010 mg/kg
• Manganese (Mn): 1.8 mg/kg
• Nickel (Ni): 0.14 mg/kg

*Other Hazards include Ingestion Hazard, Burn Hazard, Swallowing Risk, Risk of Allergy, Fall Hazard, Strangulation Hazard, Cut Hazard, Entanglement Hazard and Skin Irritation Risk with a frequency of less than 3.

*Other Categories include Tools and Hardware, Chemicals, Furniture, Construction Products and Home Electrical Appliances with a frequency of less than 3. 

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