March 2023 Regulatory Update

As required by Reese’s Law, to eliminate or adequately reduce the risk of injury from ingestion of button cell or coin batteries by children 6 years old and younger, the CPSC proposed to amend Title 16 of the Code of Federal Regulations (CFR) by adding 16 CFR Part 1263 –Safety Standard and Notification Requirements for Button Cell or Coin Batteries and Consumer Products Containing Such Batteries.

The following requirements were included in this rule:

1. Performance requirements for consumer products containing removable button cell or coin batteries:
1. Button cell or coin batteries in consumer products must not be able to be accessed during the accessibility test described in paragraph (d) of section 1263.3
2. Battery compartments must be secured using the method specified in (b)(2) of section 1263.3 and must meet the performance tests described in paragraph (e) of section 1263.3, including pre-conditioning tests such as stress relief and battery replacement, and abuse tests such as drop test, impact test, crush test, compression test, torque test and tension test
2. Performance requirements for consumer products containing non-removable button cell or coin batteries:
1. Must comply with the requirement list in point 1
2. Button cell or coin battery must be secured by soldering, fasteners such as rivets or equivalent means and pass the secureness test in paragraph (f) of section 1263.3
3. Warning label requirement for button cell or coin battery packaging:
1. Warning shown in Figure 4 of paragraph (b)(1) of section 1263.4 must be included on principal display panel
   
2. If the space is not enough, the warning shown in Figure 5 to paragraph (b)(2) of section 1263.4 shall be on the principal display panel and the warning shown in Figure 6 of paragraph (b)(2) of section 1263.4 shall be on the secondary display panel
   
   
3. Safety-related statements specified in (b)(3) of section 1263.4 must be included on the principal display panel or secondary display panel; this requirement is not applicable to button cell or coin batteries that are packaged and included separately with the consumer product
4. Warning label requirements for packaging of consumer products containing button cell or coin batteries
1. Warning shown in Figure 7 to paragraph (c)(1) of section 1263.4 must be contained on principal display panel
   
2. If the space is not enough, the warning shown in Figure 8 to paragraph (c)(3) of section 1263.4 must be on the principal display panel and the warning shown in Figure 9 to paragraph (c)(3) of section 1263.4 must be on the secondary display panel
   
3. If there is no packaging for the consumer product, the warning shown in Figure 7 to paragraph (c)(1) of section 1263.4 must be affixed to consumer product with a hang tag or a sticker label
   
4. The texts stated in (c)(5) of section 1263.4 must be included on principal display panel or secondary display panel of consumer product packaging, or on accompanying hang tag or sticker label if no packaging provided
5. Warning label requirements for consumer products containing button cell or coin battery
1. Warning shown in Figure 10 to paragraph (d)(1) of section 1263.4 must be marked on consumer products
   
2. If the space is limited, icon shown in Figure 11 to paragraph (d)(2) must be present on product display panel, and the icon must be defined in accompanying printed materials such as instructions, manual, insert or hangtag
   
3. If the product is too small, the product must have packaging containing the warning label specified in point 4 above, or must have hangtag or sticker label with full warning label specified in Figure 7 to paragraph (c)(1) of section 1263.4
   
6. Instructions / manuals accompanying consumer products containing button cell and coin batteries
1. If instructions or manuals are provided, the warning label shown in Figure 7 to paragraph (c)(1) of section 1263.4 and the warning statements described in (e) of section 1263.4 must be included
   
2. If instructions or manuals are not provided, the warning requirement in point 6) a) must be present on the principal display panel or secondary display panel of the consumer product packaging, or if there is no consumer product packaging, the accompanying hang tag or sticker label must contain the warning requirement
7. Online information
1. For button cell or coin batteries, the warning in Figure 4 to paragraph (b)(1) ) of section 1263.4 shall be included next to the product description, the product image, or the product price
   
2. For consumer products containing button cell or coin batteries, the warning in Figure 7 to paragraph (c)(1) of section 1263.4 shall be included next to the product description, the product image, or the product price

In addition, 16 CFR Part 1263 was added in 16 CFR Part 1112.15, meaning that third party conformity assessment bodies must be accredited to add 16 CFR Part 1263 to their testing scope in order to assess conformity of the aforementioned requirements.

Manufacturers and distributors should assess products to ensure compliance to these newly identified requirements.

*Other Hazards include Microbiological Hazard, Impact Hazard, Chemical Hazard, Tip-Over Hazard, Death Hazard, Drowning Hazard, Asphyxiation Hazard and Laceration Hazard with a frequency of less than 2.

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On 9 February 2023, the European Commission (EC) launched a one-month consultation on the proposal of restriction of perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds under Annex I Part A of Regulation (EU) 2019/2021 – the Persistent Organic Pollutants (POP) recast regulation. This proposal was launched as part of the European Union’s internal commitments under the Stockholm Convention on persistent organic pollutants (chemical substances). Comments for the proposed regulation were collected until 9 March 2023. The proposal has been delayed as it was originally planned for adoption in the fourth quarter of 2022.

The highlights of the proposed regulation are listed as below:

On 7 February 2023, the European Chemical Agency (ECHA) published the proposal on the restriction of per- and polyfluoroalkyl substances (PFASs), a unique family of approximately 10,000 substances which are very persistent in the environment. A detailed timeline with two different restriction proposals has been given. Its scientific committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) will now start evaluating the proposal. A six-month consultation is expected to start on 22 March 2023.

The restriction proposal was prepared by the five EU national authorities of Denmark, Germany, the Netherlands, Norway and Sweden and is intended to protect humans and the environment.

The proposal defines PFAS as “any substance that contains at least one fully fluorinated methyl (–CF3) or methylene (–CF2–) carbon atom (without any H/Cl/Br/I attached to it).”

Some important planned timelines of this PFAS restriction proposal are listed below:

Highlights of the proposed restriction with two options are shown in below table.

*If total fluorine exceeds 50 mg/kg, proof for the fluorine measured as content of either PFASs or non-PFASs is required, if requested by enforcement authorities

On 17 February 2023, the European Chemical Agency (ECHA) launched the public consultation of the 29th update of the Substances of Very High Concern (SVHC) candidate list. The public consultation period will end on 3 April 2023. Two chemical substances have been proposed as SVHC for public consultation. If the two proposed substances are identified as SVHC, this will bring the total to 235 entries of SVHC in the candidate list which is expected to be finalized in June or July 2023.

The details of the 2 proposed SVHC substances are listed as below:

On 23 January 2023, the World Trade Organization (WTO) circulated document 23-0494 which is a draft regulation from the European Commission on the revision of Annex I of Regulation (EU) 10/2011 – a specific regulation for plastic materials and articles intended to come into contact with food. Such proposal is based on the recent scientific opinions from the European Food Safety Authority (EFSA) on new substances that may be used in food contact materials and also on the uses of already approved substances.

According to the WTO document and draft regulation, the proposed timelines are listed as below:

1. Final date of receiving public comment – 24 March 2023
2. Proposed date of adoption – 31 March 2023
3. Proposed date of publication – 3 April 2023
4. Brought into force – 20 days after its publication in the Official Journal of the European Union

The draft regulation contains several important updates to Annex I of Regulation (EU) 10/2011 which include:

1. Deletion of authorizations of food contact material (FCM) substance nos. 96 (wood flour and fibers, untreated) and 121 (salicylic acid) on the Union list
2. Replacement of nine FCM substance nos., including strengthened specific migration limit (SML) for DBP (2.5 fold), BBP (5-fold) and DEHP (2.5-fold) and new requirements for the restriction of group substances (total SML.) (Details included in below table)
3. Adjustment to specification of FCM 1059 (Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate, PHBH)
4. Extension of use from poly(ethylene terephthalate) (PET) to poly(ethylene 2,5-furandicarboxylate) (PEF) of FCM 1007 (diethyl[[3,5-bis(1,1-dimethyl)-4-hydroxyphenyl]methyl] phosphate)
5. Addition of five new substances including:
• FCM no. 1078 (tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate)
• FCM no. 1080 (triethanolamine-perchlorate, sodium salt) dimer)
• FCM no. 1081 (N, N-bis(2-hydroxyethyl)stearylamine partially esterified with saturated C16/C18 fatty acids)
• FCM no. 1082 (Phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate)
• FCM no. 1083 (Benzophenone-3,3’,4,4’-tetracarboxylic dianhydride)
6. Replacement of three entries in group restriction of substances, including the consideration of DIBP in group restriction no. 32. According to group restriction no. 32, DIBP (FCM no. 1085) is not listed as an authorized substance. It may co-exist with other phthalates due to its use as a polymerization aid and thus is included in group restriction with the assignment FCM no. 1085.
7. Addition of three new entries to group restriction of substances, including group restriction no. 36 where the sum of four phthalates (DBP, BBP, DEHP and DIBP) is expressed as DEHP equivalents.

Comparison of changes of four phthalates (DBP, BBP, DEHP and DINP) listed in Annex I of Regulation (EU) 10/2011:

Note: DIDP - phthalic acid, diesters with primary, saturated C9-C11 alcohols more than 90% C10; DIBP – diisobutyl phthalate

The Commission also proposed that those plastic materials and articles complying with the current food contact regulation before the entry of this amendment, are allowed to be placed in the market with an 18-month transition period after the entry of this amendment and may remain on the market until stocks are depleted.

*Other Hazards include Drowning Hazard, Environmental Hazard, Aspiration Hazard, Health Risk Hazard and Entrapment Hazard with a frequency of less than 4.

*Other Categories include Tools and Hardware, Household Items, Stationery, Home Electrical Appliances, Accessories and Construction Products with a frequency of less than 4.

*Other Countries include Bulgaria, Luxembourg, Malta, Belgium, Czechia, Cyprus, Croatia, Slovakia, The Netherlands and Greece with a frequency of less than 5.

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The Toys and Children’s Product Safety Ordinance (Cap. 424) stipulates that a person must not manufacture, import or supply a toy or a children’s product unless it complies with all the applicable requirements contained in any one of the safety standards respectively specified in Schedules 1 and 2 to the Ordinance. The standards specified are international standards or standards adopted by major economies.

The Hong Kong government launched the update, effective 1 August 2023, which amends Schedule 2 to the Ordinance relative to four classes of Schedule 2 products (Children’s products) as mentioned:

National Standard GB/T 43293-2022 - Shoe Size is applicable to all shoe categories and replaces Standard GB/T 3293.1-1998 for Shoe Size. It will officially go into effect on 1 May 2023.

The main updates in comparison to GB/T 3293.1-1988, include but are not limited to, those identified below:

1. Indication of shoe size UPDATED
• Foot length (mandatory)
• Linear width of the foot (required, if necessary)
2. Marking format requirement of the world’s shoe sizes ADDED
3. Conversion with other world’s shoe sizes ADDED
• Refer to standard GB/T 36935 Footwear - Conversion of Sizing Systems
4. Font height requirement of shoe size labelling REMOVED
• Required following standard QB/T 2673 Footwear - Specification of Marking

Important notes:

• There is no impact for shoe size labelling which already complied with the current standard GB/T 3293.1-1998. The shoe size labelling which meets with current standard GB/T 3293.1-1998 will also meet with the marking requirements of new standard GB/T 43293-2022.

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