May 2023 Regulatory Update

A new test standard, which is applicable to textiles and textile products, was published in February 2023, ISO 4484-1:2023 (Textiles and textile products — Microplastics from textile sources — Part 1: Determination of material loss from fabrics during washing).

This test method is designed to collect material loss from fabrics under the specified laundering test conditions to achieve results that are both comparable and accurate. As outlined in the scope of the standard, there is no direct correlation to material loss during domestic and commercial laundering. The method is designed to assess material loss of all types.

During testing, the test specimen is subjected to an accelerated laundering process under standardized conditions of temperature, time and mechanical action. The resultant wash liquor is vacuum filtered. Material loss is assessed gravimetrically to approximate material loss during simulated domestic laundering.

The ratio of the mass of the material loss by the test specimen mass is reported.

Important notes:
Manufacturers of textile articles should be able to make knowledgeable decisions about the type of fabric to use to reduce/minimize shedding, as well as to test different methods of manufacture that minimize material loss during laundering, based on the utilization of this test standard.

In March 2023, the International Organization for Standardization (ISO) published first amendment ISO 8124-3:2020/Amd.1:2023 ‘Safety of Toys – Part 3: Migration of certain elements – Amendment 1: Limits for boron and other elements in slime, and barium in modeling clay’.

The revision determines the migration of certain elements from toy materials and parts including antimony (Sb), arsenic (As), barium (Ba), cadmium (Cd), chromium (Cr), lead (Pb), mercury (Hg), selenium (Se) and boron (B). The maximum acceptable element migration limits of toy materials are listed in the below table.

This new revision of the standard includes some additional important updates:

• - Adds new definition of “slime” (section 3.13)
• - Introduces new meaning of modelling clay and putty (section 3.14)
• - Includes new set of analytical corrections including boron (section 4.2)
• - Clarifies slime is not to be dewaxed (section 9.8.1)
• - Provides rationale to raise soluble barium limit in modelling clays from 250 mg/kg to 350 mg/kg and the justification for the maximum level of boron in modelling clay, putties and slimes (Annex D, D3)

The revised standard is effective immediately.

On 28 March 2023, the General Assembly of Pennsylvania introduced a law (HB 721) to restrict the use of bisphenol A (BPA) in all food and beverage containers manufactured, sold, or distributed in Pennsylvania with the concentration limit of 0.1 part per billion (ppb). Any manufacturer of these containers will be required to use the least toxic alternative when replacing BPA during production. If the law is approved, it will take effect in 60 days.

The safety of dressers and other clothing storage units (CSUs) has been a discussion topic for some time. Recent activities to address issues with these products include the following:

In November 2022, the U.S. Consumer Product Safety Commission (CPSC) published a consumer product safety standard for CSUs to protect children from tip-over-related deaths or injuries, with an effective date of 24 May 2023. As outlined, this rule required CSUs to be tested for stability, exceed minimum stability requirements, bear labels containing safety and identification information, and display a hang tag providing performance and technical data about the stability of the CSU. The rule was issued under the authority of the Consumer Product Safety Act (CPSA).

In December 2022, the President signed into law the “Stop Tip-overs of Unstable, Risky Dressers on Youth“(STURDY) legislation, which required the CPSC to either develop and promulgate a new consumer product safety standard for CSUs or determine that a voluntary standard exists that meets certain requirements specified in STURDY.

On 19 April 2023, the CPSC determined ASTM F2057-23, Standard Safety Specification for Clothing Storage Units, to be a voluntary standard that meets the requirements of STURDY. Therefore, the CPSC passed a direct final rule which adopts the requirements of ASTM F2057-23, as required by STURDY.

The voluntary standard had to contain the following performance requirements to become a mandatory standard for protecting children up to 72 months old:

• - Tests for stability when the unit is placed on carpeting,
• - Tests for stability with loaded drawers and with multiple drawers open, and
• - Tests that simulate the weight of children up to 60 pounds interacting with the unit.

It required that CSUs be designed and tested to ensure they are stable and won't tip over when a reasonable amount of force which simulates a child’s weight is applied. It also mandated that manufacturers include warning labels and instructions on how to properly anchor the products to walls or other stable structures to prevent tip-overs of dressers.

The direct final rule will supersede the CPSC's current CSUs rule which planned to promulgate as 16 CFR part 1261 on 25 November 2022. This rule is stayed from 4 May 2023, through 1 September 2023.

Effective date: The direct final rule will become effective on 1 September 2023 unless the Commission receives a significant adverse comment by 5 June 2023.

*Other Hazards include Tip-Over Hazard, Impact Hazard, Fall Hazard and Safety Risk Hazard with a frequency of less than 2.

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The Commission issued Implementing Decision (EU) 2023/600 of 13 March 2023 amending Implementing Decision (EU) 2019/1956 for harmonized standards for room heaters, aquarium luminaires, circuit-breakers and tumble dryers. The Commission, together with CEN and Cenelec, assessed the compliance of those harmonized standards and amendments. To ensure that the reference of harmonized standards in support of Directive 2014/35/EU are listed in one act, the references of those standards should be included in Annex I and Annex II of Decision (EU) 2019/1956.

The summary of Annex I and Annex II are as below:

1. The date of start of presumption of conformity of the below reference of the harmonized standards is from 17 March 2023:
   EN 60335-2-30:2009+A11:2012+A12:2020+A1:2020+A13:2022+A2:2022+AC:2010+AC: 2014,
   EN 62423:2012+A11: 2021+A12: 2022,
   EN IEC 60335-2-11:2022+A11:2022 and
   EN 60598-2-11:2013+A1:2022.
2. The date of withdraw from the Official Journal or end of presumption of conformity of the below reference of the harmonized standards is from 17 September 2023:
   EN 60335-2-30:2009+A11:2012+A12:2020 +A1:2020+AC:2010+AC: 2014
   EN 62423:2012+A11:2021,
   EN 60335-2-11: 2010+A11:2012+A1:2015 and
   EN 60598-2-11: 2013.

It is therefore appropriate to publish the references of those standards and of the amendments in the Official Journal of the European Union. (“EUR-Lex - 32020D0439 - EN - EUR-Lex”)

In February 2023, the European Committee for Standardization (Comité Européen de Normalisation, CEN) published EN 1811:2023 - a new version of reference method to determine the compliance with entry No. 27 to Annex XVII of Regulation (EC) 1907/2006 (REACH); this is specific to all post assemblies that are inserted into pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin.

According to EN 1811:2023, this standard will be given the status of a national standard by August 2023 and conflicting national standards are to be withdrawn by this date at the latest.

This new version of method has several important updated points:

• - Includes minor clarification about the definition of terms (i.e., sample area)
• - Allows the usage of “ready-to-use” solution
• - Withdraws the usage of reference disc as a quality control step
• - Mentions about the procedure for filtering of test solution after a 7-day leaching step
• - Includes examples illustrating surface area measurement including braided material

This standard does not apply to the nickel release testing of spectacle frames and sunglasses. These products are subject to the requirements of EN 16128:2015 - ‘Ophthalmic optics - Reference method for the testing of spectacle frames and sunglasses for nickel release’.

In March 2023, a new version of the Reclined Cradles European Standard EN 12790 was made available with plans to publish in September 2023. The new version is split into two parts, EN 12790-1:2023 which is applicable to reclined cradles for children up to when they start trying to sit up and EN 12790-2:2023 which covers reclined cradles for children up to when they start to stand up, introducing more stringent requirements and tests.

The scope of new EN 12790-1:2023 corresponds to that of EN 12790:2009 which is for fixed or folding reclined cradles intended for children up to when they start to try to sit up.

In comparison with EN 12790:2009, the significant technical changes relate to the following topics:
1) Chemical hazards;
2) Thermal hazards;
3) Hazards due to sound level;
4) Entrapment hazards;
5) Entanglement hazards;
6) Suffocation hazards from plastic packaging;
7) Requirements for powered mechanisms;
8) Requirements for toy bar attachments;
9) Electrical hazards;
10) General update of product information clause with the introduction of symbols following CEN/TR 13387-5;
11) Introduction of an Annex giving relevant translations for warning sentences.

For EN 12790-2:2023, the standard expands the scope to cover fixed or folding reclined cradles for children up to when they start to stand up and should be applied in addition to EN12790-1:2023.

EN12790:2009 shall be withdrawn by March 2024.

*Other Hazards include Entrapment Hazard, Damage to Hearing, Damage to Sight, Explosion Hazard, Health Risk Hazard, Swallowing Risk and Cut Hazard with a frequency of less than 3.

*Other Categories include Household Items, Furniture, Tools and Hardware, Machinery, Accessories, Home Electrical Appliances and Protective Equipment with a frequency of less than 4.

*Other Countries include Bulgaria, Slovakia, Belgium, Spain, The Netherlands, Austria, Malta, Slovenia, Croatia and Lithuania with a frequency of less than 3.

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*Other Hazards include Swallowing Risk, Microbiological Hazard, Explosion Hazard, Damage to Skin, Skin Irritation Risk, Puncture Hazard and Strangulation Hazard with a frequency of less than 3. 

*Other Categories include Tools and Hardware, Household Items, Furniture, Computer / Audio / Video / Other Electronics & Accessories and Footwear with a frequency of less than 2.

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