June 2023 Regulatory Update

ASTM F2906, the standard for bedside sleepers, includes test methods, performance requirements and requirements for warning labels and instructional literature.

The ASTM F2906 standard was reapproved in 2019 and then was updated in 2022 and 2023.

Important revisions to the Standard through 2022 included the following:

-Section 5.6: Revised the height requirements for side rails adjacent to an adult bed in response to newer bedside sleeper styles which can convert from a bassinet into a bedside sleeper.

-Section 8.3.4 Revised the instructional literature information required to accompany bedside sleepers to the change in section 5.6.

Important revisions to the Standard through 2023 include the following:

-Section 5.6: Further revised the exemption of height requirement for fixed side rails as previous version could be interpreted as allowing a fixed lower rail side to be above the adult bed mattress posing a strangulation hazard if the infant's neck is caught on the exposed rail.

After being notified by ASTM that ASTM F2906 Standard Consumer Safety Specification for Bedside Sleepers was updated to the 2023 version, the CPSC issued a direct final rule for the mandatory standard for bedside sleepers which incorporated by reference ASTM F2906-23; this will become effective 5 August 2023.

After the US President signed into law the Federal Energy Management Improvement Act Update, the authority for regulating the marking of toy, look-alike, and imitation firearms was transferred from the Department of Commerce to the Consumer Products Safety Commission (CPSC).

Newly created 16 CFR 1272, published on 11 May 2023 and effective 26 June 2023, applies to toy, look-alike, and imitation firearms having the appearance, shape, and/or configuration of a firearm and produced or manufactured and entered into commerce on or after 5 May 1989 and does not apply to:

(a) Non-firing collector replica antique firearms;

(b) Traditional B–B, paint-ball, or pellet-firing air guns that expel a projectile through the force of compressed air, compressed gas or mechanical spring action, or any combination thereof, as described in ASTM F589–85 Standard Consumer Safety Specification for Non-Powder Guns;

(c) Decorative, ornamental, and miniature objects having the appearance, shape and/or configuration of a firearm, including those intended to be displayed on a desk or worn on bracelets, necklaces, key chains, and so on, provided that the objects measure no more than thirty-eight (38) millimeters in height by seventy (70) millimeters in length, the length measurement excluding any gun stock length measurement.

The following markings are approved by the CPSC:

(a) A blaze orange (AMS STD 595A–17 color 12199) or orange color brighter than that specified by the AMS standard color number, solid plug permanently affixed to the muzzle end of the barrel as an integral part of the entire device and recessed no more than 6 millimeters from the muzzle end of the barrel.

(b) A blaze orange (AMS STD 595A–17 color 12199) or orange color brighter than that specified by the AMS standard color number, marking permanently affixed to the exterior surface of the barrel, covering the circumference of the barrel from the muzzle end for a depth of at least 6 millimeters.

(c) Construction of the device entirely of transparent or translucent materials which permits unmistakable observation of the device's complete contents.

(d) Coloration of the entire exterior surface of the device in white, bright red, bright orange, bright yellow, bright green, bright blue, bright pink, or bright purple, either singly or as the predominant color in combination with other colors in any pattern.

(e) SAE AMS STD 595A–17, Colors Used in Government Procurement, approved 10 February 2017, is incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a), Freedom of Information Act and 1 CFR Part 51, Incorporation by Reference.

On 8 May 2022, Oregon's governor signed bill SB 543 into law to prohibit the sale or distribution of any foodware containers containing intentionally added perfluoroalkyl and polyfluoroalkyl substances (PFAS). In addition, the new law bans polystyrene foam containers and packaging peanuts.

Following are the highlights of the prohibition:

The new law takes effect on 1 January 2025.

On 24 March 2023, the Governor of Minnesota signed bill (HF 2310) into law (Minnesota Session Law, Chapter 60). The law sets the ban on perfluoroalkyl and polyfluoroalkyl substances (PFAS) and includes restrictions on lead and cadmium in various products.

The new law sets the PFAS ban in different implementation stages:

• Starting 1 January 2025, intentionally added PFAS in specific products (e.g., carpets and rugs, juvenile products, etc.) will be prohibited.
• On or before 1 January 2026, the manufacturer of products containing intentionally added PFAS will be required to submit a notification that includes product reporting requirements to the state’s Pollution Control Agency (PCA) commissioner. Such products will be prohibited from being sold, offered for sale or distributed if a manufacturer fails to disclose the required information and there may be a fee imposed.
• Starting 1 January 2032, the other products containing intentionally added PFAS will be banned, unless the PCA commissioner has determined the use of PFAS is unavoidable.

In addition to PFAS, the law expands the scope of heavy metals (lead and cadmium) restrictions in certain products including toys, jewelry, clothing and footwear. At the same time, the new law repeals provisions in relation to “lead in jewelry” and “cadmium in children’s jewelry” falling under the 2022 Minnesota Statutes Section 325E.389 and 325E.3891, respectively.

The highlights of the new law are listed in the below table.

On 5 May 2023, the Governor of the state of Washington signed bill (HB 1047) concerning the use of toxic chemicals in cosmetics and personal care products into a law which is also known as the Toxic-Free Cosmetic Act. The law aims at eliminating the use of toxic and harmful chemicals in cosmetics and personal care products to protect both consumers and the environment. This law is the strongest state law in the country regulating toxic chemicals in health and beauty products to date.

As outlined in the Toxic-Free Cosmetic Act, beginning on 1 January 2025, no person may manufacture, knowingly sell, offer for sale, distribute for sale or distribute for use in the state, any cosmetic product that contains any of the following intentionally added chemicals or chemical classes:

• Ortho-phthalates (esters of ortho-phthalic acid)
• Perfluoroalkyl and polyfluoroalkyl substances (PFAS)
• Formaldehyde (CAS no. 50-00-0) and chemicals determined by the department to release formaldehyde
• Methylene glycol (CAS no. 463-57-0)
• Mercury and mercury compounds (CAS no. 7439-97-6)
• Triclosan (CAS no. 3380-34-5)
• m-Phenylenediamine and its salts (CAS no. 108-45-2)
• o-Phenylenediamine and its salts (CAS no. 95-54-5)

Additionally, the law prohibits intentionally added lead or lead compounds, as well as unintentionally added lead or lead compounds when present at 1 ppm or above. Such a limit level is 10-fold more stringent that the recommended limit set by the Food and Drug Administration (FDA) draft guidance of lead in cosmetic lip products and externally applied cosmetics.

It is interesting to note that the first ten formaldehyde-released chemicals identified by the Department of Ecology will not take effect until on or after 1 January 2026 and further formaldehyde-released chemicals may be identified and enforced on or after January 2027.

The in-state retailers may sell cosmetic products in existing stock as of the effective date until 1 January 2026.

For a complete list click here

For a complete list click here

On 22 May 2023, a new Resolution RDC No. 798 was published by the Brazil Ministry of Health/National Health Surveillance Agency/Collegiate Board. As stated in RDC No. 798, this resolution amends Resolution - RDC No. 88, of 29 June 2016, which approves the technical regulation on cellulosic materials, packaging and equipment intended to come into contact with food and other measures.

In addition to the criteria whereby ‘Pigments and dyes cannot migrate when tested to BS EN 646 - Paper and board intended to come into contact with foodstuffs - Determination of color fastness of dyed paper and board’, which is required by RDC No. 88, the new resolution also requires product to comply with a Grade 5 grayscale when tested to BS EN646.

This resolution will be effective on 22 November 2023.

For a complete list click here

Notice of Publication 0083/23 of 31 May 2023 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) was Issued by the Department for Business and Trade.

• (1) Part 1 of Annex I to this notice lists additional references to standards as an amendment for Annex 1 to notice 0079/23, such as EN 60598-2-11: 2013 + A1: 2022, EN 62423:2012 + A11:2021 + A12: 2022, EN 60335-2-30:2009 + A1:2020 + A11: 2012 + A12: 2020 + A13: 2022 + A2: 2022 + AC: 2010 + AC: 2014.
  
  Part 2 of Annex I to this notice sets out the complete list of references to standards in support to regulation 2A of S.I. 2016/1101.
  Annex I came into effect on 31 May 2023.
  
  
• (2) Part 1 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 60598-2-11:2013, EN 62423:2012 + A11:2021, EN 60335-2-30:2009 + A1:2020 + A11: 2012 + A12: 2020 + AC: 2010 + AC: 2014.
  
  Part 2 of Annex II to this notice sets out the complete list of standards which will be removed from publication.

On 29 May 2023, the European Union (EU) published Regulation (EU) 2023/293 on the Official Journal, to amend the restriction of lead and its compounds under entry 63 of Regulation (EC) No. 1907/2006 “Registration, Evaluation, Authorization and Restriction of Chemical” (REACH) Annex XVII expanding the material scope to polymers and copolymers of vinyl chloride (PVC). The latest amendment restricts lead to less than 0.1% in PVC.

The new restriction will take effect starting 29 November 2024 with exemptions for certain applications. Details of the restriction are listed in the below table.

*Other Hazards include Damage to Hearing, Health Risk Hazard and Cut Hazard with a frequency of less than 4.

*Other Categories include Chemicals, Computer / Audio / Video / Other Electronics & Accessories, Car Components, Furniture, Tools and Hardware, Machinery, Accessories, Construction Products and Stationery with a frequency of less than 5.

*Other Countries include The Netherlands, Lithuania, Malta, Slovakia, Austria, Greece, Belgium, Croatia, Estonia, Latvia and Luxembourg with a frequency of less than 6.

For a complete list click here

The Chinese Ministry of Industry and Information Technology issued a new industry standard for Textile Products for Newborns (FZ/T 08002-2022). This standard is applicable to textile products for newborns aged from birth to 28 days, including clothing, hosiery (foot covers), caps, bellybands, gloves, towels, swaddle wraps (quilts), sleeping bags, bedding, etc.

Requirements: Products must comply with the labeling requirements and the technical requirements stated in this standard, which include, but are not limited to:

• Fiber content
• Chemical requirements (Formaldehyde, Azo dyes, Total Lead (Pb) and Cadmium (Cd) Content, Phthalates, Extractable heavy metals content)
• pH value
• Odor
• Flammability
• Cords & Drawstrings
• Sharpness & attachment strength of attached components
• Absorption
• Fiber shedding
• Colorfastness (to water, to perspiration, to washing, to saliva, to rubbing, to urine, to breast milk)
• Seam strength
• Strap pulling strength
• Appearance quality
• Remains of broken sewing needle
• Filling materials (Wadding): GB 31701 Infant and Children’s Textile Products category A and GB 18383 General Technical Requirements for Products with Filling Materials

Important notes:

• Soft and light color shade cotton material should be used for direct skin contact textile products of newborns
• Brushed/peached finishes on fabric should not be used for newborn clothing
• Fabric with coating, pigment dyed/printing, functional finishing such as antibacterial, flame-retardant shall not be used for newborn textile products
• Down filling materials shall not be used for newborn textile products

This new industry standard was included in China’s No. 10 announcement of approved industry standards in 2022. The effective date was 1 October 2022.

The Standardization Administration of China has issued a national standard of Nursing Garments (GB/T 41902-2022). This standard is applicable to nursing clothes, breastfeeding clothes, breastfeeding covers, breastfeeding shawls and other accessories.

Requirements: Products must comply with the labeling requirements and the technical requirements stated in this standard, which include, but are not limited to:

• Fiber content
• Chemical requirements (Formaldehyde, Azo dyes, Total Lead (Pb) and Cadmium (Cd) Content, Phthalates, Extractable heavy metals content)
• pH value
• Odor
• Remains of broken sewing needle
• Sharpness of attached components
• Dimensional change & appearance after wash
• Pilling resistance
• Bursting strength
• Seam strength
• Colorfastness (to water, to perspiration, to washing, to rubbing, to saliva, to breast milk, to transfer in joints)
• Fiber shedding
• Appearance quality

Important note:

• The material used and the product design require compliance with section 5.1 safety requirements of this standard

This new product standard was included in China’s No. 13 announcement of approved national standards in 2022.  The effective date was 1 May 2023.

*Other Hazards include Microbiological Hazard, Skin Irritation Risk, Puncture Hazard and Chemical Hazard with a frequency of less than 2. 

For a complete list click here