May 2022 Regulatory Update

California AB-2208 Fluorescent lamps: sale and distribution prohibition was introduced on 22 February 2022 and amended in Assembly on 19 April 2022. Under this bill:

1. A compact fluorescent lamp shall not be offered for final sale as a new manufactured product on or after 1 January 2024
2. A linear fluorescent lamp shall not be offered for final sale as a new manufactured product on or after 1 January 2025
3. The following lamps are exempt from this prohibition:
1. A lamp used for image capture and projection
2. A lamp that has a high proportion of ultraviolet light emission
3. A lamp used for medical or veterinary diagnosis or treatment, or used in a medical device
4. A lamp used in pharmaceutical product manufacturing or quality control
5. A lamp used for spectroscopy and photometric applications

Some examples for point 3 include:

Mosquito killing lamp	Disinfection lamp

Effective dates for listed bans for compact fluorescent lamps and linear fluorescent lamps are 1 January 2024 and 1 January 2025, respectively.

On 31 March 2022, Washington State’s Governor signed the bill (HB 1694, concerning logistical processes for the regulation of priority chemicals in consumer products) into law. This law will accelerate the state’s ability to develop regulations for a variety of consumer products containing perfluoroalkyl and polyfluoroalkyl substances (PFAS).

The new law requires the state of Washington’s Department of Ecology (DOE) to name PFAS-containing firefighting personal protective equipment as a “priority product”. The law also allows DOE to name any product identified in the 2021 PFAS chemical action plan (CAP) as a “priority product”. This includes non-stick cookware, personal care products, cleaning agents, water-repellent clothing and gear, automotive products, and waxes and sealants for floors, skis, and cars.

Moreover, the law gives the DOE the authority to address additional PFAS containing products as “priority products”. In the past, the DOE would add products to the “priority” list every five years. This law accelerates the five-year waiting period. The law is not a complete ban on the use of PFAS; instead, it requires the DOE to determine an initial set of regulatory actions for PFAS in CAP-identified products by 1 June 2024, and then adopt rules to implement the determinations by 1 December 2025.

On 5 April 2022, the California Office of Environmental Health Hazard Assessment (OEHHA) issued a second 15-Day modification of text to proposed amendments to Prop 65 Article 6 – Clear and Reasonable Warnings – Short Form. The latest proposal removes the limitation on the use of short-form warnings for smaller products and retains the requirement to list a chemical for toxicity terminuses.

There was a first proposal of modification to the short form warning in January 2021. After reviewing the public comments of the first modification, the proposed regulatory text has been further modified by OEHHA and some of the proposed modifications are listed below:

1. The language “exposes you to” in subsections 25603(b) and 25607.2(b) is changed to “can expose you to”, which makes the language conform with the general content language in general consumer safe harbour warning (Section 25603).
2. The limitations of package shape and label size on the use of short-form warnings are removed in Section 25602(a)(4), which means that the short-form warning can be used on product labels of any size, regardless of the package shape and size.
3. The requirement in Section 25602(a)(4) is removed, which means that the requirement of having a minimum of 6-point type size when using short-form warnings in existing provision remains unchanged.
4. The date that the regulation becomes effective is modified to two years rather than one year after the effective date of the amendments in Subsections 25602(e) and 25607.2(c).

According to the latest notice of modification, public comments were to be collected until 20 April 2022. The amendments would become operative two years after the effective date of the amendments.

On 1 February 2022, ASTM notified the Consumer Product Safety Commission (CPSC) that it had revised the voluntary standard for baby changing products, approving ASTM F2388-21 Standard Consumer Safety Specification for Baby Changing Products for Domestic Use on 15 November 2021. Based on the CPSC staff’s review of ASTM F2388-21, the Commission will allow the revised voluntary standard to become the mandatory standard because the revised requirements in the voluntary standard either improve the safety of baby changing products or are neutral with respect to safety.

ASTM F2388-21 includes two substantive changes and some non-substantive revisions.

Substantive Changes:

1. Two notes have been added to Figure 9 to provide the overall width and length dimensions for the tension tool used and a metric equivalent dimension has been added for one of the dimensions shown in the figure.
2. Section 9.5 which provides warning statements that must be addressed on product labels and which requires that the warnings align with the format and text requirements illustrated in the standard have been updated:
1. Section 9.5.1 “Fall Hazard,” at the beginning of the warning statement, in ASTM F2388-21, this hazard statement has been revised to be capitalized as “FALL HAZARD”
2. Section 9.5.3 “Suffocation Hazard” at the beginning of the warning statement, in ASTM F2388-21, this warning statement has also been revised to be capitalized as “SUFFOCATION HAZARD”

Non-Substantive Revisions:

1. Footnote 1 has been revised to include “baby changing products,” instead of “changing tables,”
2. Figure 11, which provides examples of left-aligned warning label text, has been renumbered as Figure X1.1 and relocated from section 9, Marking and Labeling, to section X1, Rationale.
3. Minor wording changes and grammatical corrections have been made, including:
1. changing “example warning labels” to “example warning statements” (section 9.4.7);
2. changing the warning label statement regarding fall hazards from “stay within arm’s reach” to “stay in arm’s reach of your child” (section 9.5.1);
3. correcting the title of updated Figure X1.1 from “Example of Left Aligned Text” to “Example of Left-aligned Text.”
4. Several figure names have been revised in section 9 Marking and Labeling and section 10 Instructional Literature.

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*Other Hazards include Safety Risk Hazard, Entrapment Hazard, Laceration Hazard and Poisoning Hazard with a frequency of less than 2.

*Other Categories include Cannabis, Sporting Goods / Equipment, Tools and Hardware, Medical Devices, Food Contact Material, Pharmacy and Furniture with a frequency of less than 2.

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In February 2022, the European Committee for Standardization (Comité Européen de Normalisation, CEN) published CEN/TR 12471:2022 - a new version of the nickel screening method which is a cost-effective qualitative method for detecting the presence of nickel in articles. Such method is a completely revised and restructured edition of CR 12471:2002 ‘Screening tests for nickel release from alloys and coatings in items that come into direct and prolonged contact with the skin.’

This screening test is based upon the use of dimethylglyoxime (by the formation of a red coloured metal complex with nickel ions) for detecting the presence of nickel in articles that are inserted into pierced parts of the human body and those that are intended to come into direct and prolonged contact with the skin.

This new version of the method has several important points:

1. States that the reference method for nickel release is EN 1811 (or EN 16128 for spectacle frames and sunglasses)
2. Emphasizes the test to verify the compliance of REACH Annex XVII Entry 27 is the quantitative test method EN 1811 (or the abrasion test EN 12472 followed by EN 1811)
3. Advises that a positive finding in this screening test may not be compliant with the respective nickel release limit falling under REACH Annex XVII Entry 27

On 13 April 2022, a notification letter (document no. 22-3025) under G/TBT/N/GBR/47 from the World Trade Organization (WTO) was introduced. It is the draft regulation about the intention of a revision to the Toys (Safety) Regulation 2011 (UK Statutory Instruments 2011 No. 1881) and the Cosmetic Regulation 1223/2009 which is applicable in Great Britain (GB) including England, Wales and Scotland. The final date for comments is 14 June 2022 and the proposed date of adoption is 15 June 2022.

This draft regulation restricts or prohibits the use of chemical substances in cosmetics and toy products. For cosmetic products, there is a permission of the use of salicylic acid for uses other than as a preservative, only in specific product types. Also, there is a prohibition on the use of deoxyarbutin and a set of chemicals classified as Carcinogenic, Mutagenic or Reprotoxic (CMR) under GB Classification, Labeling and Packaging (CLP) Regulations. Relative to updates for toy products, notable changes to chemical requirements are listed below. Such chemical requirement updates in GB will further align with those requirements in the European Union (EU) Toys Safety Directive 2009/48/EC:

1. The number of allergenic fragrances is expanded from 55 substances to 58 substances by adding atranol, chloroatranol and methyl heptane carbonate (Schedule 2, Part 3, Point 11). These allergenic fragrances are prohibited. However, if they are technically unavoidable under good manufacturing practice (GMP) and the acceptable concentration level of each fragrance is no more than 100 mg/kg is met, then their presence is allowed.
2. The migration of aluminum is strengthened by 2.5-fold for all three categories of toy materials (Schedule 2, Part 3, Point 13)
3. Aniline and formaldehyde are restricted in certain toys/toy materials (Schedule 2, Appendix C)

Two identified effective dates for toy products are highlighted:

1. 15 December 2022 (specific to the migration of aluminum and the requirements of aniline and formaldehyde)
2. 15 October 2022 (for stipulations other than those indicated above)

Excluding the stipulations for the three new allergenic fragrances, toys that are made available on the market prior to 15 October 2022, can be made available on the market until 15 December 2022.

Excluding the stipulations for aluminum, aniline and formaldehyde, toys that are made available on the market prior to 15 December 2022, can be made available on the market until 15 December 2023.

The proposed requirements of aluminum, aniline and formaldehyde are shown in the below tables.

In accordance with requirements of French regulations article 17 of the French law on Fighting Against Waste and for the Circular Economy (AGEC) and Decree n° 2021-835 of 29 June 2021, two elements must be displayed:

• The Triman symbol
• Sorting information: Information specifying the sorting methods or deposit of waste resulting from the product. This is to be displayed on the product, its packaging, or failing this, contained in other documents supplied with the product (e.g., manual, instructions for use)

Example of logos (for clothing), consist of:

• Triman symbol
• Product categories
• Self-deposit bank
• URL link to the Ademe map
• The letters FR specifying this measure is governed by French Regulations

Logos for clothing, household linen and footwear can be displayed alone, or together, and with self-deposit point(s) (symbols for container, store and association).

The Triman symbol and sorting information must be physically present when the customer purchases the item and can be displayed on different media:

• on the textile label showing the fiber composition,
• on the temporary label (such as the cardboard label or hangtag),
• printed or embroidered onto the product,
• on the packaging in which the product is sold to customers (name tag, box, bag, etc.) or
• in the form of a sticker.

Important notes about implementation:

• End of the transition period: 1 February 2023
• End of the period to sell stocks of products: 1 August 2023

Stakeholders have until 1 February 2023 to put the information on products and until 1 August 2023 to ensure pre-existing stocks (products manufactured or imported before 1 February 2023) are also compliant.

*Other Hazards include Suffocation Hazard, Drowning Hazard and Strangulation Hazard with a frequency of less than 4.

*Other Categories include Household Items, Accessories, Sporting Goods / Equipment, Computer / Audio / Video / Other Electronics & Accessories, Outdoor Living Items, Stationery, Tools and Hardware and Machinery with a frequency of less than 3.

*Other Countries include Norway, Slovakia, Austria, Czechia, Luxembourg, Italy and Latvia with a frequency of less than 5.

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*Other Hazards include Suffocation Hazard, Drowning Hazard and Skin Irritation Risk with a frequency of less than 2.

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*Other Hazards include Poisoning Hazard, Entanglement Hazard, Damage to Sight, Injury Hazard, Entrapment Hazard and Cut Hazard with a frequency of less than 3.

*Other Categories include Construction Products, Chemicals and Footwear with a frequency of less than 2.

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