November 2021 Regulatory Update

On 12 October 2021, the FDA announced the intention to withdraw the three guidances for alcohol-based hand sanitizers, effective 31 December 2021. Those guidances were issued in March 2020 as temporary policies for manufacturers that were not drug manufacturers to provide regulatory flexibility to address the increase in the demand of alcohol-based hand sanitizers during the COVID-19 pandemic. The FDA is withdrawing the three guidances as current data shows a stable supply for alcohol-based hand sanitizer on the market.

After 31 December 2021, companies must stop producing alcohol-based hand sanitizers under the temporary policies. Any remaining hand sanitizer produced under the temporary guidances can no longer be sold or distributed by manufacturers after 31 March 2022.

If these manufacturers would like to continue producing hand sanitizer, they will need to comply with the tentative final monograph for over-the-counter topical antiseptics and FDA’s relevant Good Manufacturers Practice (GMP) requirements. Otherwise, they may deregister by referring to the directions on the Electronic Drug Registration and Listing System instructions page.

Specific to UL 4200A, this standard is designed to reduce the risk of children removing button and coin cell batteries from products and ingesting batteries. These lithium batteries can cause serious harm to children.

There are more and more deaths and serious injuries associated with button cell batteries. These incidents generally involve children under the age of four. Serious injury can occur when the battery remains in the digestive tract or other parts of the body.

In order to address these issues, UL has formulated standard UL 4200A to ensure the safety of products containing button batteries during their use.

UL 4200A requires that products containing removable batteries use specified methods to ensure reliable placement of batteries. The standard details performance criteria, including abuse, and aims to assess the possibility of accidental release of batteries from products.

UL 4200A also describes how the product should be marked, including warnings about hazards, and keeping batteries away from children. The standard contains specific language describing possible injuries caused by swallowing batteries and the need for immediate medical treatment.

UL 4200A scope:
1.1 These requirements cover household type products that incorporate or may use button or coin cell batteries of lithium technologies.
1.2 These requirements do not cover products that exclusively use forms of batteries other than lithium button or coin cells.
1.3 These requirements apply to consumer products containing lithium button or coin cells. They do not apply to products that by virtue of their dedicated purpose and instructions are not intended to be used in locations where they may be accessed by children, such as products for dedicated professional use or commercial use in locations where children are not normally or typically present.
1.4 These requirements are intended to supplement other safety requirements for products that incorporate button or coin cell batteries and are not intended to supersede specific requirements that are incorporated into other safety standards to mitigate physiological hazards from button or coin cells.

Website: https://www.cpsc.gov/Regulations-Laws--Standards/Voluntary-Standards/Topics/Batteries

ASTM made minor/editorial changes and substantive revisions throughout ASTM F1004-21 including the following examples:

Minor/editorial changes:

1. Hyphenated multiple terms used as adjectives, such as “single-action”, “pressure-mounted”, “partially-bounded”, and “hold-open”, throughout;
2. Corrected the spelling of “guage” to “gauge” in section 3.1.16;
3. Added conversions to Celsius in section 4.4;
4. Changed the capitalization of some terms, such as “Small Torso Probe” to “small torso probe”;

Substantive revisions:

1. Added a requirement of a visual side-pressure indicator for pressure-mounted gates that do not incorporate wall-cups.
2. Added a new section 8.5.7 to the wall-cup warning requirement.

Effective 1 January 2023, any food packaging that contains regulated perfluoroalkyl and polyfluoroalkyl substances or PFAS (≥ 100 ppm as measured in total organic fluorine) is not allowed to be sold or distributed in the State of California.

“Food packaging” means a nondurable package, packaging component, or food service ware that is comprised of paper, paperboard, or other materials originally derived from plant fibres.

Effective 1 January 2023, handles of cookware or cookware food contact surfaces that contain intentionally added chemicals present on the designated list shall post the chemical information on the internet website.

Effective 1 January 2024, handles of cookware or cookware food contact surfaces that contain intentionally added chemicals present on the designated list shall list the chemicals on the product label.

“Designated list” means the list of chemicals identified as candidate chemicals that exhibit a hazard trait or an environmental or toxicological endpoint that meets the criteria specified in regulations adopted by the Department of Toxic Substances and is published on the Department of Toxic Substances Control’s internet website.

Effective 1 July 2023, juvenile products that contain regulated PFAS chemicals (≥ 100 ppm as measured in total organic fluorine) are not allowed to be sold or distributed in the State of California.

“Juvenile product” means a product designed for use by infants and children under 12 years of age, including, but not limited to, a baby or toddler foam pillow, bassinet, bedside sleeper, booster seat, changing pad, child restraint system for use in motor vehicles and aircraft, co-sleeper, crib mattress, floor playmat, highchair, highchair pad, infant bouncer, infant carrier, infant seat, infant sleep positioner, infant swing, infant travel bed, infant walker, nap cot, nursing pad, nursing pillow, playmat, playpen, play yard, polyurethane foam mat, pad, or pillow, portable foam nap mat, portable infant sleeper, portable hook-on chair, soft-sided portable crib, stroller, and toddler mattress.

The following are excluded

• certain children’s electronic products or any associated peripheral,
• medical devices,
• inaccessible components of a juvenile product,
• adult mattresses.

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On 20 September 2021, Colombia Ministry of Health and Social Protection published Resolution No. 1440/2021 to establish a technical regulation for food contact glass, ceramic and glass-ceramic.

The new regulation mainly includes:

• Application scope: tableware, ceramic cookware and articles of glass, ceramic or glass‑ceramic that are intended to come into contact with food
• List of HS codes for products within the regulation scope
• Exceptions and exclusions
• Permissible release limits and test methods for lead and cadmium
• Labelling requirement
• Sampling requirement
• Testing laboratories accreditation requirement
• Product certificate of conformity (CoC) requirement

The new regulation will enter into force on 20 March 2022.

On 15 October 2021, France Ministries of Ecology and Economy published the Order of 24 September 2021 relating to the maximum plastic content authorized in single-use plastic cups. The order establishes the timeline for the stepwise reduction of plastic content in single-use plastic cups.

The maximum plastic content in single-use plastic cups shall be:

• 15% as of 1 January 2022
• 8% as of 1 January 2024
• achieve zero value as of 1 January 2026; an evaluation will be performed during 2024 addressing the feasibility of this target

The order will enter into force on 16 October 2021.

The decree defines the conditions for the application of the legislative provisions of the Environmental Code to ensure that any product placed on the market for households and subject to the principle of extended producer responsibility, excluding household packaging of glass beverages, is the subject of signage. This signage informs the consumer that this product is the subject of a sorting rule and contains information specifying the methods of sorting or bringing the waste from the product.

Based on this new requirement, France also published a new guideline on how the Triman Logo needs to be printed on packaging in France beginning January 2022. This is to ensure that a common format is used for the symbol and sorting device. A transition period is in place until 9 March 2023. Afterwards, packaging that is not compliant with the new Triman signage rules may no longer be placed on the French market.

Triman Logo Transition Period Milestones:

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

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

*Other Countries include Austria, Estonia, Belgium, Slovenia, Denmark, Romania, Spain, Sweden, Luxembourg and France with a frequency of less than 4.

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*Other Hazards include Fire Hazard and Drowning Hazard with a frequency of less than 2.

*Other Categories include Pharmacy, Tools and Hardware and Pet Items with a frequency of less than 2.

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On 16 September 2021, The National Food Safety Standard GB 31604.8-2021 for Food Contact Materials and Articles – Determination of Overall Migration was published by China's National Health Commission and China's State Administration for Market Regulation (SAMR). The new standard will replace the existing standard GB 31604.8-2016.

Comparing the new standard to the existing standard GB 31604.8-2016, GB 31604.8-2021,

• Revises the application scope - extends the application scope to overall migration in olive oil
• Revises the requirements for precision
• Adds ‘Part 2 Determine of overall migration in olive oil’

This standard will enter into force on 7 March 2022.

This document replaces GB/T 28011-2011 "Shoes Steel Shaft".

Compared with GB/T 28011-2011, the main technical changes are as follows:

1. Modified the file name;
2. Modified "Scope";
3. Added the definitions of "1 type shank", "L type shank" and "Y type shank";
4. Modified product classification;
5. Modified the requirements for "marks";
6. Modified the requirements for "sensory quality";
7. Modified the requirements for "longitudinal stiffness";
8. Modified the requirements for "fatigue resistance";
9. Modified the requirements for "hardness";
10. Modified the requirements for "bending performance";
11. Added icons for measuring the length of shanks, L type shanks and Y type shanks;
12. Modified the "bending performance" test method.

On 6 September 2021, FSSAI issued a Notification to amend Food Safety and Standards (Packaging) Regulations, 2018. According to the Notification, the amendment may be called the Food Safety and Standards (Packaging) Amendment Regulations, 2021 and the following restrictions will be added.

In addition, the public may provide comments to this Notification before 6 November 2021.

*Other Hazards include Skin Irritation Risk, Crash Hazard, Choking Hazard, Entanglement Hazard, Damage to Skin, Injury Hazard and Burn Hazard with a frequency of less than 3.

*Other Categories include Sporting Goods / Equipment, Footwear, Household Items and Tools and Hardware with a frequency of less than 3.

*Other Provinces include Yunnan, Jilin, Beijing and Shanghai with a frequency of less than 3.

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