noviembre 2021

The Food and Drug Administration (FDA intends to withdraw the temporary guidances for alcohol-based hand sanitizers, effective 31 December 2021. After that date, if 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 the FDA’s relevant Good Manufacturing Practice (GMP) requirements.

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.

The U.S. Consumer Product Safety Commission (CPSC) staff is participating in voluntary standard activities related to batteries in consumer products, including UL 4200A - Standard for Safety for Products that Incorporate Button or Coin Cell Batteries of Lithium Technologies.

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

In July 2021, the CPSC was notified by ASTM that ASTM F1004-19 Standard Consumer Safety Specification for Expansion Gates and Expandable Enclosures was updated to ASTM F1004-21. The CPSC has issued final rule to incorporate by reference the 2021 version of the voluntary standard. This rule will be effective on 2 January 2022.

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.

El gobierno del estado de California aprobó en octubre de 2021 la Ley de la Asamblea nº 1200 para restringir las sustancias perfluoroalquiladas y polifluoroalquiladas (PFAS) en los envases de alimentos de origen vegetal y exigió la divulgación de una lista designada de sustancias químicas en los utensilios de cocina.

A partir del 1 de enero de 2023, cualquier envase alimentario que contenga sustancias perfluoroalquiladas y polifluoroalquiladas reguladas o PFAS (≥ 100 ppm medido en flúor orgánico total) no podrá venderse ni distribuirse en el Estado de California.

"Envase alimentario": envase no duradero, componente de envase o utensilio de servicio alimentario compuesto de papel, cartón u otros materiales derivados originalmente de fibras vegetales.

A partir del 1 de enero de 2023, los manipuladores de utensilios de cocina o de superficies de utensilios de cocina en contacto con alimentos que contengan sustancias químicas añadidas intencionadamente y presentes en la lista designada publicarán la información sobre las sustancias químicas en el sitio web de Internet.

A partir del 1 de enero de 2024, los mangos de los utensilios de cocina o las superficies de contacto con los alimentos de los utensilios de cocina que contengan sustancias químicas añadidas intencionadamente y presentes en la lista designada deberán indicar las sustancias químicas en la etiqueta del producto.

"Lista designada": la lista de sustancias químicas identificadas como sustancias químicas candidatas que presentan un rasgo de peligro o un parámetro medioambiental o toxicológico que cumple los criterios especificados en la normativa adoptada por el Departamento de Sustancias Tóxicas y que se publica en el sitio web del Departamento de Control de Sustancias Tóxicas.

The California State government passed Assembly Bill No. 652 in October 2021 to restrict perfluoroalkyl and polyfluoroalkyl substances (PFAS) in products designed for use by infants and children under 12 years of age (Juvenile products). The effective date is 1 July 2023.

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.

In the US, when hazards are identified in consumer products, they will be recalled and published in the Consumer Product Safety Commission (CPSC) Recent Recalls on the CPSC website, which is updated daily. The US recalls from 01 October 2021 to 31 October 2021 are summarized below:

For a complete list click here

In Canada, when hazards are identified in consumer products, they will be recalled and published in the Recalls and Safety Alerts Database on the Health Canada website, which is updated daily. The Canada recalls from 01 October 2021 to 31 October 2021 are summarized below:

For a complete list click here

On 20 September 2021, Colombia Issued a Resolution for Food Contact Glass and Ceramics.

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 published the Decree Order of 24 September 2021 relating to the maximum plastic content authorized in single-use plastic cups.

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.

On 29 June 2021, the French government updated Decree 2021-835 to introduce new Packaging Signage Requirements that will be effective on 1 January 2022.

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:

In Europe, when hazards are identified in Non-food Consumer Products, the Products will be recalled and published in the Safety Gate system, which is updated weekly. The European recalls from 01 October 2021 to 31 October 2021 are summarized below:

*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.

For a complete list click here

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.

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.

China standard GB/T 28011-2021 Shanks for Footwear was recently published. It applies to shanks of shoes (including boots) with a shoe size of 200 (mm) and above, but it is not applicable to wooden shanks. It will be effective 1 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, the Food Safety and Standards Authority of India (FSSAI) issued a Notification to amend Food Packaging Regulation, 2018.

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.

In China, when hazards are identified in consumer products, they will be recalled and published in the SAMR Defective Product Administrative Centre, which is updated daily. The China recalls from 01 October 2021 to 31 October 2021 are summarized below:

*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.

For a complete list click here

En Australia, cuando se identifican peligros en los productos de consumo, se retiran del mercado y se publican en la base de datos de retiradas y alertas de seguridad del sitio web de la Comisión Australiana de la Competencia y los Consumidores, que se actualiza diariamente. A continuación se resumen las retiradas de Australia desde el 1 de octubre de 2021 hasta el 31 de octubre de 2021:

*Otros Peligros incluyen Peligro de Incendio y Peligro de Ahogamiento con una frecuencia inferior a 2.

*Otras categorías incluyen Farmacia, Herramientas y ferretería y Artículos para mascotas con una frecuencia inferior a 2.

Para consultar la lista completa, pulse aquí