October 2021 Regulatory Update

NORTH AMERICA NEWS

USA: Updated Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) / Guidance for Industry and Food and Drug Administration Staff

The Food and Drug Administration (FDA) issued a Revised Policy on Face Masks and Respirators during COVID-19. This document published in September 2021 supersedes “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)” issued in May 2020.

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The FDA originally issued this guidance to provide a policy to help expand the availability of face masks, barrier face coverings, and face shields for the general public, including healthcare personnel (HCP), and surgical masks and particulate filtering facepiece respirators (FFRs) (including N95 respirators) for HCP for the duration of the COVID-19 public health emergency.

The FDA revised this guidance to:

  • Include barrier face coverings intended for a medical purpose but not intended to provide liquid barrier protection within the scope of this guidance.
  • Provide recommendations about submicron particulate filtration efficiency, airflow resistance, and leakage assessments for barrier face coverings as described in ASTM F3502-21: Standard Specification for Barrier Face Coverings.
  • Remove reference to alternatives when FDA-cleared or NIOSH-approved N95 respirators are not available based on current recommendations that healthcare facilities should not be using crisis capacity strategies at the time of issuance of this guidance.
  • Add a policy that, during the public health emergency, the FDA generally does not intend to object to stockpiled, non-NIOSH-approved respirators being further distributed and used as face masks for source control (as opposed to being used as FFRs for respiratory protection) where such use does not create an undue risk in light of the public health emergency. More information is included in the guidance.

For details of Guidance, please visit the link :
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-barrier-face-coverings-face-shields-surgical-masks-and-respirators

If you have questions about this guidance, please contact Division of Industry and Consumer Education (DICE) with the link:
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice?utm_medium=email&utm_source=govdelivery

For More Information About This Story:
Contact: Davio Tsang (Eyewear Technical Consultant)
Phone: (852) 3185 8000
Email: regulatoryupdates@qima.com

USA: Public Consultation for New York’s Toxic Chemicals in Children’s Products Regulations

The New York State Department of Environmental Conservation (NYSDEC) held a virtual meeting on 15 September 2021 about the chemicals being considered for listing as Chemicals of Concern and High Priority Chemicals and their practical quantification limits (PQLs) under New York’s Toxic Chemicals in Children’s Products Regulations. Public comments can be submitted until 15 October 2021.

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New York’s Environmental Conservation Law (ECL) Article 37 Title 9 establishes an ingredient disclosure program and prohibits certain chemicals in children’s products.
Under the law, lists of chemicals of concern and high priority chemicals should be promulgated by 1 March 2022 by NYSDEC and those chemicals must be disclosed if present in children's products. Additionally, children’s products containing benzene, asbestos, or tris(1,3-dichloro-2-propyl) phosphate are also prohibited for sale effective 1 January 2023.

A rule to implement portions of the law is under development by NYSDEC. It is expected the rule would address the product categories to be covered, what specific information must be disclosed, details on the waiver procedures, and so on.

A virtual meeting to present and discuss the chemicals under consideration for listing as Chemicals of Concern and High Priority Chemicals and their practical quantification limits was held on 15 September 2021 by NYSDEC. It is now under a 30-day public comment until 15 October 2021 to allow stakeholders to comment.

For More Information About This Story:
Contact: Andy Choi (Senior Manager)
Phone: (852) 3185 8045
Email: regulatoryupdates@qima.com

USA: Santa Rosa, California Bans PFAS in Food Ware and Food Ware Accessories in Food Facilities

On 3 August 2021, Santa Rosa approved a new Zero Waste Food Ware Ordinance to prohibit per- and polyfluoroalkyl substances (PFAS) in food ware and/or food ware accessories.

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On 3 August 2021, the city of Santa Rosa in California, approved a new Zero Waste Food Ware Ordinance to reduce the community’s use and disposal of single-use food ware and food ware accessories.

According to the new Zero Waste Food Ordinance, the following applies within Santa Rosa and becomes effective on 1 January 2022:

  • Any food service ware containing polystyrene foam is prohibited.
  • Any food service ware containing PFAS is prohibited.
  • Food service facilities are required to provide plastic food ware accessories (straws, lids, cutlery, stir sticks, to-go condiments, etc.) upon request only.
  • ‘Food ware’ means all containers, boxes, bowls, cups, lids, plates, trays and other similar items that are used for prepared foods.
  • ‘Food ware accessories’ means types of items usually provided alongside prepared food, including but not limited to beverage trays, chopsticks, spoons, stirrers, straws, toothpicks and wrappers.
For More Information About This Story:
Contact: Andy Choi (Senior Manager)
Phone: (852) 3185 8045
Email: regulatoryupdates@qima.com

USA: Utah Sterilization Permit Number to be Required on Quilted Clothing Labeling

The state of Utah passed bill HB314 that introduced sterilization requirements for filling materials of animal origin, like wool, shoddy, down and feathers. Effective date for sterilization permit number on quilted clothing textile label is 1 January 2022.

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In 2016, the state of Utah passed bill HB314 that introduced sterilization requirements for filling materials of animal origin, like wool, shoddy, down and feathers for quilted clothing.

The sterilization requirements were implemented in the Act by a revision to the Utah Administrative code regulation by the Utah Department of Agriculture and Food (UDAF) Code 70-101 Bedding, Upholstered Furniture and Quilted Clothing. The revision included a five year phase-in timeframe beginning 1 January 2017, in which the sterilization permit number on the textile label should be included in order for quilted clothing manufacturers to comply with the sterilization requirements.

Effective 1 January 2022, a sterilization permit number will be required on the textile label for quilted clothing with filling material of animal origin. According to Utah’s Bedding, Upholstered Furniture and Quilted Clothing Inspection Act, “quilted clothing” is defined as padded clothing or apparel.

The State of Utah’s Bedding, Upholstered Furniture and Quilted Clothing Inspection Act applies to all bedding, upholstered furniture, and clothing made in whole or in part with filling material. Filling materials may include cotton, wool, feather and down, rubber, foam, hair, man-made or synthetic fibers and their by-products, and even vegetable fibers, seeds, etc.

For More Information About This Story:
Contact: David Zhao (Technical Consultant)
Phone: (571) 8999 7142
Email: regulatoryupdates@qima.com

United States (US) Recalls Summary (01 September 2021 to 30 September 2021)

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 September 2021 to 30 September 2021 are summarized below:

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Hazards Frequency
Laceration Hazard 2
Injury Hazard 2
Fall Hazard 4
Health Risk Hazard 1
Fire Hazard 2
Drowning Hazard 1
Suffocation Hazard 1

Product Categories Frequency
Pet Items 1
Sporting Goods / Equipment 4
Toys and Childcare Products 3
Furniture 1
Tools and Hardware 1
Electrical Appliances 1
Food 1
Outdoor Living Items 1

For a complete list click here


Canada Recalls Summary (01 September 2021 to 30 September 2021)

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 September 2021 to 30 September 2021 are summarized below:

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Hazards Frequency
Fall Hazard 4
Burn Hazard 3
Injury Hazard 3
Ingestion Hazard 2
Fire Hazard 4
Suffocation Hazard 2
Other Hazards* 6

*Other Hazards include Laceration Hazard, Tip-Over Hazard, Entrapment Hazard, Carbon Monoxide Leaking Hazard, Chemical Hazard and Choking Hazard with a frequency of less than 2.


Product Categories Frequency
Toys and Childcare Products 7
Furniture 2
Sporting Goods / Equipment 3
Household Items 2
Other Categories* 6

*Other Categories include Pet Items, Bodycare / Cosmetics, Electrical Appliances, Fabric / Textile / Garment / Home Textile, Outdoor Living Items and Chemicals with a frequency of less than 2.


For a complete list click here


EUROPE NEWS

United Kingdom: UK Defers UKCA Mark Implementation Date Until 1 January 2023

On 24 August 2021, the UK updated the Guidance of Placing manufactured goods on the market in Great Britain. Businesses can continue to use the CE marking for goods placed on the market in Great Britain (GB) until 1 January 2023.

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The UK earlier announced that goods (previously requiring a CE mark) being placed on the market in GB would be required to be labelled with a UKCA mark after Brexit.

On 24 August 2021, there was a new update from the UK. This update was implemented to allow businesses time to adjust. CE marked goods in scope of the guidance that meet EU requirements (which match UK requirements) can continue to be placed on the GB market until 1 January 2023. This includes goods which have been assessed by an EU recognized notified body.

The UKCA mark must be used for placing goods on the GB market from 1 January 2023.

For More Information About This Story:
Contact: Vivian Chan (Technical Consultant)
Phone: (852) 3185 8052
Email: regulatoryupdates@qima.com

Germany: BfR Recommendation for Rubber Has Been Updated

In July 2021, the German Federal Institute for Risk Assessment (BfR) published its latest recommendation on commodities based on natural and synthetic rubber.

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The recommendations on the health assessment of food contact materials have been issued by the German Federal Institute for Risk Assessment (BfR) and its predecessors since 1958. These Recommendations represent the current state of the scientific and technical knowledge on food contact polymers, such as plastic, silicone and rubber.

In July 2021, BfR published three recommendations on commodities based on natural and synthetic rubber:

  • BfR XXI: Commodities based on natural and synthetic rubber
  • BfR XXI/1: Commodities based on natural and synthetic rubber in contact with food
  • BfR XXI/2: Special consumer goods made of natural and synthetic rubber and of latices made of natural and synthetic rubber (formerly special category)

In addition, ‘BfR XXI/3: Consumer goods made of cross-linked thermoplastic elastomer’ is under preparation.

Highlights of the three recommendations are as follows:

Recommendation Summary
BfR XXI
  • Explains the structure of the Recommendations on commodities based on natural and synthetic rubber and the procedure for the inclusion of new substances.
  • Lists the evaluated substances for the manufacture of the products according to Recommendations XXI/1 and XXI/2.
BfR XXI/1
  • Classifies commodities based on natural and synthetic rubber into four categories.
  • Sets restriction for each category.
BfR XXI/2
  • Applies to special consumer goods (e.g., toys, mouth contact articles) made of natural and synthetic rubber.
  • Sets restriction for these articles.
For More Information About This Story:
Contact: Andy Choi (Senior Manager)
Phone: (852) 3185 8045
Email: regulatoryupdates@qima.com

Europe Recalls Summary (01 September 2021 to 30 September 2021)

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 September 2021 to 30 September 2021 are summarized below:

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Hazards Frequency
Electric Shock Hazard 20
Choking Hazard 10
Health Risk Hazard 6
Chemical Hazard 26
Fire Hazard 15
Burn Hazard 18
Injury Hazard 9
Damage to Hearing 4
Damage to Sight 6
Other Hazards* 7

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


Product Categories Frequency
Electrical Appliances 21
Toys and Childcare Products 29
Protective Equipment 3
Jewelry 3
Bodycare / Cosmetics 6
Fabric / Textile / Garment / Home Textile 4
Tools and Hardware 6
Outdoor Living Items 8
Other Categories* 8

*Other Categories include Home Electrical Appliances, Footwear, Computer / Audio / Video / Other Electronics & Accessories, Pet Items and Sporting Goods / Equipment with a frequency of less than 3.


Notifying Country Frequency
Italy 10
Hungary 16
Germany 8
Ireland 3
Cyprus 12
Czechia 6
Poland 9
Denmark 6
Belgium 3
Other Countries* 15

*Other Countries include Slovenia, Spain, Austria, Bulgaria, Croatia, Lithuania, France, The Netherlands, Finland and Romania with a frequency of less than 3.


For a complete list click here


AUSTRALIA NEWS

Australia Recalls Summary (01 September 2021 to 30 September 2021)

In Australia, when hazards are identified in consumer products, they will be recalled and published in the Recalls and Safety Alerts Database on the Australian Competition & Consumer Commission website, which is updated daily. The Australia recalls from 01 September 2021 to 30 September 2021 are summarized below:

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Hazards Frequency
Health Risk Hazard 5
Risk of Allergy 4
Burn Hazard 2
Choking Hazard 4
Injury Hazard 13
Suffocation Hazard 2
Other Hazards* 4

*Other Hazards include Microbial Hazard, Poisoning Hazard, Electric Shock Hazard and Fire Hazard with a frequency of less than 2.


Product Categories Frequency
Pharmacy 2
Food 12
Electrical Appliances 5
Toys and Childcare Products 2
Sporting Goods / Equipment 2
Other Categories* 4

*Other Categories include Household Items, Tools and Hardware, Furniture and Bodycare / Cosmetics with a frequency of less than 2.


For a complete list click here


ASIA NEWS

Saudi Arabia: Adopting a List of Mandatory Standards, Decision No. 181, August 2021

On 10 March 2021, the Saudi Standardization, Metrology and Quality Organization SASO published a list of products that will be required to obtain the applicable national recognition certificate for electrical equipment and components (IECEE) or the national recognition certificate for equipment and devices used in potentially explosive atmospheres (IECEX), beginning 1 November 2021.

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The Saudi Standards, Metrology and Quality Organization announced that from 1 November 2021, manufacturers and suppliers are obliged to obtain the “IECEE”, as well as the “IECEX”, as applicable, to allow the entry of certain products through customs to circulate in the Kingdom market.

Saudi regulations require suppliers and manufacturers to obtain "IECEE" national recognition certificates for electrical equipment and components for the following products: circuit breakers, mobile phone charger cables, electric shavers and desktop computers (PC).

The Saudi regulations also require suppliers and manufacturers to obtain “IECEX” national recognition certificates for equipment and devices used in potentially explosive atmospheres for the following products: junction boxes with cable connection points (wire crossing points), control box points with cable connections, gas detectors and sensors, gas detection systems, electrical plugs and other connecting devices, electric pumps and linear (fixed) lighting.

The "Saudi Standards" confirmed that suppliers and manufacturers are required to obtain these national approval certificates for listed products in an effort to control high risk products entering into the market and protect it from inferior equipment or counterfeit products. In addition, this would help to ensure the application of Saudi Regulations to protect consumers from imported products that do not meet the standards and specifications that verify product safety, to minimize accidents and to allow products to pass through the customs port without repeated inspection and testing.

Link: https://www.saso.gov.sa/ar/mediacenter/news/Pages/saso_news_1230.aspx

For More Information About This Story:
Contact: Vincent Wong (Technical Consultant for E&E)
Phone: (852) 3185 8000
Email: regulatoryupdates@qima.com

China: China’s Ministry of Industry and Information Technology (MIIT) Publicly Solicits Opinions on the Revised Amendment of Three Mandatory National Standards Related to Toys

On 2 September 2021, China’s MIIT published three revised amendments to GB 19865-2005, GB 6675.2-2014 and GB 6675.11-2014. Publicly solicited opinions were required to be submitted before 8 October 2021.

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The key amendments of GB19865-2005: Electric Toys Safety include the following points:

  1. Regarding the amendments to the relevant clauses of the “Battery Box”, including clauses “7.1.1” and “7.4”, it clarifies:
    1. The product structure of the battery box designed to prevent the replacement of the battery box of other battery boxes or power supply does not need to be marked with “DC symbol”;
    2. There is no necessary to declare the situation that “toys cannot be connected to more than the recommended number of power sources”.
  2. Clause “9.4” exempts the requirements for “The battery compartment that can open the battery cover with the aid of tools or at least two independent actions at the same time”.

The key amendments of GB6675.2-2014: Safety of Toys -- Part 2: Mechanical and Physical Properties include the following points:

  1. Corrects typos within the standard;
  2. Provides applicable conditions and the corresponding test method modification of requirements in clause 4.18 Projectile Toys.

The key amendments of GB6675.11-2014: Swings, Slides and Similar Activity Toys for Indoor and Outdoor Family Domestic Use include the following points:

  1. Modifications involving “4.7.7 Minimum distance between swing element and the ground”.
  2. Amends criteria from “outer diameter 330 mm” to ”diameter shall not be over 210 mm”
For More Information About This Story:
Contact: Vivian Chan (Technical Consultant)
Phone: (852) 3185 8052
Email: regulatoryupdates@qima.com

China Recalls Summary (01 September 2021 to 30 September 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 September 2021 to 30 September 2021 are summarized below:

View Story Read More
Hazards Frequency
Safety Risk Hazard 22
Electric Shock Hazard 11
Cut Hazard 2
Health Risk Hazard 3
Fire Hazard 14
Chemical Hazard 2
Burn Hazard 3
Fall Hazard 1

Product Categories Frequency
Protective Equipment 3
Electrical Appliances 21
Home Electrical Appliances 4
Sporting Goods / Equipment 4
Footwear 2
Food Contact Material 5
Toys and Childcare Products 2
Other Categories* 4

*Other Categories include Jewelry, Stationery, Household Items and Tools and Hardware with a frequency of less than 2.


Provinces Frequency
Anhui 10
Tianjin 2
Jiangsu 4
Shanghai 2
Guangdong 17
Sichuan 6
Other Provinces* 4

*Other Provinces include Beijing, Jiangxi, Fujian and Guangzhou with a frequency of less than 2.


For a complete list click here


OCTOBER CONTRIBUTORS

Andy Choi

Vivian Chan

Vincent Wong

David Zhao

Davio Tsang

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