October 2021 Regulatory Update

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

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.

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.

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.

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*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.

*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.

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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.

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:

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

*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.

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

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

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

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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

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”

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

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

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