December 2021 Regulatory Update

In November 2021, a bill called the ‘‘Keep Food Containers Safe from PFAS Act of 2021" was proposed in the United States Senate (S.3169M). The bill would ban the use of any perfluoroalkyl or polyfluoroalkyl substance (PFAS) in food packaging.

If adopted into law, it would amend the Food, Drug and Cosmetic Act (21 U.S.C. 331) by adding the following information:

• Prohibiting ‘’The introduction or delivery for introduction into interstate commerce of food packaging containing intentionally added PFAS.’’
• Defining the term ‘PFAS’ as a perfluoroalkyl substance or a polyfluoroalkyl substance that is man-made with at least one fully fluorinated carbon atom.

The amendment would be applicable beginning on 1 January 2024.

The revision to 16 CFR 1227, incorporating ASTM F833-21 Standard Consumer Safety Performance Specification for Carriages and Strollers, contains several substantive changes as well as editorial, non-substantive changes to improve the requirements.

Substantive Changes:

Non-substantive Changes:

• Renumbering of figures to account for two new parking brake figures
• Addition of hyphens to compound adjectives
• Addition of units to the first value in range
• Revision of punctuation and spacing

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*Other Hazards include Entrapment Hazard, Swallowing Risk, Poisoning Hazard, Suffocation Hazard and Choking Hazard with a frequency of less than 3.

*Other Categories include Furniture, Sporting Goods / Equipment, Footwear and Computer / Audio / Video / Other Electronics & Accessories with a frequency of less than 2.

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The Southern Common Market (Mercado Común Del Sur, Mercosur) published three resolutions in October 2021 that modify existing resolutions related to food contact materials.

These Resolutions are:

The following are the latest versions in the European harmonized standards relative to the electrotechnical field:

For EN 60034-18-42:2017/A1:2020: https://standards.cencenelec.eu/dyn/www/f?p=CENELEC:110:::::FSP_PROJECT,FSP_ORG_ID:68425,1257145&cs=1C4A1F9148CD1EB4149269F33DBFDCBF0

For EN IEC 62841-2-6:2020: https://standards.cencenelec.eu/dyn/www/f?p=CENELEC:110:::::FSP_PROJECT,FSP_ORG_ID:70011,1258713&cs=18C70CCBF577F4AA1C36E0CC52EF84307

For EN IEC 61000-4-3:2020: https://standards.cencenelec.eu/dyn/www/f?p=CENELEC:110:::::FSP_PROJECT,FSP_ORG_ID:64480,1258289&cs=165689DCEC4146219E751F9796CC95143

For EN 60335-2-5:2015/A1:2020: https://standards.cencenelec.eu/dyn/www/f?p=CENELEC:110:::::FSP_PROJECT,FSP_ORG_ID:69870,1257159&cs=165056EC078D23FD05582397A3D6EE394

On 22 November 2021, the European Commission published Commission Regulation (EU) 2021/2030 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) relative to N,N-dimethylformamide. EU 2021/2030 will be applicable in all member states.

This amendment adds ‘N,N-dimethylformamide’ as entry 76 to Annex XVII and introduces these restrictions:

• Shall not be manufactured, or used, or placed on the market as a substance or in mixtures in a concentration equal to or greater than 0.3% after 12 December 2023
• The exception to the ban is manufacturers, importers and downstream users have included in the relevant chemical safety reports and safety data sheets, Derived No-Effect Levels (DNELs) relating to exposure of workers of 6 mg/m3 for exposure by inhalation and 1.1 mg/kg/day for dermal exposure.
• The exception to the ban is the adoption of appropriate risk management measures by manufacturers and downstream users to ensure that worker exposure is below the DNELs mentioned above.
• The ban shall apply from 12 December 2024 when N,N-dimethylformamide is used as a solvent in direct or transfer polyurethane coating processes of textiles or paper material or the production of polyurethane membranes.
• The ban shall apply from 12 December 2025 when N,N-dimethylformamide is used as a solvent in the dry and wet spinning processes of synthetic fibers.

The toy standards EN71-2, EN71-3, EN71-4 and EN71-13 are updated to the latest versions. Their existing versions will be withdrawn from Toy Safety Directive 2009/48/EC after 15 May 2022. Compliance with the harmonized standards for toys gives a presumption of conformity with the requirements in the Directive.

**Details of each standard update has been listed in other articles.

The guidance document issued by the OPSS, Risk Assessing Products that Contain Small, High-powered Magnets, which accompanied the safety alert, references four types of products that contain small high-powered magnets (defined as those with a magnetic flux of greater than 50kG²mm²). These are:

1. Novelty items comprised of small high-powered accessible magnets which include desk toys or stress relievers.
2. Magnetic mouth or nose jewelry.
3. Magnetic ear and/or body jewelry.
4. Magnetic glassware charms.

Businesses and retail platforms are advised to remove from the market any products that breach the magnetic flux index where there is a risk that magnets may be ingested by a child. They must also ensure that clear warnings are included with any products that contain magnets, where there is a risk of ingestion.

OPSS is working with local authority Trading Standards to enforce consumer protection legislation and identify and take appropriate action against any products where magnets that violate the required level of magnetic flux are ingested by a child.

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

*Other Categories include Household Items, Accessories, Computer / Audio / Video / Other Electronics & Accessories, Food Contact Material, Chemicals, Bodycare / Cosmetics, Footwear, Home Electrical Appliances and Stationery with a frequency of less than 4.

*Other Countries include Estonia, The Netherlands, Belgium, Croatia, Czechia, Romania, Ireland, Italy, Denmark and Bulgaria with a frequency of less than 5.

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

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

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The draft regulations require that deep fat fryers and frying pans with a maximum oil volume of not more than 5 liters meet the standards for Household and Similar Electrical Appliances-Safety-Part 2-13: Particular requirements for deep fat fryers, frying pans and similar appliances (TIS 60335 Part 2(13)-25XX(20XX)).

This standard is the same as IEC 60335-2-13 Edition 6.1 2016-04 Household and Similar Electrical Appliances-Safety-Part 2-13: Particular requirements for deep fat fryers, frying pans and similar appliances.

Website: http://tbtims.wto.org/en/RegularNotifications/View/175425?FromAllNotifications=True

Industry Standard FZ/T 81008-2021 is specific to jackets which are made primarily of woven fabrics but does not pertain to jackets intended to be worn by children, including infants under 36 months of age. Jackets intended to be worn by infants (under 36 months of age) and children (3 - 14 years of age) shall comply with the requirements under GB 31701 Safety Technical Code for Children and Infants Textile Products.

Compared with FZ/T 81008-2011, FZ/T 81008-2021 contained many revisions which affected the standard as follows:

• Modified the assessment requirements for linings, and deleted the "special design " regulations;
• Modified and supplemented the requirements for accessories materials;
• Modified the assessment requirements for warp and weft yarn directions;
• Modified the requirements for the assessment of the qualifications of the checks;
• Deleted the requirements for joint panels;
• Deleted the color assessment for the coated adhesive interlining;
• Modified the inspection requirements for appearance defects;
• Modified the diagram in Figure 1;
• Modified the workmanship requirements for sewing;
• Modified the requirements for ironing;
• Merged the physical and chemical performance assessment requirements;
• Added the color assessment requirements for joint panels;
• Modified and supplemented the requirements of Colorfastness to washing & dry cleaning to decorative parts and embroidery threads;
• Added the requirements of tearing strength;
• Modified the requirements for Appearance change after washing;
• Modified inspection tools;
• Modified the inspection appearance measurements;
• Modified the requirements of determination of physical and chemical properties;
• Modified and revised inspection defects;
• Modified sampling rules and judgment rules;
• Deleted “Appendix A” of the 2011 edition.

Website: https://books.google.com.hk/books/about/FZ_T_81008_2021_Translated_English_of_Ch.html?id=FP9FEAAAQBAJ&redir_esc=y

*Other Hazards include Entanglement Hazard, Burn Hazard, Swallowing Risk, Risk of Allergy, Damage to Sight, Explosion Hazard, Strangulation Hazard, Choking Hazard and Cut Hazard with a frequency of less than 4.

*Other Categories include Toys and Childcare Products, Tools and Hardware, Computer / Audio / Video / Other Electronics & Accessories, Footwear, Chemicals and Sporting Goods / Equipment with a frequency of less than 5.

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