December 2021 Regulatory Update

NORTH AMERICA NEWS

USA: Proposed Bill to Ban PFAS in Food Packaging

In November 2021, lawmakers in the US House of Representatives and Senate introduced a bill to ban the use of any per- or polyfluoroalkyl substances (PFAS) in food packaging.

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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.

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

USA: CPSC Publishes Direct Final Rule for Carriages and Strollers

On 18 November 2021, the US Consumer Product Safety Commission (CPSC) published a direct final rule for 16 CFR 1227 updating the mandatory standard for carriages and strollers to incorporate by reference ASTM F833-21.
The rule will be effective on 15 February 2022.

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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:

Section Current standard
(ASTM F833-19)
New standard
(ASTM F833-21)
4.1 Testing to be conducted “On a concrete floor that shall be covered with 18/in (3mm) thick vinyl floor covering, unless test instructs differently” The word “shall” is replaced with “may”, allowing for testing on the originally specified surface, OR on an uncovered concrete floor. This change applies to all carriages and stroller tests, except parking brake testing (section 7.6) and wheel detachment from axle testing (section 7.13.1)
6.1.3 “Each parking brake shall be constructed so that it cannot be disengaged by the child within the unit when the child is secured in the unit in accordance with the instructional literature” Removes the original statements AND adds three alternative test methods by adding new sections 6.3.1.1-6.3.1.3, for evaluating the parking brake release mechanism
6.6.1 Summary did not include reference to impact requirement and head entrapment requirement Adds two more requirements to check: impact test (section 6.7.1) & head entrapment (section 6.10) and its corresponding test method

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

United States (US) Recalls Summary (01 November 2021 to 30 November 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 November 2021 to 30 November 2021 are summarized below:

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Hazards Frequency
Microbiological Hazard 1
Fire Hazard 4
Burn Hazard 1
Poisoning Hazard 1
Safety Risk Hazard 1
Injury Hazard 3
Choking Hazard 2
Fall Hazard 1
Drowning Hazard 1

Product Categories Frequency
Household Items 2
Tools and Hardware 4
Electrical Appliances 1
Outdoor Living Items 2
Protective Equipment 1
Fabric / Textile / Garment / Home Textile 2
Sporting Goods / Equipment 1

For a complete list click here


Canada Recalls Summary (01 November 2021 to 30 November 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 November 2021 to 30 November 2021 are summarized below:

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Hazards Frequency
Risk of Allergy 6
Fire Hazard 5
Burn Hazard 5
Microbiological Hazard 21
Injury Hazard 8
Chemical Hazard 4
Health Risk Hazard 7
Fall Hazard 4
Other Hazards* 6

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


Product Categories Frequency
Food 29
Electrical Appliances 2
Toys and Childcare Products 3
Outdoor Living Items 2
Pharmacy 5
Fabric / Textile / Garment / Home Textile 4
Tools and Hardware 2
Protective Equipment 3
Bodycare / Cosmetics 2
Medical Devices 2
Other Categories* 4

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


For a complete list click here


SOUTH AMERICA NEWS

Mercosur Revised Resolution on Food Contact Materials

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

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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:

Resolution Summary
GMC Res. No. 19/21
  • Modification of ‘’GMC Resolution No. 02/12 Technical Regulation on the Positive List of Monomers, Other Starting Substances, and Polymers Authorized for the Manufacture of Plastic Food Contact Packaging and Equipment”
  • Highlights of the Modification:
    • New restriction on specific migration of nine heavy metals
    • New restriction on specific migration of PAA (sum)
    • Add new substances to the positive list
  • Must incorporate into national legislation by MERCOSUR Member States by 11 April 2022
  • Establishes a 360-day period for compliance with the requirements of the resolution
GMC Res. No. 20/21
  • Modification of ‘’GMC Resolution No. 56/92 General Provisions for plastic containers and equipment in contact with food” - Amend the overall migration requirement
  • Must incorporate into national legislation by MERCOSUR Member States by 11 April 2022
  • Establishes a 360-day period for compliance with the requirements of the resolution
GMC Res. No. 21/21
  • Modification of ‘’GMC Resolution No. 40/15 Technical Regulation on Cellulosic Materials, Containers, and Equipment intended to be in contact with food” - Amend the substances to the positive list
  • Must incorporate into national legislation by MERCOSUR Member States by 11 April 2022
For More Information About This Story:
Contact: Andy Choi (Senior Manager)
Phone: (852) 3185 8045
Email: regulatoryupdates@qima.com

EUROPE NEWS

European Union (EU): New European Standards Applicable in the Electrotechnical Field

New standard versions are now in place relative to the electrotechnical field. In the EU, the new European harmonized standard version or revision becomes mandatory from the date when the presumption of conformity of the superseded standard published in the Official Journal ceases. This date is the same as the Withdrawal Date (DOW) published in the individual alternative standards.
This date marks the end of the period in which both the old and new versions of the standard can be used to declare compliance with the basic requirements of the relevant directives. After this date, products manufactured in the old version of the standard can no longer be declared to be in compliance.

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

New standard version Standard name Main context
EN 60034-18-42:2017/A1:2020 Rotating electrical machines - Part 18-42: Partial discharge resistant electrical insulation systems (Type II) used in rotating electrical machines fed from voltage converters - Qualification tests This standard version defines the criteria for evaluating the stator/rotor winding insulation systems of single-phase or multi-phase AC motors that are subjected to repetitive pulse voltages, such as voltage converters generated by pulse width modulation (PWM), which are expected to experience and withstand partial discharge activities during use.
EN IEC 62841-2-6:2020 Electric motor-operated hand-held tools, transportable tools and lawn and garden machinery - Safety - Part 2-6: Particular requirements for hand-held hammers The rated voltage of single-phase AC or DC tools does not exceed 250 V, and the rated voltage of three-phase AC tools does not exceed 480 V. This document does not apply to electric drills and impact drills. This document does not apply to tools specially designed for driving fasteners, such as palm nailers.
EN IEC 61000-4-3:2020 Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test The purpose of this document is to establish a common reference for evaluating the immunity of electrical and electronic equipment under radiated and radio frequency electromagnetic fields.
EN 60335-2-5:2015/A1:2020 Household and similar electrical appliances - Safety - Part 2-5: Particular requirements for dishwashers These dishwashers are used for washing and rinsing tableware, cutlery and other utensils, and their rated voltage does not exceed 250 V. Single-phase appliances and 480 V are used for other appliances.

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

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

European Union (EU): Amendment of ANNEX XVII of REACH

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) in regards to N,N-dimethylformamide.

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

European Union (EU): New Harmonized Standards Published for Toys

On 16 November 2021, the European Commission published Decision EU 2021/1992 with new references of standards under Toy Safety Directive 2009/48/EC.

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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.

Current Harmonized Standards
(Will be withdrawn on 15 May 2022)
New Harmonized Standards
(Will be effective after 15 May 2022)
EN 71-2:2011+A1:2014
Safety of toys – Part 2: Flammability
EN 71-2:2020
EN 71-3:2019
Safety of toys – Part 3: Migration of certain elements
EN 71-3:2019+A1:2021
EN 71-4:2013
Safety of toys – Part 4: Experimental sets for chemistry and related activities
EN 71-4:2020
EN 71-13:2014
Safety of toys – Part 13: Olfactory board, games, cosmetic kits and gustative games
EN 71-13:2021

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

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

United Kingdom (UK): October 2021, the Office for Product Safety and Standards (OPSS) Published a Guidance on Assessing Risk for Products that Contain Small High-powered Magnets

The Office for Product Safety and Standards (OPSS), the UK’s national product safety regulator, followed increasing reports of injuries from ingestion of magnets, particularly among children and young people. In response, OPSS issued a safety alert which included a risk summary and a guidance on assessing risk for products that contain small, high-powered magnets.

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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.

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

Europe Recalls Summary (01 November 2021 to 30 November 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 November 2021 to 30 November 2021 are summarized below:

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Hazards Frequency
Choking Hazard 22
Damage to Sight 16
Injury Hazard 14
Health Risk Hazard 15
Burn Hazard 12
Fire Hazard 9
Chemical Hazard 44
Environmental Hazard 27
Electric Shock Hazard 14
Other Hazards* 13

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


Product Categories Frequency
Toys and Childcare Products 59
Protective Equipment 30
Fabric / Textile / Garment / Home Textile 10
Electrical Appliances 24
Tools and Hardware 5
Jewelry 5
Outdoor Living Items 4
Sporting Goods / Equipment 4
Other Categories* 16

*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.


Notifying Country Frequency
Cyprus 6
Poland 13
Hungary 22
Slovakia 7
Sweden 30
Finland 6
France 17
Germany 25
Lithuania 9
Other Countries* 22

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


For a complete list click here


AUSTRALIA NEWS

Australia Recalls Summary (01 November 2021 to 30 November 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 November 2021 to 30 November 2021 are summarized below:

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Hazards Frequency
Risk of Allergy 6
Health Risk Hazard 4
Burn Hazard 5
Choking Hazard 15
Injury Hazard 15
Suffocation Hazard 8
Microbiological Hazard 5
Other Hazards* 3

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


Product Categories Frequency
Food 10
Medical Devices 4
Tools and Hardware 3
Sporting Goods / Equipment 3
Home Electrical Appliances 2
Toys and Childcare Products 12
Protective Equipment 2
Other Categories* 4

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


For a complete list click here


ASIA NEWS

Thailand: Mandatory Requirements for Commercial Electric Doughnut Fryers and Deep Fat Fryers, Draft Ministerial Regulation, November 2021

On 22 November 2021, the Ministry of Industry of Thailand notified the World Trade Organization (WTO) of a draft regulation on mandatory safety requirements for certain deep fat fryers and frying pans, Thai Industrial Standard (TIS) 60335 Part 2(13)-25XX(20XX).
The last date for comments is 21 January 2022.

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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

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

China: Regulatory Update (December 2021) - FZ/T 81008-2021 for Jackets will be Implemented on 1 July 2021

The Chinese Ministry of Industry and Information Technology issued its industry standard FZT 81008-2021<Jackets>. This new standard replaced the previous version, FZ/T 81008-2011 and became effective on 1 July 2021.

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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

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

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

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Hazards Frequency
Suffocation Hazard 5
Fire Hazard 32
Injury Hazard 8
Electric Shock Hazard 10
Safety Risk Hazard 34
Fall Hazard 5
Chemical Hazard 8
Health Risk Hazard 10
Other Hazards* 16

*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.


Product Categories Frequency
Home Electrical Appliances 20
Electrical Appliances 20
Protective Equipment 14
Fabric / Textile / Garment / Home Textile 8
Stationery 7
Food Contact Material 6
Furniture 5
Household Items 6
Other Categories* 12

*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.


Provinces Frequency
Guangdong 8
Zhejiang 43
Beijing 4
Yunnan 2
Anhui 20
Jiangsu 6
Hubei 4
Fujian 1
Shaanxi 7
Hunan 2
Jilin 1

For a complete list click here


DECEMBER CONTRIBUTORS

Andy Choi

Vivian Chan

Vincent Wong

David Zhao

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