January 2021 Regulatory Update

NORTH AMERICA NEWS

The California Office of Environment Health Hazard Assessment (OEHHA) proposed restrictions on the use of short-form Prop 65 warning labels

On January 8, 2021, the OEHHA promulgated a notice of proposed rulemaking to amend Article 6 of Title 27 of the California Code of Regulations. If enforced, the amendments may create a new compliance obligation to businesses selling products to consumers in the state of California by significantly limiting the use of short-form safe harbor warnings.
Public written comment period: until March 8, 2021

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In 2016, new Article 6 Clear and Reasonable Warning regulations were adopted by OEHHA which included provisions for a short-form Prop 65 warning. However, as less label space was required and the identification of a specific Prop 65 listed chemical could be avoided, the short-form could be utilized in ways that went against the intention and purpose.

Since less information is provided to the consumer by the short-form warning, the January 8 proposal would restrict its use by suggesting various changes, including:

  • Limiting the use of the short-form warning for consumer information to products with 5 square inches or less of label space available (and where the package shape or size cannot accommodate the full-length warning). The requirement of type size of the warning remains unchanged (i.e., type size no smaller than “the largest type size used for other consumer information on the product” and no smaller than 6-point type)
  • Requiring identification of at least one Prop 65 listed chemical in the warning for which the warning is being provided
  • Prohibiting the short-form warning listed for internet purchases and catalog purchases even when the warning provided on the product itself is in compliance with the regulation
  • Including the words “Risk” and “Exposure” in the warning
  • Clarifying the use of short-form warnings for food including the use of an offset boxed warning
    • A short-form warning for exposures to chemicals in food is not clearly allowed in the current regulation. OEHHA has therefore proposed a new short-form warning be included for food of which the language is very similar to the one for other products.

Under the proposal, the new warning would be more detailed, providing more information.

Below is an example warning statement when the product requires a warning from both toxicity endpoints (carcinogen and reproductive toxicant):

“WARNING: Cancer Risk from [insert chemical name] and Reproductive Risk from [insert chemical name] Exposure – www.P65Warnings.ca.gov.”

The proposed amendments will be subject to a public written comment period that runs until March 8, 2021. A web-based public hearing will be scheduled, only upon request. Considering a strong opposition from the business community, OEHHA has proposed that the regulation become operative one year after the effective date of the amendments. Any products that are manufactured within that one-year window and that carry the current short-form warning may be sold through indefinitely. As a result, the new regulations would not apply to products manufactured prior to the enforcement date of the regulations.

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

California Technical Bulletin 117-2013 is adopted as the United States (US) Federal flammability standard (HR 133) for upholstered furniture

On December 27, 2020, HR133 Consolidated Appropriations Act, 2021 was signed into action. This Act designates the FF – Other Matter of the Consolidated Appropriations Act, referred to as Title XXI – COVID-19 Regulatory Relief and Work from Home Safety Act, to be mandatory and adopts California’s flammability standard, Technical Bulletin Number 117-2013 (TB 117-2013), for indoor upholstered furniture as a mandatory flammability standard.
Effective date: June 26, 2021

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The upholstered furniture flammability legislation was sponsored by Senator Roger Wicker (R-MS) and renamed the COVID-19 Regulatory Relief and Work from Home Safety Act (S.1341). It requires the U.S. Consumer Product Safety Commission (CPSC) to adopt California’s Technical Bulletin 117-2013 as a federal flammability standard for residential upholstered furniture.

California TB 117-2013 outlines performance standards and methods for testing the smolder resistance of cover fabrics along with the barrier, filling and decking materials used in upholstered home furnishings. The American Home Furnishings Alliance (AHFA) formally petitioned the CPSC to adopt the measure as a national standard in October 2015 and later introduced SOFFA when no action from the agency was forthcoming. The legislation advanced in the House in both 2017 and 2019 but remained stalled in the Senate.

All upholstered seating furniture imported or sold in the United States must comply with the flammability test specified by California Technical Bulletin TB117-2013. In addition to the labeling requirements required from the California TB 117-2013 standard, each item of upholstered furniture is required to bear the statement, “Complies with the U.S. CPSC requirements for upholstered furniture flammability” on a permanent label located on the product after June 25, 2021.

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

The US Consumer Product Safety Commission (CPSC) has voted to amend the Federal Standard for the Flammability of Mattresses and Mattress pads (16 CFR PART 1632)

The Commission voted unanimously (4-0) to approve publication of the notice, as drafted, in the Federal Register to issue a notice of proposed rulemaking (NPR) to establish a consumer product safety standard for crib mattresses.
Comment period: by January 13, 2021

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The CPSC is proposing to amend its Standard for the Flammability of Mattresses and Mattress Pads. The ignition source cigarette specified in the standard for use in the mattress standard’s performance tests, Standard Reference Material cigarette, SRM 1196, is no longer available for purchase.

The Commission is proposing to amend the mattress standard to require a revised Standard Reference Material cigarette, SRM 1196a, which was developed by the National Institute of Standards and Technology, as the ignition source for testing to the mattress standard.

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

The Consumer Product Safety Commission (CPSC) Proposes 16 CFR 1241 Safety Standard for Crib Mattresses

The Commission is proposing a safety standard for crib mattresses. The Commission is also proposing to amend CPSC’s consumer registration requirements to identify crib mattresses within the scope of the proposed rule as durable infant or toddler products and proposing to amend CPSC’s list of notice of requirements (NORs) to include such crib mattresses.
Comment period: by January 11, 2021

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The notice of proposed rulemaking (NPR) categorizes crib mattresses as products designed to be used with infant sleep products, such as full-size cribs, non-full-size cribs, bassinets and cradles, and play yards, to provide sleeping accommodations for an infant. As specified in the NPR, the proposed rule will cover:

  • Full-size crib mattresses
  • Non-full-size crib mattresses
  • After-market mattresses for play yards

The CPSC’s notice of proposed rulemaking discusses the incident data and hazard patterns identified by the staff. Common product-related hazard patterns identified include chemical/ flammability hazards, softness, etc., but the identified hazard categories associated with fatalities are:

  • Crib mattress use in play yard
  • Face in mattress
  • Child found prone
  • Fit issues
  • Cases of multiple contributing factors

ASTM F2933 is the voluntary industry standard addressing crib mattresses. The CPSC staff’s review of current standard ASTM F2933-19 has deemed it to be insufficient in addressing the hazard patterns identified by the incident data and requirements for labeling, while noting that the ASTM subcommittee is in the process of reviewing the standard to address these issues but has met with delays due to the COVID-19 pandemic.

Key modifications proposed by the NPR to the ASTM F2933 standard include:

  • Adding a coil springs impact test ensuring there are no exposed coil springs after testing for 1000 cycles
  • Adding a mattress firmness test modeled on the Australian/ New Zealand standard AS/ NZS 8811.1 to measure surface softness
  • Modification of the mattress size measurement test to include a fitted sheet to better account for mattress compression by the fitted sheet
  • Revisions to the non-full-size crib mattress measurements and requirements to include after-market mattresses
  • Revisions to safety warning requirements and examples on product and in the instructional literature

Additionally, the CPSC is proposing to amend 16 CFR 1130 durable nursery products consumer registration requirements to include crib mattresses within the scope and is proposing to amend 16 CFR 1112 certification requirements to also include such crib mattresses.

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

AUSTRALIA NEWS

Four mandatory standards are approved by the Australia Government to reduce the risk of death and injury associated with the use of button and coin batteries

On December 18, 2020, the Australian Government issued four new mandatory safety and information standards for consumer goods containing button batteries and for button batteries themselves.
Effective date of all legislation: June of 2022

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Summary of Standards:

Legislation Simplified outline of requirements
Safety standard for consumer goods containing button batteries
  • Secure battery compartments (e.g., fastened with a screw) for consumer goods where batteries are intended to be replaced
  • Compliance testing to demonstrate the battery is secure, regardless of whether the battery is intended to be replaced
Information standard for consumer goods containing button batteries The standard requires:
  • Packaging to be marked, at a minimum, with a warning symbol
  • Instructions (if provided) to include a warning about the button battery that is clearly visible, prominent, and legible
  • If no packaging/instructions are included, the warning is to be attached to or included with the product (e.g., by a swing tag or sticker)

The standard also recommends:
  • All consumer goods be marked clearly with a warning on the product itself
  • Packaged goods contain both text and symbol warnings
  • Goods supplied via an electronic platform include a warning in the product description
  • Warnings contain the phone number for the Australian Poisons Information Centre and advice about safe disposal of button batteries
Safety standard for button batteries
  • Child-resistant packaging for lithium button batteries (of all sizes) and other types of button batteries with a diameter of 16mm and above
  • Compliance testing to demonstrate the packaging of an applicable button battery is child-resistant
  • Where multiple button batteries are supplied, packaging must be designed to release only one battery at a time
Information standard for button batteries The standard requires:
  • Packaging used to supply button batteries must be marked clearly with a warning
  • Lithium button batteries with a diameter of 20mm or more must be marked with a “keep out of reach of children” symbol on the cell of the battery

The standard also recommends
  • Lithium button batteries with a diameter less than 20mm and other types of button batteries of all sizes be marked with a “keep out of reach of children” symbol on the cell of the battery
  • Button batteries supplied via an electronic platform include a warning in the product description
  • Warnings contain the phone number for the Australian Poisons Information Centre and advice about safe disposal of button batteries
For More Information About This Story:
Contact: Vivian Chan (Technical Consultant)
Phone: (852) 3185 8052
Email: regulatoryupdates@qima.com

Australia Recalls Summary (August 1, 2020 ­– January 13, 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 August 1, 2020 ­– January 13, 2021 are summarized below:

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Hazards Frequency
Choking Hazard 29
Injury Hazard 21
Suffocation Hazard 19
Health Risk Hazard 12
Burn Hazard 12
Fire Hazard 12
Other Hazards* 10

*Other Hazards include Drowning Hazard, Electric Shock Hazard, Fall Hazard, Entrapment Hazard with a frequency of less than 7.


Product Categories Frequency
Toys and Childcare Articles 28
Home Electrical Appliances (Hair Dryer, Iron, etc.) 12
Computer / Audio / Video / Other Electronics & Accessories 11
Furniture 9
Sporting Goods/ Equipment 8
Other Categories^ 21

^Other Categories include Cosmetics, Eyewear, Fabric / Textile / Garment / Home Textile, Food Contact Material, Footwear, Personal Protective Equipment with a frequency of less than 6.

For a complete list click here


EUROPE NEWS

The European Union (EU) revised the list for allergenic fragrance in toys

On December 15, 2020, the EU published two Directives (EU) 2020/2088 and (EU) 2020/2089 to revise the two lists of allergenic fragrances in the Toy Safety Directive, 2009/48/EC.
Effective date of Directives: July 5, 2022

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The two Directives, (EU) 2020/2088 and (EU) 2020/2089, update the lists under Point 11 of Part III in Annex II of the Toy Safety Directive (TSD). These lists are:

  1. ‘Prohibited List’ – contains 55 allergenic fragrances. Their presence is allowed if it is technically unavoidable under good manufacturing practice (GMP) and each fragrance is no more than 100 mg/kg. These substances should not be used intentionally
  2. ‘Labelling List’ – contains 11 allergenic fragrances. These require their name to be listed on the toy, on an affixed label, on the packaging, or in the accompanying leaflet if their concentrations are greater than 100 mg/kg

Summary of the Amendment

List of allergenic fragrances which require labelling has been extended (from 11 to 71 allergenic fragrances)

  1. Added 61 allergenic fragrances
  2. Added 2 CAS no. to Citronellol (1117-61-9 and 7540-51-4)
  3. Removed methyl heptane carbonate (111-12-6), as it becomes a prohibited allergenic fragrance

List of prohibited allergenic fragrances has been extended (from 55 to 58 allergenic fragrances)

  1. Added 3 allergenic fragrances
Name of Allergenic Fragrances CAS Number
Atranol (2,6-Dihydroxy-4-methyl-benzaldehyde) 526-37-4
Chloroatranol (3-Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde) 57074-21-2
Methyl heptine carbonate 111-12-6
For More Information About This Story:
Contact: Andy Choi (Senior Manager)
Phone: (852) 3185 8045
Email: regulatoryupdates@qima.com

The European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Annex XVII is amended

The European Commission has published Commission Regulation (EU) 2020/2096 to amend Annex XVII to REACH Regulation (EC) No 1907/2006 (consolidated to Aug 2020) on December 16, 2020.
Enforcement date: January 5, 2021 (or other specified dates related to individual substances)

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One of the amendments made by the new regulation is an update to Appendix 10 to Annex XVII to Regulation (EC) No 1907/2006, listing testing methods for azo colorants for the purposes of entry 43 of the Annex. The testing methods are outdated and have been replaced with more up-to-date testing methods by the European Committee for Standardization. Appendix 10 is updated accordingly to express those changes. The updated harmonized standards are EN ISO 17234-1:2015, EN ISO 14362-1:2017 and EN ISO 14362-3:2017 which supersede EN ISO 17234-1:2010, EN 14362-1:2012 and EN 14362-3:2012, respectively (see below Table 1).

Superseded test standards Updated harmonized testing standard
EN ISO 17234-1:2010 EN ISO 17234-1:2015
Leather - Chemical tests for the determination of certain azo colorants in dyed leathers - Part 1: Determination of certain aromatic amines derived from azo colorants Leather - Chemical tests for the determination of certain azo colorants in dyed leathers - Part 1: Determination of certain aromatic amines derived from azo colorants
CEN ISO/TS 17234:2003 EN ISO 17234-2:2011
Leather – Chemical tests – Determination of certain azo colourants in dyed leathers Leather – Chemical tests for the determination of certain azo colorants in dyed leathers – Part 2: Determination of 4-aminoazobenzene
EN 14362-1:2012 EN ISO 14362-1:2017
Textiles - Methods for determination of certain aromatic amines derived from azo colorants - Part 1: Detection of the use of certain azo colorants accessible with and without extracting the fibres Textiles - Methods for determination of certain aromatic amines derived from azo colorants - Part 1: Detection of the use of certain azo colorants accessible with and without extracting the fibres
EN 14362-3:2012 EN ISO 14362-3:2017
Textiles - Methods for determination of certain aromatic amines derived from azo colorants - Part 3: Detection of the use of certain azo colorants, which may release 4-aminoazobenzene Textiles - Methods for determination of certain aromatic amines derived from azo colorants - Part 3: Detection of the use of certain azo colorants, which may release 4-aminoazobenzene

Table 1


There is another amendment removing Pentachlorophenol (PCP) and its salt, Decabromodiphenyl ether (DecaBDE) and Perfluorooctanoic acid (PFOA) and its salts from the Annex, as the substances are restricted more severely under Regulation (EU) 2019/1021 on persistent organic pollutants (POP Recast Regulation, consolidated to Sep 2020). Stakeholders should be aware to take appropriate measures to comply with the restriction introduced by Regulation (EU) 2019/1021 regarding those substances (highlights are summarized in below Table 2).

The amendments Reason
Entry 22 Pentachlorophenol and its salts and ester shall be deleted More severe restrictions for those substances are laid down in POPs Regulation (EU) 2019/1021 of the European Parliament and of the Council. The deletion of entry 68 was effective on July 4, 2020.
Entry 67 Bis(pentabromophenyl)ether (decabromodiphenyl ether; decaBDE) shall be deleted
Entry 68 Perfluorooctanoic acid (PFOA) and its salt shall be deleted
The testing methods for azo colorants listed in Appendix 10 shall be amended Several of the listed testing are outdated and have been replaced with more up-to-date testing methods. Table 1 has summarized the harmonized and superseded test standards.

Table 2


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

A new EN 71-2:2020 Flammability Toy Safety standard is published by the European Committee for Standardization (CEN)

On December 9, 2020, an updated EN71-2:2020 – Safety of Toys Part 2: Flammability standard was published. The new standard will supersede EN71-2:2011+A1:2014.
The standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2021, and conflicting national standards shall be withdrawn at the latest by December 2021.

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The major changes are listed below:

  1. Adds a definition for disguise costumes
  2. Adds a new requirement for disguise costumes - the test specimen is to be tested before and after washing, even if the instructions state not to wash
  3. Increases the testing of smaller specimens by allowing combined or half-size specimens
  4. Adds clarifications on the measurement of unhindered dimensions, and of test categories applicable to toys worn on the head and to toy disguise costumes
  5. Adds an annex of a guidance on how to determine the appropriate test requirement of the product
  6. Adds an annex on suggestions to manufacturers on how to reduce the rate of spread of flames for toy disguise costumes
  7. Adds an annex of flowcharts showing how to obtain test specimens from toy disguise costumes
  8. Adds definition of toys intended to be entered by a child (constructed from fabric and/or polymer sheets and films that are intended to fully or almost fully enclose a child on all sides)

The standard still needs to be harmonized. This means that it needs to be accepted by the EU Commission and Member States by publication in the Official Journal of the EU (OJEU). Only then can it be used to show compliance to the EU Toy Directive 2009/48/EC.

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

The Candidate List of Substances of Very High Concern (SVHC) is updated adding two substances that are toxic for reproduction

On January 19, 2021, the European Chemicals Agency (ECHA) added 2 new substances to the Candidate List of Substances of Very High Concern (SVHC) under Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). The Candidate List now contains 211 substances that may harm people or the environment.
The two substances were added to the Candidate List as they are toxic for reproduction and therefore, may adversely affect sexual function and fertility, and cause developmental toxicity in offspring.
Notification deadline date regarding the presence of the new SVHCs in articles: July 19, 2021 (six months after their inclusion in the list)

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Substances added to the Candidate List for authorization on January 19, 2021 are as follows:

Substance CAS Number EC Number Reason for inclusion Potential use
Bis(2-(2-methoxyethoxy)ethyl)ether 143-24-8 205-594-7 Toxic for reproduction Solvent
Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety - - Toxic for reproduction Additive in the production of plastics and rubber tires
For More Information About This Story:
Contact: Andy Choi (Senior Manager)
Phone: (852) 3185 8045
Email: regulatoryupdates@qima.com

United Kingdom (UK) issues notices of publication and a consolidated list for Toy Safety Regulation Designated Standards

On December 9, 2020, the UK issued notices of publication and a consolidated list for designated standards for toy safety which confirms that the references to standards listed in below detail are published for the purposes of regulation 3A of S.I. 2011 No. 1881 and accordingly are designated pursuant to that regulation in relation to English and Wales and Scotland.
Effective date: January 1, 2021

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The summary below consolidates the published references of standards. It contains all references which, when the summary was generated, still provided a presumption of conformity together with references already withdrawn.

Reference no. of the designation standard Title of the designation standard Restriction
EN 71-1:2014+A1:2018 Safety of toys - Part 1: Mechanical and physical properties --
EN 71-2:2011+A1:2014 Safety of toys - Part 2: Flammability --
EN 71-3:2019 Safety of toys - Part 3: Migration of certain elements --
EN 71-4:2013 Safety of toys - Part 4: Experimental sets for chemistry and related activities --
EN 71-5:2015 Safety of toys - Part 5: Chemical toys (sets) other than experimental sets --
EN 71-7:2014+A2:2018 Safety of toys - Part 7: Finger paints - Requirements and test methods Notice: For the allowed preservative climbazole (entry 22 in Table B.1 of Annex B to standard EN 71-7:2014+A2:2018) the presumption of conformity applies up to a maximum allowed concentration of 0,2 % (not: 0,5 %). This is based on the 'ADDENDUM to the Opinion on Climbazole (P64) ref. SCCS/1506/13' of the Scientific Committee on Consumer Safety (SCCS) that was adopted after the publication of the standard by CEN. https://ec.europa.eu/health/sites/health/files/scientific committees/consumer safety/docs/sccs_o_212.pdf Note 2: The allowed preservatives a) Mixture of 5-Chloro-2-methyl-isothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate and b) 2-methylisothiazol-3(2H)-one (MIT) (entries 31 and 32 in the superseded standard EN 71-7:2014) have been restricted to a) 1 mg/kg (content limit) and b) 0,25 mg/kg (content limit) in aqueous toy materials by Directive (EU) 2015/2117, OJ L 306, 24.11.2015, p. 23. Both content limits are applicable since 24 November 2017. The superseded standard therefore does not any more provide the presumption of conformity for these two preservatives.
EN 71-8:2018 Safety of toys - Part 8: Activity toys for domestic use --
EN 71-12:2013 Safety of toys - Part 12: N-Nitrosamines and N-nitrosatable substances --
EN 71-13:2014 Safety of toys - Part 13: Olfactory board games, cosmetic kits and gustative games --
EN 71-14:2018 Safety of toys - Part 14: Trampolines for domestic use --
EN 62115:2005,
EN 62115:2005/A2:2011,
EN 62115:2005/A11:2012,
EN 62115:2005/A12:2015,
EN 62115:2005/A2:2011/AC:2011
EN 62115:2005/A11:2012/AC:2013
Electric toys - Safety --
For More Information About This Story:
Contact: Vivian Chan (Technical Consultant)
Phone: (852) 3185 8052
Email: regulatoryupdates@qima.com

ASIA NEWS

China National Standard GB/T 39508-2020 (Knitted garments for infants and children) is published

This new standard specifies the terms and definitions, sizes and specifications, requirements, test methods, sampling rules, determination rules, instructions for use, packaging, transportation and storage of knitted infant and children's clothing.
Enforcement date: June 1, 2021

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GB/T 39508-2020 is applicable to infant and children's clothing mainly made of knitted fabrics. The requirements of this standard are divided into internal quality (quality after performance testing) and appearance quality (quality upon initial visual inspection).

Internal quality includes characteristics such as, but not limited to:

  • fiber content,
  • formaldehyde content,
  • pH value,
  • odor,
  • forbidden carcinogenic aromatic amine dyes,
  • bursting strength, pilling, dimensional change rate after washing,
  • dimensional change rate after dry cleaning,
  • distortion rate after washing,
  • color fastness to saliva, water, perspiration, soaping, rubbing, dry cleaning, light, perspiration, bleeding,
  • moisture permeability,
  • tensile strength, etc.

Appearance quality includes:

  • defects,
  • size deviation,
  • size difference of symmetrical parts,
  • sewing irregularities,
  • raw material index.
For More Information About This Story:
Contact: David Zhao (Technical Consultant)
Phone: (571) 8999 7142
Email: regulatoryupdates@qima.com

JANUARY CONTRIBUTORS

Andy Choi

Vivian Chan

David Zhao

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