September 2021 Regulatory Update

NORTH AMERICA NEWS

USA: Extension of Compliance Deadline for PIP (3:1) for Persistent, Bioaccumulative, and Toxic (PBT) Chemicals Under the Toxic Substances Control Act (TSCA) Section 6(h)

In September 2021, the US Environmental Protection Agency (EPA) prepared for publication a draft final rule extending the deadline for compliance with the TSCA Section 6(h) ban on a particular PBT chemical (i.e., phenol, isopropylated phosphate (3:1) (PIP (3:1)) until 8 March 2022. The publication date for the final rule, which will be followed by a 60-day comment period, has not been determined.

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Despite EPA’s extensive outreach conducted during development of the PBT rules, some comments from the stakeholders on PIP (3:1) were still received after the rule was finalized. In response to this, the EPA issued a 180-day “No Action Assurance” in March 2021 to ensure that the supply chain was not interrupted and issued a notice requesting further comments and information on the impact of the compliance dates until 4 September 2021. However, a need for varying time frames to remove PIP (3:1) from the supply chains has been identified. The EPA will issue a final rule (follow by a 60-day comment period) providing a short-term extension of compliance dates until 8 March 2022.

PIP (3:1)-containing articles covered by the short-term compliance date extension include cellular telephones, laptop computers and other electronic devices. In addition, articles that might be used in industrial and commercial equipment used in various sectors including transportation, life sciences, and semiconductor production, as well as other consumer and commercial goods are included.

At the same time, the EPA announced its intent to initiate a new rulemaking and anticipates proposing new rules for all five PBT chemicals that are the subject of final risk management rules under TSCA in the Spring of 2023. The current provisions of the final risk management rules, except the extension of the specified compliance dates for PIP (3:1), remain in effect while the EPA is working on this new rulemaking effort.

Below is a summary on the potential usage, scope, requirement, and effective date for the five PBT chemicals.

Chemical (CAS number) Potential usage Scope and Requirement Effective Date
Decabromodiphenyl ether (DecaBDE) (CAS No. 1163-19-5) a flame retardant with applications in wire and cable rubber casings, textiles, electronic equipment casings, building and construction materials, etc. Manufacturing (includes importing) and processing of DecaBDE or DecaBDE-containing products or articles: Prohibited 8 March 2021
Remark: There are other effective dates for different scenarios
Phenol, isopropylated phosphate (3:1) [PIP (3:1)] (CAS No. 68937-41-7) a flame retardant in plastics and as a functional fluid in aircraft and industrial machinery Processing and distributing in commerce for certain key consumer and commercial goods (articles) containing PIP (3:1) such as cellular telephones, laptop computers and other electronic devices: prohibited 8 March 2022
Remark: There are other effective dates for different scenarios
Pentachlorothiophenol (PCTP) (CAS No. 133-49-3) a substance with applications in the rubber industry Manufacturing (includes importing) and processing of PCTP or PCTP-containing products or articles: ≤ 1% 8 March 2021
Remark: There are other effective dates for different scenarios
Hexachlorobutadiene (HCBD) (CAS No. 87-68-3) a solvent in rubber manufacturing and in hydraulic, heat transfer or transformer fluid Manufacturing, processing, and distribution of HCBD or HCBD-containing products or articles: prohibited 8 March 2021
2,4,6-tris(tert-butyl) phenol (2,4,6-TTBP) (CAS No. 732-26-3). an antioxidant in fuel additives and fuel injector cleaners as well as an additive in oil and lubricants Distribution in containers with a volume of less than 35 gallons: ≤ 0.3% 26 January 2026
Remark: There are other effective dates for different scenarios
For More Information About This Story:
Contact: Andy Choi (Senior Manager)
Phone: (852) 3185 8045
Email: regulatoryupdates@qima.com

United States (US) Recalls Summary (01 August 2021 to 31 August 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 August 2021 to 31 August 2021 are summarized below:

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Hazards Frequency
Fire Hazard 7
Fall Hazard 3
Choking Hazard 4
Injury Hazard 2
Other Hazards* 10

*Other Hazards include Burn Hazard, Amputation Hazard, Laceration Hazard, Pinching Hazard, Entrapment Hazard, Health Risk Hazard, Crash Hazard, Skin Irritation Risk, Drowning Hazard and Exploding Hazard with a frequency of less than 2.


Product Categories Frequency
Home Electrical Appliances 2
Household Items 3
Sporting Goods / Equipment 4
Toys and Childcare Articles 5
Other Categories* 6

*Other Categories include Outdoor Living Items, Tools and Hardware, Electrical Appliances, Furniture, Stationery and Fabric / Textile / Garment / Home Textile with a frequency of less than 2.


For a complete list click here


Canada Recalls Summary (01 August 2021 to 31 August 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 August 2021 to 31 August 2021 are summarized below:

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Hazards Frequency
Choking Hazard 4
Fire Hazard 3
Burn Hazard 4
Chemical Hazard 2
Laceration Hazard 2
Entrapment Hazard 3
Fall Hazard 2
Ingestion Hazard 2
Other Hazards* 3

*Other Hazards include Swallowing Risk, Injury Hazard and Crash Hazard with a frequency of less than 2.


Product Categories Frequency
Toys and Childcare Products 8
Home Electrical Appliances 2
Electrical Appliances 2
Furniture 3
Sporting Goods / Equipment 3
Fabric / Textile / Garment / Home Textile 2
Other Categories* 2

*Other Categories include Household Items and Food Contact Material with a frequency of less than 2.


For a complete list click here


EUROPE NEWS

EU: 2021 Second Batch of Proposals for Consultation on Substances of Very High Concern (SVHCs)

Four proposals to identify new SVHCs were published on 3 September 2021. They are under public consultation and available for comments until 18 October 2021.

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This is the second batch of proposals to identify SVHCs in 2021. The first batch of proposals with eight substances was published in March; all of them were included in the current SVHCs candidate list with 219 substances in July. The candidate list is updated two times a year, generally at the beginning and in the middle of a year.

The four substances in this new batch of proposals that might be included in the upcoming update of the SVHC candidate list (expected in early January 2022) are listed below. The candidate list would increase to 223 substances if all of them are included.

Chemical Substances CAS no. Reason For Proposing Potential Usage
(±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene] bicyclo[2.2.1]heptan-2-one covering any of the individual isomers and/or combinations thereof (4-MBC) -- Endocrine disrupting properties UV filter in cosmetics and personal care products
6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol (DBMC) 119-47-1 Reprotoxic Manufacture of rubber and plastic products
S-(tricyclo[5.2.1.0'2,6]deca-3-en-8(or 9)-yl) O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate 255881-94-8 Persistent bioaccumulative toxic substances (PBTs) Lubricants and greases
tris(2-methoxyethoxy)vinylsilane 1067-53-4 Reprotoxic Manufacture of rubber and plastic, use in sealants
For More Information About This Story:
Contact: Andy Choi (Senior Manager)
Phone: (852) 3185 8045
Email: regulatoryupdates@qima.com

EU: Italy Proposes to Expand Positive List of Food Contact Stainless Steels

On 28 July 2021, the European Commission (EC) published Notification 2021/0513/I on Italy’s intention to expand the positive list of food contact stainless steels.

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Italy proposes to adopt a draft legislation on food contact stainless steels and the European Commission (EC) published Notification 2021/0513/I on Italy’s intention on 28 July 2021. If the draft legislation is adopted, it will amend the Decree of the Minister of Health of 21 March 1973, in relation to food contact stainless steels.

According to the Notification, there are two important changes addressed:

  • Adding one more type of stainless steel to the positive list - UNI EN 10088-1: 2014 Numerical designation 1.4062, also known as AISI/ASTM A240 or UNS 32202
  • Adding one specification for the concentration of certain elements in food contact stainless steels without codes or designations

In addition, the three months standstill period will end on 29 October 2021.

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

EU: European Directorate for the Quality of Medicines & HealthCare (EDQM) Issues Guideline for Food Contact Paper and Board

In May 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) published the first edition of the technical guide entitled “Paper and board used in food contact materials and articles”.

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In the absence of specific EU legislation on food contact paper and board, the EDQM published the first edition of technical guidance on “Paper and board used in food contact materials and articles’’.

This guidance aims to improve the protection of consumers against contaminants potentially released by paper and board in contact with food.

This guidance includes two aspects:

  • Part I. Council of Europe Resolution CM/Res (2020) 9 on the safety and quality of materials and articles for contact with food
  • Part II. Technical guide on paper and board used in food contact materials and articles
Item Specific Migration Limit (mg/kg)
4’-Bis(dimethylamino)
Benzophenone
(Michler’s ketone)
Not detected
Bisphenol A 0.05 or Not detected (for infants and young children)
PAAs Not detected
Lead Not detected
Di(2-ethylhexyl)
phthalate (DEHP)
1.5
Sum of dibutyl phthalate (DBP)
and diisobutyl phthalate (DiBP)
0.3
Mineral oil hydrocarbons (MOH) Under discussion
PFAS (per- and polyfluoroalkyl substances) Under discussion
For More Information About This Story:
Contact: Andy Choi (Senior Manager)
Phone: (852) 3185 8045
Email: regulatoryupdates@qima.com

EU: A New European Standard of Seating for Children has Been Published

On 31 July 2021, the European Committee for Standardization (CEN) published a new European standard of seating for children (EN 17191:2021) which supports EU Directive 2001/95/EC.
The effective date is January 2022.

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The European standard of seating for children (EN 17191:2021) has been prepared under a standardization request given to the CEN by the European Commission and the European Free Trade Association and supports essential requirements of EU Directive 2001/95/EC.

This standard specifies safety requirements, test methods and labelling requirements for children’s seating products intended to be placed on the floor, for use in both domestic and non-domestic settings, including day care centers, as well as for indoor and outdoor use. The requirements are specifically intended for children who are able to walk and sit by themselves.

This standard does not apply to children’s highchairs or childcare articles such as reclined cradles and seating in educational institutions for which other European standards exist.

In additional to meeting the safety criteria of EN17191, seating for children also needs to comply with flammability requirements (EN71 Part 2) and chemical requirements (EN71 Part 3).

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

Europe Recalls Summary (01 August 2021 to 31 August 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 August 2021 to 31 August 2021 are summarized below:

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Hazards Frequency
Chemical Hazard 13
Damage to Sight 9
Health Risk/ Other Hazard 17
Injury Hazard 7
Choking hazard 15
Electric Shock Hazard 11
Burn Hazard 3
Entrapment Hazard 3
Other Hazards* 7

*Other Hazards include Strangulation Hazard, Environmental Hazard, Cut Hazard and Fire Hazard with a frequency of less than 3.


Product Categories Frequency
Jewelry 6
Machinery 10
Protective Equipment 11
Toys and Childcare Products 22
Fabric / Textile / Garment / Home Textile 4
Home Electrical Appliances 4
Computer / Audio / Video / Other Electronics & Accessories 5
Electrical Appliances 6
Other Categories* 11

*Other Categories include Bodycare / Cosmetics, Pet Items, Household Items, Outdoor Living Items, Sporting Goods / Equipment, Stationery and Chemicals with a frequency of less than 4.


Notifying Country Frequency
Hungary 9
Germany 20
France 4
Portugal 4
Poland 9
Denmark 4
Finland 5
Lithuania 3
The Netherlands 5
Ireland 4
Other Countries* 12

*Other Countries include Slovakia, Croatia, Czechia, Romania, Slovenia, Spain and Bulgaria with a frequency of less than 4.


For a complete list click here


AUSTRALIA NEWS

A New Australian Regulation “Consumer Goods (Projectile Toys) Amendment Safety Standard 2021” has Been Set Out

On 3 August 2021, the Australian Competition and Consumer Commission (ACCC) adopted the amendment standard for projectile toys incorporating updates recently made to the voluntary Australian/New Zealand (AS/NZS ISO 8124.1) and international standards (ISO 8124.1), in addition to other minor updates.

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A summary of the main amendments on the Australian Consumer Goods (Projectile Toys) Amendment Safety Standard 2021 is as follows:

Requirement updates:

  1. Australian / New Zealand and International standard published amendments to the test standard; amendments are adopted under this update
  2. Updated transitional period to “24 months” (beginning from 12 June 2020)
  3. Omitted statement, “be accompanied by instructions for use that give the user information on how to use the toy safely” (see B.2.15, projectile toys, for guidance). This requirement only applies to projectiles in which it might be reasonably possible to aim at the face (see E.32, projectile toys)
  4. Added clause 4.19.1 of the International Standard for safety of toys modification by omitting, “Remote-controlled flying toys shall be accompanied by instructions that give the user information on how to use the toy safely “(see B.2.26.2)

Warning requirement updates:

Section 13(1)

This section applies to a projectile toy if it satisfies all of the following:

  1. It might be reasonably possible to aim the projectile toy at the eyes or face;
  2. The projectile toy is capable of launching a projectile more than 300 millimeters;
  3. The projectile toy is capable of launching a projectile with kinetic energy greater than 0.08J.

Section 13(2)

Omitted, “and the packaging”, and substituted “or the packaging”

Section 13(3)

Determining projectile range and kinetic energy

For the purposes of subsection (1), in determining whether:

  1. A projectile toy is capable of launching a projectile more than 300 millimeters; or
  2. A projectile toy is capable of launching a projectile with a kinetic energy greater than 0.08J;

The supplier must use the standard that is the basis for the requirements that the supplier intends to comply with.

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

Australia Recalls Summary (01 August 2021 to 31 August 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 August 2021 to 31 August 2021 are summarized below:

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Hazards Frequency
Health Risk Hazard 9
Injury Hazard 13
Choking Hazard 3
Fall Hazard 3
Other Hazards* 4

*Other Hazards include Fire Hazard, Burn Hazard, Suffocation Hazard and Electric Shock Hazard with a frequency of less than 3.


Product Categories Frequency
Bodycare / Cosmetics 2
Sporting Goods / Equipment 4
Toys and Childcare Products 8
Food 5
Outdoor Living Items 2
Tools and Hardware 2
Other Categories* 4

*Other Categories include Electrical Appliances, Household Items, Computer / Audio / Video / Other Electronics & Accessories and Pharmacy with a frequency of less than 2.


For a complete list click here


ASIA NEWS

South Korea: Phthalates Restriction on Children’s Products is Amended

South Korea Ministry of Trade, Industry and Energy (MOTIE) Notice No. 2021 - 132 was published on July 2021 to strengthen the phthalates restriction as specified in the “Common Safety Standards for Children's Products” from six phthalates to seven by including DIBP for children’s products. The effective date is 1 January 2022.

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The table below is a summary of the amended phthalates requirement within (MOTIE) Notice No. 2021 - 132.

Chemical Substances CAS No. Scope Limit Effective Date
Benzyl butyl phthalate (BBP) 85-68-7 Accessible components in children’s products intended for those under 13 years old 0.1 % (w/w) (Sum) 1 January 2022
Dibutyl phthalate (DBP) 84-74-2
Bis (2-ethylhexyl) phthalate (DEHP) 117-81-7
Di-‘isononyl’ phthalate (DINP) 28553-12-0 and 68515-48-0
Di-‘isodecyl’ phthalate (DIDP) 26761-40-0 and 68515-49-1
Di-n-octyl phthalate (DNOP) 117-84-0
Diisobutyl phthalate (DIBP) 84-69-5
For More Information About This Story:
Contact: Andy Choi (Senior Manager)
Phone: (852) 3185 8045
Email: regulatoryupdates@qima.com

China: Release of GB 40165-2021 Lithium-Ion Cells and Batteries Used in Stationary Electronic Equipment - Safety Technical Specification

Standard GB 40165-2021, Lithium-ion batteries and battery packs for stationary electronic equipment has been recently released.
The release date of GB 40165 was 30 April 2021, and the implementation date is 01 May 2022 which means there is a one-year transition period. After the transition period, products that meet the scope of this standard must meet the requirements of this standard.

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The fixed electronic equipment covered by GB 40165 includes:

  1. Stationary information technology equipment (IT equipment);
  2. Fixed audio and video equipment (AV equipment) and similar equipment;
  3. Fixed communication technology equipment (CT equipment);
  4. Stationary measurement control and laboratory electronic equipment and similar equipment.

In addition to lithium-ion battery packs for the above equipment, it is also suitable for lithium-ion batteries and battery packs for uninterruptible power supply (UPS) and emergency power supply (EPS).

Main test items are outlined below:

Item Clause Test name Sample number
Test condition 4.6.3/4.6.4 Sample capability test; Sample pretreatment 1~18 for 4.6.3 and 4.6.4
Safety test 6.1/6.2/6.3 External short circuit at high temperature/ overcharge/ forced discharge 1-3 for 6.1;
4~6 for 6.2;
7~9 for 6.3
Environmental safety of cells for battery 7 7.1 Low pressure; 7.2 Temperature cycling; 7.3 Vibration; 7.4 Acceleration shock; 7.5 Drop; 7.6 Impact/extrusion with weight; 7.7 Thermal abuse 1~3 for 7.1~7.4;
10~12 for 7.5;
13~15 for 7.6;
16~18 for 7.7
Environmental safety of cells for battery system 8 8.1 Environmental safety of cells for battery; 8.2 Vibration; 8.3 Acceleration shock; 8.4 Drop 1 for 8.1, 8.2 and 8.3;
2 for 8.4
Function safety of battery system 9 9.3 Overvoltage charging control,
9.4 Overcurrent charging control,
9.5 Undervoltage discharge control,
9.6 Overload control,
9.7 Short circuit control,
9.8 Reverse charging,
9.9 Overheat control,
9.10 Electrostatic discharge
3 for 9.3;
4 for 9.4;
5 for 9.5;
6 for 9.6;
7 for 9.7;
8 for 9.8;
9 for 9.9;
10 for 9.9.10

http://www.bzfyw.com/search/default.html?page=1&keyword=GB%2040165

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 (September 2021) – GB/T 40270-2021-Textiles-General Technical Requirements Based on Consumer Experience will be Implemented 1 December 2021

The new standard, GB/T 40270-2021, sets out general technical requirements based on consumers' experience and is applicable to direct-to-consumer end textile products for consumption and household use.

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The National Standard GB/T 40270-2021 " General technical requirements based on consumer experience " specifically considers the standards from the perspective of consumer experience with textile products such as clothing and home use textiles, based on consumers' sense of touch, vision, and smell, etc. The characteristics of subjective perception can directly reflect the feelings and needs of consumers. The standard outlines consumer demand-oriented practices and standardizes testing parameters to help ensure consumers have a good experience and to prevent an unpleasant experience as it relates to textile products. The standard should not be used as requirements for certain types of products, nor is it recommended to be used as a basis for product quality supervision and public comparisons.

The basic safety requirements of textile products should comply with GB 18401 or GB 31701, and quality requirements should meet the corresponding product standards.

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

China Recalls Summary (01 August 2021 to 31 August 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 August 2021 to 31 August 2021 are summarized below:

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Hazards Frequency
Electric Shock Hazard 12
Health Risk Hazard 1
Safety Risk Hazard 19
Injury Hazard 5
Burn Hazard 2
Fall Hazard 2
Fire Hazard 3
Suffocation Hazard 2

Product Categories Frequency
Home Electrical Appliances 10
Toys and Childcare Products 4
Protective Equipment 2
Electrical Appliances 8
Food Contact Material 3
Sporting Goods / Equipment 2
Fabric / Textile / Garment / Home Textile 6
Computer / Audio / Video / Other Electronics & Accessories 2
Other Categories* 3

*Other Categories include Furniture, Tools and Hardware and Footwear with a frequency of less than 2.


Provinces Frequency
Jiangsu 2
Jilin 2
Anhui 11
Shanghai 3
Hebei 8
Zhejiang 9
Other Provinces* 4

*Other Provinces include Tianjin, Hubei, Guangdong and Beijing with a frequency of less than 2.

** The province of the recall case, Motorcycle Reflexor Part on 13th August is not specified.


For a complete list click here


SEPTEMBER CONTRIBUTORS

Andy Choi

Vivian Chan

Vincent Wong

David Zhao

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