December 2024



North America News

The U.S. Food and Drug Administration is issuing this letter to inform retailers and distributors of cookware that certain imported cookware products may leach lead (Pb) into food and that this cookware should not be distributed or sold in the U.S. market.

On 12 December 2024, the U.S. Food and Drug Administration (FDA) issued a warning letter to inform stakeholders that some imported cookware products made from aluminium, brass, and aluminium alloys known as Hindalium/Hindolium or Indalium/Indolium had the potential to leach lead when tested under conditions designed to simulate their use in contact with food. Information regarding this is outlined in an article provided to the FDA by the Public Health Department of Seattle and King County (PHSKC) in Washington State.

The article is published with the following key points:

Methods

The article said the PHSKC team screened aluminium cookware and brass items for lead content using an X-ray fluorescence (XRF) analyzer and used the leachate method[1]to estimate the amount of lead that migrates into food. They also tested additional stainless-steel items to determine whether they would be safer alternatives.

Results

Many aluminium cookware products contained above 100 ppm of lead. Many also leached enough lead under simulated cooking and storage conditions to exceed recommended dietary limits outlined by the FDA. In contrast, stainless steel cookware leached much lower levels of lead.

Impact

Aluminium and brass cookware available for purchase in the United States represents a previously unrecognized source of lead exposure.

Additionally, PHSKC posted a table on their website highlighting the cookware products demonstrating the most significant lead leaching, as revealed bytheir test results. The table includes pictures, brands, and country of origin, where available.

Currently, the FDA does not administer a lead standard for metal cookware, but the FDA has placed a manufacturer of the cookware, Rashko Baba Co. Ltd., on an FDA import alert to help prevent the further sale of these products in the U.S. market.

Retailers and distributors of cookware should be aware that there may be similar products that leach lead, including Rashko Baba products subject to FDA’s import alert, which remain on the U.S. market. Therefore, we suggest retailers and distributors of cookware products made from aluminium, brass, and aluminium alloys known as Hindalium/Hindolium or Indalium/Indolium take the necessary actions to confirm that such products do not leach lead into food. Various testing methods for leachable lead are available, or you may refer to the FDA’s lead leach testing protocol [1].

Remark:

[1] “Elemental Analysis Manual (EAM) Method 4.6 Inductively Coupled Plasma Optical Emission Spectrometric Determination of Cadmium and Lead Extracted from Ceramic Foodware” (https://www.fda.gov/media/95170/download). To modify for cookware, instead of a 24-hour extraction at 22 °C ± 2 °C, the extraction conditions include a 2-hour boil followed by cooling and holding at room temperature for a total of 24 hours. All other method details remain the same.

The California Office of Environmental Health Hazard Assessment finalized changes to Proposition 65 Warning Regulations.

On 6 December 2024, the California Office of Environmental Health Hazard Assessment (OEHHA) published amendments to Proposition 65 Warning Regulations Title 27, California Code of Regulations sections 25601, 25603 and 25607.2 and added new sections 25607.50 to 25607.53 (Final Regulatory Text Updated 11-25-2024). The intention of the revisions is to make the warnings more informative and promote transparency to consumers.

The summary of the changes for consumer products is listed below:

Section

New Version

Existing Version

Internet purchase (§ 25602)

A warning on the product display page, or

A clearly marked hyperlink using the word “WARNING” or the words “CA WARNING” or “CALIFORNIA WARNING” on the product display page that links to the warning;

An otherwise prominently displayed warning provided prior to purchase that the consumer does not have to search for in the general contents of the website

Products sold online have both a warning on the website as well as on the product itself

Short form warning (§ 25603)

Requirement that the short-form warning be in type size no smaller than the largest type size used for other consumer information has been removed

The warning can be no smaller than 6-point type and must be conspicuous

Short-form warning type size shall not be smaller than the largest type size used for other consumer information

The word “WARNING:” or the words “CA WARNING:” or “CALIFORNIA WARNING:” in all capital letters and bold print

The word “WARNING” in all capital letters and bold print

At least one chemical known to cause cancer or reproductive harm must be included

Label with one of the following :

(A) For exposures to listed carcinogens, the words:

“Cancer risk from exposure to [name of chemical]. See www.P65Warnings.ca.gov.”; or

“Can expose you to [name of chemical], a carcinogen. See www.P65Warnings.ca.gov.”

(B) For exposures to listed reproductive toxicants, the words:

“Risk of reproductive harm from exposure to [name of chemical]. See www.P65Warnings.ca.gov.”; or

“Can expose you to [name of chemical], a reproductive toxicant. See www.P65Warnings.ca.gov.”

(C) For exposures to both listed carcinogens and reproductive toxicants, the words:

“Risk of cancer from exposure to [name of chemical] and reproductive harm from exposure to [name of chemical]. See www.P65Warnings.ca.gov.”; or

“Can expose you to [name of chemical], a carcinogen, and [name of chemical], a reproductive toxicant. See www.P65Warnings.ca.gov.”

(D) For exposures to a chemical that is listed as both a carcinogen and a reproductive toxicant, the words:

“Risk of cancer and reproductive harm from exposure to [name of chemical]. See www.P65Warnings.ca.gov.”; or

“Can expose you to [name of chemical], a carcinogen and reproductive toxicant. See www.P65Warnings.ca.gov.”

Do not need to specify name of chemical

The new regulation is set to take effect on 1 January 2025. Businesses that use the current short-form warnings will have a 3-years transition period to implement the new short-form content. For internet listed products for purchase, a 60-day grace period allows for updates to online warnings upon receiving revised content from manufacturers. The products labelled with the existing short-form warnings before or during the transition period may continue to be sold without the need of relabeling.

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 2024 to 30 November 2024 are summarized below:

Hazards

Frequency

Injury Hazard

7

Burn Hazard

4

Fire Hazard

3

Fall Hazard

3

Other Hazards*

10

*Other Hazards include Crushing Hazard, Crash Hazard, Entanglement Hazard, Microbiological Hazard, Impact Hazard, Poisoning Hazard, Entrapment Hazard, Risk of Death, Suffocation Hazard, Choking Hazard with a frequency of less than 2.

Product Categories

Frequency

Toys and Childcare Products

5

Fabric / Textile / Garment / Home Textile

3

Home Electrical Appliances

3

Furniture

2

Sporting Goods / Equipment

2

Protective Equipment

2

Outdoor Living Items

1

Electrical Appliances

1

For a complete list click here

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 2024 to 30 November 2024 are summarized below:

Hazards

Frequency

Choking Hazard

8

Fire Hazard

4

Injury Hazard

3

Burn Hazard

3

Microbiological Hazard

2

Safety Risk Hazard

2

Risk of Death

2

Other Hazards*

6

*Other Hazards include Lead Poisoning Hazard, Crushing Hazard, Tip-Over Hazard, Impact Hazard, Fall Hazard and Poisoning Hazard with a frequency of less than 2.

Product Categories

Frequency

Toys and Childcare Products

10

Electrical Appliances

3

Home Electrical Appliances

2

Protective Equipment

2

Chemicals

1

Food Contact Material

1

Fabric / Textile / Garment / Home Textile

1

Bodycare / Cosmetics

1

Furniture

1

Household Items

1

For a complete list click here

Europe News

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 2024 to 30 November 2024 are summarized below:

Hazards

Frequency

Chemical Hazard

217

Choking Hazard

39

Injury Hazard

27

Environmental Hazard

23

Electric Shock Hazard

22

Strangulation Hazard

20

Microbiological Hazard

6

Burn Hazard

6

Other Hazards*

16

*Other Hazards include Damage to Sight, Health Risk Hazard, Cut Hazard, Entrapment Hazard, Suffocation Hazard and Fire Hazard with a frequency of less than 4.

Product Categories

Frequency

Bodycare / Cosmetics

156

Toys and Childcare Products

70

Electrical Appliances

33

Jewelry

29

Chemicals

16

Fabric / Textile / Garment / Home Textile

10

Other Categories*

30

*Other Categories include Computer / Audio / Video / Other Electronics & Accessories, Sporting Goods / Equipment, Protective Equipment, Outdoor Living Items, Machinery, Furniture, Food Contact Material, Home Electrical Appliances, Accessories, Footwear, Car Accessories and Pet Items with a frequency of less than 6.

Notifying Country

Frequency

Italy

120

Hungary

38

Sweden

35

Germany

32

France

28

Slovakia

12

Czechia

10

Estonia

8

Bulgaria

8

Finland

8

Other Countries*

45

*Other Countries include Denmark, Croatia, Ireland, Spain, Romania, Luxembourg, Poland, Austria, Lithuania, Cyprus, Iceland and Latvia with a frequency of less than 8.

For a complete list click here

Asia News

An amendment to the Japan Specifications and Standards for Food and Food Additives, Etc. (outlined in Notice No. 370 of 1959) was issued on 5 November 2024. The amendment mainly addresses revisions of specifications and test methods for use of apparatus or for containers and packaging.

A partial amendment to the Specifications and Standards for Food and Food Additives, Etc. (Public Notice of the Ministry of Health and Welfare No. 370 of 1959) was issued on 5 November 2024. The Consumer Affairs Agency (CAA) of Japan notified the World Trade Organization (WTO) of the amendment on 12 November 2024. The 60-day comment period for the amendment ended on 26 October 2024.

Key Points:

1. Introduction of Positive List System:

  • A Positive List System was introduced earlier on 1 June 2020, to manage synthetic resins used in food containers and packaging. This system prohibits the use of materials unless explicitly allowed, ensuring only safe materials are used.

2. Regulation Updates Include:

  • Removal of obsolete test methods and standards, particularly for container strength and specific packaging materials.

  • Reorganization of regulations for better coherence and applicability.

  • Introduction of new testing methods to manage the migration of substances from packaging to food.

  • Specific changes in standards for synthetic resins and requirements for testing materials that unintentionally migrate into food.

3. Detailed Changes:

  • Introduction of total extractives tests and revisions to existing tests like the potassium permanganate consumption test and evaporative residue tests.

  • Revision of the standards for the residual solvent and Bisphenol-A (including phenol and p-tert-butylphenol) test solutions.

  • Adjustments to regulations for the use of glass containers for beverages and dairy products.

4. Implementation Timeline:

  • The amendments will be implemented in stages, starting from various dates in 2024 and 2025.

  • A transitional period of one year will be provided for compliance with the new regulations.

  • Specific materials and methods in use before the new regulations will continue to be allowed during a transitional period until 31 May 2027.

The updates, implementation dates and transitional periods should be reviewed to ensure compliance.

China News

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 2024 to 30 November 2024 are summarized below:

Hazards

Frequency

Safety Risk Hazard

46

Fire Hazard

40

Injury Hazard

25

Electric Shock Hazard

24

Burn Hazard

21

Explosion Hazard

16

Suffocation Hazard

14

Chemical Hazard

13

Crash Hazard

12

Puncture Hazard

10

Health Risk Hazard

9

Laceration Hazard

7

Fall Hazard

7

Other Hazards*

23

*Other Hazards include Swallowing Risk, Choking Hazard, Entanglement Hazard, Damage to Sight, Cut Hazard, Skin Irritation Risk and Risk of Death with a frequency of less than 7.

Product Categories

Frequency

Toys and Childcare Products

58

Sporting Goods / Equipment

34

Fabric / Textile / Garment / Home Textile

19

Food Contact Material

15

Electrical Appliances

13

Stationery

8

Home Electrical Appliances

8

Tools and Hardware

6

Other Categories*

8

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

Provinces

Frequency

Guangdong

43

Anhui

38

Tianjin

25

Hebei

16

Jiangsu

12

Hunan

9

Shanghai

5

Henan

4

Fujian

4

Other Provinces*

13

*Other Provinces include Xinjiang, Inner Mongolia, Shaanxi, Yunnan, Shandong, and Beijing with a frequency of less than 3.

For a complete list click here

Australia/New Zealand News

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 2024 ­to 30 November 2024are summarized below:

Hazards

Frequency

Injury Hazard

23

Risk of Death

10

Choking Hazard

8

Burn Hazard

7

Swallowing Risk

7

Fire Hazard

5

Drowning Hazard

2

Fall Hazard

2

Other Hazards*

4

*Other Hazards include Puncture Hazard, Risk of Allergy, Skin Irritation Risk and Poisoning Hazard with a frequency of less than 2.

Product Categories

Frequency

Electrical Appliances

7

Toys and Childcare Products

3

Sporting Goods / Equipment

3

Food Contact Material

2

Fabric / Textile / Garment / Home Textile

2

Other Categories*

9

*Other Categories include Computer / Audio / Video / Other Electronics & Accessories, Pet Items, Car Accessories, Bodycare / Cosmetics, Home Electrical Appliances, Furniture, Protective Equipment, Accessories and Jewelry with a frequency of less than 2.

For a complete list click here

Subscribe to our Regulatory Updates

Unsubscribe at any time. Read our privacy policy.