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[Chemlinked] Canada Proposes to Amend the Manufacture and Importation Requirements of Cosmetics Containing Nitrilotriacetic Acid Trisodium Salt

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등록일 2022-12-20

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Canada proposes that, under certain conditions, the manufacture and importation of cosmetics containing Na3NTA are required to submit a SNAN.

Introduction to Domestic Substances List (DSL)

The Domestic Substances List (DSL) is an inventory of substances manufactured in, or imported into Canada on a commercial scale. Substances on the DSL are grouped into 8 parts and may have one or more of the 5 available flags. For example, the S flag indicates that the substance is subject to Significant New Activity (SNAc*) requirements and is applied when the substance was subject to SNAc requirements prior to its addition to the DSL.

  • Part 1: Chemicals and polymers that are identified by their CAS numbers, or their Substance Identity Number assigned by the Department of the Environment and the name of the substance;
  • Part 2: Chemicals and polymers subject to SNAc requirements that are identified by their CAS numbers.

An introduction to other parts of the DSL can be found here.

 

*The SNAc provisions trigger an obligation for a person to submit a significant new activity notification (SNAN) to the government when proposing to use, import or manufacture the substance for a significant new activity. The government will then assess the substance for potential risks to human health and the environment. If risks are identified, the government may impose management measures.

 

On Nov. 26, 2022, Canada published the Canada Gazette, Part I, Volume 156, Number 48, including a notice of intent to amend the DSL to apply the SNAc provisions to “nitrilotriacetic acid trisodium salt”. 1 The manufacture and importation requirements for cosmetics containing “nitrilotriacetic acid trisodium salt" were proposed to be amended.

Ingredient Information

CAS No.

Common Name

Name in DSL

5064-31-3

Nitrilotriacetic acid trisodium salt (hereafter referred to as “Na3NTA”)

Glycine, N,N-bis(carboxymethyl)-, trisodium salt

Within 60 days after the publication of this notice, any suggestions can be submitte

 

Reason for Amendments

Following a screening assessment conducted by the Minister of the Environment and the Minister of Health (the ministers), Na3NTA was considered to have concern of human health effects. There is speculation that the information concerning significant new activities in relation to Na3NTA may contribute to determining the specific circumstances in which Na3NTA is toxic or capable of becoming toxic.

Canada intends to amend the DSL to indicate that under certain conditions, SNAN is required to be submitted with the manufacture and importation of products (including cosmetics) containing Na3NTA. The ministers will assess the information provided by the notifier and other available information to determine whether Na3NTA, if used in the proposed new activity, could pose a risk to the environment or human health, and, if so, whether risk management is required.

 

Proposed Amended Requirements for Cosmetics Containing Na3NTA

Na3NTA was removed from part 1 of DSL and added to part 2. SNAN is required to be submitted with cosmetics containing Na3NTA under the following conditions.

1) For the manufacture of cosmetics containing Na3NTA, SNAN is required when

  • the concentration of Na3NTA in the cosmetic is greater than 0.1% by weight; or
  • the concentration of Na3NTA in the soap is greater than 0.3% by weight.

2) For the importation of Na3NTA in cosmetics, SNAN is required when the total quantity of Na3NTA present in the product during a calendar year is greater than 10 kg if

  • the concentration of Na3NTA in the cosmetic is greater than 0.1% by weight; or
  • the concentration of Na3NTA in the soap is greater than 0.3% by weight.

SNAN shall be submitted 90 days before Na3NTA is imported, manufactured or used for a significant new activity. The Department of the Environment and the Department of Health will use the information submitted in the SNAN to conduct environmental and human health assessments within 90 days after receiving the submission.

No.

Information Required for SNAN

1

A description of the significant new activity in relation to the substance

2

The anticipated annual quantity of the substance to be used

3

The information specified in items 3 to 7 of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers)

1) The chemical name of the chemical, established in accordance with the chemical nomenclature rules of the International Union of Pure and Applied Chemistry or the Chemical Abstracts Service

2) The trade names of the chemical and the synonyms of its chemical name, if known

3) The CAS number of the chemical, if such a number can be assigned

4) A safety data sheet respecting the chemical, if available

5) The following exposure information respecting the chemical:

  • the anticipated annual quantity to be manufactured, if applicable;
  • the anticipated annual quantity to be imported, if applicable;
  • the anticipated uses within Canada;
  • its anticipated concentration in products and, if known, in end-use products.

4

The information specified in paragraphs 2(d) to (f) and 8(f) and (g) of Schedule 5 to the New Substances Notification Regulations (Chemicals and Polymers)

1) the degree of purity in its technical grade composition, if applicable;

2) known impurities present and their concentration by weight;

3) any additives, stabilizers and solvents present when the chemical is tested and their concentration by weight;

4) whether it is anticipated to be used in products intended for use by or for children;

5) the anticipated degree of direct human exposure to the chemical, including concentration, duration, frequency and circumstances of exposure, as well as factors that may limit direct human exposure.

5

A description and the intended use of the consumer product or cosmetic that contains the substance, and the function of the substance in that consumer product or cosmetic

6

The total quantity of the consumer product or cosmetic expected to be sold in Canada in a calendar year by the person proposing the significant new activity

7

All other information and test data respecting the substance that

  • are in the possession of the person proposing the significant new activity, or to which the person may reasonably be expected to have access; and
  • permit the identification of adverse effects that the substance may have on the environment and human health, as well as the degree of environmental and public exposure to the substance

8

The name of every government department or government agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the use of the substance and, if known, the department’s or agency’s file number and, if any, the outcome of the department or the agency’s assessment and the risk management actions in relation to the substance imposed by the department or agency

9

The name, civic and postal addresses, telephone number and, if any, the fax number and email address of the person proposing the significant new activity and, if they are not resident in Canada, of the person resident in Canada who is authorized to act on their behalf

10

A certification that proves the information is accurate and complete, dated and signed by the person proposing the significant new activity or, if they are not resident in Canada, of the person resident in Canada who is authorized to act on their behalf

Further Reading

 

Reference Links

[1] Canada Gazette, Part I, Volume 156, Number 48: Government Notices

 

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