ECHA Plans to Significantly Lower Concentration Limits of CMR Substances in Children's Products
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On August 23, 2023, the European Chemicals Agency (ECHA) released an investigation report regarding the presence of CMR (Carcinogenic, Mutagenic, or Reproductive Toxic) substances in children's products. This initiative aims to provide support for the development of committee restriction measures to protect children from the hazards posed by CMR 1A or 1B substances in children's products.

Scope

Applicable to all CMR substances classified as category 1A (known effects) or 1B (presumed effects) according to Annex VI Part 3 of Regulation (EC) No 1272/2008 (CLP Regulation).

Definition of Children's Products

Based on REACH Annex XVII Articles 51 and 52, as well as CEN/TC 252 standards, children's products refer to any products intended to facilitate and safeguard activities such as sleep, rest, hygiene (such as bathing, diaper changing, and body care), feeding, sucking, transportation, and protection for children under 14 years old.

The following products are not within the scope of restriction:

  • Second-hand children's products;
  • Substances in children's products that are not accessible to children; and
  • Products regulated under the medical device or cosmetic regulations.

Concentration Limits

Children are particularly vulnerable to the harmful effects of chemicals. While certain substances are prohibited in children's products, these substances might be present in trace amounts in unintended forms. This situation could arise from impurities in ingredients, factors during manufacturing and storage, or packaging migration, among others. From a technical standpoint, this is unavoidable. Therefore, to achieve effective, coordinated, and efficient implementation of restriction measures, ECHA will establish concentration limits to better safeguard children's health.

According to the CLP Regulation, the General Concentration Limit (GCL) for CMR 1A or 1B substances is typically 1,000 milligrams per kilogram (mg/kg) (applicable to carcinogenic or mutagenic substances) or 3,000 mg/kg (applicable to reproductive toxic substances). However, the GCL/Specific Concentration Limit (SCL) for CMR substances is used for classification purposes only, not based on substance-specific risk assessments. It is worth noting that CMR 1A or 1B substances also include genotoxic carcinogens for which a safe threshold cannot be established. Therefore, these GCLs/SCLs might not provide sufficient protection for specific vulnerable consumer groups, especially infants and children.

This investigation report identifies 180 substances that could be present in children's products and collects and analyzes existing concentration limits and relevant analysis methods. However, ECHA did not include 11 perfluoroalkyl substances (PFASs) due to ongoing proposals for their widespread restriction. Furthermore, ECHA will not impose restrictions on concentrations of silicon carbide due to its carcinogenic classification primarily related to inhalation exposure. No significant hazards via oral or dermal routes have been identified, and considering the limited likelihood of its use in children's products, it is not included in the consideration. For the other 168 substances, ECHA proposes a default concentration limit of 10 mg/kg (equivalent to 0.001% weight for weight (w/w)). Additionally, deviations from the default concentration limit of 10 mg/kg will be considered based on the following factors:

1) the presence of concentration limits under REACH;

2) technical reasons for deviating from 10 mg/kg;

3) the range of the substance's Limit of Quantification (LOQ); and

4) industry-specific concentration limit requirements.

ECHA has specified concentration limits for the following substances, as shown in the table below:

Serial Number

Substance

EC Number

REACH Limit (Concentration, unless specified otherwise)

Considered Limit (Concentration, unless specified otherwise)

1

Formaldehyde

200-001-8

30 mg/kg

30 mg/kg

2

Aromatic amines (listed in CLP Annex VI)

listed in CLP Annex VI

30 mg/kg

30 mg/kg

3

Benzene

200-753-7

5 mg/kg

5 mg/kg

4

α, α, α-trichlorotoluene

202-634-5

1 mg/kg

1 mg/kg

5

α-chlorotoluene

202-853-6

6

α,α,α,4-tetrachlorotoluene

226-009-1

7

Arsenic compounds (listed in CLP Annex VI)

listed in CLP Annex VI

 

10 mg As/kg (content)

1 mg/kg (extract.)

0.2 mg As/kg (extract.)

8

Cadmium and its compounds (listed in CLP Annex VI)

listed in CLP Annex VI

100 mg/kg (content)

10 mg Cd/kg (content)

 

0.1 mg Cd/kg (extract.)

9

Chromium VI compounds (listed in CLP Annex VI)

listed in CLP Annex VI

Textiles

1 mg CrVI/kg (extract.)

Textiles

1 mg CrVI/kg (extract.)

Leather:

3 mg CrVI/kg (extract.)

Leather:

3 mg CrVI/kg (extract.)

10

Cobalt compounds (listed in CLP Annex VI)

listed in CLP Annex VI

 

10 mg Co/kg (content)

 

1.0 mg Co/kg (extract.)

11

Lead and its compounds (listed in CLP Annex VI)

listed in CLP Annex VI

500 mg/kg (content)

10 mg Pb/kg (content)

1 mg Pb/kg (extract.)

0.2 mg Pb/kg (extract.)

12

Mercury

231-106-7

 

0.5 mg Hg/kg (content)

 

0.02 mg Hg/kg (extract.)

13

N-nitrosamines and Nnitrosatable substances

listed in CLP Annex VI

 

Single: 0.5 mg/kg

Total: 5 mg/kg

14

Organic dyes (listed in CLP Annex VI)

listed in CLP Annex VI

50 mg/kg

50 mg/kg

15

Organotin compounds (listed in CLP Annex VI)

listed in CLP Annex VI

1 000 mg/kg

1 mg DBT or DOT/kg

16

Polycyclic aromatic hydrocarbons (PAHs) (listed in CLP Annex VI)

listed in CLP Annex VI

0.5 mg/kg

0.5 mg/kg

17

Pesticides (listed in CLP Annex VI)

listed in CLP Annex VI

 

Total: 0.5 mg/kg

18

PFAS (listed in CLP Annex VI)

listed in CLP Annex VI

 

Please refer to the proposal for general restrictions on PFAS

19

Phthalates (listed in CLP Annex VI)

listed in CLP Annex VI

1000 mg/kg

Single: 50 mg/kg

Total: 100 mg/kg

20

Quinoline

202-051-6

50 mg/kg

50 mg/kg

This draft report will accept feedback from the public and stakeholders before September 29, 2023.

If you need any assistance or have any questions, please get in touch with us via test@cirs-group.com.

Reference

https://echa.europa.eu/calls-for-comments-and-evidence

https://echa.europa.eu/documents/10162/304346ad-3280-1680-18e0-7531260c44ee