Health risks of ingredient substances
Level:
The purpose of the requirement is to limit substances that are harmful to health, both to protect the user and to avoid spreading into the environment. The requirement limits the use of products that contain substances that are toxic or can cause cancer, genetic defects, harm fertility or the unborn child.
Details
- Type:
- Technical specification
- ID:
- 11092:4
- Group:
- Cosmetic products
- Swedish:
Criterion text
Ingredient substances1 shall not be classified with the following hazard statements in accordance with Regulation (EC) 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (CLP Regulation), neither in EU-harmonized classification (in accordance with appendix VI in the CLP Regulation) nor in self-classification.
|
Classification in accordance with the CLP Regulation |
|
|
Hazard class |
Hazard statement |
|
Acute toxicity (categories 1-3) |
H300, H301, H310, H311, H330, H331 |
|
Specific target organ toxicity - single exposure (category 1) |
H370 |
|
Specific target organ toxicity - repeated exposure (category 1) |
H372 |
|
Carcinogenic |
H350, H351 |
|
Mutagenic |
H340, H341 |
|
Toxic for reproduction |
H360, H361, H362 |
Exceptions
- Classification with H301: Sodium fluoride in rinse-off oral hygiene products (mouthwash and toothpaste).
- Classification with H372: Benzoic acid (CAS-number 65-85-0) in creams and lotions.
- Classification with hazard classes acute toxicity and/or specific target organ toxicity:
- Enzymes (including stabilizers and preservatives in the enzyme raw material) if they are in liquid form or as encapsulated granules. The exception does not apply to enzymes in spray products or products intended to be applied as a spray.
- Perfume substances.
- Colouring agents approved as food additives in accordance with Regulation (EC) 1333/2008 of the European Parliament and of the Council on food additives.
1Ingredient substances are all substances in the product, including additives such as preservatives and stabilizers. However, impurities from raw material production are not included. Impurities are residues from raw material production in concentrations below 0,01 percent by weight in the product. Substances added to a raw material deliberately and with a certain purpose are not considered impurities regardless of concentration.
Verification
The supplier shall, upon request, be able to present any of for example the following:
- Valid license for any of for example the following labels:
Good Environmental Choice for Cosmetics
EU Ecolabel for cosmetic products, (EU) 202171870
- Raw material specifications/raw material certificates for all ingredient substances, stating that the ingredient substances do not have the classifications stated above.
- Raw material supplier safety data sheets for the ingredient substances stating that the ingredient substances do not have the classifications stated above.
Proposed follow-up
Labelling
If the requirement is verified with a label, check that there is a valid license for the product in question. This can be controlled here: Good Environmental Choice, EU Ecolabel.
Safety Data Sheet
This requirement can be verified with safety data sheets for all the ingredient substances (raw materials) in the product. See section 2 “Hazard(s) identification” in the safety data sheets for the ingredient substances - the hazardous properties of the substance are listed here. Check that none of the specified hazard classes / hazard statements in the requirement are listed here.
Information about the criterion
All the stated classifications in the table are also included in combinations of several classifications. Self-classification of ingredient substances is covered by this requirement.
Environmental goals
Versions history
The version date indicates when the sustainability criterion was created or last updated. Last reviewed dated tells when we last checked that the sustainability criterion still is relevant.
- Current ID
- 11092:4
- Version date
- 2025-09-30
2025-09-30, REquirement ID 11092:4: The exceptions in the criteria text have been tightened to align with the ecolabels.
2022-07-07, Requirement ID 11092: 3: The exemption from the requirement updated.
2020-09-09, Krav ID 11092:2: The exemption for benzoic acid has been extended to include creams and lotions. Products in spray form are not excluded.