Health risks of ingredient substances
Level: Core
It is important that there are no substances in products that are toxic or can cause cancer, genetic defects, harm fertility or the unborn child. This is to protect the user, and to avoid distribution in the environment.
Details
- Type:
- Technical specification
- ID:
- 11092:3
- Group:
- Cosmetic products
- Swedish:
Criterion text
Ingredient substances1 shall not be classified with the following hazard statements in accordance with Regulation (EC) No 1272/2008 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 Regulation (EC) 1272/2008 |
|
|
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:
- Fluorine compounds in toothpaste and oral care products
- Benzoic acid in soap, creams and lotions. Products in spray form are not excluded.
- 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.
- Colouring agents approved as food additives in accordance with Regulation (EC) No 1333/2008 on food additives.
- Biological substances2, for example plant extracts
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.
- The supplier’s self-declaration including technical documentation of compliance verified by an accredited verification body, accredited for the task in accordance with ISO/IEC 17029 or equivalent standard.
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.
Self-declaration verified by an accredited verification body
If a verified self-declaration is used to prove that the requirement is fulfilled, request the supplier’s self-declaration, including documentation showing that the requirement is met. The self-declaration shall be verified by a verification body accredited for the task in accordance with ISO / IEC 17029 or equivalent standard.
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.
There are currently a limited number of accredited verification bodies for ISO/IEC 17029 (Conformity assessment - General principles and requirements for validation and verification bodies) as it is a relatively new standard. This may change, especially if the demand for verifying compliance in this way increases. More information about the standard and accredited verification bodies can be found on Swedac's website.
Environmental goals
Motive
Substances classified as highly toxic, toxic, carcinogenic, mutagenic or toxic for reproduction may cause severe adverse effects on human health at exposure. It is therefore justified to set requirements on ingredient substances in cosmetic products not to be classified in accordance with the above. The requirement applies on both substances with binding common EU- classification and on substances classified by self-classification, i.e. when the manufacturer itself classifies its substances in accordance with regulations in force.
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
- 11092:3
- Version date
- 2022-07-07
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.