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, but also to avoid distribution in the environment.
Details
- Type:
- Technical specification
- ID:
- 11092:2
- 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:
- Fluoride in toothpaste
- 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
1Counted as ingredient substances are all substances in the product at levels greater than 0.01 %. Counted as ingredient substances are intentionally added substances and impurities from the raw materials in the product. Reaction products, by-products and degradation products are counted as impurities.
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, version 2018:1
- 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
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.
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.
If the requirement has been verified with a self-declaration verified by an accredited body, request the supplier's self-declaration including technical documentation of compliance that has been verified by an accredited verification body, accredited for the task in accordance with ISO/IEC 17029.
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 no accredited verification bodies according to ISO / IEC 17029 (Conformity assessment - General principles and requirements for validation and verification bodies), as it is a relatively new standard. However, this may change, especially if the demand for verifying compliance in this way increases. This possibility is therefore included in the list of possible verifications. More information about the standard is available at www.swedac.se.
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
- 11092:2
- Version date
- 2020-09-10
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.