Health risks of ingredient substances
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.
Criterion ID
11092:2
Criterion level
Core
Criterion type
Technical specification
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.
- Labellings that fulfil the requirement, for example license in accordance with the Good Environmental Choice Criteria 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.
- Other verification showing that the requirement is met
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, i. e not with the safety data sheet for 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.
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.
Reference
Note that this requirement cannot be verified with the product’s safety data sheet. Safety data sheets for all ingredient substances in the product are required. More information on this can be found under “follow-up”.
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.
The requirements for chemical-technical products are mainly set for the properties of products and the substances contained, and only in exceptional cases are requirements set for limiting individual specified substances. The intention with this approach is to stimulate technical development so that the environmental and health characteristics of chemical-technical products are continuously improved. Another important idea behind the criteria is to combine the lifecycle perspective with a risk perspective, in other words, focusing on aspects where there is significant risk of substances contained impacting on health or the environment. In some cases, specific relevant exceptions from the requirements are stated.
- Criterion Id
- 11092
- Criterion level
- Core
- Criterion type
- Technical specification
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 KravID: 11092:2
Version date: 9/10/2020 12:24:09 PM
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.