Sensitizing (allergenic) substances
Level: Advanced
It is important to reduce the risk of allergies in people who come in contact with cosmetic products. The requirement limits sensitizing substances in the product.
Details
- Type:
- Technical specification
- ID:
- 11094:1
- Group:
- Cosmetic products
Criterion text
Ingredient substances1 shall not be classified with the following hazard classifications and hazard statements in accordance with Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP regulation), neither in EU-harmonised classification (according to appendix VI in the CLP regulation) nor in self-classification.
|
Classification in accordance with the CLP regulation (EC) No. 1272/2008 |
|
|
Hazard classification |
Hazard statement |
|
Respiratory or skin sensitisation |
H317, H334 |
Exceptions:
- Enzymes (including stabilizers and preservatives in the enzyme raw material) if they are in liquid form or as encapsulated granules.
- Tocopherol and tocopherol acetate.
- Amidoamine: max. 0,3 percent as impurity in Cocamidopropyl Betaine (CARB).
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.
Please note that the requirement applies to each individual constituent of the perfume mixture.
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:
Nordic Swan Ecolabel for Cosmetics
EU Ecolabel for Cosmetic products, (EU) 2021/1870
- Raw material supplier's safety data sheets for ingredient substances
- Product's declaration of contents/ingredients list
- Certificate from the manufacturer of the product stating that none of the substances in the product that is present in levels above 0,01 weight percent have been classified as sensitizing with H317 or H334. Safety data sheets for all the ingredient substances shall be available as a basis for the certificate.
- 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: Nordic Swan Ecolabel and EU Ecolabel.
Safety Data Sheets
This requirement can be verified with safety data sheets for all the ingredient substances 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
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
The purpose of this requirement is to exclude exposure to sensitizing substances in order to decrease the risk of allergies in people who come in contact with cosmetic products. Enzymes that are used in some products, such as toothpaste, are excluded. Enzymes are assessed as necessary in the products and are excluded when encapsulated or in liquid form.
Tocopherol and tocopherol acetate (vitamin E) are used as antioxidants in, for example, leave on products. Some suppliers self-classify these with H317.
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
- 11094:1
- Version date
- 2021-10-29
- Review date
- 2022-07-07
2021-10-29, Krav ID 11094:1: Exception added to the requirement for Amidoamine: max. 0.3 percent as a contaminant in Cocamidopropyl Betaine (CARB).