Bioaccumulation of preservatives and colouring agents
Level: Core
It is important that preservatives and colouring agents in the products are not bioaccumulative since they can accumulate in living organisms and become concentrated upwards in the food chain.
Details
- Type:
- Technical specification
- ID:
- 11289
- Group:
- Cosmetic products
Criterion text
Ingredient1 preservatives and colouring agents shall not be bioaccumulative, in accordance with Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP regulation).
Exceptions:
- Colouring agents approved as food additives in accordance with Regulation (EC) No 1333/2008 on food additives
- Preservatives with LC50, EC50 and IC50 > 100 mg/l or NOEC/ECx > 10 mg/l.
- Readily biodegradable preservatives whose degradation products have BCF or log Kow that fulfils the requirement.
- Preservatives that are not bioavailable (molar mass >700 g/mole)
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.
2The distribution coefficient (Kow) between oktanol and water should be less than 4 (log Kow < 4) or experimentally determined bioconcentration factor (BCF) should be less than 500 (BCF < 500).
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 cosmetic products, version 2018:1
Nordic Swan Ecolabel for cosmetic products, version 3
EU Ecolabel for cosmetic products, (EU) 2021/1870
- Raw material supplier's safety data sheets for all preservatives and colouring agents in the product.
- Excerpt from ECHA's database showing that the preservative or colouring agent is not bioaccumulative with the specified logKow or BCF.
- 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, Good Environmental Choice and EU Ecolabel.
Safety Data Sheets
This requirement can be verified with safety data sheets for all the colouring agents and preservatives in the product. See section 12 "Ecological information" of the safety data sheet - for example, it can be stated that "the product is not expected to be bioaccumulative". If "data does not exist" is stated, check section 9 "Physical and chemical properties" - where log Kow values can be specified under "octanol / water distribution coefficient". Make sure that log Kow <4 or BCF <500. If data is missing in both sections 12 and 9, the supplier of the colouring agent or preservative needs to supplement the information in the form of, for example, test reports.
Excerpts from ECHA's database
If the requirement has been verified with excerpts from ECHA's database, make sure that the specified values for bioaccumulation are log Kow <4 or BCF <500.
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
ECHA is the European Chemicals Agency. ECHA's website contains a searchable database for all the substances that have been registered in REACH.
The requirement covers only colouring agents and preservatives as these are primarily such raw materials that can have bioaccumulative properties.
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
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
- 11289
- Version date
- 2019-05-07