Ingredient1 preservatives and colouring agents shall not be bioaccumulative2, in accordance with Regulation (EC) 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (CLP Regulation).
Exceptions
- Colouring agents approved as food additives in accordance with Regulation (EC) 1333/2008 of the European Parliament and of the Council on food additives.
- Preservatives with LC50, EC50 and IC50 over 100 mg/l or NOEC/ECx over 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 over 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 octanol and water should be less than 4 (log Kow <4) or experimentally determined bioconcentration factor (BCF) should be less than 500 (BCF <500).
