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)
1Counted as ingredient substances are all substances in the product at levels greater than 0.01 weight percent. 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.
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).
