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%. 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).
