Health risks of ingredient substances

Ingredient substances¹ shall not be classified with the following hazard class and hazard statements 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), neither in EU-harmonised classification (in accordance with appendix VI in the CLP Regulation) nor in self-classification.

Exceptions

For classification with acute toxicity and/or specific target organ toxicity, the following are exempted:

• enzymes (including stabilizers and preservatives in the enzyme raw material)
• fragrances
• colouring agents approved as food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives
• biological substances², for example plant extracts.

For classification with H351, the following are exempted:

NTA impurities (Trisodium nitrilotriacetate, CAS 5064-31-3) in complexing agents at levels of up to 0.1 weight percent in the final product.

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.

²Biological substances are substances extracted with or without solvents from biological material, possibly purified, but not further modified. They can be vegetable or animal.