Health risks of ingredient substances

It is important that there are no substances in products that are toxic or can cause cancer, genetic defects, harm fertility or the unborn child. This is to protect the user, but also to avoid distribution in the environment.

Criterion ID

11092:2

Criterion level

Core

Criterion type

Technical specification

Criterion text

Ingredient substances1 shall not be classified with the following hazard statements in accordance with Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP regulation), neither in EU-harmonized classification (in accordance with appendix VI in the CLP regulation) nor in self-classification.

Classification in accordance with Regulation (EC) 1272/2008

Hazard class

Hazard statement 

Acute toxicity (categories 1-3)

H300, H301, H310, H311, H330, H331

Specific target organ toxicity - single exposure (category 1)

H370

Specific target organ toxicity - repeated exposure (category 1)

H372

Carcinogenic

H350, H351

Mutagenic

H340, H341

Toxic for reproduction

H360, H361, H362

Exceptions:

  • Fluoride in toothpaste
  • Benzoic acid in soap, creams and lotions. Products in spray form are not excluded.
  • Enzymes (including stabilizers and preservatives in the enzyme raw material) if they are in liquid form or as encapsulated granules. The exception does not apply to enzymes in spray products.
  • Colouring agents approved as food additives in accordance with Regulation (EC) No 1333/2008 on food additives.
  • Biological substances2, for example plant extracts

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