Division 3.4 Impurities, traces, information about the packaging material

The aim of that section of the cosmetic product safety report is to assess whether the cosmetic product contains substances that have not been intentionally added to the formulation, and which may have an impact on its safety.

Impurities are unintended substances in raw materials.

A trace is a small quantity of an unintended substance in the finished product. Traces are to be evaluated with regard to safety of the finished product. When traces of prohibited substances are present, evidence of their technical unavoidability are also to be provided.

Traces can originate from the following sources: impurities in the raw materials/substances; the manufacturing process; potential chemical evolution/interaction and/or migration of substances in the product that could occur under normal storage conditions and/or through contact with the packaging material.

Because substances may migrate from the packaging to the formulation, the relevant characteristics of the packaging material are to be considered.

In accordance with point 4 of Annex I to Regulation (EC) No 1223/2009, the section on ‘Impurities, traces, information about the packaging material’ is to address three specific issues:

1. (a)

   the purity of substances and mixtures;

2. (b)

   in case of traces of prohibited substances, evidence of their technical unavoidability;

3. (c)

   the relevant characteristics of the packaging material, in particular purity and stability.

In practical terms, those elements may be interpreted as follows:

1. (a)

   precise definition of impurities and traces (see 3.4.1);

2. (b)

   evidence of technical unavoidability of prohibited substances (see 3.4.2);

3. (c)

   potential release of substances from the packaging or possible deterioration of the product in contact with the packaging (see 3.4.3).

For the analysis of impurities and packaging material, data from suppliers are of crucial importance and should be preferred.