Mercury and its compounds have been prohibited from use in cosmetics products already in the
Cosmetics Directive 76/768/EEC and this prohibition is still applicable via entry 221 of Annex II to the Cosmetics Regulation (EC) No. 1223/2009.
Nevertheless, entries 16 and 17 of Annex V (preservatives) to the Cosmetics Regulation 1223/2009 allow the use of ‘Thiomersal’ and ‘Phenylmercuric salts (including borate)’, respectively, in cosmetic products under specific conditions. In particular, such mercury containing compounds are allowed only in eye products and with a maximum concentration that does not exceed 0,007 % (of mercury), when used alone or in combination (i.e., if mixed with other mercurial compounds that are currently authorised, the maximum concentration of mercury remains fixed at 0,007 %). In addition, cosmetic products that contain such compounds must include in their labelling the warnings ‘Contains Thiomersal’ or ‘Contains Phenylmercuric compounds’.
Apart from ‘Thiomersal’ that is a single substance, ‘Phenylmercuric salts’ cover all salts composed of the phenylmercury cation (C6H5Hg+) paired with an anion, such as acetate, benzoate, borate, bromide, chloride, oleate, etc. Mercury and its compounds are toxic, and exposure can lead to various adverse health effects, including but not limited to neurological and kidney damage, skin irritation and allergic
reactions, immune and endocrine system disruption, etc. In addition, mercury can accumulate in the body, leading to chronic toxicity even at very low levels of exposure over time. This can affect multiple organ systems, including the digestive, cardiovascular, and reproductive systems.
Given the severe health risks associated with mercury, its safe use in cosmetic products - although already strictly regulated- should be re-evaluated by the SCCS in view of technical and scientific progress. The Commission, therefore, requests the SCCS to provide a scientific advice on the safety of preservatives that contain mercury (and its compounds).
Terms of Reference
In light of technical and scientific progress and SCCS’ expert judgement and taking under consideration in particular the various health concerns, the SCCS is requested:
(1) to identify and justify whether there are specific concerns regarding the current use of ‘Thiomersal’ and ‘Phenylmercuric salts’ as preservatives in cosmetic eye products;
(2) to highlight if there is a potential risk for human health from the current use of ‘Thiomersal’ and ‘Phenylmercuric salts’ as preservatives in cosmetic eye products;
Deadline
6 months