Project

EU REACH Legislation – Aluminium

In December 2010, RSI submitted a complete toxicological assessment of aluminium to the European Chemicals Agency (ECHA). This submission was in reaction to new European legislation known as REACH (Registration, Evaluation, Authorization and Restriction of Chemicals No 1907/2006) that was introduced in 2007.

Under this legislation, manufactures and importers are responsible for assessing the hazards of their chemicals to ensure that the substances it manufactures and places on the market in the EU do not adversely affect human health or the environment at all stages in their manufacture and for all identified uses under anticipated REACH exposure scenarios.

The wide-ranging usage of aluminium (Al) compounds leads to a significant occupational and consumer exposure. In that context, it was important for Aluminium REACH Consortium to investigate potential toxicity and to characterize the hazard of Al target compounds: Al metal, Al oxide, and Al hydroxide under the new REACH Regulation. REACH-relevant health endpoints (local/systemic effects, inhalation, dermal, oral routes of exposure) include: acute toxicity; mutagenicity/genotoxicity; carcinogenicity; irritation/corrosion (eye, skin and lung); sensitization (skin, respiratory); repeated dose toxicity including neurotoxicity, bone toxicity, immunotoxicity, hepatotoxicity, nephrotoxicity, cardiotoxicity, and effects on the endocrine system; reproductive effects (developmental toxicity and effects on fertility). Despite the focus on the three main substances, data on other aluminium compounds was also used where they assisted in the assessment of the compounds of interest (i.e., application of read-across approach, etc.).

The major objectives of the project were to do the following:

  • conduct a systematic review of the literature on adverse health effects of Al target compounds under inhalation, dermal and dietary exposure situations;
  • update the existing registration REACH dossier with all relevant and reliable information on adverse effect of aluminium target compounds;
  • identify the most relevant and reliable key and supporting studies (Klimisch score 1 and 2) for a particular adverse health effect and to evaluate the strength and weight of evidence for identified hazards
  • extract information in a format suitable for inclusion in IUCLID database;
  • determine whether classification of Al target compounds is required under the Classification, Labelling and Packaging of Substances (CLP) Regulation (EC) No. 1272/2008;
  • ascertain whether a derived no-effect level (DNEL) or “Derived Minimum Effect Level” (DMEL) is necessary for any adverse health endpoint for both workers and the general population associated with exposure to Al compounds; and
  • identify REACH- required information and scientific data gaps.

The results of this work were used by the Aluminium REACH Consortium in the preparation of Chemical Safety Report on Al metal, Al oxide and Al hydroxide. The result were also used in the paper by Willhite et al. (2014) published in the “Critical Reviews of Toxicology”, and for the preparation of Aluminium Fact sheet “Potential Health Effects from Exposure to Aluminium and Aluminium Compounds”. A full assessment “The REACH Process: A Case Study of Metallic Aluminium, Aluminium Oxide and Aluminium Hydroxide” is prepared for publication in the Journal of Environmental Toxicology and Public Health.