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Health & Safety Facts

Classification

The differentiation of beryllium and its compounds is an important issue because of different physico-chemical and toxicological properties of the different substances. Currently, legal classification applies to “beryllium and its compounds” as a group. According to REACH, classification for the individual substance beryllium metal is required, and thus the classification, together with beryllium compounds, is not compliant with the legislative requirements. Documented rationales for the classifications of beryllium and beryllium compounds in the EU were requested and are not available. Only summary records of meetings of various institutions are available and, thus, a documented rationale for the classification does not exist. Consequently, there are a number of uncertainties to assess the basis for the current classification. Additionally, it is not reproducible what studies may have been considered or were not considered for classification and which of the data can be considered reliable using the quality standards that exist today.

Studies resulting from REACH requirements, conducted using OECD test standards and under Good Laboratory Practice requirements (GLP), demonstrate that the current classification of beryllium metal is inaccurate because it has historically been lumped with the toxicity associated with soluble beryllium compounds.


Quality analysis of the body of literature showed that most of the older animal studies do not meet today’s quality standards for reliability, refuting the accepted belief that beryllium metal caused cancer in various laboratory animals.

A critical review of the epidemiology studies showed that cancer studies focused basically on the same group of beryllium production workers. Cancer risk assessments had different outcomes depending on the individual investigator.

Test results demonstrate the need to change current classifications for beryllium metal.

The research clearly demonstrates that differentiation between beryllium and its compounds is an important issue because of the different physico-chemical and toxicological properties of the different beryllium compounds, especially when compared to those of beryllium metal and metallic alloys of beryllium.

The current EU classification applies to “beryllium and its compounds” as a group.

According to REACH, classification for the individual substance beryllium metal is required, and thus the classification of beryllium metal together with beryllium compounds is not compliant with the legislative requirements. Recently performed OECD-compliant animal  testing demonstrates that beryllium metal is not toxic after single oral bolus application, it is not a skin irritant and it is not an eye irritant. According to the guinea pig maximisation test, beryllium metal is not a skin sensitizer. These results are contrary to the current harmonised classification of beryllium. Since all known human respiratory sensitizers elicit positive responses in predictive tests for contact sensitisation potential, beryllium metal is not a respiratory sensitizer in the classic sense.

Furthermore, occupational health surveillance of beryllium metal production workers has indicated that exposure to beryllium metal is not associated with the development of respiratory allergic reactions such as asthma and rhinitis. It should also be noted that the testing results, compiled for the REACH Beryllium Dossier under OECD testing protocols, clearly indicated that Be metal should not be classified as a skin irritant, an eye irritant, an acute inhalation toxin, a skin sensitizer, or orally toxic as it is today.

The current toxicology assessments of beryllium and the control strategies employed today versus the much older studies and exposures profiles that existed in decades past lead to a much different conclusion. It is now clear that exposures to beryllium metal  today do not present a cancer or CBD risk to those who process beryllium containing materials in accordance with the research results that have been published in peer reviewed journals by scientific experts.

More detail is provided in the “Expert Study Evaluation of the Epidemiological and Toxicological Scientific Literature on Carcinogenicity of Beryllium Metal & Beryllium-containing Alloys conducted by Harlan Ltd for the Reach Beryllium Consortium”.


Toxicology