A one substance – one assessment principle around endocrine disrupting chemicals (EDC) has been muted by Federal Institute for Risk Assessment (BfR).
The BfR said a concept they co-devised goes beyond the European Commission proposal and that the characterization of the hazard potential by means of a decision matrix (specificity, severity, reversibility, consistency, potency) leads to a precise, transparent and comprehensible assessment.
It also appealed for a harmonized scientific criteria for identification and assessment of endocrine disruptors.
“The BfR is of the opinion that in assessing substances with endocrine-disrupting properties, the principle of ‘one substance – one assessment’ should be applied”, said Professor Dr Andreas Hensel, president of the German-based BfR.
“If a substance is used in different areas of legislation, any assessment must nevertheless be identical and must be conducted only on the basis of the intrinsic properties of that substance.”
Professor Hensel adds that a situation where different toxicological limit values are used for the same substance in different areas of legislation such as biocide, pesticide and chemicals law is not acceptable, since the intrinsic toxicity of the substance always remains the same.
The European Food Safety Authority (EFSA) issued an opinion saying
new tests and testing strategies that will soon be available would help determine safe levels of EDCs for food contact purposes last week.
The agency’s Scientific Committee added that criteria for assessing if they do have a negative impact is uncertain so decisions need to be based on a “weight of evidence approach”.
The BfR developed an assessment model for endocrine disruptors with regard to human health with the British Chemicals Regulation Directorate (CRD) in 2011.
The three-tier process includes proving whether or not the substance has to be regarded as a EDC, the hazard potential for humans then has to be characterized before the specific regulatory decision is taken.
The basis of the assessment is the World Health Orgnanization (WHO) definition stating that endocrine disruptors are substances which enter the organism from the outside and change the function of the normal system, causing adverse effects.
“From this definition arise three basic conditions which must be met: on the one hand, it must be certain that the substance impairs relevant functions of the endocrine system.
“On the other hand, harmful effects must occur as a result of this impairment, and these harmful effects must be present in an intact organism.“
The second stage of the concept makes it possible to identify endocrine disruptors that pose a high level of concern regarding human health, said the BfR.
“For experimental data it is assumed – provided that no information to the contrary exists – that the effects observed in an intact organism or test animal are relevant for humans as well.
“The most important factors notably include the specificity, severity, reversibility and consistency of the observed effects. In addition, the potency, i.e. the dose at which these effects occur, is considered to be relevant.“
The aim of the regulatory decision is to guarantee a high level of protection – which could be a non-approval or mandatory authoirization of chemicals, stated the agency.
Earlier this month, the European Parliament backed a proposal
to list EDCs as “substances of very high concern“ under the REACH legislation.