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Classification and re-classification of substances – what does this mean?

You may have heard about chemical substances being “classified” or “re-classified”. The terms and implications are often fairly technical and therefore not so easy to understand. Below you will find more information about these terms and the impacts.

Why are substances classified?

The EU Regulation on the classification, labelling and packaging of substances and mixtures (CLP) requires companies to appropriately classify, label, and package their substances and mixtures before placing them on the market. The goal is to ensure that the hazards presented by chemicals are clearly communicated to workers and consumers in the European Union.

While classification enables all actors in the value chain (substance manufacturers, companies using that substances to manufacture given products, retailers, etc.) to handle a classified substance with the appropriate safety precautions, classification does not introduce a ban on the use of a substance.

There is a difference between risks and hazard; (re)classification under the CLP is based on a hazard assessment of the substances, i.e. the evaluation whether the pure substance has the intrinsic property to harm human health or the environment. The actual risk (the possibility a person/the environment is harmed when exposed to the substance under specific circumstances) is not taken into account for this purpose. For example, a lion is intrinsically a hazard. However, when a lion is safely constrained in a zoo, it is not a risk since there is no exposure to it.

What about BPA?

Since July 2016, BPA has been officially re-classified from “Reprotoxic 2” to “Reprotoxic 1B”, which means that BPA as such would now be presumed (not anymore suspected) to have the potential to cause reproductive harm. Important caveat: this classification would apply only to BPA as a substance – it would not mean that products/articles made with BPA are themselves causing reproductive harm.

It is further worth to mention that the re-classification of BPA is not based on new scientific findings, but rather the result of the application of new stricter criteria according to the current CLP Regulation rules based on the same scientific insights that were already the basis for the former classification of BPA as “Reprotoxic 2”.

What are the impacts?

It is prohibited to sell to consumers pure BPA or mixtures containing BPA in a concentration equal to or above 0.1%. However, BPA is a chemical substance which is mainly used by industry as a building block to manufacture polycarbonate plastics and epoxy resins. These are polymeric products which only contain trace amounts of remaining free BPA. Pure BPA or mixtures containing BPA are not, and have never been sold directly to consumers. Therefore, the reclassification of BPA will not have a direct impact on consumer products made from BPA-based materials, i.e. polycarbonate and epoxy resins.

 

See also:

Regulatory Framework

Article about SVHC