Some AP/APE compounds have been designated as SVHC; although none of these compounds are carcinogenic, mutagenic or reproductive toxicants. The nominations were based on the argument that these substances have weak estrogenic activity and alleged could have “probable serious” effects in fish but not to human health.

CEPAD has submitted comments to ECHA objecting to the proposals and pointing out that these alkylphenols have only weak estrogenic activity of a potency that is between 3 and 6 orders of magnitude less than that of oestradiol [the human female hormone]. Naturally occurring phyto-oestrogens are even more potent than nonylphenol in laboratory tests. While these compounds are toxic to fish and other aquatic species, their effects are clearly not comparable to actual estrogens.

NPEs and OPEs do not warrant prioritization under Annex XIV because, they do not themselves meet the criteria for inherent toxicity specified under Article 57(f). NPE, OPE have been listed for authorization on 4th July 2017, on the basis that they are an “environmental source” of the degradants nonylphenol (NP) and octylphenol (OP). However, NPE/NP and OPE/OP are adequately controlled with existing regulations. CEPAD therefore continues to object to the nominations.

Alkylphenols are toxic to the aquatic environment and the toxicity generally increases with increasing alkyl chain length. The acute aquatic toxicity has been the reason for the widespread risk reduction as a consequence of the EU risk assessment. Nonylphenol (NP) and nonylphenol ethoxylates (NPE) are included in Annex XVII and shall not be placed on the market, or used, as substances or in mixtures in concentrations equal to or greater than 0.1 % by weight e.g. in textile articles which can reasonably be expected to be washed in water during their normal lifecycle, domestic cleaning products, or manufacturing of pulp and paper.

More information in our Q&A

 shutterstock chem 2