Regulation
Alkylphenol producers have obligations under both national and European Union legislation and regulations.
The rules which are particularly relevant to our industry include measures designed to protect human health and the environment.
REACH
Chemicals placed on the market in the European Union must be registered under the REACH regulation (Registration, Evaluation, Authorization and restriction of Chemicals). To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They have to demonstrate to the European Chemicals Agency (ECHA) how the substance can be safely used, and they must communicate the risk management measures to the users.
Many 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 EU risk assessments.
Comprehensive risk assessments conducted both by industry and various governmental authorities are available for the alkylphenols on the market which have demonstrated they can be used safely and without posing a risk to man or the environment.
Some AP/APE compounds have been designated as Substances of Very High Concern (SVHC) but none of these compounds are currently designated based on being classified as carcinogenic, mutagenic or toxic to reproduction, except for Phenol, dodecyl, branched (EC 310-154-3), which is listed in CLP Annex VI as a Reproductive toxin Category 1B. To date, nomination of AP/APE compounds to the SVHC list have mostly been based on the conclusion that these substances have weak estrogenic activity and are alleged to have “probable serious” effects in fish but not to human health. Where effects on mammalian species is suspected the substance was demonstrated to have very weak potency as an androgen and oestrogen receptor binder, with activity similar to or lesser than many phytoestrogens often found in a normal diet or in dietary supplements, no consistency of effects across different species, and no direct evidence of an adverse effect in humans. Nevertheless, the EU regulators disagreed with the industry position that there was no scientific evidence of probable serious effects to human health giving to an equivalent level of concern and Phenol, alkylation products (mainly in para position) with C12-rich branched alkyl chains from oligomerisation, covering any individual isomers and/ or combinations thereof (PDDP);EC number 799-972-3 was added to SVHC list in July 2021 (this substance group includes EC 310-154-3).
Authorisation is one of the REACH processes for managing the risks of hazardous substances. Substances that are subject to authorisation may not be used in the EU unless a company applies for and obtains authorisation to do so from ECHA. Authorised substances are listed in Annex XIV, and both OPE and NPE have been listed. Unless authorization was granted for a specific use, these APs can no longer be used in the EU since January 4, 2021. In the future, it is expected that a different REACH process for managing risks, namely Restriction, will become more prevalent. Substances which are subject to a Restriction are listed in Annex XVII along with the specific use conditions that are in scope of the restriction. Additionally, it is anticipated that in the future only Essential Uses will be exempt from Restriction for a substance or more likely a substance family, as the EU regulators have already signalled that greater use will be made of grouping of substances of a similar chemical structure for Risk Management Measures.
Drinking Water Directive
The European Council adopted in 1998 a first version of the Drinking Water Directive with the objective to protect human health from adverse effects of any contamination of water intended for human consumption, by ensuring that it is wholesome and clean. The Directive has recently been revised and will be published in 2021.
Under the new rules, the quality standards that drinking water must meet are brought up to date, and a cost-effective risk-based approach to the monitoring of water quality is introduced. The directive addresses growing concerns about the effects of endocrine disruptors, pharmaceuticals and microplastics on human health by introducing a watch list mechanism. Nonylphenol (but no other AP’s) will be included in the first watch list, to be adopted 1 year after entry into force of the directive in view of their endocrine disrupting properties.
The CEPAD members are committed to a responsible and safe use of their products, including Nonylphenols (NP). There is no actual health risk from NP through the drinking water route of exposure as it is rarely found in drinking water. If found, it is at very low concentrations and there is no risk to human health. This is recognized in the recast of the DWD that states NP was included on the watch list “Even though the WHO indicated that currently there is no evidence of risks to health from drinking water, which is a minor source of exposure, and that such risks are unlikely”.
Water Framework Directive – Environmental Quality Standards
The Water Framework Directive (WFD) aims to protect freshwater resources and ensure good ecological and chemical status of EU waters. One of the WFD daughter directives is the Environmental Quality Standards (EQS) Directive.
The aim of the EQS directive is to reduce emissions and discharges of priority substances and to phase out those of the most harmful (priority hazardous substances). Nonylphenol is listed as a priority substance which is now under review. CEPAD is contributing to the revision of the dossiers for the existing Priority Substances.
Endocrine disruptors
There is growing concern in the EU and worldwide about negative human health and environmental impacts possibly caused by endocrine disruptors. There are legislative obligations aimed at phasing out endocrine disruptors (ED) in water, industrial chemicals, plant protection products and biocides are in place..
However, there is a potential for confusion and inconsistency in identifying EDs. Categories such as “suspected EDs” or “presumed EDs” could lead to uncertainties if a substance is ED or not. CEPAD, therefore, supports introducing harmonised ED identification criteria, in line with the WHO definition, across existing EU legislation. While risk management should be implemented at sector level.
Certain alkylphenols exhibit weak estrogenic effects in laboratory experiments. Based on the test system used and the specific isomer evaluated, the estrogenic potency of alkylphenols ranges from 1,000 to 1,000,000-fold less potent than that of oestradiol [the human female hormone]. Various multigeneration toxicity and chronic fish toxicity studies do not demonstrate oestrogen related adverse effects.