The Spanish Ministry for the Ecological Transition and Demographic Challenge has concluded its evaluation of 4-nonylphenol, branched, marking the completion of a critical phase in substance evaluation under the REACH Regulation (EC) No 1907/2006. The evaluation, initially undertaken by the United Kingdom and later transferred to Spain, has detailed significant regulatory follow-ups due to confirmed environmental and human health concerns.
Scope of Evaluation
The substance, identified as 4-nonylphenol, branched, with EC No. 284-325-5 and CAS RN 84852-15-3, underwent thorough scrutiny to address concerns related to its persistent, bioaccumulative, and toxic (PBT/vPvB) properties, consumer usage, high production volumes, and extensive environmental exposure.
Key Concerns Addressed:
- Chronic aquatic toxicity
- Other environmental hazards
- Potential for human health impacts due to endocrine-disrupting properties
Uses of 4-Nonylphenol, Branched
4-Nonylphenol, branched, is extensively used across various industrial, professional, and consumer applications. In formulation, it is utilised in the production of adhesives, paints, coatings, inks, fuels, and fuel dyes, and also serves as an intermediate in chemical processes. Industrially, it acts as an intermediate in the manufacture of nonylphenol ethoxylates and polymers, and is used in adhesives, paints, coatings, and inks. Additionally, it is applied in water treatment and oilfield sites, serves as a tackifier in tyre and rubber product manufacturing, is found in functional fluids, and is employed in emulsion polymerisation processes.
Professionally, 4-nonylphenol is used in adhesives, paints, coatings, inks, and fuel applications. Consumer products containing this substance include adhesives, paints, coatings, inks, and fuels. It is also present in various articles such as those containing paints, coatings, adhesives, and machinery. According to the SPIN database, in 2020, it was used in the manufacture of chemicals and chemical products, repair and installation of machinery and equipment, manufacture of machinery and mechanical appliances, electrical equipment, sound recorders, and reproducers, civil engineering and construction, manufacture of rubber and plastic products, and fabricated metal products, as well as in wholesale and retail trade, and maintenance and repair of motor vehicles.
Uses advised against
However, the use of 4-nonylphenol, branched, is advised against in several applications as specified in entry 46 of REACH Annex XVII. These include industrial and institutional cleaning (except in specific closed systems), domestic cleaning, textiles and leather processing (except in specific controlled processes), as an emulsifier in agricultural teat dips, in metalworking (except in controlled closed systems), in the manufacture of pulp and paper, cosmetic products, other personal care products (except spermicides), and as co-formulants in pesticides and biocides, with certain exceptions for existing authorisations.
Regulatory Follow-up Actions
Conclusion on Concerns:The Spanish authority has confirmed several concerns that warrant follow-up actions at the EU level, including:
- Consumer Use: Confirmed concerns necessitate regulatory action.
- High Tonnages and Wide Dispersive Use: Requires regulatory oversight due to potential widespread environmental exposure.
- Aquatic Toxicity: Chronic toxicity confirmed, indicating the need for stringent controls.
- Other Environmental Hazards: Broad environmental impacts confirmed, highlighting the necessity for further action.
Regulatory Actions Proposed:
- Harmonised Classification and Labelling: Ensuring consistent and clear communication of hazards associated with the substance.
- Identification as SVHC: Confirming its status as a substance of very high concern due to endocrine-disrupting properties.
- Restriction: Proposing restrictions on the use of 4-nonylphenol and related substances to minimise environmental exposure and impact.
Substance Evaluation Process
Initial Evaluation:The initial evaluation conducted by the UK highlighted significant environmental and human health risks, prompting further detailed investigation by Spain. The evaluation encompassed reviewing data from multiple sources, including environmental monitoring studies, regulatory assessments, and scientific literature.
Key Findings:
- Aquatic Toxicity: New long-term tests on aquatic invertebrates revealed refined predicted no-effect concentration (PNEC) values, which are lower than previously reported, indicating higher sensitivity.
- Environmental Exposure: Extensive monitoring studies found 4-nonylphenol widely present in various environmental compartments, confirming significant exposure risks.
- Bioaccumulation and Persistence: Evidence suggested that certain isomers of 4-nonylphenol are likely persistent and bioaccumulative, further compounding environmental concerns.
Conclusion and Recommendations
The evaluation has led to the conclusion that there is a critical need for regulatory actions at the EU level to manage the risks associated with 4-nonylphenol, branched. The Spanish Ministry has recommended treating the substance as if it were a confirmed PBT/vPvB substance due to its potential environmental impact and difficulty in establishing safe exposure thresholds for endocrine disruptors.
Tentative Plan for Follow-up Actions:
- Restriction proposals to be developed and submitted for regulatory consideration.
- Continuous monitoring and assessment to ensure compliance and effectiveness of implemented measures.
