Three new restriction proposals for NPs and NPEs have been announced under REACH regulation. Earlier this month, Sweden proposed intentions to restrict three substances in manufactured goods imported into the EU market:
- 4-nonylphenol, branched
- nonylphenol ethoxylates
NPs and NPEs are grouped under alkyl phenols and their ethoxylates, used in everything from cleaning products to paint to the clothing sold in shops and malls. Among other things, the Swedish Chemicals Agency wants the EU to ban the import of textile and leather articles containing NP or NPEO which is expected to measurably affect the supply chain for clothing manufacturing and distribution.
Currently, most substances under intention for restriction under REACH are mercury compounds and phthalates. To view or download the list of 12 additional substances (before Sweden’s announcement) that have been submitted with intention for restriction, see the chart below or download REACH’s 12 intentions (pdf) for reference.
Restriction The Swedish Chemicals Agency said that the proposed restriction is a new restriction, not an amendment of an existing one. (The amendment of an existing restriction requires first a decision according to REACH article 69(5) to amend the restriction and then a decision according to the normal procedure amending the restriction.)
Annex XV dossiers are the regulatory instruments for the Authorities (Member States or the Agency) to propose and justify restriction:
- on the manufacture,
- placing on the market, or
- use of substances within the EU.
Once there is agreement on proposed restrictions, the restrictions are added to Annex XVII of the REACH Regulation. After that, any subsequent manufacture, placing on the market or use of the substance has to comply with the conditions of the restrictions.
Justification The justification for Sweden’s three new proposed market restrictions for 4-nonylphenol, branched and nonylphenol and nonylphenol ethoxylates is based on reported findings of scientific studies. Relevant findings include:
- NP (e.g., nonylphenol) and NPEs (e.g., nonylphenol ethoxylates) have been found in environmental samples taken from freshwater, saltwater, groundwater, sediment, soil and aquatic biota
- NP has also been detected in human breast milk, blood, and urine and is associated with reproductive and developmental effects in rodents
- NP is persistent in the aquatic environment, moderately bioaccumulative, and extremely toxic to aquatic organisms
- NP has also been shown to exhibit estrogenic properties in vitro and in vivo assays. NP’s main use is in the manufacture of NPEs
- NPEs are nonionic surfactants that have been used in a wide variety of industrial applications and consumer products. They can be found in textile (including leather) articles
- NPEs, though less toxic and persistent than NP, are also highly toxic to aquatic organisms, and, in the environment, degrade into NP
- Levels of NP in waters above the environmental quality standards in the Water Framework Directive (WFD) is found in several waters despite the strict restriction on the use of Nonylphenol (NP) and Nonylphenoletoxilates (NPEO) under the limitations directive 76/769/EEC (now in Reach Annex XVII, entry 46) having been in force since January 2005
- NP and NPEO in textiles have been identified as a significant source of NP in the environment
Leather & Lace Textiles and their manufacture is a big concern in the EU. Based on the above-enumerated data, the Swedish Chemicals Agency is investigating the possibility of proposing a particular restriction or even a ban on importing textile and leather articles containing NP or NPEO.
The expected date of submission for restriction of these three new substances is August 3, 2012.