EU Chemicals regulatory news, 13 September 2018
Cosmetics: Calls for regulatory action on CMR substances in personal hygiene products
The French regulator has called for restrictions under the REACH Regulation to control carcinogenic, mutagenic and reprotoxic (CMR) substances in personal hygiene products, including absorbent hygiene products. The French Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (Anses) found, following expert appraisal, that feminine hygiene products contained, inter alia, polycyclic aromatic hydrocarbons (PAHs), which are subject to a REACH restriction in articles for the supply to the general public.
While the concentration levels found were very low and remained below the applicable thresholds, and while uncertainties exist whether these substances could pose a risk in personal hygiene products, the concern remains that consumers may be exposed to these substances also from other sources.
Anses has called on manufacturers to improve the quality of raw materials and to revise manufacturing procedures to eliminate, or to reduce to the extent possible, the presence of CMR substances, endocrine disruptors and skin sensitisers. At the same time Anses calls for regulatory action at European level, in the form of a REACH restriction on CMR substances in personal hygiene products.
These products were notably excluded from the scope of a proposed REACH restriction on CMR substances in textiles on grounds of the "(…) need for such equipment and devices to fulfil specific requirements in terms of safety and functionality". The EU Ecolabel for Absorbent Hygiene Products, adopted in 2014, imposes restrictions on the use of hazardous substances but it is voluntary and applies only where manufacturers wish to benefit from the ecolabel.
REACH: The Netherlands has proposed the lowering of PAHs concentration in rubber granules and mulches used in artificial turfs
The Netherlands has submitted a REACH restriction proposal, which, if adopted, will see the permissible concentration levels of eight PAH substances lowered. The focus of the Dutch regulator's proposal, prepared in collaboration with the European Chemicals Agency (ECHA), is the concentration levels of PAH compounds in rubber granules and mulches, used in artificial turfs at sports facilities and playgrounds.
The PAH compounds are already subject to a REACH restriction insofar as they are used in articles. However, rubber granules have been defined as mixtures for the purposes of the REACH Regulation, and currently the generic concentration limits applicable for supply to the general public apply.
ECHA concluded as recently as in 2017 that PAH concentration levels in rubber granules give rise, at most, to a very low level of concern. However, the Dutch regulator has since investigated further the carcinogenic properties of the said PAH compounds and proposes that the permissible concentration limits, when found in rubber granules used in artificial turfs, be lowered from the current 100 mg/kg and 1,000 mg/kg, respectively, to 17 mg/kg for all eight substances.
The next step in the regulatory process is public consultation, which is expected to begin in September 2018.
REACH: Eurometaux and ECHA agree on cooperation for metals dossier compliance
ECHA and Eurometaux, the European association for non-ferrous metals, have agreed in June 2018 on a framework for cooperation to improve the registration data for metal compounds and inorganic substances. The Metals and Inorganics Sectorial Approach (MISA) falls within the European Chemicals Agency's (ECHA) Integrated Regulatory Strategy and contributes to the achievement of the 2020 Strategic Approach to International Chemicals Management (SAIC).
In concrete terms, the cooperation aims at resolving outstanding, critical scientific and technical issues, and "to better understand the hazard and risks posed by metals and inorganic substances, including their use in a Circular Economy." By 2020, ECHA and Eurometaux aim to identify information shortcomings under the REACH and CLP Regulations and to generate further information, as needed, as well as to improve supply chain communication.
A number of metals and metal compounds have been subject to extensive regulatory scrutiny (such as certain copper, nickel and cobalt compounds) and while MISA encourages a "priority based continuous improvement of chemicals management", it will not preclude further regulatory action when necessary.
In a separate development, Eurometaux, together with the Cobalt Institute, have raised concerns regarding the underlying scientific methodology used by the regulators in proposing a harmonised classification of cobalt metal. ECHA's Risk Assessment Committee (RAC) recommended in September 2017 a relatively low specific concentration limit following findings that cobalt metal is, inter alia, a high potency carcinogen.
However, the metals industry, supported by the German competent authority Bundesanstalt für Arbeitsschutz abd Arbeitsmedicin (BAuA), argue that the underlying methodology, which relied on a tumorigenic dose descriptor (T25), is too simplistic, was developed neither for inhalation tests nor for in-organic substances*.
The industry also argues that the consequences of the proposed harmonisation will be wide-reaching, considering that cobalt metal is an "unintentionally and unavoidably present" impurity in many primary steel products, such as final slags, ferrochrome and copper slags.
While ECHA acknowledges that the underlying methodology is simplistic, it "(…) cannot be regarded wrong per se" and considers that an expert meeting to discuss the methodology, while "(…) of course […] of interest", is not necessary in the context of cobalt and its entry into the list of harmonised classification.
Based on BAuA comments, it may be that while the modified harmonised classification will be included as part of the next technical adaptation to progress (ATP), the specific concentration level will be included only after an improvement of cobalt metal's potency evaluation has been conducted.
Finally, in the metals sector, the European Precious Metals & Rhenium Consortium has been dissolved and integrated into the European Precious Metals Federation following the completion in May 2018 of the REACH phase-in substance registrations. Indeed, the REACH Regulation itself foresees that SIEFs remain operational until 1 June 2018.
However, ECHA has published recommendations endorsing continued cooperation beyond the third and final phase-in substance registration deadline in May 2018. Such continued cooperation amongst co-registrants is necessitated by the need to address dossier updates and possible additional data requests in the context of dossier or substance evaluation. Co-registrants are free to structure their continued cooperation, remaining of course mindful of the requisites of applicable anti-trust rules.
*These documents are available through the Communication and Information Resource Centre for Administrations, Businesses and Citizens (CIRCABC) maintained by the European Commission.
