EU Endocrine Disruptor Guidance Open For Comments; Benefit Cosmetics Recall; More News In Brief
This article was originally published in The Rose Sheet
Executive Summary
A new draft guidance from the European Chemicals Agency and European Food Safety Authority could have bearing ahead on how endocrine-disrupting chemicals in cosmetic products are identified for regulatory purposes; Benefit Cosmetics recalls a line of brow gels due to contamination concerns. More news in brief.
Comment Invited On EU Endocrine Disruptor Draft Guidance
The European Chemicals Agency and European Food Safety Authority seek public comment on newly released draft guidance "for the identification of endocrine disruptors" in the context of regulations governing biocidal products and plant protection products. According to the Dec. 7 announcement, ECHA and EFSA have been developing the guidance at the European Commission's behest following the Commission's publication of two related draft legal acts in June 2016. (Also see "EC Releases Endocrine-Disruptor Criteria, Drawing Heavily On WHO Definitions" - HBW Insight, 24 Jun, 2016.) Since then, European Parliament has rejected the European Commission draft regulation for implementing the criteria under an existing PPP regulation, but a corresponding regulation for biocidal products met no such resistance, publishing Nov. 17 in the EU's Official Journal. (Also see "EU Endocrine Disruptor Regs In Limbo; Parliament Urges 'Suspected' Category" - HBW Insight, 16 Nov, 2017.) Discussions with member states on implementing the ED-identification criteria for PPP purposes will resume, ECHA and EFSA say, noting, "The Commission considers that the criteria for PPPs should not differ substantially from those adopted for BPs and will prepare a new proposal accordingly." The present draft guidance must be finalized by June 7, 2018, when the biocidal criteria regulation becomes applicable, the agencies say.
An EC review of the Cosmetics Regulation as it applies to endocrine-disrupting substances is almost three years overdue, and it is speculated that EU authorities' work on the subject in other areas, such as biocidal products and pesticides, could inform that process. The draft guidance suggests that "the principles outlined in this [document] may be useful and applicable for the determination of endocrine disrupting properties of any substance" provided that parallels in the regulatory frameworks exist.
ECHA On Preliminary REF-4 Findings
Preliminary results from REACH-EN-FORCE-4, a project focused on companies' adherence to use conditions established for restricted chemicals (Annex XVII) under the EU's Registration, Evaluation, Authorization and Restriction of Chemicals law, revealed "relatively high" incidence of noncompliant products with respect to substances of interest, according to a Nov. 16 release from the European Chemicals Agency. The Forum for Exchange of Information and Enforcement, which is made up of representatives from European Member State authorities and includes ECHA and industry participants, discussed the findings at its 28th plenary meeting in early November. ECHA says 18% of 5,600 chemical products checked by inspectors were not compliant, citing frequent breaches including phthalates in toys (19.7%) and cadmium in brazing fillers above permitted limits (14.1%). Cosmetics aren't mentioned. The Forum will consider how to respond to compliance issues at its next meeting in March 2018. (Also see "ECHA Announces Coming Enforcement Projects On REACH Compliance" - HBW Insight, 7 Jul, 2017.)
The Forum also held a "well-attended" open session with stakeholders to discuss potential actions regarding the "last resort" requirement for animal testing under REACH. ECHA has identified a number of cases where registrants submitted data from animal tests even though in vitro studies would have sufficed. Having been informed by ECHA, "the national enforcement authorities will consider which of the cases inspectors will investigate," the agency says. (Also see "ECHA: Non-Animal Tests For Complex Toxicity Endpoints Not 'Foreseeable'" - HBW Insight, 29 Nov, 2017.)
Benefit Recalls Gimme Brow Gels
LVMH subsidiary Benefit Cosmetics is voluntarily recalling its namesake-brand Gimme Brow Volumizing Eyebrow Gel, a $24 product and multi-year winner of Allure's "Best of Beauty" award, due to microbial contamination. According to FDA's Enforcement Report for the week of Nov. 27, samples of the brow gel tested positive for Pseudomonas aeruginosa, a Gram-negative bacterium that can pose human health risks, particularly to the immunocompromised. According to the FDA notice, for each Gimme Brow variant, the recall covers 750,000 units distributed in the US, and more than 10.6m worldwide. A number of kits containing the product also are affected. In a statement posted to its website, Benefit says the action is being taken "out of an abundance of caution … after discovering that recent batches of the product did not meet our stringent quality standards." According to the company, the tainted Gimme Brow product doesn't put consumers at risk when it's applied as intended. "However, if it comes into contact with the eyes, it could lead to eye irritation," Benefit says, advising consumers to stop using the product and return it to its original place of purchase for a full refund.
Faiza Whitening Cream Recall
New Reliance Trading, Inc., the US distributor of Faiza Beauty Cream, initiated a recall of the product in early October, according to FDA's Dec. 6 Enforcement Report. The cited reason for the action is that Faiza, described online as a top-selling whitening cream in Asian markets, requires a new drug approval to be marketed in the states. FDA has been actively working in recent years to crack down on skin-whitening products positioned as cosmetics that it deems potentially hazardous. (Also see "Federal Court Slaps Injunction On Skin Whitener Seller At FDA's Behest" - HBW Insight, 27 Sep, 2017.) The agency issued a notice of proposed rulemaking in 2006 that would establish over-the-counter skin-bleaching products as not generally recognized as safe and effective (GRASE), making new drug applications the required route to market. In the interim, FDA has been using enforcement discretion with regard to skin-whitening products and hydroquinone, the only active ingredient previously proposed as GRASE for OTC drug monograph inclusion before new data raised questions about its safety. According to information online, Faiza relies at least in part on kojic acid to address discoloration or otherwise lighten skin. FDA has flagged labeling and online statements about the ingredient in warning letters to firms for unapproved drug claims. (Also see "FDA Warning To L’Oreal Creates Uncertainty For Anti-Redness, Dark Spot Treatments" - HBW Insight, 25 Feb, 2015.) Faiza is manufactured by Pakistan-based Poonia Brothers, and just 513 foil packets are said to be affected by the recall.