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Community Hygiene Concern - EDCs in treatment for head lice

A campaign by Community Hygiene Concern (CHC) calls on the manufacturer of lindane products for head lice to withdraw them from the UK market. CHC is also looking into the harm to fertility caused by silicone-based cyclic compounds in lead products marketed throughout the EU.

Regulations on remedies for head lice are relaxed on safety and efficacy say a group of specialists. Manufacturers may market formulated treatments intended to eradicate lice by physical action e.g. dehydration or suffocation, as Class 1 ‘fluid’ medical devices, but these are not required to pass the independent safety and efficacy assessment to which medicinal products are subject.

In Class 1 medical devices the risk/benefit balance is not examined pre-registration. Even standards for the authorisation of treatments for lice classified as medicinal products are inadequate. According to the authors of a recent study, the market is “swamped with poorly tested and ineffective products”. Therefore, they call for efficient testing pre-registration and periodic screening and testing of effectiveness in the post-registration period”[1]. Cyclopentasiloxane (or cyclomethicone[2]) a silicone-based cyclic compound found in some formulations for head lice, cosmetics and toiletries may be toxic to fertility and cause liver damage. [3]

After reviewing new data, the EU Scientific Committee on Consumer Safety (SCCS) concluded that silicone-based cyclic compounds are "safe, except for use in body lotion and hair styling formulations and in those product forms that can give rise to lung exposure of the consumer through inhalation, e.g. aerosols, pressurised sprays, powders, etc. 3" Skin creams, including anti-ageing creams and sun creams may contain cyclopentasiloxane, which increases lubrication and imparts a luxurious feel, and it is included in hair products for its anti-static properties. In treatments for head lice cyclomethicone is used as an evaporating vehicle to spread other ingredients over the scalp and the length of the hair.

Remedies for head lice are mainly applied to children, often repeatedly, so it is especially important to follow the precautionary principle and to only use treatments for head lice that are safe for children.

Social norms oblige parents to repeat treat their children until a cure is obtained. Families need to know that they are not risking future ill health when they treat head lice, but currently they cannot rely on the regulators to provide this safeguard.

CHC believes that all formulated products for head lice should be regulated as medicinal products and that manufacturers should be urgently required to submit robust evidence of safety and efficacy to the competent authorities. Self-certification should be disallowed, and regular review of ongoing safety and efficacy introduced.

References

1. Combescot-Lang C, Vander Stichele RH, Toubate B, Veirron E, Mumcuoglu KY. Ex vivo effectiveness of French over-the-counter products against head lice (Pediculus humanus capitis De Geer, 1778) Parasitology Research 2015; 114(5): 1779-92.
2. Barnett E, Palma KG, Clayton B, Ballard T. Effectiveness of isopropyl myristrate/cyclomethicone D5 solution of removing cuticular hydrocarbons from human head lice (Pediculus humanus capitis). BMC Dermatology 2012; 12: 15. http://www.biomedcentral.com/1471-5945/12/15
3. SCCS (Scientific Committee on Consumer Safety) Opinion on decamethyicyclopentasiloxane (cyclopentasiloxane, D5) in cosmetic products, SCCS/1549/15, 25 March 2015.
4. Apoteket. Press release: Apoteket will remove all cyclic silicone products. 8 September 2015.

More information available on the CHC website http://www.chc.org/

Originally posted on 27 September 2016

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