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21 Nov 2008

25 September 2008

Pressure builds to end nanomaterials in cosmetics until new non-animal safety tests are introduced

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Consumers could be exposed to unnecessary health risks from nanomaterials in cosmetics and sunscreens because the animal safety tests used are outdated and inadequate, says leading non-animal medical research charity, the Dr Hadwen Trust1. The UK charity is urging MEPs to support an immediate ban on nanomaterials in beauty products when the European Parliament debates the ‘recast’ of the Cosmetics Directive during the coming weeks2. Well-known brands such Dior, L’Oréal, Olay, Dove, L’Occitane and Avon contain nanomaterials.

Nanoparticles measure one-billionth of a metre, and those made from metals, alloys and ceramics are already used in many products including sunscreens, paints and sticking plasters. They can be inhaled, swallowed, absorbed through the skin or injected and are of concern because when reduced to the nanoscale, the physical and chemical properties and behaviour of particles can dramatically alter.

Nanotechnology is so new, there is a significant lack of human health and environmental toxicity data on nanomaterials3. Yet, despite this, companies already manufacture and sell products containing nanomaterials based on standard animal safety tests, which are wholly inadequate for assessing risks from nanotechnology.

Hundreds of everyday products contain nanomaterials, including well-known brands by Dior, L’Oréal, Olay, Dove, L’Occitane and Avon. The brands listed here are all available in UK shops or from websites.

Brands containing nanomaterials4 :

  • L’Oréal Revitalift intensive treatment mask – enriched with Nanosomes of Pro-Retinol A
  • L’Oreal Age Re-Perfect Day with pro-calcium – SPF 15
  • Dior Forever: ‘extreme wear flawless makeup – its unique formula includes Nano-Stretch Networks, an invisible, micro-airy nano-network’
  • Olay (Procter & Gamble) Complete Defense Daily UV – SPF 30
  • Olay Complete All Day Moisture cream Normal – SPF 15
  • L’Occitane Shea Butter ultra moisturising fluid – SPF 20
  • Dove Pro-Age Day Moisturiser – SPF 15
  • Avon Anew Alternative Intensive Age Treatment Day – SPF 25

EU safety regulations, such as REACH for chemicals or the Cosmetics Directive, do not specifically address the safety testing and risk assessment of nanomaterials. The EU is developing some non-animal tests, but as they undergo a strict validation system that their animal test counterparts have not been subjected to, a full range of non-animal methods is unlikely to be ready in the immediate future. That means traditional animal tests are likely to be used for nano-products despite their limited relevance5 .

“Animal tests for regular human or environmental safety are already stretching scientific credibility.” says Dr Gill Langley, Science Director at the Dr Hadwen Trust. “There can be dramatic differences from humans in the way that animals such as rodents react even to standard chemicals in these tests. Testing nanomaterials introduces extra uncertainty to already failing and outdated animal experiments, which may therefore be virtually useless to guarantee human safety. More reliable and human-relevant non-animal tests are urgently needed. Until they are available, the only responsible course of action for the European Commission is to use the precautionary principle and ban nanomaterials from all non-essential products like cosmetics to reduce the risk of people needlessly being exposed to potential harm.”

The Dr Hadwen Trust, which funds non-animal research to replace animal procedures, urges a greater focus on non-animal tests which offer the best chance of reliably assessing the safety of nanomaterials. As well as avoiding species differences6, they can also produce results far more rapidly and cost-effectively. In vitro methods are already developed in related fields such as particulate matter toxicology, and these appear to be applicable to nanotechnology.

In vitro tests are ideal because they can reveal biological effects at the cellular level where nanomaterials are most likely to be active. Cutting-edge microscopy techniques, human cell genomics, human skin absorption tests, 3D cell-matrix chambers and the HµREL device with its multi-chambered microchip are promising in vitro methods7. Alternative tests are also being developed by EU-funded Joint Research Centre projects such as Nanotox.

MEPs are currently considering a ‘recast’ of the EU Cosmetics Directive, intended to simplify and clarify the legislation. Dr. Caroline Lucas, Green Party Leader and MEP for the South East of England, has tabled amendments calling for urgent action to develop non-animal safety tests for nanoscale cosmetic ingredients, and prohibit the use of nanomaterials in cosmetics until full safety assessments establish that they are safe without using animals.

“The absence of scientifically robust tests to assess the safety of nanomaterials means that we really have no choice: cosmetics should not contain nanoparticles.” says Caroline Lucas MEP “In line with the legislative requirement to phase out animal tests for cosmetics8, companies should be stopped from using painful animal methods that cannot be relied upon to yield relevant and reliable safety data. We need advanced non-animal test methods that can far better keep pace with the challenges of emerging technologies like nanomaterials.”

For non-essential, non-medical applications (including cosmetic and household products, food and paint), the Dr Hadwen Trust recommends that nanomaterials are prohibited immediately. In medical research, diagnostics, prevention and treatment, nanomaterial use should be considered on a case-by-case basis, with the risk/benefit assessment being informed by non-animal methods rather than animal tests.

Click here to download a PDF of the Dr Hadwen Trust’s full position statement on nanomaterials.

Notes to Editors

1 The Dr Hadwen Trust is the UK’s leading non-animal medical research charity funding exclusively non-animal techniques to replace animal experiments. www.drhadwentrust.org

2 The Cosmetics Directive 76/768/EEC has been amended and adapted more than 54 times so the legislation is now being ‘recast’ to merge those amendments in one text. Changes are also being proposed to simplify and clarify certain sections. For example, the introduction of legal definitions, a glossary of ingredient names etc. MEPs will debate amendments on Sept 9th with a final deadline of Sept 17th for all amendments.

3 Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) opinion on
the appropriateness of existing methodologies to assess the potential risks associated with engineered and adventitious products of nanotechnologies. Adopted by the SCENIHR during the 7th plenary meeting of 28-29 September 2005.

4 These products are listed on either The Project on Emerging Nanotechnologies consumer products inventory http://www.nanotechproject.org/inventories/consumer/ or the Environmental Working Group’s Skin Deep Cosmetic Safety Database. http://www.cosmeticsdatabase.com/index.php

5 Animal safety tests such as acute and repeat dose toxicity, carcinogenicity etc.

6 Extrapolating test data between species, genders and breeds of animals, including humans, is highly problematic. The anatomical, physiological, biochemical, metabolic and pharmacological differences mean there are major uncertainties in interpreting results.

7 For example, nanoparticle movements can be tracked within living human cells with a time resolution of microseconds and a spatial precision of 1.5 nanometres. The Hurel device connects different human tissue compartments (such as liver, colon or kidney) by means of fluid channels, providing safety testing data at a microscopic scale (http://www.hurelcorp.com/technology.html ).

8 The Cosmetics Directive (Directive 76/768 EEC) prohibits the marketing of cosmetics containing ingredients tested on animals from 11 March 2013.

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