REACH testing for cosmetic ingredients
What is REACH testing?
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is an EU regulation concerning the registration, evaluation, authorisation and restriction of chemicals and is applied to substances manufactured or imported into the EU in quantities of one tonne or more per year.
The hazardous properties of chemicals cannot be sufficiently determined using only non-animal methods therefore animal testing is still required to determine certain human health and environmental data. In order to minimise the use of animals REACH requires companies to share data in order to avoid unnecessary testing.
Those wishing to perform animal tests must obtain approval from the European Chemicals Agency (ECHA) which oversees REACH. Animal testing is to be avoided in favour of non-animal methods and registrants can only carry out tests involving the use of animals when there is no other option.
Read more about REACH here.
Protecting workers and the environment
As well as being subject to the EU Cosmetic Regulation, chemicals used in cosmetics and their ingredients are also subject to the REACH Regulation. This regulation requires companies who make and supply chemical substances to provide and communicate information about the properties and uses of those substances in order to control risks those they may pose to human health or the environment.
The Cosmetics Regulation only restricts vertebrate animal tests that are carried out 'in order to meet the requirements of this regulation', aimed at protecting consumers, but it is not aimed at protecting industrial workers.
Workers at industrial sites may handle substances used in cosmetics products in greater quantities, with higher concentrations and more frequently, leading to a higher risk of exposure to dangerous properties. To make sure that workers are not at risk, REACH requires safety data on the properties of the chemicals they handle.
According to REACH, to protect the health of people working in that industry, animal testing may be required – but only if no alternative tests are available. Also, to protect the environment, animal testing may be required - but again only if no alternative tests are available.
Challenging REACH regulations
Several high-profile cases have recently stirred public attention about the REACH regulations, with those opposed to animal research claiming that the EU is undermining the Cosmetics Regulation by allowing animal testing for products that are used solely in cosmetic products.
Symrise and PETA UK – October 2020 German company Symrise appealed an order by ECHA to carry out animal tests on two chemicals used within a sunscreen product, claiming that as this was only to be used in cosmetics this was unnecessary and outside of the Cosmetics Regulation. The two chemicals – homosalate and 2-ethylhexyl salicylate, had no previous data to show whether or not there would be a danger of exposure for anyone other than the end user (eg workers). In some cases, this can be waived under Section 3 of Annex XI, however Symrise had not done so in this particular case.
The Board of Appeal dismissed Symrise’s case, leading to protests from the cosmetics industry and outrage from the activist community.
ALTEX journal article – August 2021 UK newspaper, The Guardian ‘revealed’ that many cosmetic products in the UK and the EU contained ingredients that were tested on animals, following the publication of an article in the journal ALTEX that showed 63 out of 419 chemicals submitted for REACH review underwent animal testing before authorisation.
The journal paper does show that the EU ban means that fewer new chemicals require animal in vivo testing, thanks to the development of better alternative methods, however they are still required if no alternative exists to protect worker and environmental safety.
Reducing the use of animal testing in REACH
REACH, along with the ECHA, is currently working on methods to reduce the numbers of animals used in regulatory testing via a number of means. One such success is the skin sensitisation test, which has recently been adopted by the OECD Guidelines on good practice, under which new chemicals can be approved in this section without the need for in vivo testing.
Other investment has been put into the development of new workflows that allow risk assessment, based on historic data of similar chemicals that have undergone this kind of testing, as well as better sharing of data and toolboxes to help improve and reduce the need for repetition of animal testing.
However, in line with Directive 2010/63, if there is no alternative, then in vivo testing must be carried out. REACH dictates that it is the individual company’s responsibility to ensure the heath of its workers, and that it has minimal impact on the environment. If the company cannot prove these things, then in vivo experiments may be necessary before a product can be authorised.