Posted in Alternatives to animal testing (ALTEX), Researchers from the Transatlantic Think-Tank for Toxicology t4 – established by the Doerenkamp Zbinden Foundation for the defense of animal-free research, headquartered in Switzerland – studied the files submitted for registration, evaluation , the authorization and restriction of chemicals (REACH) of the European Chemicals Agency (ECHA) database listing chemicals for cosmetic use.

Cosmetic ingredients only with in vivotests under REACH

The study identified 3,206 chemical dossiers in REACH containing ingredients with cosmetic products as declared use, of which 419 listed cosmetic products as the only use. Of these 419 records, the researchers found that 63 had completed in vivotests after the ban of the Cosmetics Regulation on in vivotest.

Animal testing on all cosmetic products and cosmetic ingredients was banned by EU law in 2013 through the EU Cosmetics Regulation 1223/2009. Prior to that, there had been an initial ban on testing for finished products put in place in 2004 and for ingredients in 2009.

However, under ECHA REACH regulation 1907/2006, Certain aspects required or permitted testing on animals – notably testing of environmental parameters such as aquatic toxicity, pre-registration of certain new chemicals and long-term worker safety. And it was under REACH that post-ban animal testing was conducted on cosmetic-only ingredients, the researchers said.

“Registrants have widely used non-animal alternative methods to assess ingredients for REACH, but some have still conducted new in vivo testing to comply with REACH requirements for toxicity data and worker safety assessments ”,they wrote.

“In some cases, ECHA, the agency that assesses REACH dossiers, has rejected registrants’ alternative methods as insufficient and demanded new in vivo testing.

“Conflict between REACH and the cosmetic regulation”

The researchers, composed of representatives of the Center for Alternatives to Animal Experiments CAAT and its European branch; the University of Konstanz in Germany; Johns Hopkins University in the United States; Chinese regulatory compliance firm Knudsen & CRC; American cruelty-free beauty brand White Rabbit Beauty; and the international ingredients major Clariant, concluded: “Cosmetic ingredients in the EU are governed by two conflicting regulations.”

“… The conflict between REACH and the cosmetics regulation poses a serious dilemma for all segments of the cosmetics industry”,the researchers said – for ingredient makers, cosmetic brands, and consumers, alike.

“For ingredient manufacturers, because they may be legally required under REACH to perform in vivo testing on their ingredients, but the cosmetics market may reject ingredients with such testing; for cosmetic brands because they cannot easily identify REACH testing of ingredients in their supply chain, but if such testing is identified, a brand risks consumer backlash if it continues to use the ingredient, but finding an alternative can be difficult and expensive; and for consumers, because they can no longer trust that the EU cosmetic products they buy have not been tested on animals. “

The results of the present study analyzing REACH dossiers, they said, gave “A reason for optimism and concern”.

In vitroversus in vivo– many animal tests “could have been done away with”

“A review of cosmetic-only ingredient files shows in vivo testing declined sharply after 2009, when the initial ban on cosmetic testing came into effect. However, testing did not end at that time or in 2013 when the final ban went into effect. Trends show a continuation in vivo testing of cosmetic-only ingredients for REACH, and this is expected to continue as ECHA continues to assess REACH registration dossiers.

The study identified that new in vivopost-ban testing has been “Largely carried out because they were required by REACH”,Despite numerous dossiers exclusively using alternatives, in particular for human health parameters.

“For health endpoints with in vitro methods, most reporters who reported in vivo tests had followed the REACH principle of in vitro first, but eventually had to test in vivo to comply with REACH. The main reasons were the positive or equivocal results of in vitro tests or chemical properties that made in vitro infeasible tests.

However, the researchers said that some of these tests “Could have been canceled”By applying the possibilities listed in Annex XI of REACH or by using non-animal alternatives, in particular with regard to acute toxicity.

‘More new in vivotests for REACH are likely ‘

The researchers stressed the importance of making these tests known to the public, saying in vivotesting of cosmetic-only ingredients for REACH has “Has not been reported before” Because the EU no longer follows in vivo tests on cosmetic ingredients. The EU situation report, they said, instead counted all REACH tests as “industrial chemicals legislation” tests, including those on cosmetic ingredients.

“Further new in vivo tests for REACH are likely. As part of its dossier review process to date, ECHA has already requested new in vivo tests for cosmetic-only substances, and further requests can be expected as ECHA identifies gaps in the data in the files. In addition, ECHA’s decision that in vivo tests can be performed on only cosmetic ingredients “to assess the risks of worker exposure” affects many ingredients. With the exception of the import of a finished cosmetic product, all other cosmetic processes involve the exposure of workers to the cosmetic ingredient ”, the researchers said.

In view of this they said “more transparency”On post-ban in vivo testing was necessary, as well as a “Committed stakeholder effort to resolve the conflict”.

And such efforts had certainly already started in earnest.

Beauty industry calls for animal testing of ECHA and REACH

In November 2020, industry majors including Procter & Gamble, L’Oréal, Unilever and Avon signed an open statement released by Human Society International’s Animal-free Safety Assessment Collaboration (AFSA) claiming that ECHA and its board of appeal undermined the EU. ban on animal testing for cosmetics.

In December 2020, more than 400 beauty companies and brands also signed an open letter to the European Commission, Parliament and Council calling for a halt to new animal testing, in line with the current ban on testing on animals. animals in the EU. Signatories to this letter included Avon, Dermalogica, Molton Brown, Natura & Co and Unilever, as well as a number of nonprofits including PETA, Cruelty Free International and Human Society International.

And this year, the Cosmetics Europe industry association unveiled its latest project: the New Science Animal-Free Safety Assessment Program, which is expected to launch in 2022 and designed to advance the assessment capabilities of the non-animal safety, the regulatory use of these alternatives, and education and training. across the industry. The five-year program would be industry-led and operate globally to ultimately create a global future where cosmetics are completely free from animal testing.

Source: Alternatives to animal testing (ALTEX)
Published online ahead of print in August 2021, doi: 10.14573 / altex.2104221
Title: “Continuation of animal testing of cosmetic ingredients for REACH in the EU”
Authors: J. Knight, C. Rovida, R. Kreiling, C. Zhu, M. Knudsen and T. Hartung


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