Issue Type: Biomedical Research

Humane Society International / Europe

Science
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BRUSSELS—A new online Master Class course to train scientists in testing cosmetics and chemicals without using animals is being hailed as a game-changer for cruelty-free testing worldwide. Featuring real-world case studies to walk scientists through animal-free testing step by step, the curriculum launched by the Animal-Free Safety Assessment Collaboration (AFSA) has attracted over 1,200 participants from nearly 70 countries since its debut in 2023, highlighting a global interest in innovative, ethical testing methods. Its final module is now open for registration, completing the ten-module course.

Created with input from industry, method developers, regulatory and animal protection experts, the course guides users through every stage of “next-generation risk assessment” culminating in advanced techniques like data integration to ensure robust consumer safety conclusions. These cutting-edge methodologies not only eliminate the need for painful animal-based testing but also provide more valid and reliable results concerning the safety of chemicals and products.

A result of wide-ranging contributions from global experts in animal-free safety science, the AFSA Master Class aims to provide the educational building blocks for lasting change, encouraging kinder scientific practices that will also better ensure human safety. Regulators, product developers, contract research organizations, and academic professionals from across the globe are all active in development of the course, illustrating the truly collaborative nature of animal-free safety science worldwide.

Dr. Catherine Willett, senior director of science and regulatory affairs at Humane Society International and principal coordinator of the AFSA Master Class, said, “Consumers and companies alike want to move away from painful and outdated animal tests, but learning more about the cutting-edge tools  available in the animal-free toolbox, and how to use them to make safety decisions, can be challenging. The AFSA Master Class demystifies animal-free safety assessment, making it easier for companies to replace rats, rabbits and guinea pigs with advanced non-animal models and computer simulations.”

Course participant Mark Broussard, managing partner of Desert in Bloom Cosmetics Lab, said, “The AFSA Master Class really helped me understand the entire process of determining the safety of a novel cosmetic ingredient using non-animal methods, since I am working with a novel plant extract that has not before been safety tested or used in cosmetic/therapeutic products for human use. I think the new approach methodologies will yield more valid, more reliable results on the safety of cosmetic ingredients without subjecting animals to the painful animal-based testing procedures.”

“The safety of the cosmetics and personal care products that consumers use and trust every day is of the utmost importance,” said Dr. Julia H Fentem, EVP safety, environmental & regulatory science at Unilever. “Our unique AFSA Master Class program is focused on the safety assessment of cosmetic products and ingredients without generating new animal data and covers all aspects of using non-animal tools and data for internal company decisions-making as well as regulatory safety assessments.”

The AFSA Master Class will help equip key stakeholders with the right tools and knowledge to better explore animal-free methods of safety testing and contribute to the wider shift towards the cruelty-free future of cosmetic and chemical safety science.

The full AFSA Master Class is freely available online at AFSAcollaboration.org/masterclass.

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Media contact: Aviva Vetter, avetter@hsi.org

Editor’s note: The AFSA Master Class is a product of in-kind contributions from the following member organizations: Avon Products Inc., Crème, Delphic HSE, DSM-Firmenich, Givaudan, Humane Society International, Institute for In Vitro Sciences, International Flavors & Fragrances, Inc., Lhasa Ltd., L’Oréal, Lush Fresh Handmade Cosmetics, Procter & Gamble, Symrise, Unilever.

HSI/India welcomes the Indian Pharmacopoeia Commission’s commitment to waive off the ‘Target Animal Batch Safety Test’

Humane Society International / India

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INDIA—In a significant move, the Indian Pharmacopoeia Commission (IPC) has made a progressive amendment and waived off the Target Animal Batch Safety Test (TABST) in the Indian Pharmacopoeia, effective 1st July 2024.  

The TABST, a non-specific safety test for veterinary vaccines, typically involves the administration of vaccine overdose to animals to test that every batch of vaccine produced is safe for a specific species. However, multiple studies have proved that the method lacks specificity and is prone to producing false results. The IPC’s decision to waive the TABST will reduce the number of animals subjected to unnecessary testing and underscores the supportive atmosphere of the regulators and industry to steer away from obsolete animal-based testing.

By recognizing the shortfalls of the TABST and allowing the test to be waived, India is a step closer to aligning itself with international veterinary vaccine testing standards, joining Brazil, Europe, Canada, the US, Japan, and others.  

Alokparna Sengupta, managing director at Humane Society International/India said: “We are delighted at the recent waiver of the TABST. This reaffirms India’s commitment towards eliminating obsolete animal tests for batch release testing of vaccines. We have been working on this with both IPC and the industry since 2020 and we believe that such collaboration is pivotal in this decision. We look forward to facilitating further advancements in other areas of safety testing of vaccines as well.” 

This waiver follows a series of progressive decisions by the IPC. Back in 2018, the Rabbit Pyrogen Test was replaced with the Bacterial Endotoxin Test (BET), followed by the inclusion of the Monocyte Activation Test in 2018 and removal of the Abnormal Toxicity Test for almost all human vaccines in 2020 from Indian Pharmacopoeia monographs. 

Over the last five years, HSI/India’s Research & Toxicology department has been working with the Government of India, the veterinary industry and associated interest holders to promote the development and use of advanced non-animal methodologies. This positive step by the IPC will save countless animal lives whilst enhancing veterinary vaccine safety. 

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Media contact: Shaili Shah: 993059100: sshah@hsi.org

Animal-Free Safety Assessment Collaboration urges European Chemicals Agency to step up compliance with mandates to prevent animal testing

Humane Society International / Europe

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BRUSSELS—A new paper published this month in Regulatory Toxicology and Pharmacology by Unilever, Procter & Gamble, Innospec and other members of the Animal-Free Safety Assessment Collaboration has exposed numerous concrete examples of acceptance barriers to companies’ good-faith attempts to honour the requirement under European chemicals law that new animal testing may only be undertaken “as a last resort.”

The peer-reviewed article, “The last resort requirement under REACH: from principle to practice,” also provides recommendations to enhance the governance and enforcement of the legal requirement established in the EU Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. If implemented, the AFSA suggestions would significantly advance science and animal welfare by helping to inform upcoming plans to revise REACH and develop an EU roadmap for phasing out animal testing in the chemicals and other regulated product sectors.

Members of AFSA have issued the following statements:

“This paper highlights the challenges and type of barriers that REACH registrants often face when using non-animal methods to try to meet various test requirements,” said Anders Bergqvist, PhD, head of toxicology team for Global Product Compliance Europe. “While we will certainly continue to aptly use non-animal methods, we hope that the recommendations presented in this paper will be adopted by the European Commission and the European Chemicals Agency so that animal testing under REACH, before being phased out, can be reduced to the absolute minimum.”

“All scientists must uphold the legal requirement that animal testing is conducted only ‘as a last resort’ when addressing REACH information requirements,” said Dr Carl Westmoreland for Unilever’s Safety and Environmental Assurance Centre. “To ensure that this principle is transparently applied to all proposed testing, it is essential that new science which offers advanced approaches to adapting standard information requirements is robustly applied, discussed and submitted.”

James Dawick, senior toxicology and risk assessment manager, and Ian Callan, vice president global regulatory compliance and ESG, Innospec, together said: “Innospec is very proud to have collaborated with AFSA colleagues on this important publication. As an organisation we are working hard across multiple forums to eliminate the need for animal testing. This publication provided a great opportunity for us to highlight some of the challenges and opportunities on the subject, specifically in regard to EU REACH. Innospec sincerely hopes the case studies and solutions provided in this AFSA paper serves to stimulate dialogue with key stakeholders and catalyse the necessary changes to ensure animal testing is used as a last resort under EU REACH.”

“As P&G is a founding member of AFSA, we are happy to have contributed to hands-on ingredient examples evidencing how well animal-free methods address safety questions without the need for new animal data,” said Dr Xiaoling Zhang, senior scientist and toxicologist, Central Product Safety, Global Product Stewardship for Procter & Gamble. “We hope this paper will build trust and help accelerate the global adoption of non-animal methods for chemical safety assessments.”

“We are proud to support efforts that will help drive greater acceptance of new approach methodologies to validate the safety of ingredients around the world,” said Ben Carrick, head of global public policy at Kenvue.  “Through the implementation of these recommendations, we hope we can reduce the need for unnecessary testing on animals and only leverage these outdated methods as a last resort for chemicals regulation in the EU.”

“Companies should not be penalised for obeying the law and making best efforts to avoid new animal testing except as a ‘last resort’,” said Jay Ingram, director of chemicals for Humane Society International. “Chemicals, chemical regulations, guidance and regulatory compliance reviews by the European Chemicals Agency and EU Member States should facilitate, not impede, compliance with this legal mandate. We hope our publication sparks dialogue and action to ensure regulatory enforcement mechanisms are appropriately leveraged in the pursuit of protecting human and environmental health and animal welfare—a true win, win, win for everyone.”

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Media Contact: Emily Ehrhorn: eehrhorn@humanesociety.org; 202-779-1814

Notes:

  • Despite efforts from regulatory bodies to increase the use and acceptance of non-animal methods such as read-across, a popular non-animal approach, their use has remained static from 2016 to 2022. Given the predicted increase in the number of chemicals proposed in the EU over the next 30 years, it is vital that companies are adequately supported in the safety assessment process.
  • Co-operative efforts to further support the transition towards an animal-free future of chemical legislation require genuine intentions to execute the last resort requirement. The peer-reviewed article sets out recommendations for the European Commission, ECHA, and companies registering new products:
  • The study has revealed the redundancy of ECHA’s requested animal tests, Companies who adhere to REACH’s last resort requirement and sufficiently establish safety using non-animal methods have been asked by ECHA to reconsider their approach, being left with no option but to test on animals.
  • Some EU-based companies initially use animal tests rather than as a last resort, due to ECHA’s lack of provision, whereby those collecting data to register new chemicals and products face several challenges in satisfying the last resort requirement. For example, data from read-across is often rejected after ECHA reviews.
  • Inflexible administrative processes, non-acceptance of non-animal methods, and redundancy of testing can contribute to a fear of rejection from regulators, creating an environment not conducive to mainstream adherence of REACH’s last resort requirement.
  • In 2021, the European Parliament called for acceleration towards the transition to innovation without the use of animals in regulatory testing. A 2022 European Citizens initiative signed by over 1.4 million people echoed this notion, supporting the phasing out of animal testing in the EU. The European Parliament response to this initiative repeats its commitment to ‘reducing and potentially eliminating animal testing in the context of chemicals legislation’.

Humane Society International / South Korea

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SEOUL—Humane Society International/Korea and 346 South Korean academic and industry experts delivered a letter to the chair of National Assembly’s Health and Welfare Committee, Dong Kun Shin, urging the Korean government to pass bills promoting state-of-the-art science replacing animal testing.

With an increasing consensus among scientists recognizing the importance of providing systemic support in developing and implementing human-based non-animal methods, two bills were introduced at the National Assembly; the Act on the Promotion of Development, Dissemination and Use of Alternatives to Animal Testing Methods (PAAM Act), sponsored by Assembly member In-Soon Nam in 2020, and the Act on the Vitalization of Development, Dissemination, and Use of Alternatives to Animal Testing Methods (VAAM Act), sponsored by Assembly member Jeoung Ae Han in 2022.

Through a series of political forums to discuss these bills with authorities and wider stakeholders in the past few years, a general agreement has been established that South Korea is at a pivotal moment in advancing health and safety science without relying on animal models. To achieve this, the bills stipulate collaborative work between authorities by providing a basic plan every five years. In addition, a committee consisting of experts in alternative approaches to animal testing will be established pursuant to the Act.

One of the signatories of the letter, Professor Kyungmin Lim, at Ehwa University said: “As a researcher, I work closely with new method developers and end-users. I experience time and time again the need to have a legislation in Korea to support those scientists and a relevant network for collective efforts in developing and accepting alternative approaches to animal use.”

HSI/Korea’s director of government affairs, Borami Seo said: “There is an increasing interest in using modern technologies that are more predictive of human responses than animal models. Last May, ’Korea’s innovative strategic industry committee’ selected the cell-based human mimetic method organoid as an ‘innovative strategic technology’ and promised research and development support. We are witnessing an increasing demand for these technologies, and the PAAM Act and VAAM Act are exactly the bills that are crucial to ensure these research and development efforts lead to its regulatory uptake and industrial use in the field. Now is a critical time to pass this legislation.”

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Media contact: Borami Seo bseo@hsi.org

Humane Society International / Europe

HSI

BRUSSELS —The European Commission today kick-started a plan to phase out animal testing for chemicals across Europe but will not protect the EU ban on animal testing for cosmetics in response to the “

Save Cruelty Free Cosmetics – Commit to a Europe Without Animal Testing” European citizens’ initiative (ECI) signed by 1.2 million European citizens.

While campaigners welcome the plan to ultimately eliminate animal testing for chemicals and the longer-term proposals to reduce and phase out the use of animals in research and education, the Commission  ignored citizens’ calls to uphold the ban on animal testing for cosmetics; a ban established by legislators over a decade ago.

Despite the introduction of an EU ban on animal testing for cosmetics ingredients in 2009, animal tests for chemicals handled by industrial workers or which may be released into the environment are still being required under the EU’s REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulation. Disturbingly, proposed updates to REACH indicate that animal testing for chemicals is set to surge over the coming years. Rather than waiting for the EU courts to resolve this issue, citizens’ demands must be addressed to prevent further animal suffering.

In the EU and Norway, a shocking 7.9 million animals suffered in laboratories in 2020 – among them rabbits, mice, cats, and dogs. Substances are forcibly administered down their throats, and they are infected with debilitating diseases, genetically manipulated, given brain damage through surgery, exposed to severe pain, and used in breeding programs that perpetuate this cycle of suffering. Although the Commission is exploring actions to accelerate the development and use of non-animal methods, these do not constitute the root-and-branch reform demanded by EU citizens via the ECI.

The ECI was launched in August 2021 by animal protection groups Cruelty Free Europe, Eurogroup for Animals, the European Coalition to End Animal Experiments, Humane Society International/Europe, and People for the Ethical Treatment of Animals, with the backing of beauty brands The Body Shop and Dove. The ECI called for the strengthening and protection of the ban on animal testing for cosmetics, the transformation of chemicals regulations to bring an end to testing on animals, and a commitment to phasing out all testing on animals in Europe.

Positive commitments made by the Commission in response to the ECI include the following:

  • To develop a roadmap to end all mandated tests on animals for industrial chemicals, pesticides, biocides and human and veterinary medicines
  • To explore the creation of an expert scientific committee to provide advice on the development and uptake of non-animal approaches
  • To propose an action of the European Research Area to coordinate national policies to replace the use of animals in laboratories and speed up development and implementation of non-animal methods
  • To organise one or more workshops with experts to determine future priority areas of research to accelerate the transition to animal-free science.

Citizens will now expect that everyone involved works to ensure that the measures suggested by the EC have maximum and meaningful impact, and we will continue to advocate for more action where it is needed.

“The people of Europe have made it clear that experimentation on animals has no place in our modern society,” says Sabrina Engel, chair of the ECI organising committee. “While we welcome positive actions to replace the use of animals in experiments and chemicals tests, we wholly condemn the Commission for failing to end the suffering of thousands of animals used in cosmetics tests. The Commission must now propose meaningful changes to existing legislation and policies to set member states, regulators, and assessment bodies on the path to phasing out all uses of animals in laboratories. Therefore, we are calling on all actors to pursue the goals of the ECI.”

Notes

  • Here is a briefing on the “Save Cruelty Free Cosmetics – Commit to a Europe without Animal Testing” ECI.
  • “Save Cruelty Free Cosmetics” is the second ECI on the issue that has surpassed 1 million signatures, after “Stop Vivisection” in 2015, and only the ninth ECI that has been successful out of more than 100 that have been submitted.
  • Across the EU, approximately 8 million animals are used in experiments or for the breeding and maintenance of genetically altered animals each year. A further 10 million animals languish in cages without being used in procedures or are used as part of the laboratory supply chain, either for breeding or so that their body parts may be used in experiments.

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Media contact: Cassie Bodin-Duval, international coordinator for media relations: cbodinduval@hsi.org ; +32 (0) 469 149 469

Humane Society International / South Korea

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SEOUL—Animal protection organization Humane Society International Korea (HSI/Korea) welcomes the Ministry of Food and Drug Safety’s announcement of a phaseout of the use of horseshoe crab blood for toxicity tests. Alternatives are available, and a synthetic recombinant Factor C (rFC) will be used instead of wild-caught horseshoe crab blood.

The horseshoe crab is a blue-blooded marine species, more ancient than dinosaurs. Now, its population having dwindled, it is endangered according to the International Union for Conservation of Nature. Capture and bleeding for pharmaceutical use has not helped, as an extract of horseshoe crab’s blood, Limulus amebocyte lysate (LAL) is used to test the toxicity of some biological products. To obtain that extract, horseshoe crabs have been the target of human catch for many years and the entire ecosystem associated with them has been put under severe stress.

Humane concerns about how horseshoe crabs are caught, transported and restrained to extract a significant amount of blood, a process which involves long periods out of the water, has helped drive the use of rFC as an alternative. Use of the alternative will alleviate the threats to the ecosystem of which horseshoe crabs are a part. More specifically, it will ensure that the flow of essential materials (reagents) for the testing of biopharmaceutical products will continue uninterrupted, independently of horseshoe crabs’ numbers, with a more sustainable, validated and consistent methodology. It will guarantee that drugs, biological products, including vaccines and medical equipment, will be available and released on time.

The Ministry of Food and Drug Safety’s announcement places South Korea on the same plane as other regions (Europe and North America) and countries (Japan, China) that recognize or provide guidance on the use of rFC.

HSI/Korea Director, Government Affairs Borami Seo said “We welcome the government’s decision to accept this horseshoe crab replacement method at a regulatory level. It is important to update regulatory guidelines with more scientific, non-animal replacement methods. However, its implementation also should be emphasized to ensure wide use of the new method. We urge the authority to provide support for industry to actively adopt the rFC method.”

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Media contact: Borami Seo, director of HSI/Korea; bseo@hsi.org

Humane Society International/Canada applauds the passage of historic measures in Bill S-5 to amend the Canadian Environmental Protection Act

Humane Society International / Canada

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OTTAWA—Humane Society International/Canada is celebrating the passage of amendments to the Canadian Environmental Protection Act, aimed at phasing out the use of animals for chemical toxicity testing in Canada. The measures were included in Bill S-5, to amend the Canadian Environmental Protection Act, which passed third and final reading in the Senate today and will now receive Royal Assent.

Shaarika Sarasija, senior strategist, research and regulatory science for HSI/Canada, stated: “We are happy to see the passage of Bill S-5 with provisions to phase out chemical testing using animals. A concerted move away from animal-based toxicity tests could spare tens of thousands of animals each year and advance public health and environmental protection with more advanced and relevant tests for the benefit of all Canadians.”

Conventional toxicity testing involves poisoning rats, mice, rabbits, fish, birds and other animals with chemicals via force-feeding, inhalation or skin absorption for days, months or even years without pain relief, to see the extent to which it disrupts normal bodily functions. According to the Canadian Council on Animal Care, half of the more than 150,000 animals used for regulatory testing in Canada in 2021 experienced anywhere from “moderate to severe distress” to “severe pain near, at or beyond the pain tolerance threshold.” Many of these tests were developed decades ago and represent outdated science that provides incomplete or inconclusive data at best, while inflicting needless animal suffering.

Today’s toolbox of non-animal methods includes an array of sophisticated molecular biology tests that are more time and cost efficient and human relevant. The amendments in Bill S-5 promote their use, paving the way to reducing and ultimately eliminating animal suffering in chemical toxicity testing through technological progress. The new measures include:

  • Requiring new approach testing methods that do not use animals where scientifically justified and “practicable.”
  • Encouraging the timely development and implementation of alternative methods to animal testing.
  • Requiring the government to publish a plan, within two years, detailing steps to achieve these goals.

HSI/Canada is committed to working alongside the Government of Canada and other stakeholders to ensure that all use of animals in toxicity testing—including for pesticides, food and other regulated products—is ultimately relegated to the history books. Furthermore, HSI/Canada will work with these stakeholders to ensure that faster, more effective and relevant new approach methods that do not involve animals are developed and implemented within the Liberal government’s stated timeline of ending all toxicity animal testing by 2035.

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Media contact: Michael Bernard, deputy director for HSI/Canada: 438-873-5769; mbernard@hsi.org

Save Cruelty-Free Cosmetics: Commit to a Europe without Animal Testing ECI moves forward with a hearing at the European Parliament.

Humane Society International / Europe

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BRUSSELS—In an unprecedented milestone, the European Citizens Initiative  “‘Save Cruelty-Free Cosmetics —Commit to a Europe without animal testing” reached more than 1.2 million validated signatures in January. This is the second ECI on this issue that has surpassed the one million signature mark.

Continuing on its formal journey, after an initial meeting between the ECI organisers and the European Commission, the next step was the parliamentary hearing, held by the Committees of the European Parliament. The hearing was divided into three parts, corresponding with the ECI’s three objectives:

  • Protect and strengthen the cosmetics animal testing ban: initiate legislative change to achieve consumer, worker and environmental protection for all cosmetics ingredients without testing on animals for any purpose at any time.
  • Transform EU chemicals regulation: ensure human health and the environment are protected by managing chemicals without the addition of new animal testing requirements.
  • Modernise science in the EU: commit to a legislative proposal, plotting a roadmap to phase-out all animal testing in the EU, before the end of the current legislative term.

The ECI organisers: Cruelty Free Europe, Eurogroup for Animals, the European Coalition to End Animal Experiments, Humane Society International/Europe, and People for the Ethical Treatment of Animals proposed actions for a win-win-win scenario for science, society and animals by supporting once again a plan to transition to non-animal science.

During the hearing, the Directorate General for Internal Market, Industry, Entrepreneurship and SMEs—the Commission’s department for growth—committed to “try to be as ambitious as we can possibly be” in reaching their “ultimate goal of phasing out animal testing in the long-term”. This was reiterated by Ms Carmen Laplaza Santos, of the EC’s Health Innovations & Ecosystems unit, who promised the Commission’s final and detailed response to the Initiative by the end of July.

Over ten million animals—cats, dogs, rabbits, mice and others—are harmed every year in research and testing in laboratories around Europe. European citizens are demanding an end to the use of animals in cosmetics and other chemical tests, as well as an achievable plan to transition to a science without the use of animals.

Troy Seidle, Humane Society International vice president of research and toxicology, said:

“Reforms to the EU’s chemicals law are urgently needed to close loopholes that have allowed authorities to demand new animal tests for cosmetic ingredients, and reposition animal-free approaches as the gold standard for modern safety assessment. The much anticipated REACH reform process is a once-in-a-generation opportunity for EU institutions to honour the will of citizens who supported this ECI by standing firm against the introduction of new or expanded animal test requirements. Going forward, citizens expect that every legal reform process will tangibly reduce the testing burden on animals—not make it worse—until the EU’s stated goal of full replacement is achieved.”

This overwhelming public support echoes the position taken in 2021 by the European Parliament, which led to a resolution calling on the European Commission to coordinate, together with Member States, a concrete plan to accelerate the transition to non-animal testing.

The EP hearing was also the occasion to launch the Save Cruelty Free Cosmetics – Commit to a Europe without Animal Testing briefing prepared by the ECI organisers.

“Citizens are calling on the EC to take a leadership role in the transition to non-animal science and drive a new way of thinking without animal experiments. We would like to thank the citizens, the NGOs, the researchers, the industry, the governments and the members of parliament that already support these goals. This ECI shows that EU citizens share many of this Parliament’s positions as laid out in the EP Resolution. We are confident that the EP will help to break the cycle of harms that come with animal experimentation, by supporting once again the end of all animal testing for cosmetics, no additional animal tests for safety assessments, and a roadmap to accelerate the transition to non-animal research, regulatory testing, and education,” commented Sabrina Engel, chair of the organising committee for the ECI.

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Notes

Media contact: Cassie Bodin-Duval, International Coordinator, Media Relations, Humane Society International/Europe: cbodinduval@hsi.org ; +32 (0) 469 149 469

#BeCrueltyFree campaign applauds largest beauty market in South America for restricting cosmetics animal testing

Humane Society International / Global

sirius_r/iStockphoto

Brasilia, BRAZIL—A partial ban on animal testing for cosmetics in Brazil was introduced by the National Council for the Control of Animal Experimentation via regulatory restriction No. 58, of Feb. 24, 2023, published today in the Union Official Journal. The restriction prohibits animal testing for cosmetic ingredients with “known effects” and obligates the use of alternative methods for “unknown ingredients.”

Humane Society International government affairs specialist in Brazil, Antoniana Ottoni, said: “We are thrilled to see our efforts come to fruition after a decade of campaigning resulting in state bans and federal progress. This new Brazilian norm is a welcome next step in the right direction and something for which we have long advocated. However, a domestic testing ban on its own will not prevent the import and sale of newly animal-tested cosmetics from other countries. This will put our personal care industry at a competitive disadvantage, and fall short of the cruelty-free beauty sector that Brazilian consumers have made clear that they want. For this reason, our work to secure a federal law must continue, and we look forward to working with the Chamber of Deputies to build on this positive momentum to see a federal law in place this year.”

As an extension of the Ministry of Science and Technology, CONCEA does not have the legal jurisdiction to include certain important issues in its resolutions, including a restriction on marketing cosmetics that rely on new animal data. As such, the new CONCEA normative should be seen as a partial solution only, and one that requires the support of lawmakers to augment.

At the end of last year, language for a federal bill was agreed to by Humane Society International and The Brazilian Association of Personal Hygiene, Perfumery and Cosmetics Industry, and through a cooperative effort, it cleared the Federal Senate. Today, PL 3062/2022 is in urgent status and stands ready for approval by the Chamber of Deputies, and contains all the essential provisions to complement the CONCEA normative and guarantee an end to cosmetic animal testing in Brazil.

Humane Society International has led a decade-long global effort to outlaw animal testing for cosmetics and has played a pivotal role in securing national bans in India, Norway, Switzerland, South Korea, Australia and Mexico. #BeCrueltyFree Brazil, led by Humane Society International and Te Protejo, was instrumental in attaining state-level bans in São Paulo, Rio de Janeiro, Mato Grosso do Sul, Minas Gerais, Amazonas, Pará, Santa Catarina, Paraná, Pernambuco, Espírito Santo, Acre, Paraíba and the Federal Distict.

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Media Contact: Antoniana Ottoni: aottoni@hsi.org; +5561981403636

Humane Society International

HSI

KOREA—A joint public-private discussion forum will take place on Feb. 8 at the National Assembly to request the swift enactment of a bill proposed to advance animal-free approaches in science.

The forum discussion entitled “An era that runs tests with novel technologies instead of animals” is hosted by the National Assembly Animal Welfare Forum and organized by Humane Society International/Korea, and Reps. Nam In-soon and Lee Joo-hwan. It takes place at the National Office Members’ Office Building from 2-4:30 p.m. on Feb. 8.

A number of domestic and overseas experts will be joining the discussion to share the past cases of public-private collaborative efforts in working to replace animal testing. The forum will start with HSI/Korea’s director of government affairs Borami Seo providing an introduction on the status on the PAAM Act—the Act on the Promotion of Development, Dissemination and Use of Alternatives to Animal Testing Methods. This will be followed by a session led by Dr. Lorna Ewart, chief scientific officer of Boston-based life science company Emulate, who will share examples of public-private cooperation in developing organ-on-a-chip technologies. Jae-ho Oh, director of the Korean Center for the Validation of Alternative Methods, will then provide a presentation of related activities.

In the closing discussion session led by Ewha Womans University Pharmaceutical Sciences Prof. Kyung Min-Lim, a range of experts will share their thoughts and ideas on non-animal test methods. The experts include:

  • Nam-geun Song, head of the Animal Welfare and Environment Policy Bureau at the Ministry of Agriculture, Food and Rural Affairs.
  • Jung-kwan Seo, a director with the Risk Assessment Division at the National Institute of Environmental Research. Young-ji Kim, a director at the Division of Regenerative Medicine Policy’s Regenerative Medicine Innovation Task Force at the Ministry of Health and Welfare.
  • Young-jin Song, a director with the Bio-Convergence Industry Division at the Ministry of Trade, Industry and Energy.
  • Tae-ho Lee, deputy director of the Bioscience Technology Division at the Ministry of Science and ICT.
  • Young-jin Ahn, director of the Clinical Trials Division at the Ministry of Food and Drug Safety.
  • Young-jae Cho, a professor at Seoul National University Bundang Hospital.
  • Bae-hwan Kim, chairman of the Korea Society for Alternatives to Animal Experiments.

HSI/Korea’s Borami Seo said: “As cases of public-private cooperation have proven critical in the process of developing many innovative technologies in the past, technological development through such cooperation is crucial in the case of animal-free testing. Korea recognizes the importance of animal-free testing and has actively conducted technology research efforts in this area. However, the lack of cooperative working structures among ministries and the absence of a legal basis have prevented public-private cooperative efforts from taking place, which has caused difficulties in nurturing the industry. By co-organizing this event, HSI/Korea is excited to provide an opportunity for related ministries to share their ideas and emphasize the importance of public-private cooperation, by opening a channel for communication towards the enactment of the PAAM Act.”

Dr. Lorna Ewart said: “With the advancement of human relevant technologies that are more predictive than two dimensional cell culture or animal testing, companies must be willing to invest in research and development, as well as commercialization efforts, while working hand-in-hand with regulatory agencies. To bring efficient, accurate and safe preclinical testing models to the world market, Korea must initiate and integrate these actions.”

Research and development efforts for creating and commercializing human analog models, organ-on-a-chip, organoid, 3D-printing-used tissue reconstruction, computer modeling and big data analysis have gained speed worldwide. Both the public and private sectors are encouraged to make investments to make technological development more effective and efficient.

Korea has also been working to support infrastructural expansion of animal-free testing methods by joining forces with centers for the validation of alternative methods in the United States, Japan, Canada and Europe. Yet despite this effort, problems of duplicating R&D budgets, difficulties of commercializing new technologies and the absence of a validation system due to the lack of cooperative working structures persist in Korea. The situation has drawn the National Assembly Budget Office and many experts to request more efficient R&D cycle management and administrative innovation.

Since consensus was reached on the need to advance a bill on promoting the development, dissemination and use of animal-free testing methods, a cross-ministerial discussion forum was held on the topic at the National Assembly in 2019, followed by the Korea Legislative Research Institute’s research study on the need for the bill the same year.

After expert opinions were gathered for such a bill to be drafted in 2020, two bills on promoting animal-free testing methods were proposed and are awaiting review at the National Assembly. The first was proposed by Rep. In-soon Nam in December 2020, and the second was proposed by Rep. Jeoung-ae Han two years later in December 2022.

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Media contact: Borami Seo, bseo@hsi.org

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