“the animal testing ban – what is next?” - conusbato cruelty free international (claims to be...

31 EURO COSMETICS6-2014

REGULATION & LEGISLATION

“The Animal Testing Ban – What is next?” A Retrospective look at the full day In-Cosmetics Hamburg 1. April 2014 Workshop

Steven L. Hanft, M.A., President, CONUSBAT & co-organizer of this workshop, et al.

On April 1st, in the Chicago room at Hamburg’s Exhibition Center,

the workshop „The Animal Testing Ban – What is next?” occurred.

CONUSBAT once again had been asked to organize the full-day

(2-sessions) regulatory event for Reed Exhibition, which it had gladly

accepted.

The In-Cosmetics Animal Testing Ban’s list

of esteemed speakers and panelists

with their topics were:

Workshop, part 1, morning session

Dr. Annelie Struessmann, Technical Director, CONUSBAT,

Aachen, Germany and co-organizer of this workshop Animal

Animal Testing for Cosmetics in a World-wide Perspective

Dr. Patric Amcoff, Interim Director Science & Research,

Cosmetics Europe, Brussels, Belgium

The EU’s Animal Testing Ban

Dr. Joop de Knecht, Environment Directorate, OECD, Paris,

France

Implementing Altenatives to Animal Testing

Dr. Christian Pellevoisin, Scientifi c Coordinator, SkinEthic

Academy (L’Oreal), Lyon, France

Existing Alternative for Skin Irritation / Corrosion

Mr. Des Caves, Toxicologist & Account Manager Early Develop-

ment Services, Bioreliance, UK

3D Tissue for Genotoxicity – A Validation Scenario

Workshop, part 2, afternoon session

Dr. Nava Dayan, Nava Dayan LLC, Fairlawn, NJ, USA

Skin Toxicology: Biochemical Mechanisms and their Refl ection

in Toxicological Testing

Dr. Reinhard Kreiling, Clariant, Sulzbach, Germany

Skin Sensitization as Example of a Comprehensive Testing

Strategy

Ms. Ellen Pfrommer, BASF, Ludwigshafen, Germany

Animal Testing Ban / Marketing Ban – Consequences for

Cosmetic Ingredients

Dr. Theresa Callaghan, CCI (claims expertise), Hamburg,

Germany

The 2 sessions addressed the following issues:

Part 1 Session: Why should the Animal Testing Ban be the end of

innovation in cosmetics? Learning about new in-vitro, in-silico and

in-chemico methods that form the elements of the new toolbox for

assessing ingredient safety.

Part 2 Session: Gaining insight about multi-tier alternative strate-

gies for the example of skin sensitization. Explore the biochemical

mechanisms behind the effect, how these are addressed by alterna-

tive methods and see the way information is put together like mosaic

pieces for sensitization assessment. What are the consequences for

the industry in supporting existing and new ingredients within the

European regulatory processes?

Historical Background for Animal Protection

In order to know where we are headed with the ban on animal

testing for cosmetics and cosmetic ingredients in the EU, it is impor-

tant to know from where the ban gained its origins. Stemming its

roots in the Animal Rights Movement, no one can give an exact date

as to when this movement was founded.

However, it could be argued that the initial link for the Animal

Rights Movement was the link to religion and more specifi cally to

the Hindu religion. After all, the earliest Hindu Veda (meaning

‘knowledge’) scriptural texts show that vegetarianism has always

been a mainstream thought. In the Mahabharata, the great warrior

Bhishma explains to Yudhisthira, eldest of the Pandava princes,

“that the meat of animals is like the fl esh of one's own son, and that

the foolish person who eats meat must be considered the vilest of

human beings.” The Atharva Veda proclaims, ”Those noble souls

who practice meditation and other yogic ways, which are ever

careful about all beings, who protect all animals, are committed to

spiritual practices.“

As for Western thought, in 1875, Ms. Frances P. Cobbe (born in

Dublin, Ireland, and a leading woman’s suffragist) founded the UK-

based National Anti-Vivisection Society (NAVS), which was the

world’s fi rst NGO opposing experiments on animals. The NAVS

gathered many notable people of the day to support its cause, one

was Queen Victoria. Many of the social reformers of the day, working

for children's rights and women's rights, supported the aims of the

NAVS.


By 1876, the British Parliament passed the fi rst anti-vivisection

law, the ‘Cruelty to Animals Act’. In 1883, the readers of ‘Science’,

the organ of the American Association for the Advancement of

Science (AAAS), were warned that American scientists in the US

faced a similar legislation and thus issues of using animals for testing.

In view of this threat, the author advised the medical profession to

“inform the laity” how and why animal experimentation was used in

scientifi c research. Inspired by Ms. Cobbe, the American Anti-Vivi-

section Society (AAVS; Philadelphia, Pennsylvania, USA) was

founded in 1883 with the goal of regulating the use of animals in

science and society.

The ideology continuously evolved over millennia, but many

animal activists point to the publication of “Animal Liberation” by

Professor Peter Singer in 1975 as the catalyst for the modern Ameri-

can animal rights movement. Singer, whose family hails from Vienna

(due to Nazi persecution, the family left Austria in 1938 to Australia)

now heads up a bioethics chair at Princeton University, Princeton,

NJ, USA.

NGOs as drivers of the Animal Test Ban

Many animal rights protection agencies/organizations espouse a

number of approaches, and are bitterly divided on the issue of direct

action and violence, with very few activists or writers publicly advo-

cating the latter tactic as a justifi ed method to use. It should be also

noted, that the animal rights movement has other cause célèbre,

which included stopping the sale of animal furs (seals, mink, etc.) or

to end humans waging bets in cock (roosters) or dog fi ghting. Each

NGO has n organization structure, staff and its own campaign to

support; thus, monetary donations are their key source to achieving

their goals.

Whether liked or disliked, the NGOs and their members are the

main drivers for the Animal Test Ban, some of whom hail from rock

star status (i.e., Paul McCartney) to VIP’s from the entertainment

world (TV, fi lm, etc.). The following Animal Right’s NGOs are con-

sidered as the being mostly in the main stream:

NAVS - National Anti-Vivisection Society; founded in 1875, London,

UK

AAVS - American Anti-Vivisection Society; founded in 1883, Jen-

kintown, Pennsylvania, USA

The Humane Society, also sometimes referred to as the Society for

the Prevention of Cruelty to Animals (SPCA); founded in 1954,

Washington, DC, USA (European offi ce: London, UK)

WWF - World Wildlife Fund (directed more towards protecting

endangered species and concern towards pollution, climate

change); found in 1961, Gland (near Geneva), Switzerland

PETA - People for the Ethical Treatment of Animals; founded in

1980, Norfolk, Virginia, USA

Cruelty Free International (claims to be ‘the only global organiza-

tion working solely to end animal testing for cosmetics and con-

sumer products’); offi ces in London/UK, Boston, Massachusetts/

USA & Singapore

Background to the Animal Test Ban

in Europe for Cosmetics

The 11. March 2013 deadline ‘came and went’ for the fi nal imple-

mentation of the animal testing ban for cosmetics products in the

EU. The last step for the ban applied towards marketing of cosmetic

products and their ingredients when tested on animals for the most

complex human health effects: skin sensitization, carcinogenicity,

repeated-dose systemic toxicity, reproductive toxicity and toxicoki-

netics. At the time of fi nal implementation, the EU Commissions

stated, ‘The testing and marketing bans in the Cosmetics Regulation

apply even in case alternative methods to animal testing are not yet

available’.

On that day, the animal test ban news even made into the New

York Times, which is considered America’s most widely read news-

paper. Considering that Europe (incl. Switzerland and Norway) pos-

sesses the world’s largest share of the cosmetic sector at € 72billion

(US$ 91billion), the newspaper was citing global cosmetics manufac-

turers, stating, that increasing efforts exist in the companies seeking

global acceptance for products with proof of safety not relying on

animal tests. However, the NY Times also cited representatives of

the European cosmetics industry, who were criticizing the EU Com-

mission for putting a ban into effect before alternatives existed for

some of the most complex tests.

As such, these representatives were contributing to an already

‘hot topic’, as in their view, the ban would mean jeopardizing the

cosmetic industry’s ability towards innovation. Accordingly, con-

sumers in Europe would not have access to new products because

the industry cannot assure the safety for some of the ingredients

without having access to suitable and adequate testing.

While the discussions are often emotional or narrowed in their

objectivity, certainly hurdles do exist. However, it is often over-

looked how many impressive alternative approaches to proving the

safety of ingredients and products exist already. Based on extensive

efforts and money being put into the research of alternatives for this

nascent science area of human toxicology, an array of new in-silico,

in-chemico and in-vitro methods has evolved. Also, tools for new

multi-tiered testing strategies were designed, which are based on the

awareness that one alternative test cannot cover the complexity of

human biochemical mechanisms. Presenting key results obtained

from past year’s research and depicting strategies for assessing cos-

metics by alternative approaches was the goal of the regulatory

workshop in Hamburg.



Key Results from the Workshop in Hamburg -Contents and Quotations from the Esteemed Speakers

Dr. Annelie Struessmann opened the day by looking into the status

worldwide on existence of animal testing bans for consumer product

areas. She concluded that the EU took the lead and banning of animal

testing for cosmetics is under review worldwide. During the past

years, major moves happened in various countries, including, the

implementation of animal testing bans and the introduction of pro-

grams for research of test alternatives. Dr. Struessmann predicted

that with alternatives becoming completely available animal testing

on cosmetics will be phased out on a worldwide scale. A main hin-

drance at this time are outstanding replacement methods for

complex toxicological endpoints, the REACH testing requirements

and the European Chemicals Agency’s (ECHA) role in interpretation

of the compliance criteria towards these, as well as, still existing

different views in some major markets on the needs for testing of

cosmetics.

The second speaker was Dr. Patric Amcoff from the industry asso-

ciation Cosmetics Europe (Brussels, Belgium), formerly known as

Colipa. He provided an overview of the EU Commission’s and the

cosmetic industry’s goals and programs on research for testing

alternatives. The joint program under the Steering Committee on

Animal Test Ban – Implementation Deadlines Date

Testing ban on fi nished cosmetic products 11. Sept. 2004

Testing ban on ingredients or combination of ingredients 11. March 2009

Marketing ban when tested for human health effects with the exception of the specifi c effects of repeated-dose toxicity, reproductive toxicity and toxicokinetics

11. March 2009

Marketing ban when tested on the specifi c effects 11. March 2013

The ban applies irrespectively on the availability of alternative non-animal tests

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Germany

Supercritical Extracts by

Experience the Essence of Nature


Alternatives to Animal Testing (AAT)’s for the time phase from 2008-

2016 will be followed up by a long range science strategy 2016-20 via

the European Partnership for Alternative Approaches to Animal

Testing (EPAA), the International Cooperation on Cosmetic Regula-

tion (ICCR), and other sector organisations. The new approach will

focus exclusively on test replacements, while before the 3R principal

of replacement, refi nement and reduction formed the base for

research. His conclusions were, that new internationally agreed

tools and testing approaches such as AOP (Adverse Outcome

Pathway), ITS (Integrated Testing Strategies), IATA (Integrated

Approaches to Testing and Assessment), etc., will form the basis for

reseach and a conceptual change in performing safety assessments

based on mechanistical understanding will be the consequence. An

issue in his view is the time required for validation of methods and

their regulatory acceptance, e.g. for the SCCS’ ingredient evaluation

process. This issue will considerably increase the total time period

until availability of the completed new toxicology toolbox.

Another part of Dr. Amcoff’s speech covered the EC’s Interpreta-

tion on use of animal testing data after the 2013 deadline. Accord-

ingly, tests performed after March 2013 on ingredients exclusively

used in cosmetics trigger the ban. Animal data generated for third

country cosmetics regulations cannot be used for EU safety assess-

ments; however, use of non-cosmetics data generated for EU- and

non-EU regulatory regimes is allowed with an interpretation from

the European Court of Justice still pending. No derogative scheme

exists for new cosmetics-unique ingredients, but current Member

State derogation schemes for existing ingredients remain valid.

Dr. Joop de Knecht introduced the OECD’s tools and programs in

the area of testing alternatives and started with available guidelines

for in-vitro tests, which include, but are not limited to skin corro-

sion, phototoxicity, skin absorption, eye corrosion, genotoxicity and

endocrine disruption. Further efforts address integrated approaches;

draft OECD guidance, which is in the reviewing phase, exists on

how to integrate all existing information on corrosion and irritation

potentials for fi nal decisions on classifi cation and labelling of chemi-

cals. Another alternative approach uses grouping of chemicals for

read-across, promoting use of data from analogue substances to fi ll

data gaps. Existing guidance has recently been augmented with

examples encountered in the OECD Cooperative Chemicals Assess-

ment Program; publication of the update is anticipated for 2014. The

eChemPortal is a global portal with information on chemical sub-

stances and provides direct links to information from a large number

of data sources. Another alternative OECD approach is the (Q)SAR

project and toolbox, which is attempting to identify similarities in

structural characteristics and mechanisms for chemicals and subse-

quent use of existing experimental data in read-across approaches.

Finally, Joop de Knecht reported on the OECD’s activities in the area

of Adverse Outcome Pathways (AOPs) with a current work plan of

about twenty AOP projects for the different assays, endpoints or

databases, including the implementation of AOPs into the (Q)SAR

Toolbox.

Dr. Christian Pellevoisin introduced two existing alternative and

fully validated methods, OECD TG 431 is an in vitro method for skin

corrosion and OECD TG 439 is an in vitro method for skin irritation.

Using reconstructed human epidermis (RhE) as a biological model,

both tests are accepted as full replacement methods. Predictive

methods have been developed for effi cacy and toxicity testing of

ingredients and validation was achieved for safety testing. RhE pre-

dictivity methods with can also be used for determining the skin

irritation potential of fi nished cosmetic products.

The last speaker for the morning session was Des Cave, who

depicted the validation scenario in progress for the 3D skin micronu-

cleus assay, a promising and relevant new non-animal approach for

genotoxicity evaluation of cosmetics. In the three-step validation

process, the method showed usefulness for following up chemicals

which are positive in the standard in-vitro genotoxicity assays.

Results from the validation steps showed that the test can be readily

transferred to new laboratories, it is robust enough for standard GLP

testing, and it allows establishing inter and intra-laboratory repro-

ducibility. At this point global validation of the method appears as

being very promising.

Dr. Nava Dayan opened up the afternoon session by exposing the

complexity of the human body’s largest immune response organ, the

skin, and the diffi culty of addressing the toxicological responses in

testing procedures. She evaluated the biochemical mechanisms

leading to the induction of skin sensitization reactions and the

various types of hypersensitization and their attributes. While

looking into the functionality of cosmetic ingredients in inducing

sensitization reactions it was reminded that the risks determined do

not consider the fi nal cosmetic formulations. Gaps for risk assess-

ment result also from current skin sensitization testing approaches

which do not address all different biochemical responses suffi ciently

and also, most often, do not consider accumulation for chemical

exposure. Animal testing is limited due to the differences between

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animal and human skin which is easily expressed by the difference

in number of follicles. Finally, in addressing replacement for animal

test she emphasized to further investigate the use of gene expression

and proteomics, methods frequently used in pharmaceutical testing.

As an example of a comprehensive testing strategy, Dr. Reinhard

Kreiling addressed AOPs for skin sensitization. Traditionally, quanti-

tative potency estimates for contact dermatitis were based on the

in-vivo Local Lymph Node Assay (LLNA). Current integrated evalua-

tion methods use a stepwise process integrating all relevant informa-

tion and approaches on a case-by-case basis to reach science-based

decisions in a weight-of-evidence (WoE) assessment. Adverse

outcome pathways (AOPs) refl ect the shift towards knowledge-

driven approaches to toxicological hazard & risk assessment. Impor-

tant for establishing AOPs are the identifi cation of key targets and

events for a given endpoint, the development of assessment tools

(alternative assays) and the development of extrapolation tools to

translate mechanistic data into reliable predictions of in vivo out-

comes. According to Dr. Kreiling, skin sensitization strategies need

to address both, the potential and the potency for a skin sensitizer.

Integrated Testing Strategies (ITS) in form of combination(s) of (test)

methods may allow the identifi cation and classifi cation of skin sensi-

tization hazard but lack to date the information on potency. Includ-

ing addressing this gap in an IATA, he generally sees the need for an

OECD wide agreed guidance on the signifi cance and application of

IATA (Integrated Approaches to Testing and Assessment) for all rel-

evant regulatory objectives.

Ellen Pfrommer spoke from the ingredient supplier’s perspective

about consequences from the animal testing ban / marketing ban.

For Europe, ingredient suppliers need to address two key regulatory

areas, one is chemicals’ legislation and consequently compliance

with REACH. At the same time, support for cosmetic product manu-

facturers in their compliance with the Cosmetic Product Regulation

is requested. Therefore, two different sets of testing requirements

exist, with REACH requiring defi ned testing standards. Issues arising

from this situation include the status on availability of alternative

test methods, as such the questions if tests are accepted under

REACH. Also critical is in case of animal tests performed, how to

document in the PIF that they were generated for non-cosmetic

purposes, etc. Ms. Pfrommer concluded, that for break-through

innovations animal testing so far is not avoidable and serious risks

exist for ingredient manufacturers in developing long-term R&D

strategies for these. Therefore, her statement and general conclusion

was: ‘avoiding animal tests is key; however, no general rule exists

and strategies need to be developed in case-by-case decision’.

The workshop concluded with a panel discussion interacting with

a highly energetic audience. The outlook for the industry included

that the Animal Testing Ban will not vanish. The presence depicts an

interim phase where extensive input into research on still missing

alternatives is made. The future will provide alternative approaches

for all toxicological endpoints – new tools and testing approaches

will lead to a conceptual change in performing safety assessments.

While amazing progress for test alternatives has been made, and

further results are in the pipeline, existing key issues remain, as

such:

a lack of methods for complex toxicological endpoints

long time frames for validation processes

reluctant approach towards alternative data by authorities

extensive requirements on professionals while gaining

experience with the complex new methods.

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