n tests sur animaux horreur , mensonge = "aucune' cruauté!

Positions:


The Commission and industry said in a joint statement that "the adoption of this ambitious action programme clearly shows our commitment to pool resources and to work together to drive research forward in this crucial area. The refinement, reduction and replacement of animal testing is the goal of all members of the partnership, and we hope that the publication of this programme will encourage others to work with us."
Animal rights groups have welcomed the plan, but think that faster action is needed to end animal suffering.

Développements récents et prochaines étapes:

• Reports on the implementation of the activities of the action programme will be presented in an EPAA conference on 18 December 2006.
  

Liens

[url=]Documents officiels de l'UE[/url]

• European Partnership on Alternative Approaches to Animal Testing (EPAA): Action Programme (21 June 2006)
  
• European Partnership on Alternative Approaches to Animal Testing (EPAA) press release: New action programme to accelerate research into alternative approaches to animal testing (21 June 2006)
  
• Commission: European Partnership on Alternative Approaches to Animal Testing (EPAA)
  
• Commission press release: Reducing animal testing: Industry commits to action programme, Commission tables guidelines for labelling cosmetics as “not tested on animals” (21 June 2006) [FR] [DE]
  
• Commission: Commission Recommendation Establishing guidelines on the use of claims referring to the absence of tests on animals pursuant to Council Directive 76/768/EEC (7 June 2006) [FR] [DE]
  
• Commission: Cosmetics [FR] [DE]
  
• Eurobarometer: Attitudes of consumers towards the welfare of farmed animals (June 2005)
  

[url=]Fédérations[/url]

• The European Cosmetic Toiletry and Perfumery Association (COLIPA)
  
• European Federation on Pharmaceutical Industries and Associations (EFPIA)
  
• European Association for Bio-Industries (EuropaBio)
  
• International Federation for Animal Health Europe (IFAH Europe)
  
• European Chemical Industry Council (CEFIC)
  
• European Crop Protection Association (ECPA)
  
• International Association for Soaps, Detergents and Maintenance Product Industry in Europe (AISE)
  

[url=]ONG[/url]

• Eurogroup for animal welfare
  

[url=]Articles de Presse[/url]

• International Herald Tribune: EU in pact to limit use of animals in product testing
  

EUROPEAN PARTNERSHIP FOR
ALTERNATIVE APPROACHES TO
ANIMAL TESTING

Welcome to the EPAA’s online information library. Here you will find regular updates about the progress of our work programme aimed at refining, reducing and replacing the use of animals in safety assessment tests. You will also find details of meetings and events, further information about our aims and objectives, and details of how to contact us.

Nobody likes animal testing. Many millions of euros have been invested in research to find alternative ways to assess safety, and this research has massively reduced the number of animal tests that must be conducted by law. Despite this, in many cases we can only understand the safety risk to humans of medicines, consumer goods, chemicals or pesticides by testing on animals. Therefore, further, better co-ordinated research is needed if we are to continue refining, reducing and replacing animal use. Society demands this, and both the European Commission and European industry are committed to delivering it. For this reason the European Partnership on Alternative Approaches to Animal Testing was launched in November 2005 by the Vice President of the European Commission, Gunter Verheugen, and Commissioner Janez Potocnik.
The EPAA is an unprecedented collaboration between the European Commission services and major companies from seven industry sectors. The partners have committed to pooling knowledge, research and resources to accelerate the development, validation and acceptance of alternative approaches over an initial five-year period. An action programme to promote change has been agreed and progress against this will be published regularly on this website.
Our commitment is that we will increase and co-ordinate efforts to significantly accelerate the rate at which alternatives are agreed, validated and put into practice. Our goal is to ensure that every opportunity is taken to refine, reduce and replace the use of animals in safety assessment tests.
All those committed to the ‘3Rs Declaration’ agreed at the launch of the EPAA are warmly invited to join the Partnership.
Georgette Lalis, Director DG Enterprise (European Commission)
Charles Laroche, Vice President External Affairs, Unilever Europe, on behalf of the industry partners
Co-chairs, EPAA Steering Group

Reducing animal testing: Industry commits to action programme, Commission tables guidelines for labelling cosmetics as “not tested on animals”







Reference: IP/06/814 Date: 21/06/2006








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Reducing animal testing: Industry commits to action programme, Commission tables guidelines for labelling cosmetics as “not tested on animals”


The fight against animal testing gets more concrete. Initiated by the European Commission, the new “European Partnership on Alternative Approaches to Animal Testing” published today an action programme. It follows the so-called “3 Rs” concept, aimed at refining, reducing and replacing animal use to meet regulatory safety requirements. The partnership on alternative approaches to animal testing between the Commission, industry associations[1] and major companies[2] in the area of chemicals, pharmaceuticals, biotechnology, crop protection and cosmetics was initiated a year ago. In addition, the Commission has published guidelines for labelling cosmetic products[3] as “not tested on animals”. They will enable industry to indicate that no animal tests have been carried out by the manufacturer and his suppliers in relation to the product development. Common criteria are applied for the use of such claims, in particular to ensure that they do not mislead the consumer or lead to unfair competition. Moreover, industry that chose to have this labelling must be able to prove the reality of the absence of animal testing.
European Commission Vice President, Günter Verheugen, responsible for enterprise and industry policy, said: “The European Partnership is an important contribution to find alternatives to animal testing. We are now moving from words to deeds. I invite more companies to join our common efforts to reduce the number of animals used in safety testing in areas such as REACH and cosmetics.”
Commissioner for Science and Research, Janez Potočnik, added: "We know from public opinion surveys that animal rights are very close to the hearts of Europeans. Through research we can develop ways of offering consumers a greater choice of products that have not been tested on animals. We will continue to support research, development and evaluation of alternative testing methods through the European Research Framework Programme."
The action programme is the first outcome of the commitment to cooperate in fields such as research, validation of alternative test methods and sharing best practice. It includes a number of activities covering five key topics:

• Mapping of past and current 3R activities to better inform the planning and prioritisation of subsequent actions;
  
• Prioritisation, promotion and implementation of future research based on the application of the 3Rs;
  
• Identification, dissemination and implementation of best practice in the use of the 3Rs;
  
• Implementation of the 3Rs in regulation and decision making, and
  
• Validation and acceptance of alternative test methods based on the 3Rs.
  

Roughly 20 % of the tests carried out on animals in Europe can be considered as regulatory testing. They are performed due to high safety requirements in areas such as pharmaceuticals, chemicals, cosmetics, biotechnology as well as food and feed. The challenge is to develop alternative methods or strategies that provide for at least the same level of consumer safety as animal tests.
Background
The regulatory framework for safety requirements differs according to industrial sectors, due to the different uses of substances and products manufactured. According to European legislation, animal tests are in principle only to be performed as a last resort. Alternative methods to animal tests are to be applied as soon as they are available.
The promotion of alternative methods has become particular important, since European legislation was reinforced in 2003 by banning cosmetics and cosmetics ingredients tested on animals if validated alternatives were available. Even more, cosmetics will be banned as from 2009 if they are based on animal testing, even if non-animal tests are not available. For a few complex tests methods, this deadline will be 2013.
Similarly, the Proposal for Registration, Evaluation and Authorization of Chemicals (REACH) includes specific provisions aiming at promoting alternative approaches to reduce the number of animal tests as far as possible. Applying alternative approaches for getting hazard information, the needs for tests could dramatically be reduced resulting in significant savings in testing costs and use of animals. According to estimations of the Joint Research Centre of the European Commission, the animal and cost saving potential of intelligent testing strategies over a period of 11 years can be 1.3-1.9 million animals and € 800-1130 million[4].

Today, 23 alternative methods have been validated in Europe and about 30 others are under validation in the European Centre for Validation of Alternative Methods (ECVAM). The Action Programme will prioritise and facilitate the validation of alternative methods/strategies currently being developed by ECVAM.
Reports on the implementation of the activities of the Action Programme will be made available at the European Partnership Conference scheduled for 18 December 2006 in Brussels. The Action Programme will be reviewed on a regular basis, in particular in cooperation with a Mirror Group, made up of experts from various interest groups, including animal welfare.
Website Action programme
http://ec.europa.eu/enterprise/epaa/index_en.htm
Website link to guidelines ‘not tested on animals”
http://ec.europa.eu/enterprise/cosmetics/html/cosm_guidance_docs.htm


[1] European Chemical Industry Council (CEFIC),European Crop Protection Association (ECPA), European Bio-industry Association (EuropaBio), European Cosmetic Toiletry and Perfumery Association (COLIPA), International Association for Soaps, Detergents and Maintenance Product (A.I.S.E.), European Federation on Pharmaceutical Industries and Associations (EFPIA), International Federation for Animal Health Europe (IFAH)
[2] BASF, Bayer, Henkel, Johnson & Johnson, L’Oréal, Pfizer, Procter & Gamble, Unilever
[3] Commission recommendation establishing guidelines on the use of claims referring to the absence of tests on animals pursuant to Council Directive 76/768/EEC (OJ L 158 of 7.6.2006 p 18)
[4] According to the “Fourth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union (2002)” the total number of animals used in the EU Member States in 2002 was 10.7 Million (COM (2005) 7 of 20.01.2005

Cosmetics - Introduction








The European cosmetics industry is






-
a world leader, with a value of output of more than 35 billion €.

-
highly innovative: on average, major cosmetic companies replace or reformulate around 25% of their products every year.

-
a significant employer: over 150.000 Europeans are employed directly; a further 350.000 jobs are created indirectly in retail, distribution and transport.


Cosmetic products are also important consumer products: apart from "traditional" cosmetic products, such as make-up and perfumes, it also includes products for personal hygiene, for example tooth-care products, shampoos and soaps.

The main regulatory framework which aims at ensuring the free circulation of cosmetic products in the internal market and safeguarding the safety of cosmetic products placed on the EU-market is the Council Directive 76/768 of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products ("Cosmetics Directive").

The unit Cosmetics and Medical Devices, at the European Commission/ Directorate General Enterprise and Industry is in charge not only of competitiveness issues of the European industry but also of administering the Cosmetics Directive and supervising its correct implementation.










European Commission - Enterprise and Industry Directorate General - Consumer goods - Cosmetics - Last update : 23/01/06

Cosmetiques - Introduction








L'industrie cosmétique européenne est :






-
un leader mondial : avec une production représentant plus de 35milliards d’euros.


-
hautement innovatrice : les principales entreprises cosmétiques remplacent ou reformulent, en moyenne, 25% de leurs produits chaque année.


-
un employeur significatif : plus de 150.000 européens sont employés directement ; de plus 350.000 emplois sont créés indirectement dans la vente, la distribution et le transport.



Les produits cosmétiques sont également des produits de consommation importants : outre les produits cosmétiques ‘traditionnels’ comme le maquillage et les parfums, il y a également des produits pour l'hygiène personnelle, par exemple des produits de soins dentaires, des shampooings et des savons.

Le principal cadre réglementaire qui vise à assurer la libre circulation des produits cosmétiques sur le marché intérieur et à sauvegarder la sécurité de ces produits est la directive du Conseil 76/768 du 27 juillet 1976 concernant le rapprochement des législations des États membres relatives aux produits cosmétiques (la directive « Cosmétique »).

L’unité « Cosmétiques et dispositifs médicaux » à la Commission européenne/Direction générale Entreprise et Industrie est responsable non seulement des questions de compétitivité de l'industrie européenne mais également de l’administration de la directive « cosmétique » et de la supervision de sa correcte mise en oeuvre.

Plan du site





Commission Européenne - Direction Générale Entreprises et Industrie - Biens de consommation - Cosmetiques - Dernière mise à jour : 24/01/06

• Phototoxicity: Toxicity that occurs when a substance is exposed to ultraviolet (UV) light.
  
• Skin corrosion: Irreversible destruction of tissue by a chemical.
  
• Percutaneous absorption: Absorption of a substance through the skin.
  
• Skin sensitisation: Allergic sensitivity of the skin to a chemical's effect following repeated exposure.
  

• Systemic effects: Effects in all body systems and organs rather than being localised in one area or organ.
  

Overview
EU Cosmetics Directive



Overview



The main objective of the European Cosmetics Directive, adopted in 1976, is to safeguard public health. The Directive primarily attributes this responsibility to the cosmetic manufacturer. The Directive represents the European cosmetic regulatory "bible", and literally serves as a model for global harmonisation.
In 1991, the Sixth Amendment to the Cosmetics Directive was put forward. The European Parliament of that time proposed the introduction of a clause prohibiting the marketing of cosmetic products containing ingredients or combinations of ingredients tested on animals, as of 1998.
This clause was adopted with the proviso that the date of implementation would be postponed in the absence of sufficient alternative testing methods to guarantee the consumer an equivalent level of protection. This date has had to be postponed twice for safety reasons, and also to avoid a conflict with our international trading partners.
In the meantime, under Colipa's leadership, industry has invested more than €500 million in the development, promotion and use of alternative testing methods.
Significant progress has been made: animal testing on finished products has come to an end and three validated alternative methods, namely in the areas of photo toxicity, skin corrosion and percutaneous absorption, are available for use across the EU chemicals industry. A fourth one, to test for skin sensitisation will be published shortly as an OECD guideline.
The development of alternative testing methods has proven to be a long and complex process in which industry is continuing its investment and ultimately research alternatives to assess the potential systemic effects on the human body of chemical ingredients used in cosmetics, then the EU must make an equally serious commitment in terms of time.
To avoid a further postponement of the 6th Amendment and to eliminate the risk of a global trade conflict, the European Commission proposed a 7th Amendment to the Cosmetics Directive in April 2000.
The Amendment replaces the inapplicable marketing ban with a more pragmatic testing ban.
Although industry continues to fully support the move to alternative methods, it has serious reservations regarding the proposed timing for the development and validation of all of the alternative methods needed to totally eliminate animal testing.
As a co-decision body in this process, in November 2001, the 15 Member States in Council adopted a common position supporting a ban on animal testing and on the marketing of cosmetic products whose ingredients have been tested on animals as soon as alternative test methods are found and validated at international level.
Meanwhile Directive 86/609 on Animal Experiments is reinforced to ensure that alternative methods are used when they exist.
The Council's Common Position achieves the best possible balance of interests between consumer protection, animal welfare and industry development.
It allows for the issue of animal testing to be dealt with through a comprehensive strategy including all stakeholders.
The European Parliament's Environment Committee is currently scrutinising the common position at the stage of the second reading.

Animal welfare

The pharmaceutical industry researches and develops new, safe and efficacious medicines for patients. The process that leads to the development of a new medicine is long and complex and involves a range of different research methods. The use of animals is an essential part of that process and provides vital safety information. Without animal research and testing, there would be no new medicines.

Animals hold the key to cures

• The biological similarity between humans and other animals means that most potential effects of a medicine can be predicted.
  
• Although there have been great advances in scientific knowledge and technology, the use of animals in research is essential for understanding the disease mechanisms and evaluating the safety and efficacy of potential medicines.
  
  Animal research is required and regulated by European law
  
• All aspects of animal testing are highly regulated and controlled in Europe.
  
• European and national pharmaceutical laws set specific regulatory obligations for safety, quality and efficacy that can currently only be fulfilled with the results of animal studies.
  
• Safety and regulatory requirements are continuously being reviewed, which has resulted in an increase in requirements.
  
• It is unethical and illegal to use a new substance in humans without ensuring maximal possible safety prior to studying a compound in humans.
  
• The role for animal studies prior to human exposure is explicit in the World Medical Associations Ethical Principals for Medical Research Involving Human Subjects (“Helsinki Declaration”).
  

Animal testing and animal welfare




Animals are used in the assessment of the safety of crop protection products, to both humans and the environment, as required by European law (Directive 91/414/EEC). Although computer studies and other alternative test methods have reduced the reliance on animal testing and the number of animals involved, computer simulations and test tube methods cannot replicate the complexity or reactions of a living creature.
Nevetheless, the crop protection industry is committed to the minimal and responsible use of animals, using alternative research and testing methods where possible. This is the essence of the “Three Rs” concept (“Refine, Reduce, Replace”). The research-based crop protection industry is committed to:

• using the minimum number of animals;
  
• using them appropriately and responsibly;
  

and using alternative research and testing methods whenever feasible.
The European Partnership for Alternative Approaches to Animal Testing (EPAA)
The EPAA is an unprecedented collaboration between the European Commission services and seven industry sectors including ECPA. The partners have committed to pooling knowledge, research and resources to accelerate the development, validation and acceptance of alternative approaches over an initial five-year period. An action programme has been agreed and specific areas assigned to six working groups:

1. Mapping of past and current 3R activities
   
2. Prioritisation, promotion and implementation of new research
   
3. Identification, dissemination and implementation of best practice
   
4. Implementation of the 3Rs in regulation and decision making
   
5. Validation and acceptance
   
6. Communications
   

The goal of the EPAA goal is to ensure that every opportunity is taken to refine, reduce and replace the use of animals in safety assessment tests.
ILSI-ACSA project
The crop protection industry has actively supported a project called Agricultural Chemical Safety Assessment (ACSA), which was initiated in 2000 under the auspices of the International Life Sciences Institute (ILSI). The goal of the project is to develop a consensus across sectors (government, academia, and industry) on a credible and viable testing approach for assessing safety of crop protection products. The project has developed an innovative, improved tiered testing scheme, which provides greater efficiency, uses fewer animals and provides improved data for the safety assessment.
Animal welfare legislation
Animal testing is thus tightly controlled within the EU. Commission Directive 86/609 regulates the protection of animals used for experimental and other scientific purposes, and this has been translated into national animal welfare legislation in the Member States. The crop protection industry operates to high ethical standards, and uses only appropriately licensed, reputable organisations to carry out safety assessment work.
For more information:
3 Rs Declaration
EPAA website
EPAA newsletter
Press release issued jointly by the signatories of the 3Rs declaration
Commission Directive 86/609
ILSI-ACSA website
Perspectives article – March 2007
Perspectives article – July 2006
Perspectives article – November 2005

EUROPEAN PARTNERSHIP FOR
ALTERNATIVE APPROACHES TO
ANIMAL TESTING

Welcome to the EPAA’s online information library. Here you will find regular updates about the progress of our work programme aimed at refining, reducing and replacing the use of animals in safety assessment tests. You will also find details of meetings and events, further information about our aims and objectives, and details of how to contact us.

Nobody likes animal testing. Many millions of euros have been invested in research to find alternative ways to assess safety, and this research has massively reduced the number of animal tests that must be conducted by law. Despite this, in many cases we can only understand the safety risk to humans of medicines, consumer goods, chemicals or pesticides by testing on animals. Therefore, further, better co-ordinated research is needed if we are to continue refining, reducing and replacing animal use. Society demands this, and both the European Commission and European industry are committed to delivering it. For this reason the European Partnership on Alternative Approaches to Animal Testing was launched in November 2005 by the Vice President of the European Commission, Gunter Verheugen, and Commissioner Janez Potocnik.
The EPAA is an unprecedented collaboration between the European Commission services and major companies from seven industry sectors. The partners have committed to pooling knowledge, research and resources to accelerate the development, validation and acceptance of alternative approaches over an initial five-year period. An action programme to promote change has been agreed and progress against this will be published regularly on this website.
Our commitment is that we will increase and co-ordinate efforts to significantly accelerate the rate at which alternatives are agreed, validated and put into practice. Our goal is to ensure that every opportunity is taken to refine, reduce and replace the use of animals in safety assessment tests.
All those committed to the ‘3Rs Declaration’ agreed at the launch of the EPAA are warmly invited to join the Partnership.
Georgette Lalis, Director DG Enterprise (European Commission)
Charles Laroche, Vice President External Affairs, Unilever Europe, on behalf of the industry partners
Co-chairs, EPAA Steering Group

News release








European crop protection industry unveils participation in multi-stakeholder project for innovative testing scheme to contribute to animal welfare
back to list




BRUSSELS, 14 November 2005 – The European crop protection industry has announced its participation in a multi-year project involving government, academia and industry representatives whose aim is to develop an innovative, improved testing scheme for the safety assessment of crop protection products. The ILSI-ACSA project has developed viable methods for assessing the safety of crop protection chemicals more efficiently with the reduction, refinement and, where possible, the replacement of animal testing.
This project was developed in part by experts from the European crop protection industry and was officially launched in 2004 at a conference of the Society of Toxicology. Rollout in Europe has just begun, and the project will be presented on 16 November at the 3-day conference on risk assessment methodologies hosted by the ILSI Health and Environmental Sciences Institute.
This announcement comes just days after ECPA officially signed up to the European Partnership to Promote Alternative Approaches on Animal Testing at a Commission-hosted conference in Brussels. This so-called 3 Rs Declaration was signed by the leaders of 7 industry associations who all outlined their commitment to work together and in partnership with the European Commission to identify new alternative approaches to animal testing and to collaborate with all those concerned with the validation of new tests in order to speed up their regulatory acceptance and implementation. This partnership will include the development of an Action Plan to implement practical aspects of the declaration.
With the testing requirements for the crop protection industry currently under review, ECPA is hoping that the recommendations of the ILSI-ACSA project will be considered, as they offer an excellent opportunity to implement the objectives of the 3 Rs Declaration.
ECPA’s Manager for Science and Technical Affairs, Peter Day, commented: “As an industry, we have regulatory and ethical responsibilities to produce products that are safe to human health and the environment – and we have a responsibility to ensure the protection of animal welfare. We are looking forward to working in partnership with the Commission and other stakeholders to explore opportunities to reduce, refine and replace the use of animals in safety assessments.”

### END ###
Notes to Editors:
1. For more information about the 16 November workshop on framework approaches to risk assessment, please visit: http://www.hesiglobal.org/Events/frameworkapproaches-part3.htm. The project will be presented at the session on Agricultural Chemical Safety Assessment.
2. For more information about ILSI-ACSA, please visit: http://www.hesiglobal.org/Committees/TechnicalCommittees/acsa/
3. For more information about the 7 November Commission-hosted conference on Alternative Approaches to Animal Testing, please visit: http://europa.eu.int/comm/enterprise/events/animal_tests/index_en.htm
4. To receive a copy of the 3 Rs Declaration, please contact Peter Day at ECPA. (peter.day@ecpa.be)
5. Organisations supporting the 3 Rs Declaration are:
- CEFIC (www.cefic.be)
- EFPIA (www.efpia.org)
- Colipa (www.colipa.com)
- EuropaBio (www.europabio.org)
- AISE (www.aise-net.org)
- ECPA (www.ecpa.be)
- IFAH-Europe (www.ifahsec.org)
For more information, please contact:
Peter Day, Science and Technical Affairs Manager
tel: +32 2 663 1601
peter.day@ecpa.be

ILSI Health and Environmental » Committees » Technical Committees » Agricultural Chemical Safety Assessment (ACSA)

Agricultural Chemical Safety Assessment (ACSA)



The mission of the HESI Agricultural Chemical Safety Assessment (ACSA) Technical Committee is to develop a consensus across sectors (government, academia, and industry) on a credible and viable testing approach for assessing the safety of crop protection chemicals. The approach will include scientifically appropriate studies that are necessary without being redundant, emphasize toxicological endpoints and exposure durations that are relevant for risk assessment, provide greater efficiency, use fewer animals, use resources more wisely, and generally include improved data for risk assessment purposes.

For more information on the ACSA Technical Committee’s membership and activities, click here.

ANNOUNCEMENT OF AVAILABILITY OF PROPOSED ACSA TIERED TESTING APPROACH

After six years of scientific discussion, data mining, case study development, and consensus-building, as well as countless meetings and conference calls, the ACSA Technical Committee announced its final version of an improved tiered testing scheme for assessing the safety of crop protection chemicals. The ACSA approach, which departs from the current standardized list of hazard studies used by many national authorities, includes scientifically appropriate studies, emphasizes toxicological endpoints and exposure durations that are relevant for risk assessment, provides greater efficiency, uses fewer animals, uses resources more wisely, and includes improved data for risk assessment purposes. The HESI effort has been hailed as the first comprehensive effort of its kind to scientifically re-design the testing framework for agricultural chemicals.

Four manuscripts which describe

Four manuscripts which describe the ACSA tiered testing proposal have been published as a “Special Issue” in the journal Critical Reviews in Toxicology, Volume 36, Issue 1 (January 2006):
<BLOCKQUOTE dir=ltr style="MARGIN-RIGHT: 0px">

Carmichael, NG, Barton, HA, Boobis, AR, Cooper, RL, Dellarco, VL, Doerrer, NG, Fenner-Crisp, PA, Doe, JE, Lamb, JC, and Pastoor, TP. 2006. Agricultural chemical safety assessment: a multi-sector approach to the modernization of human safety requirements. Crit Rev Toxicol. 36, 1-7. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16708692&query_hl=1&itool=pubmed_docsum

Barton, HA, Pastoor, TP, Baetcke, K, Chambers, JE, Diliberto, J, Doerrer, NG, Driver, JH, Hastings, CE, Iyengar, S, Krieger, R, Stahl, B, and Timchalk, C. 2006. The acquisition and application of absorption, distribution, metabolism, and excretion (ADME) data in agricultural chemical safety assessments. Crit Rev Toxicol. 36, 9-35. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16708693&query_hl=5&itool=pubmed_docsum

Doe, JE, Boobis, AR, Blacker, A, Dellarco, VL, Doerrer, NG, Franklin, C, Goodman, JI, Kronenberg, JM, Lewis, R, McConnell, EE, Mercier, T, Moretto, A, Nolan, C, Padilla, S, Phang, W, Solecki, R, Tilbury, L, van Ravenswaay, B, and Wolf, DC. 2006. A tiered approach to systemic toxicity testing for agricultural chemical safety assessment. Crit Rev Toxicol. 36, 37-68. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16708694&query_hl=7&itool=pubmed_docsum

Cooper, RL, Lamb, JC, Barlow, SM, Bentley, K, Brady, AM, Doerrer, NG, Eisenbrandt, DL, Fenner-Crisp, PA, Hines, RN, Irvine, LFH, Kimmel, CA, Koeter, H, Li, AA, Makris, SL, Sheets, L, Speijers, GJA, and Whitby, K. 2006. A tiered approach to life stages testing for agricultural chemical safety assessment. Crit Rev Toxicol. 36, 69-98. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16708695&query_hl=9&itool=pubmed_docsum</BLOCKQUOTE>

Proposed ACSA Tiered Testing Approach Featured at November 2005 HESI Workshop on Framework Approaches to Risk Assessment

More than 100 scientists from HESI member and non-member companies, academic institutions, and national and international government agencies participated in a “Frameworks” workshop organized and sponsored by HESI in Nice, France, on November 14-16, 2005. Three sessions focused on different project areas addressed by HESI activities, including: DNA Adducts in Risk Assessment, Rodent Liver Tumors as a Predictor of Human Cancer Risk, and the tiered-testing strategy for assessing the safety of crop protection chemicals developed by the HESI ACSA Technical Committee.

To view the speaker presentations on the proposed ACSA tiered testing approach for crop protection chemicals, click here.

Files



Download the English Agricultural Chemical Safety Assessment Technical Committee fact sheet here

Download the Japanese Agricultural Chemical Safety Assessment Technical Committee fact sheet here

Continuing the commitment to animal welfare


EU regulatory requirements designed to demonstrate safety of substances to humans require animal testing. The testing is highly regulated and controlled, but all parties involved would obviously like to avoid the use of animals wherever possible.




As reported in Perspectives in July last year, ECPA is a partner in the European Partnership for Alternative Approaches to Animal Testing (EPAA), together with the European Commission and six other trade associations (for more information, see http://ec.europa.eu/enterprise/epaa/index_en.htm). A number of individual companies are also partners, including ECPA members BASF, Bayer and Syngenta. Here we give an update on activities, and cover developments in two related areas: the revision of Directive 86/609 on the welfare of laboratory animals and the revision to the data requirements for approval of plant protection products under Directive 91/414.
EPAA update
Started in late 2005, the EPAA held its first annual conference on 18 December 2006, at the same time issuing its first report on progress. Attendees at the conference included representatives from industry, academia, animal welfare groups and European and national institutions.
At the launch, all partners committed themselves to the 3Rs principle: to work to replace, reduce or refine the use of animals in safety testing. Specific areas were then assigned to six working groups:
1. Mapping of past and current 3R activities
2. Prioritisation, promotion and implementation of new research
3. Identification, dissemination and implementation of best practice
4. Implementation of the 3Rs in regulation and decision making
5. Validation and acceptance
6. Communications
Since then, the partners have identified areas of common interest, assessed the main needs and produced a five-year plan of action. During 2006, there was good progress on documenting all relevant 3R activities, and action taken to facilitate validation of new priority testing methods. This forms a sound basis for the longer-term objectives of the programme. The main drivers of animal testing are, of course, statutory requirements, and a review of all relevant legislation has identified a number of areas where industry and regulators can work together to reduce the number of animal tests.

Animal welfare legislation
A related issue is the forthcoming revision of Directive 86/609 on the protection of animals used for experimental and other scientific purposes. The Amsterdam treaty of 1997, via an animal welfare protocol, also places obligations on Member States, and in late 2002 the European Parliament called on the Commission to propose a revision of the Directive. Against this background, the Commission (DG Environment) has recently undertaken a public consultation and is now assessing the impact of different policy options. It is due to publish proposals for revision of the Directive shortly.
The plant protection industry already operates to high ethical standards, and uses only appropriately licensed, reputable organisations to carry out safety assessment work. In these circumstances, ECPA is awaiting the final Commission proposal to assess what impact these legislative changes may have on the regulatory testing required under Directive 91/414. Members should be aware of the forthcoming changes and the possible implications on for example for testing approval and inspections.
Further background and details of the consultation can be found on the DG Environment website: http://ec.europa.eu/environment/chemicals/lab_animals/home_en.htm.
Revisions to the data requirements for plant protection products under Directive 91/414
Linked to the proposed replacement of Directive 91/414, the Commission (DG SANCO) is amending the data requirements for approval of active substances and plant protection products. These include those tests necessary to demonstrate safety to humans. The proposed requirements have recently been reviewed by a scientific expert panel within the European Food Safety Authority (PPR Panel) and the Commission is likely to release its final proposal in early 2008.

Working together to reduce animal testing


Current approval procedures for a wide range of chemicals in everyday use, including components of crop protection products, require a degree of animal testing. Such testing – carried out under strictly licensed controls and involving rodents in the vast majority of cases – is at present the only ethical way of testing for a range of direct and indirect toxicological effects. Nevertheless, there are many reasons both the public and private sectors continue to look for alternatives. In addition to the ethical objections put forward by some, testing on animals is time-consuming, expensive and, in some instances, does not give a fully accurate picture of the risks to humans of using particular compounds.




Working in partnership to reduce animal testing
In November 2005, the Commission, together with a range of industry bodies (including ECPA) formed the European Partnership for Alternative Approaches to Animal Testing (EPAA) to co-operate on developing test protocols which either require fewer animals or, ultimately, enable reliable safety assessments to be done without any use of animals. This represents a significant part of the European effort on the so-called “3Rs” – refinement, reduction and replacement of animal testing.
The partnership now comprises seven trade associations, eight major companies and the Commission. Activities are coordinated by a steering committee, with co-chairs from the Commission and industry.

A first action plan
Having now had time to establish itself, the Partnership put forward its first action plan in June, listing 21 key activities to be carried out over the next five years. These form an integrated web of activities, grouped under five main headings:
· Evaluation of regulatory drivers for animal use
· Mapping and evaluation of past and current 3R activity
· Prioritisation and implementation of research based on the 3Rs
· Validation of new and alternative test methods and strategies
· Identification, dissemination and implementation of 3R best practice across the EU
At the launch of the action plan, the co-chairs of the steering group (Georgette Lalis of the Commission and Colin Humphris from CEFIC) said “The European Commission and European industry have both achieved much in recent years to refine, reduce and replace the need for animals in safety testing, but society rightly demands that we all increase our efforts. The adoption of this ambitious action programme clearly shows our commitment to pool resources and to work together to drive research forward in this crucial area. The refinement, reduction and replacement of animal testing is the goal of all members of the partnership, and we hope that the publication of this programme will encourage others to work with us.” The complete programme will be reviewed regularly and an annual report issued. The first report is expected to be published at the end of the year.