Word
Action number 15018 Last updated 30/11/2012 18:23:28 Year 2013
Title Systems Toxicology
Acronym ST
Type Action
Url
Institute JRC.I Institute for Health and Consumer Protection (Ispra)
Leader BELZ SUSANNE JRC.I.5   E-Mail
Thematic Area TA4 - Safety of Food and Consumer Products
TA4.HLO2 - To develop improved frameworks, systems, and tools for the safety assessment of chemicals (including nanomaterials) to scientifically underpin the EU legislative process and contribute to international harmonisation
1 Prosperity in a Knowledge intensive society
1.5 Life Sciences and biotechnology
15024 - NBS

ENV - Environment
JRC KB - JRC Knowledge Base
RTD - Research and Innovation
SANCO - Health and Consumers


Cosmetics Europe - European Cosmetics Association
ECHA - European Chemicals Agency (ECHA)
OECD - Organisation for Economic Co-operation and Development (OECD)

ENTR - Enterprise and Industry
ENV - Environment
RTD - Research and Innovation
SANCO - Health and Consumers


CONSUMERS ASSOCIATION THE QUALITY OF LIFE
CONSUMERS INTERNATIONAL
European Consumers' Organisation
Health Canada
Safety of Chemicals in Consumer Products
AISE - Association of Soaps and Detergents (AISE)
Ani Wel NGOs - EU wide operating animal welfare NGOs
CEFIC - European Chemical Industry Council (CEFIC)
CoE - Council of Europe
Cons Ass EU - Consumer associations EU
Cosmetics Europe - European Cosmetics Association
ECHA - European Chemicals Agency (ECHA)
EDQM - European Directorate for the Quality of Medicines and HealthCare (EDQM, Council of Europe)
EFPIA - European Federation of the Pharmaceutical Industries and Associations (EFPIA)
EFSA - European Food Safety Agency
EMA - European Medicines Agency (EMA)
EP - European Parliament
EPAA - European Partnership on Alternative Approaches to Animal Testing (EPAA)
ESF - European Science Foundation (ESF)
ICCVAM - Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM)
JaCVAM - Japanese Centre for the Validation of Alternative Methods (JaCVAM)
KoCVAM - KoCVAM (Korea)
OECD - Organisation for Economic Co-operation and Development (OECD)
Pat Ass EU - Patient associations
WHO - World Health Organization
toxicology, safety assessment, mode of action, adverse outcome pathway, key event, in vitro method, non-testing method, computational modelling, structure-activity relationship, QSAR, chemical category, read-across, molecular modelling, toxicokinetics, toxicodynamics, PBBK, PBPK, high-throughput screening, high content imaging, neurotoxicity, hepatotoxicity, combined exposure, mixture, chemometrics, biological model, cell model, stem cell, endocrine active substance, endocrine disrupting chemical, ED, endocrine disruption, nanomaterial, OHT, intermediate effect, standardisation, human biomonitoring, exposure, threshold of toxicological concern, TTC, validation, chemicals, chemical safety, cosmetics, chemicals, integrated testing strategies, Principles of Good Laboratory Practices (GLP); Good Cell Culture Practices (GCCP), ECVAM Database Service on Alternative Methods (DB-ALM), INVITTOX protocols, EURL ECVAM
Rationale
The Systems Toxicology (ST) Action provides scientific support to EU policies and legislation that ensure the safe use of chemicals in the EU and worldwide for the protection of the consumer, worker and the environment. In particular, the ST Action strives to develop the safety assessment science that underpins regulatory decisions about chemicals while reducing our reliance on animal testing. In this regard the Action addresses a number of objectives related to the development, integration, evaluation, validation and demonstration of modern toxicological methods based on theoretical, experimental (in vitro) and computational approaches to predict adverse effects in humans and the environment. The ST Action also covers the activities of the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) established by Directive 2010/63/EU on the protection of animals used for scientific purposes. The key responsibilities of the EURL ECVAM are to (1) guide and participate in the development of alternative methods, (2) conduct and coordinate validation studies, (3) facilitate regulatory acceptance and (4) promote the use of alternative methods by end-users.
Chemical safety assessment has traditionally been based on animal testing but the EU has been promoting for many years the replacement, reduction, and refinement of animal testing. The Directive on the protection of animals used for scientific purposes (2010/63/EU), the Regulation on cosmetic products (EC 1223/2009), and the Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH, EC 1907/2006) are prominent examples of legislation that require replacing animal testing wherever possible. The development of suitable in vitro methods provides one viable means for achieving the goal of replacement, reduction and refinement of animal testing (3Rs principle); and the validation of such methods, i.e. the demonstration that the methods work reliably and predict the toxicological response in question correctly, paves the way to regulatory acceptance.
Besides being costly, lengthy and ethically questionable, traditional risk assessment methods applying animal testing are based on purely phenomenological observations. However, there is enough scientific knowledge to build a new safety assessment paradigm based on understanding rather than simple observation. Thus the basic premise behind the scientific approach of the ST Action is that to be ultimately predictive of adverse effects in humans and the environment that a chemical may cause requires a thorough understanding of its toxicological mode-of-action within the exposed organism. The mode-of-action is described by sequence of biochemical or biological events at different levels of biological organisation (e.g. cell, tissue, organ, organism, and even population) that lead to an adverse effect. The thinking is that although in the most detailed sense the action of every chemical is somewhat unique, in more general terms chemicals can be classified and grouped together based on their common mode-of-action. This mode-of-action driven approach to toxicology will pave the way for using combinations of alternative methods to profile the toxicokinetic and toxicodynamic profile of chemicals thereby facilitating hazard identification, mechanistic based read-across and ultimately the prediction of derived no-effect levels necessary for quantitative risk assessment. Moreover, this will also provide a scientific basis for the assessment of combined exposure to multiple chemicals which is more relevant to the real life situation that the traditional approach to assess chemicals individually.

In order to fulfil its objectives, the ST Action is networking and collaborating with major EU and International stakeholders. The ST Action is a main contributor to the private-public research initiative SEURAT-1 (Safety Evaluation Replacing Animal Testing) co-funded by Cosmetics Europe and the European Commission under the FP7 Health programme. The Action is also a collaboration partner within the US interagency Tox 21 initiative and participates in many international activities related to safety assessment and standardisation of assessment approaches at the OECD and WHO, especially in the context of the International Programme on Chemical Safety (IPCS). The ST Action serves EU policies on safety of food and consumer products, including cross-cutting issues such as endocrine disruption, combined exposure, nanomaterials, alternative methods, as well as sectoral policies such as REACH, CLP and Biocidal Products Regulations.
Summary of the activity
In 2013, the ST Action will focus on (i) development, evaluation and application of assessment science concepts and tools to support EU policies on chemicals and consumer products, (ii) optimisation, standardisation and validation of in vitro methods suitable for regulatory safety assessment, (iii) improvement of the biological models used, including evaluation of the suitability of the model for human safety assessment, (iv) implementation of in vitro assays in high throughput screening for the classification of a high number of tested materials based on their organelle and cellular effects, and (v) development of data and knowledge base to facilitate efficient exchange of information across the entire research community and use this as a tool for building safety assessment strategies. A significant proportion of these innovation, validation and communication activities will support the role of EURL ECVAM.
The ST Action will continue activities focussed on a common strategy towards a mode-of-action based safety assessment of chemicals using alternative methods, both in vitro and in silico. This will also be applied for the EURL ECVAM testing strategies. A general evaluation of alternative methods currently used within the EU and further development of EURL ECVAM strategies for alternative testing are described under Objective 1.Objectives 2 and 3 are focussing on further development of safety assessment strategies including quantitative predictions based on in vitro testing and theoretical prediction models where most deliverables are related to indirect actions. The processes directly connected to the operation of EURL ECVAM are described in Objectives 5 and 6, including the standardisation and harmonisation of alternative methods in an international regulatory context. Objective 7 is related to the provision of informatics tools necessary for a successful implementation and harmonised use of alternative methods in chemicals safety assessment. This objective can directly serve activities carried out under Objectives 1-3, 5 and 6 and strongly and directly contributes to several international initiatives in the context of OECD and WHO and in close collaboration with US EPA.

The different activities on endocrine disrupting chemicals (EDCs) described under Objective 4 give strong support to the EU Community Strategy on EDCs, thereby providing an example of how research activities under ST Objectives 2, 3 and 7 can be directly exploited to support EU policies within one specific field of concern. The activities under objective 4 are partly financed through Administrative Agreements with DG ENV. Direct support to DG ENV is provided also under Objective 8 on the complex task to predict adverse effects originating from combined exposure to chemicals and chemical mixtures.
 
  1
Evaluation of the application of alternative methods under the current EU legislation and development of EURL ECVAM strategies for increase of the impact of 3Rs principles in the regulatory context
  1.1
Evaluation on how alternative, testing and non testing, methods can be applied under current EU legislation on chemicals
State-of-the-art report on non-standard methods that reduce animal testing with regard to their relevance and possible use in the assessment of chemical properties under REACH, CLP and the Biocidal Products Regulation (BPR)
31/10/2013
JRC Scientific Support - Scientific and policy reports
1.2.4 The single market
TypeYearNumberTitle
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20081272 Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures
REG 2012528 Regulation (EC) 528/2012 concerning the making available on the market and use of biocidal products
JRC KB  - JRC Knowledge Base
ECHA  - European Chemicals Agency (ECHA)
Briefing reports dealing with selected methods or topical issues considered directly applicable within REACH, CLP and BPR, as identified in Deliverable 3.1.1
31/10/2013
JRC Scientific Support - Scientific and policy reports
1.2.4 The single market
TypeYearNumberTitle
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20081272 Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures
REG 2012528 Regulation (EC) 528/2012 concerning the making available on the market and use of biocidal products
JRC KB  - JRC Knowledge Base
ECHA  - European Chemicals Agency (ECHA)
Report on status of alternative methods with regard to provision of the Cosmetics Regulation
30/06/2013
JRC Scientific Support - Scientific and policy reports
1.2.4 The single market
TypeYearNumberTitle
REG 20091223 Cosmetic Products Regulation
SANCO  - Health and Consumers
  1.2
Elaboration of EURL ECVAM strategies for delivering integrated testing and assessment solutions using modern non-animal methods to address various health effects and the quality control of vaccines in different regulatory sectors
Strategy documents on four areas: toxicokinetics, genotoxicity/carcinogenicity, (developmental) neurotoxicity and quality control of vaccines
31/12/2013
JRC Scientific Support - Scientific and policy reports
1.2.4 The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
DIR 201182 Directive 2001/82/EC on the Community Code Relating to Veterinary Medicinal Products
DIR 201183 Directive 2001/83/EC on the Community Code Relating to Medicinal Products for Human Use
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20091223 Cosmetic Products Regulation
JRC KB  - JRC Knowledge Base
Reports form expert and stakeholder workshops on strategic development in four areas as described for deliverable 1.2.1
31/12/2013
JRC Scientific Support - Scientific and policy reports
1.2.4 The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
DIR 201182 Directive 2001/82/EC on the Community Code Relating to Veterinary Medicinal Products
DIR 201183 Directive 2001/83/EC on the Community Code Relating to Medicinal Products for Human Use
REG 200619907 The document specified has not been found in the set of policy documents managed by the system. Please type the title in this box.
REG 20091223 Cosmetic Products Regulation
JRC KB  - JRC Knowledge Base
  1.3
Development of integrated assessment and testing strategies based on the Adverse Outcome pathways (AOP) defined by OECD.
Project description(s) and plan(s) on Adverse Outcome Pathway(s) in skin sensitisation, included in OECD's standard project submission form
30/04/2013
JRC Scientific Support - Scientific and policy reports
1.2.4 The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20091223 Cosmetic Products Regulation
JRC KB  - JRC Knowledge Base
OECD  - Organisation for Economic Co-operation and Development (OECD)
Status report on the development of integrated assessment and testing strategies based on the Adverse Outcome pathways (AOP)
31/12/2013
JRC Scientific Support - Scientific and policy reports
1.2.4 The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20091223 Cosmetic Products Regulation
JRC KB  - JRC Knowledge Base
  2
Development of novel ways of categorising chemicals according to their toxicological modes-of-action to facilitate read-across and quantitative prediction of adverse effects for the safety assessment of chemicals also considering combination effects of chemicals.
Deliverable  2.1
Workshop reports and presentations supporting the establishment of a mode-of-action based safety assessment for repeat-dose systemic toxicity in the context of SEURAT-1 cluster (FP7) and third-party-contract with Cosmetics Europe (32485) and other international collaborations
20/12/2013
JRC Scientific Support - Scientific and policy reports
The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20091223 Cosmetic Products Regulation
JRC KB - JRC Knowledge Base
RTD - Research and Innovation
Cosmetics Europe - European Cosmetics Association
Deliverable  2.2
Datasets as collected in ActivityBase from in vitro testing, such as High Throughput Screening (HTS) and High Content Imaging (HCI) to support mode-of-action identification and category formation partly contributing to SEURAT-1 cluster (FP7) and third-party-contract with Cosmetics Europe (32485), Predict IV (FP7) and Nanomile (FP7)
20/12/2013
JRC Scientific Support - Scientific and policy reports
The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20091223 Cosmetic Products Regulation
SEC 20082036 REGULATORY ASPECTS OF NANOMATERIALS
JRC KB - JRC Knowledge Base
RTD - Research and Innovation
Cosmetics Europe - European Cosmetics Association
Deliverable  2.3
Report for COSMOS (FP7) on a TTC (Threshold of Toxicological Concern) approach for cosmetics
30/06/2013
JRC Scientific Support - Scientific and policy reports
The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20091223 Cosmetic Products Regulation
JRC KB - JRC Knowledge Base
RTD - Research and Innovation
Deliverable  2.4
Human stem cell based in vitro models, including the characterisation of their derivatives, definition of cell culture protocols, and evaluation of their suitability for safety assessment as an input to ESNATS (FP7), SEURAT-1 cluster (FP7)
31/05/2013
JRC Scientific Support - Scientific and policy reports
The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20091223 Cosmetic Products Regulation
JRC KB - JRC Knowledge Base
RTD - Research and Innovation
Deliverable  2.5
Evaluation of human cell based assays for developmental neurotoxicity
31/12/2013
JRC Scientific Support - Scientific and policy reports
The single market
TypeYearNumberTitle
COM 201063 The document specified has not been found in the set of policy documents managed by the system. Please type the title in this box.
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20091223 Cosmetic Products Regulation
JRC KB - JRC Knowledge Base
  3
Development of biokinetic models to enable the use of results from in vitro testing to predict in vivo toxicity of chemicals, and to extrapolate between different routes of exposure and different species facilitating the use of historical data
Deliverable  3.1
Report for COSMOS (FP7)/third-party-contract with Cosmetics Europe (32485) on physiological-based pharmaco-kinetic (PBPK) based computer models relating exposure data to internal dose for establishing in vivo activity thresholds (e.g. no-effect levels) from in vitro dose-response data
31/12/2013
JRC Scientific Support - Scientific and policy reports
The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20091223 Cosmetic Products Regulation
JRC KB - JRC Knowledge Base
RTD - Research and Innovation
Cosmetics Europe - European Cosmetics Association
Deliverable  3.2
Report for the third-party-contract with Cosmetics Europe (32485) including a review on the availability of methods for assessing dermal bioavailability
31/08/2013
JRC Scientific Support - Scientific and policy reports
The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20091223 Cosmetic Products Regulation
JRC KB - JRC Knowledge Base
RTD - Research and Innovation
Cosmetics Europe - European Cosmetics Association
Deliverable  3.3
Report on the development and use of computer models based on tailor-made experimental data from in vitro models in the context of COSMOS (FP7) and third-party-contract (Cosmetics Europe)
31/12/2013
JRC Scientific Support - Scientific and policy reports
The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20091223 Cosmetic Products Regulation
JRC KB - JRC Knowledge Base
RTD - Research and Innovation
Cosmetics Europe - European Cosmetics Association
  4
Support to the implementation of the EU Community Strategy on Endocrine Disrupting Chemicals (EDCs), by participating in the definition of scientific criteria to identify EDCs, identifying substances of potential ED concern and releasing the public version of the web-based Endocrine Active Substances Information System (EASIS).
Deliverable  4.1
Contribution (through DG ENV) to the EC 2013 proposal for horizontal criteria for the identification of endocrine disrupting chemicals (EDCs), for incorporation into relevant EU chemicals legislation (e.g. PPPR, BPR, REACH, Cosmetic Products Regulation, Water Framework Directive).
30/06/2013
JRC contributions to policy documents
The single market
TypeYearNumberTitle
SEC 20111001 4th Report on the implementation of the ''Community Strategy for Endocrine Disrupters'' a range of substances suspected of interfering with the hormone systems of humans and wildlife (COM (1999) 706).
ENV - Environment
Deliverable  4.2
Scientific advice on test strategy development, method validation, and performance-based test guideline definitions in the OECD EDTA AG (Endocrine Disrupter Testing and Assessment Advisory Group) and the OECD VMG NA (Validation Management Group for Non-Animal Testing)
31/12/2013
JRC contributions to policy documents
The single market
TypeYearNumberTitle
SEC 20111001 4th Report on the implementation of the ''Community Strategy for Endocrine Disrupters'' a range of substances suspected of interfering with the hormone systems of humans and wildlife (COM (1999) 706).
15024 - NBS
ENV - Environment
OECD - Organisation for Economic Co-operation and Development (OECD)
Deliverable  4.3
Method development and data collection for high throughput screening (HTS) measurements of oestrogen receptor transactivation (ERTA) assays, contributing to performance evaluation and standardisation of such assays for inclusion in the OECD Test Guidelines Programme and Conceptual Framework for assessment of EDCs.
31/07/2013
JRC Scientific Support - Scientific and policy reports
The single market
TypeYearNumberTitle
SEC 20111001 4th Report on the implementation of the ''Community Strategy for Endocrine Disrupters'' a range of substances suspected of interfering with the hormone systems of humans and wildlife (COM (1999) 706).
JRC KB - JRC Knowledge Base
Deliverable  4.4
Report on the applicability of a Cytochrome P450-induction method to assess the metabolic capacity of cell lines (used in ED assays) after exposure to chemicals that may become Endocrine Disruptors through biotransformation.
31/10/2013
JRC Scientific Support - Scientific and policy reports
The single market
TypeYearNumberTitle
SEC 20111001 4th Report on the implementation of the ''Community Strategy for Endocrine Disrupters'' a range of substances suspected of interfering with the hormone systems of humans and wildlife (COM (1999) 706).
JRC KB - JRC Knowledge Base
Deliverable  4.5
Report on an integrated model providing an optimal combination of in silico and in vitro models to identify EDs to be provided in the context of an Administrative Agreement with DG ENV.
31/05/2013
JRC Scientific Support - Scientific and policy reports
The single market
TypeYearNumberTitle
SEC 20111001 4th Report on the implementation of the ''Community Strategy for Endocrine Disrupters'' a range of substances suspected of interfering with the hormone systems of humans and wildlife (COM (1999) 706).
ENV - Environment
Deliverable  4.6
Web-based Endocrine Active Substances Information System (EASIS) publicly available on-line
31/03/2013
JRC Scientific Support - Scientific information systems and databases
The single market
TypeYearNumberTitle
SEC 20111001 4th Report on the implementation of the ''Community Strategy for Endocrine Disrupters'' a range of substances suspected of interfering with the hormone systems of humans and wildlife (COM (1999) 706).
ENV - Environment
  5
Management of the validation process from submission to peer-review and evaluation by EURL ECVAM
  5.1
Assessment of test methods submitted to EURL ECVAM with regard to their readiness to enter validation, including prioritisation and selection of test methods on the basis of their regulatory relevance and impact on the 3Rs
Overview on the assessment status of test methods submitted to EURL ECVAM
20/12/2013
JRC Scientific Support - Scientific and policy reports
1.2.4 The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20091223 Cosmetic Products Regulation
ENV  - Environment
Summary report about the submission, evaluation and prioritisation of test methods submitted to EURL ECVAM
20/12/2013
JRC Scientific Support - Scientific and policy reports
1.2.4 The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20091223 Cosmetic Products Regulation
ENV  - Environment
Establishment of a web-based test method submission tool
31/12/2013
JRC Scientific Support - Scientific information systems and databases
1.2.4 The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20091223 Cosmetic Products Regulation
JRC KB  - JRC Knowledge Base
  5.2
Coordination of EURL ECVAM's advisory group on the Preliminary Assessment of Regulatory Relevance (PARERE) and the EURL ECVAM Stakeholder Forum (ESTAF)
Report on the annual ESTAF and PARERE meetings
31/12/2013
JRC Scientific Support - Scientific and policy reports
1.2.4 The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
ENV  - Environment
  5.3
Improvement of the definition and description of test methods selected for validation
Optimised and standardised assay protocols for test methods selected for validation by EURL ECVAM, in particular for two androgen-receptor transcriptional activation assays
31/12/2013
JRC Scientific Support - Scientific and policy reports
1.2.4 The single market
TypeYearNumberTitle
COM 1999706 Community Strategy for Endocrine Disruptors
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20091223 Cosmetic Products Regulation
SEC 20111001 4th Report on the implementation of the ''Community Strategy for Endocrine Disrupters'' a range of substances suspected of interfering with the hormone systems of humans and wildlife (COM (1999) 706).
JRC KB  - JRC Knowledge Base
Guidance document on test method definition and description, leading to reliable and robust testing protocols and forms
31/12/2013
JRC Scientific Support - Scientific and policy reports
1.2.4 The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20091223 Cosmetic Products Regulation
JRC KB  - JRC Knowledge Base
Standardised assay protocol on a pulmonary absorption assay as a source for parameters for PBTK modelling
30/09/2013
JRC Scientific Support - Scientific and policy reports
1.2.4 The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20091223 Cosmetic Products Regulation
JRC KB  - JRC Knowledge Base
  5.4
Initiation, supervision and coordination of validation projects, including support to external participating laboratories and the establishment of the European Network of Validation Laboratories (NETVAL)
Validation Study Plans and study reports for validation projects on two androgen-receptor transcriptional activation assays and a cryopreserved hepatocytes CYP induction assay
31/12/2013
JRC Scientific Support - Scientific and policy reports
1.2.4 The single market
TypeYearNumberTitle
COM 1999706 Community Strategy for Endocrine Disruptors
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20091223 Cosmetic Products Regulation
SEC 20111001 4th Report on the implementation of the ''Community Strategy for Endocrine Disrupters'' a range of substances suspected of interfering with the hormone systems of humans and wildlife (COM (1999) 706).
JRC KB  - JRC Knowledge Base
Validation project (progress) reports in the areas of toxicokinetics (Cytochrome P450 induction), skin sensitisation, eye irritation and the detection of endocrine disruptors
31/12/2013
JRC Scientific Support - Validated methods, Reference methods and measurements
1.2.4 The single market
TypeYearNumberTitle
COM 1999706 Community Strategy for Endocrine Disruptors
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20091223 Cosmetic Products Regulation
SEC 20111001 4th Report on the implementation of the ''Community Strategy for Endocrine Disrupters'' a range of substances suspected of interfering with the hormone systems of humans and wildlife (COM (1999) 706).
JRC KB  - JRC Knowledge Base
Established procedures for the control and management of test systems and test items
31/12/2013
1.2.4 The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20091223 Cosmetic Products Regulation
JRC KB  - JRC Knowledge Base
Report on the establishment and launch of the European Network of Validation Laboratories (NETVAL) to increase the validation capacity and throughput in the EU
30/06/2013
JRC Scientific Support - Scientific and policy reports
1.2.4 The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
ENV  - Environment
Training material for participating laboratories in an ECVAM led validation study
31/12/2013
JRC Scientific Support - Training
1.2.4 The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20091223 Cosmetic Products Regulation
JRC KB  - JRC Knowledge Base
  5.5
Organisation of the peer-review process of validated test methods and the formulation of EURL ECVAM Recommendations
Opinions of the ECVAM Scientific Advisory Committee (ESAC) and reports of its working groups on test methods in the areas of ecotoxicology, skin sensitisation, eye irritation, carcinogenicity, toxicokinetics and endocrine disruptors
31/12/2013
JRC Scientific Support - Scientific and policy reports
1.2.4 The single market
TypeYearNumberTitle
COM 1999706 Community Strategy for Endocrine Disruptors
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20091223 Cosmetic Products Regulation
SEC 20111001 4th Report on the implementation of the ''Community Strategy for Endocrine Disrupters'' a range of substances suspected of interfering with the hormone systems of humans and wildlife (COM (1999) 706).
JRC KB  - JRC Knowledge Base
EURL ECVAM Recommendations on validated test methods following the finalisation of ESAC opinions
30/11/2013
JRC Scientific Support - Scientific and policy reports
1.2.4 The single market
TypeYearNumberTitle
COM 1999706 Community Strategy for Endocrine Disruptors
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20091223 Cosmetic Products Regulation
SEC 20111001 4th Report on the implementation of the ''Community Strategy for Endocrine Disrupters'' a range of substances suspected of interfering with the hormone systems of humans and wildlife (COM (1999) 706).
ENV  - Environment
SANCO  - Health and Consumers
OECD  - Organisation for Economic Co-operation and Development (OECD)
  6
Support to standardisation and harmonisation of alternative methods towards international regulatory acceptance
  6.1
Support and engagement in OECD projects and advisory groups for the development of Test Guidelines and Performance Standards
Summary report on the activities contributing to the OECD Test Guidelines Programme
31/12/2013
JRC Scientific Support - Scientific and policy reports
1.2.4 The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20091223 Cosmetic Products Regulation
ENV  - Environment
Drafts for OECD Test Guidelines in the areas of skin sensitisation and endocrine disruptors
31/12/2013
JRC Scientific Support - Scientific and policy reports
1.2.4 The single market
TypeYearNumberTitle
COM 1999706 Community Strategy for Endocrine Disruptors
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20091223 Cosmetic Products Regulation
SEC 20111001 4th Report on the implementation of the ''Community Strategy for Endocrine Disrupters'' a range of substances suspected of interfering with the hormone systems of humans and wildlife (COM (1999) 706).
15024 NBS
OECD  - Organisation for Economic Co-operation and Development (OECD)
Draft for a revised OECD Test Guideline 437 on a test method for eye irritation testing delivered to OECD
31/07/2013
JRC Scientific Support - Scientific and policy reports
1.2.4 The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20091223 Cosmetic Products Regulation
15024 NBS
OECD  - Organisation for Economic Co-operation and Development (OECD)
  6.2
Participation in the activities of the International Cooperation on Alternative Test Methods (ICATM)
Regulatory acceptance status report on the methods validated in the framework of ICATM as delivered to the International Collaboration of Cosmetics (ICCR)
30/06/2013
JRC Scientific Support - Scientific and policy reports
1.2.4 The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20091223 Cosmetic Products Regulation
JRC KB  - JRC Knowledge Base
Expansion of the TSAR information system to provide comprehensive updates of validation activities of all ICATM partners
31/12/2013
JRC Scientific Support - Scientific information systems and databases
1.2.4 The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20091223 Cosmetic Products Regulation
  7
Facilitating and promoting the sharing and dissemination of knowledge on alternative methods for safety assessment of chemicals
  7.1
Promotion of development and use of alternative methods through the provision of public information systems and services by operating and further developing the EURL ECVAM Database Service on Alternative Methods (DB-ALM) and its portal, as well as providing guidance and support on how to find high quality information on alternatives in the World Wide Web
New and updated datasheets on alternative test methods/strategies available in DB-ALM
31/12/2013
JRC Scientific Support - Scientific information systems and databases
1.2.4 The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20091223 Cosmetic Products Regulation
JRC KB  - JRC Knowledge Base
Further developed DB-ALM application in order to adapt to changed data requirements and to enhance the user friendliness during data storage and retrieval procedures, complemented by a new portal with integrated access to different information systems/sectors on alternative methods
30/11/2013
JRC Scientific Support - Scientific information systems and databases
1.2.4 The single market
TypeYearNumberTitle
DIR 201063 Directive on the protection of animals used for scientific purposes
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 20091223 Cosmetic Products Regulation
JRC KB  - JRC Knowledge Base
  7.2
Provision of information systems including data management tools and knowledge-bases to support the use of innovative safety assessment approaches in a regulatory context
Further development and harmonisation of data/knowledge management systems(e.g. Mode-of-Action Wiki, Effectopedia, WikiPathways) developed for a mode-of-action approach to safety assessment benefiting from the development of such assessments in the context of SEURAT-1 (FP7) and other external collaboration partners
20/12/2013
JRC Scientific Support - Scientific information systems and databases
RTD  - Research and Innovation
OECD  - Organisation for Economic Co-operation and Development (OECD)
Model of a portal that provides homogenous access to heterogeneous publicly available databases on chemico/physico/toxicological features of different classes of chemicals related to human health to support diXa (FP7)
30/06/2013
JRC Scientific Support - Scientific information systems and databases
1.2.4 The single market
TypeYearNumberTitle
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
RTD  - Research and Innovation
Content update and maintenance of databases supporting implementation of chemicals legislation and related activities, such as JRC QSAR Model Database and CHELIST (Chemical Lists Information System).
31/12/2013
JRC Scientific Support - Scientific information systems and databases
1.2.4 The single market
TypeYearNumberTitle
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
JRC KB  - JRC Knowledge Base
  8
Support to the implementation of the EU Community Strategy on Combination Effects of Chemicals, by coordinating the preparation of a guidance document on how to assess combined exposure, provide risk assessment of selected case studies and to set up prediction models based on mode-of-action categorisation.
Deliverable  8.1
Guidance document on safety assessment of combined exposure to chemicals for horizontal applicability in EU chemicals legislation in support to DG ENV.
29/11/2013
JRC contributions to policy documents
The single market
TypeYearNumberTitle
C 200917280 Combination effects of chemicals - Council conclusions
ENV - Environment
Deliverable  8.2
Report on selected case studies for realistic combined exposure to chemicals as a basis for risk management within EU in support to DG ENV.
29/11/2013
JRC Scientific Support - Scientific and policy reports
The single market
TypeYearNumberTitle
C 200917820 Combination effects of chemicals - Council conclusions
ENV - Environment
Deliverable  8.3
Report on prediction models for combined exposure to chemicals based on mode-of-action categorisation.
31/10/2013
Scientific Publications
The single market
TypeYearNumberTitle
C 200917820 Combination effects of chemicals - Council conclusions
JRC KB - JRC Knowledge Base
  • Search by Keyword icon.help