Contributing to REACH implementation

Within its science strategy, many of ECETOC's activities contribute to REACH implementation, either:

• 1. to provide the scientific foundation to support industry's positioning in the development of the methodologies behind the regulation
• 2. or as direct and targeted objectives

Examples of each are outlined as follows:

Development of the methodologies

Intelligent or Integrated Testing Strategies (ITS) are methodologies that help scientists more efficiently evaluate chemicals.  The development of the scientific foundations for ITS forms a strategic science area for ECETOC and encompasses relevant projects including:

• Future ITS strategies
  ECETOC is organising a symposium on future developments of ITS strategies at the 2008 EUROTOX annual meeting.
  
  
• 'Triggering and waiving criteria for an extended one-generation reproduction toxicity study'
  These criteria are aimed to be applicable for industrial chemicals and to allow this study design to be substituted for the more expensive and time consuming multigeneration study required under REACH for high tonnage chemicals. An ECETOC task force prepared a briefing document that was used as the basis of a workshop co-hosted by ECVAM and which was used as an input to the OECD expert group. During the workshop, participants were asked to discuss the triggering and waiving criteria, agree on their relevance and on possible validation needs. The results are to be summarised and published as an ECETOC workshop report.
  
  
• 6th Framework Programme Integrated Project ‘OSIRIS'
  ECETOC represents its members in relevant scientific fora and a specific representative is participating in the OSIRIS project.  Its goal is to develop integrated testing strategies fit for REACH that enable to significantly increase the use of non-testing information for regulatory decision making, and thus to minimise the need for animal testing. To this end, operational procedures are developed, tested and disseminated that guide a transparent and scientifically sound evaluation of chemical substances in a risk-driven, context-specific and substance-tailored manner.
  
  
• REACH Implementation Programme
  In the recent past, ECETOC was active in on the Project Management Team for the European Commission's REACH Implementation Programme (RIP) 3.3. Project which delivered comprehensive guidance on testing strategies. ECETOC successfully coordinated 11 working groups to provide expert contributions from industry, Member States and research institutes.

Direct and targeted objectives

More specific and REACH implementation-targeted activities include the following ongoing ECETOC task forces, whose objectives are outlined below:

• Targeted Risk Assessment (TRA)
  ECETOC is developing its online TRA tool in collaboration with ECHA for eventual incorporation into the REACH IT tools suite. This tool is an integral part of the guidance for compiling a Chemicals Safety Assessment.
  
  
• Assessment and evaluation of dermal risks from industrial chemicals
  The remit of the task force is to develop a tiered, practical strategy for the assessment and evaluation of dermal risks from chemicals, thereby taking into account recent scientific advances.  This activity will be a valuable input to chemical assessments for REACH in relation to exposure scenarios, and it could guide industry internal decision making when designing toxicological studies.
  
  
• Guidance for the classification of carcinogens under GHS
  The criteria for classification and labelling under the Global Harmonised System (GHS) are currently being formatted by the EU Commission ready for introduction as a new regulation alongside the REACH regulation.  They will replace the current classification and labelling guidelines. Regulatory authorities worldwide are beginning to use these GHS criteria and it is already being noticed that their interpretation varies in different parts of the world.  Therefore, ECETOC considers it important to develop an opinion on the application of the GHS criteria, in particular with respect to the endpoint carcinogenicity to ensure consistent use and application of this scheme.
  
  
• Interpretation framework for human data
  The approach to the use of human data within the REACH regulations is considered inconsistent and therefore a task force was set up to develop a framework for the evaluation of available human data and the use of this data in deriving DNEL's.
  
  The framework should help to improve the scientific interpretation of human data in risk assessment, by integrating different types and qualities of existing human data with animal or other data.  This should enable better use of human data in different risk assessment and risk management applications, particularly in the context of current GHS and REACH proposals.
  
  
• Threshold of toxicological concern for industrial chemicals
  The threshold of toxicological concern (TTC) is a concept that refers to a human exposure threshold value for chemicals, below which there would be no appreciable risk to health.  The concept is reflected in the US FDA's principle of ‘threshold of regulation' and is proposed for low exposures to industrial chemicals to be evaluated under REACH. The task force is working with Cefic LRI to develop data and promote the use of this concept in REACH for chemicals with very low potential exposure.
  
  
• Guidance on interpreting endocrine disrupting effects within the constraints of REACH and the revised 91/414 directive
  Endocrine disruption is considered a toxicological property of high concern under the new European chemical regulations, leading to severe restrictions on marketing of products classified for this property. The guidance in the legislation is very unclear about the use of data in arriving at this classification. The task force will give guidance about the use of toxicological and ecotoxicological data in arriving at such a classification.
  
  
• Potency values from the LLNA: Application to classification, labelling and risk assessment
  Under the upcoming REACH legislation and the guidelines for its implementation, which will include applying the criteria of the Global Harmonised System (GHS), the Local Lymph Node Assay (LLNA) will be given priority when testing for skin sensitisation.  The measure of potency of skin sensitisation in the LLNA is the EC3 value, i.e. the concentration causing a threefold increase in the lymph node stimulation index. 
  
  This task force is asked to determine whether an EC3 potency value derived from the LLNA can provide a cut-off criterion for classification and labelling of both individual substances and preparations, and, if confirmed, develop sub-categories based on the EC3 value.  The development of the criterion should build on the report of the previous ECETOC task force on ‘Contact Sensitisation: Classification According to Potency' and an evaluation of the current use of LLNA data in risk assessment approaches for skin sensitizers.