European Chemicals Agency ECHA

The European Chemicals Agency s metal-specific tools were presented to a February 2, 2012 workshop (http //echa.europa.eu/documents/10162/17098/01Jl metal-specific tool use communication d2 lrws 20120203 en.pdf). While the tools did not include QSARs, appendix R.7.13-2 Environmental risk assessment for metals and metal compounds, discusses the possible use of QSARs for predicting the toxicity of metal ions (http //guidance.echa.europa.eu/docs/guidance document/information requirements r7 13 2 en.pdf). The following quote is from page 41  

The development of QSAR methods for metals and inorganic metal compounds has not been as actively pursued as for organic substances. However, for some inorganic substances, predicting toxicity from chemical properties may be relevant. 

In this respect, Quantitative Ion Character-Activity Relationships (QICARs) and Quantitative Cationic-Activity Relationships (QCARs) have recently been developed (Ownby and Newman 2003, Walker et al. 2003). More research efforts are needed in this field, however, in order to develop and validate appropriate models. 

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This safety check is in the first approach a check the responsible manufacturer or importer has to do in his own responsibility. In a second approach, it is to some extent also a check which is done by the competent authorities, especially the European Chemicals Agency (ECHA) and the national authorities. 

ECHA (2011) Recommendation of the European Chemicals Agency (ECHA) of 20 December 2011 for inclusion of substances in Annex XIV. http //echa.europa.eu/documents/10162/ 13640/opinion draft recommendation annex xiv third en.pdf... 

The European Chemicals Agency (ECHA) will manage the technical, scientific, and administrative aspects of the REACH system at Community level, aiming to ensure that REACH functions well and has credibility with all stakeholders. 

European Chemicals Agency (2009) Substance Name 5-tert-Butyl-2,4,6-trinitro-m-xylene (Musk Xylene), EC Number 201-329-4, CAS Number 81-15-2, Prioritisation and Annex XIV Background Information. European Chemicals Agency (ECHA), 14 January 2009 http //echa.europa.eu/doc/ consultations /recommendations/ prioritisations /... 

ECHA (2008a) Guidance on requirements for substances in articles, European Chemicals Agency ECHA-08-GF-03-EN, http //echa.europa.eu/reach en.asp (accessed May 2008). 

According to the novel European regulations named REACH System (Registration, Evaluation, Authorization of Chemicals), every chemical substance introduced into the market at the total amount of more than 1 ton per year has to be registered in the European Chemicals Agency (ECHA). Moreover, if the yearly production or import of the substance exceeds 10 tons, a comprehensive Chemical Safety Report (CSR) is required for the registration [1, 2],... 

Within risk management scientists, experts, stakeholders and decision-makers interact to address fundamental questions such as what type and how much data should be required before a particular risk is judged as intolerable and when and to what extent measures to reduce exposures are required. It is evident that these questions include both scientific and policy-related aspects. One specific illustration of these science-policy interactions can be seen in the discussions and various opinions expressed among experts, stakeholders and decision-makers in connection with the current review of the REACH criteria for PBT/vPvB substances where e.g. environmental NGOs such as WWF (Reineke 2008) as well as the European Chemicals Agency (ECHA 2008) argue that the criteria need to be adjusted so that also non-standard scientific information such as monitoring data should be considered if relevant and available. 

What remains to be seen is the extent to which the European Chemicals Agency (ECHA) will recognise exposure factors and economic and societal benefits, and not simply ban a substance based on toxicity. It is the responsibility of the companies participating in REACH to provide ECHA with adequate information and data to convince ECHA to allow certain uses and conditions for continuing manufacture of SVHC substances. 

Chemical identity issues are of central importance to the successful implementation of Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), both for the regulated community and for the European Chemical Agency (ECHA) responsible for REACH S implementation. A variety of nomenclature systems exists, some with similar naming convention but also with critically important differences. 

Chapter 4 - Classification and Labelling - Manufacturers or importers of a polymer have a duty to classify and label the polymer before placing it on the market. Manufacturers or importers that place a polymer on the market must also make a notification to the classification and labelling inventory at the European Chemicals Agency (ECHA). Manufacturers or importers of a polymer have a duty to classify monomer substances that they are registering as part of the technical dossier. This chapter describes what needs to be done to classify the chemicals used and how to label them. This chapter also explains who needs to do the labelling and classification, and how any health hazards are to be dealt with in the labelling. 

A notification to European Chemicals Agency (ECHA) may be required under Classification, Labelling and Packaging Regulation and/or... 

Manufacturers or importers that place a polymer on the market must make a notification to the classification and labelling inventory at the European Chemicals Agency (ECHA),... 

Assess the new use and advice against that use this will subsequently require a written notification to the European Chemicals Agency (ECHA) and to the DU. 

European Chemicals Agency (ECHA), Document ECHA-2011-g-08-en, Guidance on the Compilation of Safety Data Sheets - Version 1.1, 2011, accessible from http //echa.europa.eu/documents/10162/13643Zsds en.pdf (accessed 2014.03.01). 

In case that no MSDS is available, there exists the possibility to search the required information in the databank of the European Chemicals Agency (ECHA). In the C L-Inventory, the CAS and/or EINECS numbers, the corresponding classi cation, required labels and the corresponding H (hazard) and the P (precautionary) statements, and the CHS pictograms of all chemicals registered in the EU can be found. However, this ECHA databank is of help only for orientation, as, for example, there exist for Orange Oil sweet CAS No. 8028-48-6 a total of 56 entries. 

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