ITRI began preparation work for REACH on behalf of our tin producing member companies in 2005 and formed a tin metal consortium at the beginning of October 2007, which is open to any company to join. This allows access to, and cost sharing of, the set of REACH required data that is needed for registration.
ITRI has also conducted some preparatory studies for a wide range of inorganic tin compounds to establish how these substances can best be registered under REACH. Work on organotin compounds will, however, be co-ordinated by another organisation.
If you are an EU tin metal or chemical producer, a non-EU metal, alloy or chemical producer wishing to export to the EU, or an EU downstream user of metal or chemicals you will be affected by REACH.
You can read more about the possible impacts, and how ITRI may be able to help, in the REACH webpages.
ITRI assessment work on tin metal and inorganic tin compounds
Being a high tonnage substance, tin metal required registration, under REACH, before 1 December 2010.
Since 2005 ITRI has been preparing industry for REACH, forming a consortium at the beginning of 2007. The consortium is open to any company to join and allows access to, and cost sharing of, the information needed for REACH registration of tin. Work has involved both the assessment of available information from literature together with generation of new information through chemical, and toxicology, testing. The overall assessment strategy, together with a number of tests undertaken, has been novel to tin due to its unusual chemical behaviour in different environments. Additional studies were needed to find out how tin behaves in different parts of the body, and in different environmental compartments, before its effects could be duly assessed. ITRI also managed dossier preparation- relevant information from tests and literature was assessed, and recorded, in the joint tin dossier; an assessment on tin use and exposure was also included.
Substance Assessment under REACH
The scope of the dossier includes tin metal only; inorganic compounds will be considered separately and organotins are not included. Under REACH, the evaluation and control of the risks posed by substances is carried out in four steps: i) data collection, ii) data gap analysis, iii) risk characterisation, iv) risk reduction (if required):
i) Data collection involves an extensive search for all existing published and industry sponsored data on tin metal and tin compounds in order to carry out:
• An exposure assessment (who and what is exposed). Assessment for REACH involves two exposure routes. An environmental exposure assessment and a human health assessment. An environmental exposure assessment is conducted on aquatic and terrestrial (sediment etc) ecosystems and looks for exposure data on a substance during its whole lifecycle, from production to disposal (including amounts recycled and incinerated). A human health assessment is focused on workforce, consumers and humans exposed via the environment. In both cases EU production data, production processes information, consumption data, import data, export data, use patterns and quantities are essential.
• Effects assessment (at what concentration a substance can cause hazards).
For the effects assessment, an extensive search and collection of data on effects of tin metal on organisms in aquatic and terrestrial ecosystems, as well as on vertebrate animals and humans, is carried out.
ii) Data gap analysis. The data compilation produced then undergoes evaluation against the information requirements and data gaps are identified. The additional toxicological and ecotoxicological testing needed to fill the data gaps that are required under REACH is established - additional data is then generated through testing.
iii) Risk characterisation is carried out on basis of results of exposure and hazard assessments. If the concentration of tin in the environment or a human organ is lower than the level at which known adverse effect can be observed then we can be sure there is no risk to human health or environment.
Assessment work on Tin
The ITRI REACH project focuses on tin metal and to some extent its inorganic compounds; organotin compounds are not included but are dealt with by a separate consortium.
Assessment work on tin started with the following, initial, steps which have been undertaken and completed;
1. Search and evaluation of available ecotoxicity, and environmental fate, data
2. Search and evaluation of available toxicity information relevant to human health
3. Improving material flow and statistical information for the EU
4. Assessment of environmental exposure from data searching and industry surveys
5. Assessment of worker exposure from data searching and industry surveys
Following on from the work stages mentioned above tin was found to be a very data-poor metal; significant data gaps were highlighted relating to;
A. Physicochemical properties
B. Ecotoxicity data in aquatic, terrestrial and sediment compartments of the environment
C. Metal availability in the environment and relevant to human exposure
D. Speciation in the environment and with regards to human health
E. Human health toxicology data
F. Industrial monitoring data for tin; worker health and safety and environmental emission control
Along with all of the required physic-chemical, toxicological and eco-toxicological test data, additional information on tin solubility, speciation and chemical behaviour has been investigated and included in the dossier to help explain the unusual chemical behaviour of tin that has been observed during testing as well as to help rationalise some spurious results relating to apparent tin concentrations in test media.
Information on tin, as has been included in the tin metal REACH registration dossier, can be viewed on the ECHA dissemination portal which is accessible here.