ECHA

 

From screening to a proposal for harmonised classification and labelling

 

Dioctyltin dilaurate (EC 222-883-3) is an organometallic substance, which was registered ahead of the second REACH deadline in 2013. It is used in the production of polymers, masterbatches and compounds, additives and plastics. In the Classification and Labelling Inventory, a significant proportion of manufacturers and importers classified it as toxic to reproduction. The inventory also contains notifications reporting specific toxicity to the thymus through repeated exposure.
 

Dioctyltin dilaurate was picked up by the automated IT screening performed annually to try to identify potential substances of very high concern (SVHCs) and consider them for regulatory risk management. It is done based on specific criteria developed by ECHA and the Member States. Dioctyltin dilaurate was identified as potentially hazardous based on the significant number of notifications with severe classifications. It was further prioritised for manual verification because of the wide range of uses and potential for exposure to humans and the environment.
 

Based on the screening, the Swedish Chemicals Agency examined the substance. It found that the concerns for reproductive and specific target organ toxicity were reasonable and valid. It then concluded that harmonised classification and labelling was the most appropriate Community-wide risk management option for this potential reproductive toxicant. In September 2015, it notified ECHA of its intention to prepare a dossier for the harmonised classification and labelling (CLH) of dioctyltin dilaurate.
 

The substance is listed in the Registry of Intentions (RoI), which is a list of the authorities' plans for future risk management measures. Being in the RoI gives an important signal for industry to ensure that their registration dossiers are up- to-date. It also gives industry and other stakeholders more time to prepare for commenting later in the process. At present, ECHA is waiting for Sweden to submit a dossier for CLH.
 

Once the proposal for CLH is successfully submitted, a public consultation will begin. During the consultation, all concerned parties can comment on the proposal. These comments are taken into account when the proposal is discussed in ECHA's Committee for Risk Assessment.

 

From risk management option analysis to the Candidate List
 

1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters (EC 271-094-0, 272-013-1) are mixed alkyl diesters used as plasticisers and lubricants in adhesives, coatings, building material, cable compounding, polymer foils, PVC compounds and artist supplies (such as modelling clay and finger paints). These uses lead to exposure of both consumers and workers.
 

Both substances are also classified as toxic for reproduction (Repr. 1B) when they contain 0.3% or more of dihexyl phthalate (EC 201-559-5).
 

Based on these facts, the Swedish competent authority performed a risk management option analysis (RMOA) for these substances in 2014. The purpose of the RMOA is to help authorities decide whether further regulatory risk management activities are required and to identify the most appropriate instrument to address their concern.
 

The substance was listed in the Public Activities Coordination Tool (PACT). This is a list of all the substances for which an RMOA or an informal hazard assessment for specific properties is either under development or has been completed. This list also give forewarming to industry and stakeholders of the next steps.
 

Sweden concluded that inclusion in the Candidate List was the appropriate regulatory risk management measure. It also believed that it would encourage companies to start substituting the substance already before it is included in the Authorisation List (Annex XIV of REACH).
 

Placing a substance on the Candidate List would also make sure that information about the substance contained in articles is made available to consumers, workers and ECHA. Inclusion in the Authorisation List would require manufacturers and importers as well as users to consider replacing it with suitable safer alternatives.
 

In February 2015, the Swedish competent authority submitted a dossier to identify the mixed alkyl diesters as SVHCs because of their toxic for reproduction properties. In its meeting in May 2015, the Member State Committee unanimously agreed to the identification of the substances as SVHCs. This led to the substances being included in the Candidate List in June 2015.

 

Further information: