DEHP and REACH
REACH is the Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1st June 2007 to streamline and improve the former legislative framework on chemicals of the European Union (EU).
Under the REACH legislation all chemicals will have to be registered for use with the European Chemicals Agency and certain chemicals will eventually have to be authorised for use if they are considered to be Substances of Very High Concern (SVHC). The REACH Authorisation process contains the following key steps; identification and prioritisation of substances by European authorities, the application for authorisation by industry and the granting of authorisation by the European Commission. These steps are explained further here.
On 28 October 2008, the European Chemicals Agency (ECHA) published a list of the first substances to enter onto the REACH authorisation "candidate list". As expected, DEHP was included on the list due to its EU hazard classification. The full list of substances is available here.
Recommendation
On 14 January 2009, ECHA published its draft recommendation on the prioritisation of DEHP and invited interested parties to submit comments on the ECHA website before 14 April 2009. The consultation page of ECHA is available here.
On June 1 2009, ECHA subsequently recommended that DEHP is prioritised for entry into the REACH Annex. If - as is expected - the ECHA recommendation is accepted, the European Commission will amend the REACH Annex (probably by the end of 2009), and industry will have until around mid-2012 to apply for authorisation for uses of DEHP. Producers and users who have not applied for authorisation before that date would have until around the end of 2013 to continue to use the substance.
DEHP can continue to be used
DEHP users can continue to use DEHP with confidence. Furthermore, DEHP producers remain committed to managing this regulatory process to ensure the continued availability of DEHP beyond 2013.
The inclusion of DEHP on the “candidate list” for authorisation means that any supplier of an article containing more than 0.1% weight by weight (w/w) DEHP now has an obligation to provide information to the recipient of that article. As a minimum, recipients - who can be anyone in the supply chain from a distributors and retailers to professional end-users - need to be told that the article contains DEHP.
Further down the supply chain, retailers also have an obligation to provide the same information to consumers, but only if a consumer requests it. A retailer has 45 days in which to provide the information. For this purpose, ECPI has produced a fact sheet on DEHP.
A letter from the European Commission also clarifies some of the legal obligations in this context.
Notification
From 1 June 2011 the presence in articles of substances included in the candidate list will have to be notified to the European Chemical Agency (ECHA) if the substance is present in those articles in more than one tonne per producer or importer per year and if it is present in those articles above a concentration of 0.1% weight by weight.
DEHP should receive authorisation for the majority of its uses. The results of the European Union's Risk Assessment of DEHP, conducted under the Existing Substances Regulation EEC 793/93, have proven that any risks arising from the production and use of DEHP can be adequately controlled.
Although DEHP is classified in the European Union as a Category 2 reproductive toxicant for both fertility and developmental effects consumers can remain assured that its use in everyday products does not pose a health risk.