2013 sees the first deadlines under the Authorisation program of REACH.
Uses of substances that are listed on Annex XIV of REACH will be subject to a system of pre-approval otherwise called Authorisation.
Companies using these substances must apply to the European Chemicals Agency (ECHA) by the Latest Application Date (see the table below) for an Authorisation for continued use. Companies which do not apply for their use of the substance to be authorised by ECHA must stop that particular use by the Sunset Date set by the European Commission.
Certain uses are exempt from the need to apply for an Authorisation; at the current time these are specific uses of certain phthalates (butyl benzyl, bis(2-ethylhexyl) and dibutyl) in the intermediate packaging of medicinal products. Full details can be found on the ECHA Annex XIV webpage: authorisation list.
Substances listed in the table below have Latest Application Dates in 2013-
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In addition to the substances listed above three substances have latest application dates of 21 February 2014: Hexabromocyclododecane and its isomers; 2,4-dinitrotoluene and tris(2-chloroethyl) phosphate.
Recently ECHA has recommended that a further 10 substances should be placed on Annex XIV ECHA recommendations for Authorisation. These proposals are currently being assessed by the Commission and a decision will be taken in the near future concerning their inclusion on Annex XIV and the relevant Latest Application and Sunset dates.
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If your company uses or imports any of these substances you need to be aware of your obligations concerning authorisation and begin planning accordingly.
An application for authorisation must include the following:
- The identity of the substance
- Details of the person making the application
- The actual request for authorisation specifying the uses of the substance for which the authorisation is sought
- A chemical safety report (unless submitted with the Registration dossier) detailing the risks to human health and the environment from the proposed uses.
- An assessment of available alternative substances, including the risks from use and the technical and economic feasibility of substitution. Any relevant information on the applicants’ research and development activities into alternatives must be included.
- Where suitable alternatives are identified, a timetabled substitution plan.
The preparation of an authorisation application can be time consuming and costly. The minimum application (“filing”) fees are 7,500€ for a micro enterprise, 25,000€ for a small enterprise and 50,000€ for a standard application, with extra fees for additional uses and applicants. These do not include the costs for the preparation of the authorisation dossier and the assessment of alternatives and socio-economic considerations.
It should also be understood that ultimately the application may not be successful and the proposed use is not accepted.
A very relevant presentation on the economic considerations associated with an Authorisation Application was given by Richard Dubourg at the ECHA Stakeholder day in 2012. The slide set is available from the following hyperlink: Analysis of alternatives and Socio-economic analysis while the actual presentation can be found here .
Any application for authorisation needs to be weighed against the long term needs of the business, given that any permissions granted for the continued use of an Annex XIV substance are only temporary in nature.
H2 Compliance will be happy to talk to you about any further queries concerning the Authorisation process.
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