2007
Press Release
Tuesday 5 June 2007
For Immediate Release
E.C. ‘REACH’ Directive introduced 1 June 2007
– is it the right formula for Ireland’s PharmaChem industry?
As of 1 June 2007 any producer, exporter, importer or distributor of chemicals in Ireland, in volumes of one tonne or more, will have to register them with a new E.U. chemicals agency recently established for the purpose in Helsinki.
The Regulation, Evaluation and Authorisation of CHemicals, known as REACH, has been brought into force by an E.C. Directive implemented in all Member States on Friday 1 June, and will require the registration of approximately 30,000 chemicals over the next 11 years.
John Whelan, Chief Executive of the Irish Exporters Association (IEA) stated:
“The cost of registration is estimated at €23 million to cover all Irish producers, exporters and importers over the 11 year period, to meet the REACH requirements.”
He went on to say:
“Clearly, companies affected by the new Directive will seek to pass increased costs down the supply chain.” And he acknowledged that it will affect all European manufacturers.
”However” he stated, “there is a competitive challenge in that neither Asian countries nor US chemical and pharmaceutical manufacturers are currently required to meet the same rigorous registration regime.”
He further stated:
“There is a critical role for the Irish Government to ensure that, despite EC Directives such as REACH, Ireland maintains an attractive environment for international pharmaceutical and chemical companies, not only for those directly employed by them but also for the myriad of support industries that have grown up around them.”
He concluded by saying:
“The Irish pharmaceutical industry has been based on bulk manufacture of active agents or ingredients. The REACH Directive will add to the need to rapidly progress towards adding complementary activities in completed products and in R&D of new products.”
ENDS
For further information contact: John Whelan
Telephone: 01 661 2182 – Fax 01 661 2315
Email: jfwhelan@irishexporters.ie
05/06/07
For further information on REACH, please see below.
About the Irish Exporters Association (IEA)
The IEA represents the needs of export industry ensuring that the necessary conditions are created and the necessary support is provided to assist companies to maximise their export sales. The IEA draws its membership from every exporting sector, ensuring that the interests of all industries are represented and promoted at the highest level. http://www.irishexporters.ie/
Further information on REACH:
In October 2003 the European Commission proposed a new regulatory system. The Regulation, Evaluation and Authorisation of CHemicals, known as REACH, came into force on 1June 2007 and requires the registration of 30,000 chemicals over 11 years. Any producer or importer of chemicals in volumes of one tonne or more a year will have to register them with a new EU Chemicals Agency. Registration must include information on properties, uses and safe ways of handling them and will enable public authorities to look in more detail at registration dossiers and at substances of concern and request more information if necessary. Furthermore, use-specific authorisation will be required for chemicals that cause cancer, mutations or problems with reproduction, or that accumulate in the body and the environment. Authorisation will only be granted to those companies that can show that risks are adequately controlled or where social and economic benefits outweigh the risks if there are not suitable alternative substances or technologies.
The EC will be able to restrict the use of certain dangerous substances at EU level and REACH will introduce clearer procedures to allow decisions to be taken more quickly than is currently the case.
The cost of registration is estimated at €2.3 billion over the 11 years, but to downstream users this is estimated at between €2.8 billion and €5.2 billion. According to the EU, if REACH succeeds in reducing chemical related diseases by only 10%, the health benefits have been estimated at €50 billion over 30 years.
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