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The provisions of REACH apply to the manufacturing, marketing or use of substances on their own, in preparations or in articles.
Unlike previous regulations, REACH removes all tasks and responsibilities from the competent authorities and transfers them to the industry. It dispenses with the differentiation between “existing” and “new” chemicals by introducing uniform procedures and testing requirements for all substances.
Registration and pre-registration
According to the REACH Regulation, all substances manufactured or imported into the European Union in quantities of 1 tonne per year or more shall be registered.
Delayed registration applies to so-called “phased-in” substances, provided they are pre-registered. Pre-registration is free and requires only basic information (identification of the company and substance, quantity manufactured annually and planned registration deadline).
Registration, however, requires 8000 data per substance, supported by studies and review summaries. The compilation cost of the dossier is approximately €250,000 per substance. Manufacturers of the same substance may form a consortium and share dossier costs. In this case, the registration fee is €23,250 per substance per manufacturer.
The following deadlines have been determined by REACH:
1 June 2008 – 3 November 2008: pre-registration (irrespective of manufactured/imported amount)
1 December 2010: registration of substances manufactured or imported in quantities of over 1,000 tonnes per year
1 June 2013: registration of substances manufactured or imported in quantities of over 100 tonnes per year
1 June 2018: registration of substances manufactured or imported in quantities of over 1 tonne per year
There are two types of evaluation:
Dossier evaluation is carried out by the European Chemicals Agency (ECHA). The registrars check the completeness of the dossier, formally evaluate the data and make further testing proposals.
Substance evaluation can be initiated and carried out by the competent authorities of any member state, if they can justify the suspicion that manufacturing and use of a substance endangers human health or the environment.
Substances subject to authorisation can only be used if the particular use has been authorised and the user meets the requirements stated in the permission, or if the use is exempted from licensing obligation (e.g. intermediate uses).
Only the most dangerous substances for health and the environment are placed on the list of substances subject to authorisation. These include Category 1 and 2 carcinogenic substances, mutagenic substances, substances that are toxic for reproduction (CMR 1 and 2) and persistent, bio-accumulative and toxic substances.
Substances subject to authorisation are placed on a candidate list first. Then, based on the decision of the Commission, they are added to Annex XIV of REACH, the list of substances to be authorised. A so called “sunset date” is assigned to each one. After this date, the substance can only be used with permission.
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