Regulation (EC) No. 1907/2006 of the European Parliament and the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals entered into force on 1st June 2007. The aim of the Regulation is to ensure a high level protection of human health and the environment as well as the free circulation of substances within the European market, while enhancing competitiveness and innovation. The provisions of REACH shall apply to the manufacturing, marketing or use of substances on their own, in preparations or in articles.
A considerable difference compared to the previous regulations is that REACH takes all the tasks and responsibilities away from the competent authorities and transfers them to the industry, thereby it terminates the differentiation between ”existing” and ”new” chemicals by introducing a uniform order of proceedings and testing requirements for all substances.
According to the REACH Regulation, all substances manufactured in or imported in minimum 1 t/year into the European Union shall be registered. Delayed registration applies to the so called phased-in substances, providing we pre-register them. The pre-registration is free and it requires only basic information (identification of the company, identification of the substance, annual manufactured quantity and the planned registration deadline). On the contrary, the registration dossier contains 8000 data/substance, whose adequacy has to be justified with studies and review summaries. In case of joint submission, the registration fee is €23,250 /substance per manufacturer, the compilation cost of dossiers is much more expensive, approx. €250,000 /substance. There is an opportunity for manufacturers of the same substance to form a consortium and share the compilation costs of the dossier.
The following deadlines are determined by REACH:
There are two types of evaluation. The dossier evaluation is carried out by the European Chemicals Agency (ECHA) and consists of the dossier completeness check, the content and formal evaluation of data as well as the judgement on the further testing proposals made by the registrars.
In the course of ”substance evaluation”, the competent authorities of any member state could initiate the evaluation of any substance, if they can convincingly justify the suspicion that both manufacturing and the use of that substance is dangerous to human health and the environment. The substance evaluation is performed by the competent authorities of the Member States.
Substances subject to authorisation can be used only in case the particular use has been authorised and the user meets the requirements stated in the permission, or the use is exempted from the licensing obligation (e.g. intermediate uses).
Only substances being the most dangerous to health and the environment are placed on the list of substances subject to authorisation. Category 1 and 2 carcinogenic, mutagenic and substances toxic for reproduction (CMR 1 and 2) as well as persistent, bio-accumulative and toxic substances are concerned in that case. Substances subject to authorisation are continuously put on a candidate list first, then into Annex 14 of REACH based on the decision of the Commission, to the list of substances to be authorized. A so called ”sunset date” is assigned to each substance subject to authorisation and following this date the substance can be used only with permission.
In the interest of smooth raw and auxiliary material supply necessary for production, we have to ascertain that all of our suppliers will pre-register then register their manufactured substances, since following 30th of November 2008, the substances without pre-registration can not be manufactured/imported to the Community. In the interest thereof, we sent out questionnaires to all suppliers, wherein we inquired about their pre-registration/registration intentions. Approx. two thirds of the questionnaires were returned, which we processed and recorded their responses. Lately, more and more companies have been using the Internet questionnaires, which are processed automatically. With the help of our IT department, we have expanded BorsodChem’s website with a function that is suitable for this task.
It is necessary to prepare a material inventory concerning our manufactured substances for pre-registration and later registration. Since only pre-registered substances can be registered, therefore it is required to regard all the substances aimed to be manufactured in the future. In the course of pre-registration, relatively few data need to be given, but in some cases the obtaining/observation of the required information is especially difficult.
BorsodChem has pre-registered all their manufactured substances.
Questionnaires from our downstream users are continuously arriving at the moment, in which they inquire about our registration aim. Our actual point of view is that we will register all of our manufactured substances. In the later stage of REACH we shall obtain information on the application of our manufactured substances and the exposure of the user. Related thereto, we shall elaborate exposure scenarios as part of the chemical safety report and on this basis we shall determinate the range of utilisations suggested by us.
Once a manufacturer or an importer pre-registers his substance, on the ECHA REACH-IT information surface they will have access to those manufacturers who have also pre-registered the actual substance. Thereafter, manufacturers of the same substance will form a Substance Information Exchange Forum (SIEF), wherein they jointly make and submit the registration dossier. BorsodChem participates in the work of several trade organizations (ISOPA, Euro Chlor, ECVM), which have already commenced to arrange the establishment of consortium..
REACH Coordination
E-mail: reach@borsodchem.hu