How we are engaged in the restriction process in accordance with the REACH Regulation
REACH envisages a restriction of substances which pose an unacceptable risk to human health or the environment. In such cases, we have the opportunity to submit a restriction proposal if, from our point of view, the problem should be addressed at the EU-wide level.
The REACH Regulation allows the competent authorities of the Member States to propose restrictions for specific substances. The prerequisite for this is the presence of an unacceptable risk requiring a Europe-wide regulation.
Restrictions can refer to the use of a substance itself, to the presence of a substance in an article, or can stipulate minimum standards of use. Outside the scope of the restriction, usage remains permitted.
The REACH Assessment Unit OSH is engaged in the restriction process and conducts research in order to determine what risks arise for workers from certain substances or procedures. The research results and a proposal for a restriction are set out in the so-called restriction dossier of the REACH Regulation.
This dossier includes an analysis of the socio-economic impacts of the proposed restriction measure. The costs to be expected due to the measure are compared to its benefits. This is to ascertain whether the proposed restriction is proportional. Both, the impact on users and the economy in general are taken into account.
During the course of the process involved actors and interested parties have several opportunities to comment. The first opportunity occurs when a substance is named publicly in the Public Activity Coordination Tool (PACT). In a consultation process initiated by Germany, the Assessment Units gather information with the purpose of determining the most appropriate risk management measure for the corresponding substance. Following the assessment of the comments, the possible risk management options are analysed and a decision is made regarding the further approach. The results are reported in a so-called Risk Management Options Analysis (RMOA).
When the restriction dossier is discussed in the committees of the ECHA (Risk Assessment Committee (RAC) and Socio-economic Analysis Committee (SEAC)), it is possible for stakeholders to submit comments on the substances and processes again. All of the comments made and information to be submitted are taken into consideration in the decision.
The final decision of whether a restriction will enter into force is made by the European Commission on the basis of the recommendations of RAC and SEAC.