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3.: Dossiers for restrictions proposal

Proposal

The proposal shall include the identity of the substance and the restriction(s) proposed for the manufacture, placing on the market or use(s) and a summary of the justification.

Information on hazard and risk

The risks to be addressed with the restriction shall be described based on an assessment of the hazard and risks according to the relevant parts of Annex I and shall be documented in the format set out in Part B of that Annex for the Chemical Safety Report.
Evidence shall be provided that implemented risk management measures (including those identified in registrations under Articles 10 to 14) are not sufficient.

Information on alternatives

Available information on alternative substances and techniques shall be provided, including:
information on the risks to human health and the environment related to the manufacture or use of the alternatives,
availability, including the time scale,
technical and economical feasibility.

Justification for Restrictions at Community Level

Justification shall be provided that:
action is required on a Community-wide basis,

 a restriction is the most appropriate Community wide measure which shall be assessed using the following criteria:

 

(i) effectiveness: the restriction must be targeted to the effects or exposures that cause the risks identified, capable of reducing these risks to an acceptable level within a reasonable period of time and proportional to the risk;

(ii) practicality: the restriction must be implementable, enforceable and manageable;

(iii) monitorability: it must be possible to monitor the result of the implementation of the proposed restriction.

Socio-economic assessment

The socio-economic impacts of the proposed restriction may be analysed with reference to Annex XVI. To this end, the net benefits to human health and the environment of the proposed restriction may be compared to its net costs to manufacturers, importers, downstream users, distributors, consumers and society as a whole.

Information on stakeholder consultation

Information on any consultation of stakeholders and how their views have been taken into account shall be included in the dossier.