REGULATION & COMPLIANCE

In developing REACH restrictions , an EU member state or ECHA reports the justification for the proposed restriction . This includes information on alternatives and costs , as well as benefits of the restriction . An intention to prepare a restriction proposal is published beforehand . That is a moment for companies to gather and send socio-economic information to the authority drafting the proposal . Further on in the process , the Socio-Economic Assessment Committee of REACH will give its opinion on the socio-economic aspects . A draft report is published and stakeholders can respond to that draft in the public consultation . In the REACH authorisation process , it is up to the applicants for authorisation to prepare a dossier . This dossier must include a socioeconomic assessment if it cannot be shown that there will be no risk when the authorisation is granted . Even where there is no risk , it is advisable to supply a socioeconomic assessment to support the application as well . Specific guidance and formats are available for this application .

BPR exclusion criteria can likewise arise , even though substances that are considered too hazardous , such as carcinogens or substances toxic to reproduction , are in principle not acceptable under the BPR . In some cases they can be accepted , specifically if the benefits for society are larger than the expected negative impacts . This can be shown by the applicant by justifying that non-approval will lead to serious dangers to human health , animal health or the environment , or by showing a disproportionate negative impact on society . Occupational exposure limits ( OELs ) are derived under the rules of the CAD or the CMD . This is the responsibility of DG Employment , Social Affairs & Inclusion . The full process is a seven-step process from the selection of chemicals for evaluation to the adaptation of the Directive with the OEL and publication in the Official Journal . Step four is the impact assessment . This is also the responsibility of the DG , but in practice is carried out by consultants . Part of the process is gathering information from stakeholders , basically the producers and users of the substance , usually via ( internet ) questionnaires . Socioeconomic aspects are a crucial part in the information to be provided .

How to provide information

The ways in which information can be provided on the socio-economic impact of a regulatory proposal are variable . This can be via a format described by a guidance document , or via a free-text e-mail . In some cases , questionnaires are used to gather information from stakeholders . Whatever the format , actual convincing information is crucial for input to be taken seriously . Simply stating ‘ This is too expensive ’ will have little or no effect on the process . Almost all formats and processes allow for a proper analysis to be submitted , either within the given format or as an appendix . A proper study of the impact with calculated costs for different sectors in Europe , without neglecting the benefits , should not be simply neglected . For example , based on a socioeconomic assessment of possible OEL values of 1,3-butadiene , made on behalf of a number of affected sector groups , the Socio-Economic Council

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. Figure 2 – Examples of regulatory risk management tools for chemicals

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