L 136/128

ENOfficial Journal of the European Union
ANNEX XVISOCIO-ECONOMIC ANALYSISThis Annex outlines the information that may be addressed by those submitting a socio-economic analysis (SEA) with anapplication for authorisation, as specified in Article 62(5)(a), or in connection with a proposed restriction, as specified inArticle 69(6)(b).
The Agency shall prepare guidance for the preparation of SEAs. SEAs, or contributions to them, shall be submitted in theformat specified by the Agency in accordance with Article 111.
However, the level of detail and scope of the SEA, or contributions to them, shall be the responsibility of the applicant forauthorisation, or, in the case of a proposed restriction, the interested party. The information provided can address thesocio-economic impacts at any level.
An SEA may include the following elements:— impact of a granted or refused authorisation on the applicant(s), or, in the case of a proposed restriction, the impact
on industry (e.g. manufacturers and importers). The impact on all other actors in the supply chain, downstream users
and associated businesses in terms of commercial consequences such as impact on investment, research and development, innovation, one-off and operating costs (e.g. compliance, transitional arrangements, changes to existingprocesses, reporting and monitoring systems, installation of new technology, etc.) taking into account general trends
in the market and technology,— impacts of a granted or refused authorisation, or a proposed restriction, on consumers. For example, product prices,changes in composition or quality or performance of products, availability of products, consumer choice, as well aseffects on human health and the environment to the extent that these affect consumers,— social implications of a granted or refused authorisation, or a proposed restriction. For example job security andemployment,— availability, suitability, and technical feasibility of alternative substances and/or technologies, and economic consequences thereof, and information on the rates of, and potential for, technological change in the sector(s) concerned. In
the case of an application for authorisation, the social and/or economic impacts of using any available alternatives,— wider implications on trade, competition and economic development (in particular for SMEs and in relation to thirdcountries) of a granted or refused authorisation, or a proposed restriction. This may include consideration of local,regional, national or international aspects,— in the case of a proposed restriction, proposals for other regulatory or non-regulatory measures that could meet theaim of the proposed restriction (this shall take account of existing legislation). This should include an assessment of
the effectiveness and the costs linked to alternative risk management measures,— in the case of a proposed restriction or refused authorisation, the benefits for human health and the environment aswell as the social and economic benefits of the proposed restriction. For example, worker health, environmental
performance and the distribution of these benefits, for example, geographically, population groups,— an SEA may also address any other issue that is considered to be relevant by the applicant(s) or interested party.

29.5.2007