These Regulations implement Directive 2001/42/EC of the European Parliament and Council on the assessment of the effects of certain plans and programs on the environment, as regards plans and programs which relate solely to the whole or any part of Scotland. Subject to the exceptions, where the first formal preparatory act in relation to a plan or program to which the Regulations apply is after 21 July 2004, the plan or program cannot be adopted, or submitted for adoption, unless it has been subjected to environmental assessment under the Regulations. The requirement for environmental assessment applies, in particular, to any plan or program prepared for agriculture, forestry, fisheries, energy, industry, transport, waste management, water management, telecommunications, tourism, town and country planning or land use, which sets the framework for future development consent of projects listed in Annex I or II to Council Directive 85/33/EEC on the assessment of the effects of certain public and private projects on the environment, as amended by Council Directive 97/11/EC; and to any plan or program which, in view of the likely effect on sites, has been determined to require an assessment pursuant to Article 6 or 7 of Council Directive 92/43/EEC on the conservation of natural habitats and of wild flora and fauna, as last amended by Council Directive 97/11/EC. Regulation 13 deals with the making of determinations by the responsible authority as to whether a plan or program is likely to have significant environmental effects. Regulation 21 provides for the monitoring of the significant environmental effects of implementing plans and programs. Other provisions deal with assessment procedures and institutions involved.