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substantial change

as defined in Directive 2008/1/EC of the European Parliament and of the Council of 15 January…, Article 2, point (11) (Definitions)

a change in operation which, in the opinion of the competent authority, may have significant negative effects on human beings or the environment; for the purposes of this definition, any change to or extension of an operation shall be deemed to be substantial if the change or extension in itself meets the thresholds, if any, set out in Annex I

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