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(b)

either: the Commission has requested one or more European standardisation organisations to draft a harmonised standard and there are undue delays in the standardisation procedure or the request has not been accepted by any European standardisation organisations; or the Commission can demonstrate that a technical specification respects the requirements laid down in Annex II of Regulation (EU) No 1025/2012, except for the requirement that the technical specifications should have been developed by a non-profit making organisation.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.