technical equivalence

Definitions over time (2)

29/03/2021 – today applies on 12/11/2026 Article 3, Regulation (EU) No 528/2012 Scope: Whole act

For the purposes of this Regulation, the following definitions shall apply:

‘technical equivalence’ means similarity, as regards the chemical composition and hazard profile, of a substance produced either from a source different to the reference source, or from the reference source but following a change to the manufacturing process and/or manufacturing location, compared to the substance of the reference source in respect of which the initial risk assessment was carried out, as established in Article 54;
23/09/2013 – 25/04/2014 Article 3, Regulation (EU) No 528/2012 Scope: Whole act

For the purposes of this Regulation, the following definitions shall apply:

‘technical equivalence’ means similarity, as regards the chemical composition and hazard profile, of a substance produced either from a source different to the reference source, or from the reference source but following a change to the manufacturing process and/or manufacturing location, compared to the substance of the reference source in respect of which the initial risk assessment was carried out, as established in Article 54;

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