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Regulation (EU) No 528/2012

Preamble
Recitals 76
Chapter I - SCOPE AND DEFINITIONS (Article 1-3) 3
Chapter II - APPROVAL OF ACTIVE SUBSTANCES (Article 4-11) 8
Chapter III - RENEWAL AND REVIEW OF APPROVAL OF AN ACTIVE SUBSTANCE (Article 12-16) 5
Chapter IV - GENERAL PRINCIPLES CONCERNING THE AUTHORISATION OF BIOCIDAL PRODUCTS (Article 17-24) 8
Chapter V - SIMPLIFIED AUTHORISATION PROCEDURE (Article 25-28) 4
Chapter VI - NATIONAL AUTHORISATIONS OF BIOCIDAL PRODUCTS (Article 29-31) 3
Chapter VII - MUTUAL RECOGNITION PROCEDURES (Article 32-40) 9
Chapter VIII - UNION AUTHORISATIONS OF BIOCIDAL PRODUCTS (Article 41-46) 6
Chapter IX - CANCELLATION, REVIEW AND AMENDMENT OF AUTHORISATIONS (Article 47-52) 6
Chapter X - PARALLEL TRADE (Article 53) 1
Chapter XI - TECHNICAL EQUIVALENCE (Article 54) 1
Chapter XII - DEROGATIONS (Article 55-57) 3
Chapter XIII - TREATED ARTICLES (Article 58) 1
Chapter XIV - DATA PROTECTION AND DATA-SHARING (Article 59-64) 6
Chapter XV - INFORMATION AND COMMUNICATION (Article 65-73) 9
Chapter XVI - THE AGENCY (Article 74-79) 6
Chapter XVII - FINAL PROVISIONS (Article 80-97) 18
Annexes 7

new active substance

Defined in Article 3, Regulation (EU) No 528/2012

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:

‘new active substance’ means a substance which was not on the market on 14 May 2000 as an active substance of a biocidal product for purposes other than scientific or product and process-orientated research and development;
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:

‘new active substance’ means a substance which was not on the market on 14 May 2000 as an active substance of a biocidal product for purposes other than scientific or product and process-orientated research and development;

Earlier definition records in this act (2)

Open an entry to see its definitions, dates and uses. Separate scopes and histories are kept intact.

Article 3(1)(e) Historical · definitions end 23/09/2013
Article 3(1)(e) Historical · definitions end 29/03/2021

Used in (13 places in 6 provisions on 12/11/2026)

Regulation (EU) No 528/2012 (13 in 6)

Recital 7⁴ · Recital 56 · Article 3 · Article 42 · Article 55⁴ · Article 60²