anx_IV__cpt_1__cpt_1__cpt_1__cpt_3__text_1

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products Text with EEA relevance · European Union

As a general rule, in accordance with Article 7(3) of Regulation (EC) No 1272/2008, tests on humans shall not be performed for the purposes of this Regulation. However, existing historical human data, such as epidemiological studies on exposed populations, accidental or occupational exposure data, biomonitoring studies, clinical studies and human volunteer studies performed in accordance with internationally accepted ethical standards shall be considered.

← 1.1.3. Historical human data · All articles · anx_IV__cpt_1__cpt_1__cpt_1__cpt_3__text_2 →

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