in force 2013-09-01
32012R0528 → 02012R0528-20130923
Amended by Regulation (EU) No 736/2013 32013R0736 · Regulation (EU) No 334/2014 32014R0334
Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market Text with EEA relevance
in force 2013-08-20, 2013-09-01 · detected 2026-09-04
4 provisions touched — 3 substantive, 1 date-only, 3 disputed · 2 changes without an explanation
Emendrix checks every change against three independent sources. Where they disagree it says so rather than picking a winner.
DEFERRED +17 −12 Art. 89 Transitional measures§
applies from: 2024-12-31
dates added to the text: 2024-12-31 · dates removed: 2014-05-14
The only change in this provision is the target date by which the Commission aims to complete the work programme for examining existing active substances, which was shifted from 14 May 2014 to 31 December 2024.
All other text in Article 89, including the remaining paragraphs on transitional arrangements for biocidal products, is unchanged between the two versions.
Cited: Art. 89, v1 · Art. 89, v2
text before / after
32012R0528 → 02012R0528-20130923
Article 89
Transitional measures
1. The Commission shall carry on with the work programme for the systematic examination of all existing active substances commenced in accordance with Article 16(2) of Directive 98/8/EC with the aim of achieving it by 14 May 2014. 31 December 2024. To that end, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 concerning the carrying out of the work programme and specification of the related rights and obligations of the competent authorities and the participants … 600 unchanged words … longer be made available on the market 180 days after the date of such rejection or decision. Disposal and use of existing stocks of such biocidal products may continue until 365 days after the date of such rejection or decision.
MODIFIED ±0 Art. 94§
applies from: unknown
Sources disagree — the EU's own amendment metadata found this change; the text comparison finds no difference in the provision's text. Both are shown; neither is overruled.
No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.
text before / after
No text on either side: this unit was named by a signal that carries no text, and only the structural diff carries any.
MODIFIED ±0 Art. 95§
applies from: unknown
Sources disagree — the EU's own amendment metadata found this change; the text comparison finds no difference in the provision's text. Both are shown; neither is overruled.
No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.
text before / after
No text on either side: this unit was named by a signal that carries no text, and only the structural diff carries any.
MODIFIED +1,150 −0 Annex III ANNEX III§
applies from: unknown (the text changed beyond its dates, so no date that moved can be read as the application date)
dates added to the text: 2013-09-01
Sources disagree — the text comparison found this change; the EU's own amendment metadata does not list it. Both are shown; neither is overruled.
A new point 2.5 has been added to the identity-of-the-biocidal-product sections of both the chemical products title and the micro-organisms title, requiring evidence of technical equivalence where the active substance was manufactured at different locations, by different processes, or from different starting materials than the substance evaluated for approval.
The added text specifies that this equivalence must have been established under Article 54 of the Regulation or, for an evaluation started before 1 September 2013, by a competent authority designated under Article 26 of Directive 98/8/EC.
Cited: Annex III, v2
text before / after
32012R0528 → 02012R0528-20130923
ANNEX III INFORMATION REQUIREMENTS FOR BIOCIDAL PRODUCTS 1. This Annex sets out the information requirements that shall be included in the dossier for the biocidal product accompanying an application for the approval of an active substance in accordance with point (b) of … 1,095 unchanged words … relevant information on individual ingredients, their function and, in the case of a reaction mixture, the final composition of the biocidal product shall be given 2.4. Formulation type and nature of the biocidal product, e.g. emulsifiable concentrate, wettable powder, solution 2.5. Where the biocidal product contains an active substance that has been manufactured in locations or according to processes or from starting materials other than those of the active substance evaluated for the purpose of approval pursuant to Article 9 of this Regulation, evidence has to be provided that technical equivalence has been established in accordance with Article 54 of this Regulation or has been established, following an evaluation having started before 1 September 2013, by a competent authority designated in accordance with Article 26 of Directive 98/8/EC 3. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES 3.1. Appearance (at 20 °C and 101,3 kPa) 3.1.1. Physical state (at 20 °C and 101,3 kPa) 3.1.2. Colour (at 20 °C and 101,3 kPa) 3.1.3. Odour (at 20 °C and 101,3 kPa) 3.2. Acidity/alkalinity The test … 2,621 unchanged words … biocidal product, e.g. micro-organism, active substance(s) and product non-active substances and any other relevant components. All relevant information on individual ingredients and the final composition of the biocidal product shall be given 2.4. Formulation type and nature of the biocidal product 2.5. Where the biocidal product contains an active substance that has been manufactured in locations or according to processes or from starting materials other than those of the active substance evaluated for the purpose of approval pursuant to Article 9 of this Regulation, evidence has to be provided that technical equivalence has been established in accordance with Article 54 of this Regulation or has been established, following an evaluation having started before 1 September 2013, by a competent authority designated in accordance with Article 26 of Directive 98/8/EC 3. BIOLOGICAL, PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE BIOCIDAL PRODUCT 3.1. Biological properties of the micro-organism in the biocidal product 3.2. Appearance (at 20 °C and 101,3 kPa) 3.2.1. Colour (at 20 °C and 101,3 kPa) 3.2.2. Odour (at 20 °C … 1,529 unchanged words … Packaging (type, materials, size, etc.), compatibility of the product with proposed packaging materials to be included 13. SUMMARY AND EVALUATION The key information identified from the endpoints in each subsection (2-12) is summarised, evaluated and a draft risk assessment is performed
The full entry, with the citation mapping v1 = 32012R0528, v2 = 02012R0528-20130923, is committed at eu/32012R0528/CHANGELOG.md.