emendrixAccount

Version · BPR

Version in force

Made by Regulation (EU) No 736/2013 32013R0736 on EUR-Lex (external, EUR-Lex) · Regulation (EU) No 334/2014 32014R0334 on EUR-Lex (external, EUR-Lex)

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

Version 1 of 10 recorded for BPR, the oldest recorded.

In force , . First seen by emendrix on , when it first read this version; that is not a legal date.

4 changes in this version

  • 3 substantive
  • 1 dates only
  • 3 where sources differ
  • 1 not in every list
  • 2 no text found
  • 2 without an explanation

What these mean

Consolidated versions 32012R0528 → 02012R0528-20130923. v1 is the previous version, v2 this one.The date in a version's code is the date EUR-Lex gives that consolidated text, which can differ from its in-force date: this version, coded 20130923, is in force from 1 September 2013.

Everything Regulation (EU) No 736/2013 changed

Everything Regulation (EU) No 334/2014 changed

What changed

Art. 89 Transitional measures, Deferred

+17 −12 characters · Applies from: 2024-12-31

dates added to the text: 2024-12-31 · dates removed: 2014-05-14

Explanation, written by a model and checked against the cited text

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 (external, EUR-Lex) · Art. 89, v2 (external, EUR-Lex)

v1 is the previous version, v2 this one.

Text from EUR-Lex, before and after

Previous version 32012R0528 → this version, in force 1 September 2013 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.

Annex III INFORMATION REQUIREMENTS FOR BIOCIDAL PRODUCTS, Modified

+1,150 −0 characters · Applies from: not readable (the text changed beyond its dates, so no date that moved can be read as the application date) why

dates added to the text: 2013-09-01

Not in every listWhat this means

Found in the text, but not every source lists it — the text comparison found this change; the EU's own amendment metadata does not list it. The source that does not name it is the EU's own amendment metadata. Both are shown; neither is overruled.

Explanation, written by a model and checked against the cited text

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 (external, EUR-Lex)

v1 is the previous version, v2 this one.

Text from EUR-Lex, before and after

Previous version 32012R0528 → this version, in force 1 September 2013 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

2 provisions named with no text to show

Each row carries the provision and the source that named it, and opens in place from the § link at its end. None was dropped and every one still counts where sources differ above.

Art. 94, Modified named by the EU's own amendment metadata

Applies from: not readable why

No text foundWhat this means

A source lists it, but there is no text to show — the EU's own amendment metadata found this change; the text comparison finds no difference in the provision's text. Only the EU's own amendment metadata names it, and it carries no text. Both are shown; neither is overruled.

No explanation shipped — the text comparison did not see this change, so it carries no text; another source named the provision, and it is listed where sources differ.

Text from EUR-Lex: none to show

No text on either side: this unit was named by a signal that carries no text, and only the structural diff carries any.

Art. 95, Modified named by the EU's own amendment metadata

Applies from: not readable why

No text foundWhat this means

A source lists it, but there is no text to show — the EU's own amendment metadata found this change; the text comparison finds no difference in the provision's text. Only the EU's own amendment metadata names it, and it carries no text. Both are shown; neither is overruled.

No explanation shipped — the text comparison did not see this change, so it carries no text; another source named the provision, and it is listed where sources differ.

Text from EUR-Lex: none to show

No text on either side: this unit was named by a signal that carries no text, and only the structural diff carries any.

The full entry is committed at eu/32012R0528/CHANGELOG.md.