Changes from adopted text to adopted text

RemovedArticle 34 Transitional provisions

RemovedMember States shall not impede the making available on the market of detergents and surfactants which are placed on the market before [OP: please insert the date = 30 months from the date of entry into force of this Regulation] in conformity with Regulation (EC) No 648/2004 as applicable on … [OP: please insert the date = one day before 30 months from the date of entry into force of this Regulation]

RemovedDetergents and surfactants which, are placed on the market after [OP: please insert the date of application = one day before 30 months from the date of entry into force of this Regulation] and which at the moment of their placing on the market comply with Regulation (EC) No 648/2004 as applicable on [OP: please insert the date of application = one day before 30 months from the date of entry into force of this Regulation], may be made available on the market until [OP: please insert the date = 36 months from the date of entry into force of this Regulation].

RemovedArticle 35 Entry into force and application

RemovedThis Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

RemovedThis Regulation shall apply as of … [OP: please insert the date = 30 months from the date of entry into force of this Regulation].

RemovedThis Regulation shall be binding in its entirety and directly applicable in all Member States.

RemovedDone at …,

RemovedFor the European Parliament For the Council

RemovedThe President The President

RemovedAnnex I

RemovedBIODEGRADABILITY REQUIREMENTS REFERRED TO IN ARTICLE 4

RemovedULTIMATE BIODEGRADABILITY CRITERIA AND TEST METHODS FOR SURFACTANTS AND SURFACTANTS IN DETERGENTS

Removed1. The reference method for laboratory testing of surfactant ultimate biodegradability in this Regulation is based on the EN ISO standard 14593: 1999 (CO2 headspace test).

Removed2. Surfactants and surfactants contained in detergents shall be ultimately biodegradable as determined in accordance with the criteria laid down in point 3.

Removed3. Surfactants and surfactants contained in detergents shall be considered as ultimately biodegradable if they meet one of the following criteria:

Removed(a) the level of biodegradability (mineralisation) is at least 60 % within 28 days measured in accordance with one of the following test methods:

Removed(i) EN ISO Standard 14593: 1999 — Water quality — Evaluation of ultimate aerobic biodegradability of organic compounds in aqueous medium — Method by analysis of inorganic carbon in sealed vessels (CO2 headspace test);

Removed(ii) method C.4.-C Carbon dioxide (CO2) Evolution Test (Modified Sturm Test), described in Part C, Part IV, of the Annex to Commission Regulation (EC) No 440/20081;

Removed(iii) method C.4-D, manometric respirometry test, described in Part C, Part V, of the Annex to Regulation (EC) No 440/2008;

Removed(iv) method C.4-E, closed bottle test, described in Part C, Part VI, of the Annex to Regulation (EC) No 440/2008;

Removed(v) method C.4-F Ministry of International Trade and Industry, Japan (M.I.T.I.) described in Part C, Part VII, of the Annex to Regulation (EC) No 440/2008;

Removed(vi) ISO 10708: 1997 — Water quality — Evaluation in an aqueous medium of the ultimate aerobic biodegradability of organic compounds — Determination of biochemical oxygen demand in a two-phase closed bottle test.

Removed(b) the level of biodegradability (mineralisation) is at least 70% within 28 days measured in accordance with one of the following test methods:

Removed(i) method C.4-A DOC die-away test described in Part C, Part II, of the Annex to Regulation (EC) No 440/2008;

Removed(ii) method C.4-B, modified OECD screening test described in Part C, Part III, of the Annex to Regulation (EC) No 440/2008.

RemovedPre-adaptation shall not be used and the 10-day window principle shall not be applied in any of the test methods referred to in points (a) and (b) .

Removed4. The tests referred to in point 3 shall be conducted by laboratories meeting any of the following conditions:

Removed(a) the laboratories are complying with the principles of good laboratory practice provided for in Directive 2004/10/EC of the European Parliament and of the Council2 or international standards recognised as being equivalent;

Removed(b) the laboratories are accredited in accordance with the standard for laboratories referred to in Regulation (EC) No 765/2008.

RemovedAnnex II

RemovedREQUIREMENTS FOR DETERGENTS CONTAINING MICROORGANISMS REFERRED TO IN ARTICLE 5

Removed1. Micro-organisms intentionally added to detergents shall comply with the following conditions:

Removed(a) shall have an American Type Culture Collection (ATCC) number, belong to a collection of an International Depository Authority (IDA) or have had their DNA identified in accordance with a “Strain identification protocol” (using 16S ribosomal DNA sequencing or an equivalent method); [Am. 124]

Removed(b) shall belong to both of the following:

Removed(i) Risk Group I as defined by Directive 2000/54/EC – biological agents at work;

Removed(ii) The Qualified Presumption of Safety (QPS) list issued by the European Food Safety Authority (EFSA).

RemovedThis point shall not apply to micro-organisms intentionally added to detergents placed on the market for research and development purposes.

Removed2. The following pathogenic micro-organisms shall not be present in any of the strains included in the finished product when screened using the indicated test methods or equivalent:

Removed(a) E. coli, test method ISO 16649-3:2005;

Removed(b) Streptococcus (Enterococcus), test method ISO 21528-1:2004;

Removed(c) Staphylococcus aureus, test method ISO 6888-1;

Removed(d) Bacillus cereus, test method ISO 7932:2004 or ISO 21871;

Removed(e) Salmonella, test method ISO 6579:2002 or ISO 19250.

Removed(ea) Pseudomonas aeruginosa, test method ISO 22717:2015; [Am. 125]

Removed(eb) Candida albicans, test method ISO 18416:2015; [Am. 126]

Removed(ec) any other micro-organisms listed in Annex 1, Table 4 of Regulation (EU) 2020/7411. [Am. 127]

Removed3. Intentionally added micro-organisms shall not be genetically modified microorganisms.

Removed4. Intentionally added micro-organisms shall be, with the exception of intrinsic resistance, susceptible to each of the major antibiotic classes, namely aminoglycoside, macrolide, beta-lactam, tetracycline and fluoroquinolones, in accordance with the European Committee on Antimicrobial Susceptibility Testing (EUCAST) disk diffusion method or equivalent.

Removed5. When placed on the market, detergents containing micro-organisms shall have a standard plate count equal to or greater than 1x105 colony-forming units (CFUs) per ml in accordance with ISO 21149 or ISO 4833-1:2014. [Am. 128]

Removed6. The minimum shelf life of a detergent containing micro-organisms shall not be lower than 24 months and the microbial count shall not decrease by more than 10 % every 12 months in accordance with ISO 21149 or ISO 4833-1:2014. [Am. 129]

Removed7. Detergents containing micro-organisms contained in detergents that areshall be allowed to be placed on the market in a spray format shall pass the acute inhalation toxicity testafter appropriate non-animal approaches to testing the respiratory sensitisation properties of micro-organisms have been established in accordance with the test method B.2Article 26(6a)., described in Part B of the Annex to Regulation (EC) No 440/2008. [Am. 130]

Removed8. Detergents containing micro-organisms shall not be placed on the market in a refill format.

Removed9. All claims made by The manufacturer shall substantiate all claims made regarding the actions or performance of the micro-organisms contained in the product with appropriate tests. Those tests shall be supported by third-party testingverified by an independent third party. [Am. 131]

Removed10. It is prohibited to claim or suggest on the label or by any other communication that the detergent has an antimicrobial or disinfecting effect, unless the detergent complies with Regulation (EU) No 528/2012.

Removed11. The tests referred to in points 2, 5, 6, 7 and 9 shall be conducted by laboratories meeting any of the following conditions:

Removed(a) the laboratories are complying with the principles of good laboratory practice provided for in Directive 2004/10/EC of the European Parliament and of the Council2 or international standards recognised as being equivalent;

Removed(b) the laboratories are accredited in accordance with the standard for laboratories referred to in Regulation (EC) No 765/2008.

RemovedAnnex III

RemovedLIMITATIONS ON THE CONTENT OF PHOSPHATES AND OTHER PHOSPHORUS COMPOUNDS REFERRED TO IN ARTICLE 6