Changes from plenary report to adopted text

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

AddedPre-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) .

Added4. The tests referred to in point 3 shall be conducted by laboratories meeting any of the following conditions:

Added(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;

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

AddedAnnex II

AddedREQUIREMENTS FOR DETERGENTS CONTAINING MICROORGANISMS REFERRED TO IN ARTICLE 5

Added1. Micro-organisms intentionally added to detergents shall comply with the following conditions:

Added(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]

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

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

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

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

Added2. 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:

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

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

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

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

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

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

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

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

Added3. Intentionally added micro-organisms shall not be genetically modified microorganisms.

Added4. 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.

Added5. 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]

Added6. 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]

Added7. 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]

Added8. Detergents containing micro-organisms shall not be placed on the market in a refill format.

Added9. 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]

Added10. 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.

Added11. The tests referred to in points 2, 5, 6, 7 and 9 shall be conducted by laboratories meeting any of the following conditions:

Added(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;

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

AddedAnnex III

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

Added[Am. 132]

AddedAnnex IV

AddedCONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 7(2)

AddedModule A - Internal production protocol

Added1. Description of the module

AddedInternal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his or her sole responsibility that the detergent or surfactant concerned satisfy the requirements of this Regulation that apply to them.

Added2. Technical documentation

Added2.1. The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess conformity of the detergent or surfactant with the relevant requirements, and shall include an adequate analysis and assessment of the risks.

Added2.2. The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and intended use of the detergent or surfactant. The technical documentation shall contain, where applicable, at least the following elements:

Added(a) a general description of the detergent or surfactant and a description of the intended use;

Added(b) the test reports demonstrating the compliance with Annex I and, where applicable, with Annexes II and III;

Added(c) a list of test methods used to demonstrate compliance with the requirements of this Regulation ;

Added(d) results of calculations made and examinations carried out;

Added(e) an ingredient data sheet which meets the following requirements:

Added(i) lists all intentionally added substances and preservatives referred to in Part A of Annex V;

Added(ii) the common chemical name or IUPAC name and, where available, the INCI name, the CAS number, and the European Pharmacopoeia name, is given for each ingredient;

Added(iii) all substances are listed in order of decreasing abundance by weight, and the list is sub-divided into the following weight percentage ranges:

Added(1) 10 % or more,

Added(2) 1 % or over, but less than 10 %,

Added(3) 0,1 % or over, but less than 1 %,

Added(4) less than 0,1 %.

AddedFor the purposes of point (e), a perfume, an essential oil, or a colouring agent shall be considered to be a single component.

Added3. Manufacturing

AddedThe manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the detergent or surfactant with the technical documentation referred to in point 2 and with the requirements of this Regulation that apply to them.

AddedAnnex V