Changes from adopted text to adopted text

Removed[Am. 132]

RemovedAnnex IV

RemovedCONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 7(2)

RemovedModule A - Internal production protocol

Removed1. Description of the module

RemovedInternal 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.

Removed2. Technical documentation

Removed2.1. 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.

Removed2.2. 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:

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

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

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

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

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

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

Removed(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;

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

Removed(1) 10 % or more,

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

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

Removed(4) less than 0,1 %.

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

Removed3. Manufacturing

RemovedThe 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.

RemovedAnnex V

RemovedLABELLING REQUIREMENTS

RemovedPART A – LABELLING OF CONTENTS

RemovedThe information to be included on the labels of detergents and surfactants made available on the market

Removed1. The weight percentage ranges ‘less than 5 %’, ‘5 % or over but less than 15 %’, ‘15 % or over but less than 30 %’, ‘30 % and more’, shall be used to indicate the content of the constituents listed below where they are added in a concentration above 0,2 % by weight:

Removed(a) phosphates,

Removed(b) phosphonates,

Removed(c) anionic surfactants, [Am. 133]

Removed(d) cationic surfactants, [Am. 134]

Removed(e) amphoteric surfactants, [Am. 135]

Removed(f) non-ionic surfactants, [Am. 136]

Removed(g) oxygen-based bleaching agents,

Removed(h) chlorine-based bleaching agents,

Removed(i) EDTA and salts thereof,

Removed(j) NTA (nitrilotriacetic acid) and salts thereof,

Removed(k) phenols and halogenated phenols,

Removed(l) paradichlorobenzene,

Removed(m) aromatic hydrocarbons,

Removed(n) aliphatic hydrocarbons,

Removed(o) halogenated hydrocarbons,

Removed(p) soap,

Removed(q) zeolites,

Removed(r) polycarboxylates.

Removed2. The following classes of constituents, if added, shall be listed irrespective of their concentration:

Removed(a) enzymes,

Removed(b) micro-organisms,

Removed(c) optical brighteners,

Removed(d) perfumes.

Removed3. Preservatives shall be listed, using where possible the system referred to in Article 33 of Regulation (EC) No 1223/2009, irrespective of their concentration, provided that they meet the following conditions:

Removed(a) contribute to the qualification of the detergent as a treated article within the meaning of Article 3(1), point (l), of Regulation (EU) No 528/2012;

Removed(b) are labelled on a constituent of the detergent.

RemovedThe condition listed in point (b) of the first subparagraph does not have to be met where preservatives do not exceed the elicitation thresholds referred to in point 3.4.3.3. / table 3.4.6. of Annex I to Regulation (EC) No 1272/2008 or they no longer have a preservation function in the final product even in synergies with other preservatives.

RemovedWhere a digital label is provided in accordance with Article 16(1) of this Regulation, the preservatives shall be listed, using where possible the system referred to in Article 33 of Regulation (EC) No 1223/2009, irrespective of their concentration. [Am. 137]

Removed4. If added at concentrations exceeding 0,01 % by weight, the allergenic fragrances that are listed in entries 45, 67-92 and [X] to [X] of Annex III to Regulation (EC) No 1223/2009, shall be labelled using the system referred to in Article 33 of that Regulation. The first sentence shall not apply to allergenic fragrances that meet the labelling thresholds under Regulation (EC) No 1272/2008.

Removed5. The requirements referred to in points 1 to 4 shall not apply to professional detergents and surfactants, provided that the equivalent information to that required in those points is provided in section 15 of the safety data sheet drawn up in accordance with Article 31 of Regulation (EC) No 1907/2006.

Removed6. In addition to the information listed in points 1 to 5, as applicable, the label of detergents containing micro-organisms shall bear the following information: