Forslag til EUROPA-PARLAMENTETS OG RÅDETS FORORDNING om vaske- og rengøringsmidler og overfladeaktive stoffer, om ændring af forordning (EU) 2019/1020 og om ophævelse af forordning (EF) nr. 648/2004

EN EN
EUROPEAN
COMMISSION
Brussels, 28.4.2023
COM(2023) 217 final
ANNEXES 1 to 8
ANNEXES
to the
proposal for a Regulation of the European Parliament and of the Council
on detergents and surfactants, amending Regulation (EU) 2019/1020 and repealing
Regulation (EC) No 648/2004
{SEC(2023) 170 final} - {SWD(2023) 113 final} - {SWD(2023) 114 final} -
{SWD(2023) 115 final}
Offentligt
KOM (2023) 0217 - Forslag til forordning
Europaudvalget 2023
EN 1 EN
ANNEX I
BIODEGRADABILITY REQUIREMENTS REFERRED TO IN ARTICLE 4
ULTIMATE BIODEGRADABILITY CRITERIA AND TEST METHODS FOR
SURFACTANTS AND SURFACTANTS IN DETERGENTS
1. 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).
2. Surfactants and surfactants contained in detergents shall be ultimately biodegradable
as determined in accordance with the criteria laid down in point 3.
3. Surfactants and surfactants contained in detergents shall be considered as ultimately
biodegradable if they meet one of the following criteria:
(a) the level of biodegradability (mineralisation) is at least 60 % within 28 days
measured in accordance with one of the following test methods:
(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);
(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
;
(iii) method C.4-D, manometric respirometry test, described in Part C, Part V,
of the Annex to Regulation (EC) No 440/2008;
(iv) method C.4-E, closed bottle test, described in Part C, Part VI, of the
Annex to Regulation (EC) No 440/2008;
(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;
(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.
(b) the level of biodegradability (mineralisation) is at least 70% within 28 days
measured in accordance with one of the following test methods:
(i) method C.4-A DOC die-away test described in Part C, Part II, of the
Annex to Regulation (EC) No 440/2008;
(ii) method C.4-B, modified OECD screening test described in Part C, Part
III, of the Annex to Regulation (EC) No 440/2008.
1
Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to
Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration,
Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 142, 31.5.2008, p. 1).
EN 2 EN
Pre-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) .
4. The tests referred to in point 3 shall be conducted by laboratories meeting any of the
following conditions:
(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;
(b) the laboratories are accredited in accordance with the standard for laboratories
referred to in Regulation (EC) No 765/2008.
2
Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the
harmonisation of laws, regulations and administrative provisions relating to the application of the
principles of good laboratory practice and the verification of their applications for tests on chemical
substances (OJ L 50, 20.2.2004, p. 44).
EN 3 EN
ANNEX II
REQUIREMENTS FOR DETERGENTS CONTAINING MICROORGANISMS
REFERRED TO IN ARTICLE 5
1. Micro-organisms intentionally added to detergents shall comply with the following
conditions:
(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);
(b) shall belong to both of the following:
(i) Risk Group I as defined by Directive 2000/54/EC – biological agents at
work;
(ii) The Qualified Presumption of Safety (QPS) list issued by the European
Food Safety Authority (EFSA).
This point shall not apply to micro-organisms intentionally added to detergents
placed on the market for research and development purposes.
2. 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:
(a) E. coli, test method ISO 16649-3:2005;
(b) Streptococcus (Enterococcus), test method ISO 21528-1:2004;
(c) Staphylococcus aureus, test method ISO 6888-1;
(d) Bacillus cereus, test method ISO 7932:2004 or ISO 21871;
(e) Salmonella, test method ISO 6579:2002 or ISO 19250.
3. Intentionally added micro-organisms shall not be genetically modified
microorganisms.
4. 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.
5. 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 4833-1:2014.
6. 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 4833-1:2014.
7. Micro-organisms contained in detergents that are placed on the market in a spray
format shall pass the acute inhalation toxicity test in accordance with the test method
B.2., described in Part B of the Annex to Regulation (EC) No 440/2008.
8. Detergents containing micro-organisms shall not be placed on the market in a refill
format.
EN 4 EN
9. All claims made by the manufacturer regarding the actions of the micro-organisms
contained in the product shall be supported by third-party testing.
10. 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.
11. The tests referred to in points 2, 5, 6, 7 and 9 shall be conducted by laboratories
meeting any of the following conditions:
(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
Council3
or international standards recognised as being equivalent;
(b) the laboratories are accredited in accordance with the standard for laboratories
referred to in Regulation (EC) No 765/2008.
3
Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the
harmonisation of laws, regulations and administrative provisions relating to the application of the
principles of good laboratory practice and the verification of their applications for tests on chemical
substances (OJ L 50, 20.2.2004, p. 44).
EN 5 EN
ANNEX III
LIMITATIONS ON THE CONTENT OF PHOSPHATES AND OTHER
PHOSPHORUS COMPOUNDS REFERRED TO IN ARTICLE 6
Detergent Limitations
Consumer laundry detergents Shall not be placed on the market if the total
content of phosphorus is equal to or greater
than 0,5 grams in the recommended quantity
of the detergent to be used in the main cycle
of the washing process for a standard
washing machine load as defined in Part B of
Annex V for hard water:
– for ‘normally soiled’ fabrics in the
case of heavy-duty detergents,
– for ‘lightly soiled’ fabrics in the
case of detergents for delicate
fabrics.
Consumer automatic dishwasher detergents Shall not be placed on the market if the total
content of phosphorus is equal to or greater
than 0,3 grams in the standard dosage as
defined in Part B of Annex V.
EN 6 EN
ANNEX IV
CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 7(2)
Module A - Internal production protocol
1. Description of the module
Internal 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.
2. Technical documentation
2.1. 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.
2.2. 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:
(a) a general description of the detergent or surfactant and a description of the
intended use;
(b) the test reports demonstrating the compliance with Annex I and, where
applicable, with Annexes II and III;
(c) a list of test methods used to demonstrate compliance with the requirements of
this Regulation ;
(d) results of calculations made and examinations carried out;
(e) an ingredient data sheet which meets the following requirements:
(i) lists all intentionally added substances and preservatives referred to in
Part A of Annex V;
(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;
(iii) all substances are listed in order of decreasing abundance by weight, and
the list is sub-divided into the following weight percentage ranges:
(1) 10 % or more,
(2) 1 % or over, but less than 10 %,
(3) 0,1 % or over, but less than 1 %,
(4) less than 0,1 %.
For the purposes of point (e), a perfume, an essential oil, or a colouring agent shall be
considered to be a single component.
3. Manufacturing
EN 7 EN
The 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.
EN 8 EN
ANNEX V
LABELLING REQUIREMENTS
PART A – LABELLING OF CONTENTS
The information to be included on the labels of detergents and surfactants made available on
the market
1. 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:
(a) phosphates,
(b) phosphonates,
(c) anionic surfactants,
(d) cationic surfactants,
(e) amphoteric surfactants,
(f) non-ionic surfactants,
(g) oxygen-based bleaching agents,
(h) chlorine-based bleaching agents,
(i) EDTA and salts thereof,
(j) NTA (nitrilotriacetic acid) and salts thereof,
(k) phenols and halogenated phenols,
(l) paradichlorobenzene,
(m) aromatic hydrocarbons,
(n) aliphatic hydrocarbons,
(o) halogenated hydrocarbons,
(p) soap,
(q) zeolites,
(r) polycarboxylates.
2. The following classes of constituents, if added, shall be listed irrespective of their
concentration:
(a) enzymes,
(b) micro-organisms,
(c) optical brighteners,
(d) perfumes.
3. 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:
EN 9 EN
(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;
(b) are labelled on a constituent of the detergent.
The 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.
4. 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.
5. 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.
6. 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:
(a) an indication or a precautionary statement that the product is not to be used on
surfaces in contact with food;
(b) an indication of the shelf life of the product;
(c) use instructions or special precautions, where relevant.
PART B – LABELLING OF DOSAGE INFORMATION
The information to be included on the label of consumer laundry detergents and consumer
automatic dishwasher detergents
1. The label of consumer laundry detergents shall contain the following information:
(a) the recommended quantities and/or dosage instructions expressed in millilitres
or grams appropriate to a standard washing machine load, for soft, medium and
hard water hardness levels and making provision for one or two cycle washing
processes,
(b) for heavy-duty detergents, the number of standard washing machine loads of
‘normally soiled’ fabrics, and, for detergents for delicate fabrics, the number of
standard washing machine loads of ‘lightly soiled’ fabrics, that can be washed
with the contents of the package using water of medium hardness,
corresponding to 2,5 millimoles CaCO3/l,
(c) the capacity of any measuring cup, if provided, shall be indicated in millilitres
or grams, and markings shall be provided to indicate the dose of detergent
appropriate for a standard washing machine load for soft, medium and hard
water hardness levels,
2. For the purposes of point 1, the standard washing machine loads shall be 4,5 kg dry
fabric for heavy-duty detergents and 2,5 kg dry fabric for light-duty detergents. A
detergent shall be considered to be a heavy-duty detergent unless the claims of the
EN 10 EN
manufacturer predominantly promote fabric care, namely low temperature wash,
delicate fibres and colours.
3. The label of consumer automatic dishwasher detergents shall indicate the standard
dosage expressed in grams or millilitres or number of tablets for the main washing
cycle for normally soiled tableware in a fully loaded 12 place settings dishwasher,
adjusting the standard dosage, where relevant, for soft, medium, and hard water
hardness.
PART C – DIGITAL LABELLING
The following content information referred to in part A, may be provided on the digital label
only, in accordance with Article 16(1), second subparagraph, in the manner specified in that
part:
(a) anionic surfactants;
(b) cationic surfactants;
(c) amphoteric surfactants;
(d) non-ionic surfactants;
(e) phosphates;
(f) phosphonates;
(g) soap.
PART D – SIMPLIFIED DOSAGE INFORMATION FOR CONSUMER LAUNDRY
DETERGENTS
The simplified dosage grid shall contain the following information:
(a) basic instructions for use, where relevant;
(b) the recommended quantities based on medium/average water hardness and
different degrees of fabric soiling; and
(c) an indication of the washing machine load.
EN 11 EN
ANNEX VI
PRODUCT PASSPORT
The product passport shall include the following information:
(a) the unique product identifier of the detergent or surfactant;
(b) the name, the address of the manufacturer or the manufacturer’s authorised
representative as well the manufacturer’s unique operator identifier;
(c) the identification of detergent or surfactant allowing traceability, including a
colour image of sufficient clarity to enable the identification of the detergent or
surfactant;
(d) the commodity code under which the detergent or surfactant is classified at the
moment the product passport is created, as set out in Council Regulation (EEC)
No 2658/874
;
(e) references to Union legal acts that the detergent or surfactant complies with;
(f) a full list of substances intentionally added in the detergent or surfactant and of
preservatives labelled in accordance with part A, point 3, first subparagraph,
point (b), of Annex V, using the International Nomenclature of Cosmetic
Ingredients, or where it is not available, the European Pharmacopoeia name
and, when also the latter is not available, the common chemical name or
International Union of Pure and Applied Chemists name.
The obligation referred to in point (f) shall not apply to professional detergents, or to
surfactants for professional detergents, for which a safety data sheet referred to in
Article 31 of Regulation (EC) No 1907/2006 is available.
4
Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on
the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).
EN 12 EN
ANNEX VII
TEST METHODS REFERRED TO IN ARTICLE 22(2)
1. REFERENCE METHOD (CONFIRMATORY TEST)
1.1. Definition
This method describes a laboratory model of the activated sludge and secondary
settler which is designed to simulate municipal sewage treatment. Improved state-of-
the-art operating conditions can be applied to this test method as described in EN
ISO 11733.
1.2. Equipment needed for measurement
The method of measurement employs the small-activated sludge plant shown in
Figure 1, and in greater detail in Figure 2. The equipment consists of a sewage vessel
A for synthetic sewage, dosing pump B, aeration vessel C, settling vessel D, air-lift
pump E to recycle the activated sludge, and vessel F for collecting the treated
effluent.
Vessels A and F must be of glass or suitable plastic and hold at least twenty-four
litres. Pump B must provide a constant flow of synthetic sewage to the aeration
vessel; this vessel, during normal operation, contains three litres of mixed liquor. A
sintered aeration cube G is suspended in the vessel C at the apex of the cone. The
quantity of air blown through the aerator shall be monitored by means of a flow
meter H.
1.3. Synthetic sewage
A synthetic sewage is employed for the test. Dissolve in each litre of tap water:
– 160 mg peptone;
– 110 mg meat extract;
– 30 mg urea, CO(NH2)2;
– 7 mg sodium chloride, NaCl;
– 4 mg calcium chloride, CaCl2.2H2O;
– 2 mg magnesium sulphate, MgSO4.7H2O;
– 28 mg of di-potassium hydrogen phosphate, K2HPO4;
– and 10 ± 1 mg of the surfactant.
The synthetic sewage is freshly prepared daily.
1.4. Preparation of samples
Uncompounded surfactants are examined in the original state. Active content of
surfactant samples must be determined in order to prepare the synthetic sewage
(point 1.3).
1.5. Operation of equipment
Initially, fill aeration vessel C and settling vessel D with synthetic sewage. The
height of the vessel D should be so fixed that the volume contained in the aeration
vessel C is three litres. Inoculation is made by introducing 3 ml of a secondary
effluent of good quality, freshly collected from a treatment plant dealing with a
EN 13 EN
predominantly domestic sewage. The effluent must be kept under aerobic conditions
in the period between sampling and application. Then set the aerator G, air-lift E and
dosing device B in operation. The synthetic sewage must pass through the aeration
vessel C at a rate of one litre per hour; this gives a mean retention time of three
hours.
The rate of aeration should be so regulated that the contents of vessel C are kept
constantly in suspension and the dissolved oxygen content is at least 2 mg/l. Foaming
must be prevented by appropriate means. Anti-foaming agents that inhibit the
activated sludge or contain surfactants must not be used. The air-lift pump E must be
set so that the activated sludge from the settling vessel is continually and regularly
recycled to aeration vessel C. Sludge which has accumulated around the top of the
aeration vessel C, in the base of the settling vessel D, or in the circulation circuit
must be returned to the circulation at least once each day by brushing or some other
appropriate means. When the sludge fails to settle, its settleability may be increased
by the addition of 2 ml portions of a 5 % solution of ferric chloride, repeated as
necessary.
The effluent from the settling vessel D is accumulated in vessel F for twenty-four
hours, following which a sample is taken after thorough mixing. Vessel F must then
be carefully cleaned.
1.6. Checking measuring equipment
The surfactant content (in mg/l) of the synthetic sewage is determined immediately
before use.
The surfactant content (in mg/l) of the effluent collected over twenty-four hours in
vessel F should be determined analytically by the same method, immediately after
collection: otherwise the samples must be preserved, preferably by freezing. The
concentrations must be determined to the nearest 0,1 mg/l surfactant
As a check on the efficiency of the process, the chemical oxygen demand (COD) or
the dissolved organic carbon (DOC) of the glass fibre filtered effluent accumulated
in vessel F and of the filtered synthetic sewage in vessel A is measured at least twice
per week.
The reduction in COD or DOC should level off when a roughly regular daily
surfactant degradation is obtained at the end of the running-in period shown in Figure
3.
The content of dry matter in the activated sludge contained in the aeration vessel
should be determined twice a week in g/l. If it is more than 2,5 g/l, the excess
activated sludge must be discarded.
The degradation test is performed at room temperature; this should be steady and
kept between 19-24 ° C.
1.7. Calculation of biodegradability
The percentage degradation of surfactant must be calculated every day on the basis
of the surfactant content in mg/l of the synthetic sewage and of the corresponding
effluent accumulated in vessel F.
The degradability values thus obtained should be presented graphically as in Figure
3.
EN 14 EN
The degradability of the surfactant should be calculated as the arithmetic mean of the
values obtained over the twenty-one days that follow the running-in and
acclimatisation period, during which degradation has been regular and the operation
of the plant trouble-free. In any event the duration of the running-in period should
not exceed six weeks.
The daily degradation values are calculated to the nearest 0,1 % but the final result is
given to the nearest whole number.
In some cases it may be permissible to reduce the frequency of sampling but at least
fourteen results collected over the twenty-one days which follow the running-in
period should be used in calculating the average.
2. DETERMINATION OF ANIONIC SURFACTANTS IN BIODEGRADABILITY TESTS
2.1. Principle
The method is based on the fact that the cationic dye methylene blue forms blue salts
with anionic surfactants (MBAS), which can be extracted with chloroform. To
eliminate interference, the extraction is first effected from alkaline solution and the
extract is then shaken with acidic methylene blue solution. The absorbency of the
separated organic phase is measured photometrically at the wavelength of maximum
absorption of 650 nm.
2.2. Reagents and equipment
2.2.1. Buffer solution pH 10
Dissolve 24 g sodium bicarbonate, NaHCO3 AR, and 27 g anhydrous sodium
carbonate (Na2CO3) AR in deionised water and dilute to 1000 ml.
2.2.2. Neutral methylene blue solution
Dissolve 0,35 g methylene blue AR in deionised water and dilute to 1000 ml. Prepare
the solution at least twenty-four hours before use. The absorbency of the blank
chloroform phase, measured against chloroform must not exceed 0,015 per 1 cm of
layer thickness at 650 nm.
2.2.3. Acidic methylene blue solution
Dissolve 0,35 g methylene blue AR in 500 ml deionised water and mix with 6,5 ml
H2SO4 (d = 1,84 g/ml). Dilute to 1000 ml with deionised water. Prepare the solution
at least twenty-four hours before use. The absorbency of the blank chloroform phase,
measured against chloroform must not exceed 0,015 per 1 cm of layer thickness at
650 nm.
2.2.4. Chloroform (trichloromethane) AR freshly distilled
2.2.5. Dodecyl benzene sulphonic acid methyl ester
2.2.6. Ethanolic potassium hydroxide solution, KOH 0,1 M
2.2.7. Ethanol pure, C2H5OH
2.2.8. sulphuric acid, H2SO4 0,5 M
2.2.9. Phenolphthalein solution
Dissolve 1 g phenolphthalein in 50 ml ethanol and add 50 ml deionised water while
stirring continuously. Filter off any precipitate obtained.
EN 15 EN
2.2.10. Methanolic hydrochloric acid: 250 ml hydrochloric acid AR and 750 ml methanol
2.2.11. Separating funnel, 250 ml
2.2.12. Graduated flask, 50 ml
2.2.13. Graduated flask, 500 ml
2.2.14. Graduated flask, 1000 ml
2.2.15. Round-bottomed flask with ground glass stopper and reflux condenser, 250 ml;
boiling granules
2.2.16. pH meter
2.2.17. Photometer for measurements at 650 nm, with 1 to 5 cm cells
2.2.18. Qualitative grade filter paper
2.3. Procedure
The samples for analysis must not be taken through a layer of foam.
After thorough cleaning with water, the equipment used for the analysis must be
thoroughly rinsed with methanolic hydrochloric acid (point 2.2.10) and then with
deionised water before using.
Filter the activated sludge plant influent and effluent to be examined immediately on
sampling. Discard the first 100 ml of the filtrates.
Place a measured volume of the sample, neutralised if necessary, into a 250 ml
separating funnel (point 2.2.11). The volume of sample should contain between 20
and 150 g of MBAS. At the lower MBAS content, up to 100 ml of sample may be
used. When using less than 100 ml, dilute to 100 ml with deionised water. Add to the
sample 10 ml of buffer solution (point 2.2.1), 5 ml of neutral methylene blue solution
(point 2.2.2) and 15 ml of chloroform (point 2.2.4). Shake the mixture uniformly and
not too vigorously for one minute. After phase separation, run the chloroform layer
into a second separating funnel, containing 110 ml of deionised water and 5 ml of
acidic methylene blue solution (point 2.2.3). Shake the mixture for one minute. Pass
the chloroform layer through a cotton-wool filter previously cleaned and wetted with
chloroform into a graduated flask (point 2.2.12).
Extract the alkaline and acid solutions three times, using 10 ml of chloroform for the
second and third extractions. Filter the combined chloroform extracts through the
same cotton wool filter and dilute to the mark in the 50 ml flask (point 2.2.12) with
chloroform used for rewashing the cotton wool. Measure the absorbency of the
chloroform solution with a photometer at 650 nm in 1 to 5 cm cells against
chloroform. Run a blank determination through the whole procedure.
2.4. Calibration curve
Prepare a calibration solution from the standard substance dodecylbenzene sulphonic
acid methyl ester (tetrapropylene type mol. wt. 340) after saponification into the
potassium salt. The MBAS is calculated as sodium dodecyl benzene sulphonate (mol.
wt. 348).
From a weighing pipette, weigh 400 to 450 mg of dodecyl-benzene-sulphonic-acid-
methyl-ester (point 2.2.5) to the nearest 0,1 mg in a round-bottomed flask and add 50
ml of ethanolic potassium hydroxide solution (point 2.2.6) and some boiling
granules. After mounting the reflux condenser, boil for one hour. After cooling, wash
EN 16 EN
the condenser and ground glass joint with about 30 ml of ethanol, and add these
washings to the contents of the flask. Titrate the solution with sulphuric acid against
phenolphthalein until it becomes colourless. Transfer this solution to a 1000 ml
graduated flask (point 2.2.14), dilute to the mark with deionised water and mix.
Part of this surfactant stock solution is then further diluted. Withdraw 25 ml, transfer
to a 500 ml graduated flask (point 2.2.13), dilute to the mark with deionised water
and mix.
This standard solution contains:
where E is the sample weight in mg.
To establish the calibration curve, withdraw 1, 2, 4, 6, 8 ml portions of the standard
solution and dilute each to 100 ml with deionised water. Then proceed as stated
under point 2.3 including a blank determination.
2.5. Calculation of results
The amount of anionic surfactant (MBAS) in the sample is read from the calibration
curve (point 2.4). The MBAS content of the sample is given by:
where: V = ml volume of the sample used.
Express the results as sodium dodecylbenzene sulphonate (MW 348).
2.6. Expression of results
Express the results as MBAS mg/l to the nearest 0,1.
3. DETERMINATION OF NON-IONIC SURFACTANTS IN BIODEGRADATION TEST LIQUORS
3.1. Principle
Surface active agents are concentrated and isolated by gas stripping. In the sample
used, the quantity of non-ionic surfactant should be in the range 250-800 g.
The stripped surfactant is dissolved in ethyl acetate.
After phase separation and evaporation of the solvent, the non-ionic surfactant is
precipitated in aqueous solution with modified Dragendorff reagent (KBiI4 + BaCl2 +
glacial acetic acid).
The precipitate is filtered, washed with glacial acetic acid and dissolved in
ammonium tartrate solution. The bismuth in the solution is titrated potentiometrically
with pyrrolidinedithiocarbamate solution at pH 4-5 using a bright platinum indicator
electrode and a calomel or silver/silver chloride reference electrode. The method is
applicable to non-ionic surfactants containing 6-30 alkylene oxide groups.
EN 17 EN
The titration result is multiplied by the empirical factor of 54 for conversion to the
reference substance nonylphenol condensed with 10 mols ethylene oxide (NP 10).
3.2. Reagents and Equipment
Reagents are to be made up in deionised water.
3.2.1. Pure ethyl acetate, freshly distilled.
3.2.2. Sodium bicarbonate, NaHCO3 AR.
3.2.3. Dilute hydrochloric acid [20 ml concentrated acid (HCl) diluted to 1000 ml
with water]
3.2.4. Methanol AR, freshly distilled, stored in a glass bottle.
3.2.5. Bromocresol purple, 0,1 g in 100 ml methanol.
3.2.6. Precipitating agent: the precipitating agent is a mixture of two volumes of
solution A and one volume of solution B. The mixture is stored in a brown bottle and
can be used for up to one week after mixing.
3.2.6.1. Solution A
Dissolve 1,7 g bismuth nitrate, BiONO3.H2O AR, in 20 ml glacial acetic acid, and
make up to 100 ml with water. Then dissolve 65 g potassium iodide AR in 200 ml
water. Mix these two solutions in a 1000 ml measuring flask, add 200 ml glacial
acetic acid (point 3.2.7) and make up to 1000 ml with water.
3.2.6.2. Solution B
Dissolve 290 g barium chloride, BaCl2.2H2O AR, in 1000 ml of water.
3.2.7. Glacial acetic acid 99-100 % (lower concentrations are unsuitable).
3.2.8. Ammonium tartrate solution: mix 12,4 g tartaric acid AR and 12,4 ml of
ammonia solution AR (d = 0,910 g/ml) and make up to 1000 ml with water (or use
the equivalent amount of ammonium tartrate AR).
3.2.9. Dilute ammonia solution: 40 ml ammonia solution AR (d = 0,910 g/ml) diluted
to 1000 ml with water.
3.2.10. Standard acetate buffer: dissolve 40 g solid sodium hydroxide AR, in
500 ml water in a beaker and allow to cool. Add 120 ml glacial acetic acid (point
3.2.7). Mix thoroughly, cool and transfer to a 1000 ml volumetric flask. Make up to
the mark with water.
3.2.11. Pyrrolidinedithiocarbamate solution (known as ‘carbate solution’):
dissolve 103 mg sodium pyrrolidinedithiocarbamate, C5H8NNaS2.2H2O, in about 500
ml water, add 10 ml of n-amyl alcohol AR and 0,5 g NaHCO3 AR, and make up to
1000 ml with water.
3.2.12. Copper sulphate solution (for standardisation of point 3.2.11).
STOCK SOLUTION
Mix 1,249 g copper sulphate, CuSO4.5H2O AR, with 50 ml 0,5 M sulphuric
acid and make up to 1000 ml with water.
STANDARD SOLUTION
Mix 50 ml stock solution with 10 ml 0,5 M H2SO4 and make up to 1000 ml
with water.
EN 18 EN
3.2.13. Sodium chloride AR.
3.2.14. Gas-stripping apparatus (see Figure 5). The diameter of the sintered
disc must be the same as the internal diameter of the cylinder.
3.2.15. Separating funnel, 250 ml.
3.2.16. Magnetic stirrer with magnet 25-30 mm.
3.2.17. Gooch crucible, diameter of the perforated base = 25 mm, Type G4.
3.2.18. Circular glass-fibre filter papers, 27 mm diameter with fibre diameter
0,3-1,5 m.
3.2.19. Two filter flasks with adapters and rubber collars, 500 and 250 ml
respectively.
3.2.20. Recording potentiometer fitted with a bright platinum indicator
electrode and a calomel or silver/silver chloride reference electrode with a 250 mV
range, with automatic burette of 20-25 ml capacity, or alternative manual equipment.
3.3. Method
3.3.1. Concentration and separation of the surfactant
Filter the aqueous sample through a qualitative filter paper. Discard the first 100 ml
of the filtrate.
Into the stripping apparatus, previously rinsed with ethyl acetate, place a measured
quantity of the sample, such that it contains between 250-800 g non-ionic surfactant.
To improve the separation add 100 g sodium chloride and 5 g sodium bicarbonate.
If the volume of the sample exceeds 500 ml, add these salts to the stripping apparatus
in solid form, and dissolve by passing nitrogen or air through.
If a smaller-sized sample is used, dissolve the salts in 400 ml water and then add to
the stripping apparatus.
Add water to bring the level to the upper stopcock.
Cautiously add 100 ml ethyl acetate on top of the water.
Fill the wash-bottle in the gas-line (nitrogen or air) two-thirds full with ethyl acetate.
Pass a gas stream of 30-60 l/h through the apparatus; the use of a flowmeter is
recommended. The rate of aeration must be increased gradually at the beginning. The
gas rate must be so adjusted that the phases remain noticeably separate to minimise
the mixing of the phases and the solution of the ethyl acetate in the water. Stop the
gas flow after five minutes.
If there is a reduction of more than 20 % in the volume of the organic phase through
solution in water, the sublation must be repeated paying special attention to the rate
of gas flow.
Run off the organic phase into a separating funnel. Return any water in the separating
funnel from the aqueous phase — it should only be a few ml — to the stripping
apparatus. Filter the ethyl acetate phase through a dry qualitative filter paper into a
250 ml beaker.
Put a further 100 ml ethyl acetate into the stripping apparatus and again pass nitrogen
or air through for five minutes. Draw off the organic phase into the separating funnel
EN 19 EN
used for the first separation, reject the aqueous phase and run the organic phase
through the same filter as the first ethyl acetate portion. Rinse both the separating
funnel and the filter with about 20 ml ethyl acetate.
Evaporate the ethyl acetate extract to dryness using a water-bath (fume cupboard).
Direct a gentle stream of air over the surface of the solution to accelerate the
evaporation.
3.3.2. Precipitation and filtration
Dissolve the dry residue from 3.3.1 in 5 ml methanol, add 40 ml water and 0,5 ml
dilute HCl (point 3.2.3) and stir the mixture with a magnetic stirrer.
To this solution add 30 ml of precipitating agent (point 3.2.6) from a measuring
cylinder. The precipitate forms after repeated stirring. After stirring for ten minutes
leave the mixture to stand for at least five minutes.
Filter the mixture through a Gooch crucible, the base of which is covered with a
glass-fibre filter paper. First wash the filter under suction with about 2 ml glacial
acetic acid. Then thoroughly wash the beaker, magnet, and crucible with glacial
acetic acid, of which about 40-50 ml is necessary. It is not necessary to quantitatively
transfer the precipitate adhering to the sides of the beaker, to the filter, because the
solution of the precipitate for the titration is returned to the precipitating beaker, and
the remaining precipitate will then be dissolved.
3.3.3. Dissolution of the precipitate
Dissolve the precipitate in the filter crucible by the addition of hot ammonium
tartrate solution (about 80 ° C) (point 3.2.8) in three portions of 10 ml each. Allow
each portion to stand in the crucible for some minutes before being sucked through
the filter into the flask.
Put the contents of the filter flask into the beaker used for the precipitation. Rinse the
sides of the beaker with a further 20 ml of tartrate solution to dissolve the rest of the
precipitate.
Carefully wash the crucible, adapter and filter flask with 150-200 ml water, and
return the rinsing water to the beaker used for the precipitation.
3.3.4. The titration
Stir the solution using a magnetic stirrer (point 3.2.16), add a few drops of
bromocresol purple (point 3.2.5) and add the dilute ammonia solution (point 3.2.9)
until the colour turns violet (the solution is initially weakly acid from the residue of
acetic acid used for rinsing).
Then add 10 ml standard acetate buffer (point 3.2.10), immerse the electrodes in the
solution, and titrate potentiometrically with standard ‘carbate solution’ (point 3.2.11),
the burette tip being immersed in the solution.
The titration rate should not exceed 2 ml/min.
The endpoint is the intersection of the tangents to the two branches of the potential
curve.
It will be observed occasionally that the inflection in the potential curve becomes
flattened; this can be eliminated by carefully cleaning the platinum electrode (by
polishing with emery paper).
EN 20 EN
3.3.5. Blank determinations
At the same time run a blank determination through the whole procedure with 5 ml
methanol and 40 ml water, according to the instructions in point 3.3.2. The blank
titration should be below 1 ml, otherwise the purity of the reagents (points 3.2.3,
3.2.7, 3.2.8, 3.2.9, 3.2.10) is suspect, especially their content of heavy metals, and
they must be replaced. The blank must be taken into account in the calculation of the
results.
3.3.6. Control of the factor of the ‘carbate solution’
Determine the factor for the carbate solution on the day of use. To do this, titrate 10
ml of the copper sulphate solution (point 3.2.12) with ‘carbate solution’ after the
addition of 100 ml water and 10 ml standard acetate buffer (point 3.2.10). If the
amount used is a ml, the factor f is:
and all the results of the titration are multiplied by this factor.
3.4. Calculation of results
Every non-ionic surfactant has its own factor, depending on its composition,
particularly on the length of the alkene oxide chain. The concentration of non-ionic
surfactant is expressed in relation to a standard substance — a nonyl phenol with ten
ethylene oxide units (NP 10) — for which the conversion factor is 0,054.
Using this factor the amount of surfactant present in the sample is found expressed as
mg of NP 10 equivalent, as follows:
(b — c) xfx 0,054 = mg non-ionic surfactant as NP 10
where:
b = volume of ‘carbate solution’ used by the sample
(ml),
c = volume of ‘carbate solution’ used by the blank
(ml),
f = factor of the ‘carbate solution’.
3.5. Expression of results
Express the results in mg/l as NP 10 to the nearest 0,1.
EN 21 EN
Figure 1 Activated sludge plant: overviews
A Storage vessel
B Dosing device
C Aeration chamber (three litres capacity)
D Settling vessel
E Air-lift pump
F Collector
G Sintered aerator
H Air-flow meter
I Air
EN 22 EN
Figure 2 Activated sludge plant: detail (dimensions in millimetres)
A Liquid level
B Hard PVC
C Glass or waterproof plastic (hard PVC)
EN 23 EN
Figure 3 Calculation of biodegradability - Confirmatory test
A Running-in period
B Period used for calculation (twenty-one days)
C Readily biodegradable surfactant
D Surfactant not readily biodegradable
E Biodegradation ( %)
F Time (days)
EN 24 EN
ANNEX VIII
CORRELATION TABLE
Regulation (EC) No 648/2004
This Regulation
Article 1(1)
Article 1(1)
Article 1(2)
-
Article 2(1)
Article 2, point (1)
Article 2(1a)
Article 2, point (2)
Article 2(1b)
Article 2, point (3)
Article 2(2)
-
Article 2(3)
Article 2, point (6)
Article 2(4)
Article 2, point (7)
Article 2(5)
Article 2, point (8)
Article 2(6)
Article 2, point (11)
Article 2(7)
-
Article 2(8)
Article 2, point (12)
Article 2(9)
Article 2, point (14)
Article 2(9a)
Article 2, point (13)
Article 2(10)
Article 2, point (15)
Article 2(11)
-
Article 2(12)
Article 2, point (5)
Article 3(1)
Article 3(1) and Article 4(2)
Article 3(2)
-
Article 3(3)
Article 7(1)
Article 4(1)
Article 4(1)
Article 4(2)
-
Article 4(3)
-
Article 4a
Article 6
Article 5(1)
-
Article 5(2)
-
Article 5(3)
-
Article 5(4)
-
Article 5(5)
-
Article 5(6)
-
Article 6(1)
-
EN 25 EN
Article 6(2)
-
Article 6(3)
-
Article 6(4)
-
Article 7
-
Article 8(1)
-
Article 8(2)
-
Article 8(3)
-
Article 8(4) -
Article 9(1) Article 8(2)
Article 9(2) -
Article 9(3) Article 7(6)
Article 10(1) -
Article 10(2) Article 22(2)
Article 11(1) Article 1(2), point (b)
Article 11(2) and (3) Article 15(3)
Article 11(4) Article 15(4)
Article 11(5) Article 15(5)
Article 11(6)
-
Article 12 Article 28
Article 13 Article 26
Article 13a(1) Article 27(1)
Article 13a(2) Article 27(2)
Article 13a(3) Article 27(3)
Article 13a(4) Article 27(5)
Article 13a(5) Article 27(6)
EN 26 EN
Article 14(1) Article 3(2)
Article 14(2) -
Article 14(3) -
Article 14(4) -
Article 14(5) -
Article 15(1), first subparagraph Article 24(1)
Article 15(1), second subparagraph Article 24(3)
Article 15(2) Article 25(4)
Article 16(1) -
Article 16(2) -
Article 17 Article 33
Article 18 Article 29
Article 19 Article 35


EN EN
EUROPEAN
COMMISSION
Brussels, 28.4.2023
COM(2023) 217 final
2023/0124 (COD)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
on detergents and surfactants, amending Regulation (EU) 2019/1020 and repealing
Regulation (EC) No 648/2004
(Text with EEA relevance)
{SEC(2023) 170 final} - {SWD(2023) 113 final} - {SWD(2023) 114 final} -
{SWD(2023) 115 final}
Offentligt
KOM (2023) 0217 - Forslag til forordning
Europaudvalget 2023
EN 1 EN
EXPLANATORY MEMORANDUM
1. CONTEXT OF THE PROPOSAL
• Reasons for and objectives of the proposal
Detergents play a central role in our everyday lives. They help deliver health and hygiene in
almost all areas of human activity from households and schools to gyms, offices, hospitals,
hotels and restaurants. Detergents are, however, chemicals with intrinsic properties that have
the potential to pose risks to human health and the environment. Regulation (EC) No
648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents1
(‘the Detergents Regulation’) lays down the rules that detergents need to comply with in order
to be placed and move freely in the EU market. These are rules that ensure the safe use of
detergents (labelling and other information requirements) and the high-environmental
performance of detergents and surfactants2
for detergents (biodegradability requirements and
phosphorus limits).
The 2019 evaluation of the Detergents Regulation3
identified a number of weaknesses that
have emerged since the legislation was adopted in 2004. The fitness check of the most
relevant chemicals legislation (excluding REACH)4
highlighted the complexity of the EU
regulatory framework for chemicals. This complexity was attributed to the large number of
product and sector specific pieces of legislation with embedded links with each other. The
fitness check also pointed out that there is room for simplification in the communication of
information of overcrowded labels to product users and found that the use of innovative tools
for communicating product information is currently suboptimal.
The updated industrial strategy adopted in May 20215
further emphasises the importance of
accelerating the green and digital transitions of the EU industry, supported by i.a. a coherent
and stable regulatory framework.
Moreover, the Commission Communication of 16 March 2023 on long-term competitiveness
of the EU: looking beyond 20306
outlines how the EU can build on its strengths and achieve
more than merely bridging the growth and innovation gap. To foster competitiveness, the
Commission proposes to work along nine mutually reinforcing drivers, including a
functioning Single Market and digitalisation through broad-based take-up of digital tools
across the economy.
1
OJ L 104, 8.4.2004, p. 1.
2
Surfactants are surface-active agents that help break down the interface between water and oils and/or
dirt. They are one of the main ingredients used in detergents.
3
Evaluation of Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31
March 2004 on detergents, SWD(2019)298
4
Fitness Check of the most relevant chemicals legislation (excluding REACH) SWD(2019)199
5
Communication from the Commission to the European Parliament, the Council, the European
Economic and Social Committee and the Committee of the Regions Updating the 2020 New Industrial
Strategy: Building a stronger Single Market for Europe’s recovery; COM(2021) 350 final
6
Communication from the Commission to the European Parliament, the Council, the European
Economic and Social Committee and the Committee of the Regions, Long-term competitiveness of the
EU: looking beyond 2030; 168 final
EN 2 EN
Furthermore, the Commission’s 2022 work programme7
lists the revision of the Detergent
Regulation as a REFIT initiative.
In view of the shortcomings identified in the Regulation’s evaluation 8
and in the chemicals
fitness check9
, and which were thoroughly developed in the impact assessment report on the
revision of the Detergents Regulation10
, this proposal aims at updating the rules on detergents,
strengthening enforcement so that more compliant detergents and surfactants enter the Union
market and at addressing the following issues:
(1) The Detergents Regulation does not take account of new market
developments: Innovative products and sustainable new practices have been
developed since the adoption of the Regulation in 2004, which the current rules
either do not accommodate (microbial cleaning products) or it is not clear if
and how they accommodate them (refill sales).
(2) Lack of efficient information requirements for detergents: Legislative
overlaps between the Detergents and the Classification, Labelling and
Packaging (CLP)11
Regulations often lead to the same substance appearing
twice or three times on the same label and sometimes under completely
different names. Another overlap between these pieces of EU legislation is the
duplication of information on the emergency health response for detergents
classified as hazardous under the CLP Regulation (ingredient data sheets under
the Detergents Regulation and information to poison centres under CLP).
• Consistency with existing policy provisions in the policy area
The proposal ensures that the Union rules specific to detergents remain complementary to the
general provisions applicable to chemicals – including detergents – placed on the Union
market, notably the CLP Regulation and the REACH Regulation12
. As with the existing
Detergents Regulation, the provisions in this proposal will address concerns that are specific
to detergents.
This proposal is consistent with priorities and current trends on digitalisation by default
including the conclusions on digitalising product information in the Evaluation of the New
Legislative Framework13
. By relying on the product passport proposed by the Commission in
7
https://ec.europa.eu/info/publications/2022-commission-work-programme-key-documents_en
8
Evaluation of Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31
March 2004 on detergents, SWD(2019)298
9
Fitness Check of the most relevant chemicals legislation (excluding REACH), SWD(2019)199
10
Commission Staff Working Document - Impact assessment report accompanying the Proposal for a
Regulation of the European Parliament and of the Council on detergents and surfactants, amending
Regulation (EU) 2019/1020 and repealing Regulation (EC) No 648/2004.
11
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on
classification, labelling and packaging of substances and mixtures, amending and repealing Directives
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006
12
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),
establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and
2000/21/EC
13
SWD(2022)364.
EN 3 EN
its proposal for a regulation on ecodesign for sustainable products14
, consistency will be
ensured and synergies can be achieved once detergent and surfactants are covered by that
Regulation.
In addition, this proposal also takes into account the legislative proposal for a regulation on
packaging and packaging waste15
which aims at reducing the amount of packaging placed on
the market in terms of its volume and weight, and preventing the generation of packaging
waste, especially through packaging minimisation (using only the amount of packaging that is
absolutely necessary). This minimisation requirement will reduce the space available for
consumer information on the label and therefore encourage manufacturers to explore the
possibilities offered by digital labelling. Moreover, the packaging and packaging waste
proposal requires businesses who sell refill products to provide certain information to end-
users and ensure that refill stations comply with the requirements laid down in the regulation.
Furthermore, this proposal is also consistent with the European declaration on digital rights
and principles for the digital decade16
.
• Consistency with other Union policies
The proposal will provide a coherent and stable regulatory framework supporting the green
and digital transitions of the EU industry announced both in the updated 2021 industrial
strategy17
and the recently adopted Green Deal Industrial Plan for the Net-Zero Age18
. It is
also consistent with broader EU policy and regulatory developments, in terms of future and
ongoing regulatory work under the chemicals strategy for sustainability19
. The proposed new
rules on microbial cleaning products will be consistent with the voluntary scheme provided by
the EU Ecolabel Regulation20
. The proposed new rules on digital labelling will be consistent
with the digitalisation of chemicals’ labels, notably under the revision of the CLP Regulation
and that of the Fertilising Products Regulation21
. It reflects the development of the Union’s
rules for biocidal products since the adoption of the Detergents Regulation, and complements
those rules.
14
Proposal for a Regulation of the European Parliament and of the Council establishing a framework for
setting ecodesign requirements for sustainable products and repealing Directive 2009/125/EC of 30
March 2022, COM(2022) 142 final.
15
Proposal for a Regulation of the European Parliament and of the Council on packaging and packaging
waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive
94/62/EC, COM(2022)677.
16
https://digital-strategy.ec.europa.eu/en/library/european-declaration-digital-rights-and-principles
17
Communication from the Commission to the European Parliament, the Council, the European
Economic and Social Committee and the Committee of the Regions Updating the 2020 New Industrial
Strategy: Building a stronger Single Market for Europe’s recovery; COM(2021) 350 final
18
A Green Deal Industrial Plan for the Net-Zero Age: https://commission.europa.eu/document/41514677-
9598-4d89-a572-abe21cb037f4_en
19
Communication from the Commission to the European Parliament, the Council, the European
Economic and Social Committee and the Committee of the Regions Chemicals Strategy for
Sustainability Towards a Toxic-Free Environment; COM 667 final
20
Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on
the EU Ecolabel
21
Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down
rules on the making available on the market of EU fertilising products and amending Regulations (EC)
No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003
EN 4 EN
2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
• Legal basis
The proposal has the same legal basis as the existing Detergents Regulation, i.e. Article 114
of the Treaty on the Functioning of the European Union.
• Subsidiarity (for non-exclusive competence)
The evaluation of the Detergents Regulation concluded that the added value of having
harmonisation rules for the making available and placing on the market of detergents was
undisputed. The Detergents Regulation has helped to level the playing field for detergents'
manufacturers, making it easier for companies to trade cross border and delivering positive
results for human health and the environment.
Further, during the consultation activities for the evaluation, there was widespread consensus
among stakeholders that the issues addressed by the Regulation continue to require action at
the EU level. This is because, the aspects dealt with under the Detergents Regulation, both in
terms of protection of human health and the environment, have an EU-wide dimension. The
same applies to the identified problems that do not present any specific national or sub-
national characteristics but rather have an EU-wide impact (e.g. refill sales, microbial
cleaning products, lack of understanding and awareness of chemicals labels by consumers).
Therefore, these issues need to be addressed at EU level to ensure the well-functioning of the
single market and an equal level of human health and environmental protection across the EU.
Regulatory action at EU level would ensure a regulatory context that enables innovation for
new types of products, new marketing techniques and new labelling technologies across the
single market while providing the same level of protection of human health and the
environment across the EU. It would bring the legislation up to date by including innovative
products and sustainable new practices in the scope of the Regulation; reduce the regulatory
burden for detergents manufacturers through simplified and streamlined (information)
requirements; and adapt the legislation to the digital age through the introduction of digital
labelling. Regulatory action of this sort would: (i) help further develop the single market; (ii)
provide legal certainty and a level playing field for the industry; and (iii) ensure an optimised
protection of human health and the environment.
• Proportionality
This proposal replaces an existing EU Regulation. It aims to eliminate redundant regulatory
overlaps as much as possible, which will ease the regulatory burden without jeopardising the
current level of health and environmental protection. Facilitation of refill sales and regulatory
acceptance of digital labelling will also have that effect. The new measures for microbial
cleaning products are based on the latest scientific knowledge about the effects of the
products in this emerging market.
The introduction of a product passport that contains compliance information will be effective
in reducing the amount of non-compliant detergents and surfactants in the Union market,
including through online sales. The Regulation will ensure that a detergent or surfactant
which is presented at customs is released for free circulation and placed on the Union market
only if it has a corresponding product passport. This will lead to significant efficiency gains
for both market surveillance authorities and customs authorities without imposing
disproportionate costs on industry. It will be subject to the same technical requirements as the
product passport proposed under the ecodesign for sustainable products proposal in order to
avoid duplicating industry’s digitalisation efforts and ensure interoperability with product
passports created under other Union legislation.
EN 5 EN
3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER
CONSULTATIONS AND IMPACT ASSESSMENTS
• Ex-post evaluations/fitness checks of existing legislation
The evaluation of the Detergents Regulation concluded that the Regulation has been working
well and has been effective overall in achieving its objectives, namely of ensuring the free
movement of detergents and surfactants in the single market and of providing a high level of
protection of human health and the environment. However, the evaluation also identified a
number of weaknesses and areas of further improvement that have emerged during the
practical application of the Regulation since its adoption in 2004. In particular, certain
overlaps between the Detergents Regulation and other pieces of EU chemicals legislation
were identified (notably the CLP Regulation, the Biocidal Products Regulation and the
REACH Regulation). These overlaps often lead to duplications in the labelling requirements
for detergents that, on one hand, put unnecessary burden to the detergents industry. The
overlaps also jeopardise the effective communication of safety and use information to
consumers because they result in overloaded labels with unclear and repetitive text.
Furthermore, the evaluation concluded that the use of innovative digital tools for
communicating such information is currently suboptimal.
The fitness check of the most relevant chemicals legislation (excluding REACH) highlighted
the complexity of the EU regulatory framework for chemicals. It attributed this complexity to
the embedded links between the different pieces of legislation applicable to the same
products. In line with the findings of the detergents evaluation, the chemicals fitness check
also concluded that the communication of hazard and safety information to consumers can be
simplified and that the use of innovative digital tools for the communication of such
information is currently not as good as it could be.
This proposal seeks to address the findings of the detergents evaluation and the chemicals
fitness check.
• Stakeholder consultations
To prepare this proposal, the Commission carried out a number of consultation activities to
collect evidence and views from a broad range of stakeholders on the identified problems with
the current legislation and potential solutions. The activities included a 12-week dedicated
public consultation that closed on 25 May 2022, a stakeholder workshop held on 12 May
2022, discussions with Member States at the Detergents Working Group, stakeholder
interviews (scoping and targeted) and feedback collected in response to the Commission’s
inception impact assessment. The stakeholders consulted included national authorities,
industry associations, companies, consumer associations, civil society and academia.
The consultation activities have confirmed broad support across stakeholders (including
industry, public authorities and representatives of the civil society) to digitalise some labelling
information and maintain the ingredient data sheet for non-hazardous detergents. Between
sub-options to streamline the labelling requirements, the industry slightly preferred to
eliminate duplicated requirements under the Detergents Regulation (sub-option 2). However,
this group also showed wide support to the first sub-option, which was also preferred by other
types of stakeholders, notably public authorities and representatives of civil society.
Stakeholders also widely supported facilitating and digitalising the refill sale of detergents.. It
should, however, be noted that business organisations and larger companies showed less
support for adding requirements for refill sales in the Detergents Regulation compared to
EN 6 EN
other stakeholders such as small and medium-sized companies (SMEs), non-governmental
organisations, and environmental and consumer organisations.. Introducing generic criteria
for the risk management of microbial cleaning products was not widely supported among the
proposed risk management measures22
. However, industry stakeholders stated that introducing
rules for microbial cleaning products in general under the Detergents Regulation would create
an unnecessary regulatory burden23
.
• Impact assessment
The Commission carried out an impact assessment on the revision of the Detergents
Regulation. The Regulatory Scrutiny Board delivered a positive opinion on the draft impact
assessment on 16 September 2022. The opinion of the Board as well as the final impact
assessment and its executive summary are published together with this proposal.
Besides the baseline scenario of no action, this impact assessment identifies two options (1a
and 1b) to address problem 1 (on new market developments not being accounted for), and two
options (2a and 2b) to address problem 2 (lack of efficient information requirements).
Policy option 1a would ensure that consumers receive the necessary information when
buying refilled detergents and that the rules are levelled for detergents manufacturers.
Microbial cleaning products would be brought under the scope of the Detergents Regulation
and minimum information requirements (labelling) would be imposed so that end users can be
informed about the presence of microbes in the product through which the cleaning function
is achieved.
Policy option 1b builds on option 1a regarding refill sales by proposing, in addition, the
introduction of digital labelling for refilled detergents. To further facilitate this sustainable
practice and unlock its full potential, all labelling information required under the Detergents
Regulation apart from dosage instructions can be provided through a digital label. As regards
microbial cleaning products, option 1b proposes the introduction of risk management
requirements for these products. These include generic criteria for the use of microbes in
detergents, labelling requirements, certain restrictions on the use of microbes and a review
clause.
Under policy option 2a the ingredient data sheet would be abolished for both hazardous and
non-hazardous detergents. The option also suggests to streamline the labelling requirements
and to introduce the possibility of digital labelling. The streamlining could be achieved either
by labelling only once in accordance with the stricter rules (sub-option 1); or by removing the
duplicated provisions from the Detergents Regulation (sub-option 2). By opting for digital
labelling, manufacturers would also benefit from the possibility of providing certain
information only through the digital label. Manufacturers could only put digital labels on their
products when mandatory principles for digital labelling would be applied.
Policy option 2b proposes to abolish only the duplicated requirement to provide an ingredient
data sheet for hazardous detergents and to maintain it for non-hazardous detergents under the
Detergents Regulation. In terms of labelling, option 2b is the same as option 2a above.
The preferred combination of policy options consists of Policy Option 1b (PO1b) and Policy
Option 2b (PO2b). These options scored better overall compared to their alternatives across a
range of criteria (positive economic, social, environmental and health impacts, effectiveness,
efficiency and coherence). In particular, options 1b and 2b are expected to bring benefits in
22
The introduction of labelling requirements under option 1a was the most preferred option
23
This concerns the introduction of requirements in general, i.e. under both option 1a and option 1b.
EN 7 EN
terms of burden reduction and cost savings for the industry, as well as improved readability of
detergents labels. They are also expected to reduce the burdens for businesses by tackling the
extensive and overlapping labelling requirements under the wider EU regulatory framework
applicable to detergents. This will notably be achieved b eliminating all duplications in the
information requirements and by offering the flexibility to provide some information through
a digital label. There would also be economies of scale because the physical label space could
allow for more languages, meaning cost savings in terms of distribution of sales, and the full
potential of the single market for detergents would be achieved.
Setting harmonised criteria and clarifying requirements for more sustainable products
(microbial cleaning products) and new practices (refill sales), will facilitate the green
transition while ensuring that innovation is not hampered. Given that these market segments
are currently dominated by SMEs, this will increase SME access and integration into value
chains and the market overall, thus contributing to the achievement of the United Nations’
Sustainable Development Goal24
(SDG) #9 ‘Industry, innovation and infrastructure’.
The combination of policy options 1b and 2b ensures a higher level of protection of human
health, of safety, and of the environment and contributes to the achievement of SDG #3 ‘Good
health and well-being’ and SDG #12 ‘Ensure sustainable consumption and production
patterns’. In particular, the introduction of risk management measures for microbial cleaning
products will ensure that microbes used in detergents are safe both from a human health and
environmental perspective and will allow end users to make informed choices and better
protect themselves in case of prior sensitisation or vulnerability. Targeted and simplified use
instructions on the label will help product users to correctly use these products, thus providing
an optimised environmental protection. Furthermore, the introduction of specific requirements
for refill sales will ensure that consumers receive all safety and use information when buying
refilled detergents and promote a sustainable practice with significant environmental benefits
in terms of packaging waste. Allowing some of the labelling information to be provided only
digitally would further reduce waste resulting from the disposal of unused label stock.
Streamlining and simplifying labelling requirements will make detergent labels more readable
and easier to understand. This will help end users find the relevant information more easily
and quickly, which is crucial especially in the event of an accident.
Sub-option 1 of policy option 2a, according to which ingredients are labelled only once based
on the stricter applicable rules is preferred as it will offer a higher level of human health
protection. Moreover, the introduction of optional digital labelling will on one hand provide
additional ease of use and awareness as the essential information remaining on the physical
label becomes clearer and on the other hand yield additional benefits for vulnerable and
visually impaired users. The digital principles, which will apply when economic operators
decide to label digitally, will further safeguard the high level of protection of human health.
Finally, the maintenance of the ingredient data sheet for non-hazardous detergents under the
Regulation will ensure that the level of protection remains very high.
Under the preferred option, the functioning of the single market benefits from the introduction
of harmonised rules for microbial cleaning products and refill sales, which will ensure a level
playing field for them. The preferred option will entail no or negligible costs for companies
and large cost savings. The biggest impact – in the form of cost savings – results from the
abolition of ingredient data sheet for hazardous detergents, with an annual estimated saving of
EUR 7 million per year. The current format of the ingredient data sheet will be maintained to
avoid unnecessary additional costs and complexity for the industry, especially SMEs.
24
https://sdgs.un.org/goals
EN 8 EN
Additional annual small burdens due to the risk management requirements for microbial
cleaning products are expected for SMEs, in the area of EUR 200.000 per company. It should,
however, be noted that this is an upper bound estimate, and calculated based on the average
costs for testing and the highest number of batches reported by manufacturers. This number is
also highly likely to vary depending on several factors (e.g. company or portfolio size; current
level of compliance etc.) but will not, in any event, negatively impact the manufacturers
(mostly SMEs), who reported during the interviews that these costs are within the acceptable
range. For companies currently working on “known microbes” the costs of new requirements
is expected to be negligible as many of the proposed requirements are already met or can be
met at a negligible cost. These firms will, therefore, be able to work and expand their
production at no extra cost.
The preferred option complies with the proportionality principle. It does not exceed what is
needed to achieve the objectives sought. The elimination of regulatory overlaps will ensure a
greater consistency with the wider EU regulatory framework applicable to detergents. The
facilitation of refill sales is in line with overarching EU initiatives aiming at reducing the
environmental impact and with SDG #12 ‘Ensure sustainable consumption and production
patterns’. The introduction of (optional) digital labelling both for refill detergents and overall
is consistent with the transition to the digital era and with parallel digitalisation initiatives in
the chemicals field such as CLP and the Fertilising Products Regulation. As experience and
confidence is gained in digital labelling, it could be possible to increase the amount of
information available digitally in the future, which may further increase the simplification
potential for the industry.
• Regulatory fitness and simplification
One of the main objectives of this initiative is to simplify the rules applicable to detergents
and reduce the regulatory burden for detergent manufacturers.
 Simplifying and streamlining labelling requirements will reduce the regulatory
burden for economic operators as it will be easier for them to comply with the rules.
 Abolishing the ingredient data sheet for hazardous detergents will generate cost
savings of EUR 7 million per year.
 The proposal also abolishes the obligatory involvement of approved laboratories
that had to perform tests under the Regulation.
 The proposal eliminates the obligation for detergent and surfactant manufacturers to
be established in the EU. However, the introduction of the product passport and new
provisions for market surveillance of detergents will ensure that all detergents and
surfactants placed on the EU market comply with the requirements, regardless of the
manufacturer’s place of establishment.
 The facilitation of refill sales is estimated to generate annual cost savings for the
detergent industry due to less disposal of plastic waste. While it was not possible to
quantify these savings, under the baseline these are estimated to be EUR 3.3 million.
Overall, the preferred option is estimated to generate annual cost savings of more
than EUR 10 million for the detergent industry per year.
4. BUDGETARY IMPLICATIONS
The proposal will not have any impact on the EU budget.
EN 9 EN
5. OTHER ELEMENTS
• Implementation plans and monitoring, evaluation and reporting arrangements
To assess their effectiveness, the Commission will monitor the implementation and
application of these new provisions and compliance with them. The Regulation will provide
for a regular Commission evaluation and review, and the associated public report will be
submitted to the European Parliament and the Council.
• Detailed explanation of the specific provisions of the proposal
Chapter I – General provisions
The proposed Regulation covers detergents and surfactants either placed on the market on
their own or contained in detergents. In addition, the proposed Regulation continues to set
strict biodegradability requirements for surfactants. However, compared to Regulation (EC)
No 648/2004, the possibility to expand the scope in the future to cover the biodegradability of
substances and mixtures in detergents has been introduced. The expanded scope also covers
the digitalisation of detergents labels and the safety of micro-organisms in detergents.
The proposal keeps a number of the existing definitions but it also introduces a new definition
of detergent. This definition is largely based on the one included in Regulation (EC) No
648/2004 but has, on one hand, been clarified and, on the other, updated to also cover new
products to which micro-organisms are intentionally added.
The proposal also uses the general definitions of the Decision 768/2008/EC25
and includes
additional definitions in relation to the product passport, in line with the definitions set out in
the European sustainable products proposal. A definition of refill is aligned with the definition
used in the packaging and packaging waste proposal.
Chapter II – Product Requirements
As with Regulation (EC) No 648/2004, surfactants need to meet the criteria of ultimate
biodegradability in order to be placed on the market whether on their own or contained in
detergents. This proposal introduces for the first time safety requirements that micro-
organisms in detergents need to comply with.
The limitations on the content of phosphates and other phosphorus compounds in consumer
laundry detergents and consumer automatic dishwasher detergents have been maintained.
Chapter III - Obligations of economic operators
The proposal streamlines the obligations for manufacturers, importers and distributors with
those set out in Decision 768/2008/EC. This clarifies the respective obligations which are
proportionate to the economic operators’ responsibilities. Instead of issuing a declaration of
conformity as set out in Decision 768/2008/EC, the manufacturer will create a product
passport for the detergent or surfactant that will include the relevant compliance information.
Manufacturers of detergents and surfactants are no longer obliged to be established in the EU.
However, where manufactures are not established in the EU, they should appoint an
authorised representative to carry out specific tasks on their behalf.
Manufacturers will have to assess the conformity of detergents and surfactants to ensure that
they comply with the requirements laid down in the Regulation. The proposal only provides
25
Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common
framework for the marketing of products, and repealing Council Decision 93/465/EEC; ELI:
http://data.europa.eu/eli/dec/2008/768(1)/oj.
EN 10 EN
for first party conformity assessment (self-declaration) and relies on the corresponding
Module A of Decision 768/2008/EC.
An ingredient data sheet is now only required for non-hazardous detergents. This data sheet
will also need to be provided directly to the Member States’ appointed bodies responsible for
receiving information relating to emergency health response (poison centres), upon request.
From now on, the ingredient data sheet will be part of the technical documentation that
manufacturers will have to prepare.
Chapter IV – CE marking and labelling
Upon completion of the conformity assessment, manufacturers must affix the CE marking on
detergents and surfactants in line with the general principles and rules applicable to CE
marking.
The proposal maintains most of the existing labelling rules set out in Regulation (EC) No
648/2004, while introducing the possibility of a digital label, as described above.
Chapter V – Product passport
It is important for a level playing field on the single market to ensure, on the one hand, more
transparency in the value chain on the main characteristics of detergents and surfactants and,
on the other, to strengthen the enforcement of the rules to reduce non-compliance. Instead of
relying on the EU declaration of conformity provided for in Decision 768/2008/EC, this
proposal goes for an innovative way to achieve this dual objective. The evaluation of the New
Legislative Framework26
indicated that a possible future revision of the Framework may want
to consider introducing the possibility of the product passport. According to the evaluation,
the product passport could include an electronic declaration of conformity and a description of
the conformity assessment procedure. The evaluation points out that the digitalisation of
product information could make the work of market surveillance authorities and customs
more effective.
To make this regulation future-proof, this proposal replaces the EU declaration of conformity
set out in Decision 768/2008/EC with the obligation for detergents and surfactants to have a
product passport demonstrating compliance with the requirements of this Regulation. The
product passport will be connected through a data carrier to a unique product identifier, and
meet the same technical requirements for a product passport under the ecodesign for
sustainable products regulation27
. The reference of the product passport must be included in a
Commission central registry that will be set up under the ecodesign for sustainable products
regulation, and this information must be presented at customs.
Chapter VI - Market surveillance
Besides the product passport, this proposal creates a clearer framework for a better
enforcement of the rules. It confirms that Regulation (EU) 2019/1020 will continue to apply
to detergents and surfactants. In addition, the proposal sets out more detailed market
surveillance provisions based on Decision 768/2008/EC. Furthermore, a specific provision
based on the Decision 768/2008 gives specific grounds for acting against detergents or
surfactants that comply with the requirements but pose a risk to health or the environment.
26
SWD(2022)364.
27
Proposal for a Regulation of the European Parliament and of the Council establishing a framework for
setting ecodesign requirements for sustainable products and repealing Directive 2009/125/EC of 30
March 2022, COM(2022) 142 final.
EN 11 EN
The provision ultimately gives the Commission the power to adopt measures against specific
detergents or surfactants under certain circumstances.
Chapter VII – Delegated powers and Committee procedure
The proposal empowers the Commission to adopt delegated acts in order to take into account
technical and scientific progress, new scientific evidence, and the level of digital
readiness/literacy. This power should be delegated to the Commission, in particular, to (i)
supplement the general requirements on digital labelling; (ii) amend the list of the labelling
information that may be provided in digital format only; (iii) adapt the limit of the allergenic
fragrances when individual risk-based concentration limits for fragrance allergens are
established under Regulation (EC) No 1223/2009; (iv) lay down biodegradability
requirements for substances and mixtures other than surfactants in detergents (including
detergent capsules) when new scientific evidence so requires; (v) amend the specific
information that should be included in the passport, as well as the information to be included
in the Commission registry; (vi) determine the additional information stored in the registry to
be controlled by customs authorities; (vii) provide an Annex to this Regulation containing a
list of Combined Nomenclature codes, as set out in Annex I to Regulation (EEC) No 2658/87,
and product descriptions of detergents and surfactants and update such Annex; and (viii)
amend Annexes I to VII.
The proposal empowers the Commission to adopt, where appropriate, implementing acts to
ensure the uniform application of this Regulation. In particular, implementing powers should
be conferred on the Commission to establish the detailed technical requirements for the
product passport for detergents and surfactants. Those powers should be exercised in
accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council
of 16 February 2011 laying down the rules and general principles concerning mechanisms for
control by the Member States of the Commission's exercise of implementing powers.
The Commission should also be granted implementing powers to establish whether a national
measure in respect of a detergent or surfactant presenting a risk to health and safety of persons
or the environment is justified. The Commission should also be granted implementing powers
to determine whether a national measure in respect of compliant detergents or surfactants
which a Member State finds to pose a risk to health and safety of persons or the environment
is justified. Given their special and technical nature, those implementing acts will not be
adopted in accordance with the provisions on implementing acts set out in Regulation (EU)
No 182/2011.
Chapter VIII – Transitional and final provisions
To assess their effectiveness, the Commission will monitor the implementation and
application of these new provisions as well as compliance with them. The Commission will
submit a report to the European Parliament and the Council assessing the effectiveness of the
Regulation after 5 years of application. The proposal also provides for the review of the safety
requirements for micro-organisms in detergents and the possibility to allow for more strains of
micro-organisms to be used in detergents.
The proposed Regulation will become applicable 2 and a half years after its entry into force to
on one hand allow the Commission to prepare the implemetation of the product passport’s
technical requirements and on the other to allow manufacturers and Member States time to
adapt to the new requirements set out in this Regulation. Transitional provisions are foreseen
for detergents and surfactants that have been manufactured in accordance with Regulation
(EC) No 648/2004 so that stock that is either in the distribution chain or in storage at the
EN 12 EN
manufacturer’s or importer’s site at the time when this Regulation starts applying can be sold.
Regulation (EC) No 648/2004 will be repealed and replaced by the proposed Regulation.
EN 13 EN
2023/0124 (COD)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
on detergents and surfactants, amending Regulation (EU) 2019/1020 and repealing
Regulation (EC) No 648/2004
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular
Article 114 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee28
,
Acting in accordance with the ordinary legislative procedure,
Whereas:
(1) The conditions for placing and making available on the market of detergents and
surfactants for detergents have been harmonised through Regulation (EC) No
648/2004 of the European Parliament and of the Council29
.
(2) The Commission evaluation of Regulation (EC) No 648/200430
concluded that overall
that Regulation has achieved its objectives to a large extent. However, the evaluation
also identified a number of weaknesses and areas for further improvement. In recent
years, the regulatory framework for chemicals has changed radically creating a lack of
coherence and duplications in the rules applicable to detergents and notably their
information requirements. There is therefore a need to ensure consistency and to
eliminate the duplicated information requirements.
(3) New market developments, in particular the development of detergents containing
micro-organisms and the refill sale of detergents have emerged that are either
completely or partially not covered by Regulation (EC) No 648/2004. On the other
hand, digitalisation offers opportunities for simplification, burden reduction and
increased ease of use and understandability of safety and use information that are
currently missed. It is therefore necessary to take account of the newly emerged
products and practices and step up the digitalisation efforts in line with the
overarching objectives of the Union especially in terms of sustainability, green and
digital transition.
28
OJ C , , p. .
29
Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on
detergents (OJ L 104, 8.4.2004, p. 1).
30
Evaluation of Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31
March 2004 on detergents (SWD(2019)298).
EN 14 EN
(4) The Fitness Check of the most relevant chemicals legislation31
(excluding Regulation
(EC) No 1907/2006 of the European Parliament and of the Council32
) highlighted the
complexity of the Union regulatory framework for chemicals and attributed it to the
large number of product and sector specific pieces of legislation with embedded links
with each other. It also pointed out that there is room for simplification in the
communication of information of overcrowded labels to product users, and found that
the use of innovative tools for communicating product information is currently not
being taken advantage of. It is, therefore, necessary that the current rules are simplified
to reduce burden for economic operators, improve consumer understanding and
facilitate market surveillance. Regulation (EC) No 648/2004 should therefore be
replaced.
(5) Decision No 768/2008/EC of the European Parliament and of the Council33
lays down
common principles and reference provisions intended to apply across sectoral
legislation in order to provide a coherent basis for a revision of that legislation. The
new legal framework for detergents and surfactants should be aligned to the extent
possible to those common principles and reference provisions.
(6) In order to ensure legal certainty and a level playing field for economic operators, the
definition of detergent should cover all products falling in the scope of harmonisation,
including the newly developed detergents containing intentionally added micro-
organisms. The definition should also cover products for cleaning the surface of fruits
and vegetables.
(7) Since surfactants are primarily sold in business-to-business transactions in order to be
used in the manufacturing of detergents, they do not need to be subject to the same
requirements as detergents. Therefore, minimum rules for surfactants should be laid
down, namely rules on ultimate biodegradability, a minimum set of labelling
information and the obligation of economic operators to draw up a technical
documentation and to create a product passport.
(8) This Regulation should complement existing rules set out in other legislative
instruments and should not affect the application of existing Union legislation relating
to aspects of protection of health, of safety and of the environment not covered by this
Regulation. This Regulation should, in particular, apply without prejudice to
Regulation (EC) No 1907/2006, Regulation (EU) No 528/2012 of the European
Parliament and of the Council34
and to Regulation (EC) No 1272/2008 of the
European Parliament and of the Council35
.
31
Fitness Check of the most relevant chemicals legislation (excluding REACH), SWD(2019)199
32
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),
establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and
2000/21/EC (OJ L 396, 30.12.2006, p. 1).
33
Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common
framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218,
13.8.2008, p. 82).
34
Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012
concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).
35
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on
classification, labelling and packaging of substances and mixtures, amending and repealing Directives
EN 15 EN
(9) Surfactants are surface-active agents that help break down the interface between water
and oils or dirt. They are one of the main ingredients used in detergents. Surfactants
could, however, pose a risk to the environment as they are discharged into sewage
systems or directly into surface waters. To prevent any adverse effects that surfactants
could have on the environment, it is necessary to set requirements ensuring that
surfactants are completely biodegradable either when placed on the market on their
own and intended for use in detergents or when contained in detergents.
(10) Phosphorus is a key ingredient used in detergents. However, phosphorus and its
compounds could cause damage to ecosystems and aquatic environments as they
contribute to eutrophication. To further ensure a high level of protection of the
environment, and reduce the contribution of detergents to that phenomenon, it is
necessary to establish harmonised limits on the content of phosphates and phosphorus
compounds in consumer laundry and consumer automatic dishwasher detergents.
Similar limitations are not required for other types of detergents either because their
contribution is not significant or because suitable alternatives are currently not
available.
(11) In recent years, novel cleaning products have been developed that contain living
micro-organisms as active ingredients. Micro-organisms have their own biology and
response to the environment. Due to their ability to proliferate, there is a clear
difference between conventional and microbial detergents. Therefore, the inherent
hazards and arising risks are not necessarily of the same nature as those presented by
chemicals, especially in relation to the capacity of micro-organisms to persist and
multiply in different environments and to produce a range of different metabolites and
toxins of potential toxicological significance.
(12) Since micro-organisms are not subject to registration under Regulation (EC) No
1907/2006 or any other Union legislation requiring manufacturers to demonstrate that
the intended use is safe, they should be eligible for use in detergents only to the extent
that they have been clearly identified and supported by data demonstrating that their
use is safe, and subject to specific requirements governing their safety. Harmonised
rules governing the safety of micro-organisms in detergents as well as relevant test
methods for economic operators to demonstrate compliance with those rules should,
therefore, be established. Restrictions are required on the format in which detergents
containing micro-organisms are placed on the market when sensitising ingredients are
included in their composition. To ensure a high level of protection of human health
even for sensitised persons, detergents containing micro-organisms and which are
placed on the market in a spray format should, therefore, be found safe for use in this
format.
(13) To ensure a high level of protection of the aspects of public interest, and to guarantee
fair competition on the internal market, economic operators should be responsible for
the compliance of detergents or surfactants with this Regulation, in relation to their
respective roles in the supply chain. Whenever appropriate, manufacturers and
importers should carry out sample testing of the detergents and surfactants that they
have made available on the market, in order to protect the health and safety of
consumers and the environment.
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p.
1).
EN 16 EN
(14) All economic operators intervening in the supply and distribution chain should take
appropriate measures to ensure that they only make available on the Union market
detergents and surfactants which are in conformity with this Regulation. It is necessary
to provide for a clear and proportionate distribution of obligations which correspond to
the role of each economic operator in the supply and distribution chain.
(15) In order to enable economic operators to demonstrate and the competent authorities to
verify that detergents and surfactants made available on the market comply with the
requirements of this Regulation, it is necessary to provide for a conformity assessment
procedure. Decision No 768/2008/EC establishes modules for conformity assessment
procedures, from the least stringent to the most stringent, in proportion to the level of
risk involved and the level of safety required. In order to ensure inter-sectoral
coherence and to avoid ad-hoc variants, Decision No 768/2008/EC specifies that
conformity assessment procedures should be chosen from among those modules.
(16) The manufacturer, having detailed knowledge of the design and production process, is
best placed to ensure compliance of the detergent or surfactant with the requirements
of this Regulation. Manufacturers should therefore be solely responsible for carrying
out the conformity assessment procedure for detergents and surfactants. Module A
should be applicable for the conformity assessment of detergents and surfactants.
Manufacturers should also put together a technical dossier demonstrating compliance
of the detergent or surfactant with the relevant rules and test methods.
(17) To facilitate compliance of the manufacturers with their obligations under this
Regulation, manufacturers established in the Union should be allowed to appoint an
authorised representative to carry out specific tasks on their behalf. Moreover, to
ensure a clear and proportionate distribution of responsibilities between the
manufacturer and the authorised representative it is necessary to set out the list of tasks
that manufacturers should be allowed to entrust the authorised representative with.
Further, to ensure the enforceability and effectiveness of the market surveillance
requirements and that only compliant detergents and surfactants are placed on the
Union market, the appointment of an authorised representative should be mandatory
when the manufacturer is established outside of the Union.
(18) With a view to facilitating the communication between economic operators, market
surveillance authorities and consumers, economic operators should, as part of their
contact details, indicate a website address in addition to the postal address.
(19) In order to safeguard the functioning of the internal market and to ensure that the
objective of providing a high level of protection of health and the environment is
achieved, it is necessary to establish that detergents and surfactants from third
countries entering the Union market also comply with this Regulation. In particular, it
is necessary to ensure that appropriate conformity assessment procedures have been
carried out by manufacturers with regard to those products. It is also necessary to lay
down rules for importers to ensure that the detergents and surfactants they place on the
market comply with those requirements and that the documentation drawn up by
manufacturers and, where relevant, the CE marking are available for inspection by the
competent national authorities. Provision should also be made for importers to ensure
that a product passport is available for those products.
(20) Since importers play a key role in guaranteeing the compliance of imported detergents
and surfactants in the Union market, when placing a detergent or surfactant on the
market, importers should indicate on the product their name, registered trade name or
EN 17 EN
registered trade mark as well as their postal address and, where available, electronic
means of communication through which they can be contacted.
(21) As the distributor makes a detergent or surfactant available on the market after it has
been placed there by the manufacturer or importer, the distributor should act with due
care in relation to the applicable requirements. The distributor should also ensure that
its handling of the detergent or surfactant does not adversely affect its compliance with
the requirements of this Regulation.
(22) Since distributors and importers are close to the marketplace and have an important
role in ensuring product compliance, they should be involved in market surveillance
tasks carried out by the competent national authorities, and should be prepared to
participate actively, providing those authorities with all necessary information relating
to the detergent or surfactant concerned.
(23) Economic operators that either place a detergent or surfactant on the market under
their own name or trade mark or modify a detergent or surfactant in such a way that
compliance with this Regulation could be affected should be considered to be
manufacturers and should assume the obligations of manufacturers. In other cases,
economic operators that only package or repackage a detergent or surfactant already
placed on the market by other economic operators should be able to prove that
compliance with the requirements of this Regulation has not been affected, by
indicating their identity on the package and by keeping a copy of the original labelling
information.
(24) The CE marking, indicating the conformity of a detergent with this Regulation, is the
visible consequence of a whole process comprising conformity assessment in a broad
sense. Regulation (EC) No 765/2008 of the European Parliament and of the Council36
lays down the general principles of the CE marking. That Regulation should be
applicable to detergents covered by this Regulation in order to ensure that products
benefiting from the free movement of goods within the Union fulfil requirements
providing a high level of protection of public interests such as health and the
environment. In line with Regulation (EC) No 765/2008, the CE marking should be
the only marking of conformity indicating that the detergent is in conformity with
Union harmonisation legislation.
(25) To ensure a high level of protection of human health, manufacturers should be
required to provide an ingredient data sheet for non-hazardous detergents. In order to
optimise efficiency of the relevant requirements and in view of the system related to
emergency health response already established under Regulation (EC) No 1272/2008,
manufacturers should hold this information at the disposal of poison centres, upon
request.
(26) Labels communicate important use and safety information to users, such as the
presence of skin or respiratory sensitisers (e.g. allergenic fragrances, preservatives or
enzymes) in detergents and surfactants. By providing information on the content of
those substances on the labels of detergents and surfactants, it is possible for users
with allergies or allergic predispositions to make informed choices, and potential
36
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out
the requirements for accreditation and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p.
30).
EN 18 EN
reactions related to the use of detergents and surfactants are thus reduced. It is
therefore necessary to establish labelling requirements for detergents and surfactants.
(27) Since the labelling of detergents and surfactants may fall under multiple pieces of
Union legislation, the information on detergents' and surfactants’ labels needs to be
streamlined so that when similar information stemming from different pieces of Union
legislation is required on detergents’ and surfactants’ labels, this information is
provided only once in accordance with the stricter rules. This will, on one hand,
improve the readability and understandability of detergents’ and surfactants’ labels by
end users and, on the other, reduce regulatory burden for detergents’ and surfactants’
manufacturers.
(28) Fragrance substances are organic compounds with characteristic, usually pleasant,
odours, which are widely used in detergents but also in many other products such as
perfumes and other perfumed cosmetics. Those substances could cause an allergic
reaction upon contact, especially to sensitised persons, even when contained in low
concentrations. Therefore, it is important to provide information on the presence of
individual allergenic fragrances in detergents so that sensitised persons can avoid
contact with the substance to which they are allergic. It is therefore necessary to lay
down strict requirements for the labelling of allergenic fragrances. However, those
substances could also trigger a labelling requirement under Regulation (EC) No
1272/2008. Specific labelling requirements should therefore be established that would
apply only when the labelling thresholds under Regulation (EC) No 1272/2008 are not
met. This will not only prevent the unnecessary burden for economic operators but
also ensure that end-users receive this information presented in a clear manner thus
providing a high level of protection of human health even for sensitised persons.
(29) Additional labelling requirements are needed for certain substances such as
preservatives in order to ensure a high level of health protection. The labelling
requirements for preservatives should, therefore, cover not only those preservatives
intentionally added by the manufacturer in the detergent but also those that ensue from
its constituent mixtures and which are often referred to as ‘carry-over preservatives’.
(30) Information on the correct amount of detergent that consumers need to use when
undertaking cleaning activities, namely, dosage information, should be included on
the label of consumer laundry and consumer automatic dishwasher detergents in order
to prevent the potential over-use of detergents thus reducing the total amount of
detergent and surfactant entering the environment.
(31) Digital labelling could improve the communication of labelling information both by
avoiding overcrowded physical labels and by allowing users to rely on various reading
options available only for digital formats, such as increased font, automatic search,
loud speakers or translation into other languages. Providing digital labels could also
lead to a more efficient management of the labelling obligations by economic
operators, by facilitating the update of labelling information, reducing labelling costs
and permitting a more targeted information of users. Therefore, economic operators
should be allowed to provide certain labelling information only through the digital
label subject to certain conditions to ensure a high level of protection of detergents’
users.
(32) To avoid imposing an unnecessary administrative burden for economic operators and
since, in most cases, the digital label is only complementary to the physical one,
economic operators should be able to decide whether to use digital labels or provide
all the information on a physical label only. The choice to provide a digital label
EN 19 EN
should rest with manufacturers and importers, who are responsible for providing the
accurate set of labelling information.
(33) Digital labelling could also create challenges for the vulnerable population groups
with no or insufficient digital skills and lead to an accentuation of the digital divide.
For this reason, the specific information to be provided only in a digital label should
reflect the current state of the digitalisation of the society and the particular situation
of detergents users. In addition, all the labelling information concerning the protection
of health and the environment, as well as minimum use instructions of detergents,
should remain on the physical label, to enable all end-users to make informed choices
before buying the detergent and to ensure its safe handling.
(34) An exception should, nevertheless, be made for detergents sold to end-users in a refill
format. In order to fully reap not only the benefits offered by digitalisation but also the
large environmental benefits in terms of reduction of packaging and related packaging
waste that the practice of refill sales offers, it should be permitted to provide all
labelling information digitally with the exception of dosage instructions for consumer
laundry detergents.
(35) To ensure a level playing field among economic operators making available detergents
on the market, and to protect end-users, general requirements for digital labelling
should be laid down. For example, economic operators should ensure free and easy
access to digital labels and that mandatory labelling information requested under this
Regulation is separated from other information.
(36) Given the current development of the digital skills, economic operators should also
provide the labelling information by alternative means to end-users when they cannot
access the digital label. This obligation should be imposed as a safety measure to
reduce any potential risks by the unavailability of the labelling information, in
particular as regards refilled detergents, where all the information may be provided in
a digital label.
(37) Since detergents have the same use and present the same risks irrespective of the
format in which they are made available on the market, economic operators making
detergents available on the market in a refill format should ensure that these comply
with the same requirements as the pre-packaged ones. In addition, consumers should
receive the required labelling information also when opting for refilled detergents. The
refill sale of detergents should, therefore, be explicitly covered by this Regulation in
order to ensure a high level of protection of health and the environment and a level
playing field for economic operators.
(38) Ensuring traceability of a detergent or surfactant throughout the whole supply chain
helps to make market surveillance simpler and more efficient. An efficient traceability
system facilitates market surveillance authorities’ task of tracing economic operators
who made non-compliant detergents or surfactants available on the market.
(39) Manufacturers should create a product passport to provide information on the
conformity of detergents and surfactants with this Regulation, as well as with any
other legislation that the detergent or surfactant must comply with. In order to
facilitate checks on detergents or surfactants and to allow the actors in the supply
chain and end-users to access necessary information such as ingredients and use
instructions, the information on the product passport should be provided digitally and
in a directly accessible manner, through a data carrier affixed to the label of the
detergent or surfactant, its packaging or the accompanying documentation. Market
EN 20 EN
surveillance authorities, economic operators and end-users should, therefore, have
immediate access to compliance or other information on the detergent or surfactant
through the data carrier.
(40) To avoid duplication of investment into digitalisation by all actors involved, including
manufacturers, market surveillance authorities and customs authorities, the product
passport established under this Regulation should be fully interoperable with the
product passport required under other Union legislation.
(41) In particular, Regulation (EU) …/… [of the European Parliament and of the Council
establishing a framework for setting ecodesign requirements for sustainable products
and repealing Directive 2009/125/EC] also lays down requirements and technical
specifications for a digital product passport, the establishment of a Commission central
registry where passport information is stored and the interconnection of that registry
with the customs IT systems. That Regulation could include detergents or surfactants
within its scope in the medium term, thus requiring that a digital product passport is
available for them.
(42) The product passport for detergents and surfactants created under this Regulation
should therefore comply with the same requirements and technical elements as those
set out in Regulation (EU) …/… on ecodesign requirements for sustainable products,
including its technical, semantic and organisational aspects of end-to-end
communication and data transfer.
(43) When other Union legislation applicable to detergents or surfactants requires a product
passport, a single product passport should be available for detergents and surfactants
containing the information required under this Regulation and the other Union
legislation.
(44) It is crucial to make clear to both manufacturers and users that by creating the product
passport for detergent or surfactant and, where relevant, by affixing the CE marking,
the manufacturer declares that the detergent or surfactant is in conformity with all
applicable requirements and that the manufacturer takes full responsibility thereof.
(45) Where certain information is provided only digitally, it is necessary to clarify that this
information needs to be provided separately and clearly distinguished from each other
but through a single data carrier. This will facilitate the work of market surveillance
authorities but also provide clarity to end users regarding the different pieces of
information that are available to them in a digital format.
(46) Chapter VII of Regulation (EU) 2019/1020 of the European Parliament and the
Council37
, setting up the rules of controls on products entering the Union market,
applies to detergents and surfactants. The authorities in charge of those controls, which
in almost all Member States are the customs authorities, are to perform them on the
basis of risk analysis as referred to in Articles 46 and 47 of Regulation (EU) No
952/2013 of the European Parliament and of the Council38
, its implementing
legislation and the corresponding guidance. This Regulation should therefore not
modify in any way Chapter VII of Regulation (EU) 2019/1020 and the way the
37
Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market
surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No
765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1).
38
Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying
down the Union Customs Code (OJ L 269, 10.10.2013, p. 1).
EN 21 EN
authorities in charge of controls on products entering the Union market organise
themselves and perform their activities.
(47) In addition to the framework of controls established by Chapter VII of Regulation
(EU) 2019/1020, customs authorities should be able to automatically verify that a
product passport exists for imported detergents and surfactants subject to this
Regulation in order to strengthen the controls at the Union’s external borders and
prevent non-compliant detergents and surfactants from entering the Union market.
(48) When detergents and surfactants coming from third countries are presented for release
for free circulation, customs should ensure that the reference of a product passport is
made available to customs authorities by the economic operator and that this reference
corresponds to a unique product identifier that is stored in the product passport registry
established by the Commission under [Article 12 of Regulation (EU) …/… on
Ecodesign for Sustainable Products]. The interconnection between this registry and
the customs IT system as provided for in [Article 13 of Regulation (EU) …/… on
ecodesign requirements for sustainable products] should allow for automatic
verification of the product passport presented to customs for that detergent or
surfactant, so as to ensure that only detergents and surfactants with a valid reference to
a unique product identifier as included in the registry are released for free circulation.
(49) Where other information in addition to the unique product identifier and the unique
operator identifier is stored in the product passport registry established under [Article
12 of Regulation (EU) …/… on Ecodesign for Sustainable Products], the Commission
should be able to provide in a delegated act, that customs authorities are allowed to
verify the consistency between this additional information and the information made
available by the economic operator to customs, in order to improve the compliance of
detergents and surfactants placed under the customs procedure of release for free
circulation with this Regulation.
(50) The information included in the product passport may allow customs authorities to
enrich and facilitate risk management and enable the better targeting of controls at the
Union’s external borders. Therefore, customs authorities should be able to retrieve and
use the information included in the product passport and the related registry for
carrying out their tasks in accordance with Union legislation including for risk
management in accordance with Regulation (EU) No 952/2013.
(51) It is appropriate to provide for the publication of a notice in the Official Journal of the
European Union indicating the date when the interconnection between the registry and
the EU Customs Single Window Certificates Exchange System referred to in [Article
13 of Regulation (EU) …/… on Ecodesign for Sustainable Products] becomes
operational in order to facilitate public access to that information.
(52) The automatic verification by customs of the product passport reference for detergents
and surfactants entering the Union market should not replace or modify the
responsibilities of the market surveillance authorities but only complement the overall
framework for controls on products entering the Union market. The market
surveillance authorities should, in line with Regulation (EU) 2019/1020, carry out
checks of the information contained in products passports, checks on products within
the market and, in case of suspension of release for free circulation by the authorities
designated for controls at Union’s external borders, determine the compliance and
serious risks of products pursuant to Chapter VII of Regulation (EU) 2019/1020.
EN 22 EN
(53) Market surveillance is an essential instrument inasmuch as it ensures the proper and
uniform application of Union legislation. Regulation (EU) 2019/1020 sets out the
framework for market surveillance of products subject to Union harmonisation
legislation. Member States should therefore organise and carry out market surveillance
of detergents and surfactants in accordance with that Regulation.
(54) Regulation (EU) 2019/1020 already applies to detergents and surfactants, since
Regulation (EC) No 648/2004 is listed in its Annex I. However, in order to ensure
legal certainty, it is necessary to clarify that rules on internal market surveillance and
control of products entering the internal market provided for in Regulation (EU)
2019/1020 also apply to detergents and surfactants covered by this Regulation. This
Regulation should not prevent Member States from choosing the competent authorities
to carry out those tasks. Regulation (EU) 2019/1020 should therefore be amended to
include a reference to this Regulation.
(55) Regulation (EC) No 648/2004 provided for a safeguard procedure allowing the
Commission to examine the justification for a measure taken by a Member State
against detergents and surfactants considered to constitute a risk. In order to increase
transparency and to reduce processing time, it is necessary to improve the previous
safeguard procedure, with the view to making it more efficient and drawing on the
expertise available in Member States. The previous system should be replaced by a
procedure under which interested parties are informed of measures intended to be
taken with regard to detergents and surfactants presenting a risk to health or the
environment. Market surveillance authorities should be allowed, in cooperation with
the relevant economic operators, to act at an early stage in respect of such detergents
and surfactants. The Commission should, by means of implementing acts and, given
their special and technical nature, acting without the application of Regulation (EU)
No 182/2011, determine whether a national measure in respect of a detergent or
surfactant presenting a risk is justified.
(56) Experience with Regulation (EC) No 648/2004 has shown that detergents and
surfactants which were compliant with the applicable requirements have in specific
cases posed a risk to health or the environment. Provisions should be made to ensure
that market surveillance authorities take action against any detergent or surfactant
presenting a risk to health or the environment, even when compliant with the legal
requirements. The Commission should, by means of implementing acts and, given
their special and technical nature, acting without the application of Regulation (EU)
No 182/2011, determine whether a national measure in respect of compliant detergents
or surfactants which a Member State finds to pose a risk to health and safety of
persons or the environment is justified.
(57) In order to take into account technical and scientific progress or new scientific
evidence, and the level of digital readiness, the power to adopt acts in accordance with
Article 290 of the Treaty on the Functioning of the European Union should be
delegated to the Commission in respect of further supplementing the general
requirements on digital labelling; amending the labelling information that may be
provided in digital format only; amending the limit of the allergenic fragrances when
individual risk-based concentration limits for fragrance allergens are established under
Regulation (EC) No 1223/2009; amending the existing biodegradability requirements
to introduce biodegradability requirements for substances and mixtures other than
surfactants in detergents (including detergent capsules) when new scientific evidence
so requires; and amending Annexes I to VII. The Commission should also be
empowered to amend the specific information that should be included in the product
EN 23 EN
passport, as well as the information to be included in the Commission registry.
Moreover, the Commission should be empowered to supplement this Regulation by
determining the additional information stored in the registry to be controlled by
customs authorities. In addition, in order to facilitate the work of customs authorities
in relation to detergents and surfactants and the requirements set out in this
Regulation, the Commission should be empowered to adopt delegated acts amending
this Regulation by providing an Annex containing a list of Combined Nomenclature
codes, as set out in Annex I to Regulation (EEC) No 2658/87, and product descriptions
of detergents and surfactants and by updating such Annex.
(58) When adopting delegated acts under this Regulation, it is of particular importance that
the Commission carry out appropriate consultations during its preparatory work,
including at expert level, and that those consultations be conducted in accordance with
the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better
Law-Making39
. In particular, to ensure equal participation in the preparation of
delegated acts, the European Parliament and the Council receive all documents at the
same time as Member States’ experts, and their experts systematically have access to
meetings of Commission expert groups dealing with the preparation of delegated acts.
(59) In order to ensure uniform conditions for the implementation of this Regulation,
implementing powers should be conferred on the Commission to establish the detailed
technical requirements for the product passport for detergents and surfactants. Those
powers should be exercised in accordance with Regulation (EU) No 182/2011 of the
European Parliament and of the Council40
.
(60) In view of the need to ensure a high level of human health and environmental
protection and the need to take into account new developments based on scientific
facts, the Commission should submit to the European Parliament and to the Council a
report on the application of this Regulation. The Commission should in its report
assess inter alia if this Regulation is achieving its objectives, taking into account the
impacts on small and medium-sized enterprises.
(61) In order to ensure a high level of protection of health and the environment, foster
innovation and boost competitiveness, the Commission should assess the safety
requirements for detergents containing micro-organisms and the possibility to allow
the use of new micro-organisms or strains of micro-organisms in detergents.
(62) This Regulation introduces the possibility of providing all or part of the mandatory
labelling requirements only in digital labels in certain situations and requires the
creation of a digital product passport for detergents and surfactants. It is, therefore,
necessary to provide for sufficient time for economic operators to comply with their
obligations under this Regulation, for Member States to set up the administrative
infrastructure necessary for its application and for the Commission to prepare the
implementation of the product passport’s technical requirements. Consequently, the
application of this Regulation should be deferred to a date where those preparations
can reasonably be finalised.
(63) In order to ensure legal certainty and to prevent waste, economic operators need to be
able to sell stock that is either in the distribution chain or in storage at the date of
39
OJ L 123, 12.5.2016, p. 1.
40
Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011
laying down the rules and general principles concerning mechanisms for control by Member States of
the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13)
EN 24 EN
application of this Regulation. It is, therefore, necessary to provide for transitional
arrangements that allow the making available on the market of detergents and
surfactants that have been placed on the market in accordance with Regulation (EC)
No 648/2004 before the date of application of this Regulation without those products
having to comply with product requirements laid down by this Regulation.
Distributors should therefore be able to supply detergents and surfactants that have
been placed on the market, namely stock that is already in the distribution chain,
before the date of application of this Regulation.
(64) Transitional arrangements should also be made that allow the placing on the market of
detergents and surfactants that at the date of application of this Regulation are not yet
in the distribution chain without those products having to comply with the
requirements laid down by this Regulation, provided that at the time of their placing
on the market they are still compliant with Regulation (EC) No 648/2004.
Manufacturers and importers should therefore be able to place on the market
detergents and surfactants, namely stock that is not yet in the distribution chain, after
the date of application of this Regulation.
(65) Since the objective of this Regulation, namely to guarantee the functioning of the
internal market while ensuring that detergents and surfactants on the market fulfil the
requirements providing for a high level of protection of health and the environment,
cannot be sufficiently achieved by the Member States but can rather, by reason of its
scale and effects, be better achieved at Union level, the Union may adopt measures, in
accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on
European Union. In accordance with the principle of proportionality, as set out in that
Article, this Regulation does not go beyond what is necessary in order to achieve that
objective,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter
1. This Regulation establishes rules for the free movement of detergents and surfactants
in the internal market while, at the same time, ensuring a high degree of protection of
health and the environment.
2. This Regulation does not affect the application of the following legal acts:
(a) Regulation (EC) No 1907/2006 of the European Parliament and of the
Council41
;
41
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),
establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and
2000/21/EC (OJ L 396, 30.12.2006, p. 1).
EN 25 EN
(b) Regulation (EC) No 1272/2008 of the European Parliament and of the
Council42
;
(c) Regulation (EU) No 528/2012 of the European Parliament and of the
Council43
.
Article 2
Definitions
For the purpose of this Regulation, the following definitions apply:
(1) ‘detergent’ means any of the following:
– a substance, mixture or micro-organism, or two or more such materials in
combination, which is intended for cleaning of fabrics, dishes or surfaces;
– a mixture intended for soaking (pre-washing), rinsing or bleaching fabrics or
dishes;
– a mixture intended to modify the feel of fabrics in processes which are to
complement the washing of fabrics;
(2) ‘consumer laundry detergent’ means a detergent for laundry placed on the market for
use by non-professionals, including in public laundrettes;
(3) ‘consumer automatic dishwasher detergent’ means a detergent placed on the market
for use in automatic dishwashers by non-professionals;
(4) ‘detergent containing micro-organisms’ means a detergent in which one or more
micro-organisms has been intentionally added, either on its own or via one of the
components of the detergent;
(5) ‘professional detergent’ means a detergent for cleaning outside the domestic sphere,
carried out by specialised personnel using specific products;
(6) ‘cleaning’ means the process by which an undesirable deposit is dislodged from a
substrate or from within a substrate and brought into a state of solution or dispersion;
(7) ‘substance’ means a substance as defined in Article 3, point (1), of Regulation (EC)
No 1907/2006;
(8) ‘mixture’ means a mixture as defined in Article 3, point (2), of Regulation (EC) No
1907/2006;
(9) ‘micro-organism’ means a micro-organism as defined in Article 3(1), point (b), of
Regulation (EU) No 528/2012;
(10) ‘genetically modified micro-organisms’ means micro-organisms in which the genetic
material has been altered using gene or cell technology or in any other way that does
not occur naturally by mating or natural recombination.
42
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on
classification, labelling and packaging of substances and mixtures, amending and repealing Directives
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p.
1).
43
Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012
concerning the making available on the market and use of biocidal products OJ L 167, 27.6.2012, p. 1).
EN 26 EN
(11) ‘surfactant’ means any organic substance or mixture used in detergents, which has
surface-active properties and which consists of one or more hydrophilic and one or
more hydrophobic groups of such a nature and size that it is capable to perform all of
the following actions:
– to reduce the surface tension of water below 45 mN/m;
– to form spreading or adsorption monolayers at the water-air interface;
– to form emulsions and/or microemulsions and/or micelles;
– to adsorpt at water-solid interfaces;
(12) ‘ultimate aerobic biodegradation’ means the level of biodegradation achieved when
the substance or mixture is totally used by micro-organisms in the presence of
oxygen resulting in its breakdown to carbon dioxide, water and mineral salts of any
other elements present, as measured by test methods listed in Annex I, and new
microbial cellular constituents;
(13) ‘making available on the market’ means any supply for distribution, consumption or
use on the Union market in the course of a commercial activity, whether in return for
payment or free of charge;
(14) ‘placing on the market’ means the first making available on the Union market;
(15) ‘manufacturer’ means any natural or legal persons that manufacture or have a
detergent or a surfactant designed or manufactured, and place that detergent or
surfactant on the market under their name or trademark;
(16) ‘authorised representative’ means any natural or legal persons established within the
Union that have received a written mandate from a manufacturer to act on their
behalf in relation to specified tasks;
(17) ‘importer’ means any natural or legal persons established within the Union that place
a detergent or surfactant from a third country on the Union market;
(18) ‘distributor’ means any natural or legal persons in the supply chain, other than the
manufacturer or the importer, that make a detergent or surfactant available on the
market;
(19) ‘economic operator’ means the manufacturer, the authorised representative, the
importer or the distributor;
(20) ‘market surveillance’ means the activities carried out and measures taken by market
surveillance authorities to ensure that products comply with the requirements set out
in this Regulation;
(21) ‘market surveillance authority’ means a market surveillance authority as defined in
Article 3, point 4, of Regulation (EU) 2019/1020;
(22) ‘recall’ means a recall as defined Article 3, point 22, of Regulation (EU) 2019/1020;
(23) ‘withdrawal’ means a withdrawal as defined in Article 3, point 23, of Regulation
(EU) 2019/1020;
(24) ‘CE marking’ means a marking by which the manufacturer indicates that the
detergent is in conformity with the applicable requirements set out in Union
harmonisation legislation providing for its affixing;
(25) ‘corrective measure’ means a measure as defined in Article 3, point 16, of Regulation
(EU) 2019/1020;
EN 27 EN
(26) ‘release for free circulation’ means the procedure laid down in Article 201 of
Regulation (EU) No 952/2013;
(27) ‘data carrier’ means a linear bar code symbol, a two-dimensional symbol or other
automatic identification data capture medium that can be read by a device;
(28) ‘unique product identifier’ means a unique string of characters that allows the
identification of a product and enables a web link to the product passport;
(29) ‘unique operator identifier’ means a unique string of characters for the identification
of economic operators involved in the value chain of products;
(30) ‘customs authorities’ means customs authorities as defined in Article 5, point 1, of
Regulation (EU) No 952/2013;
(31) ‘EU Customs Single Window Certificates Exchange System’ means the system
referred to in Article 4 of the Regulation (EU) 2022/2399 of the European Parliament
and of the Council 44
;
(32) ‘individual packaging’ means packaging in which the detergent or surfactant is made
available on the market and which is intended to accompany the content to the place
of use;
(33) ‘refill’ means the operation by which the detergent is filled in-store from a large
container in the end-users’ own package either manually or through automatic or
semi-automatic equipment;
(34) ‘batch’ means a defined quantity of finished products that meets the following
conditions:
– is produced in a single manufacturing process or a series of processes during
the same manufacturing cycle;
– is intended to have a uniform composition when tested in accordance with the
same test methods; and
– is clearly defined by a type number, batch number or other element allowing its
identification.
(35) ‘end-user’ means any natural or legal person residing or established in the Union, to
whom a detergent or surfactant has been made available either as a consumer outside
of any trade, business, craft or profession or as a professional end-user in the course
of its industrial or professional activities.
44
Regulation (EU) 2022/2399 of the European Parliament and of the Council of 23 November 2022
establishing the European Union Single Window Environment for Customs and amending Regulation
(EU) No 952/2013 (OJ L 317, 9.12.2022, p. 1).
EN 28 EN
CHAPTER II
PRODUCT REQUIREMENTS
Article 3
Free movement
1. Detergents and surfactants may only be placed on the market if they comply with this
Regulation.
2. Member States shall not prohibit, restrict or impede the placing on the market of
detergents or surfactants which comply with this Regulation.
Article 4
Biodegradability
1. Detergents and surfactants shall comply with the biodegradability requirements laid
down in Annex I.
2. Paragraph 1 shall not apply to the following:
(a) surfactants that are active substances within the meaning of Article 3(1), point
(c), of Regulation (EU) No 528/2012 and that are used as disinfectants where
they meet any of the following conditions:
(i) the surfactants are included in the Union list of approved active
substances as laid down in Article 9(2) of Regulation (EU) No 528/2012;
(ii) the surfactants are included in the review programme as set out in
Commission Delegated Regulation (EU) No 1062/201445
;
(b) surfactants that are constituents of biocidal products authorised in accordance
with Regulation (EU) No 528/2012;
(c) surfactants that are constituents of biocidal products and which may be made
available on the market or used in accordance with Article 89(2) of Regulation
(EU) No 528/2012.
Article 5
Detergents containing micro-organisms
Detergents containing micro-organisms shall comply with the requirements laid down in
Annex II.
Article 6
Limitations on the content of phosphates and other phosphorus compounds
45
Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for
the systematic examination of all existing active substances contained in biocidal products referred to in
Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p.
1).
EN 29 EN
Detergents listed in Annex III shall comply with the limitations on the content of phosphates
and other phosphorus compounds laid down in that Annex.
CHAPTER III
OBLIGATIONS OF ECONOMIC OPERATORS
Article 7
Obligations of manufacturers
1. When placing detergents or surfactants on the market, manufacturers shall ensure
that those detergents or surfactants have been designed and manufactured in
accordance with this Regulation.
2. Manufacturers shall draw up the technical documentation referred to in Annex IV
and carry out the conformity assessment procedure referred to in that Annex.
Where compliance of a detergent or surfactant with the applicable requirements has
been demonstrated by the procedure referred to in the first subparagraph,
manufacturers shall:
(a) create a product passport in accordance with Article 18,
(b) ensure that the data carrier is printed or otherwise placed on the label or on the
packaging of the detergent or surfactant in a visible and legible manner in
accordance with Article 18(3),
(c) where relevant, affix the CE marking in accordance with Article 14,
(d) before placing detergents or surfactants on the market, manufacturers shall
include a reference of the product passport in the registry referred to in Article
20(1).
3. Manufacturers shall keep the technical documentation and the product passport for
10 years after the detergent or the surfactant covered by that documentation or
product passport has been placed on the market.
4. Manufacturers shall ensure that procedures are in place for series production to
remain in conformity. Changes in product design or characteristics and changes in
the test methods by reference to which conformity of a product is declared shall be
adequately taken into account.
When deemed appropriate with regard to the performance of, or the risks presented
by, a detergent or surfactant, manufacturers shall carry out sample testing of such
detergents or surfactants, investigate, and, if necessary, keep a register of complaints,
of non-conforming detergents or surfactants and recalls of such detergent or
surfactants, and shall keep distributors informed of any such monitoring.
5. Manufacturers placing on the market detergents or surfactants shall ensure that they
comply with the labelling requirements laid down in Articles 15, 16 and 17.
6. Manufacturers placing on the market detergents that do not meet the criteria for
classification as hazardous within the meaning of Regulation (EC) No 1272/2008,
shall provide to Member States’ appointed bodies referred to in Article 45 of that
Regulation, the ingredient datasheet referred to in point 2.2 (e) of Annex IV.
EN 30 EN
Manufacturers shall provide the ingredient data sheet to the Member States’
appointed bodies referred to in the first subparagraph in the following cases:
(a) upon request from the Member States’ appointed bodies;
(b) when the detergent for which a data sheet has already been requested no
longer corresponds to the information included in that datasheet.
The appointed body referred to in the first subparagraph and the medical personnel to
which the information contained in the datasheet has been provided shall keep it
confidential and use it for medical purposes only.
7. Manufacturers that consider or have reason to believe that a detergent or surfactant
which they have placed on the market is not in conformity with this Regulation shall
immediately take the corrective measures necessary to bring that detergent or
surfactant into conformity, to withdraw it or to recall it, as appropriate. Furthermore,
where manufacturers consider or have reason to believe that a detergent or surfactant
which they have placed on the market presents a risk to health or to the environment,
they shall immediately inform the competent national authorities of the Member
States in which they made the detergent or surfactant available on the market to that
effect, giving details, in particular, of any non-compliance and of any corrective
measures taken.
8. Manufacturers shall, further to a reasoned request from a competent national
authority, provide it with all the information and documentation, in paper or
electronic form, necessary to demonstrate the conformity of the detergent or
surfactant with this Regulation, in a language which can be easily understood by that
authority. They shall cooperate with that authority, at its request, on any action taken
to eliminate the risks posed by a detergent or surfactant which they have placed on
the market.
Article 8
Authorised representative
1. Manufacturers may, by a written mandate, appoint an authorised representative.
2. Where the manufacturer is not established in the Union, the detergent or surfactant
may only be placed on the Union market if the manufacturer designates, by a written
mandate, an authorised representative.
3. An authorised representative shall perform the tasks specified in the mandate
received from the manufacturer. The authorised representative shall provide a copy
of the mandate to the competent authority, upon request.
The mandate shall allow the authorised representative to do at least the following:
(a) verify that the product passport has been created in accordance with Article
7(2), point (a), that the technical documentation has been drawn up and the
conformity assessment procedure has been carried out by the manufacturer in
accordance with Article 7(2);
(b) keep the product passport and technical documentation at the disposal of
national market surveillance authorities for 10 years after the detergent or
surfactant covered by those documents has been placed on the market;
EN 31 EN
(c) further to a reasoned request from a competent national authority, provide that
authority with all the information and documentation necessary to demonstrate
the conformity of the detergent or surfactant with the requirements laid down
in this Regulation;
(d) cooperate with the competent national authorities, at their request, on any
action taken to eliminate the risks posed by a detergent or surfactant covered
by the authorised representative’s mandate.
(e) terminate the mandate if the manufacturer does not comply with the
obligations of the manufacturer under this Regulation.
4. The obligations laid down in Article 7(1) and the obligation to draw up technical
documentation referred to in Article 7(2) shall not form part of the authorised
representative’s mandate.
Article 9
Obligations of importers
1. Importers shall place only compliant detergents or surfactants on the market.
2. Before placing a detergent or surfactant on the market importers shall ensure the
following:
(a) the manufacturer has carried out the conformity assessment procedure and
drawn up the technical documentation referred to in Article 7(2);
(b) the detergent bears the CE marking referred to in Article 14;
(c) the manufacturer has created the product passport referred to in Article 7(2);
(d) the relevant information on the product passport has been included in the
registry referred to in Article 20(1);
3. Where an importer considers or has reason to believe that a detergent or surfactant is
not in conformity with this Regulation, the importer shall not place the detergent or
surfactant on the market until it has been brought into conformity. Furthermore,
where the detergent or surfactant presents a risk to health or to the environment, the
importer shall inform the manufacturer and the market surveillance authorities to that
effect.
4. Importers shall indicate their name, registered trade name or registered trade mark
and the postal and email address at which they can be contacted on the label of the
detergent or surfactant. The contact details shall be in a language easily understood
by end-users and market surveillance authorities.
5. Importers shall ensure that detergents and surfactants that they place on the market
comply with the labelling requirements laid down in Articles 15, 16 and 17.
6. Importers shall ensure that, while a detergent or surfactant is under their
responsibility, its storage or transport conditions do not jeopardise its compliance
with this Regulation.
7. When deemed appropriate with regard to the performance of a detergent or surfactant
or the risks presented by them, importers shall carry out sample testing of such
detergents and surfactants, investigate, and, if necessary, keep a register of
complaints, of non-conforming detergents and surfactants and recalls of such
EN 32 EN
detergents and surfactants, and shall keep distributors informed of any such
monitoring.
8. Importers that consider or have reason to believe that a detergent or surfactant which
they have placed on the market is not in conformity with this Regulation shall
immediately take the corrective measures necessary to bring that detergent or
surfactant into conformity, to withdraw it or to recall it, as appropriate. Furthermore,
where importers consider or have reason to believe that a detergent or surfactant
which they have placed on the market presents a risk to health or the environment,
they shall immediately inform the competent national authorities of the Member
States in which they made the detergent or surfactant available on the market to that
effect, giving details, in particular, of any non-compliance and of any corrective
measures taken.
9. Importers shall keep the reference to the unique product identifier at the disposal of
the market surveillance authorities for a period of 10 years after the detergent or
surfactant has been placed on the market and shall ensure that the technical
documentation can be made available to those authorities, upon request.
10. Importers shall, further to a reasoned request from a competent national authority,
provide it with all the information and documentation, in paper or electronic form,
necessary to demonstrate the conformity of the detergent or surfactant with this
Regulation in a language which can be easily understood by that authority. They
shall cooperate with that authority, at its request, on any action taken to eliminate the
risks posed by a detergent or surfactant which they have placed on the market.
Article 10
Obligations of distributors
1. When making a detergent or surfactant available on the market distributors shall act
with due care in relation to the requirements of this Regulation.
2. Before making a detergent or surfactant available on the market distributors shall
verify that the following conditions have been met:
(a) the detergent or surfactant is accompanied by the required documents and by a
label that meets the requirements laid down in Articles 15, 16 and 17;
(b) the detergent bears the CE marking referred to in Article 14;
(c) the manufacturer has complied with the requirements set out in Article 7(2)
and (3) or, as applicable, the importer has complied with the requirements set
out in Article 9(2).
3. Where a distributor considers or has reason to believe that a detergent or surfactant is
not in conformity with this Regulation, the distributor shall not make the detergent or
surfactant available on the market until it has been brought into conformity.
Furthermore, where the detergent or surfactant presents a risk to health or the
environment, the distributor shall inform the manufacturer and, where relevant, the
authorised representative or the importer to that effect as well as the market
surveillance authorities.
4. Distributors shall ensure that, while a detergent or surfactant is under their
responsibility, its storage or transport conditions do not jeopardise its compliance
with this Regulation.
EN 33 EN
5. Distributors that consider or have reason to believe that a detergent or a surfactant
which they have made available on the market is not in conformity with this
Regulation shall make sure that the corrective measures necessary to bring that
detergent or surfactant into conformity, to withdraw it or to recall it, as appropriate,
are taken. Furthermore, where distributors consider or have reason to believe that a
detergent or surfactant which they have made available on the market presents a risk
to health or to the environment, they shall immediately inform the competent
national authorities of the Member States in which they made the detergent or
surfactant available on the market to that effect, giving details, in particular, of any
non-compliance and of any corrective measures taken.
6. Distributors shall, further to a reasoned request from a competent national authority,
provide it with all the information and documentation, in paper or electronic form,
necessary to demonstrate the conformity of the detergent or surfactant with this
Regulation. They shall cooperate with that authority, at its request, on any action
taken to eliminate the risks posed by detergents and surfactants which they have
made available on the market.
Article 11
Cases in which obligations of manufacturers apply to importers and distributors
An importer or distributor shall be considered a manufacturer for the purposes of this
Regulation and shall be subject to the obligations of the manufacturer under Article 7 where
that importer or distributor places a detergent or surfactant on the market under his or her
name or trademark or modifies a detergent or surfactant already placed on the market in such
a way that compliance with this Regulation may be affected.
Article 12
Packaging and repackaging by importers and distributors
Where an importer or distributor packages or repackages a detergent or surfactant and is not
subject to the obligations of the manufacturer pursuant to Article 11, that importer or
distributor, as applicable, shall have the following obligations:
(a) to ensure that the package bears his or her name, registered trade name or registered
trade mark and postal address preceded by the words ‘packaged by’ or ‘repackaged
by’;
(b) to ensure compliance with Articles 14 to 17;
(c) to keep the reference to the unique product identifier at the disposal of the market
surveillance authorities for 10 years after having made the detergent or surfactant
available on the market.
Article 13
Identification of economic operators
1. Economic operators shall, on request, identify the following to the market
surveillance authorities:
(a) any economic operator who has supplied them with a detergent or a surfactant;
(b) any economic operator to whom they have supplied a detergent or a surfactant.
EN 34 EN
2. Economic operators shall be able to provide the information referred to in paragraph
1 for 10 years after they have been supplied with the detergent or surfactant and for
10 years after they have supplied the detergent or surfactant.
CHAPTER IV
CE MARKING AND LABELLING
Article 14
Rules and conditions for affixing the CE marking
1. The CE marking shall be subject to the general principles set out in Article 30 of
Regulation (EC) No 765/2008.
2. The CE marking shall be affixed visibly, legibly and indelibly before a detergent is
placed on the market.
The CE marking shall be affixed either to the label or the packaging of a detergent
or, where the detergent is supplied in bulk, to a document accompanying the
detergent.
Where, in accordance with Article 16(2), economic operators may provide a digital
label only, the CE marking shall be provided on the digital label.
3. Member States shall build upon existing mechanisms to ensure correct application of
the regime governing the CE marking and shall take appropriate action in the event
of improper use of that marking.
Article 15
General labelling requirements
1. Detergents and surfactants that are made available on the market in individual
packaging or in a refill format shall be accompanied by a label.
2. An economic operator making a detergent available on the market directly to an end-
user in a refill format shall provide the physical label or the data carrier through
which the digital label is accessible to the end-user.
3. The label of detergents and surfactants shall contain the following information:
(a) a type number, batch number or other element allowing their identification;
(b) the manufacturer’s name, registered trade name or registered trade mark and
the postal and email address at which they can be contacted. The postal address
shall indicate a single point at which the manufacturer can be contacted;
(c) the name and trade name of the product;
(d) the content of the detergent or surfactant in accordance with part A of Annex
V;
(e) instructions for use and special precautions, where necessary and relevant.
The information referred to in points (a), (b) and (c) of the first subparagraph shall
appear on all documents accompanying detergents and surfactants transported in
bulk.
EN 35 EN
4. In addition to the information referred to in paragraph 3, the label of consumer
laundry detergents and consumer automatic dishwasher detergents shall contain
dosage information in accordance with part B of Annex V.
5. The information referred to in paragraphs 3 and 4 shall be in a language which can
be easily understood by end-users, as determined by the Member State concerned,
and shall be clear, understandable and intelligible. The label shall be accessible for
inspection purposes where the detergent or surfactant is made available on the
market.
Article 16
Forms of labelling
1. Where detergents or surfactants are made available on the market, they shall be
accompanied by the label elements set out in Article 15(3) and, where applicable,
Article 15(4) in the following form:
(a) on a physical label;
(b) on a digital label and duplicated on a physical label.
By way of derogation from point (b) of the first subparagraph, the labelling elements
set out in part C of Annex V do not have to be duplicated on the physical label. In
addition, where the dosage information for consumer laundry detergents in
accordance with points 1 and 2 of part B of Annex V is provided on the digital label,
a simplified dosage grid as set out in part D of Annex V may be provided on the
physical label.
2. By way of derogation from paragraph 1, where detergents are made available on the
market directly to an end-user in a refill format, the label elements set out in Article
15(3) and (4) may be provided in a digital label only, with the exception of dosage
information for consumer laundry detergents as set out in point 1 and 2 of part B of
Annex V, which needs to be provided also on a physical label.
Article 17
Requirements for digital labelling
1. Where detergents and surfactants carry a digital label in accordance with Article 16,
the following rules shall apply to that label:
(a) all label elements referred to in Article 15(3) and, where applicable, Article
15(4) shall be provided in one place and separated from other information;
(b) the information on the digital label shall be searchable;
(c) the information on the digital label shall be accessible to all users in the Union;
(d) the digital label shall be accessible free of charge, without the need for prior
registration, download or installation of applications, or to provide a password;
(e) the information on the digital label shall be presented in a way that addresses
the needs of vulnerable groups and supports, as relevant, the necessary
adaptations to facilitate access to the information by those groups;
(f) the digital label shall be accessible through digital technologies widely used
and compatible with all major operating systems and browsers;
EN 36 EN
(g) when the digital label is available in more than one language, the choice of
language shall not be conditioned on the geographical location of the end-user;
(h) the digital label shall remain available for a period of 10 years from the
moment the detergent or surfactant is placed on the market, also in cases of an
insolvency, a liquidation or a cessation of activity in the Union of the economic
operator that created it, or for a longer period as required under other Union
legislation covering the information that it contains;
(i) the information on the digital label shall be accessible via the data carrier.
2. The data carrier shall be physically present on the detergent or surfactant, their
packaging or the documentation accompanying them.
In addition to the requirement in the first subparagraph, where detergents and
surfactants are made available on the market in a refill format, the data carrier shall
be present on the refill station.
The data carrier shall be clearly visible to the end-user before any purchase and to
market surveillance authorities, including, where applicable, in cases where the
detergent or surfactant is made available through distance sales.
3. Where economic operators provide a digital label, the data carrier shall be
accompanied by the statement ‘More comprehensive information on the product is
available online’ or by a similar statement.
4. Economic operators providing a digital label shall not track, analyse or use any
usage information for purposes other than what is absolutely necessary for providing
the information on the digital label online.
5. Economic operators providing a digital label shall provide the information present in
the digital label by other means in any of the following cases:
(a) upon oral or written request by the end-user;
(b) when the digital label is temporarily unavailable, including at the time of
purchase.
Economic operators shall provide the information referred to in the first
subparagraph independently from a purchase of a detergent or surfactant and free of
charge.
CHAPTER V
PRODUCT PASSPORT
Article 18
Product passport
1. Before placing a detergent or surfactant on the market, manufacturers shall create a
product passport for those products. The product passport shall meet the
requirements laid down in this Article and Article 19.
2. The product passport shall meet the following requirements:
(a) it shall correspond to a specific batch of the detergent or surfactant;
EN 37 EN
(b) it shall state that compliance of the detergent or surfactant with the
requirements set out in this Regulation has been demonstrated, and, where
relevant, indicate the test methods used;
(c) it shall contain at least the information included in Annex VI;
(d) it shall be up-to date;
(e) it shall be available in the language or languages required by the Member State
where the detergent or surfactant is placed or made available on the market;
(f) it shall be accessible to end-users, market surveillance authorities, customs
authorities, the Commission and other economic operators;
(g) it shall be available for a period of 10 years after the detergent or surfactant is
placed on the market, also in cases of an insolvency, a liquidation or a
cessation of activity in the Union of the economic operator that created the
product passport;
(h) it shall be accessible through a data carrier;
(i) it shall fulfil the specific and technical requirements laid down pursuant to
paragraph 8.
3. The data carrier shall be physically present on the detergent or surfactant, their
packaging or the documentation accompanying them, in accordance with the
implementing act referred to in paragraph 8.
In addition to the requirement in the first subparagraph, where detergents and
surfactants are made available on the market in a refill format, the data carrier shall
be present on the refill station.
The data carrier shall be clearly visible to the end-user before any purchase and to
market surveillance authorities, including, where applicable, in cases where the
detergent or surfactant is made available through distance sales.
4. Where economic operators provide a digital label, a single data carrier shall be used
to access the product passport and the digital label.
5. Where other Union legislation requires information on the detergent or surfactant to
be available via a data carrier, a single data carrier shall be used to provide the
information required under this Regulation and the other Union legislation.
6. Where other Union legislation applying to detergents and surfactants requires a
product passport, a single product passport shall be created for detergents and
surfactants, containing the information set out in paragraph 2 as well as any other
information required for the product passport by that other Union legislation.
7. Economic operators may, in addition to the information referred to in paragraphs 5
and 6, make other information accessible through the data carrier referred to in
paragraph 6. Where this is the case, that information shall be clearly separated from
the information required under this Regulation and, where relevant, under other
Union legislation.
8. By creating the product passport, the manufacturer shall assume the responsibility for
the compliance of the detergent or surfactant with this Regulation.
9. The Commission shall adopt an implementing act determining the specific and
technical requirements related to the product passport for detergents and surfactants.
Those requirements shall set out at least the following:
EN 38 EN
(a) the types of data carrier to be used;
(b) the layout in which the data carrier shall be presented and its positioning;
(c) the technical elements of the passport for which defined European or
international standards shall be used;
(d) the actors that may introduce or update the information in the product passport,
including where needed the creation of a new product passport, including
manufacturers, competent national authorities, and the Commission, or any
organisation acting on their behalf, and the types of information they may
introduce or update;
Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 28(2).
Article 19
Technical design and operation of the product passport
The technical design and operation of the product passport shall comply with the following
requirements:
(a) product passports created under this Regulation shall be fully interoperable with
product passports required by other Union legislation in relation to the technical,
semantic and organisational aspects of end-to-end communication and data transfer;
(b) all information included in the product passport shall be based on open standards
developed with an interoperable format and shall be machine readable, structured
and searchable;
(c) end-users, economic operators and other relevant actors shall have access to the
product passport free of charge;
(d) the data included in the product passport shall be stored by the economic operator
responsible for its creation or by operators authorised to act on their behalf;
(e) if the data included in the product passport is stored or otherwise processed by
operators authorised to act on behalf of economic operators placing the detergent or
surfactant on the market, those operators shall not be allowed to sell, re-use or
process such data, in whole or in part, beyond what is necessary for the provision of
the relevant storing or processing services;
(f) economic operators may not track, analyse or use any usage information for purposes
other than what is absolutely necessary for providing the information on the product
passport online.
Article 20
Product passport registry
1. Before placing a detergent or surfactant on the market, economic operators shall
upload, in the registry established under Article 12(1) of Regulation (EU) …/… on
Ecodesign for Sustainable Products the unique product identifier and the unique
operator identifier for the detergent or surfactant.
EN 39 EN
2. The Commission, the market surveillance authorities and the customs authorities
shall have access to the registry referred to in paragraph 1 for carrying out their
duties pursuant to this Regulation.
Article 21
Customs controls relating to the product passport
1. Detergents and surfactants entering the Union market shall be subject to verifications
and other measures laid down in this Article.
2. Declarants as defined in Article 5, point (15), of Regulation (EU) 952/2013 shall
include the unique product identifier in the customs declaration for release for free
circulation of any detergent or surfactant.
3. Customs authorities shall verify whether the unique product identifier indicated by
the declarant in accordance with paragraph 2 of this Article matches a unique product
identifier included in the registry in accordance with Article 20(1).
4. In addition to the verification referred to in paragraph 3, customs authorities shall
verify the consistency of information made available to customs by declarants with
other information stored in the registry referred to in Article 20(1) listed in the
delegated act referred to in Article 26(3).
5. The verifications referred to in paragraph 3 and 4 shall take place electronically and
automatically before the release for free circulation.
6. For the purpose of paragraphs 3 to 5, the interconnection between the registry
referred to in Article 20(1) and the EU Customs Single Window Certificates
Exchange System referred to in [Article 13 of Regulation (EU) …/… on Ecodesign
for Sustainable Products] shall be used.
7. Paragraphs 3, 4 and 5 shall apply from the day when the interconnection between the
registry and the EU Customs Single Window Certificates Exchange System referred
to in [Article 13 of Regulation (EU) …/… on Ecodesign for Sustainable Products]
becomes operational.
The Commission shall publish a notice in the Official Journal of the European Union
to that effect indicating the date when the interconnection becomes operational.
8. Customs authorities may retrieve and use the information included in the product
passport and the registry referred to in Article 20(1) for carrying out their duties
pursuant to Union legislation, including for risk management in accordance with
Articles 46 and 47 of Regulation (EU) No 952/2013.
9. The verifications and other measures laid down in this Article shall be carried out on
the basis of a list of Combined Nomenclature codes, as set out in Annex I to
Regulation (EEC) No 2658/87, under which detergents and surfactants are classified
as well as the product descriptions of those detergents and surfactants.
10. The verifications and measures laid down in this Article shall not affect the
application of other Union legal acts governing the release for free circulation of
products, including Articles 46, 47 and 134 of Regulation (EU) No 952/2013, as well
as the controls referred to in Chapter VII of Regulation (EU) 2019/1020.
EN 40 EN
CHAPTER VI
MARKET SURVEILLANCE
Article 22
Procedure at national level for dealing with detergents and surfactants presenting a risk
1. Where the market surveillance authorities of one Member State have sufficient
reason to believe that a detergent or surfactant presents a risk to health or the
environment, they shall carry out an evaluation in relation to the detergent or
surfactant concerned covering all relevant requirements laid down in this Regulation.
The relevant economic operators shall cooperate as necessary with the market
surveillance authorities for that purpose.
2. Where the market surveillance authorities of one Member State have sufficient
reason to believe that a test carried out in accordance with the methods listed in
Annex I or Annex II has produced false results, they shall perform controls to verify
the compliance of the detergent or surfactant with this Regulation in accordance with
the reference methods set out in Annexes I, II and VII. Economic operators shall not
be obliged to pay for any repeat or additional test, provided that the initial test has
shown compliance of detergents, or surfactants, with this Regulation.
3. Where, in the course of the controls referred to in paragraph 1 or paragraph 2, the
market surveillance authorities find that the detergent or surfactant does not comply
with the requirements laid down in this Regulation, they shall without delay require
the relevant economic operators to take all appropriate corrective action to bring the
detergent or surfactant into compliance with those requirements, to withdraw it from
the market, or to recall it within a reasonable period which is commensurate with the
nature of the risk referred to in paragraph 1.
4. Where the market surveillance authorities consider that non-compliance is not
restricted to their national territory, they shall inform the Commission and the market
surveillance authorities of other Member States of the results of the evaluation and of
the actions which they have required the economic operator to take.
5. The economic operator shall ensure that all appropriate corrective action is taken in
respect of all the concerned detergents or surfactants that the economic operator has
made available on the market throughout the Union.
6. Where the relevant economic operator does not take adequate corrective action
within the period referred to in paragraph 3, the market surveillance authorities shall
take all appropriate provisional measures to prohibit or restrict making available on
their national market of the detergent or surfactant, to withdraw the detergent or
surfactant from that market or to recall it.
The market surveillance authorities shall inform the Commission and the market
surveillance authorities of other Member States, without delay, of those measures.
The information referred to in the second subparagraph shall include all available
details, in particular the data necessary for the identification of the non-compliant
detergent or surfactant, the origin of that detergent or surfactant, the nature of the
non-compliance alleged and the risk involved, the nature and duration of the national
measures taken and the arguments put forward by the relevant economic operator.
EN 41 EN
7. Market surveillance authorities of Member States other than the Member State
initiating the procedure under this Article shall without delay inform the Commission
and the market surveillance authorities of other Member States of any measures
adopted and of any additional information at their disposal relating to the non-
compliance of the detergent or surfactant concerned, and, in the event of
disagreement with the adopted national measure, of their objections.
8. Where, within three months of receipt of the information referred to in paragraph 6,
second subparagraph, no objection has been raised by either a market surveillance
authority or the Commission in respect of a provisional measure taken by a Member
State, that measure shall be deemed justified.
9. Market surveillance authorities shall ensure that appropriate restrictive measures,
such as withdrawal of the detergent or surfactant from the market, are taken in
respect of the detergent or surfactant concerned without delay.
10. Where, for the purposes of paragraphs 4, 6, 7 and 8, information is communicated to
the Commission or other market surveillance authorities that information shall be
communicated through the information and communication system referred to in
Article 34(1) of Regulation (EU) 2019/1020.
Article 23
Union safeguard procedure
1. Where, on completion of the procedure set out in Article 22(3), (4) and (5),
objections are raised against a measure taken by a market surveillance authority, or
where the Commission considers a national measure to be contrary to Union
legislation, the Commission shall without delay enter into consultation with the
market surveillance authorities and the relevant economic operator or operators and
shall evaluate the national measure. On the basis of the results of that evaluation, the
Commission shall adopt an implementing act determining whether the national
measure is justified or not.
The Commission shall address its decision to all Member States and shall without
delay communicate it to them and the relevant economic operator or operators.
2. If the national measure is considered justified, all Member States shall take the
necessary measures to ensure that the non-compliant detergent or surfactant is
withdrawn from their market, and shall inform the Commission accordingly.
3. If the national measure is considered unjustified, the Member State concerned shall
withdraw that measure.
Article 24
Compliant detergents and surfactants which present a risk to health or to the
environment
1. Where, having carried out an evaluation under Article 22(1), a market surveillance
authority finds that although a detergent or surfactant is in compliance with this
Regulation, it presents a risk to health or to the environment, it shall require the
relevant economic operator to take all appropriate measures to ensure that the
detergent or surfactant concerned, when placed on the market, no longer presents that
risk, to withdraw the detergent or surfactant from the market or to recall it, within a
reasonable period which is commensurate with the nature of that risk.
EN 42 EN
2. The economic operator shall ensure that corrective action is taken in respect of all the
concerned detergents or surfactants that the economic operator has made available on
the market throughout the Union.
3. The market surveillance authority shall immediately inform the Commission and the
market surveillance authorities of the other Member States. That information shall
include all available details, in particular the data necessary for the identification of
the detergents or surfactants concerned, the origin and the supply chain of the
detergent or surfactant, the nature of the risk involved and the nature and duration of
the national measures taken.
4. The Commission shall without delay enter into consultation with the market
surveillance authorities and the relevant economic operator or operators and shall
evaluate the national measures taken. On the basis of the results of that evaluation,
the Commission shall adopt an implementing act determining whether the national
measure is justified or not and, where necessary, propose appropriate measures.
The Commission shall address its decision to all Member States and shall
immediately communicate it to them and the relevant economic operator or
operators.
Article 25
Formal non-compliance
1. Without prejudice to Article 22, where a market surveillance authority makes one of
the following findings, it shall require the relevant economic operator to put an end
to the non-compliance concerned:
(a) the CE marking has been affixed in violation of Article 14 or not affixed at all;
(b) the product passport has not been drawn up in accordance with Articles 18 and
19;
(c) the technical documentation referred to in Article 7(2) is either not available or
incomplete;
(d) the data carrier through which the product passport and, where relevant, the
digital label is accessible is not present on the detergent or surfactant, their
packaging, the documentation accompanying them or on the refill station, as
applicable;
(e) the label has not been provided or the labelling information referred to in
Articles 15 and Annex V is false or incomplete;
2. Where the non-compliance referred to in paragraph 1 persists, the Member State
concerned shall take all appropriate measures to restrict or prohibit the detergent or
surfactant being made available on the market or ensure that it is recalled or
withdrawn from the market.
EN 43 EN
CHAPTER VII
DELEGATED POWERS AND COMMITTEE PROCEDURE
Article 26
Delegated powers
1. The Commission is empowered to adopt delegated acts in accordance with Article 27
amending Annex VI, as regards the information to be provided in the product
passport, for the purposes of adapting it to technical and scientific progress and to the
level of digital readiness of market surveillance authorities and of end-users.
2. The Commission is empowered to adopt delegated acts in accordance with Article
27, amending Article 20(1) by requiring that additional information among the
information listed in Annex VI be stored in the registry.
When adopting the delegated acts in accordance with the first subparagraph, the
Commission shall take into account the following criteria:
(a) coherence with other relevant Union acts where relevant;
(b) the need to allow for the verification of the authenticity of the product passport;
(c) the relevance of information for improving the efficiency and effectiveness of
market surveillance checks and customs controls for detergents and surfactants;
(d) the need to avoid disproportionate administrative burden for economic
operators.
3. The Commission is empowered to adopt delegated acts in accordance with Article 27
supplementing this Regulation by determining additional information stored in the
registry referred to in Article 20(1) that is to be controlled by customs authorities.
4. The Commission is empowered to adopt delegated acts in accordance with Article 27
amending this Regulation by providing an Annex containing a list of Combined
Nomenclature codes, as set out in Annex I to Regulation (EEC) No 2658/87, and
product descriptions of detergents and surfactants and by updating such Annex.
5. The Commission is empowered to adopt delegated acts in accordance with Article 27
amending Annexes I to VII to take into account scientific and technical progress.
6. Where new scientific evidence points to the need to introduce biodegradability
requirements for substances and mixtures other than surfactants in detergents,
including detergent capsules, the Commission is empowered to adopt delegated acts
in accordance with Article 27 amending Annex I to lay down biodegradability
criteria for those substances and mixtures and test methods to verify compliance with
them.
When adopting delegated acts in accordance with the first subparagraph, the
Commission shall take into account the current manufacturing practices, the
availability of technically and economically feasible alternatives and the impacts to
small and medium-sized enterprises.
7. Where individual risk-based concentration limits for fragrance allergens are
established in Regulation (EC) No 1223/2009 of the European Parliament and of the
EN 44 EN
Council46
, the Commission shall adopt delegated acts in accordance with Article 27
amending Annex V in order to adapt the limit of the allergenic fragrances listed in
Annex III to that Regulation accordingly.
8. By [OP please insert the date = the first day of the month following 30 months after
the date of entry into force of this Regulation], the Commission shall adopt delegated
acts in accordance with Article 27 to supplement this Regulation, by determining the
specific requirements for the digital labelling of detergents. Those requirements shall
at least establish the types of IT solutions, which economic operators may use, and
the alternative means for providing the information on the digital label, referred to in
Article 17.
When adopting the delegated act referred to in the first subparagraph, the
Commission shall take into account the following criteria:
(a) coherence with other relevant Union acts where relevant;
(b) the need to encourage innovation;
(c) technological neutrality characterised by absence of constraints or prescriptions
on the choice of technology or equipment, within the bounds of compatibility
and avoidance of interference;
(d) the need for the digital labelling not to compromise the safety of the end-users
and the environment.
(e) the level of digital readiness among all population groups in the Union.
9. The Commission is empowered to adopt delegated acts in accordance with Article 27
amending Annex V, as regards the labelling information, which economic operators
are allowed to provide only digitally in accordance with Article 16, for the purposes
of adapting it to technical and scientific progress and to the level of digital readiness
among the end-users of detergents. When adopting those delegated acts, the
Commission shall take into account the need to ensure a high level of protection of
health and environment.
Article 27
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the
conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Article 26 shall be conferred on the
Commission for an indeterminate period of time.
3. The delegation of power referred to in Article 26 may be revoked at any time by the
European Parliament or by the Council. A decision to revoke shall put an end to the
delegation of the power specified in that decision. It shall take effect the day
following the publication of the decision in the Official Journal of the European
Union or at a later date specified therein. It shall not affect the validity of any
delegated acts already in force.
46
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009
on cosmetic products (OJ L 342, 22.12.2009, p. 59).
EN 45 EN
4. Before adopting a delegated act, the Commission shall consult experts designated by
each Member State in accordance with the principles laid down in the
Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to
the European Parliament and to the Council.
6. A delegated act adopted pursuant to Article 26 shall enter into force only if no
objection has been expressed either by the European Parliament or the Council
within a period of two months of notification of that act to the European Parliament
and the Council or if, before the expiry of that period, the European Parliament and
the Council have both informed the Commission that they will not object. That
period shall be extended by two months at the initiative of the European Parliament
or the Council.
Article 28
Committee procedure
1. The Commission shall be assisted by the Committee on detergents. That committee
shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No
182/2011 shall apply.
CHAPTER VIII
TRANSITIONAL AND FINAL PROVISIONS
Article 29
Penalties
Member States shall lay down the rules on penalties applicable to infringements of this
Regulation and shall take all measures necessary to ensure that they are implemented. The
penalties provided for shall be effective, proportionate and dissuasive. Member States shall,
without delay, notify the Commission of those measures and of any subsequent amendment
affecting them.
Article 30
Amendment of Regulation (EU) 2019/1020
In Annex I of Regulation (EU) 2019/1020, point 15 is replaced by the following:
‘15. Regulation (EU) …/… of the European Parliament and of the Council of … on the
making available on the market of detergents and surfactants (OJ L …)’.
Article 31
Report
By [OP: please insert the date = 5 years from the date of application of this Regulation], the
Commission shall submit to the European Parliament and to the Council a report on the
application of this Regulation. The report shall contain an assessment of how this Regulation
is achieving its objectives, including an assessment on the impact on small and medium-sized
enterprises.
EN 46 EN
Article 32
Micro-organisms review
By [OP: please insert the date = 3 years from the date of application of this Regulation], the
Commission shall assess the effectiveness and relevance of the requirements of this
Regulation for detergents containing micro-organisms as well as the possibility to include
new micro-organisms or strains of micro-organisms allowed in detergents in Annex II.
Article 33
Repeal of Regulation (EC) No 648/2004
Regulation (EC) No 648/2004 is repealed.
References to the repealed Regulation shall be construed as references to this Regulation and
read in accordance with the correlation table in Annex VIII.
Article 34
Transitional provisions
Member 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]
Detergents 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].
Article 35
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Union.
This Regulation shall apply as of [OP: please insert the date = 30 months from the date of
entry into force of this Regulation].
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the European Parliament For the Council
The President The President