Commission Regulation (EC) No 907/2006 of  20 June 2006  amending Regulation (EC) No 648/2004 of the European Parliament and of the Council on detergents, in order to adapt Annexes III and VII thereto   (Text with EEA relevance)
Date: 2006-06-20
Institutions: European Commission
Subjects: analytical chemistry, biodegradability, free movement of goods, labelling, polishing and scouring preparations, public health

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COMMISSION REGULATION (EC) No 907/2006

of 20 June 2006

amending Regulation (EC) No 648/2004 of the European Parliament and of the Council on
detergents, in order to adapt Annexes III and VII thereto

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

packaging of the detergent from which the list of ingre-
dients mentioned in Section D of Annex VII to Regu-
lation (EC) No 648/2004 can be easily obtained.

Having regard to the Treaty
Community,

establishing the European

Having regard to Regulation (EC) No 648/2004 of the European
Parliament and of
the Council of 31 March 2004 on
detergents (1), and in particular Article 13(1) thereof,

Whereas:

(1)

(2)

Regulation (EC) No 648/2004 ensures the free circulation
of detergents on the internal market while at the same
time providing a high level of protection to the envir-
onment and to human health by laying down rules for
the ultimate biodegradation of surfactants for detergents,
and for the labelling of detergent ingredients.

Some of the methods laid down in Annex III to Regu-
lation (EC) No 648/2004, e.g. the ISO 14593 reference
method, are also applicable for testing substances that are
poorly-soluble in water,
if adequate dispersion of the
substance is ensured. More guidance for testing poorly-
soluble substances is given in ISO 10634. However, an
additional test method should be introduced for use with
surfactants that are poorly-soluble in water. The addi-
tional
ISO standard
test method
10708:1997 ‘Water
quality — Evaluation in an
aqueous medium of the ultimate aerobic biodegradability
of organic compounds’. The Scientific Committee on
Health and Environmental Risks
(SCHER) concluded
that ISO 10708 is of an equivalent standard to the test
methods already included in Annex III to that Regulation
and was in favour of its use.

proposed

is

(3)

To ensure a high level of health protection, information
concerning detergent composition needs to be made
more easily available to the general public. The address
of a website should therefore be provided on the

(1) OJ L 104, 8.4.2004, p. 1.

(4)

(5)

(6)

(7)

(8)

There is a requirement to declare allergenic fragrances if
they are added in the form of pure substances. However
there is no requirement to declare them if they are added
as constituents of complex ingredients such as essential
oils or perfumes. To ensure better transparency to the
consumer, allergenic fragrances in detergents should be
declared irrespective of the way they are added to the
detergent.

the use of

The list of ingredients intended for the general public
that is given in section D of Annex VII to Regulation
specialised
(EC) No 648/2004 requires
scientific nomenclature that may hinder
than
rather
help the general public. Moreover,
there are some
inconsistencies between the information made
minor
available to the general public compared to that to be
made available to medical personnel under section C of
the same Annex. The ingredient
information for the
general public should be made more easily under-
standable by using the INCI nomenclature already in
use for cosmetic ingredients, and sections C and D
should be made compatible.

The definition of ‘detergent’ in the Regulation makes it
clear that the rules on labelling apply to all detergents
they contain surfactants or not. However,
whether
(EC)
section D of Annex VII
those
No 648/2004 lays down different
industrial
contain
surfactants compared with those that do not. This
difference in labelling requirements serves no useful
purpose and should be eliminated.

and institutional detergents

Regulation
for
rules

that

to

Annexes III and VII to Regulation (EC) No 648/2004
should be amended accordingly.
In the interest of
clarity it is appropriate to replace those Annexes.

The measures provided for in this Regulation are in
accordance with
detergents
Committee,

opinion

the

the

of

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HAS ADOPTED THIS REGULATION:

Article 1

Article 2

Entry into force

Regulation (EC) No 648/2004 is amended as follows:

This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.

1. Annex III is replaced by the text set out in Annex I to this

Regulation.

2. Annex VII is replaced by the text set out in Annex II to this

Regulation.

Article 1(2) shall apply from the day falling six months after the
entry into force of this Regulation.

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

Done at Brussels, 20 June 2006.

For the Commission

Günter VERHEUGEN
Vice-President

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ANNEX I

‘ANNEX III

ULTIMATE BIODEGRADABILITY (MINERALISATION) TEST METHODS

FOR SURFACTANTS

IN

DETERGENTS

A. 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).

Surfactants in detergents shall be considered as biodegradable if the level of biodegradability (mineralisation) measured
according to one of the following tests (1) is at least 60 % within 28 days:

1. 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).
Pre-adaptation is not to be used. The 10-day window principle is not applied (reference method).

2. Directive 67/548/EEC method, Annex V.C.4-C (carbon dioxide (CO2) Eeolution modified Sturm test): pre-adap-

tation is not to be used. The 10-day window principle is not applied.

3. Directive 67/548/EEC method, Annex V.C.4-E (closed Bottle): pre-adaptation is not to be used. The 10-day window

principle is not applied.

4. Directive 67/548/EEC method, Annex V.C.4-D (manometric respirometry): pre-adaptation is not to be used. The

10-day window principle is not applied.

5. Directive 67/548/EEC method, Annex V.C.4-F (MITI: Ministry of International Trade and Industry, Japan): pre-

adaptation is not to be used. The 10-day window principle is not applied.

6. 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. Pre-
adaptation is not to be used. The 10-day window principle is not applied.

B. Depending on the physical characteristics of the surfactant, one of the methods listed below may be used if appro-
priately justified (2). It should be noted that the pass criterion of at least 70 % of these methods is to be considered as
equivalent to the pass criterion of at least 60 % referred to in methods listed in point A. The adequacy of the choice of
the methods listed below shall be decided on a case-by-case confirmation,
in accordance with Article 5 of this
Regulation.

1. Directive 67/548/EEC method, Annex V.C.4-A (dissolved organic carbon DOC die-away): pre-adaptation is not to
be used. The 10-day window principle is not applied. The pass criteria for biodegradability measured according to
the test shall be at least 70 % within 28 days.

2. Directive 67/548/EEC method, Annex V.C.4-B (modified OECD screening-DOC die-away): pre-adaptation is not to
be used. The 10-day window principle is not applied. The pass criteria for biodegradability measured according to
the test shall be at least 70 % within 28 days.

NB: Those of the abovementioned methods that are taken from Council Directive 67/548/EEC can also be found in the
publication “Classification, Packaging and Labelling of Dangerous Substances in the European Union”, Part 2:
“Testing Methods”. European Commission 1997, ISBN 92-828-0076-8.

(1) These tests are identified as the most suitable for surfactants.
(2) The DOC methods could give results on the removal and not on the ultimate biodegradation. The manometric respirometry and the
MITI and two-phase BOD methods would not be appropriate in some cases because the high initial test concentration could be
inhibitory.’

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ANNEX II

‘ANNEX VII

LABELLING AND INGREDIENT DATA SHEET

A. Labelling of contents

The following provisions on labelling shall apply to the packaging of detergents sold to the general public.

The following 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:

— phosphates,

— phosphonates,

— anionic surfactants,

— cationic surfactants,

— amphoteric surfactants,

— non-ionic surfactants,

— oxygen-based bleaching agents,

— chlorine-based bleaching agents,

— EDTA and salts thereof,

— NTA (nitrilotriacetic acid) and salts thereof,

— phenols and halogenated phenols,

— paradichlorobenzene,

— aromatic hydrocarbons,

— aliphatic hydrocarbons,

— halogenated hydrocarbons,

— soap,

— zeolites,

— polycarboxylates.

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The following classes of constituent, if added, shall be listed irrespective of their concentration:

— enzymes,

— disinfectants,

— optical brighteners,

— perfumes.

irrespective of their concentration, using where possible the common
If added, preservation agents shall be listed,
nomenclature established under Article 8 of Council Directive 76/768/EEC of 27 July 1976 on the approximation of
laws of the Member States relating to cosmetic products (1).

If added at concentrations exceeding 0,01 % by weight, the allergenic fragrances that appear on the list of substances in
Annex III, Part 1 to Directive 76/768/EEC, as a result of its amendment by Directive 2003/15/EC of the European
Parliament and of the Council (2) to include the allergenic perfume ingredients from the list first established by the
Scientific Committee on Cosmetics and Non-food Products (SCCNFP) in its opinion SCCNFP/0017/98, shall be listed
using the nomenclature of that Directive, as shall any other allergenic fragrances that are subsequently added to Annex III,
Part 1 to Directive 76/768/EEC by adaptation of that Annex to technical progress.

If individual risk-based concentration limits for fragrance allergens are subsequently established by the SCCNFP, the
Commission shall propose the adoption,
in accordance with Article 12(2), of such limits to replace the limit of
0,01 % mentioned above.

The website address, from which the list of ingredients mentioned in section D of Annex VII can be obtained, shall be
given on the packaging.

For detergents intended to be used in the industrial and institutional sector, and not made available to members of the
general public, the abovementioned requirements do not have to be fulfilled if the equivalent information is provided by
means of technical data sheets, safety data sheets, or in a similar appropriate manner.

B. Labelling of dosage information

As prescribed in Article 11(4), the following provisions on labelling shall apply to the packaging of detergents sold to the
general public. The packaging of detergents sold to the general public intended to be used as laundry detergents shall bear
the following information:

— 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,

— 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,

— 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.

(1) OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2005/80/EC (OJ L 303, 22.11.2005, p. 32).
(2) OJ L 66, 11.3.2003, p. 26.

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The standard washing machine loads are 4,5 kg dry fabric for heavy-duty detergents and 2,5 kg dry fabric for light-duty
detergents in line with the definitions of Commission Decision 1999/476/EC of 10 June 1999 establishing the Ecological
Criteria for the award of the Community eco-label to Laundry Detergents (1). A detergent shall be considered to be a
heavy-duty detergent unless the claims of the manufacturer predominantly promotes fabric care i.e. low temperature
wash, delicate fibres and colours.

C.

Ingredient data sheet

The following provisions shall apply to the listing of ingredients on the data sheet referred to in Article 9(3).

The data sheet shall list the name of the detergent and that of the manufacturer.

All ingredients shall be listed; in order of decreasing abundance by weight, and the list shall be sub-divided into the
following weight percentage ranges:

— 10 % or more,

— 1 % or over, but less than 10 %,

— 0,1 % or over, but less than 1 %,

— less than 0,1 %.

Impurities shall not be considered to be ingredients.

“Ingredient” means any chemical substance, of synthetic or natural origin, intentionally included in the composition of a
detergent. For the purpose of this Annex, a perfume, an essential oil, or a colouring agent shall be considered to be a
single ingredient and none of the substances that they contain shall be listed, with the exception of those allergenic
fragrance substances that appear on the list of substances in Annex III, Part 1 to Directive 76/768/EEC if the total
concentration of the allergenic fragrance substance in the detergent exceeds the limit mentioned in section A.

The common chemical name or IUPAC (2) name and, where available, the INCI (3) name, the CAS number, and the
European Pharmacopoeia name, shall be given for each ingredient.

D. Publication of the list of ingredients

Manufacturers shall make available on a website the ingredient data sheet mentioned above except for the following:

— information on weight percentage ranges is not required

— CAS numbers are not required

— the ingredient names shall be given in INCI nomenclature, or where this is not available, the European Pharmacopoeia
name, shall be given. If neither name is available, the common chemical name or IUPAC name shall be used instead.
For a perfume the word “parfum” shall be used and for a colouring agent, the word “colorant”. A perfume, an essential
oil, or a colouring agent shall be considered to be a single ingredient and none of the substances that they contain
shall be listed, with the exception of those allergenic fragrance substances that appear on the list of substances in
Annex III, Part 1 to Directive 76/768/EEC if the total concentration of the allergenic fragrance substance in the
detergent exceeds the limit mentioned in section A.

Access to the website shall not be subject to any restriction or condition and the content of the website shall be kept up
to date. The website shall include a link to the Commission Pharmacos website or to any other suitable website that
provides a table of correspondence between INCI names, European Pharmacopoeia names, and CAS numbers.

This obligation shall not apply to industrial or institutional detergents, or to surfactants for industrial or institutional
detergents, for which a technical data sheet or safety data sheet is available.

(1) OJ L 187, 20.7.1999, p. 52. Decision as last amended by Decision 2003/200/EC (OJ L 76, 22.3.2003, p. 25).
(2) International Union of Pure and Applied Chemistry.
(3) International Nomenclature Cosmetic Ingredient.’