Amended proposal for a Regulation of the European Parliament and of the Council on Detergents
Date: 2003-06-05
Institutions: European Commission
Subjects: environmental protection, free movement of goods, labelling, polishing and scouring preparations, product safety, public health

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 5.6.2003
COM(2003) 306 final

2002/0216 (COD)

Amended proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on Detergents

(presented by the Commission)

2002/0216 (COD)

Amended proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on Detergents

(presented by the Commission pursuant to Article 250 (2) of the EC Treaty)
(Text with EEA relevance)

1.

STATE OF PROCEDURE

The  proposal  –  COM(2002)458 final  –  2002/0216 (COD)  was  adopted  by  the
Commission on 4th September 2002 and was transmitted to the European Parliament
and to the Council on the same date.

The  European  Economic  and  Social  Committee  adopted  its  opinion  on  the
Commission proposal on 26th February 2003.

The European Parliament adopted 53 amendments in the first reading on 10th April
2003.

2.

OBJECTIVE OF THE PROPOSAL

The  objective  of  the  proposal  is  to  ensure  the  free  movement  of  detergents  in  the
internal market while at the same time providing a high level of protection to human
health  and  the  environment.  The  proposal  seeks  to  achieve  these  objectives  by
modernising the directives that lay down rules for the biodegradability of surfactants
used  in  detergents  and  by  incorporating  and  expanding  labelling  rules  contained  in
Commission  recommendation  89/542/EEC.  Modernisation  is  provided  by  new
biodegradability  tests  which  will  provide  an  enhanced  level  of  protection  to  the
aquatic compartment. In addition, the scope of the tests is extended to all classes of
surfactant  thereby  including  the  10%  of  surfactants  that  escape  current  legislation.
Labelling  rules  are  extended  to  include  fragrance  ingredients  that  could  cause
allergies,  and  manufacturers  are  obliged  to  disclose  a  full  list  of  ingredients  to
medical  practitioners  treating  patients  suffering  from  allergies.  A  Regulation  is
proposed  to  ensure  that  the  new  rules,  and  subsequent  adaptations  of  them  to
technical progress, will apply simultaneously in all Member States without the need
for transposition of lengthy technical annexes into 25 separate national legislations.

3.

OBJECTIVE OF THE AMENDED PROPOSAL

The amended proposal adapts the original proposal for a Regulation on Detergents in
a number of respects concerning the clarity of the text and of the definitions, and also
concerning a number of detailed improvements on matters of substance which are in
line with the Commission’s original proposal.

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4.

COMMENTS ON THE AMENDMENTS ADOPTED BY THE PARLIAMENT

4.1.

Amendments accepted by the Commission

Amendments  2,  4,  8,  17,  and  53  can  be  accepted  as  they  are  presented  by  the
Parliament  as  these  amendments  add  clarity  to  the  text  and  improve  certain
definitions.

4.2.

Amendments accepted by the Commission in part or subject to reformulation

Amendments 3, 18, 27, 34, 35, 36, 37, 45, 46, 52, 55 and 57 can be accepted in part,
or  in  principle  subject  to  reformulation,  because  they  introduce  a  number  of
improvements concerning either the clarity of the text or concerning certain matters
of detail, or of additions that could be useful in the implementation of the proposal.
These changes are in line with the Commission’s original proposal.

4.2.1.

Amendment 3 (Recital 14)

The mention of complementary risk assessment in the Parliament’s amendment can
be accepted in principle. However,  as the  complementary  risk  assessment will  be a
new feature in the legislation  it is not appropriate  to say that it  will be maintained.
Instead, the Commission proposes the following reformulation:

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“The  existing  requirements  regarding  primary  biodegradability  [and 
complementary  risk assessment] are to be maintained  on  a  second  hierarchy  level,
and  are  to  be  supplemented  by  a  complementary  risk  assessment,  for  those
surfactants failing “ultimate biodegradability” tests; furthermore surfactants failing
primary  biodegradability  tests  cannot  obtain  marketing  authorisation  by  way  of
derogation;”

4.2.2.

Amendment 18 (Article 2)

The  Commission  can  support  in  principle  an  additional  definition  in  Article  2  for
industrial and institutional detergents. Having introduced the definition, however, it
is  necessary  to  make  use  of  it.  This  is  done  in  Article  4,  as  described  under
amendment 55, in relation to derogations.

““Industrial  and  institutional”  detergent  means  a  detergent  for  washing  and
cleaning  outside  the  domestic  sphere,  carried  out  by  specialised  personnel  using
specific products.”

4.2.3.

Amendment 27 (Article 9(3))

The  Commission  can  accept  in  principle  that  part  of  the  amendment  concerning
medical  staff  bound  by  professional  secrecy  as  a  useful  additional  requirement  to
preserve the confidentiality of ingredient data.  To be consistent with  amendment 8,
which the Commission accepts, the term adopted in the Commission’s reformulation
is  “medical  personnel”.  Furthermore,  it  would  be  useful  to  more  fully  define
“medical  personnel”  in  Article  2,  including  the  necessity  for  confidentiality.  The
Commission’s reformulation is as follows:

“3.  Manufacturers  placing  on  the  market  the  preparations  covered  by  this
Regulation shall, upon request, make available without delay and free of charge to

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medical  [staff]  personnel  a  datasheet  listing  all  ingredients  as  stipulated  in
Annex VIII.C

This  is  without  prejudice  to  the  right  of  a  Member  State  to  request  that  such  a
datasheet be made available to  a  specific public  body to which  the Member  State
has assigned the task of providing this information to medical personnel.”

And, in Article 2, the following definition:

“Medical  personnel”  means  a  doctor  of  medicine  acting  to  provide  patient  care,
make  a  diagnosis,  or  administer  treatment  and  who  is  bound  by  professional
confidentiality.

4.2.4.

Amendment 34 (Annex II, point A)

The  Commission  can  accept  the  introduction  of  a  reference  to  specific  analytical
methods. However, it would partially negate the benefit that could be obtained from
these methods if they were to be restricted to only those surfactants that do not react
with MBAS. The Commission therefore reformulates the Parliament’s amendment as
follows:

“For those anionic surfactants not reacting to the above-mentioned MBAS method,
or if it seems more appropriate for reasons of efficiency or precision, appropriate
specific  instrumental  analyses  such  as  high  performance  liquid  chromatography
(HPLC) [and]or gas chromatography (GC) are to be applied. Samples of the pure
surfactant  of  interest  shall  be  provided  by  the  manufacturer  to  the  competent
national authorities of the Member States upon request.”

4.2.5.

Amendment 35 (Annex II, point B)

The  Commission  can  accept  the  introduction  of  a  reference  to  specific  analytical
methods. However, it would partially negate the benefit that could be obtained from
these methods if they were to be restricted to only those surfactants that do not react
with BiAS. The Commission therefore reformulates the Parliament’s amendment as
follows:

“For those non-ionic surfactants not reacting to the above-mentioned BiAS method,
or if it seems more appropriate for reasons of efficiency or precision, appropriate
specific  instrumental  analyses  such  as  (high  performance  liquid  chromatography
(HPLC) [and]or gas chromatography (GC) are to be applied. Samples of the pure
surfactant  of  interest  shall  be  provided  by  the  manufacturer  to  the  competent
national authorities of the Member States upon request.”

4.2.6.

Amendment 36 (Annex II, point C)

The  Commission  can  accept  the  introduction  of  a  reference  to  specific  analytical
methods. However, it would partially negate the benefit that could be obtained from
these methods if they were to be restricted to only those surfactants that do not react
with DBAS. The Commission therefore reformulates the Parliament’s amendment as
follows:

“For those cationic surfactants not reacting to the above-mentioned test method, or
if  it  seems  more  appropriate  for  reasons  of  efficiency  or  precision,  appropriate

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specific  instrumental  analyses  such  as  high  performance  liquid  chromatography
(HPLC) [and] or gas chromatography (GC) are to be applied. Samples of the pure
surfactant  of  interest  shall  be  provided  by  the  manufacturer  to  the  competent
national authorities of the Member States upon request.”

4.2.7.

Amendment 37 (Annex II, point A)

The  Commission  can  accept  the  introduction  of  a  reference  to  specific  analytical
methods. However, it would partially negate the benefit that could be obtained from
these  methods if  they were to  be  restricted  to  only  those  surfactants  that  cannot  be
analysed  with  the  two  non-instrumental  methods  specified.  The  Commission
therefore reformulates the Parliament’s amendment as follows:

“For those amphoteric surfactants not reacting to the above-mentioned tests, or if it
seems more appropriate for reasons of efficiency or precision, appropriate specific
instrumental  analyses  such  as  high  performance  liquid  chromatography  (HPLC)
[and]or gas chromatography (GC) are to be applied. Samples of the pure surfactant
of  interest  shall  be  provided  by  the  manufacturer  to  the  competent  national
authorities of the Member States upon request.”

4.2.8.

Amendment 45 (Annex VIII, point B, paragraph 1, indent 2)

The Commission can accept the Parliament’s amendment in principle because it will
introduce  useful  additional  information  for  the  consumer  for  the  two  different
categories  of  detergent.  However,  the  term  used  for  the  two  categories  are  heavy-
duty and low-duty detergents in the subsequent text. The Parliament’s amendment is
therefore reformulated as:

“-  For  [normal]  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.”

4.2.9.

Amendment 46 (Article 2, point 6)

The Commission can accept the Parliament’s amendment in principle concerning the
definition of a surfactant exclusively in terms of an extended list of properties instead
of including the intention of the manufacturer. The list is reformatted to make clearer
the cumulative nature of the list.

“6.  “Surfactant”  means  any  organic  substance  and/or  preparation  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  of  reducing  the  surface  tension  of  water,  and  of  forming  spreading  or
adsorption monolayers at the water-air interface, and of forming emulsions and/or
microemulsions and/or micelles, and of adsorption at water-solid interfaces;”

4.2.10. Amendment 52 (Recital 16)

The  Commission  can  accept  in  principle  the  Parliament’s  amendment  because
criteria  for  refusing  derogations  are  given  in  Art  6  and  not  in  the  Annexes.  The
criteria for derogations will therefore remain subject to the codecision procedure

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“(16) The determination of biodegradability test-methods and the record-keeping of
lists of derogations are technical matters[. The setting of criteria for derogations is a
political  matter.  These  matters]  which  need  to  be  revised  taking  into  account
technical  and  scientific  developments  as  well  as  regulatory  [and  political]
developments;”

4.2.11. Amendment 55 (Article 4(1))

The  part  of  the  amendment  that  places  the  limits  for  the  biodegradability  test  in
Article  4  instead  of  in  Annex  III  cannot  be  accepted  because  these  limits  refer
specifically to the test method mentioned in that Annex. If the limits are placed in the
annex,  then  they  can  be  adapted  in  parallel,  e.g.  revised  upwards,  with  any  future
change to the test method.

For  consistency  with  the  introduction  in  amendment  18  of  a  definition  of  the  term
“industrial and institutional detergents”, use is made of the term here to make clearer
that derogations are intended only for these low volume speciality products and not
for laundry detergents. Without this addition, the definition would not used anywhere
in the proposal.

The  addition,  in  the  Parliament’s  amendment,  of  a  mention  of  the  action  to  follow
from a request for derogation is acceptable in principle to the Commission. However,
as Article 6 deals with refusal of derogation and not with granting of derogation, the
following reformulation has been made:

“1.  If  a  detergent  contains  surfactants  for  which  the  level  of  “ultimate  aerobic
biodegradation” is less than  that stipulated in Annex III  [60% within  28 days, or
for  which  the  tests  pursuant  to  Annex  IV,  point  3  have  shown  toxicity  of  the  test
liquor],  manufacturers  of 
institutional  detergents  containing
surfactants, and/or of surfactants for industrial or  institutional detergents may  ask
for  derogation.  Requests  for  derogation  shall  be  made  and  [granted]  decided  in
accordance with the provisions of Articles 5, 6 and 9.”

industrial  or 

4.2.12. Amendment 57 (Article 5)

The  Commission  can  accept  parts  of  the  Parliament’s  amendment  concerning
paragraphs  2,  3  (except  last  sentence)  and  4  as  useful  clarifications  concerning  the
implementation of the provisions.

The  parts  of  the  amendment  in  Article  4(2)  and  4(3)  concerning  Annex  IV  and
testing  strategies  respectively  cannot  be  accepted  because  Annex  IV  testing  is
designed to  demonstrate that the  surfactant  is  not  toxic  to  the  environment,  despite
failing the ultimate biodegradability test. The range of tests specified in Annex IV is
the minimum necessary to ensure this. A tiered approach, by requesting less than the
minimum  information  for  assessing  the  toxicity  risk,  might  create  loopholes  for
surfactants that are toxic, or that have toxic metabolites.

The part of the amendment to Article 4(3) concerning a timeframe can be accepted in
principle.  Manufacturers  should  be  prevented  from  marketing  indefinitely  products
that require a derogation. For this reason, mention also needs to be made that Article
6(2)  shall  no  longer  apply  if  the  information  is  not  made  available  within  the
timeframe.  The  length  of  time  manufacturers  are  to  be  allowed  for  providing

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information  should  be  12  months  to  allow  sufficient  time  in  case  a  manufacturer
needs to contract a third party to carry out further testing on his behalf.

The part of the amendment concerning Article 4(4) which introduces the words “On
the basis of the evaluation done by the Member States” cannot be accepted because
the Commission needs to preserve the right to act in cases where Member States are
slow to complete an evaluation. The part of the amendment concerning Article 4(4)
which  introduces  the  word  “shall”  can  be  accepted  by  the  Commission  as  it  is  a
logical compliment to the qualification “if necessary” earlier in the sentence.

This part of the amendment concerning Article 5(5) cannot be accepted. Derogations
are  granted  on  the  basis  of  risk  assessments,  evaluated  by  Member  States,  that
demonstrate that there is no risk to the environment. Derogations will therefore not
be granted for surfactants that pose such a risk. There is no justification for measures
that  would  lead  to  the  replacement  of  a  surfactant  that  poses  no  risk  to  the
environment. There is no safer alternative to a substance that poses no risk.

The Commission has therefore reformulated the text as follows:

“2.  Applications  shall  include  a  technical  file  supplying  all  the  information  and
justifications necessary for evaluating the safety aspects related to the specific use of
surfactants in detergents failing to comply with the biodegradability limits, as set out
in [Article 4(1), or showing toxicity of the test liquor pursuant to Annex IV, point 3]
Annex III.

In  addition  to  the  results  of  tests  stipulated  in  Annex III,  the  technical  file  shall
include results of tests, as stipulated in Annexes II and IV.

[2a. The tests laid down in Annex IV(4) shall be carried out on the basis of a graded
risk  assessment  (tiered  approach).  Before  …*,  the  Commission  shall  lay  down  an
appropriate  technical  guideline  in  accordance  with  the  procedure  referred  to  in
Article 12(2).]

3.  The  competent  authorities  of  the  Member  States,  receiving  applications  for
derogation  according  to  paragraphs 1  and  2  above,  shall  examine  the  requests,
evaluate  their  compliance  with  the  conditions  for  derogation  and  inform  the
Commission about the results without delay.

information,  verification  and/or  confirmatory 

If the competent authority of the Member State deems it necessary, for the evaluation
of the risk which may be caused by a substance and/or a preparation, it shall ask for
further 
these
substances and/or preparations or their transformation products, of which they have
been notified or have received information under this Regulation. If the [necessary]
requested information is not provided within [a timeframe to be clearly specified,]
twelve months, the application shall be considered incomplete and thus invalid. In
such a case Article 6(2) shall not apply.

tests  concerning 

[If further information on metabolites is sought, stepwise testing strategies should be
employed to ensure maximum use of in-vitro and other non-animal test methods.]

4. [On the basis of the evaluation done by the Member States, the] The Commission
may  grant  derogation  in  accordance  with  the  procedure  set  out  in  Article 12(2).  If

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necessary  before  granting  derogation  the  Commission  shall  evaluate  further  the
matters indicated in paragraph 3 of this Article.

5. Such derogations may allow, limit  or  severely restrict the  placing on  the market
and  the  use  of  surfactants  in  detergents,  depending  on  the  results  of  the
complementary risk assessment, as defined in Annex IV of this Regulation. They may
include a  phase-out  period  for  placing  on  the  market  and  the  use  of  surfactants  in
detergents.  [A  derogation  must  be  reviewed  after  5  years  and  the  applicant  must
provide information that he is developing alternatives, which will fulfil the demands
to the "ultimate aerobic biodegradation"]”.

4.3.

Amendments not accepted by the Commission

Amendments 1, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 20, 24, 25, 26, 28, 29, 30, 32,
33,  38,  39,  40,  41,  42,  43,  44,  47,  48,  49,  55,  56,  57,  59,  60,  61,  62  cannot  be
accepted by the Commission.

5.

AMENDED PROPOSAL

Having  regard  to  Article  250  (2)  of  the  EC  Treaty,  the  Commission  amends  its
proposal as indicated above.

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