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Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (Text with EEA relevance)

EU Regulation No 648/2004 · Adopted 31 March 2004 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

Regulation (EC) No 648/2004 of the European Parliament and of the Council

of 31 March 2004

on detergents

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the Opinion of the European Economic and Social Committeef1,

Acting in accordance with the procedure laid down in Article 251 of the Treatyf2,

Whereas:

(1)

Council Directives 73/404/EEC of 22 November 1973 on the approximation of the laws of the Member States relating to detergentsf3, 73/405/EEC of 22 November 1973 on the approximation of the laws of the Member States relating to methods of testing the biodegradability of anionic surfactantsf4, 82/242/EEC of 31 March 1982 on the approximation of the laws of the Member States relating to methods of testing the biodegradability of non-ionic surfactantsf5, 82/243/EEC of 31 March 1982 amending Directive 73/405/EEC on the approximation of the laws of the Member States relating to methods of testing the biodegradability of anionic surfactantsf6 and 86/94/EEC of 10 March 1986 amending for the second time Directive 73/404/EEC on the approximation of the laws of the Member States relating to detergentsf7, have been significantly amended on several occasions. It is desirable, for reasons of clarity and rationalisation, that the provisions in question should be recast by bringing them all together in a single text. Commission Recommendation 89/542/EEC of 13 September 1989f8, as regards labelling provisions concerning detergents and cleaning products, should also be included in the single text.

(2)

Since the objective of this Regulation, to ensure the internal market in detergents, cannot be sufficiently achieved by the Member States, if there is no common technical criteria throughout the Community, and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of propotionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. A Regulation is the appropriate legal instrument as it imposes directly on manufacturers precise requirements to be implemented at the same time and in the same manner throughout the Community; in the area of technical legislation, uniformity of application in the Member States is needed, and this can only be guaranteed by a Regulation.

(3)

A new definition for detergents is needed to cover equivalent uses and be in line with developments at Member State level.

(4)

It is necessary to introduce a surfactant definition, which was lacking in the existing legislation.

(5)

It is important to give a clear and precise description of the relevant types of biodegradability.

(6)

Measures concerning detergents should be adopted to ensure the functioning of the internal market and avoid restricting competition in the Community.

(7)

As confirmed by the Commission White Paper on the strategy for a future Chemical Policy, appropriate measures concerning detergents should ensure a high level of environmental protection, especially of the aquatic environment.

(8)

Detergents are already subject to certain Community provisions concerning their manufacture, proper handling, usage and labelling, in particular with reference to Commission Recommendation 89/542/EEC and Commission Recommendation 98/480/EC of 22 July 1998 concerning good environmental practice for household laundry detergentsf9; Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparationsf10 applies to detergents.

(9)

Ditallow-dimethyl-ammonium-chloride (DTDMAC) and nonylphenol (including ethoxylates derivatives-APEs) are priority substances undergoing at Community level risk assessment activities, in accordance with Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substancesf11, and if necessary adequate strategies to limit the risks of exposure to these substances should therefore be recommended and implemented in the framework of other Community provisions.

(10)

The existing legislation on biodegradability of surfactants in detergents only covers primary biodegradabilityf12 and it is only applicable to anionicf13 and non-ionicf14 surfactants; therefore it should be replaced by new legislation, which lays the main emphasis on ultimate biodegradability and meets the important concerns related to the potential toxicity of persistent metabolites.

(11)

This requires the introduction of a new set of tests based on EN ISO standards and OECD guidelines, which governs the granting of direct permission for placing detergents on the market.

(12)

To provide a high level of protection of the environment, detergents not fulfilling requirements laid down by this Regulation should not be placed on the market.

(13)

On 25 November 1999 the Scientific Committee on Toxicity, Ecotoxicity and the Environment issued an opinion on biodegradability of surfactants in detergents and relevance of test-methods for regulatory control in this area.

(14)

The existing requirements regarding primary biodegradability should be maintained on a second hierarchy level and supplemented by a complementary risk assessment, for those surfactants failing ultimate biodegradability tests; furthermore surfactants failing primary biodegradability tests should not obtain marketing authorisation by way of derogation

(15)

The primary biodegradability requirements should be extended to all surfactants, in particular cationic and amphoteric, whilst allowing the possibility of applying instrumental analyses in those cases in which semi-specific analytical methods are not suitable.

(16)

The determination of biodegradability test-methods and the record-keeping of lists of derogations are technical matters and should be revised taking into account technical and scientific developments as well as regulatory developments.

(17)

Test-methods should produce data that give sufficient assurance of aerobic biodegradability of surfactants in detergents.

(18)

Methods to test biodegradability of surfactants in detergents may produce variable results. In such cases they should be complemented by additional assessments in order to determine the risks of continued use.

(19)

Provisions should also be laid down regarding the placing on the market in exceptional cases of surfactants in detergents failing ultimate biodegradability tests and this should take place on the basis of all relevant information to ensure environmental protection and on a case by case basis.

(20)

The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commissionf15.

(21)

It is appropriate to recall that other horizontal legislation is applicable to detergent surfactants, in particular Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparationsf16 by which the marketing and use of dangerous substances covered by this Regulation might be banned or restricted, Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substancesf17, Commission Directive 93/67/EEC of 20 July 1993 laying down the principles for assessment of risks to man and the environment of substances notified in accordance with Council Directive 67/548/EECf18, Regulation (EEC) No 793/93, and Commission Regulation (EC) No 1488/94 of 28 June 1994 laying down the principles for the assessment of risks to man and the environment of existing substancesf19; Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the marketf20; 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 application for tests on chemical substances (codified version)f21; Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (codified version)f22; and Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposesf23.

(22)

It should be the responsibility of manufacturers to refrain from marketing detergents not complying with this Regulation and to have at the disposal of the national authorities the technical files for all substances and F1mixtures covered by this Regulation; this should also apply to surfactants that have failed to pass the tests mentioned in Annex III.

(23)

Manufacturers should be able to request a derogation from the Commission, which should have the possibility to grant such derogation in accordance with the procedure referred to in Article 12(2).

(24)

Member States' competent authorities should be able to apply control measures to detergents on the market, but should avoid repeating tests made by the competent laboratories.

(25)

The existing labelling provisions for detergents should be continued, including those in Recommendation 89/542/EEC, which are included in this Regulation in order to fulfil the objective of modernising the rules on detergents. Specific labelling is introduced to inform consumers about fragrance substances and preservation agents that are present in detergents. Medical personnel should be able to obtain from the manufacturer upon request a full listing of all ingredients of a detergent to assist them investigate whether a causal link exists between the development of an allergic response and exposure to a particular chemical substance, and Member States should be able to require that such a listing is also made available to a specific public body designated to provide this information to medical personnel.

(26)

All the above points call for new legislation replacing the existing legislation; however, for a certain period, Member States can continue to apply their existing laws.

F2(27)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(28)

Detergents complying with this Regulation should be allowed to be placed on the market without prejudice to other relevant Community provisions.

(29)

In order to ensure the protection of man and the environment from unforeseen risks of detergents, a safeguard clause is needed.

(30)

The tests specified for the biodegradability of surfactants should be carried out in laboratories meeting an internationally recognised standard, namely EN/ISO/IEC/17025 or the principles of good laboratory practice; it would not be justified to ask for the application of this latter requirement to existing surfactants to the extent that the available tests on them had been performed before the entering into force of the above standard and still provide a comparable level of scientific quality.

(31)

The issues relating to anaerobic biodegradation, the biodegradation of the main non-surfactant organic detergent ingredients, and phosphate content, which are not dealt with in this Regulation should be examined by the Commission and, where this is justified, a proposal should be presented to the European Parliament and the Council. Pending further harmonisation, the Member States may maintain or lay down national rules concerning the above issues.

(32)

The five Directives and the Commission Recommendation mentioned in recital (1) which are replaced by this Regulation should be repealed,

HAVE ADOPTED THIS REGULATION:

Annotations to the whole text

Textual amendments

F1

Substituted by Regulation (EC) No 1336/2008 of the European Parliament and of the Council of 16 December 2008 amending Regulation (EC) No 648/2004 in order to adapt it to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (Text with EEA relevance).

F2

Deleted by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part Two.

Footnotes

f1

OJ C 95, 23.4.2003, p. 24.

f2

Opinion of the European Parliament of 10 April 2003 (not yet published in the Official Journal), Council Common Position of 4 November 2003 (OJ C 305 E, 16.12.2003, p. 11) and Position of the European Parliament of 14 January 2004 (not yet published in the Official Journal). Decision of the Council of 11 March 2004.

f3

OJ L 347, 17.12.1973, p. 51. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122,16.5.2003, p. 36).

f4

OJ L 347, 17.12.1973, p. 53. Directive as amended by Directive 82/243/EEC (OJ L 109, 22.4.1982, p. 11).

f5

OJ L 109, 22.4.1982, p. 1.

f6

OJ L 109, 22.4.1982, p. 18.

f7

OJ L 80, 25.3.1986, p. 51.

f8

OJ L 291, 10.10.1989, p. 55.

f9

OJ L 215, 1.8.1998, p. 73.

f10

OJ L 200, 30.7.1999, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

f11

OJ L 84, 5.4.1993, p. 1. Regulation as amended by Regulation (EC) No 1882/2003.

f12

Directives 73/404/EEC and 86/94/EEC.

f13

Directives 73/405/EEC and 82/243/EEC.

f14

Directive 82/242/EEC.

f15

OJ L 184, 17.7.1999, p. 23.

f16

OJ L 262, 27.9.1976, p. 201. Directive as last amended by Commission Directive 2004/21/EC (OJ L 57, 25.2.2004, p. 4).

f17

OJ L 196, 16.8.1967, p. 1. Directive as last amended by Regulation (EC) No 807/2003.

f18

OJ L 227, 8.9.1993, p. 9.

f19

OJ L 161, 29.6.1994, p. 3.

f20

OJ L 123, 24.4.1998, p. 1. Directive as amended by Regulation (EC) No 1882/2003.

f21

OJ L 50, 20.2.2004, p. 44.

f22

OJ L 50, 20.2.2004, p. 28.

f23

OJ L 358, 18.12.1986, p. 1. Directive as amended by Directive 2003/65/EC of the European Parliament and of the Council (OJ L 230, 16.9.2003, p. 32).

Contents

  1. 1Objectives and scope
  2. 2Definitions
  3. 3The placing on the market
  4. 3AQualifying Northern Ireland goods
  5. 4Limitations based on the biodegradability of surfactants
  6. 4aLimitations on the content of phosphates and of other phosphorus compounds
  7. 5Granting of derogation
  8. 6Conditions for granting a derogation
  9. 7Testing of surfactants
  10. 8Approved laboratories
  11. 9Information to be provided by manufacturers
  12. 10Control measures
  13. 11Labelling
  14. 12Committee procedure Repealed
  15. 13Power to amend the Annexes
  16. 13aExercise of the delegation Repealed
  17. 14Free movement clause Repealed
  18. 15Safeguard clause
  19. 16Report Repealed
  20. 17Legislation to be repealed
  21. 18Penalties Repealed
  22. 18AAppeals
  23. 19Entry into force
  24. Signature
  25. Annex I: Standards of accreditation, good laboratory practice and animal protection concerning the laboratories that are competent and authorised to provide the necessary service for checking compliance of detergents with the requirements of this Regulation and its Annexes
  26. 1Standards applicable at the level of the laboratories:
  27. 2Standards applicable at the level of the accreditation bodies and good laboratory practice monitoring authorities:
  28. Annex IIPRIMARY BIODEGRADABILITY TEST METHODS FOR SURFACTANTS IN DETERGENTS
  29. Test methods
  30. (1)Division (1)
  31. (2)Division (2)
  32. (3)Division (3)
  33. (4)Division (4)
  34. (5)Division (5)
  35. AANALYTICAL METHODS FOR ANIONIC SURFACTANTS
  36. BANALYTICAL METHODS FOR NON-IONIC SURFACTANTS
  37. CANALYTICAL METHODS FOR CATIONIC SURFACTANTS
  38. DANALYTICAL METHODS FOR AMPHOTERIC SURFACTANTS
  39. Annex III: ULTIMATE BIODEGRADABILITY (MINERALISATION) TEST METHODS FOR SURFACTANTS IN DETERGENTS
  40. AThe reference method for laboratory testing of surfactant ultimate biodegradability in this Regulation is based on the EN ISO standard 14593: 1999 (CO 2 headspace test).
  41. BDepending on the physical characteristics of the surfactant, one of the methods listed below may be used if appropriately justified . 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.
  42. Annex IVCOMPLEMENTARY RISK ASSESSMENT FOR SURFACTANTS IN DETERGENTS
  43. Identity of the surfactant ....
  44. Name
  45. 1.1.1Division 1.1.1
  46. 1.1.2Division 1.1.2
  47. 1.1.3Division 1.1.3
  48. 1.1.4Division 1.1.4
  49. Molecular and structural formula
  50. Composition of the surfactant
  51. Information on the surfactant
  52. 2.1Division 2.1
  53. 2.2Division 2.2
  54. 3Information on the potential recalcitrant metabolites
  55. Additional studies
  56. Biodegradability tests
  57. 4.1.1Pre-adapted inoculum
  58. 4.1.2Inherent Biodegradability Tests
  59. 4.1.3Activated Sludge Simulation Biodegradability Tests
  60. 4.2Toxicity testing of biodegradation test liquors
  61. 4.2.1Chemical and physical information, such as:
  62. 4.2.2Effects on organisms. Tests to be conducted in compliance with the principles of good laboratory practice.
  63. 4.2.3Degradation
  64. Division
  65. Annex VLIST OF SURFACTANTS THAT HAVE OBTAINED A DEROGATION
  66. Annex VILIST OF BANNED OR RESTRICTED DETERGENT SURFACTANTS
  67. Annex VIaAnnex VIa
  68. Annex VII: LABELLING AND INGREDIENT DATA SHEET
  69. ALabelling of contents
  70. BLabelling of dosage information
  71. Consumer laundry detergents
  72. Consumer automatic dishwasher detergents
  73. CIngredient data sheet
  74. DPublication of the list of ingredients
  75. Annex VIIITEST METHODS AND ANALYTICAL METHODS
  76. Reference method (confirmatory test)
  77. 1.1Definition
  78. 1.2Equipment needed for measurement
  79. 1.3Synthetic sewage
  80. 1.4Preparation of samples
  81. 1.5Operation of equipment
  82. 1.6Checking measuring equipment
  83. 1.7Calculation of biodegradability
  84. Determination of anionic surfactants in biodegradability tests
  85. 2.1Principle
  86. Reagents and equipment
  87. 2.2.1Buffer solution pH 10
  88. 2.2.2Neutral methylene blue solution
  89. 2.2.3Acidic methylene blue solution
  90. 2.2.4Division 2.2.4
  91. 2.2.5Division 2.2.5
  92. 2.2.6Division 2.2.6
  93. 2.2.7Division 2.2.7
  94. 2.2.8Division 2.2.8
  95. 2.2.9Division 2.2.9
  96. 2.2.10Division 2.2.10
  97. 2.2.11Division 2.2.11
  98. 2.2.12Division 2.2.12
  99. 2.2.13Division 2.2.13
  100. 2.2.14Division 2.2.14
  101. 2.2.15Division 2.2.15
  102. 2.2.16Division 2.2.16
  103. 2.2.17Division 2.2.17
  104. 2.2.18Division 2.2.18
  105. 2.3Procedure
  106. 2.4Calibration curve
  107. 2.5Calculation of results
  108. 2.6Expression of results
  109. Determination of non-ionic surfactants in biodegradation test liquors
  110. 3.1Principle
  111. 3.2Reagents and Equipment
  112. 3.2.1Division 3.2.1
  113. 3.2.2Division 3.2.2
  114. 3.2.3Division 3.2.3
  115. 3.2.4Division 3.2.4
  116. 3.2.5Division 3.2.5
  117. 3.2.6Division 3.2.6
  118. 3.2.6.1Solution A
  119. 3.2.6.2Solution B
  120. 3.2.7Division 3.2.7
  121. 3.2.8Division 3.2.8
  122. 3.2.9Division 3.2.9
  123. 3.2.10Division 3.2.10
  124. 3.2.11Division 3.2.11
  125. 3.2.12Division 3.2.12
  126. STOCK SOLUTION
  127. STANDARDSOLUTION
  128. 3.2.13Division 3.2.13
  129. 3.2.14Division 3.2.14
  130. 3.2.15Division 3.2.15
  131. 3.2.16Division 3.2.16
  132. 3.2.17Division 3.2.17
  133. 3.2.18Division 3.2.18
  134. 3.2.19Division 3.2.19
  135. 3.2.20Division 3.2.20
  136. Method
  137. 3.3.1Concentration and separation of the surfactant
  138. 3.3.2Precipitation and filtration
  139. 3.3.3Dissolution of the precipitate
  140. 3.3.4The titration
  141. 3.3.5Blank determinations
  142. 3.3.6Control of the factor of the ‘carbate solution’
  143. 3.4Calculation of results
  144. 3.5Expression of results
  145. Preliminary treatment of anionic surfactants to be tested
  146. Preliminary notes
  147. 4.1.1Treatment of samples
  148. 4.1.2Ion-exchange procedure
  149. 4.1.3Analytical control
  150. 4.2Principle
  151. Chemicals and equipment
  152. 4.3.1Division 4.3.1
  153. 4.3.2Division 4.3.2
  154. 4.3.3Isopropanol/water mixture (50/50 v/v):
  155. 4.3.4Division 4.3.4
  156. 4.3.5Division 4.3.5
  157. 4.3.6Division 4.3.6
  158. 4.3.7Division 4.3.7
  159. 4.3.8Division 4.3.8
  160. 4.3.9Division 4.3.9
  161. 4.3.10Division 4.3.10
  162. 4.3.11Division 4.3.11
  163. 4.3.12Division 4.3.12
  164. 4.3.13Division 4.3.13
  165. 4.3.14Division 4.3.14
  166. 4.3.15Division 4.3.15
  167. 4.3.16Division 4.3.16
  168. Preparation of extract and separation of anionic active agents
  169. 4.4.1Preparation of extract
  170. 4.4.2Isolation of alcohol-soluble constituents
  171. 4.4.3CATION-EXCHANGE COLUMN
  172. ANION-EXCHANGE COLUMN
  173. 4.4.4Division 4.4.4
  174. 4.4.5The cation exchanger is rejected after use.
  175. Preliminary notes
  176. Treatment of samples
  177. 5.1.1Division 5.1.1
  178. 5.1.2Division 5.1.2
  179. 5.1.3Division 5.1.3
  180. 5.2Division 5.2
  181. Deionised water
  182. 5.3.1Division 5.3.1
  183. 5.3.2Division 5.3.2
  184. 5.3.350 parts by volume isopropanol, CH3CHOH.CH3, and
  185. 5.3.40,3 mol NH4HCO3 in 1 000 ml of an isopropanol/water mixture consisting of 60 parts by volume isopropanol and 40 parts by volume water (5.3.1)
  186. 5.3.5Division 5.3.5
  187. 5.3.6Division 5.3.6
  188. 5.3.7Division 5.3.7
  189. 5.3.8Division 5.3.8
  190. 5.3.9Division 5.3.9
  191. 5.3.10Division 5.3.10
  192. 5.3.11Division 5.3.11
  193. 5.3.12Division 5.3.12
  194. 5.3.13Division 5.3.13
  195. 5.3.14Division 5.3.14
  196. 5.3.15Division 5.3.15
  197. Preparation of extract
  198. 5.4.1Division 5.4.1
  199. 5.4.2Division 5.4.2
  200. Preparation of ion-exchange columns
  201. CATION-EXCHANGE COLUMN
  202. ANION-EXCHANGE COLUMN
  203. 5.4.4Ion-exchange procedure
  204. 5.4.5Regeneration of ion exchange resins