Regulation (EC) No 648/2004 on Detergents
When did regulation (EC) NO 648/2004 on detergents come into force?
Regulation 648/2004 came into force on 8 October 2005.
Who will be designated as the “Competent authority” in the UK?
The Competent authority in the UK is the Chemicals Regulation Directorate (CRD), part of the Health and Safety Executive (HSE).
Who will be enforcing Regulation 648/2004 on the ground?
The Detergents Regulations 2010 have been introduced, superseding the 2005 Regulations, setting out measures to enforce Regulation 648/2004. The Regulations will be enforced by local authority Trading Standards Officers.
What will be covered by Regulation 648/2004?
Article 2 of Regulation 648/2004 states that:
“‘Detergent’ means any substance or preparation containing soaps and/or other surfactants intended for washing and cleaning processes. Detergents may be in any form (liquid, powder, paste, bar, cake, moulded piece, shape, etc.) and marketed for or used in household, or institutional or industrial purposes.
Other products to be considered as detergents are:
- ‘Auxiliary washing preparation’, intended for soaking (pre-washing), rinsing or bleaching clothes, household linen, etc.;
- ‘Laundry fabric-softener’, intended to modify the feel of fabrics in processes which are to complement the washing of fabrics;
- ‘Cleaning preparation’, intended for domestic all purposes cleaners and/or other cleaning of surfaces (e.g.: materials, products, machinery, mechanical appliances, means of transport and associated equipment, instruments, apparatus, etc.);
- ‘Other cleaning and washing preparations’, intended for any other washing and cleaning processes.”
This definition of ‘detergent’ means that manufacturers of cleaning products not containing surfactants will need to comply with the labelling and other data provision requirements of Regulation 648/2004.
What are the main provisions of Regulation 648/2004?
Regulation 648/2004:
- Tightens the biodegradability testing requirements for surfactants in detergents;
- Requires fuller contents information to be provided on detergent labels;
- Repeals the following existing detergent Council Directives and Recommendation: Directive 73/404/EEC; Directive 73/405/EEC; Directive 82/242/EEC; Directive 82/243/EEC; Directive 86/94/EEC, and Recommendation 89/524/EEC;
- Facilitates future technical amendments for the contents of the Regulation without a lengthy procedure for implementation of necessary changes;
- Requires manufacturers to produce data sheets to provide medical professionals with more information when treating allergies, as well as a less detailed data sheet available to everyone.
What is derogation?
If a surfactant fails the more stringent test for ultimate biodegradability but passes the primary biodegradability test, a manufacturer can apply for derogation in order to keep that surfactant on the market.
Can derogation be applied for in respect of any surfactant that fails the ultimate biodegradability test?
Only industrial and institutional surfactants can receive derogation from the Commission. It is expected that derogations will only be granted to surfactants used in niche applications where no realistic alternative exists.
Must I apply for derogation by a certain date?
Manufacturers had until October 2007 to apply for a derogation if they wanted to keep their surfactant on the market while the application was being considered. Each application had to be supported by a technical file. The Commission has produced a Technical Guidance Document giving more details on what this file should contain.
How long will it take for a decision on a derogation application to be made?
CRD must produce an evaluation of the derogation request within 6 months of receipt. If we require further information, the six months starts from the date that the final piece of information is received. CRD then submits its evaluation to the Commission, which has up to twelve months to adjudicate except in certain circumstances when it has eighteen months.
What happens to products containing a surfactant that requires derogation while the application for derogation is being considered?
If the application was made by 8 October 2007, a surfactant could stay on the market until the derogation application had been dealt with. This is only the case for surfactants that were already on the market before 8 October 2005.
Can I apply for a derogation if the surfactant has failed the primary biodegradability test?
No. A derogation can only be granted for those surfactants that fail the ultimate biodegradability test.
How will Regulation 648/2004 be implemented in the UK?
Unlike a Directive, a Regulation is “directly applicable” and applies throughout the European Union on its own, without the further need for domestic legislation. However, domestic legislation needs to be made to provide for machinery to deal with applications for derogations and to provide for enforcement measures (including criminal penalties for breach of Regulation 648/2004). This domestic legislation takes the form of regulations made under section 2(2) of the European Communities Act 1972. Regulations will be issued in two stages: The Detergents Regulations 2005 set out enforcement measures and came into force on 8 October 2005. This enabled us to consult more fully on the procedure for handling derogation applications before introducing new legislation in 2010.
How can I apply for a derogation if the procedures are not in place?
Regulations which set out the procedures for the handling of applications were introduced in 2010.
How much will derogation cost?
Competent authorities (CRD in the UK) will be able to charge fees for processing and evaluating applications. However, these fees may not exceed the costs of processing the application and must not be levied in a discriminatory way.
Will there be a transitional period for me to comply with the labelling requirements?
There was already an eighteen month transitional period between the publication of Regulation 648/2004 in April 2004 and the date on which it came into force (8 October 2005). However, a light touch attitude was taken in relation to enforcement when Regulation 648/2004 initially came into force.
Will stock need to conform to the new labelling requirements if it is already on the market but hadn’t been sold by 8 October 2005?
The Commission indicated that stock that was already placed on the market by 8 October 2005 was not subject to the new labelling requirements. A definition of “placing on the market” can be found in article 2(9) of Regulation 648/2004.
Do the biodegradability tests have to be carried out in accordance with Good Laboratory Practice?
Article 7 of Regulation 648/2004 states:
"All tests referred to in Articles 3 and 4 and in Annexes II, III, IV and VIII shall be conducted in compliance with the standards mentioned in Annex I.1 and in accordance with testing requirements under Article 10(5) of Regulation (EEC) No 793/93. For this purpose, it is sufficient to apply either the EN ISO/IEC standard or the principles of good laboratory practice, except for those tests for which the principles of good laboratory practice have been made mandatory."
Who can carry out the tests?
Each competent Authority submits the names of laboratories they deem capable of carrying out the tests to the Commission. The Commission then releases a list of approved laboratories.
How do I become an approved laboratory?
Please write to:
Adrian Dixon
Policy Implementation Team
Chemicals Regulation Directorate
Health and Safety Executive
Room 214 Mallard House
Kings Pool
3 Peasholme Green
York YO1 7PX
Regulation 648/2004 mentions that data sheets should be available on a website. Does this place a legal obligation on a supplier to have a website?
There is a requirement under Annex VII.D for an edited version of the data sheet to be made available on a website. There is no specific obligation for suppliers to have their own websites, as long as the edited version of the data sheet is made available somewhere on the web. It might be possible for smaller suppliers who do not have their own websites to make use of a trade association website.
Regarding the web site again, the obligation appears to be that the data sheet has only to be made available to health professionals. Can the supplier place security on the web site that restricts download to health professionals only? Is it not sufficient to register the details with a poison centre?
There is a distinction between the edited version of the data sheet that must be made available on a web site under Annex VII.D and the complete version of the data sheet (containing all of the information listed in Annex VII.C) that must be made available to health professionals under Article 9(3).
Only the less detailed version need appear on a website, though it must be freely accessible.
In relation to registration with a poisons centre (or similar central information point), Article 9(3) provides that this is an optional extra that Member States can insist upon, not an optional alternative.
If a detergent contains fragrances not restricted by the Cosmetics Directive, does the label still have to state contains fragrance? Does it have to specify the particular fragrance?
Annex VII.A contains two separate obligations in relation to fragrance (perfumes):
- An obligation to list perfumes as a generic ingredient if any have been added at all;
- And an obligation to name specific allergenic fragrances annexed to the Cosmetics Directive (Directive 76/768, as amended: Annex III, Part 1) that have been added to the product at significant concentrations (0.01% or, if applicable, the risk-based threshold for the specific substance).
In other words, if fragrances that are not restricted under the Cosmetics Directive (and only such fragrances) are added to a product, the label must state that the product contains fragrances but need not specify the particular fragrance or fragrances added.
Is it necessary to hold biodegradability test results for each surfactant, or may products be grouped together and biodegradability data applied by analogy where the surfactant molecules are chemically similar?
If a manufacturer wishes to apply test results by analogy, he is likely to have to make a case in each instance to the competent authority as to why read across would be appropriate or justified in that instance.
Does Regulation 648/2004 extend to organic substances such as enzymes, microbes and bugs?
No. Regulation 648/2004 only covers detergents and surfactants. Regulation 648/2004 has a wider scope than existing legislation with the inclusion of amphoteric and cationic surfactants, but microbes are not included.
Is there a mechanism to review Regulation 648/2004?
Article 16 states that by April 2009 the Commission will report on the application of Regulation 648/2004. It may also submit proposals relating to anaerobic biodegradation and the biodegradation of main non-surfactant organic detergent ingredients. The Commission is still to report on this.
