Regulation EC 648/2004, effective from 8 October 2005, replaces existing Directives concerning the supply of detergents (ie. cleaning agents). The regulation ensures harmonised assessment of biodegradability, seen to be the critical factor in determining if products are suitable for cleaning processes – processes that typically use large volumes of water that will be discharged to the environment with or without suitable waste water treatment procedures.
Regulation EC 648/2004 includes specific labelling requirements, a data sheet with instructions for use and the publication of such information on the internet for products supplied to the public – this is in addition to other chemical supply legislation.
Article 1 defines a detergent as any ‘substance or preparation containing soaps and/or other surfactants intended for washing or cleaning purposes’. ‘Auxiliary’ products such as fabric conditions, pre-washing preparations, machine cleaners, vehicle cleaners etc are all included and there is a catch-all phrase of ‘other cleaning and washing preparations, intended for any other washing and cleaning processes’.
Biocidal products covered under Directive 98/8/EC are exempt from this Regulation.
If a surfactant being used in a ‘detergent’ is ultimately biodegradable under aerobic conditions (described in Annex III of the Regulation), the substance can be supplied in detergents with no further limitation other than those relating to the general supply of substances and preparations. Methods described in Annex III are those recognised in Annex V of Directive 67/548/EEC (as amended) – ie. standard European test methods for substances, including an ISO method that is used for reference.
The pass rate for these tests is considered to be 60 or 70% over 28 days (depending on the method) and pre-adaptation of the biological media is not permitted. Surfactants failing these biodegradation tests may still be used in detergents if a derogation is requested.
The first stage of this derogation is to undertake the primary degradation methods described in Annex II. The science of the Annex II methods is designed to reflect real life situations in water treatment.
Requesting a derogation
If a detergent is to be supplied that fails the Annex III ultimate biodegradation tests, it is necessary to apply to the appropriate national competent authority for a derogation. The application needs to be supported by Annex II and III biodegradation data, together with other safety and technical data described in Annex IV of the Regulation; this should include information on the potential metabolites formed during partial biodegradation. The toxicity of these metabolites to aquatic organisms should be tested and a risk assessment is required.
Guidelines on the risk assessment and derogation procedure will be issued before October 2007 and for the first 2 years of the Regulation being in force, supply of detergents with non-biodegradable components is permitted (assuming they were being commercially supplied before 8 October 2005).
The granting of a derogation is expected to take up to 18 months, with initial review and approval by the Member State and then ultimately agreed by the European Commission. In the UK, the Pesticides Safety Directorate (PSD) has been assigned the role as Competent Authority. A derogation, if granted, may limit uses to those resulting in low environmental exposure such as for specific industrial applications.
The Dangerous Preparations Directive 1999/45/EC (or by 1 June 2015 the CLP Regulation EC (No 1272/2008)) will apply to detergents the same way as other chemical substances and preparations, but additional labelling will be required for laundry products for use by the general public. It will also be necessary to describe the contents of the detergent (as defined in Annex VIIA) and state that a product data sheet is available free of charge – together with suitable contact details to obtain such a data sheet. These requirements apply even if the detergent is non-hazardous under the terms of Directives 67/548/EEC and 1999/45/EC, or Regulation 1272/2008.
Publication of ingredients
The content of the data sheet should be published on the internet, including the composition of the detergent, for products to be supplied to the general public. Note that this applies to non-hazardous components of preparations.
As with all chemical products, the new CLP Regulation which implements the Global Harmonised System (GHS) in the EU will affect the classification and labelling procedure and components will also need registration under REACH.