This document provides guidance on Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents, which came into force on 8 October 2005.
Regulation 648/2004 updates and consolidates existing Directives on detergents. It imposes a two-tier testing regime on the biodegradability of the active ingredients of detergents (known as surfactants).
Those surfactants that pass the more stringent "ultimate" biodegradability test can remain on the market. Industrial or institutional surfactants that fail the test for ultimate biodegradability but pass the less stringent test for "primary" biodegradability can remain on the market, if the manufacturer is granted derogation by the European Commission. At the moment, surfactants are only required to be tested for primary biodegradability.
The scope of Regulation 648/2004 is also wider than that of existing legislation, with all surfactants now being covered. Previously, two categories of surfactant (around 10% of the total) were outside the scope of European Community (EC) legislation.
Regulation 648/2004 also places more stringent labelling requirements on detergent manufacturers. However, due to existing voluntary agreements, most household detergents sold in the UK already comply with new labelling requirements to list product ingredients, because of consumer demand for more environmentally friendly products.
Manufacturers are also required to make ingredients datasheets available to medical personnel on request, to help with the treatment of allergies. Manufacturers of domestic detergents must also make available a less detailed version of the data sheet to the general public on a website.
A Regulation (as opposed to a Directive) is “directly applicable” and applies throughout the European Union on its own, without the further need for domestic legislation. However, domestic legislation will be made setting out the process for handling derogation applications and to provide for enforcement measures (including criminal penalties for breach of Regulation 648/2004).
The Detergents Regulations 2010 (SI 2010 740) have been introduced setting out measures to enforce Regulation 648/2004. They came into force on 6 April 2010, with the exception of regulation 9, which restricts the amount of phosphates in domestic laundry detergents and comes into force on 1 January 2015. Regulations setting out the procedure for handling derogation applications will be introduced following a round of public consultation.
Objectives and Scope
Article 1 of Regulation 648/2004 sets out its objectives and scope. The objective of Regulation 648/2004 is to establish rules designed to achieve the free movement of detergents and surfactants for detergents on the internal market while, at the same time, ensuring a high degree of protection of the environment and public health. It harmonises rules on the biodegradability of surfactants in detergents, imposes restrictions or bans on surfactants on grounds of biodegradability, makes provision for the additional labelling of detergents including fragrance allergens and the information that manufacturers must hold at the disposal of the Member States’ competent authorities and medical personnel. The Chemicals Regulation Directorate (CRD) of the Health and Safety Executive (HSE) is the competent authority in the UK for the purposes of Regulation 648/2004. Enforcement on the ground will be carried out by local authority trading standards officers.
As mentioned above, a Regulation is “directly applicable” throughout the European Union. Its wording is therefore binding on all Member States, meaning that a Member State cannot elaborate on or change any definitions included within it.
Under Regulation 648/2004, detergent is defined as "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".
CRD has received a number of queries as to whether certain types of product are in scope.
Detergents not containing surfactants are covered by Regulation 648/2004 if they contain soap instead of a surfactant or if they fall within one of the four specific categories mentioned above. This 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. If a detergent contains a surfactant that is not the primary cleaning agent, it is still caught by Regulation 648/2004.
Placing on the market
Article 2(9) of Regulation 648/2004 is amended by Regulation (EU) No. 259 of 2012, which defines placing on the market as:
“The first making available on the Union market. Import into the Union shall be deemed to be placing on the market".
Regulation (EU) No. 259 of 2012 also introduces a definition of 'making available on the market':
"Any supply for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge".
There has been debate as to when a product is on the market. New labelling requirements are contained in Regulation 648/2004 and were applicable from 8 October 2005. However, industry informed us that supply chains in the detergents industry can be long, and there were likely to be stocks of detergents in warehouses or on retailers’ shelves after 8 October 2005 which bore old-style labels. If stock in warehouses were not considered to be on the market, then it would have to be written off as it would not comply with Regulation 648/2004. However, the Commission indicated that any stock downstream of the manufacturer was considered to be on the market and could be sold for an unlimited period. Thus, stock in warehouses or on retailers’ shelves bearing old labels could continue to be sold after 8 October 2005, as long as it was placed on the market before that date.
Industrial or institutional detergent
For the purposes of Regulation 648/2004, an industrial or institutional detergent is one used outside the domestic sphere. It must be a specific product and used by specialised personnel. A detergent is not an industrial or institutional detergent if it is a domestic detergent sold in bulk to an institution or industrial concern.
If a surfactant passes the primary biodegradability test but fails the ultimate biodegradability test, and is used for industrial or institutional purposes, the manufacturer of that surfactant can apply for derogation. Derogation applications are initially handled by the Member State’s competent authority, which has six months to reach a decision. If a Member State requests further information in support of the application, the period of six months starts from when the final piece of information is received, i.e. when the dossier is complete. The competent authority then passes its findings to the Commission which in turn has twelve months to decide whether or not derogation should be granted, except in certain circumstances when the time period is 18 months. Derogation is only expected to be granted for niche products that are not widely used and where no product alternative exists. Risks to the environment must be outweighed by the benefits of keeping the surfactant on the market.
The application will need to be supported by a technical file containing the results from the ultimate and primary biodegradability tests as set out in annexes 2 and 3. A complimentary risk assessment must also be included as set out in annex 4. The Commission has produced a Technical Guidance Document giving more detail on the risk assessment procedure.
Regulations setting out in more detail the procedures for handling derogation applications will be introduced in 2010.
Labelling and Data Sheets
Articles 9 and 11 and Annex VII of Regulation 648/2004 impose numerous obligations on manufacturers to provide information about their products on labels and data sheets.
This information will enable consumers to make better informed choices as to the products they buy. It will also help medical personnel in the treatment of allergies, which have been linked to fragrances in detergents. Manufacturers must also hold at the disposal of the competent authority the results of ultimate biodegradability tests, and, where appropriate, results and technical files relating to primary biodegradability tests.
Article 11 specifies the information that needs to appear on a detergent label. This includes the name or trade name of the detergent, the address of the person responsible for placing the product on the market and the address, email address (if available) and phone number from which the data sheet that must be made available to medical personnel can be obtained. Under article 2(10) the manufacturer is defined as the natural or legal person responsible for placing a detergent or a surfactant for a detergent on the market.
We have been asked, in the case of an own brand product, whether the address of the retailer could be included on the label as the address from which the data sheet can be obtained, rather than that of the manufacturer. Regulation 648/2004 does not stipulate that the address from which the data sheet can be obtained has to be the manufacturer’s.
Annex VII.A specifies what information on product content needs to be included on the label. Precise details of formulation are not required and only types or categories of ingredient need to be listed in percentage ranges where they are added in a concentration above 0.2%. Additionally, certain categories of ingredients must be listed regardless of concentration, e.g. fragrances. This should allay any concerns relating to formula piracy. In any event, formulations can be easily obtained from modern analytical methods, and patent rights are not affected by Regulation 648/2004.
Manufacturers are required to give more detailed information on datasheets that must be made available to medical personnel in accordance with Article 9(3) and Annex VII.C. Again, there is little risk of formula piracy, as any information must be kept confidential and a person who unlawfully discloses it commits an offence. The version of the data sheet that must be placed in the public domain (on a website) is less detailed.
Regulation 648/2004 does not specify a layout for the data sheet, merely the information that it must contain. Therefore if an existing technical data sheet can be modified to include the necessary information, this will prove sufficient to meet this obligation.
There were requests from industry for an implementation period to make the necessary changes to product labels. The labelling requirements came into force at the same time as the rest of Regulation 648/2004 - on 8 October 2005. However, Regulation 648/2004 was published in the Official Journal in April 2004. Consequently businesses had an 18-month implementation period to make the necessary changes and were aware of the likely need for label changes for almost three years. As mentioned in the section of this guidance relating to “placing on the market”, any product bearing an old-style label could be sold after 8 October 2005 as long as it was on the market before that date.
Regulation 6 of the Detergents Regulations 2010 stipulates that where Regulation 648/2004 requires the provision of information in relation to a controlled produuct, such requirement is deemed not to have been met unless the information is provided in the English language.
Enforcement and Implementation
Article 10 allows Member States to introduce control measures for the purpose of enforcing Regulation 648/2004. Article 18 requires Member States to introduce effective, dissuasive and proportionate sanctions.
Under the Detergents Regulations 2010, enforcement officers from the constituent councils in the UK will be able to issue enforcement notices if there is a breach of Regulation 648/2004, setting out the action that needs to be taken and the time period in which the problem should be rectified. Due to the potential environmental or public health consequences that could result from a breach of Regulation 648/2004, criminal sanctions are also available under the Detergents Regulations 2010. The most serious offences will be triable either way and punishable by up to two years imprisonment and/or an unlimited fine.
Enforcement officers from the constituent councils in the UK will also be responsible for the enforcement of regulation 9 of the Detergents Regulations 2010, concerning the restriction on the amount of phosphates in domestic laundry detergents. It is expected that the amount of enforcement will be limited and may only apply to non-regulated detergents that may be imported from outside the UK. By 2015 all UK manufacture of detergents containing more than the specified limit of inorganic phosphate should have ceased since the sale of such domestic laundry cleaning products will be illegal in the UK.
Restrictions on the Amount of Phosphates in Domestic Laundry Cleaning Products
Article 14 allows Member States to lay down national rules concerning the use of phosphates in detergents. After consultation, the UK has decided to limit the weight of inorganic phosphate expressed as phosphorus in domestic laundry detergents to no more that 0.4% of the weight of the detergent. By virtue of paragraph 9 of the Detergents Regulations 2010 it will be prohibited to place on the market a domestic laundry detergent that fails to comply with this requirement after 1 January 2015.
On 19 April 2012 a consolidated version of Regulation (EC) No. 648/2004 was published, containing the latest adopted amendment, Regulation (EU) No. 259/2012. This imposes a restriction on phosphates in domestic laundry and dishwasher detergents. The UK is currently considering the process of transposition.
You can view the associated documents on the EU website.
Article 16 provides that the Commission will review and report on Regulation 648/2004. It may submit proposals if appropriate dealing with anaerobic biodegradation, and with the biodegradation of the main non-surfactant ingredients in organic detergents.
It may submit proposals for the regulation of phosphates used in detergents.
Note: This document represents guidance only. It is not for the UK Government to offer a definitive legal interpretation on Regulation 648/2004. This is a matter for the Commission, and ultimately, the courts. While every effort is made to ensure the accuracy of the above information, the Government will not be held liable for any reliance placed on the same.