Detergents: Great Britain
This page provides guidance on the retained EU law that applies in Great Britain:
- The Detergents Regulation - Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (as amended)
The Detergents Regulation is the retained EU law on detergents that applies in Great Britain, following the UK's exit from the EU on 31 March 2020 and the end of the transitional period on 31 December 2020.
To ensure that the detergents regulatory regime continues to operate effectively in Great Britain after the end of the transitional period, the EU Detergents Regulation - has been amended by the Detergents EU Exit Statutory Instruments (SIs), that is:
- the Detergents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/672)
- the Detergents (Safeguarding) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/671)
- the Detergents (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1617)
The Detergent EU Exit SIs correct deficiencies in the retained EU law while ensuring that the EU Detergents Regulation applies in Northern Ireland as provided for by the Northern Ireland Protocol.
Legislation.gov.uk is where you will find legislation originating from the EU, as it stood at 31 December 2020. This will usually be a revised version that includes amendments made by the EU up to 31 December 2020, but versions will be subsequently updated with any amendments made by the UK.
The EU Detergents Regulation will continue to apply in Northern Ireland under the terms of the Withdrawal Agreement and the provisions of the Northern Ireland Protocol.
There will be no transitional period to comply with changes from the EU Detergents Regulation to the retained Detergents Regulation.
However, Article 41(1) of the Withdrawal Agreement provides that an existing and individually identifiable good lawfully placed on the market in the EU or the United Kingdom before the end of the transition period may be further made available on the market of the EU or of the United Kingdom and circulate between these two markets until it reaches its end user.
The economic operator relying on that provision bears the burden of proof of demonstrating on the basis of any relevant document that the good was placed on the market in the EU or the United Kingdom before the end of the transition period.
Introduction
Background
The EU Detergents Regulation that came into force in the EU on 8 October 2005 updated and consolidated previous Directives on detergents. It imposed a two-tier testing regime on the biodegradability of the active ingredients of detergents (known as surfactants).
Surfactants that had passed the more stringent "ultimate" biodegradability test could remain on the market but industrial or institutional surfactants that failed the test for ultimate biodegradability but passed the less stringent test for "primary" biodegradability were allowed to remain on the market in the EU and the Single Market but only if the manufacturer had been granted derogation by the European Commission.
The scope of the EU Detergents Regulation was widened with all surfactants now being covered. Previously, two categories of surfactant (around 10% of the total) had been outside the scope of EU legislation.
The EU Detergents Regulation placed more stringent labelling requirements on detergent manufacturers. However, due to existing voluntary agreements, most household detergents sold in the UK already complied with the new labelling requirements to list product ingredients, because of consumer demand for more environmentally friendly products.
Manufacturers were also now required to make ingredients datasheets available to medical personnel on request, to help with emergency response and the treatment of allergies. Manufacturers of domestic detergents also had to make available a less detailed version of the data sheet to the general public on a website.
Directly applicable EU Regulations like the EU Detergents Regulation (as opposed to a Directive) apply throughout the EU without the need for further legislation. However, domestic UK legislation was required to put in place official control and enforcement measures (including criminal penalties) through the 2010 Detergents Enforcement Regulations (SI 2010/740) as amended by The Detergents (Amendment) Regulations 2013 (S.I. 2013/1244), and The Detergents (Amendment) Regulations 2016 (S.I. 2016/1165),
Restrictions on the Amount of Phosphates in Domestic Laundry Cleaning Products
Article 14 allowed Member States to lay down national rules concerning the use of phosphates in detergents. After consultation, the UK 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.
However, on 19 April 2012, the EU Detergents Regulation was amended by Regulation (EU) No. 259/2012 which imposed an EU-wide restriction of 0.5% for phosphates in domestic laundry and 0.3% for automatic dishwasher detergents. The UK then removed the previous national restriction on inorganic phosphates in domestic laundry cleaning products through the Detergents (Amendment) Regulations 2013 (S.I. 2013/1244).
Objectives and scope
Article 1 of the Detergents Regulation sets out its objectives and scope.
The objective of the Detergents Regulation is to achieve the free movement of detergents throughout Great Britain, and the free movement of those products classified as qualifying Northern Ireland goods from Northern Ireland to Great Britain, while, at the same time, ensuring a high degree of protection for human health and the environment.
The Detergents Regulation establishes technical standards and requirements in relation to detergents and surfactants for detergents. The Detergents Regulation:
- 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
- sets out the information that manufacturers must hold at the disposal of the competent authority and medical personnel
The Detergents Regulation covers the manufacturing of detergents/surfactants and placing and making them available on the Great Britain market. Any natural or legal person established in Great Britain or Northern Ireland responsible for placing a detergent or a surfactant for a detergent on the Great Britain market must comply with the requirements in the regulations.
- manufacturers/producers of detergents
- importers of detergents
- any person changing the characteristics of a detergent
- any person changing the labelling or packaging of a detergent
- packagers working on their own account (eg company 'A' purchases a detergent in bulk from company 'B' and re-packages the detergent with its "own" name on the box)
Distributors that do not change the characteristics, labelling or packaging of a detergent or of a surfactant for a detergent are not manufacturers/producers of detergents under the Detergents Regulation except where they act as importers.
Note: GB-based distributors supplying the GB market that are currently supplied from the EU/EEA will become importers under the Detergents Regulation and will be obliged to undertake the full duties of an importer if these supply arrangements continue after 31 December 2020.
Competent authority
The Secretary of State for the Department of the Environment. Food and Rural Affairs is the competent authority for the Detergents Regulation in Great Britain.
The Health and Safety Executive (HSE) acts as the competent authority in Great Britain for the purposes of the Detergents Regulation under an Agency Agreement with the Secretary of State. The Chemicals Regulation Division (CRD), part of the Health and Safety Executive (HSE), leads on this work.
Definitions
Detergent
Under the Detergents Regulation, 'detergent' is defined as
"any substance or mixture 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 mixtures', 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 mixtures', intended for domestic all purposes cleaners and/or other cleaning of surfaces (eg materials, products, machinery, mechanical appliances, means of transport and associated equipment, instruments, apparatus, etc.);
- 'Other cleaning and washing mixtures', intended for any other washing and cleaning processes".
Detergents not containing surfactants are still covered by the Detergents Regulation, 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 mixtures or products not containing surfactants will need to comply with the labelling and other data provision requirements of the Detergents Regulation. Even if a detergent contains a surfactant that is not the primary cleaning agent, it may still be caught by the Detergents Regulation.
The Detergents Regulation only covers detergents and surfactants. Organic substances such as enzymes and microbes are not included but enzymes must be listed on the detergent label and ingredient data sheet if they are present in the detergent at any concentration.
Placing on the market
Article 2(9) of the Detergents Regulation now defines placing on the market as: "the first making available on the Great Britain market. Import into Great Britain shall be deemed to be placing on the market".
Making available on the market
This means - "any supply for distribution, consumption or use on the Great Britain market in the course of a commercial activity, whether in return for payment or free of charge".
Industrial or institutional detergent
For the purposes of the Detergents Regulation, 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.
Derogation
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 may apply for derogation. Annex V outlines the list of surfactants for which a derogation has been granted.
Only those placing industrial and institutional detergents on the market can apply for a derogation. Application for derogations may be submitted to HSE acting as the competent authority.
Derogation applications will be handled by HSE as the competent authority, which has six months to reach a decision. If HSE requests further information in support of the application, the period of six months starts from when the final piece of information is received, ie when the dossier is complete.
HSE acting as the competent authority 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.
HSE as the competent authority will then pass its findings to the Secretary of State who 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.
However, derogation is only expected to be granted for niche products where no product alternative exists. Risks to the environment must be outweighed by the benefits of allowing the surfactant to remain or be placed on the market. As this derogation was intended to be a limited measure introduced to allow industrial and institutional products already on the market before 2004 to remain on the market, it is unlikely that derogation will be granted unless there are exceptional circumstances.
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 II and III. A complimentary risk assessment must also be included as set out in Annex IV.
The Commission's Technical Guidance Document on the risk assessment procedure will continue to be used under the GB system.
Approved laboratories and good laboratory practice
Article 7 of the Detergents Regulation 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 Article 13(4) of the REACH Regulation. 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".
'Approved laboratories' are laboratories that are:
- members of the UK GLP compliance programme referred to in the Good Laboratory Practice Regulations 1999, or
- able to demonstrate compliance with standard EN ISO/IEC 17025: 2017 (general requirements for the competence of testing and calibration laboratories) to the satisfaction of the competent authority.
Current Members of the UK GLP compliance programme (GOV.UK website)
Results and technical files relating to ultimate and primary biodegradability tests
Under Article 9, manufacturers must hold the results of ultimate biodegradability tests, and, where appropriate, results and technical files relating to primary biodegradability tests at the disposal of the competent authority.
If manufacturers wish to group products together and apply test results and biodegradability results by analogy where the surfactant molecules are chemically similar, they will 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.
Labelling and data sheets
Article 11 together with Annex VII of the Detergents Regulation imposes obligations on manufacturers to provide information about their detergents 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, for example in emergency response or in the treatment of allergies, which have been linked to fragrances in detergents.
Labelling requirements
Article 11 specifies the information that needs to appear on the detergent label or on packaging of detergents which are for sale to the general public:
- Name and trade name of the detergent
- Name, full address and telephone number of the party responsible for placing the product on the Great Britain market
- The address, e-mail address (where available) and telephone number where the ingredient data sheet that must be made available to medical personnel can be obtained
- Website address where the list of ingredients of the detergent is provided for consumers
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%
- There are eighteen specific constituents listed in the Regulation, which must be stated on the label if present as a constituent in the detergent product at greater than 0.2% by weight; for example, all surfactant types, phosphates and aliphatic hydrocarbons.
- The following weight percentage ranges must be provided when indicating the content of these constituents:
- less than 5 %,
- 5 % or over but less than 15 %,
- 15 % or over but less than 30 %,
- 30 % and more
- Names of allergenic fragrances listed in the retained Cosmetics Products Regulation (EC) No. 1223/2009 must be included on the label if present at greater than 0.01% by weight (or at a replacement limit), for example Citral, d-Limonene, Oak moss and tree moss extract and Linalool.
- Enzymes, disinfectants, optical brighteners, perfumes and preservation agents must be stated at any concentration.
Specific labelling requirements on packaging of consumer laundry detergents
- Recommended quantities and/or dosage instructions for a standard machine load for soft, medium and hard water classes for one or two cycle washing processes
- Capacity of any measuring cup in mls or grams.
- Number of standard washing machine loads of normally and lightly soiled fabrics that can be washed using medium water hardness.
Note: For detergents intended to be solely used for professional use ie industrial and institutional uses, the above mentioned labelling and packaging requirements do not have to be fulfilled if the equivalent information is provided by means of a technical data sheet/safety data sheet or in a similar manner.
All detergents which are classified as hazardous must be labelled and packaged in accordance with the requirements of the retained GB Classification, Labelling and Packaging of substances and mixtures Regulation (GB CLP Regulation) - Regulation (EC) No 1272/2008 (as amended).
Detergents containing fragrances not restricted by the Cosmetic Products Regulation - Regulation (EC) No 1223/2009 on cosmetic products (as amended)
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
- an obligation to name specific allergenic fragrances annexed to the Cosmetic Products Regulation 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 retained Cosmetic Products Regulation (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.
Labelling detergent products in English
Article 11(5) of the Detergents Regulation requires information on labels to be provided in English although this does not prevent the same information from also appearing in other languages.
Ingredient data sheets
Manufacturers are required to give more detailed information on the ingredient data sheets that must be made available to medical personnel in accordance with Article 9(3) and Annex VII.C. This includes in Great Britain, the National Poisons Information Service.
Any information must be kept confidential and a person who unlawfully discloses it commits an offence.
The version of the ingredient data sheet that must be placed in the public domain (on a website) is less detailed.
The Detergents Regulation does not specify a layout for the ingredient data sheet, merely the information that it must contain. If an existing data sheet can be modified to include the necessary information; this will prove sufficient to meet this obligation.
For detergents intended to be solely used for professional use, that is for industrial and institutional uses, equivalent information to the ingredient sheet may be provided by means of a technical data sheet/safety data sheet or in a similar manner.
The address, e-mail address (where available) and telephone number where the ingredient data sheet that must be made available to medical personnel does not have be the same as the manufacturer's address, e-mail address (where available) and telephone number.
Making data sheets available on a website
There is a requirement under Annex VII.D for an edited version of the ingredient 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 ingredient data sheet is made available on a website that is freely accessible to the public. It might be possible for smaller suppliers who do not have their own websites to make use of a trade association website.
Making data sheets available to medical professionals
There is a distinction between the edited version of the data sheet that must be made available on a website 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 medical professionals under Article 9(3).
In relation to notification to an appointed body or poisons centre (or similar central information point), Article 9(3) provides that this is an optional extra not an optional alternative.
Biocidal detergent products
Detergents with a biocidal action may include disinfectants, sanitisers, anti-microbials, anti-bacterials and any detergents with biocidal activity. Detergents that contain biocidal active substances must comply with the Biocidal Products Regulation - Regulation (EU) No 528/2012 (as amended) - in addition to complying with the Detergents Regulation.
Detergents which contain surfactants which also have active biocidal activity and that are used as disinfectants are exempt from the following provisions in the Detergents Regulation:
- primary and ultimate degradability testing
- preparation of a risk assessment and the requirement to use test and analytical methods in the detergent legislation (providing the substance with biocidal activity is as stated in the retained Biocidal Products Regulation)
Nevertheless, the labelling and packaging provisions of the Detergents Regulation (Article 11 and Annex VII.A) will still apply to the packaging of biocidal detergent products.
Cosmetic products
Personal hygiene products, for example shower gels, shampoos do not fall within the scope of the Detergent Regulation. They are regulated by the retained Cosmetic Products Regulation - Regulation (EC) No. 1223/2009 (as amended).
Enforcement and implementation
Article 10 allows the Secretary of State to introduce control measures for the purpose of enforcing the Detergents Regulation.
Under the 2010 Detergents Enforcement Regulations (as amended), enforcement officers (trading standards officers) from the constituent councils in Great Britain can issue enforcement notices if there is a breach of the Detergents Regulation, 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 the Detergents Regulation, criminal sanctions are also available under the 2010 Detergents Enforcement Regulations (as amended). The most serious offences will be triable either way and punishable by up to two years imprisonment and/or an unlimited fine.
Enforcement officers will also be responsible for the enforcement of the restriction on the amount of phosphates in domestic laundry detergents in Annex VIa of the Detergents Regulation.
Safeguarding provision (Article 15)
The safeguard clause may only be used provisionally on a case-by-case basis for a specific detergent, not for a class of product and cannot, therefore, be used to introduce risk management measures of a general nature. The safeguard clause is an important, and beneficial, element of the Detergents Regulation, even if (to date) it has rarely been used.
The Detergents (Safeguarding) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/671) provide that where the Secretary of State or a devolved authority (ministers in Scotland and Wales) take provisional measures, they must immediately inform the other authorities, giving reasons for their action and submitting the scientific or technical information on which it is based. The other authorities must then decide whether to impose the same provisional measures within their devolved competence.
Appeals
For more information on the appeals procedures, please contact the Defra Helpline or HSE acting as the competent authority in Great Britain for the Detergents Regulation at CRD Information Management - Email: [email protected].
Technical annexes
The Secretary of State can update the technical Annexes to the Regulation in line with scientific and technical progress at any time.
These updates of the technical Annexes will be carried out by the Secretary of State making secondary regulations (Statutory rather than as an administrative function (see the amended Article 13 of the Regulation).
Updates will not take place very often as the test methods are long standing and include OECD and national test methods.
Any secondary legislation will be subject to formal public consultation.
Note: This page represents general guidance only.