Detergents are cleaning products that meet specific requirements with regard to their marketing.
Please, refer to the section ‘cleaning products’ for a general explanation of detergents, their impact on the environment and the rules governing their labelling.
A sectoral agreement on detergents, concluded between the Federal Minister with competence for the Environment and the relevant professional organisations, has been in place since 2011. The aim of this agreement is to gradually increase and diversify the offer of detergents that leave a smaller ecological footprint.
Regulation (EC) No 648/2004 on detergents lays down the rules governing the placing on the market of these products. As these rules are complex and sometimes difficult to interpret, the European Commission has published a guidance document that answers the questions economic operators or national authorities tasked with implementing this regulation most frequently ask (FAQ).
These FAQ relate to:
- Annex VI to the Regulation
- Biodegradation
- Labelling
- The management of old product stocks (i.e. products that no longer meet the provisions of the Regulation)
- The scope of the Regulation
1.1. Should nonyl phenol (NP) or nonyl phenol ethoxylate (NPE) be put on Annex VI of the Detergents Regulation (EC) No 648/2004?
NP/NPE will not be included in Annex VI of the Detergents Regulation because that Annex is intended only for surfactants that have failed the tests of biodegradability specified in the Detergents Regulation. The restrictions imposed on NP/NPE previously imposed under Directive 76/769/EEC, have now been transferred without change to Annex XVII of the Regulation (EC) 1907/2006 (REACH Regulation); these restrictions on NP and NPE can be found now in the Annex to Commission Regulation N°552/2009 amending REACH regulation, under the entry 46.
These restrictions were not made on the grounds of biodegradability but rather because of the environmental toxicity of the substances, as was established by means of a risk assessment.
The initial Commission proposal for the Detergents Regulation had an additional annex for listing substances such as NP/NPE that are banned or restricted under other legislation. This was included for the convenience of listing in one place all the substances restricted for detergent use.
However, that additional annex was dropped from the proposal during the co-decision procedure because it merely duplicates information available elsewhere, and it was thought that any delay in updating such an annex might give rise to confusion as to whether the restrictions was actually in force or not.
2.1 Under what conditions does the Regulation enable the placing on the market of surfactants readily biodegradable but failing to pass the ultimate biodegradability criteria if they are only used in closed system?
As part of the tiered-approach to testing, Member States and the Commission services agreed on a general approach to grant derogation enabling the placing on the market of above mentioned surfactants without the need for detailed toxicological testing providing they are used only in closed systems and if the manufacturer can demonstrate that there is no discharge into the environment, for example because the waste is incinerated.
2.2 Can methods other than those defined in Annexes II and III to define the primary and ultimate biodegradability features of surfactants be used?
No. Only test methods reported in Annex II and III could be used to define the primary and ultimate biodegradability of surfactants used in detergents.
Indeed EU Member States agreed that the placing on the market of surfactants shall be subject to a high environmental standard, taking both into consideration their primary and ultimate biodegradability properties, through an exhaustive set of standardised test methods. If a Member State decides to allow new standards, such a measure might be regarded by some economic operators as a barrier to the free movement of goods.
2.3 Does the Regulation permit the use of the “read -across” approach for generating data on surfactant homologs for the granting of derogation (Art. 5)?
The principle of “read -across” of data from one substance to a similar substance is already recognized in international risk assessment activities, including the OECD HPV Chemicals Programme.
This approach allows establishing the properties of individual substances by “reading -across” from the properties of substances on either side in the same homologous series.
This means the Grouping of substances whose physicochemical, toxicological or eco-toxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity. Therefore these substances may be considered as a group, or “category” of substances. Application of the group concept requires that physicochemical properties, human health effects and environmental effects/fate may be predicted from data for a reference substance within the group by interpolation to other substances in the group (read -across approach). This avoids the need to test every substance for every endpoint.
The similarities may be based upon:
1. a common functional group,
2. the common precursors and/or the likelihood of common breakdown products via physical and biological processes, which result in structurally similar chemicals, or
3. a constant pattern in the changing of the potency of the properties across the category.
As many commercial surfactants consist of a mixture of several substances belonging to the same homologous series, it was accepted in the Detergent’s Working Group meetings that interpolation should be integrated into the guideline on the methodology for the tiered approach to testing for surfactants that are primarily but not ultimately biodegradable.
Commission Recommendation C /2005/5677 on tiered approach technical guidance document for the purpose of implementing Regulation (EC) No 648/2004):
In contrast, extrapolation is excluded from the “read -across” process.
It was agreed by the Detergents Working Group that the technical dossier addressed to the competent authority granting derogation should explicitly mention cases where interpolations have been taken into consideration for determining the ultimate biodegradability features of surfactants.
2.4 Do the biodegradability criteria of the Detergents Regulation apply independently of the intended function of the surfactant in the detergent formulation?
The objective of the Detergents Regulation as stated in Article 1(2) is to harmonize the rules concerning the biodegradability of surfactants in detergents. The definition of surfactant given in Article 2(6) is made exclusively in terms of the physico-chemical properties of the substance. The function of the substance in the detergent formulation is not mentioned in the definition of surfactant, nor anywhere else in the Regulation. Therefore, the application of the Regulation does not depend on the intention of the manufacturer concerning the purpose or function of the surfactant in the detergent formulation. Therefore, if a surfactant is not used for its surface active substances but added for another function, the manufacturer has still to ensure that it meets the biodegradability criteria as laid down in the Annexes II and III of the Detergents Regulation.
3.1. Should the act of translating the label be considered as a change to the label?
The Regulation defines any person changing the labelling of a detergent or surfactant as a manufacturer. Manufacturers have extensive responsibilities under Article 9 of the Regulation.
The European Court of First Instance has previously recognized, in another context, that a distinction must be made between the information content of the label and the language used to present that information (case C- 33/97). According to this ruling, an accurate translation does not change the information content and such a translation is therefore not considered to be a change to the labelling. Within the meaning of the Detergent’s Regulation, a person who affixes an accurate translation to a package would therefore not be considered to be a manufacturer. An inaccurate translation which changes the information content of the label would however constitute a change to the labelling, and the person who does this assumes the responsibilities of a manufacturer.
3.2 Can INCI names be translated into national languages?
INCI nomenclature is an agreed standard within the EU and no translation of these substance names is needed. The labelling of detergents must also conform to the provision of the Dangerous Preparations Directive 1999/45/EC (DPD) and the risk and safety phrases specified by the DPD are already given for all of the 20 languages of the Member States so that accurate translations are available.
3.3 Could “Blind trials” be exempted from label requirements?
These blind trials involve the comparative testing of detergents by a limited number of consumers for the purposes of market research (e.g. is product X better than product Y?). According to the Regulation, such trials involve placing detergents on the market because they are made available to third parties, and the detergents should therefore be labelled. However, an essential feature of such trials is that the products are tested “blind” i.e. without information which may influence the judgement of the tester. Labelling in accordance with the Regulation would render blind testing impossible.
Member states and the Commission agreed that no action should be taken against blind testing, provided it is done on a limited scale and for a short period only. The manufacture should therefore keep records to show that these conditions are respected.
3.4 Must detergents for specific use with medical products carry CE marking?
CE marking for medical products is intended for medical devices covered by Directive 93/42/EC concerning medical devices, Directive 90/385/EEC concerning Active Implantable Medical Devices, and Directive 98/79/EC concerning In Vitro Diagnostics. For these directives, ISO 9001 accreditation is useful in the context of the manufacturer’s declaration of conformity.
CE marking of detergents as medical devices must be such that it is clearly pertinent only to the properties assessed according to medical devices directive.
Instead, cleaning agents, insofar as they contain surfactants, fall within the scope of the detergents legislation and must comply with rules concerning the biodegradability of surfactants. Furthermore, disinfectants, or cleaning agents containing disinfectants, are subject to the biocides directive 98/8/EC.
3.5 How long shall the Ingredient Data Sheet of a withdrawn detergent be made available for the consumer?
The Detergents regulation does not specify for how long the Ingredient data sheet has to be made available after a product is withdrawn from sale. However the objective of Article 11(2) is that information should be available to the consumer . It is then logical that the consumer could ask for this information as long as the product remains in the supply chain.
REACH provisions require that Safety Data Sheets are maintained for a period of 10 years. Although the SDS does not have the same purpose as the Ingredient Data Sheet (See question 5.6), consistency with REACH has not been opposed by the detergent Industry. Therefore, it is recommended to keep Ingredient Data Sheets available for 10 years after the detergent is withdrawn from the market place.
3.6 Is the provision of “equivalent information” on detergent ingredients in Safety Data Sheets (SDS) in compliance with Annex VIIA ?
The criteria in Annex VIIA of the Detergents Regulation for listing detergent ingredients differ in three important respects from the corresponding criteria for Section 3 of the SDS as given in Annex II of REACH (previously Section 2 of the Annex to the Safety Data Sheet Directive 91/155/EC):
• annex VIIA does not distinguish between hazardous and non-hazardous ingredients, whereas the SDS requires only dangerous substances to be listed;
• the concentration thresholds for listing ingredients are higher in the SDS than in Annex VIIA;
• the SDS requires listing of individual dangerous substances, whereas Annex VIIA requires listing of classes of substances.
Therefore, a single ingredient list cannot be expected to successfully meet the requirements of both pieces of legislation. However, both lists (list of hazardous substances according to the DSD, and list of detergents ingredients according to the Detergents Regulation) can be displayed under Section 3 of the SDS, providing that these are clearly distinguished from each other by means of suitable (sub) headings indicating to which piece of legislation they apply.
4.1 How should old stock which does not comply with the new Regulation be treated?
Since 2005, both industry and Member States emphasised their commitment to ensuring that stock on the shelves of retailers would be labelled in accordance with the Regulation. Nevertheless, it is possible that some stocks of some specialized cleaning products may remain unsold in small retailers by this date. It was agreed that these small scale stocks would not need to be withdrawn. This flexibility would not however be extended to larger retailers such as supermarkets, or to distributors.
5.1 Criteria for deciding if a product falls within the scope of the Regulation?
There are a number of products on the market for which it is not immediately clear whether they fall within the scope of the Detergents Regulation or not.
An example is furniture polish. A useful criterion to apply in such cases is whether the product has a cleaning action. A polish which contains a surfactant may simply apply a wax layer to a surface, or it may have a combined cleaning plus wax application action, similar to a car shampoo. In the first case the polish would not fall under the Regulation, but in the second case it would.
Furthermore, it should be noted that under Article 2(1) last bullet point, i.e. ‘ other cleaning and washing preparations /mixtures’ intended for any other washing and cleaning processes it follows that detergents do not necessarily need to contain surfactants to fall within the scope of the Regulation. For example, an alcohol-based cleaning product without surfactants would still need to comply with all the labelling provisions of the Detergents Regulation. Whether a particular product falls within the scope of Detergents Regulation depends on its purpose (cleaning function or not) and not on its composition (containing surfactants or not ).
However, that bullet point is not intended to include in its scope soaps and shampoo intended for personal care; those products are covered by the Cosmetics Directive 76/768/EEC.
5.2 Do products that have a rinsing function (including those based on organic solvents) fall within the scope of the Detergents Regulation?
Rinsing preparations /mixtures which do not have a cleaning function within the meaning of Article 2(3) would be classified as auxiliary washing preparations /mixtures under Article 2(1) 'Other cleaning and washing mixtures' . These auxiliary preparations /mixtures do fall within the scope of the Regulation . Consequently, rinsing additives for dishwashers are considered to fall within the scope of the Detergents Regulation.
Moreover, Article 13(2) explicitly mentions “solvent-based” detergents i.e. organic solvent–based detergents. Therefore, any products having a cleaning function and based on organic solvents would still need to comply with the labelling provisions of the Detergents Regulation.
5.3 How should “soap” and “fragrances” be labelled?
Different pieces of European legislation apply to the labelling of soap depending on the usage of this ingredient. As a surfactant, soap may be used in a wide range of applications. If the surfactant is used as a component of detergent (intended for washing and cleaning processes), then the requirements on labelling and classification are those set out in Regulation (EC) N° 648/2004, Directive 1999/45/EC ,Directive 67/548/EEC and Regulation(EC) N°1 272/2008.
On the other hand, if the soap is used as a cosmetic product (intended for cleaning the human body), then the provisions set out in Directive 76/768/EEC on cosmetics apply.
With regard to “fragrances”, similar considerations apply. If the fragrance is sold as an ingredient for a cosmetic purpose, it must follow the requirements provided by Directive 76/768/EEC and be labelled under the indication "parfum" or "aroma" (Art 6.g) of that directive. In particular, the 7th amendment (2003/15/EC) of Directive 76/768/EEC requires the labelling of 26 fragrances that may cause allergies.
If the fragrance is added to a detergent preparation /mixture, then it must be labelled as required by Regulation (EC) No 648/2004 and Directive 1999/45/EC or Regulation (EC) N°1272/2008.
5.4 Do contact lens care solutions fall under the Detergents Regulation?
Contact lens care solutions do not fall under the Detergents Regulation. Instead they fall under the Medical Devices Directive where they must comply with the requirements for class IIb medical devices.
Although contact lens care solutions may contain surfactants, they do not have a cleaning function within the meaning of the Detergents Regulation. Article 2(3) of the Regulation makes use of the ISO definition which refers to cleaning as the removal of “soil” i.e. to the “removal of an undesirable deposit on and/or within the substrate which changes some characteristics or appearance or feel of a clean surface”. In fact, deposits on contact lenses continue to build up despite daily treatment with the care solutions until the lenses can no longer be worn and have to be replaced. The main purpose of the surfactants in the care solutions is to rewet the surface of the lens, not to clean it.
5.5 Do hydrocarbon propellants in oven cleaning spray products have to be listed as ingredients of the detergent?
The propellants in oven cleaning sprays are gases such as butane/propane i.e. they are aliphatic hydrocarbons. As such they are specifically mentioned in Annex VIIA as one of the constituents that must be labelled. Moreover, the propellant clearly has a dual role: it produces a foam as well as acting as a propellant. The bubbles of propellant in the foam constitute an integral part of the preparation. The propellant is therefore an ingredient that must comply with the requirements of Annex VII of the Detergents Regulation.
5.6 Do “fuel additives” and “lube-oils” fall within the scope of the Detergents Regulation?
(a) Lube-oils
These products are exclusively used to prevent deposition within the engine (e.g. to keep particles in suspension in engine oil), thereby to keep combustion and wear residues from settling in the engine oil circuits. Member States and the Commission agreed that these products do not fall within the ISO definition of cleaning (as mentioned in Article 2(3) of the Detergents Regulation) , therefore they fall outside the scope of the Detergents Regulation.
(b) Fuel additives
Two types of after-market fuel additives have been considered. One is intended to keep engine parts such as fuel injectors clean by reducing engine deposits . The other is intended to increase the cetane rating of diesel fuel. Additives are already present in about 75% of the fuels sold to the public in the EU, but additives are also sold separately for the consumer to add to the fuel. Both types of additives are completely combusted before leaving the engine . Neither type is considered to fall under the Detergents Regulation as neither has a cleaning action within the meaning of the Regulation. This is clearly the case with additives that increase the cetane rating of diesel fuel as they are intended only to improve fuel combustion and no cleaning action is claimed by the manufacturer.
In contrast, additives that keep engines clean are often claimed by the manufacturer to have a cleaning action. However, such additives do not clean in the strict sense of the Detergents Regulation. Deposits are both created and removed by thermal processes in engines and the rates of the two processes reach an equilibrium associated with specific driving behaviour and fuel quality. Fuel additives act to reduce the rate of deposition by changing the equilibrium between the deposition and removal processes, leading to a reduced amount of deposit in the engine. The additives do not affect the removal of deposits, which is a purely thermal process. Therefore, considering that fuel additives do not have a cleaning effect within the meaning of the Regulation, Member States and the Commission agreed that these products do not fall within the scope of the Detergents Regulation.
5.7 Do animal cleaning products fall within the scope of the Detergent s Regulation?
(a) Products for cleaning of pets (e.g. shampoo for dogs, horses etc.)
The Commission and Member States agree that these types of products do not fall under the Detergents Regulation as the cleaning of the hair, fur or skin of live animals is not covered by the definition of washing in Article 2(2). Shampoo for humans falls under the Cosmetics Directive as regards human health effects, and environmental effects are covered by REACH. There is no sector specific EU legislation for the products used for the cleaning of pets.
(b) Products for cleaning the nipples of animals (e.g. cows or goats). As with case (a) above, these products fall outside the scope of Detergents Regulation. However, they fall within the scope of the Directive 98/8/EC on the placing on the market of biocidal products (as indicated by Commission Regulation (EC) No 1662/2006 amending Regulation (EC) No 853/2004 laying down specific hygiene rules for food of animal origin ). It should be noted that if the Biocidal Product Directive is applicable, the biodegradability criteria of the Detergents Regulation are also satisfied as the biodegradability criteria are the same in both pieces of legislation.
5.8 Do products for the cleaning of food and vegetables fall within the scope of the Detergents Regulation?
The Commission and Member States agree that products for cleaning of fruits and vegetables fall within the scope of the Detergents Regulation as they are used for washing purposes (e.g. for removing the wax on fruit) so they meet the ISO definition of cleaning (Article 2(3)). Moreover, other legislation may apply in addition to the Detergents Regulation for this type of products, such as the Biocidal Products Directive requirements in case a biocidal effect is claimed.
5.9 Do cleaning products containing bacteria fall within the scope of the Detergents Regulation?
The Commission and Members States examined a request for clarification as to whether a product with a claimed cleaning effect depending on the action of bacteria falls within the scope of the Detergents Regulation. The label of the product claims that its cleaning action is a result of applying bacteria to feed on the excrement of dust mites. It was agreed that such a product, though it contains surfactants, does not seem to have a cleaning action within the meaning of ISO definition (i.e. “the process by which soil is dislodged from the substrate and brought into a state of solution or dispersion”).
5.10 The status of manufacturer’s claims concerning the cleaning action of a product.
The question of whether a product falls within the scope of the Detergents Regulation is not determined by the manufacturer’s claims regarding the cleaning action of the product.
Instead, the decision should depend on whether the product has a cleaning action within the meaning of the Regulation. The Detergents Regulation therefore differs from, for example, the Biocides Directive in which it is sufficient to claim a biocidal action (more precisely to state an intended use for the product) to automatically fall within the scope of that Directive.
It is necessary to make a further distinction regarding claims about cleaning action because the definition of “cleaning” in the Regulation does not always fully coincide with the normal usage of the word “cleaning”. It is therefore possible , without misleading the consumer, for a manufacturer to claim a cleaning action for a product that does not have a cleaning action within the meaning of the Regulation.
An example of such a “normal usage” meaning of cleaning is that of a fuel additive as mentioned in 7.6(b) which prevent deposits forming in engines, and which therefore has a cleaning action in the sense of keeping a surface clean.
There is no infringement of the Regulation if the manufacturer makes a cleaning claim that is not consistent with the definition of cleaning in the Detergents Regulation. However, if the cleaning claim is not consistent with either the definition of cleaning in the Detergents Regulation , nor with the wider “normal usage” meaning of cleaning, then the marketing of such a product might be contested under consumer protection legislation .
5.11 Do 'soaps nuts' fall within the scope of the Detergents Regulation?
Soap nuts are not considered to be either a substance or a mixture according to the definitions of the Detergents Regulation, and consequently soap nuts fall outside the scope of the Detergents Regulation.
However, as consumer products , soap nuts are covered by the rules of the General Product Safety Directive (Directive 2001/95/EC) and the Market Surveillance Regulation (Regulation (EC) N° 765/2008).
5.12. Do 'foam sponges' fall within the scope of the Detergents Regulation?
It has been questioned if 'foam sponges which aim to clean and polish shoes' fall within the scope of the Detergents Regulation or not.
Foam sponges that are pre-charged with detergent when placed on the market, and that are intended for cleaning and polishing (for example shoes or cars), are considered to be a form of packaging for a carrier for that detergent. The foam sponge itself is therefore not considered to be one of the ingredients of the detergent formulation, but the detergent in the sponge does fall within the scope of the Regulation. Thus detergent pre-charged foam sponges are considered to fall within the scope of the Detergents Regulation.
But foam sponges intended for cleaning that are not pre-charged with detergent when placed on the market are considered to be articles and do not fall within the scope of the Regulation.