How to Comply with the EU Detergent Regulation?  5/19/2016


The European Detergent Regulation
The Regulation No 648/2004 came into force in 2005 and harmonized the various existing directives throughout EU Member States. Concerns for detergents started in the 70s due to the presence of surfactants, compounds that lowers the surface tension between two liquids or between a liquid and a solid. Surfactants have toxic effects on aquatic fauna and flora. National directives in the early 70s set criteria for biodegradability of products to avoid toxic accumulation in the environment.


In 2004, the European Commission published Regulation 648/2004 for the entire European Union. This Regulation aims to avoid foaming in rivers, protect the environment and the end consumer.


A few definitions from Article 2 of Regulation 648/2004
According to the definition provided by the EU Regulation a ‘Detergent’ “means 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 mixture”, 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 mixture”, 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 mixtures”, intended for any other washing and cleaning processes.


Glossary
For a more understandable reading, please find few definitions of key words of detergent regulation:
  • Surfactant: "means any organic substance and/or mixture used in detergents which has surface-active properties and which consists of one or more hydrophilic and one or more hydrophobic groups of such a nature size that it is capable of reducing the surface tension of water, and of forming spreading or adsorption monolayers at the water-air interface, and of forming emulsions and/or mircoemulsions and/or micelles, and of adsorption at water-solid interfaces".
  • Primary biodegradation: "means the structural change (transformation) of a surfactant by micro-organisms resulting in the loss of its surface-active properties due to the degradation of the parent substance and consequential loss of the surface-active property as measured by test methods listed in Annex II."
  • Ultimate aerobic biodegradation: "means the level of biodegradation achieved when the surfactant is totally used by micro-organisms in the presence of oxygen resulting in its breakdown to carbon dioxide, water and mineral salts of any other elements (mineralization), as measured by test methods listed in Annex III, and new microbial cellular constituents (biomass)."


Biodegradability of surfactants
After use, the majority of detergents are found in waste water collection systems. To avoid the destruction of the ecosystem, the EU Regulation 648/2004 requires surfactants to be biodegradable. Depending on the quality of the surfactant used, biodegradation times will vary, making it more or less harmful to the environment. The biodegradability of a substance is its ability to be broken down into simpler substances by microorganisms (bacteria, fungi) in waters or into the ground.
The EU Detergent Regulation uses OECD’s method as a reference to assess the biodegradability of a surfactant. This method can be found in the OECD’s publication of June 1976 on the “Proposed Method for the determination of the Biodegradability of Surfactants in Synthetic Detergents”. Annex II of Regulation No 648/2004 details 4 analytical test methods depending on the surfactant:
  • Anionic Surfactants
  • Non-ionic Surfactants
  • Cationic Surfactants
  • Amphoteric Surfactants
Ultimate biodegradability
According to Annex III “Surfactants in detergents shall be considered as biodegradable if the level of biodegradability (mineralization) measured according to one of the following test (please see the Annex) is at least 60 % within 28 days”.



Surfactants also used as biocidal active substances
If the surfactant is also used as a biocidal active substance, you must comply with the Detergent Regulation AND the Biocidal Product Regulation No 528/2012 (BPR).

Article 3 of the detergent Regulation states: “ When placed on the market, detergents and surfactants for detergents referred to in Article 1 shall conform with the conditions, characteristics and limits laid down in this Regulation and its Annexes and, where relevant, with Directive 98/8/EC –now BPR Regulation No 528/2013- and with any other relevant Community legislation. Surfactants that are also active substances within the meaning of Directive 98/8/EC and that are used as disinfectants are exempt from the provisions of Annexes II, III, IV and VIII of this Regulation […]”



Restrictions on Phosphates
Article 4a of the Regulation 259/2012 amending regulation 648/2004 states “Detergents listed in Annex VIa that do not comply with the limitations on the content of phosphates and of other phosphorus compounds laid down in that Annex shall not be placed on the market from the dates set out therein.

The limitations on the content of phosphates and of other phosphorus compounds concern mainly:
  • Consumer laundry detergents: The detergent must “not be placed on the market if the total content of phosphorus is equal to or greater than 0, 5 grams in the recommended quantity of the detergent to be used in the main cycle of the washing process for a standard washing load […]”. This ban entered into force on 30 June 2013.
  • Consumer automatic dishwasher detergents: “Shall not be placed on the market if the total content of phosphorus is equal to or greater than 0, 3 grams in the standard dosage […]”. This ban will apply on 1 January 2017.


How to label detergent products?
The label of a detergent product must comply with the Classification, Labeling and Packaging (CLP) Regulation (EC) No 1272/2008.

The requirements are:
  • The name and trade name of the product
  • The name or trade name or trademark and full address and telephone number of the party responsible for placing the product on the market
  • The address, email, where available, and telephone number from which the referred datasheet can be obtained
This information is defined by Article 11 of the Detergent Regulation and must appear in legible, visible and indelible characters on the packaging for consumers. The packaging must indicate the content, in accordance with the specifications provided in Annex VII A. It shall also indicate instructions for use and special precautions, if required.

Annex VII of Regulation 648/2004 lays down the requirements for the labeling and ingredient datasheet. The following provisions on labeling must apply to the packaging of detergents sold to the general public. 

The following weight percentage ranges:
  • Less than 5 %
  • 5 % over but less than 15 %
  • 15 % or over but less than 30 %
  • 30 % and more
Must be used to indicate the content of the constituents listed below where they are added in a concentration above 0.2 % by weight:
Phosphates, — phosphonates, — anionic surfactants, — cationic surfactants, — amphoteric surfactants, — non-ionic surfactants, — oxygen-based bleaching agents, — chlorine-based bleaching agents, — EDTA and salts thereof, — NTA (nitrilotriacetic acid) and salts thereof, — phenols and halogenated phenols, — paradichlorobenzene, — aromatic hydrocarbons, — aliphatic hydrocarbons, — halogenated hydrocarbons, — soap, — zeolites, — polycarboxylates.

The following classes of constituent, if added, must be listed irrespective of their concentration:
Enzymes, — disinfectants, — optical brighteners, — perfumes

If added, as such, at concentrations exceeding 0.01 % by weight, the allergenic fragrances that appear on the list of cosmetic Regulation (EC) No 1223/2009 must be listed on the label.


Scope of the detergent Regulation

In 2011, the European Commission published a guidance based on frequently asked questions. Here is a non-exhaustive list of specific cases:

1- Contact lens care
Contact lens care solutions are considered as Medical Devices. The product must then comply with the Medical Devices Directive. Indeed, the main purpose of the surfactants in the care solutions is to rewet the surface of the lens, not to clean it.

2- Animal cleaning product
Animal cleaning products are not considered as detergent and there is no specific EU legislation dedicated to products used for the cleaning of pets. As chemical mixtures, such products must still comply with the CLP and REACH regulations.

3- Foam sponges

Foam sponges that are pre-charged with detergent when placed on the market, and that are intended for cleaning and polishing (e.g. shoes), are considered to be a form of vehicle delivering the detergent formula. Therefore, the foam sponge by itself is not considered as a detergent but as an ‘article’.



What is compliance based on?
Compliance with the Detergent Regulation and its various requirements will rely on several steps:
  1. Define the classification of the finished product based on its formula, the SDS of the surfactants and the criteria of the CLP Regulation.
  2. Check that biodegradability studies are in accordance with Annex II and III of the Regulation.
  3. Bring the SDS of the finished product in compliance with the REACH and CLP Regulations.
  4. Bring the label of the finished product in with the CLP & Detergent regulations, i.e. ingredient listing, claims and translation should be carefully checked.
  5. For finished products sold to the general public, make sure that the web page dedicated to such product is aligned with the requirements of the Detergent Regulation.
  6. Final registration before the relevant Anti-Poison centers of the concerned EU countries should be done.


EcoMundo’s Services
Do not hesitate to contact us: contact@ecomundo.eu, if you have any question about detergent compliance or if you’re looking for specific services. EcoMundo can help you place your products on the EU market and can provide the following services:
  • Detergent Regulation 648/2004 services
  • Detergent compliance for Europe
  • Detergent labeling compliance services
  • Detergent artwork services
  • Detergent Safety Data Sheets (SDS)
  • Detergent Biodegradability studies
Contact us via phone: for North-America please use +1 (778) 231-1607 or for Europe +33 (0)1 83 64 20 54.


Interested in Learning More? 
Join us for the upcoming International Health & Beauty Care Efficient Program Planning Session (EPPS) on June 12th from 5:40-6:20pm to hear Marie Roussel of EcoMundo speak about practical details you should know if you intend to do business with Europe. She’ll also explain how the EU Regulatory framework is impacting other international markets such as Middle East, Brazil or Australia. View more presentation details here!

Marie Roussel

EcoMundo

After having obtained a Master’s degree in International Studies from Adelaide University (Australia) and a Master in Business from Paris University (France), Marie joined EcoMundo in 2009 and developed a strong expertise in EU Regulatory management, including the REACH Regulation for chemicals. In 2012, Marie launched EcoMundo’s North American branch, from Vancouver, Canada. Today, she mainly assists US, Canadian but also Australian companies in complying with EU Regulations and ensuring sec

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