Europe tightens detergent rules: manufacturers and importers of detergent formulations will...

Chemical control legislation in the European Union is significant and of some complexity (something which will continue with the impending REACH European legislation on chemicals). The development of the existing framework of chemical legislation has reflected the dual objectives of i) avoiding

technical barriers to trade and ii) establishing a broadly preventative approach to control and protection of man and the environment. Beyond the generic regimes for chemical management, there are market- or application-related regulatory schemes, of which the Detergent Regulation is just one example.

It is widely recognised that surfactants used in detergents are subject to European Community legislation and have been for a number of years. In the 1960s, many member states experienced foaming problems in rivers and in response to this problem, European legislation on the biodegradability of surfactants in detergents was put into place in the early 1970s.

The initial legislation was introduced under the Community Environmental Protection programme with the first directive in this area being 73/404/EEC (commonly known as the enabling directive). This directive set out the principle that surfactants used in detergents should have an average 90% minimum biodegradability.

As an enabling law, it had no tangible effect and only became active following the introduction of specific directives dealing with the biodegradability and analytical methods for each type of surfactant.

Anionic and non-ionic surfactants were addressed in Directives 82/243/EEC and 82/242/EEC. These laid down a minimum 80% biodegradability requirement based on tests measuring primary biodegradability. (Primary biodegradation relates to the structural change [ie transformation] of a surfactant by microorganisms resulting in the loss of its surface active properties).

The difference in the biodegradability level between the framework and individual directives has caused some confusion over the years but, in effect, means that any single surfactant should be a minimum of 80% biodegradable with the overall average biodegradability of mixed surfactants in the formulation being 90%.

Two further groups of surfactants--cationic and amphoteric surfactants (which are used, for example, in fabric softeners and dishwasher products)--were not addressed under the existing legislation due to their lower scale of use in detergents and lack of suitable test methods.

In 1995, the European Commission set about updating the existing detergents legislation in order to address the gaps and issues that had arisen since the introduction of the initial legislation, with the specific aims of:

1. Improving environmental protection by:

* Extending testing for biodegradability to all groups of surfactants used in detergents.

* Tightening the biodegradability testing requirements for surfactants in detergents by replacing the primary biodegradability test with one for ultimate biodegradability. Ultimate biodegradation relates to the level of biodegradation achieved when the surfactant is totally used by microorganisms in the presence of oxygen resulting in its breakdown to carbon dioxide, water and mineral salts of any other elements present (ie mineralisation).

2. Addressing human health concerns by:

* Requiring fuller content information to be provided on detergent labels.

* Including a requirement that a complete ingredient listing of detergent and cleaning should be made available to health care professionals on request.

The new regulation

The resulting new detergents regulation (Regulation EC No 648/2004) was published on 8 April 2004 and will enter into force on 8 October 2005, when the existing detergent legislation (Directives 73/404/EEC, 73/405/EEC, 82/242/EEC, 82/243/EEC and 86/94/EEC) will be repealed.

This means that as of 8 October 2005, manufacturers and importers of detergent formulations will need to ensure that products they offer for sale in Europe comply with this legislation. Practically speaking, this date is likely to apply to products leaving the factory gate rather than product already on supermarket shelves, but this is not clear in the regulation.

Labelling provisions for detergents and cleaning products from Commission Recommendation 89/542/EEC have also been incorporated into the new regulation. The recommendation aims to harmonise the type of information provided on detergent packaging. The extended scope of the new regulation is certainly now starting to mirror other application-specific controls, such as those for cosmetics.

It is important to note that the new legislation is an EU regulation. This means that it will be effective in all member states without any national modification, imposing directly on detergent manufacturers requirements to be implemented at the same time and in the same manner throughout the community.

The key to understanding and applying this regulation correctly is the definitions section (Article 2). For the first time, the legislation includes a definition for a surfactant. There is also a new definition for detergent. Some key descriptions have been extracted below, but it is recommended that the original text is referred to for details of the exact definitions

'Detergent' means any substance or preparation containing soaps and/or other surfactants intended for washing and cleaning of laundry, fabrics, dishes and other hard surfaces when marketed for household, industrial or institutional purposes.

Auxiliary washing preparations intended for soaking (pre-washing), rinsing and bleaching, as well as laundry fabric softeners, are also considered as detergents.

Compare this with the definition appearing in Article 1 of Directive 73/404/EEC: 'Detergent shall mean the composition of which has been specially studied with a view to developing its detergent properties, and which is made up of essential constituents (surfactants) and, in general, additional constituents (adjuvants, intensifying agents, fillers additives and other auxiliary constituents)'.

'Surfactant' is defined in terms of general structure and physical/chemical properties, but no specific test parameters or methods are cited. Consequently, additional guidance from the Commission will be particularly welcomed in this area, especially as non-surfactant components of detergent products fall outside the scope of the biodegradability requirements of the legislation.

In addition to the definitions, it is also important to be aware of the fact that an official Technical Guidance Document (TGD) is currently being developed by the EU Commission (DG-Enterprise) to accompany this regulation. This TGD should assist with the practical interpretation of the regulation by member states and manufacturers alike and underlines the need for clarity and consistency of interpretation. The Commission recognises the importance of having this TGD made available as soon as possible, but official approval of the TGD can only be in place once the regulation comes into force ie 8 October 2005.

Implications of the new regulation

Leaving aside the ingredient information and labelling provisions introduced by the regulation, the most significant change for the surfactants and detergents industry is the new requirement for ultimate biodegradability thresholds to be met for all surfactants used in detergent formulations, whereas the legislation repealed from 8 October 2005 relies on primary biodegradability for non-ionic and anionic surfactants only.

The key action is therefore to determine whether all the surfactant components of a detergent product meet the ultimate biodegradability criteria of the new regulation. Many surfactants will meet the new requirements, but some surfactants, which currently meet the primary biodegradability criteria of the detergent directives (82/242/EEC and 82/243/EEC), or are out of scope until 8 October 2005 (ie cationic and amphoteric surfactants), may not meet the stricter ultimate biodegradability criteria of the new regulation. Detergents containing surfactants that do not fulfil this new requirement will not be permitted on the EU market from 8 October 2005.

The new regulation does include a derogation (exemption) procedure but this is only under very exceptional circumstances. The process will include a requirement for additional test data and a full environmental risk assessment. It is anticipated that this will be a costly and time-consuming process with few successes--certainly not a route to be relied upon.

However, the new criteria do offer a potential opportunity for some non-ionic and anionic surfactants currently failing the primary biodegradability requirement but shown to be ultimately biodegradable. These surfactants will be available for use in detergency applications previously prohibited. Examples may include certain groups of alkoxylated surfactants.

Specialty surfactant manufacturers, such as Uniqema, are already discussing and providing information to detergent formulators on how individual surfactants are affected by the new regulation and, where appropriate, are helping to identify suitable alternatives considered to be ultimately biodegradable.

At this point it is appropriate to raise the question of roles and responsibilities. In accordance with 'Information to be provided by manufacturers' (Article 9 of the regulation), it will be up to the suppliers of surfactants to assess whether their product meets the biodegradability criteria set out in the new regulation and they will be responsible for advising their detergent customers accordingly. Surfactant suppliers are only allowed to base these assessments on data for which they are a) in possession of the necessary documentation and b) allowed to benefit from the property rights associated with this data.

It is likely that surfactant suppliers will use the safety data sheet to convey this information to detergent formulators, holding the original test reports at the disposal of the competent authorities of the member states as appropriate.

It is important to note that data displayed on individual companies' safety data sheets is not considered public domain data and remains the property right of the individual company concerned.

Conclusion

There are many concerns within the European surfactants and detergents industry on the impact and timing of this particular piece of application specific legislation. It represents an additional regulatory burden ahead of the impending REACH legislation. Its value is therefore questionable, since, unlike some legislation (eg certain aspects of the cosmetics directive 76/768/EEC), detergents and their ingredients will not fall outside the REACH processes and controls. Many surfactant ingredients meeting the requirements of the new legislation will still be subject to further regulation under REACH.

The new detergent regulation does, however, provide an opportunity for speciality surfactant manufacturers and detergent formulators to work together more closely, helping to create advantages for both parties.

Martina Williams works for Uniqema's Product Safety & Regulatory Affairs department The text of the full regulation can be found at: http://europa.eu.int/comm/enterprise/ chemicals/legislation/detergents/index.htm