REACH implications for the UK Water Industry

This article describes how REACH will impact down stream users including water & wastewater treatment

“What are the implications of the New EU Chemicals Strategy and the REACH Initiative for the UK Water Industry?”

The EU Published a White Paper for a future chemicals Policy in February 2001 which set out a proposed approach to the regulation of chemicals based on an innovative system called REACH (Registration, Evaluation and Authorisation of Chemicals). The objective of the new system was to have a single regulatory regime for new and existing chemicals and to streamline the registration process. The system would identify those chemicals that are of most concern and require industry to seek authorisation of these chemicals for specified uses that have been demonstrated to be safe. Other uses would be banned and any new uses of a chemical of concern would require re-registration.

The White paper has been the subject of much discussion within the EU by the EU Parliament, the individual Member States and Industry. Several major Stakeholders Conferences have been held by the European Commission which have looked, inter alia, at the business impact of the new Chemicals Policy. One of the areas of greatest uncertainty and concern, which may have implications for the Water Industry, has been the requirement that ‘downstream users’ of a chemical of concern should supply information on their particular use of that chemical as part of the registration process. The European Parliament, in one of its responses to the White paper, picked up on one aspect of the duty on users saying that it:

"Considers that manufacturers, importers, downstream users and distributors should have a general duty to provide comprehensive information on the content and properties of chemicals in products”

After extensive debate and lobbying by the chemical industry, downstream users of chemicals and the NGOs, REACH is nearing finalisation in the EU Parliament. It now appears that there will be only minor modifications to the original proposals and the REACH Implementation Projects (RIPs) were carried out on that assumption. Many of the RIPs have now been completed and these include the Technical Guidance Document (TGD) for REACH, so what does this say about downstream users? Some relevant sections from the TGD are quoted below:

“Under REACH manufacturers, importers and downstream users should demonstrate that the manufacture/import/use of a substance does not adversely affect human health and that risks are adequately controlled. In other words, they have to demonstrate that the identified exposures for that substance are below a certain ‘safe, health-based exposure level’. Under REACH this level has been defined as the Derived No-Effect Level (DNEL), in analogy to the Predicted No-Effect Concentration (PNEC) used in environmental risk characterisation.“

“The exposure/DNEL comparison in principle presents a simple tool for risk assessment, especially for downstream users who do not have the hazard data at their disposal.”

“REACH requires that Emission Scenarios (ESs) shall be developed for identified uses, and provides any downstream user with the possibility to make a use known to his supplier with the purpose of making his use an “identified use” for which an ES shall be developed to the extent that the supplier accepts and supports this use. However, a manufacturer or importer is not obliged to be proactive in seeking information on uses of his chemicals, but he can await a reaction from his customers before developing an ES for uses that were not previously identified. Nevertheless, if a downstream user makes his use known to his supplier, the supplier may decide to develop an ES for that specific use and update his Chemical Safety Assessment (CSA).”

“Typically, the communication (by a producer) with downstream users will require that information is transferred through more than one level of the supply chain, as several levels including distributors and intermediate formulators (producing pre-formulations or master batches) may exist between the manufacturer or importer and the final downstream user who possesses the necessary information on the ultimate use of the chemical.”

The use of chemicals by the water industry probably falls in to the example of ‘generic’ use given in the TGD and in this case the user is required to develop a general description of typical operational conditions and typical risk management measures (RMMs) that are implemented. The user has a responsibility to ensure that the use that they make of a chemical was (or will be for most existing chemicals) considered and accepted as part of the authorisation granted during registration, they may need to supply information on the use of a chemical of concern (for example relating to amounts used, procedures for use, storage, disposal of waste containing the chemical, emissions to the environment (to water and air)) to the ‘consortium’ that is formed to gain registration of the chemical. Such information from a number of users would be assessed to determine whether that use presented an acceptable risk. 

Update: On the 5 October 2005 the EU Parliament Environment Committee vote on REACH effectively reversed some of the proposals that had been made to make the regulations more workable. The amendments dilute the risk-based approach, call for extended data requirements for volumes of 10 - 100 tonnes and support the mandatory substitution of hazardous chemicals without taking the risk-based approach into consideration. The outcome of the vote was received with dismay by the European and UK Chemical Industry’s representative bodies. 

The full technical guidance note with the questionnaire is available at the European Chemical Bureau's web site.