Select Committee on Science and Technology Written Evidence


Memorandum from the Royal Society of Chemistry

  The European Commission White Paper Strategy for a Future Chemicals Policy was published in February 2001 outlining proposals for the future regulatory control of chemicals. This initiative, now known as REACH (Registration, Evaluation, Authorisation, and Restriction, of Chemicals) is arguably the most significant development in European legislation with regard to controlling chemicals with far reaching implications for the science and practice of chemistry within the European Union.

  One of the key aims of the chemicals policy is to introduce laws that will provide a faster, more efficient approach to managing chemicals of high concern. Since its publication the strategy has undergone many modifications and amendments, resulting in submission of a proposal for legislation to the Council and the European Parliament in October 2003.

  The Royal Society of Chemistry Charter obliges it to serve the public interest by acting in an independent advisory capacity. It is in this capacity that the Society has made an input into official UK and EC consultations and inquiries with an interest in the proposed policy and legislation.

  The RSC finds the latest version setting out the proposed regulations to be more balanced and more pragmatic than earlier versions. However, we still have significant concerns about the workability of some aspects of the proposal, and we believe that more information and guidance is required if it is to achieve its intended objectives. The Society is aware that the process of developing the proposals into legislation has only just begun and hopes that further improvements will be made to ensure the effectiveness and workability of the eventual legislation.

  The current EU system is fragmented and cumbersome. In principle the Royal Society of Chemistry would welcome a single harmonised regime for assessing and controlling the effects of chemicals on health and the environment.

  However the Society would like to stress that:


  Substances should generally not be banned on the basis of intrinsic hazard alone. Intrinsic hazard is not a good measure of the actual threat that a substance poses to humans or the environment. Risk is a better measure because it is based on the likelihood that an intrinsic hazard associated with a substance will cause actual harm. Using tonnage to trigger the REACH process is not ideal although it offers a pragmatic solution for new substances. There is a need for improved prioritization procedures for existing substances.

  The Society would have preferred prioritisation (to identify and deal with substances of high concern) on the basis of risk to be built in at the Registration stage. Exposure scenarios required for registration will differ on the basis of use and this will have a key impact on the risk that a chemical (substance) poses. By focusing on the volume of chemical produced or imported, the danger exists that effort may be misdirected on high volume but low toxicity substances such as sodium chloride—common table salt, rather than on substances of high concern used in smaller quantities. In this regard it may also be appropriate to revise Annex II which provides for exemptions from the obligation to register (in accordance with Article 6(a)).


  Efforts must also be made to minimise duplication with other legislation.

  REACH will replace about 40 Directives and regulations on chemicals but leave more than 20 others in place. The Commission when implementing REACH should recognise and where appropriate incorporate the outputs of the Intergovernmental Forum on Chemical Safety (IFCS), the UNEP strategic approach to chemicals management, the OECD cooperative programme for testing and assessing High Production Volume (HPV) chemicals (ie the ICCA HPV programme), the Rotterdam convention on Prior Informed Consent (PIC) regulating trade in certain dangerous substances and the Stockholm Convention on Persistent Organic Pollutants (POPs), which came into force this year. REACH should also be compatible with the proposed Global Harmonised system for classification and labelling of substances.


  Transparency is vital to enhance public confidence in chemistry. The challenge is to create a balance between transparency and commercial confidentiality.

  All aspects of the REACH process need to be transparent so that interested parties can see how decisions are made. However this should not extend to providing detailed commercially sensitive information that would impact on competitiveness without providing any useful benefit, such as on the intermediates used in pharmaceutical syntheses, or on details of formulations that would allow competitors to copy mixtures or articles (finished products). Commercial enterprises should only have an obligation to declare hazardous components of mixtures and articles that could have public safety implications. The Society recognises the need for, and wishes to promote, dialogue between the chemical industry and other stakeholders to discuss information needs in the context of mutually desired outcomes.


  This is particularly true for "existing chemicals" that have been in use for many years with no apparent adverse effects.

  Production and importation levels are not ideal indicators of potential harm or exposure. Therefore testing thresholds should, where practicable, take account of estimated actual exposure and potential impact.

  Furthermore, there should be greater acceptance of scientifically reliable historical data gathered for other toxicological assessments required under other regimes. In addition, data in dossiers produced to meet the requirements of other chemical evaluation programmes such as the US High Production Volume challenge should be mutually acceptable for REACH. There is a need for European Chemicals Agency guidance on using read across toxicity data and advice on what level of information is required at the Registration stage to enable a move away from a tick box approach.

  There is concern that if dossiers will only be checked for completeness, prior to being placed on the database, that this will encourage registrants to generate comprehensive datasets and thus the use of experimental animals for toxicity testing is likely to increase unnecessarily. Testing on animals should be minimised. It would be unethical to require animal testing simply to complete a bureaucratic box ticking exercise.

  For low volume chemicals (1-10 tonnes/year/manufacturer or importer) the European Commission has recognised the need to avoid animal testing as far as is possible.

  For higher volumes animal testing may be necessary if existing information and validated alternative methods are not sufficient.

  Even though the Commission is proposing to allow the maximum use of existing non-animal test methods and encourage the development of new tests that do not use animals, this may not reduce the use of experimental animals in the short and medium term.

  New test methods will take time to develop, validate and gain acceptability by regulators. The regime should also be flexible enough to adapt to developments in toxicology, such as those resulting from the fast developing area of genomic science. In general companies prefer to use test methods that don't involve animals. However a company cannot use alternative tests until legislators and regulatory agencies have confirmed that they will accept the results. In the past it has taken many years of international validation studies before legislators and regulatory agencies would accept the results from alternative test methods.

  There tends to be more information about chemicals of high concern. Consequently, data waivers should be allowed where there are good surrogate measures. Provision is made for this in Annex IX (rules for adaptation of standard testing regime) which also covers the need for additional standard information requirements for substances in excess of 100 tonnes (Annexes V to VII ). The Society also recognises that the revised proposals also make provision for data sharing between enterprises but it is not clear on how this will be achieved in practice without excessive bureaucratic interference.

  The Society is also concerned about the practicalities of the Registration of 30,000 or so substances, including the 1,500 substances of high concern requiring Evaluation and Authorization within the 12 years of REACH coming into force. In addition to these substances, 40,000 intermediates will also need to be registered even though the requirements for registering these will be significantly lighter. In view of the number of chemicals that will fall within the REACH process it seems unlikely the Competent Authorities will have the resources to devote sufficient time to chemicals of lower concern, ie those requiring Registration and Evaluation but not Authorisation.


  There is a need for people with the necessary skills and experience to be available throughout all three stages of the REACH process in order to avoid Registration being downgraded to a box ticking exercise.

  Expert judgement is required in specifying what data (including existing data) and which tests are acceptable in the first instance. Then there is a need to be able to go beyond the completeness to check validity of dossier contents. The Registration process also needs to be enhanced by instituting a sampling regime to ensure that harmful substances classified into categories not intended for rapid evaluation do not slip through because the data is not properly scrutinised. This requires a level of expertise to counter the ability of registrants to finesse a dossier that could hide issues requiring more careful scrutiny.

  With regard to the Evaluation of dossiers and substances by the Competent Authorities in Member States, the European Chemicals Agency will have to provide guidance to ensure consistency and a level playing field. This guidance needs to address both registrants and Member States.

  Differences in interpretation by Member States must be minimised. As registrants will not know which Member State will be conducting the evaluation, clear guidance should be given as to what data is required, because without it registrants will be likely to generate the maximum amount of test data that any Member State might require, to ensure that applications are successful. This in turn is will create an unnecessary amount of work and, possibly, unnecessary animal testing.


  Any chemicals that are withdrawn should be those that are least desirable for health, safety or environmental reasons.

  The "best" or "safest" substances should not be withdrawn simply because they generate insufficient profit to cover the cost of testing.

  The Commission estimates that 1-2% of substances currently on the market will be lost. The Society and others believe that this may be a significant underestimation. This situation is likely to arise in those cases where a producer would have to spend a large amount of money to test a low economic value substance for the purposes of Registration. In such cases economic sense dictates that the producer/importer drop that substance rather than pay for the tests. A similar situation has resulted in a loss of around 60% active substances in plant protection products and probably an even larger proportion of active substances in biocidal products.

  It is difficult to quantify cost of compliance with REACH. However the current cost estimate from the Commission for complying with the proposals is 2.8 billion euros with most of this being for testing and Registration. It is likely however that the biggest costs will be incurred downstream in the supply chain due to mixture and article reformulation and this in turn will depend on the number of substances that will be taken off the market. It is important to note that the quantity of material does not relate to value of a component in a formulation which may not be possible to reformulate in some cases.

  Whatever the figures turn out to be it is already clear that implementing REACH will place significant costs on industry and there are fears that this could be a factor when industry decides whether to remain in the EU.

  The Commission should therefore consider developing options for allowing some, generic substances that do not have sponsorship to continue to be manufactured within the Community. Enforcement of REACH may be a serious problem when dealing with downstream users, and proper enforcement also represents a significant cost.


  Innovation is essential to achieving sustainable development, and chemistry can provide a range of "solutions" to support sustainable development. The Society welcomes the exemptions on registration for the purposes of research and development together with lower registration costs to facilitate the introduction of new substances aimed promoting innovation. There is some concern that innovation as envisaged by the Commission is primarily focused on substitution. Although substitution can lead to environmental benefits it is unlikely to lead to truly innovative articles (products) which contribute to the economic profits needed to underpin sustainable development.

  The Royal Society of Chemistry is the UK Professional Body for chemical scientists and an international Learned Society for the chemical sciences with 46,000 members world-wide. It is a major international publisher of chemical information, supports the teaching of the chemical sciences at all levels and is a leader in bringing science to the public.

January 2004

previous page contents next page

House of Commons home page Parliament home page House of Lords home page search page enquiries index

© Parliamentary copyright 2004
Prepared 12 May 2004