The Royal Society of Edinburgh (RSE) is pleased to respond to the Department of the Environment, Transport and the Regions consultation on the European Commission's Chemicals White Paper. The RSE is Scotland’s premier Learned Society, comprising Fellows elected on the basis of their distinction, from the full range of academic disciplines, and from industry, commerce and the professions. This response has been compiled by the General Secretary with the assistance of a number of Fellows with substantial experience in this area.
Although the immediate impact of the proposed strategy will be on industrial producers, importers and downstream users, the envisaged benefits to the general public and environment make the paper pertinent to a wide audience. From the research scientist's point of view, any improvement in the availability and quality of hazard/risk data on chemical substances is most welcome. Researchers draw heavily upon the data provided by their chemical suppliers, typically in the form of chemical safety data sheets, in order to perform risk assessments on all experimental procedures carried out within their laboratories. More readily available information on the intrinsic hazards and exposure risks associated with the substances involved in their work allows for a more thorough assessment of the short and long term risks. This, in turn, facilitates the making of an informed decision on the containment measures and working practices required to control them.
 
The specific details identified in the White Paper are addressed below:

1. Scope of Strategy

Will the system ensure a high level of protection for health and the environment reflecting the precautionary principle and the principle of sustainability, while ensuring that other relevant aspects are taken into account

Formal definitions
The formal definitions of terms appearing in the glossary appear to be inconsistent. "Substances" are defined essentially as single chemical compounds, while "chemicals" also incorporates mixtures. However "Existing substances" is defined to include "chemicals" and even explicitly "mixtures of different chemicals occurring naturally". The definition of "Existing substances" explicitly excludes various naturally occurring materials, usually mixtures, such as ores and foods. However, the components of these must fall under the definition of "substances" to which the proposed regulations apply. If there are intended to be continuing exclusions, the boundaries need to be made clear. In principle, everything is a mixture or composite of chemical substances. Work needs to be done on a set of definitions that make scientific, legal and policy sense. For example, pharmaceuticals used for human and animal health are nominally "chemicals" or "medicaments", but are already regulated. The paper should specify whether their regulation will be "instead of" or "as well as" the proposals in the White Paper.

Alternative synthetic routes and side products
The proposed legislation appears to concentrate on products. However, particular chemicals can be prepared by several different routes, and the nature and quantity of side products, contaminants and waste (which can be more dangerous than the desired chemical - e.g. a few % of benzene in other aromatic hydrocarbons) are greatly dependent on the production process selected. To those working on the production process, the side products may also present the greatest risks as they will usually be at higher levels during the production process than the contaminants in the final products, but the current proposals do not seem to provide for the evaluation of their hazards. Side products (or their further transformed derivatives) may leave the production site as chemical waste. Once again, this may pose significant risks to both people and the environment. The document does not seem to make provision for the assessment of components of chemical waste (unless they are major products in their own right).

Degradation products
Some persistent organic chemicals are not directly produced by manufacture but are degradation products. The paper should consider whose responsibility these are and explicitly define the limits of responsibility.
 
2. Producer responsibility

Will the approach of having the responsibility for testing and assessing chemicals placed on producers and importers, with the national authorities evaluating the information provided by industry, be sufficient to ensure that the chemicals are properly assessed, while placing a reasonable burden on the chemicals industry?

Independent analysis
Public acceptance of the scheme is likely to be greater the more the testing is seen to be independent. It would be preferable for testing to be done by independent laboratories, rather than the manufacturers or importers themselves, so that all results obtained would be free from pressures of commercial interest. The supplier could then either accept these findings, or have additional testing from an alternative independent source. The use of certified independent laboratories would also fit well with the system for sharing costs between different manufacturers and importers and would increase public and government confidence in the accuracy of the findings.
 
Proposed procedures for testing chemicals
It is not just the lack of data on existing chemicals which is important, but the validity of the tests. The report highlights the difficulties of determining long-term risks from the results of short-term testing and assessment. Moreover, traditionally dangerous substances and uses have been identified from general observations and health-and-death statistics for people engaged in certain activities and living in certain places. However, the paper does not present practicable guidelines to address the problems and it may be unrealistic to expect chemical companies and "downstream users" to engage in this broader scale of research.

Responsibilities of downstream users
Requiring downstream users to be responsible for generating and assessing data and assessing the risks of the use of the substances may place a heavy burden upon small and medium sized enterprises and bodies such as schools, colleges, universities and hospitals. Many of the chemicals used are proprietary formulations (e.g. mixtures of chemicals) and one problem might be to define content. The conflict between manufacturers who will seek to limit the intended uses, and innovators who wish to increase uses, will be acute. Care will also need to be taken to ensure that research work is not in conflict in that disclosure to the relevant authorities may be required in sufficient detail to invalidate subsequent patent protection.

New chemical control requirements will require consideration of the appropriate handling facilities and, in particular, the necessary requirements in relation to having these facilities available within Higher Education Institutions to allow research to be conducted safely. It will be important that the Higher Education Funding Councils are aware of the likely costs which would be incurred by institutions in responding to such issues and that appropriate funding provision be made for refurbishment costs to allow laboratory based subjects to respond to the challenge of being able to continue to carry out research in a safe environment.

3. Administration and resources

Can the challenges posed by the strategy be met through an expanded European Chemicals Bureau, with the cost of testing met by industry and the administrative costs recovered by a fee-based system

Burden on the chemicals industry
The chemicals industry is likely to be reluctant to carry the financial burden all by itself and the consumer may, ultimately, foot the bill for the testing programme through paying higher prices for end products. Small to medium sized enterprises inparticular feel the burden at a time when the profitability of the chemical industry as a whole is under considerable pressure. Some companies will also be developing a particular chemical to gain a competitive advantage. The chemical control registration of such a chemical should, therefore, avoid unintentionally but effectively leading to its revelation to the company's competitors, or it will undermine the competitiveness of the industry and could hamper the implementation of the legislation.

International collaboration
The Society also supports the proposed action to improve the quality of safety data sheets and the intention to implement a 'Globally Harmonised System' for classification and labelling of substances. Between the US and the EU, the majority of chemicals used in bulk that pose a significant risk, in current use and identified as priority chemicals, should be assessed quickly.

Implications for animal testing
A highly sensitive issue, common to both industry and academia, is the use of animals in testing and research. The Commission's proposed strategy potentially increases the level of animal testing, as a side effect of addressing the problem of insufficient test data on the large number of existing substances that has arisen under the current legislation. However, to allay such fears, the paper highlights elements of the Registration, Evaluation and Authorisation of CHemicals (REACH) system that have been specifically designed to minimise animal testing and promote the development of alternative methods using fewer or no animals. There would also be merit in further investigation into how effective the system will be in attaining this objective. Over all, the Commission makes very clear its full commitment to the European Centre for the Validation of Alternative Methods' (ECVAM) endeavours to reduce, refine or replace animal experiments; and to actively promote the expansion of international acceptance of test results; and to support EC directives that avoid duplicate testing within the Community.

Additional Information
In responding to this consultation the Society would like to like to draw attention to the following Royal Society of Edinburgh responses which are of relevance to this subject: The Basis for Environmental Standards (January 1996) and Long-Term Effects of Chemicals in the Environment (January 2001).

Further information is available from the Research Officer, Dr Marc Rands