CHEMICALS & RISK CHEMICALS & HAZARD REGULATORY COMPLIANCE REACH TECHNICAL EXPERTISE

Technical Expertise > Product Stewardship

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Regulatory compliance
Review of product portfolio
Substitution
SEE ALSO - HPV Initiatives

Regulatory compliance

Some aspects of product stewardship are covered by statutory requirements under national or European legislation. Under REACH, the onus is on industry (manufacturers and importers, and downstream users, of chemicals) to assemble the appropriate chemical data, undertake chemical safety assessment, and prepare relevant documentation.

Hazard communication for a substance in the form of a material safety data sheet (MSDS) is a requirement under CHIP. An MSDS contains very important data for those handling the substance throughout its supply chain. It includes information about hazards to human health and the environment, and guidance as to precautions in the event of spillage or exposure.

CHIP contains other provisions that are relevant to product stewardship (in particular standard classification and labelling - click here for more information). Legislation also exists under which a substance must be appropriately classified and labelled in respect of transport by various routes.

Even for substances not covered by REACH, registration of chemicals on or entering the market is another important regulatory requirement, and separate legislation exists to cover biocides, plant protection products, and veterinary and human medicinal products. All of these areas of legislation now include the need for a risk assessment for the environment.

Voluntary activities in the area of product stewardship are more general and flexible, and the chemical industry has the opportunity to tailor initiatives to particular sectors.

The Marketing and Use Directive, which imposes controls on specific dangerous substances and preparations, will be repealed by the REACH regulation with effect from June 2009.

Review of product portfolio

Legislation affecting chemical products is frequently updated and amended. Of particular relevance at the present time is the recent implementation of the Registration, Evaluation and Authorisation of Chemicals (REACH) Regulation, which ends the previous distinction between 'new' and 'existing' chemicals. Click here for more information on REACH. The implementation of REACH may be the catalyst for review of company product portfolios at an unprecedented level of detail in some cases.

Subtle differences in product chemistry and properties may be relevant and can mean that different products are affected in different ways. For example, Persistence, Bioaccumulation and Toxic properties (PBT) are particularly important properties under REACH and various other contexts.

Are there benefits in a company adopting a responsible approach and looking hard at its product range, even when legislation does not demand it? One positive benefit is in the way that customers respond to Material Safety Data Sheets. Good information and presentation can help clarify these documents, which are often produced by consortia to share costs and information that should, by its nature, be in the public domain. The costs of producing and marketing substances can be reduced by this kind of analysis. Producing formulations that are safer (i.e. need a less severe classification) is a positive attraction for customers. Finally, having a sound strategy in respect of health and environmental issues can aid planning and budgets, and avoid crises requiring expensive emergency actions.

Our extensive experience at the interface between data gathering and its use in legislative procedures makes us well qualified to review product portfolios for compliance with new developments. We can offer services that range between advising on the status of compliance to the development of cost-effective strategies to meet data gaps. Such gaps might be filled using read-across, property prediction tools, such as QSARs or the judicious use of testing. Contact us for more information.

Substitution of chemicals

Chemicals that are successful in the market do well because they have properties that are useful, at an acceptable price. Their hazards and risks, where known, need to be acceptable too. The criteria for acceptability have changed over the years, but there has always been a need to consider whether a substance or process should and can be replaced. There will be particular pressure to identify substitutes for substances that require "Authorisation" under REACH.

Use of chemicals that have a favourable environmental profile is one of the key principles of Green Chemistry. Substitution of environmentally hazardous substances for 'green' alternatives is an aspect of many companies' sustainability activities. It is clear that the substitute must, in overall terms, be more sustainable than the original.

There is no doubt that in the present and foreseeable future:

  • There will be regulatory pressures to substitute.
  • There will be possible economic benefits to be gained.

    BUT

  • 'Off the shelf' acceptable substitution is rarely possible.
  • Substitution via new R and D is time consuming.

    Forward-looking research has always been aware of opportunities.

    In recent years, the need for a sustainable chemical industry has increased the need for a more active approach to substitution. Some governments and stakeholders have been impatient for change, but answers appear to be limited.

    A variety of tools exist to support decision making in industry in relation to possible substitution of chemicals. A thorough understanding of the relationship between chemical structure and properties, use of predictive methods and models allows scientists to consider the theoretical environmental impact of a particular candidate chemical in a given application, at the very earliest stages of development.

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    Diane Wilkin

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