Chemicals are controlled throughout the World and although there is some harmonisation
between regions (such as test methods and UN transport labelling), it is important to understand the rationale behind the
main principles of chemical control. The EU REACH Regulation appears to be a barrier to non-EU industry wanting to supply in Europe; in reality, the burden on EU industry and
non-EU industry is comparable and in balance, REACH will not favour (or favor) US or EU industry as a whole, with some winners
and losers in different sectors.
The concepts of legislation must first be understood before trying to understand
the legal elements of legislation. It may be hard to believe, but once the philosophy
of various regulations has been understood, it actually makes some logical sense.
The main difference between the EU and US is that the US legislation has a stronger legal basis
and disputes are frequently settled by lawyers; conversely, the EU legislation is based on the 'spirit' of the law and disputes
tend to be settled by scientists.
Concept of legislation
It is important to understand the reasons why legislation has to be applied. The simple
answer is that without regulation of any sort, there would be an unacceptable risk of harming workers, consumers or the environment. Chemical supply regulations have been put into place to ensure that the level of hazard
is understood and that risk reduction measures are taken.
The end-point of chemical supply legislation in Europe is to provide sufficient information
to enable a Hazard Assessment to be made to enable safe handling of the product. This
is mainly in the form of applying classification and a selection of ‘Risk’ and ‘Safety’ phrases. A more basic approach is applied for international transport legislation, but again
the concept is to provide those in potential contact with the chemical sufficient Hazard information.
Regional variations
Although legislation concerning
the supply of chemicals has a common objective to help protect workers, consumers and the environment, a different approach
is taken in different parts of the World. Regional variation can be simplified
by describing it as three types; European, US and Japanese. Countries in other
parts of the World either follow one of these types of approach to legislation, or have taken the better parts of these systems
and adapted for their own needs. Global harmonisation may one day ensure
consistency, and the Global Harmonisation System (GHS) has been agreed in principle among most nations.
Summary of regional regulatory philosophy
Description |
Europe |
US |
Japan |
List of Existing Substances |
Yes |
Yes |
Yes |
Mandatory set of testing for New Substances
|
Yes |
No |
Yes |
Classification of chemical products for supply |
Yes |
No |
No |
Classification of chemical products for transport
(UN) |
Yes |
Yes |
Yes |
Emphasis on acute effects for worker safety |
Yes |
Yes |
No |
Emphasis on long-term health effects for consumers |
Yes |
No |
Yes |
Emphasis on environmental fate and effects
|
Yes |
No |
Yes |
Testing of health effects for mixtures encouraged
|
No |
Yes |
No |
Hazard-based testing regime |
Yes |
No |
No |
Risk-based testing regime |
No |
Yes |
Yes |
This summary
must be viewed as being very simplistic, but effectively European legislation has the greatest burden of hazard testing on
substances, covering acute effects to workers, health effects to consumers and environmental impact. These test methods are designed to provide a Hazard Assessment that allows hazard phrases and symbols to
be assigned. The European Preparations Directive discourages testing on mixtures
and requires that labelling is calculated from hazards of the components.
The US has a more risk-based approach
and new substances require testing in relation to their risk. Mixtures that are
supplied to the consumer should normally be tested in their own right to ensure consumer safety. Environmental safety in the US centres on effluent and waste as this is seen to be the greatest source
of contamination – European philosophy is to assess the hazards of each substance and then calculate the net effects.
Japanese
regulations have been established to protect against long-term health effects to the population through food and water contamination. Emphasis is put on biodegradation, removal from the environment and bioaccumulation. Less emphasis is put on worker safety as workers can be protected through use of personal
safety equipment and engineering controls.
Many parts of the World have
followed the EU model, and in some cases, improved on it; these countries include Australia, Canada, Switzerland, Russia and
to a certain extent, much of Asia.
Data ‘translation’
When moving chemicals
across international boundaries, it is necessary to be able to assess hazards and potential risk using one set of data and
applying it to other assessment systems. This is especially important when attempting
to avoid animal test work.