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Denehurst Chemical Safety Ltd

US vs Europe

Recognising (or recognizing) fundemental differences in philosophy of testing and data evaluation between the EU and US

 

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.
 

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