INTRODUCTION
What is reach?
REACH is the acronym for the new European Union regulation covering the Registration, Evaluation, Authorisation and restriction of CHemicals. It came into force in the European Union (EU) on 1st June 2007 replacing a about 40 different European Directives and Regulations with a single system.
Aims.
The stated aims of REACH are as follows:
01. Improve the protection of human health and the environment from the risks that can be posed by chemicals
02. Enhance the competitiveness of the EU chemicals industry, a key sector for the economy of the EU
03. Promote alternative methods for the assessment of hazards of substances
04. Ensure the free circulation of substances on the internal market of the European Union
No data, no market.
The fundamental principle upon which REACH is based on is “No data, no market”
Under REACH, there is a requirement for manufacturers or importers of substances to register them with a central European Chemicals Agency (ECHA) A registration package will be supported by a standard set of data on that substance. The amount of data required is proportionate to the amount of substance manufactured or supplied.
If you do not register your substances, then the data on them will not be available and as a result, you will no longer be able to manufacture or supply them legally, i.e. no data, no market!
Exemptions.
Under the current regulations, some categories of substances are either outside the scope or exempted from REACH. These are substances that present low risks to health and the environment, substances which occur in nature and have not been chemically modified. Following is a partial list of exempted substances:
01. Pharmaceutical products for human or veterinary use
02. Food or feeding stuff additives
03. Animal nutrition
04. Substances listed in Annex IV (like Glucose, Water, etc.)
05. Substances fulfilling the criteria of Annex V (several natural substances, unintended reaction products, etc.)
06. Non-isolated intermediates
07. Polymers
Three ways to look at REACH.
The first is from a legal perspective that starts by reading and memorising the legal text of Regulation (EC) No 1907/2006 and this continues into a check-list of things you must do and those you must not. The problem with this approach is that the concepts and principles can be lost in the detail.
A second approach is to follow the spirit of the legislation that sets out, quite rightly, to ensure that chemicals manufactured, supplied and used are ‘fit for purpose’. This has no set boundaries and without keeping the regulations and practicalities in perspective, time and money can quickly disappear while aiming for perfection.
The third approach, favoured by this guide, is to do sufficient to ensure that adequate hazard and risk communication is taking place and to ensure that you are doing enough for compliance. To meet this objective, we do need to know a bit about the legal text and also need to understand the science of why we are doing all this to ensure that the chemicals are fit for purpose.
This short guide is aimed at those who need to know enough about REACH to get on with their ‘day-jobs’ of buying or selling chemical products, manufacturing goods or just working with chemicals. It is important that industry believes that REACH is not an impenetrable tangle of legislation, but a tool to catalogue the hazards and risks of substances supplied in Europe. REACH appears very complicated and frightening if just reading the legal texts, but the concepts are simple and we need to continually go back to the spirit of the law to find the answers.
|
