This article will be useful reading for all small business owners and managers.
What is REACH?
REACH is a European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of chemicals. It took effect from 1st June 2007 and replaces a number of European Directives and Regulations with a single system.
Its aims are to:
- Provide a high level of protection of human health and the environment from the use of chemicals.
- To make the people who place chemicals on the market responsible for understanding and managing the risks associated with their use.
- To enhance innovation in and the competitiveness of the EU chemicals industry.
This article provides basic information to help you understand how you as a chemical user could be affected by REACH.
Do you use chemicals in your business?
Most businesses use chemicals and many rely on them without realising it. For example you may use them in the manufacture of finished goods or simply to keep your machinery operating and your premises clean. Examples include paints, metals, glues, solvents and cleaning materials.
What will happen to chemicals under REACH?
Chemicals that are manufactured or imported into the EU will need to be registered with the new European Chemical Agency (ECHA) in
Helsinki. The process starts with pre-registration next year and will be phased in over a period of years.
Will it affect my business?
As a user, REACH may make things better for you as it¡¯s designed to provide more information on chemicals and increase confidence in their safe use. In particular, better information on the hazards of chemicals and how to use them safely will be passed down the supply chain by chemical manufacturers and importers through improved Safety Data Sheets. Unless you make or import chemicals yourself, as a user it is highly unlikely that you will need to register chemicals.
What do I need to do?
Ask yourself what you do in your business and where chemicals might be used? For example, if you make anything from formulations (for example, paints, coatings) through to objects for sale then the chances are you use chemicals in some form.
Generally, if you are using chemicals or mixtures of them (for example, paint, lubricants, cleaning agents) in the way that is expected then REACH probably won¡¯t mean significant changes for you.
If your business relies on using unusual chemicals (that aren¡¯t very common) you may need to be sure that these will still be available in the future. You should consider contacting your supplier to find out if the chemical(s) in question will be registered by whoever makes or imports it. It is possible that some companies, for example for business reasons, may decide not to register chemicals. If so, then you may need to find an alternative source or even re-think your processes. You really need to be thinking about this now to avoid any problems next year.
If you use a chemical in a novel way that is perhaps not expected then you will need to consider letting your supplier know. This use will need to be considered for registration by the supplier. If you don¡¯t want to let your supplier know about this use (for example because of commercial concerns) then you don¡¯t have to but it will mean that you will have to let the ECHA know about this use and possibly have to submit your own risk assessment.
What do I need to do?
REACH will impact most businesses in the UK in some way. It is important to understand what your role is in REACH, and what you can do now to be sure you are ready.
Compile an inventory: Build an inventory of every chemical that comes into, is part of, or goes out of the business - what feed stocks, intermediates (isolated or otherwise), and products are used or created?
You need to know all the substances you use; for preparations you need to find out what the ingredients are. Keep a record of each one, and include essential information for example the name of the chemical and the percentage in any preparations. You can use this information to determine the tonnage per year.
Additionally you need to know whether you produce or import articles. If you do, establish if any substance (which is intended to be released under normal or reasonably foreseeable conditions of use) is present in these articles in quantities totaling over 1 tonne.
Once this inventory has been established, you can begin to understand what substances you rely on, and consider the impact on your business should REACH influence the supply (or for registrants, the production or import) of a substance. Consider contingencies, for example alternative supply, routes, chemicals or processes, or supporting suppliers in their REACH obligations, etc.
Prioritise: Every business making use of chemicals that aren¡¯t exempt from REACH needs to understand how valuable these substances are to them, and plan to make effective business decisions based on this knowledge. Consider the importance of each substance to your business. Ask yourself the following sorts of question:
- What do you use it for?
- Are the uses to which you put chemicals going to be supported by their registrants?
- How much of it do you use?
- Are there any alternative substances or processes that could replace this?
- Will your supplier/s maintain supply of important substances if REACH impacts the commercial viability of doing so?
- What will be the impact for you if the price increases or the supply drops, and what can you do about it?
- Do you want to share information back to registrants about what you use chemicals for, or is this information so sensitive that you would prefer to compile risk assessments yourself, and submit these directly to the European Chemicals Agency? What will this involve?
Identify any chemicals that may be 'substances of very high concern'.
Determine your role in relation to each substance on the inventory - see 'What is your role in REACH?'.
Build relationships: establish a relationship with your suppliers and any downstream users. You need to know how REACH is going to impact on your supply chain before you can decide what to do about it. Identify an appropriate person as the main REACH contact in your organisation and make them the focus for communications with suppliers and customers.
Pre-register: The first major new REACH activity for manufacturers/importers of substances is pre-registration, in order for the company to take advantage of this activity the substance must be what is known as a ¡®phase-in¡¯ substance. This means that:
- The substance is listed on EINECS.
- The substance was manufactured in the Community, or in countries acceding to the EU on the 1st January 1995 or on 1st May 2004, but not placed on the market by the manufacturer, at least once in the 15 years before entry into force of this Regulation, provided the manufacturer has documentary evidence of this. Basically, the substance was not placed on the market at all and was a site limited or export only chemical, however evidence of this must be provided.
- The substance was placed on the market in the Community, or in the countries acceding to the EU on 1st January 1995 or on May 2004, before entry into force of this Regulation by the manufacturer or importer and was considered as having been notified in accordance with the first indent of Article 8 (1) of Directive 67/548/EEC but does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this (so called ¡®no longer polymer¡¯ substances).
If the above applies to any of the substances a company imports or manufactures then they can pre-register the substance from the 1 June 2008 to 30 November 2008 (inclusive). Pre-registration will mean informing the European Chemicals Agency (ECHA) of:
- The name of the substance as specified in section 2 of REACH Annex VI, this includes CAS, EINECS or other identification codes
- Name and address of the contact person or representative
- Envisaged deadline for the registration and the tonnage band
- Identifier information of any structurally similar chemical which you may wish to rely on to provide useful evidence on hazards as part of your registration package
Once pre-registered the European Chemicals Agency will identify who is intending to register the same substance and put them in contact with each other. The potential registrants can then come together and form a 'Substance Information Exchange Forum¡¯ (SIEF) where they can negotiate sharing their available data and the costs of generating any new data.
Please note that pre-registration is not a legal requirement of REACH, but it is recommended that companies do pre-register in order to take advantage of the phased-in tonnage deadlines for registration and the SIEF arrangements.
When do I have to comply with REACH?
When and how you have to comply with REACH depends on your status within the supply chain (see ¡®how does REACH affect me?¡¯) and also if you can, and have, pre-registered your substance.
What if I have pre-registered?
If you have pre-registered then you qualify for the phased-in registration deadlines, these deadlines depend on the classification and tonnage of the substance supplied. These deadlines are set out in the timeline below as phases 1, 2 and 3.
What happens if I don¡¯t pre-register my substance?
This means that you cannot take advantage of the ¡®phase-in¡¯ periods under REACH and must register your substance on the 1 December 2008.
What happens if I have a ¡®new¡¯ substance?
A substance that is ¡®new¡¯ means that it is not on EINECS and has not been manufactured previously. These substances must be registered from the 1 June 2008, they are not eligible for ¡®phase-in¡¯ and are called ¡®non phase-in¡¯ substances under REACH. Until then the current Notification of New Substances Regulations (NONS) continue to apply.
How do I register?
Registration is the process of collecting and collating specified sets of information on the properties of substances. How much information is needed depends on the tonnage and hazards associated with the substance that is to be registered. These requirements can be found within the REACH text. The information is then used to perform an assessment of the hazards and risks that a substance may pose and how these risks can be controlled. This information and the associated assessment are then submitted to the European Chemicals Agency (ECHA) in Helsinki.
For more detailed information on registration see the ECHA guidance document.
When do I register?
When you register depends on the type of chemicals you use.
Date
|
Action
|
1 June 2008 |
Pre-registration for existing (¡®phase-in¡¯) substances starts
Registration for new (¡®non phase-in¡¯) substances starts
|
30 November 2008
|
Pre-registration for ¡®phase-in¡¯ substances ends |
1 December 2008
|
Registration for existing substances (that have not been pre-registered) starts
|
1 January 2009
|
List of pre-registered substances published and SIEFs are formed
|
1 June 2009 |
First recommendation of priority substances to be considered for authorisation published by ECHA
|
1 December 2010: Phase 1
|
The following pre-registered ¡®phase-in¡¯ substances should have been registered when supplied at:
- ¡Ý 1000 tonnes per annum (tpa) or;
- ¡Ý 100 tpa and classified under CHIP as very toxic to aquatic organisms or;
- ¡Ý 1 tpa and classified under CHIP as Cat 1 or 2 carcinogens, mutagens or reproductive toxicants
|
1 June 2013: Phase 2
|
Deadline for registration of substances supplied at ¡Ý 100 tpa |
1 June 2018: Phase 3
|
Deadline for registration of substances supplied at ¡Ý 1 tpa
|
| 
