If you are an importer or manufacturer of substances in the EU and you do not register your substances as and when required, you will not legally be able to import or manufacture those substances in the EU. REACH is the EU Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals (Regulation (EC) No 1907/2006). It aims to streamline and improve the former legislative framework on chemicals in the European Union. Under REACH, a substance cannot be manufactured in the EU or placed on, or imported into, the market unless it has been registered with the European Chemicals Agency. The responsibility is on YOU, as manufacturer or importer of substances into the EU, to register those substances in order that they can be managed effectively to reduce risks to health and the environment.
What is a substance?
A substance can be a chemical element or a compound. Substances in their natural state or substances obtained from a chemical manufacturing process are included. Additives and impurities are included where these are part of the substance’s manufacturing process (but excluding any solvent which can be separated without affecting the stability of the substance or changing its composition).
- Is your business established within the EC?
- Are you a manufacturer of substances in the EU?
- Are you an importer of substances into the EU?
- Do you manufacture or import in quantities of 1 tonne or more?
If the answer to the above questions is yes, there is a strong likelihood that REACH will impact your business.
REACH requires manufacturers and importers to gather comprehensive information on the properties of all substances produced or imported in quantities greater than 1 tonne per year and to submit the necessary information to demonstrate their safe use in a registration dossier to the European Chemicals Agency. The obligation to register began on 1 June 2008. Failure to register will mean the substance cannot be manufactured or imported into the EU market.
Although you might be considered an importer under other legislation, will you be an importer under REACH? An importer is defined under REACH as ‘any natural or legal person established within the Community who is responsible for import’. Import is defined as the ‘physical introduction into the customs territory of the EU’. There is no conclusive answer to the question of who is the importer for REACH purposes. It depends on a variety of factors and is decided on a case by-case basis.
A manufacturer is defined under REACH as ‘any natural or legal person established within the Community who manufactures a substance within the Community’. Manufacture is defined as the ‘production or extraction of substances in their natural state’.
Where substances have long been in the EU market (so-called ‘phase-in substances’ such as jet fuel, diesel oil and gas oil), there is a simpler pre-registration requirement. Pre-registration of these substances runs from now until 30 November 2008 inclusive. Pre-registering before the deadline allows you to benefit from extended full registration deadlines (as shown in the timeline). Also, pre-registration is free and simple!
Many substances are exempt from registration under REACH because their hazards and risks are well known or they are substances for which registration is deemed inappropriate/unnecessary.
Some of the more common substances exempted from registration are:
- mineral ores
- crude oil
- natural gas
- natural gas condensate
- process gases
- basic elemental substances (for example hydrogen, oxygen, noble gases, nitrogen)
This is not an exhaustive list – there are many more substances which are exempt from the obligation to register.