Reach for more regulations!

REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) is the new system for controlling chemicals in Europe. It became law in the UK on 1 June 2007.

Because any company could be affected by REACH: it is important that they understand what REACH requires and their duties under the legislation. Identifying where your company fits into the supply chain is important as this will dictate what you have to do and when you have to do it – not all requirements of REACH apply now. Below are summarised the key stages in the process.

Any company manufacturing or importing a substance on its own, in a preparation (mixture of substances), or in articles (finished manufactured goods) at or above 1 tonne per year may have to register it. This is done by submitting a dossier to the new European Chemicals Agency (the Agency), based in Helsinki, providing details of the substance’s properties, other relevant information about risks and how these risks can be managed. You will not be able to market or use the substance, or article containing a substance within the EU unless it has been registered.

To ease the move to the new REACH provisions, registration will be ‘phased-in’ over 11 years, generally for those substances that have been around since 1981. More information on the various registration deadlines is given in REACH CA Information Leaflet No. 6 – REACH Timelines, but the key registration deadlines are given below. Chemicals manufactured or imported in large volumes and certain ‘substances of very high concern’ (i.e. with particular hazardous properties) will need to be registered first, those manufactured or imported in smaller volumes may be registered later.

There are some exemptions from registration, as well as other parts of REACH, and you should check whether any apply to your business. More information on exemptions can be found in REACH CA Information Leaflet No. 8 – Exemptions from REACH.

Companies that only use chemicals purchased from within the EU do not have a duty to register or pre-register. However, if they use speciality chemicals or common chemicals in a novel way they should think about contacting their suppliers.

Evaluation means two things under REACH. The first is simply that the Agency will assess a proportion of the substance registration dossiers it receives to ensure they contain the correct information. Any proposals for further animal toxicity tests to obtain missing information to complete registration dossiers will also be carefully considered at this point by the Agency, before deciding whether to approve the proposed tests. These proposals will be particularly closely scrutinised to make sure they are absolutely necessary, to keep these to a minimum.

Secondly, in order to ensure a harmonised approach, the Agency shall in cooperation with the Member States develop criteria for prioritising substances with a view to further evaluation. Prioritisation shall be on a risk-based approach.

Substances of very high concern (SVHC) may need to be authorised for specific uses. SVHC are likely to fall into the following categories:

1. • Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction category 1 or 2 in accordance with Directive 67/548/EEC;
2. • Substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII of REACH;
3. • Substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII of REACH;
4. • Substances – such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the above criteria for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances meeting the above criteria and which are identified on a case-by-case basis.

There will not be any sort of “blanket” authorisation for a substance to be used generally. Instead, applications for authorisation may be made by companies that register the substances, or by those that use them.

Authorisation decisions will be made by the European Commission advised by the Agency in agreement with the national Competent Authorities, and can be granted in two ways:

This is a direct and unambiguous means of controlling the risks associated with any given hazardous substance. A substance on its own, in a preparation or in an article, which has been restricted shall not be manufactured, placed on the market or used unless it complies with the conditions of that restriction. Restriction will be used when it is felt that action at the European level is needed. Restriction decisions will also be made by the Agency, consulting with EU Member States and others. Restrictions in place already from previous legislation are carried over into REACH.

An important part of chemical management is clear provision of information about any dangerous properties a chemical may have. The classification of different chemicals according to their characteristics (for example those that may cause cancer, or are toxic to the aquatic environment) currently follows an established system. Work is underway to establish a world-wide classification and labelling system over the next few years called the Globally Harmonised System – GHS. REACH has been written with GHS in mind.

The passage of information up and down the supply chain is the key feature of REACH – users should be able to understand what manufacturers and importers know about the dangers involved in using chemicals, and they can also pass information back up the supply chain.

REACH adopts and builds on an existing system for passing information in a structured way down to chemicals users – the Safety Data Sheet. This should accompany materials down through the supply chain, providing the information that users need to ensure chemicals are safely managed. REACH will also allow for information on uses of chemicals to be passed back up the supply chain, so that these can be reflected in the safety data sheets.

Downstream users of chemicals will be obliged to follow any new instructions in the safety data sheets that detail how to manage the risks posed by the chemicals. Such instructions will be known as “exposure scenarios”.

DON’T PANIC

If you need to find which of these tasks apply to you and the details of what you need to do to fulfil these tasks, there is plenty of information available to help. The UK REACH Competent Authority website gives you more information on the areas covered in this leaflet, and on REACH in general. It can be found at:

Visit the European Chemicals Agency website for more detailed information, and to access a useful tool called Navigator which will help you work out where your chemicals fall within REACH. This can be found at:

WHATEVER YOUR BUSINESS IS, FIND OUT MORE TODAY- don’t leave it until it is too late