What is REACH?

REACH is a new European Union regulation covering the Registration, Evaluation, Authorisation and Restriction of Chemicals.

It was brought into force on the 1st June 2007 and amalgamates over 40 pieces of existing European Directives and Regulations into a single system.

REACH has been described as the most complex piece of legislation within the European Unions history.

The Aims of REACH are as follows:

• To provide a high level of protection to the environment and human health from the use of chemicals.
• To make manufacturers and importers of chemicals responsible for understanding and managing the risks associated with their use by providing safety information that will be passed down the supply chain.  
• To maintain and enhance the innovation and competitiveness of the EU chemical industry as a whole.
• To allow the free movement of substances on the EU market.
• To promote non-animal testing by providing alternative methods for the assessment of hazardous properties within certain substances.
• To be fully integrated with international efforts whilst conforming to the EU international obligations under the WTO.

How REACH will work

REACH consists of four main elements:

1. Registration

A major component of REACH is the requirement for manufacturers or importers of substances above 1 tonne per company per year to be registered with a central European Chemicals Agency (ECHA). This will cover approximately 30,000 substances in total, and be phased over 11 years (2007-1018).  Companies who do not register their substances will no longer be able to manufacture or supply them legally, i.e. “no data, no market.

The regulation requires manufacturers and importers to submit: a technical dossier, for substances in quantities of 1 tonne or more; and a chemical safety report (CSR) for substances in quantities of 10 tonnes or more.

Substances already being supplied or manufactured can be pre-registered by submitting a brief set of information to the ECHA from 1 June until 1 December 2008. Although pre-registration is not a legal requirement of REACH, it is nonetheless recommended by the UK Competent Authority.

2. Evaluation

Dossiers submitted in support of registration will then be subjected to evaluation by REACH as follows:

Compliance Checking – involving the checking of information provided by the industry.

Dossier Evaluation – for those substances registered at the highest tonnage levels i.e. greater than 100 tonnes/per annum) a proposal must be made by the registrant detailing those animal tests they think are required from the list of standard tests. The ECHA will evaluate these tests to make sure no unnecessary animal testing occurs.

Substance evaluation – for substances that have been prioritised for potential regulatory action due to their hazardous properties.

3. Authorisation

For substances of very high concern (e.g. PBT’s and vBvP’s) authorisation will be required for their use and placing on the market. The ECHA will publish a list of these substances by 1 June 2009. Decisions for authorisation will ultimately be made by the European Commission (EC).

4. Restrictions

A substance that poses an unacceptable risk to the environment or human health can be restricted. Restrictions can range in severity; i.e. not being allowed to supply the general public, or a total ban. Proposals for restriction will be prepared by Member States or by the ECHA on behalf of the EC.

Registration requirements for lime products

Technically, lime products are regarded as phase-in-substances (a substance listed in the European Inventory of Existing Chemical Substances) and therefore must be registered. These include:

• Calcium Oxide (CaO), also known as lime, quicklime or burnt lime.
• Calcium Magnesium Oxide (CaO. MgO), also known as dolime, dolomitic lime, dolomitic quick lime or burnt dolomite.
• Calcium Dihydroxide (Ca (OH)₂), also known as hydrated lime or calcium hydroxide.
• Calcium Magnesium Tetrahydroxide (Ca (OH)₂.Mg (OH)₂), also known as dolomitic hydrated lime or calcium magnesium hydroxide.
• Calcium Carbonate Synthetic (PCC), also known as precipitated calcium carbonate.

However, there are a number of substances that are exempt from the obligations to register. Annex IV of the Regulation lists substances for which sufficient information is available to consider them as minimal risk to human health and/or the environment. This includes: Calcium Carbonate (CaCO₃) also known as limestone. In addition, Annex V contains substances occurring in nature such as minerals that are not chemically modified, including dolomite (CaCO₃.MgCO₃).

Key deadlines

Registration deadlines generally vary depending on the substance and quantity of the chemical in question.

Key deadlines are as follows:

• 1 December 2008: Deadline for all companies intending to register a substance to notify their intention to the EU chemicals agency (also known as ‘pre-registration’)
• 1 December 2010: Registration deadline for manufacturers/importers supplying a substance above 1,000 tonnes per year, or CMR cat. 1 or 2 substance above 1 tonne per year, or an R50-53 substance above 100 tonnes per year.
• 1 June 2013: Registration deadline for manufacturers/importers supplying a substance above 100 tonnes per year.
• 1 June 2018: Registration deadline for manufacturers/importers supplying a substance above 1 tonne per year.

Links to relevant legislation

Regulation (EC) No 1907/2006 is the central act of the new European chemicals policy, and is often referred to as the "REACH Regulation". It also provides that, within 18 months from the entry into force, the Commission shall carry out a review of several Annexes of the Regulation. Following the subsequent reviews, the Commission will prepare amendments to the relevant Annexes to take into account the results of the reviews.                          

Directive 2006/121/EC contains technical adaptations of Directive 67/548/EEC that are necessary in the light of the new REACH Regulation (Directive 67/548 concerns the classification, packaging and labeling of dangerous substances and applies in parallel with REACH).

Any other useful information

Downstream users

Lime Companies may also act as downstream users (DU) within the REACH regulation. This concept refers to anyone who uses the substance, either on its own or in a preparation, in the course of his industrial or professional activities. They are specifically required to consider the safety of their uses of substances, based primarily on the information received from their suppliers, and to apply appropriate risk management measures. DU will need to communicate effectively with their suppliers, to get the information they need in the safety data sheet (SDS) supplied to them.

Joint registration for lime companies

In cases where a substance is manufactured or imported by more than one company, they are required by the Regulation to submit certain information together. Lime products are often manufactured by a number of companies, and as a result are subject to a joint submission of data.

Business specific (e.g. company name) and business sensitive (e.g. how it is used) information is submitted individually. Companies then work together to get an assessment on information sharing through a Substance Information Exchange Forum (SIEF). Companies who submit joint registrations via a SIEF benefit from a reduced registration fee.

CA REACH helpdesk contact numbers

For any more information or technical advice regarding the REACH Regulation, please contact the CA REACH Helpdesk on 0845 408 9575, or alternatively email ukreachca@hse.gsi.gov.uk.