REACH Regulations 2013 – Chemical Registration
Are you prepared for the 2013 chemicals registration?
The current REACH regulations are now up for review in 2013 and there are likely to be changes to the register of substances to keep pace with new products and processes in the chemicals industry. Here we consider the implications for chemical manufacturers, importers and downstream users.
The European Regulation for the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) came into force on 1 June 2007, replacing about 40 items of earlier legislation. Its primary purpose is to protect human health and the environment from the potential risks associated with the use of chemicals, while enhancing the competitiveness of the EU chemicals industry.
REACH is a major component of health, safety and environmental legislation and the distribution and management of chemicals across the supply chain has improved significantly in all Member States since the regulation was introduced. But a recent survey from the manufacturers’ organisation EEF suggests there is still a lack of awareness of the scope and significance of REACH in many supply chain companies, particularly among SMEs.
Not just the chemical industry…
It is a common misconception that REACH regulations only apply to the chemicals industry: this is not the case. Manufacturers, importers, assemblers and users of chemical substances and articles in the supply chain must take account of their legal obligations that apply to their organisations. Under the regulation, manufacturers, importers and all downstream users are responsible for identifying, assessing and managing the risks posed by chemicals and for providing appropriate safety information to their uses.
The European Chemicals Agency (ECHA), based in Helsinki, is the EU administrative centre for REACH with responsibility for implementing and monitoring the system. ECHA’s primary role is to help companies comply with the legislation, address chemicals of concern and provide information on chemicals.
Through REACH, companies are required to provide ECHA with information and data on the hazards, the risks and the safe use of all chemicals that are manufactured, sold or used in quantities exceeding one tonne per year. This information is registered with ECHA and certain of it made freely available on its central website which helps minimise the number of tests required. Routes of exposure have to be identified, and recommended risk management measures must be given to downstream users. To date, the register contains over 5,000 hazardous and most commonly used chemical substances.
The REACH Enforcement Regulations were introduced in the UK in 2008. The Department for Environment, Food and Rural Affairs (Defra) has responsibility for policy and developed the enforcement regime working in conjunction with the Department for Business, Innovations & Skills (BIS) and the devolved administrations for Scotland, Wales and Northern Ireland. In the UK, the Competent Authority is hosted by the Health and Safety Executive, working with the Environment Agency and other government departments.
The HSE has far-reaching responsibilities to enforce compliance, evaluate selected prioritised substances, identify SVHCs for authorisation and propose restrictions.
Substance of Very High Concern (SVHCs)
One of the key elements of REACH is to identify substances of very high concern (SVHCs), which are hazards with serious consequences for human health or the environment.
SVHCs are presented in article 57 of the REACH regulation and are defined as having carcinogenic or mutagenic characteristics or are toxic for reproduction or bioaccumulative. A process exists to require that certain of these substances are authorised before they can be placed on the market. Those that fail the authorisation process may be banned. However, an additional 54 new SVHCs were added to the Candidate List (ie the list from which substances are prioritised for consideration to be included in the list of substances subject to authorisation) following authorisation in December 2012; the total has now risen to 138 SVHCs.
The Classification, Labelling and Packaging of Substances and Mixtures Regulation (CLP) introduced a generic classification and labelling regime for hazardous chemicals.
CLP came into legal effect in all EU Member States in January 2009 and was introduced in response to an international agreement for a UN-based Globally Harmonized System (GHS). The transitional period for implementing CLP will be completed in 2015. This is to give suppliers and users of chemicals time to change from the current Dangerous Substances and Dangerous Preparations Directives 67/548/EEC and 1999/45/EC. The transitional arrangements for CLP are also being handled by the HSE, and the current Chemicals (Hazard Information and Packaging for Supply) Regulations 2009 (CHIP 4) have been aligned with the transitional arrangements in the CLP Regulations.
Most businesses in the UK will be affected in some way by REACH. The HSE advises all manufacturers, importers and downstream uses to establish a REACH management regime to avoid unnecessary risks to business.
Stage 1 – Compile an inventory of all chemicals used in the business
This involves establishing a record of all the substances and preparations that involve chemicals, including essential information such as the name of the chemicals and the percentage in preparation. Quantify the materials to determine tonnage used per year. The inventory provides a clear picture of what is used and an opportunity to consider alternatives or substitutes if, for example, the REACH regulation should have a bearing on the supply of the substances.
Stage 2 – Prioritise the value of the substances in the inventory
Some substances may be vital to your organisation’s products or services – consider what would happen if these substances were affected by REACH. Consider the risk if supplies are withdrawn from the market. Can you guarantee continued supply? Are there alternatives? What happens if the cost of the substances or products (articles) increases because of additional regulations?
Stage 3 – Maintain good relations and communications with suppliers and users
This works both ways – upstream with suppliers and downstream with customers. The whole supply chain can be affected by changes to a substance’s REACH status. Confirm with your supplier that they are aware of REACH and comply with requirements. Ensure someone in your organisation is the main REACH contact and maintain regular contact with suppliers and customers.
Safety Data Sheets (SDS)
Key aspects of REACH include traceability and accountability of chemical substances. Safety data sheets (SDS) are used to ensure manufacturers and importers communicate the right information along the supply chain to allow safe use of their substances or mixtures. Guidance on SDS and further details of how best to prepare for REACH are available from a dedicated HSE site.
Deadlines and concerns
REACH has been in force for over five years. Over 3,500 phase-in substances were first registered in 2010 and the list is growing. The second deadline for industry to register all phase-in substances manufactured or imported in the EU at or above 100 tonnes a year is 31st May 2013, and over 3,500 more substances are expected to be registered. The deadline for registration of substances manufactured or imported at >
1 tonne per year is 31st May 2018.
The REACH regulation has successfully harmonised the protocol for the safe management of chemical substances used or imported into the EU. ECHA expects the process of registration to become more uniform and easier, based on lessons learned so far. But there are still worries that many small manufacturers and other downstream users of chemicals are unaware of their legal obligations. There are concerns too that some highly toxic materials may be slipping through the net, such as some nanomaterials, where volumes and weights can be measured in kilogrammes rather than hundreds of tonnes and therefore fall well below the current EU levels set for registration. Classification, labelling and SDS will, of course, be required for any of these that are hazardous.