The REACH regulation entered into force on 1st June 2007, and impacts all manufacturers and importers of chemicals as well as downstream users (e.g. formulators, article producers, end users of chemicals), distributors and retailers in the EU. This includes individual substances, substances in a preparation (a mixture of substances) or intentionally released from articles (finished manufactured goods) at or above 1 tonne. It will affect most businesses in Ireland in some way.
REACH stands for Registration, Restriction, Evaluation and Authorisation of CHemicals. Registration with the European Chemicals Agency (ECHA) is required for all manufacturers or importers of chemicals in the EU on a phased basis (1000 tonnes+/annum and CMR (completed), 100-1000 tonnes/annum (finalising) and 1-100 tonnes/annum (deadline 31st May 2018)). Chemicals which are not yet due for registration must have been pre-registered. Both pre-registration and registration dossiers are created using a special software called IUCLID.
Authorisation refer to Substances of Very High Concern (SVHC) drawn from a ‘Candidate List’ only whereby special authorisations are required to continue their usage based on appropriate risk management measures. Restrictions may also be placed on such substances and the longer-term emphasis is on substituting them with less hazardous chemicals.
Evaluation includes ‘compliance checking’ on submitted dossiers, ‘dossier’ evaluation for substances registered at 100 tonnes or more to approve further testing to obtain missing information and ‘substance’ evaluation for substances which may need regulatory action.
What is the purpose of REACH?
REACH aims to protect human health and the environment, enhance EU chemical industry competitiveness, allow free movement of substances on the EU market and reduce animal testing by promoting alternative methods of dangerous substance assessment. The different types of companies affected have specific compliance responsibilities that need to be understood and managed to ensure legal compliance.
REACH and CLP
The REACH regulation is also reinforced by the Classification, Labelling and Packaging (CLP) Regulation (EC) No. 1272/2008 which updates hazardous product labelling and Safety Data Sheet (SDS) information requirements. CLP facilitates global trade and improves worker and consumer safety by implementing the United Nations’ Globally Harmonised System (GHS) for the Classification and Labelling of Chemicals which will ultimately be implemented worldwide. All single substances must have been notified to ECHA since 2010 and be carrying the new hazard pictograms (as must the SDS). Manufacturers and importers of mixtures of chemicals have until June 2015 to notify ECHA and begin using the new pictograms.
How does it impact you?
If you produce or import between 1 to 100 tonnes per year of substances, you have until 31st May 2018 to complete your registration. Sounds a long time enough, but as it concerns low volume substances, many SMEs will fall into this range bracket and will have to complete the registration process. It is recommended to start preparing for the registration process now as it takes a lot of time to compile a registration dossier so don’t underestimate the work involved!
4 Tips to prepare for REACH
- Know your role in the supply chain: Are you a manufacturer? Importer? Downstream user? Article producer? Different responsibilities apply to each different category.
- Identify and compile an inventory: Inventory every chemical that comes into, is part of, or goes out of the business – what feedstocks, 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.
- 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.
- 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.
Want to find out more? Just call us on 087 9678 372. We also provide REACH and CLP awareness course to help you understand the implications of REACH and CLP Regulations for your business, what actions you need to take (including reclassification of substances and mixtures), and be able to effectively communicate and share correct information with your customers and suppliers.
HSA: Example of new hazard label