Compliance with REACH and Biocides legislation continues to present challenges for businesses whether you are based in the EEA and manufacturing or importing, or based outside the EEA and supplying into the EEA.
REACH/biocides audits are an increasing part of the regulatory landscape in the EEA. Whether it is you or one of your customers that is being audited your compliance will be under the spot light. A REACH audit protocol is essential to ensure that key information is assembled quickly and efficiently.
REACH Registration
If you have a registration obligation, your starting point is to ensure your registrations/pre-registrations are held by the correct group company i.e. the company which is the manufacturer or “importer” for REACH purposes. This is not always as straightforward as it sounds. Just because an entity is an importer for tax purposes doesn’t automatically make it an importer under REACH. If your registrations are not in the correct name you are not REACH compliant. It may be possible for you to re-organise your internal supply chain to make one entity the importer into the EEA. Product could then be transferred from the “importer” to other entities in the same group. Alternatively it may be possible to transfer your REACH registrations/pre-registrations through a ‘legal entity change’. This requires careful consideration, to assess whether your situation can qualify as a “legal entity change”, and if so how this should be documented.
Another common problem is incorrectly appointed Only Representatives (“OR”). Many non EEA companies, sourcing products from the Far East, have appointed ORs when they had no right to do so. Only a person established outside the EEA who manufactures a substance on its own or in a mixture, formulates a mixture or produces an article which is then imported into the EEA can appoint an OR.
REACH requires each manufacturer, importer, downstream user and distributor to retain all relevant information to carry out its REACH duties for at least 10 years from the last date of manufacture, import, supply or use of the substance or product. This information has to be made available without delay on request of any EEA regulator in any Member State in which it is established or to ECHA (European Chemicals Agency).
Key considerations include:
- Do you have systems in place to provide this information quickly?
- How competent are your local staff to respond to initial queries from the regulator?
- Who will attend any audit?
- Will your safety data sheets stand up to scrutiny?
Biocides
Whilst the focus has been on REACH compliance, there have been wide ranging changes to the way biocides are regulated in the EEA.
Transitional arrangements apply whilst ECHA and the European Commission consider an active substance (and Product Type) in the Review Programme. During this period the challenge for business is to comply with national law in the Member State where the product containing that active substance is placed on the market. Requirements vary depending where the product is sourced. Your local entity may need its own approval or registration under that national law. From September 2015, a biocidal product cannot be supplied for distribution or use in the EEA unless the active substance supplier or biocidal product supplier is on the approved list in the Product Type applicable to your use. The key is demonstrating someone in your supply chain is listed. Don’t forget that only the active substance in the product is exempt from REACH. Any other ingredients should be checked for REACH compliance.
Non-compliance raises concerns about enforcement by regulators, potential breaches of customer contracts and commercial considerations regarding your ability to supply product in the EEA. As regulators focus more on auditing compliance, and with 2018 looming, whether you are newly affected or a larger group with registrations already in place, now is the right time to revisit your REACH and biocides compliance.
For more information please contact:
Elizabeth Shepherd
Head of Environment
Tel: 0845 497 8215
Intl: +44 161 831 8215
