REACH the European Chemicals Regulation (1907/2006) imposes obligations on suppliers, manufacturers, importers, distributors and those further down the supply chain. The main obligations affect substances (individually or contained within a mixture) however in certain circumstances obligations also affect products.
How prepared are you for a REACH audit in the EEA? Receiving notification (sometimes at relatively short notice) that one of your operations in the EEA is the subject of a REACH audit can be stressful. Preparation is key to maximise your chances of avoiding enforcement. It should also make your compliance more robust going forwards.
The starting point for the Inspector will be Article 36 of REACH – the obligation on each manufacturer, importer, downstream user and distributor to “assemble and keep available” all the information he requires to carry out his duties under REACH for at least 10 years after he last manufactured, imported, supplied or used the substance. This is a relatively onerous obligation, and it follows that it can be time/resource intensive for information to be put together to respond to the Inspector’s questions;
Each individual member of a group which manufactures chemical substances in or imports them into the EEA must have its own REACH registrations/pre registrations. However, in practice you may have organised your supply chain so as to have centralised REACH compliance. This approach brings many benefits but it does not absolve a particular group member in a particular EEA Member State from complying with the requirements of Article 36 by having all relevant information to hand.
Often the Inspector will initially request some basic information. It goes without saying that if your local colleagues can respond knowledgeably about REACH a good impression is created and potentially a site audit may be avoided. However the converse is also true – if those responding to the initial request display little or no knowledge then a site audit is almost inevitable. Another concern is that your local colleagues may not realise the significance of the Inspector’s requests and not respond in a timely way – delay at the outset leaves even less time in which to gather the information needed.
Decide early on who should attend the audit. If you have a centralised REACH/ chemical compliance function they will be required. A presence from head office and involving external advisors can demonstrate the importance you are placing on the audit and compliance generally.
Do your representatives speak the same language as the Inspector? Not just literally but in terms of REACH. Businesses may use expressions such as “import”, “manufacturer” “intermediate” “polymer” in the general sense of the word rather than in a REACH specific context. Misuse of key REACH terms creates a bad impression.
Different Member States have different priorities – do your research on the particular Inspector. Don’t assume that what you did in one Member State will necessarily satisfy a different regulator in another. However, don’t be surprised if issues which were identified in one Member State are picked up again as Inspectors do talk to each other.
A key area to focus on is data management – you must keep track of all of the substances you manufacture or import, and those benefitting from an Only Representative arrangement. The inspector may also be interested in how you justify the classification of substances, the labelling of your products, the content of your SDS and eSDS and whether you supply or use biocides. This encompasses a wide range of data and potentially representatives from different internal groups from sales and purchasing to product stewardship. Legal and technical support can pay dividends by ensuring not only that any concerns identified are corrected to the fullest extent pre-audit, but also that information is presented to the Inspector in the best possible way.
If you have centralised your REACH compliance function it is key to ensure that you communicate relevant information to the people on the ground, wherever they are based, to demonstrate that each member of your group is meeting its Article 36 obligations.
Customers may also request information in order to respond to their own REACH audit. They may report your inability/failure to respond fully in a timely manner in order to explain why they are unable to provide the information requested. The Inspector may then target your own operations for audit.
On the positive side, in our experience, regulators in the EEA are often pragmatic and appreciative of the massive challenges which REACH presents. Valuable feedback can be obtained and then incorporated into your ongoing compliance approach. Customers are often grateful for any support provided which can strengthen relationships. Responding fully and in a timely manner to customer audits can also reduce the risk of being a target for future REACH inspections.
A version of this article first appeared in Chemicals Northwest Elements Magazine REACH Focus April 2015.