For many businesses receiving notification that you are to be the subject of a REACH audit is a stressful experience. However, if you seek appropriate legal and technical support and are well prepared it may prove useful.
The starting point for the Inspector will be Article 36 – 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.
Whilst individual members of a group require their own REACH registrations/pre registrations, in practice many companies will have centralised REACH compliance. This approach brings many benefits but it does not absolve a particular subsidiary in a particular EU Member State from complying with the requirements of Article 36.
Often the Inspector will initially request some basic information. It goes without saying that if your people on the ground 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.
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.
Are your representatives speaking the same language as the inspector? Not just literally but in terms of REACH. Businesses may use expressions such as “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.
One of the key areas to focus on is data management – you are obliged to 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 and the content of your SDSs. This encompasses a wide range of data and potentially representatives from different internal groups from sales and purchasing to product stewardship.
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 the group is meeting its Article 36 obligations.
On the positive side, in our experience, regulators are often pragmatic and appreciative of the massive challenges which REACH presents. Valuable feedback can be obtained and then incorporated into your compliance approach going forwards.
For more information please contact:
Elizabeth Shepherd
Head of Environment
Tel: 0845 497 8215
Intl: +44 161 831 8215
elizabethshepherd@eversheds.com
