REACH has been a dot on the horizon for some companies, while others have undertaken big investments in outcomplying others. In any event, I see in practice that companies have different senses of urgency when it comes to REACH compliance. I have the feeling that this is no different in the medical devices industry, while REACH applies to the medical devices industry more or less as it does to all other industries, except that in certain cases there is an exemption for the obligation to provide information about the substances throughout the supply chain. For a more precise discussion about the scope of REACH for medical devices, you can read my annotation of the first case at the European Court regarding REACH (in Dutch). It also discusses how REACH applies to medicinal products, which is convenient if your company happens to sell combination products or also sells medicinal products.
The first REACH deadline is now around the corner: 30 November 2010. Another important chemical substances related deadline expires on 3 January 2011 (notification on the classification and labeling of substances used in products to ECHA, the European Chemicals Agency, as required by the EU CLP Regulation ( Classification, Labeling and Packaging of substances and mixtures)). More about that in another post on this blog at a later date.
So, what happens on 30 November? The phase-in registration deadine ends for all EU/EEA manufacturers and importers of pre-registered substances in annual volumes of: (a) 1000 tons or more; (b) 100 tons or more if the substances are classified as very toxic to aquatic organisms that may cause long-term adverse effects in the aquatic environment (R50/53); or (c) one ton or more if the substances are classified as Cat. 1 or 2 carcinogens, mutagens, or toxic to reproduction substances (“CMRs”). For other applicable substances, the deadlines for registration are 31 May 2013 and 31 May 2018, as you can see in this nice overview I copied from on of ECHA’s guidance documents.
What is the consequence of the deadline expiring? Bad news: it is prohibited to manufacture, import and/or market substances subject to this registration deadline in the EU/EEA as of 1 December 2010 if they have not been registered. The prohibition does not only concern substances, but also the finished products of which they form part, such as medical devices. This can of course be severely disruptive for your business. A manufacturer of medical devices therefore should already have done due diligence on its suppliers of component and substances to be sure that the substances in them had been registered in time to avoid disruption of its own supply chain. In case of uncertainty about whether the suppliers have done their REACH homework and registered the substance also for the use of the medical devices manufacturer, the manufacturer can take things into his own hand. The manufacturer can choose to submit a registration to ECHA himself, even if that is incomplete, to make the deadline and continue operations without contravening the law. He can work on completing the dossier in the period that it will take ECHA to find out that the dossier is incomplete plus the reasonable period ECHA has to give to complete it. Furthermore the ECHA decision can be challenged at the EU General Court, which will buy the manufacturer even more time in which it can continue to supply the market.
Remember, REACH has been dubbed to be the most complicated piece of EU legislation ever and incredibly difficult to apply. So, are you sure your company has everything in order? The EU is ever more working on coordinating REACH enforcement by the member states’ authorities and penalties from non-compliance can be criminal sanctions or administrative sanctions, depending on the member state concerned. The fines are stellar: for example up to 55 million Euros in Belgium and even no limit in the UK, according to the European Commission’s report on enforcement of REACH that provides a nice overview of what is going on in REACH enforcement. It’s like with the joke about the two guys being chased by the lion: maybe you can’t outrun the lion, but you can avoid being caught by it if you outrun the other guy. Time to start outcomplying your competitors, because the resources of the authorities are finite and they normally go for the most visible targets.
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