What to do if you are relying on an upstream Authorisation that only gets a 4 years review period?
Given the experience of some broad upstream applications for Authorisation, like MOCA and the CTAC application covering many hundreds or thousands of downstream users, with complex supply chains and hidden dependencies, what is the next step for companies currently covered by these applications?
Initially when the Authorisation process was starting it was envisaged that the process would be similar to that of REACH registration. Upstream actors would apply and these applications would cover all the uses of their downstream supply chain.
In this way a company that, for example, formulates a mixture would secure its own market while ensuring good function of the internal market to its customers, their customers and their customers’ customers.
Issues, however, arose with this Authorisation application strategy, it became clear quite early in the life of the process that such application, unless very specifically defined, would fall foul of uncertainties in the mind of the authorities. Nevertheless, instead of failing the applications due to the level of uncertainty, it seems that the approach taken was to give short reviews periods of 4 years as well as adding Conditions of Use for approval.
So what should you do if your use has been covered by one of these upstream umbrella applications that has only received either a 4 years review period recommendation from ECHA, or a 4 years review period from the Commission?
Well the first thing to consider is whether it is possible for you to substitute in the given timeframe?
If the answer is Yes, then there is nothing to worry about and you should substitute!
But if the answer is No, then you will need to come up with a strategy to protect your use of the substance. You should make sure, however, that, as a minimum, you implement any Conditions of Use from the upstream application that covers you at the moment.
Some Authorisation strategies that you might consider could be:
- Formulator/re-packager covering specific sectors of interest:
If you formulate, re-formulate or re-package a substance and sell this to your customers who then use it, for example in surface treatment, an application would need to encompass the formulation, re-packaging as well as your customers’ use.
Such a strategy could be structured in a way that reflects the priorities of your company. This could mean that the application focuses on, for example the most important industry segments for you that would maximise the return on investment in applying for Authorisation, i.e. a so-called sector specific group applications.
It is also the most specific type of group application and can reduce the potential uncertainty about granting an application from the decision makers.
A potential drawback is that the upstream supply of a particular substance might not be guaranteed, especially if the Authorisation uses covered are for niche sectors.
In addition, if a company is located in the UK, in order to protect your uses and the uses of your supply chain, we would suggest considering an Authorisation application as a Risk Management Measure. This is because should the UK remain a REACH territory after its exit from the EU, there might not be enough time to begin preparing an application by the time it is known what the UK’s status well be.
- Hope that the current application will be renewed and rely on this to cover your uses:
This could be a risky scenario for your company as you must be able to quickly adapt to a decision by the upstream to not apply.
As the current mood from the authorities around such broad upstream applications is negative it is possible that to re-apply in this manner might be difficult. Especially considering that the ECHA opinions for these types of applications have specified that more detailed and representative information from all members of a supply chain is required; this information being extremely difficult or impossible to collect.
Possible problems with this Authorisation option are that factors such as the non-use scenario, alternatives landscape, exposure and number of companies within the supply chain may differ, company to company and supply chain to supply chain.
Nevertheless, it could be useful to approach the upstream actors to check if they are considering a re-application. Should this be the case it is important to make sure that your use(s) and those of your supply chain are covered. You must also ensure that any Conditions of Use for the original application are in place so that you are actually covered.
- Rely on your downstream customers applying:
Downstream end user applications for Authorisation remove some levels of uncertainty that can be present in broad upstream applications. Even if a group of downstream companies apply together the level of uncertainty is reduced compared to broad upstream applications covering multiple sectors, all with potentially different alternatives landscapes, substitution timeframes and non-use scenarios.
Ultimately this would be the most specific type of application, however, it can limit your company’s market if not all its customers are involved in the consortium.
Furthermore, only the named applicants would be covered by a possible Authorisation from the downstream in this way, meaning that new/potential customers in the EU would not be covered and they would require their own Authorisation for use your products.
Should your upstream Authorisation holder not re-apply, your uses will no longer be covered which would have the consequence of meaning that your uses of a substance or formulation, and those of your customers, will no longer be legal in the EU.
Given the complexity of such broad upstream applications it is probable that at least some of these Authorisation holders will decide not to submit a review for their current Authorisation applications.
Furthermore, if you are considered a Downstream user covered by an upstream Authorisation, any application by you will be considered an “Initial” application and not a review of a current application.
This means that if the Latest Application Date has already passed, you will NOT be covered by any “Transitional Arrangements” that an Authorisation holder might benefit from if they submit a review report 18 months before the end of the “review period” of their current application.
With many potential pitfalls, we would advise that companies commence actions to protect their use(s) of SVHC substances with 4 years review period opinions from ECHA as soon as possible and by early 2019, at the latest to ensure that a decision comes from the European Commission before the end of the upstream application review period.