Hi Whitney.
I hate to say it this way but if you are just now starting to implement a plan to deal with REACH you are about 7 years late in getting off the ground. Simple answer to your general question is, as it almost always seems to be, "it depends".
However, let me try to give you some ideas as to how we tried to manage it. As for your internal team, your best situation would be to have as wide a cross-functional team as possible without making the team unwieldy. I mean you really need to have input from R&D, regulatory, EHS, quality, purchasing and anyone else involved in dealing with, using, or specifying chemicals to be used in your facilities. Optimally, in my opinion, your team should be between 5-7 people because much more than that causes it to become a "group-think tank" and fewer means that (1) you don't have all the interested stakeholders at the table; (2) you don't necessarily have all the correct expertise at the table; and (3) your group is too small to make a difference and you might as well try to do this alone - in my opinion not a reasonable possibility.
As to gathering data, you really needed to be doing that months (or even years) ago depending on the number of chemical entities you currently purchase and send to the EU or use within the EU.
Key here is to remember that the REACH Directive doesn't care how many trade names or mixtures you use - the determining factor is the CAS number(s) assigned to the individual chemicals. So if you have a water, glycerin, chemical X blend, you actually will be required to track three separate chemicals every time you use that blend and determine if any combination of these breech the 1 metric ton threshold requiring reporting/registering in the EU.
Second important point here is that REACH only applies to EU substances. So based on the fact that your signature looks to be from the US, it would only apply to the amount of each chemical entity that is exported to the EU.
Third point - REACH is calculated according to the individual company that imports the chemical entity in to the EU - so if you sell through multiple distributors, you would potentially be able to avoid some of the registrations (assuming these are truly independent distributors and not subsidiaries or somehow connected either to each other or your company) because each importer is allowed up to 1 metric ton before registration requirements impact.
Fourth point - if you have the same chemical entity in multiple products or solutions or whatever you are selling, you need to aggregate the total amount of the CAS number being exported to each distributor in the EU (see point 3). You also need to understand that the "importer" is generally thought to be the person/company/entity that pays the customs duty or provides the necessary information for the chemical entity to clear customs in the EU.
As for training and communication - you are really going to need to work really hard with your teams both internally and your user teams externally as well as any distribution points. The communication needs to start immediately to explain to these people what your plan is for managing REACH and the questions that will be coming up very shortly. If I remember correctly you only have about 5 - 6 months left in the "honeymoon" period where if you pre-registered the substances you can continue to ship into the EU if you aren't over 100 metric tons exported to the EU to any one distributor. Next, you will need to be prepared to coordinate with your customers (especially in the EU) about your plan to ensure you have all of the necessary items covered either through an "only representative" (a concept in the EU where a single entity can manage all of your EU imports for you - for a fee and a need to know a lot about your individual products and potentially the customers in the EU - a story for another day - yell if you need more info on this point!) or through your distributors or your own company if they are going to take formal responsibility for the imports into the EU. The folks in the EU are not going to be able to get the chemicals in the near future from you if you are not registered and go over the 1 metric ton limit. Finally, I hate to inform you of this point but, it is now outside of the "late pre-registration" period for adding your chemical to the pre-registration lists. This means that you are essentially going to have to register every one of your materials that on average over the past 3 years have been imported into the EU at an average of 1 metric ton or more.
Last point - remember that REACH is a law that "requires" animal data but the EU is a non-animal testing jurisdiction. So if you don't have the necessary data in your own files, it is likely you will need to "buy in" to a consortium that already has the data and has registered the substance. Key point here is that unlike the US where if your chemical is on TSCA you can freely sell the chemical in the US, in the EU the requirement is that the chemical is registered and that you are on the list of registrants. So be prepared if you don't have necessary data to comply with the requirements to be purchasing access to that data from other companies in the consortium.
Sorry for the length of this but the questions involve some rather significant issues that you will face in the near future. Please feel free to reach out to me if you have any further questions on these points!
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Victor Mencarelli
Director Regulatory Affairs
United States
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Original Message:
Sent: 30-Mar-2018 06:30
From: Whitney Davis
Subject: REACH Compliance Project Plan
I am in search of a project plan or template for the implementation of our REACH Compliance Project.
I am using a 3rd party for the data collection and services. I am most interested in the internal team activity pertaining to the Kick Off, internal team selection, ongoing communication plan and cadence, training plan and gathering of internal data to provide the 3rd party solution.
Any help or examples would be greatly appreciated!
Whitney Davis
Global Regulatory Affairs Specialist
Laboratory Products Division
Thermo Fisher Scientific
401 Millcreek Road | Marietta, OH 45750
Tel: +1 (740) - 568-5798 | Mobile: +1 (304) 893-4442 | Fax: +1 (740) -376-2879
whitney.davis@thermofisher.com | www.thermofisher.com
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