Qué debe considerar para su empresa
Demonstrating the safe use of your substance in a registration dossier requires a significant investment of time, money and expertise.
You will need to have dialogue and, normally, contractual arrangements with co-registrant companies to agree on how to share the cost of the necessary hazard data and related work on the risk assessment. You will also need to agree on how to present this information in the registration dossier.
Remember that with registration you are able to show to your customers that you are a responsible supplier who has contributed to the safer use of chemicals.
Know your customers' needs
The substance you manufacture or import may be crucial for your customers. Inform your customers about your registration intentions early, so you can understand the demand for the substance.
Consider the regulatory forecast for your substance
Do the intrinsic properties of your substance mean that it may cause a concern for human health or the environment? If yes, it might be on its way to being phased out under other REACH processes in the near future.
Decide on the type of registration
Do you plan to register for 1-10 tonnes a year or 10-100 tonnes a year? Or is your registration for intermediate uses only? The data required in your registration is very different according to the tonnage. This will of course affect costs.
Collect and assess the available information on your substance
Based on your registration type, you need to collect the information on your substance and its effects to human health and the environment. This is expert work. Do you have the expertise in house or do you need to outsource this?
Compile you own registration dossier
Although most of the information is expected to be submitted jointly with other companies, certain information is required from each registrant individually. You need to decide whether to outsource this work or do this in house.
REACH registration requires payment of a fee to ECHA, varying from 65 to 4 674 euros for registrations between 1 to 100 tonnes a year depending on your company size and registration type.
Small and medium-sized companies benefit from reduced registration fees. You need to carefully check if you fall into this category.
Map the uses and conditions of use for your substance for your own uses and uses in your supply chain
Do you have uses that you wish to keep confidential? If it concerns a substance that you will register in the tonnage band of 10 tonnes a year or more, you will need to carry out a chemical safety assessment for that substance by yourself.
Do you know what the key uses of your substance are for your customers? What uses do you want to support in your registration?
Do you know your customers and your suppliers well? If you do, you can probably count on them to help you collect information for your registration. If not, you need to reserve time and resources to dig out the necessary data.
Do you belong to a sector organisation? If yes, have they organised the work for collecting information on uses? Otherwise, you may need to compile this information yourself.
Keep the registration up-to-date
After registering, you need to keep your registrations up-to-date. For example, new uses need to be assessed to prove that they are safe and included in the registration. Authorities may also ask for updates. Reserve resources for preparing the updates.
Find your co-registrants
If you have co-registrants for your substance, you are expected to share the costs of registration with them. This will decrease your individual costs. Joint registration also helps to prevent work from being duplicated.
You may also be the only one registering the substance. While this means no resources are spent on cooperating with others, all the work for the registration falls on you.
Kick off the cooperation with your co-registrants
Co-registrants need to agree on how they work together. This is most effortless if your co-registrants have already registered.
If you start organising yourself with your co-registrants from scratch, you need to invest time and resources in the start-up phase for the cooperation.
Interact with your co-registrants
You need to agree on the content of the joint registration with your co-registrants. This means that you need to invest in collaborative activities such as meetings or web conferences.
Assess information that you have as a group of co-registrants
Based on your registration type and the information identified by your co-registrants, you need to consider both the reliability and the relevance of the information. This is expert work. You need to decide with your co-registrants whether or not to outsource this task.
Negotiate on sharing data
Owners of data are entitled to compensation for it. You need to reserve resources for these negotiations.
Get the missing information for your registration
If you or your co-registrants don't have all the data required for the registration, you need to decide on the best way forward to fill in the data gaps. Remember that tests on vertebrate animals should only be used as a last resort. This is expert work. You need to decide with your co-registrants whether or not to outsource this task.
Compile the joint registration dossier
The registration information needs to be entered into a registration dossier field-by-field. You need to decide with your co-registrants whether this task should be outsourced.
Keep your registration up-to-date
After registering, you also need to keep the joint part of your registrations up-to-date. In addition, authorities may request updates. Reserve resources for preparing the updates, whether they are required by ECHA or to reflect changes in your uses, tonnage, or additional studies you may have got.
Assess how many substances you will register and make a plan to spread the work over time
Preparing a registration can take a year. If no existing information is available on the hazards, it may even take longer. If you have several substances to register, make a clear project plan so that you can manage the workload.
When you prioritise, consider which of your substances are already registered, for which you will be a co-registrant, and for which you want to be the lead registrant.
If you have several substances to register, go through the whole registration process with one substance as early as possible. This way you will get to know the process and the tools and be able to assess the remaining workload.
Streamline your internal processes for REACH registration
Do your colleagues know about REACH and what it means to your company? In the long run, it pays off to have an internal tracking system for REACH issues. You need to involve, for example, invoicing, sales and colleagues drafting the safety data sheets.
Plan how you can track the substance volumes in your company. For one substance you may, for example, have imports from different countries, intermediate and non-intermediate uses, or imports of substance as such and in mixtures - all of these will affect your duties.
Anticipate the need to revise your safety data sheets
New information gathered during the registration process may lead to changes, for example, in the classification of the substance, and the safety data sheets need to be updated. When the safety data sheet is updated you need to attach exposure scenarios for hazardous substances registered at or above 10 tonnes a year.