The years 2010 to 2018 have been key strategic years for many companies that are producing, importing or using chemicals in the EU. However, the implementation of the high impact REACH legislation (and in parallel CLP) still requires companies to prepare and manage a huge numbers of activities after the last REACH registration deadline on May 31, 2018.
Are you affected by REACH?
If you manufacture chemical substances or import them from outside the EU above one tonne per year, you may have registration obligations under REACH. Additionally, if you manufacture or import a product (mixture, article), it may contain substances that need to be registered individually.
You should start preparing for the REACH registrations by analysing the company’s portfolio from the REACH perspective and making a plan for managing the registrations.
It is expected that the registration deadline of 31 May 2018 will be quite different from the two previous ones, in terms of both the number of registrations and the type of registrants. It is expected that up to 70 000 registrations will be prepared for 2018. This is three times more than previously prepared for either of the previous deadlines. Significantly, many more of the registrants are expected to be inexperienced and located outside the chemical sector, and there will be more small and medium-sized enterprises (SMEs) than for the previous registration deadlines.
The new substance information exchange forums (SIEFs) will also be small or even consist of only a single company, while at the same time, there will be less information available on the substances to be registered.
Roadmap for the registration
The preparations for successful registration under REACH can be divided into seven phases:
- Understanding if and how the REACH registration 2018 deadline affects a particular company;
- Finding co-registrants;
- Co-operating with co-registrants;
- Assessing hazards and risks;
- Preparing the registration dossier in IUCLID;
- Submitting the registration dossier in REACH-IT; and
- Keeping the registration up-to-date.
Understanding if and how the REACH registration 2018 deadline affects a particular company;
As a first step in preparing for the REACH 2018 registration, companies need to know whether and how the REACH registration 2018 deadline affects them. Recent studies and events have indicated that the bottlenecks identified by SMEs include:
- a lack of awareness;
- difficulties in accessing information;
- inadequate understanding of cost implication;
- a need for sector specific/tailor-made information; and
- difficulties in approaching ECHA.
Although a vast amount of information is already available, the relevant information is not always easy to find in a manner that is targeted to the roles of the reader under REACH. The aim of this phase is to make sure that companies are aware of and have the information that they need, and that the amount, format and level of complexity of the information is appropriate to the specific situation of the company. Specifically, companies should already at this stage be able to perceive the approximate costs of registration, which requires early communication on cost sharing of both data and joint submission.
When a company has established that it needs to register its substances by the 2018 deadline, the next phase is to find its co-registrants. REACH foresees only one registration per substance, and companies registering the same substance are expected to share their data and to submit their registration jointly. To bring potential registrants of the same substance together, fit-for-purpose IT tools and further guidance on substance sameness will be crucial. To start this phase, companies first need to identify their substance in a consistent manner that is fit for regulatory purposes and can be shared with potential co-registrants. Well-documented, unambiguous substance identification is essential for a solid registration.
Co-operating with co-registrants
At the core of REACH lies the principle that companies registering the same substance should not duplicate tests involving vertebrate animals but instead share the available data. These companies are typically competitors on the European market, but nevertheless they have to come to an agreement on sharing the data to avoid unnecessary animal tests.
Therefore, as a third phase for preparing a registration, once a potential registrant has clearly identified their substance in a way that allows them to comply with the regulatory requirements (see Phase 2), they need to get in contact with other potential and/or existing registrants of the same substance to discuss the need for data and the sharing of available studies in the respective SIEF.
Potential registrants are faced with a number of challenges, which may differ based on what the situation of the SIEF is and the level of involvement the company wishes to have in its SIEF.
- To find a volunteer for the role of lead registrant within a SIEF
- To find a volunteer in a SIEF to perform a missing study
- Data and cost-sharing negotiations and disputes
Assessing hazards and risks
Phase 4 in the registration process concerns the collecting of information on hazardous properties and uses of substance, assessing the resulting exposure, and documenting all this in the registration dossier. The following regulatory, scientific and technical challenges may be encountered by the registrant:
- Collecting information on uses and current conditions of use from the supply chain;
- Understanding the information requirements triggered by the properties, hazards, tonnage and uses of the substance;
- Assessing the amount (coverage) and quality of the hazard information available within the SIEF;
- Developing a strategy to fill any resulting data gaps, taking into account the obligation to use animal testing only as a last resort (e.g. commissioning of new studies or justifying missing information by scientifically solid readacross, data waivers etc.);
- Using these hazard data to arrive at an agreed classification within the SIEF;
- Documenting the hazard data and classification in the registration dossier in a REACH-compliant manner; and
- Where required, carrying out the chemical safety assessment and documenting it in a REACH-compliant chemical safety report.
The 2018 registration deadline will also bring some information requirements that are only applied to phase-in registrations of 1-10 tonnes, and are hence implemented for the first time. These include assessing whether the substance is such that only physico-chemical information on its properties needs to be included in the registration (i.e. whetherthe substance falls into the scope of Annex III or not), and documenting the use and exposure information for substances for which a chemical safety report is not required.
Preparing the registration dossier in IUCLID
After compiling all the information needed, the company has to enter the information in IUCLID. IUCLID is a mandatory format for data submission to ECHA, and IUCLID software, developed by ECHA in cooperation with the OECD, has had an integral role towards the successful practical implementation of REACH. However, REACH registrants have highlighted the complexity of IUCLID as one of the main challenges when registering substances.
Submitting the registration dossier in REACH-IT
In the final phase of the registration, after compiling all the information needed, and having prepared the registration dossier in IUCLID, the company has to send the dossier to ECHA through REACH-IT. REACH-IT will also undergo a revision ahead of the 2018 registration deadline. The identified challenges include e.g. managing own submissions and joining the joint submission.
Keeping the registration up-to-date
Registering a substance under REACH is not a onetime exercise, but the registrants have the obligation to keep their registration dossiers up-to-date. The need for updating the dossier may arise either from a regulatory action, such as dossier or substance evaluation, or spontaneously if e.g. circumstances related to the registration change. An example of the latter is a new use for a substance to be assessed or a change in the tonnage manufactured/imported.
If your company fails to comply with the REACH requirements, it can have a significant impact on you as you may not be using the chemicals safely. National enforcement authorities may also take action against your employer with potential cost implications and may even shut down your production lines.