A decade of REACH - Five things we’ve learned about managing REACH dossier updates

More than ten years on from the implementation of the EU’s REACH regulation, NiPERA’s Tara Lyons-Darden looks back and shares some of the learnings and the challenges of maintaining REACH dossiers from the perspective of the Nickel REACH Consortia.

When it was launched in 2007, one of the main purposes of the EU REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation was to assemble a database of relevant information on the physical properties, toxicity, manufacture and use of chemicals imported or manufactured in the EU above one tonne per year, with an overall objective of ensuring that chemicals can be manufactured and used safely.

The main aims of REACH are to ensure a high level of protection for human health and the environment, including the promotion of alternative test methods, as well as the free circulation of substances on the internal market and the enhancement of competitiveness and innovation.

European Commission

To ensure continued EU market access, registration of the chemical substances with the European Chemicals Agency (ECHA) was required with the initial deadline of 2010 for the most stringently classified and high tonnage chemicals.

Over the last 10 years, the Nickel REACH Consortia has continuously enhanced and strengthened the quality of the joint registration dossiers for the 13 nickel substances that it covers in its agreements. This is in line with the REACH obligations to constantly improve registration dossiers by evaluating new scientific developments and/or new available information.

Most of these dossiers have been updated every year since 2010. The updates include new or revised compositions, classifications, toxicity data, and exposure assessments.

Over the years, ECHA has introduced numerous initiatives involving additional updates based on new or updated guidance documents (e.g., the Read-Across Assessment Framework), recommendations, amendments to the Regulation, and cooperative programmes, such as the recent Metals and Inorganic Sectoral Approach (MISA). Here we take a look back and share our top five tips learned over the last ten years of regular annual updates of the nickel REACH registration dossiers.


Get organized - Implement a regular process

This sounds very straightforward but with complex files such as REACH dossiers, we learned early on that it is very important to prepare a list of all tasks that need to be done for your planned update. Determine the cost, time, and human resources needed to accomplish the tasks within your scheduled timeframe. Assign a person and deadline for each task identified. Be sure to build in time for internal review of the completed tasks. This step should also include a regular process, based on the timing specified in the recently published “Implementing Regulation on Dossier Updates” (EU/2020/1435), for how and when new information is received, evaluated, and incorporated into your REACH update.


Start early - Be proactive

As soon as new requirements apply or new guidance is available, start looking at how to implement them into your dossiers, possibly in several phases over time. Do not wait for regulatory or enforcement pressure and strive to continuously improve your dossiers. Always think one to two years beyond your current plans for updating and proactively prepare for new regulatory trends or upcoming guidance. Keep a running list of areas within the dossiers to be updated regularly as well as any new or updated issue-specific guidance or recommendations.


Work together – Communicate clearly and regularly with key stakeholders

REACH dossiers can be large and complex, including an extensive database of chemical properties, toxicological information, use and exposure information as well as risk management. This requires expertise across these various subject areas and emphasizes the importance of teamwork. Establish a core team that makes sure the tasks are completed and clearly communicates with the dossier registrants and downstream users, as well as external consultants, to ensure that the information is accurate and correctly incorporated. Regular communication and collaboration within and between all internal and external parties is imperative to keep the updates on track.


Get clarification – Interact with ECHA

Do not hesitate to contact ECHA for guidance or suggestions regarding how to address any uncertainties or particular issues.

We have found that the ECHA Helpdesk, IUCLID LinkedIn page, ECHA webinars, detailed discussions with ECHA through MISA workshops, and even consortia- or registrant-initiated teleconferences with ECHA representatives have all been helpful resources to discuss certain aspects of our dossiers.


Provide details – Be thorough

Always include details and justifications for your approach to various issues, such as grouping and classification modifications. To the extent possible, do not leave anything open to interpretation. The goal is to be as thorough and transparent as possible.

Our 13 Nickel REACH dossiers consist of 13 IUCLID files (each over 23 MB) and 13 Chemical Safety Reports (each over 1,000 pages) with a combined total of 198 exposure scenarios, at least 19 supporting appendices in each dossier, and well over 30,000 published manuscripts screened for relevance over the last 10 years.

REACH has demanded a lot from chemicals producers and it’s been a massive exercise to register and keep up to date the dossiers for the chemicals covered by the Nickel REACH Consortia.

But ultimately it is satisfying to know that the chemicals that we cover are accompanied by a wealth of available data that permit these substances to be manufactured and used safely and contribute their unique properties to enhance competitiveness and innovation, for the benefit of us all.

These five learnings have been implemented in the preparation of our annual dossier updates over the last 10 years. Hopefully, they will help ease your dossier update process as well and ensure access to the European marketplace.