Penman Consulting News

Dossier Updates

Posted by Rhianon Price | September 23, 2020

What Does a “Dossier Update” Really Mean?

The European Commission is set to approve new EU-wide deadlines for REACH registration dossier updates, therefore, accurate and timely submissions are becoming ever more important.

This means, for the first time, that the chemical industry is legally obligated to add any new relevant information to their dossiers within a set period. Already REACH Article 22 required registrants to update “without undue delay”, however, this has resulted in differing interpretations and, in some cases, failing to execute updates unless requested by ECHA.

Registrants will have 3 months to complete updates of a “more administrative nature”, and deadlines of 6, 9 or 12 months will be given to registrants undertaking “more complex” dossier updates, such as requiring the generation of data based on a testing proposal, changes to the chemical safety report (CSR) or the guidance on safe use.

These deadlines have been set under 13 articles and include…

At Penman Consulting, we have been working with IUCLID and have performed over 800 dossier updates over the last 10 years. We ensure that dossier updates are performed on time and to the highest quality and scientific standards.  A dossier is the main point of information exchange between a registrant and the regulator. However, new information is generated continually for substances, by the manufacturers and the scientific community. Therefore, the burden of proof is on the company to provide new information to the regulators as part of the continuing assessment of the hazard profile. Additionally, ECHA can request new data and the dossier will also have to be updated. A dossier update can be the provision of new information or the revision of historic data to ensure that it is correct.

The process of screening new data, evaluating it and summarising it in IUCLID forms the basis of dossier updating, we typically do this on a biannual basis, however, the period between dossier updates will soon by mandated by the regulation as stated above.

Our scientific team…

We also maintain a very keen awareness of the latest changes in IUCLID, such as keeping up with new VAT (Validation Assistant Tool) errors as they are added to IUCLID during updates. There are usually a number of changes with every IUCLID update, with additional requirements to address in order to pass ECHA submission and completeness checks. Every time a new IUCLID version is released, we check a standard registration dossier to assess any impacts and we then use that knowledge to fix other registration dossiers to ensure they are compliant. Different members of the team are involved in different sections of the IUCLID dossier. We have Environmental Scientists and Toxicologists specialising in different areas of toxicology, such as Repeated Dose Toxicity, Developmental and Reproductive Toxicity (DART), Acute Toxicity and in vitro alternative toxicity testing, etc. We also have a team of regulatory specialists who can help with Only Representative (OR), REACH-IT and regulatory issues.

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