ECHA head Geert Dancet spoke with the European Parliament’s Environment Committee (Envi) last week and used some strong words about chemical companies’ ongoing responsibilities under REACH. Regular dossier updates, he said, should be considered “normal.”
Article 22 of REACH
Dancet referenced Article 22 of REACH, saying that companies “ignore” this article, called “Further duties of registrants.” Article 22 lists nine reasons dossiers might need to be updated:
- If there is a change in the status of the registrant, from a new address to a change from manufacturer to importer, the registrant information must be updated.
- Any change in the composition of the substance has to be updated immediately.
- Changes in the annual or total quantities manufactured or imported, or in the amount of a substance used in an article, by any company will require an update in the dossier. This is especially important if there is a change in the tonnage band. For example, a company that registered in the one metric tonne group meeting the 2018 deadline which increases it use to 15 tonnes a year would have to update their dossier. If the company stops manufacturing or importing a substance, they will have to update the dossier.
- When new uses for a substance are discovered, that information must be updated. This is also required if a usage which was not allowed becomes acceptable.
- If new evidence of a substance’s dangers to human health or to the environment is discovered, companies must update their safety data sheets and dossiers.
- If the classification or labeling of a substance should change, dossier updates must reflect that change.
- Any change in the chemical safety report will also trigger the requirement to update the dossier.
- If the registrant believes that new testing is advisable, a testing proposal must be filed.
- The dossier must also be updated to reflect any change in the availability of or access to the data referenced in the file. For example, if data was publicly available online, but the web page is taken down, an update will be required.
The new normal
Dancet said that companies should expect to update their dossiers every five to ten years, implying that some change listed in Article 22 is likely to take place in that time frame. Updating every five to ten years, he said, should be considered normal.
He also said that companies should be prepared to pay fees for those updates, because they will require work on the part of ECHA. Dancet’s remarks seem to show some frustration with chemical companies, but chemical companies also feel some frustration with REACH dossier updates. According to a recent Chemical Watch survey, chemical companies feel that they must put dossier updates on the back burner in order to meet the REACH 2018 deadline for registrations of smaller tonnage band substances.
The right tools
Meeting REACH registration deadlines is understandably top of mind for registrants. Completing required dossiers naturally brings a sense of relief. But the need for regular updates for dossiers — as well as responses to requests for more information, which can continue for years — isn’t the real problem.
For too many companies, completing a dossier is an ordeal. Data is gathered in paper documents and shared in email threads. Collaboration relies on phone calls and conversations in hallways. Information rests with different people in different places, and is only as secure and accessible as the owners choose to make it.
That’s why we created EUPHOR. It’s a project management software solution designed specifically for chemical regulation compliance. It was built in collaboration between IT experts and a chemical company, so it has the advantages of well-designed software with the insights of chemical experts. It gathers all data and all collaborations in one well-organized place, so updates are manageable no matter when they’re required. Schedule a demonstration and see just how much time, money, and stress EUPHOR can save your company.