New requirements for the SDS: The unexpected change
It sounds like a title of a Willy & Wanda / Bob & Bobette comic strip, but unfortunately nothing is further from the truth. It is a new chapter in the Saga "The New requirements for the SDS".
From recent conversations with our Dutch Inspecting Authorities (ILenT), it appears that the REACH-EN-FORCE project number 11 (REF-11) (https://echa.europa.eu/about-us/who-we-are/enforcement-forum/forum-enforcement-projects), which starts on January 1st, 2023, is being heavily weighed on the changes in Section 9. We are not talking about the whole change that took place in the order of paragraphs and parameters that need to be mentioned. We specifically refer to the reason why a parameter is not mentioned in Section 9.
Terms such as "not relevant", "not determined" and "not available" are very common in safety data sheets and were previously accepted. The latest adjustment to Annex II of REACH apparently still brought about some change according to the inspecting authorities. We have delved a bit deeper into it and have put the "old requirements" & "new requirements" next to each other for both the general requirement and the requirements per parameter.
| "Old requirements" Regulation 2015/830 | "New requirements" Regulation 2020/878 |
| "If it is stated that a particular property does not apply or if information on a particular property is not available, the reasons shall be given. " | "If it is stated that a particular property does not apply or if information on a particular property is not available, this shall be clearly indicated, giving the reasons where possible." |
If we analyze the text well, and in particular the underlined parts, I conclude that the new requirements make it easier than before to leave out the reason. The new requirements say: If you don't know a parameter or if it's not applicable, you should clearly indicate that, with the reason where possible. This sounds much looser than the old requirements; If a parameter is not available or not applicable, the reason should be stated.
Although there are certainly interpretation options that translators have to consider, I really can't read a stricter requirement from the text in the new requirements for the European safety data sheet.
Specifically per parameter:
Although we did not find a real tightening in the general requirements, we can find that in the requirements for specific parameters. The requirements per parameter have become stricter, for example for the flashpoint:
| "Old requirements" Regulation 2015/830 | "New requirements" Regulation 2020/878 |
| "(g) Flash point;" | "(h) Flash point Does not apply to gases, aerosols and solids. For mixtures, a value for the mixture shall be indicated, if available. Otherwise, the flash point(s) of the substance(s) with the lowest flash point(s) shall be indicated." |
In practice:
Practice has yet to determine which "reasons" will or will not be accepted. Likely during the first inspections in 2023. One thing I am sure of is that section 9 will never be fully filled. Not all parameters of mixtures & substances are known; not in the REACH files, not in the supply chain and not at all for mixtures.
Suppliers will not easily (let) determine the parameters either, the costs for this are simply too high. Testing 10-15 of the parameters from section 9.1 can easily cost more than € 10,000. Very few suppliers and manufacturers of mixtures in particular, will be able to justify these costs. Would "not tested, testing not economically feasible" or "not known in the supply chain" be an accepted reason? Technically the legislation cannot exclude that, since no requirements are imposed on the reason, only that a reason must be mentioned... if possible.
That is again up for interpretation and who knows in this case even for lawyers...
We will keep an eye on it for you and let you know as soon as we encounter it in an inspection. For now, where possible, we will align as closely as possible to the "new requirements". However, a fully filled section 9 you will unfortunately not find with us unless you have deep pockets for the missing parameters...
Reaction of the Dutch Inspecting Authorities (ILenT, unfortunately only in Dutch):
“In de gewijzigde Annex II worden onder rubriek 9.1 de verplichte fysische en chemische eigenschappen uitgebreid. Bijvoorbeeld wordt voor meerdere eigenschappen als het niet mogelijk is deze technisch te bepalen een alternatief beschreven. Als gebruik gemaakt moet worden van dit alternatief, is de eis expliciet te vermelden: technisch niet mogelijk.
Wanneer gegevens over een specifieke eigenschap niet relevant zijn of er over een specifieke eigenschap geen informatie beschikbaar is, behoort dat duidelijk te worden aangegeven met de reden. Per geval zal de inspectie de gegevens controleren. Dit neemt niet weg dat de leverancier zelf verantwoordelijk is om de juiste gegevens te verstrekken aan zijn afnemer(s).
Vergeet niet om informatie die helpt bij het identificeren en beheren van de risico’s die samenhangen met gebruik en de behandeling van de stof of het mengsel te vermelden onder rubriek 9.2.”
