Safer Chemicals Podcast.
Sound science on harmful chemicals.
The project had two key goals.
The first goal was to check whether the new requirements are complied with.
And the second goal was to look at the quality of the information in the safety data sheets.
Safety data sheets -
35 % had something missing or the information was incorrect or the safety data sheets were not provided at all.
But there's a good side of the project,
which we found that 95 % of the suppliers actually provide the safety data sheets,
which means the system is working.
This enforcement project
has shown us that there is visible progress in compliance of safety dead sheets but there is still room for improvement. In the past we saw non-compliance rates as high as 52 %, today the non-compliance rate is at 35 % of the checked safety date sheets. Improvement
is visible and the industry has clearly made efforts to provide better information. However, after three decades of implementing the safety date sheets the non-compliance rate should be much lower than that.
Availability and quality of information remain a frequent issue.
Suppliers should provide safety data sheets with high-quality information so that workers can use hazardous chemicals safely.
Welcome to the European Chemicals Agency's Safer Chemicals podcast.
I'm your host,
Päivi Jokiniemi.
Today we talk about one of the core tools for chemical safety in the workplace - safety data sheets.
They contain information on how to safely handle,
store and dispose of chemicals.
It is the responsibility of the supplier to provide safety data sheets to their customer when selling hazardous chemicals or mixtures.
In 2021,
new requirements for safety data sheets were introduced under the REACH Regulation and during 2023,
ECHA's Enforcement Forum carried out an EU-wide project to check if companies are following these updated rules.
The new requirements mean companies need to provide clearer and more detailed safety information.
They must include,
for example,
the Unique Formuladentifier for each product and mention any nano-sized particles in a chemical.
Safety data sheets also need to flag any risks related to hormone disruption and include specific concentration limits and acute toxicity estimates.
This information will help companies and workers to handle chemicals safely.
My guests today are Abdulqadir Mohamad Suleiman,
the Norwegian alternate member of ECHA's Enforcement Forum,
and the chair of the working group managing this enforcement project.
And also Maciej Baranski,
leading the Harmonised Enforcement team here at ECHA.
And this team has contributed also to the project.
Thank you for joining us.
Thank you
for having us.
Pleasure to be here.
Thank you.
So before we go into the details of the project and its findings,
let's hear what our stakeholders say about the importance of safety data sheets.
We'll start with Marko Sušnik,
who represents
SME United,
an employer's organisation for crafts and small and medium-sized companies.
I would say the most important aspect of safety data sheets is that these should be a part of the product.
So basically,
if you get
a chemical with a safety data sheet that is not okay,
the product chemical is basically broken.
And as a user,
as a downstream user,
you should complain to your supplier because simply safety data sheets are a very important tool and they should be treated like that.
They should be handled by the suppliers like that and they should be expected by the downstream users like that.
And we've seen over the years with REACH,
and here we see a very important role with REACH,
that safety data sheets have improved a lot and we are confident they will improve even more.
We see some difficulties,
but I think that's manageable.
Extended safety data sheets are a bit too complicated,
but as I said,
we can,
I'm pretty sure,
solve that also in the coming years.
We also asked the same question from Tony Musu,
who represents the European Trade Union Institute that is protecting workers'interests in Europe.
Let's have a listen.
So the safety data sheets are extremely important for the health and safety of workers that are exposed to hazardous substances because they contain information that can help the employers to do the risk assessment that they need to do.
Also,
under the workers protection legislation and the OSH legislation,
there is this mandatory risk assessment.
And of course,
the safety data sheets,
they contain risk management measures that are really helpful for the employers to do the risk assessment,
but also to propose the measures that are needed to ensure safe use of the chemicals at the workplace.
Of course,
the safety data sheets are now more complex compared to the pre-REACH time.
And so it means that workers need to be trained in order to best use the information that are available in the safety data sheet.
So both Marko and Tony echo that safety data sheets are central to the protection of workers and the environment.
What are your initial reactions to these comments?
Abdulqadir?
I agree totally with both what they've said.
And I think it's more interesting that SME United is preoccupied with safety data sheets and that they want improvement to that because we know the small and medium-sized enterprises have difficulties in preparation and in use of safety data sheets.
And at the same time,
when you have the trade unions also
advocating for improving of safety data sheets,
I think it's a positive development.
And Maciej?
Well,
I fully agree with
Tony and Marko about the importance of the safety data sheets.
They are as relevant to the safety of workers as they were 30 years ago.
However,
as a result of this project,
we still see the significant compliance problem.
So during 2023,
inspectors from altogether
28 countries of the European Economic Area did checks covering over 1 000
distributors,
650 downstream users and 700 manufacturers,
as well as nearly
150 importers.
So the goal was to find out if companies had updated their safety data sheets following these new requirements.
Now finally,
let's get to the results.
What can you tell us?
There were two main objectives of the project.
The primary goal was completeness
check and what is completeness check?
It means that you check if the required information is provided in the safety data sheet.
That is to check completeness.
We checked the requirements which came into force from 1 January 2023.
Then the secondary goal was to check at the quality of the content because if the content is not of good quality,
then it doesn't help much.
Overall,
there were 35 % safety data sheets which were
among those which were checked,
which were reported non-compliant.
The non-compliance cover a wide range of things.
It could be missing information.
It could be information that is not correct.
It could be information that the inspectors found implausable.
It could be the case where the safety data sheets were not provided at all.
Those were the findings of the non-compliant safety data sheet.
However,
when it comes to specifically availability of the safety data sheets,
the project found that the suppliers nearly always provide the safety data sheets where they are required.
Only about
4 % of the cases controlled were safety data sheets not actively provided.
This means that the system of information flow is working.
And that's,
of course,
good news.
What about you,
Maciej?
What can you tell about the results?
Well,
if we look at some of the other high-level findings,
there are good news about the language of the safety date sheets,
because we see that this requirement is nearly always fulfilled.
And only 5 % of the safety date sheets that were supplied were in the wrong language for the country in which they were supplied.
Then,
if we look at the requirement to update the safety date sheet,
if there's any change in the risk management measures,
for example,
then we see that,
again,
most companies have complied with this duty.
But around 19 %
of the suppliers did not have special routines for updating and practically providing the safety date sheets to the recipients which they've provided the substance in the last 12 months.
Then thirdly,
if we look at the first objective of the project was to check the completeness of the SDS,
the inspectors saw that the format was in most cases updated and only 13 % of the safety date sheets did not have all the requirement elements and the subsections required by the new
regulation.
But of course,
if we look deeply into the content,
it's that the specific requirements are not always fulfilled and the non-compliance may be higher.
And now we go into the content and the specific requirements.
So the inspectors checked more than
2 500 safety data sheets.
Which were the elements that they really focused on and where did they find most deficient?
The new information required that were checked included the provision of information on nanoforms,
on endocrine disrupting properties and extended physical and chemical properties.
Information about authoridation of substances of very high concern,
including risk conditions of use and monitoring arrangements as required.
New requirements also include some other parameters relevant for safe use such as specific concentration limits,
acute toxicity estimates and multiplication factor for environmental aquatic hazards.
But the most problematic new areas or new requirements was provision of information on nanoforms.
For the safety data sheets where such information was required,
over two thirds,
that's 67 %,
did not include the information sufficiently in the safety data sheet.
The second new requirement for which
SDS were frequently deficient was the provision of information on endocrine disrupting properties.
Nearly half of the SDS of the substance or mixtures that have endocrine disrupting properties did not provide the information required.
The other new requirement with non-compliance rate,
which is also quite high,
range from 16 to 35 also.
That's also quite significant.
The primary method for checking whether the SDS complied with the new information requirement was completeness check.
This means that the inspectors checked under every section if the information required is provided,
that there was no empty spaces
in the safety data sheet.
Quite serious findings.
Anything to add there,
Maciej?
Well,
if we look into the content and the quality,
this was a very important part of the project,
to check the correctness and the consistency of the information in the safety data sheet.
And these checks were done per section when the inspectors were looking at the different elements of the SDS.
And of course,
they focused on checking whether the new requirements were fulfilled,
but not limited to them.
So inspectors also looked into those parts and requirements that were there for quite a long time.
And when we look at these results,
here we see that
27 % of all the
SDSs checked in this project had some quality deficiencies in some of the sections.
So the inspectors considered the information was incorrect or implausible.
If we look deeper into the specific sections,
then there were,
of course,
some problems that were more frequent than others.
So in section one,
on the identification of the product company,
the most frequent issue was lack of
UFI number or the incorrect indication of uses.
In section two,
on the hazard identification,
the most frequent problem was incorrect or incomplete classification.
So a pretty serious problem.
In section three,
on the composition,
it was usually the absence of necessary new information
or again incorrect classification of the ingredients of the mixture.
In section eight,
on the exposure controls,
problems were the absence or insufficient information on personal protective equipment or lack of information on occupational exposure limits.
In section nine,
on the physical and chemical properties,
it was usually the absence of the available data in that section that was a challenge.
If we look at the content problems,
another finding that the inspectors also brought forward was that nearly one fifth,
18 % of all the SDSs were lacking the exposure scenarios where they were required.
They were either not attached or not incorporated in the content of the SDS.
But this is not the first time when the enforcement authorities have been looking at safety data sheets.
So there have been also earlier EU-wide projects looking at this same kind of information.
Compared to these earlier projects,
what would you say?
How do the results compare to the previous ones?
And are companies making any progress here?
Looking at earlier results from earlier projects,
earlier enforcement projects focusing on safety data sheets the last 20 years,
generally speaking,
we can say that there is some improvement when it comes to compliance with the safety data sheets.
20 years ago there was a project conducted by Cleen Network and in that project the safety data sheets which were not compliant were identified as
48 %.
11 years ago when we had the
REF2 project of the forum there were 52 % non-compliance of safety data sheets.
There were also more projects in the meantime,
but now we can see that the non-compliance rate is reported at 35 %.
So the overall trend of the compliance seems to be improving.
But this information has to be taken with a pinch of salt.
The projects across the years were all about the
SDS, but focused on slightly different aspects from project to project.
And the requirements have changed.
New regulations have come into force across the years.
So the results are not exactly entirely comparable.
The improvement can be attributed mostly to harmonised requirements that
REACH brought, together with the great efforts from the industry to improve the SDS.
And I believe the continued focus on the enforcement side also.
I fully agree that there is a positive trend that we see.
but
I think we also need to put this into a broader perspective.
The safety dead sheets have been introduced for mixtures already three decades ago,
in 1991,
and they were always a tool to deliver information on safe use to the workers.
And these fundamentals have not changed.
They still serve the same purpose,
and the overall structure is the same as it was decades ago.
What has changed is the scope of the information that needs to be provided.
They have become more complex.
There's more information that needs to be in them,
but also the requirements in REACH are more specific about what should be included,
which should help companies in compiling them to a better degree.
And what we see that part of the deficiencies that the inspectors found is indeed about this new information that is still missing,
but it's definitely not all of the issues.
So what we continue seeing is again and again the same issues that were there decades ago in the old projects,
and deficiencies in fundamental information,
hazard information,
wrong classification,
issues with composition of mixtures,
incomplete information on exposure controls.
None of this is new.
So yes,
there is improvement,
but companies had over three decades to get used to implementing the SDS.
Yet we still see that one in three of the checked safety date sheets are non-compliant.
Companies should do much better than that.
Having seen that one in three of the checked cases,
the safety data sheet still does not comply with the requirements,
this must have some kind of impact on the workers'safety.
What would you say and what actions have authorities taken to improve the situation?
The impact is clear that when a third of the companies do not receive the information they require for safe handling of the substances and mixtures,
it means the managers don't have the information they need to do their risk
assessment and to do their controls and to control exposure.
That means that the employer will not have the information they require.
They need to conduct their assessments of their specific workplaces and to manage the risk.
As a result,
a third of the workers may not be able to use the substances safely.
This remains a serious shortcoming and the industry should improve the situation.
Of course,
in the specific cases where
inspection found non-compliances,
the issue had been addressed.
And inspectors took enforcement measures to bring safety data sheets into compliance.
In most cases,
this took the form of written advice.
In some cases,
there were also fines or administrative orders given.
And in few cases,
even handing over the cases to the public prosecutors.
The overall approach is that the first steps inspectors guide the suppliers to fix the issues with the safety data sheets rather than resort to more severe policing measures.
So companies are guided so that they would be able to improve,
they could fix those issues that the safety data sheets have.
What's next then?
What happens with the project next?
Will there be some follow-up actions?
The project is not completely over yet.
We are going to the follow-up phase where we will prepare two outputs.
The first one is a practical guide for inspectors for control of safety data sheets,
which they can use for inspections.
The guide will summarise the learnings from this project.
And the second one is a Forum Stakeholders workshop to discuss the findings and the recommendations with the representatives of industry and encourage them to work with their constituent companies on improving the situation.
We will invite
accredited stakeholder organistions but the workshop will be publicly broadcast online for greater transparency.
Anyone interested is invited to follow.
And is there already a date for this stakeholder workshop?
We look at having the workshop around spring time.
Okay,
something to keep an eye on then.
Good. What about Enforcement Forum side then?
Do you give some advice,
recommendations?
Sure.
The project,
as all the projects of the Forum,
formulate some recommendations for the different actors.
Duty holders,
primarily,
but also the Enforcement Authorities, Forum,
the European Commission and ECHA itself.
The most important recommendations,
of course,
are for the duty holders,
because they are the ones who compile the
SDSs. That's the suppliers,
manufacturers,
formulators,
or importers of chemicals.
Their recommendations for the duty holders are primarily focused on the suppliers.
And the first recommendation is,
of course,
for the duty holders to prepare safety sheets following the current requirements.
That's a no-brainer,
really.
The second one is for the companies to improve their understanding of the requirements,
because of course it has been changing for years.
And the best way to do this is to consult the questions and answers,
guidance,
or follow the information provided by the stakeholder organisations.
The third recommendation,
particularly for suppliers,
is to make the safety date sheets a bit more customised to the recipients.
So the manufacturers,
importers,
and formulators who make the SDSs,
they should have a look at the uses
and then tailor the information in the safety data sheets to the uses of their own downstream users.
It's important that the safety data sheets are not overloaded with information,
but only contain that information which is relevant for the specific users.
Such as,
for example,
the need on authorisation requirements and the conditions for monitoring arrangements for the authorisation.
The next recommendation is more for the recipients of the safety data sheets,
and here it's important whenever a company,
such as a downstream user,
receives
safety data sheet,
they should have in place a process to check that this safety data sheet they received is in line with the current requirements.
And lastly,
we hope that the industry or organisations would be encouraged to raise awareness of the legal duties and the requirements for the safety data sheets.
So if all these recommendations are put in place,
then we will definitely see better safety data sheets in the future.
Well said.
Indeed,
I think this is a perfect place to conclude this episode.
Very good advice and recommendations.
Hopefully those really are put in place,
as you said,
Maciej.
Thank you very much,
Abdulqadir,
Maciej,
for walking us through the findings of this project.
Thank you for the invitation to do this podcast and hope people will find it useful.
Thank you for having us.
Also,
I'd like to take a chance to thank Marko and Tony for giving us insights from the SME and worker safety perspectives.
And of course, thank you all listeners for tuning in.
And now if you want to read more about this enforcement project,
maybe have a look at the report,
you can find the news and link to the full report on our website at echa.europa.eu.
Thanks for this time.
Bye bye.
Safer Chemicals podcast.
Sound science on harmful chemicals.